[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Rules and Regulations]
[Pages 69404-70700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23873]
[[Page 69403]]
Vol. 87
Friday,
No. 222
November 18, 2022
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare and Medicaid Programs; CY 2023 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Implementing
Requirements for Manufacturers of Certain Single-dose Container or
Single-use Package Drugs To Provide Refunds With Respect to Discarded
Amounts; and COVID-19 Interim Final Rules; Final and Interim Final
Rules
Federal Register / Vol. 87 , No. 222 / Friday, November 18, 2022 /
Rules and Regulations
[[Page 69404]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 423, 424, 425, and 455
[CMS-1770-F, CMS-1751-F2, CMS-1744-F2, CMS-5531-IFC]
RINs 0938-AU81, 0938-AU95, 0938-AU31, 0938-AU32
Medicare and Medicaid Programs; CY 2023 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Implementing Requirements for Manufacturers of Certain Single-dose
Container or Single-use Package Drugs To Provide Refunds With Respect
to Discarded Amounts; and COVID-19 Interim Final Rules
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule and interim final rules.
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SUMMARY: This major final rule addresses: changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
Medicare Shared Savings Program requirements; updates to the Quality
Payment Program; Medicare coverage of opioid use disorder services
furnished by opioid treatment programs; updates to certain Medicare and
Medicaid provider enrollment policies, including for skilled nursing
facilities; updates to conditions of payment for DMEPOS suppliers;
HCPCS Level II coding and payment for wound care management products;
electronic prescribing for controlled substances for a covered Part D
drug under a prescription drug plan or an MA-PD plan under the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act);
updates to the Medicare Ground Ambulance Data Collection System;
provisions under the Infrastructure Investment and Jobs Act; and
finalizes the CY 2022 Methadone Payment Exception for Opioid Treatment
Programs IFC. We are also finalizing, as implemented, a few provisions
included in the COVID-19 interim final rules with comment period.
DATES: These regulations are effective on January 1, 2023.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not identified
below. Please indicate the specific issue in the subject line of the
email.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and PFS specialty-specific
impacts.
Kris Corwin, (410) 786-8864, for issues related to the comment
solicitation on strategies for updates to practice expense data
collection and methodology.
Sarah Leipnik, (410) 786-3933, and Anne Blackfield, (410) 786-8518,
for issues related to the comment solicitation on strategies for
improving global surgical package valuation.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to telehealth services
and other services involving communications technology.
Regina Walker-Wren, (410) 786-9160, for issues related to nurse
practitioner and clinical nurse specialist certification by the Nurse
Portfolio Credentialing Center (NPCC).
Lindsey Baldwin, (410) 786-1694, or
[email protected], for issues related to PFS
payment for behavioral health services.
[email protected], for issues related to PFS
payment for evaluation and management services.
Geri Mondowney, (410) 786-1172, Morgan Kitzmiller, (410) 786-1623,
Julie Rauch, (410) 786-8932, and Tamika Brock, (312) 886-7904, for
issues related to malpractice RVUs and geographic practice cost indices
(GPCIs).
[email protected], for issues related to
non-face-to-face nonphysician services/remote therapeutic monitoring
services (RTM).
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to payment
of skin substitutes.
Pamela West, (410) 786-2302, for issues related to revisions to
regulations to allow audiologists to furnish diagnostic tests, as
appropriate without a physician order.
Emily Forrest, (410) 786-8011, Laura Ashbaugh, (410) 786-1113, Anne
Blackfield, (410) 786-8518, and Erick Carrera, (410) 786-8949, for
issues related to PFS payment for dental services.
Heidi Oumarou, (410) 786-7942, for issues related to the rebasing
and revising of the Medicare Economic Index (MEI).
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to requiring
manufacturers of certain single-dose container or single-use package
drugs payable under Medicare Part B to provide refunds with respect to
discarded amounts.
Laura Ashbaugh, (410) 786-1113, and Rasheeda Arthur, (410) 786-
3434, for issues related to Clinical Laboratory Fee Schedule.
Lisa Parker, (410) 786-4949, or [email protected], for issues
related to FQHCs.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHCs.
Daniel Feller, (410) 786-6913, and Elizabeth Truong (410) 786-6005,
for issues related to coverage of colorectal cancer screening.
Heather Hostetler, (410) 786-4515, for issues related to removal of
selected national coverage determinations.
Lindsey Baldwin, (410) 786-1694, for issues related to Medicare
coverage of opioid use disorder treatment services furnished by opioid
treatment programs.
Sabrina Ahmed, (410) 786-7499, or [email protected],
for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Aryanna Abouzari, (415) 744-3668, or
[email protected], for issues related to the Shared
Savings Program burden reduction proposal on OHCAs.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment and financial methodology.
Lucy Bertocci, (410) 786-4008, or [email protected],
for inquiries related to Shared Savings Program advance investment
payments, participation options and burden reduction policies.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to vaccine administration services.
Katie Parker, (410) 786-0537, for issues related to medical
necessity and documentation requirements for nonemergency, scheduled,
repetitive ambulance services.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider
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enrollment regulation updates (including for skilled nursing
facilities), State options for implementing Medicaid provider
enrollment affiliation provisions, and conditions of payment for DMEPOS
suppliers.
Mei Zhang, (410) 786-7837, and 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 [email protected],
for issues related to the Medicare Ground Ambulance Data Collection
System and Ambulance Fee Schedule (AFS).
Sundus Ashar, [email protected], for issues related to
HCPCS Level II Coding for skin substitutes.
Renee O'Neill, (410) 786-8821, or Kati Moore, (410) 786-5471, for
inquiries related to Merit-based Incentive Payment System (MIPS).
Richard Jensen, (410) 786-6126, for inquiries related to
Alternative Payment Models (APMs).
Lindsey Baldwin, (410) 786-1694 for inquiries related to Opioid
Treatment Programs: CY 2022 Methadone Payment Exception.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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, 2022 (CAA,
2022) (Pub. L. 117-103, March 15, 2022), Protecting Medicare and
American Farmers from Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71,
December 10, 2021), Infrastructure Investment and Jobs Act (Pub. L.
117-58, November 15, 2021), Consolidated Appropriations Act, 2021 (CAA,
2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of
2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act)
(Pub. L. 115-271, October 24, 2018), related to Medicare Part B
payment. In addition, this major final rule includes provisions
regarding other Medicare payment policies described in sections III.
and IV.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that 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.
In this major final rule, we are establishing RVUs for CY 2023 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This final rule also includes discussions
and provisions regarding several other Medicare Part B payment
policies.
Specifically, this final rule addresses:
Determination of PE RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section
II.C.)
Payment for Medicare Telehealth Services Under Section
1834(m) of the Act (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Geographic Practice Cost Indices (GPCI) (section II.G.)
Determination of Malpractice Relative Value Units (RVUs)
(section II.H.)
Non-Face-to-Face/Remote Therapeutic Monitoring (RTM)
Services (section II.I.)
Payment for Skin Substitutes (section II.J.)
Provision to Allow Audiologists to Furnish Certain
Diagnostic Tests Without a Physician Order (section II.K.)
Provisions on Medicare Parts A and B Payment for Dental
Services (section II.L.)
Rebasing and Revising the Medicare Economic Index (MEI)
(section II.M.)
Requiring Manufacturers of Certain Single-dose Container
or Single-use Package Drugs to Provide Refunds with Respect to
Discarded Amounts (Sec. Sec. 414.902 and 414.940) (section III.A.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions, and Policies for Specimen
Collection Fees and Travel Allowance for Clinical Diagnostic Laboratory
Tests (section III.C.)
Expansion of Coverage for Colorectal Cancer Screening and
Reducing Barriers (section III.D.)
Removal of Selected National Coverage Determinations
(section III.E.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Medicare Part B Payment for Preventive Vaccine
Administration Services (section III.H.)
Medical Necessity and Documentation Requirements for
Nonemergency, Scheduled, Repetitive Ambulance Services (section III.I.)
Medicare Provider and Supplier Enrollment and Conditions
of DMEPOS Payment (section III.J.)
State Options for Implementing Medicaid Provider
Enrollment Affiliation Provision (section III.K.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.L.)
Medicare Ground Ambulance Data Collection System (GADCS)
(section III.M.)
Revisions to HCPCS Level II Coding Procedures for Skin
Substitutes Products (section III.N.)
Updates to the Quality Payment Program (section IV.)
Opioid Treatment Programs: CY 2022 Methadone Payment
Exception and Origin and Destination Requirements Under the Ambulance
Fee Schedule (section V.A.)
Finalizing provisions from the Medicare and Medicaid
Programs; Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency (CMS-1744-IFC) (Section V.B.)
Finalizing provisions from the Medicare and Medicaid
Programs, Basic Health Program, and Exchanges; Additional Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency and Delay of Certain Reporting Requirements for the Skilled
Nursing Facility Quality Reporting Program (CMS-5531-IFC) (Section
V.C.)
Collection of Information Requirements (section VI.)
Regulatory Impact Analysis (section VII.)
3. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic
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impacts, see section VII., Regulatory Impact Analysis, of this final
rule.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice (MP) expenses, as specified in section
1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of
the Act, we use a resource-based system for determining PE RVUs for
each physicians' service. We develop PE RVUs by considering the direct
and indirect practice resources involved in furnishing each service.
Direct expense categories include clinical labor, medical supplies, and
medical equipment. Indirect expenses include administrative labor,
office expense, and all other expenses. The sections that follow
provide more detailed information about the methodology for translating
the resources involved in furnishing each service into service specific
PE RVUs. We refer readers to the CY 2010 Physician Fee Schedule (PFS)
final rule with comment period (74 FR 61743 through 61748) for a more
detailed explanation of the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice 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 2023 PFS final rule PE/HR'' on the
CMS website under downloads for the CY 2023 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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
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indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: a
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we
direct readers to the CY 2010 PFS final rule with comment period (74 FR
61745 through 61746). We also direct readers to the file titled
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our website under downloads for the CY 2023 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to 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
[[Page 69408]]
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 2023. 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 service in question, we are finalizing the
additions in Table 1 to the list of expected specialty assignments for
low volume services.
BILLING CODE 4150-28-P
[[Page 69409]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.000
[[Page 69410]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.001
BILLING CODE 4150-28-C
Comment: Commenters recommended an expected specialty assignment of
interventional cardiology for CPT codes 33370, 33894, 33895, 33897, and
33997.
Response: We do not have PE/HR data for the interventional
cardiology specialty as it was not part of the PPIS when it was
conducted in 2007. We use the cardiology specialty for this specialty's
PE/HR data, and therefore, we have crosswalked the CPT codes in
question to the cardiology specialty on the list of expected specialty
assignments for low volume services.
Comment: Commenters also recommended an expected specialty
assignment of hand surgery for CPT code 26705.
Response: During our review of claims data for this code, we found
that the most frequently reported specialty for CPT code 26705 was
orthopedic surgery, reported more than twice as often as the hand
surgery specialty. Therefore, we are finalizing orthopedic surgery and
not hand surgery as the expected specialty assignment for CPT code
26705.
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 volume for the code
in question rises to over 100 services for an individual calendar year.
The HCPCS codes and expected specialty assignment remain on the list,
and will be applied should the volume fall below 100 services in any
calendar year; 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 above.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: the direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty specific indirect PE/HR data,
calculate specialty specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated
[[Page 69411]]
in Step 16 to the service level adjusted indirect allocators calculated
in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 2.
BILLING CODE 4150-28-P
[[Page 69412]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.002
BILLING CODE 4150-28-C
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time
[[Page 69413]]
accordingly. Table 3 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TR18NO22.003
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.
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)[supcaret] 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 69414]]
types of equipment, the vast majority of which fall in the range of 5
to 10 years, and none of which are lower than 2 years in duration. We
believe that the updated editions of this reference material remain the
most accurate source for estimating the useful life of depreciable
medical equipment.
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
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.
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] TR18NO22.004
We did not propose and we are not finalizing any changes to the
equipment interest rates for CY 2023.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
For CY 2023, as explained in detail in section II.M. of this final
rule, we proposed to rebase and revise the Medicare Economic Index
(MEI) to reflect more current market conditions faced by physicians in
furnishing physicians' services. The MEI is an index that measures
changes in the market price of the inputs used to furnish physician
services. This index measure is authorized under section 1842(b)(3) of
the Act, and is developed by the CMS Office of the Actuary. We believe
that the MEI is the best measure available of the relative weights of
the three components in payments under the PFS--work, PE and
malpractice. Accordingly, we believe that to assure that the PFS
payments reflect the relative resources in each of these components as
required by section 1848(c)(3) of the Act, the RVUs used in developing
rates should reflect the same weights in each component as the MEI. In
the past, we have proposed (and subsequently, finalized) to accomplish
this by holding the work RVUs constant and adjusting the PE RVUs, the
MP RVUs and the CF to produce the appropriate balance in RVUs among the
PFS components and payment rates for individual services. The most
recent adjustments to the RVUs to reflect changes in the MEI weights
were made for the CY 2014 RVUs, when the MEI was last updated. In the
CY 2014 PFS proposed rule (78 FR 43287 through 43288) and final rule
(78 FR 74236 through 74237), we detailed the steps necessary to
accomplish this result (see steps 3, 10, and 18). The CY 2014 proposed
and 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 past when we have proposed a rebasing and/or revision of the
MEI, as we discuss in section II.M. of this final rule, we typically
have also proposed to modify steps 3 and 10 to adjust the aggregate
pools of PE costs (direct PE in step 3 and indirect PE in step 10) in
proportion to the change in the PE share in the rebased and revised MEI
cost share weights, as previously described in the CY 2014 PFS final
rule (78 FR 74236 and 74237), and to recalibrate the relativity
adjustment that we apply in step 18 as described in the CY 2014 PFS
final rule. Instead, we proposed to delay the adjustments to the PE
pools in steps 3 and 10 and the recalibration of the relativity
adjustment in step 18 until the public had an opportunity to comment on
the proposed rebased and revised MEI, which is being finalized for CY
2023, as discussed in section II.M. of this final rule. Because we
proposed significant methodological and data source changes to the MEI
for CY 2023 and significant time has elapsed since
[[Page 69415]]
the last rebasing and revision of the MEI, we explained that we believe
it is important to allow public comment and finalization of the
proposed MEI changes based on the review of public comment before we
incorporated the updated MEI into PFS ratesetting, and we believe this
is consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. We refer readers to the discussion of our comment solicitation
in section II.B. of this final rule, where we review our ongoing
efforts to update data inputs for PE to aid stability, transparency,
efficiency, and data adequacy. Similarly, we delayed the implementation
of the proposed rebased and revised MEI for use in the PE geographic
practice cost index (GPCI) and solicited comment on appropriate timing
for implementation for potential future rulemaking, discussed in detail
in section II.G. and section VI. of this final rule.
In light of the proposed delay in using the proposed update to the
MEI to make the adjustments to the PE pools in steps 3 and 10 and the
relativity adjustment in step 18, we solicited comment on when and how
to best incorporate the proposed rebased and revised MEI discussed in
section II.M. of the proposed rule into PFS ratesetting, and whether it
would be appropriate to consider a transition to full implementation
for potential future rulemaking. In section VI. of this final rule, we
present the impacts of implementing the proposed rebased and revised
MEI in PFS ratesetting through a 4-year transition and through full
immediate implementation, that is, with no transition period. Given the
significance of the impacts that result from a full implementation and
the interaction with other CY 2023 proposals, we did not consider
proposing to fully implement a rebased and revised MEI in PFS
ratesetting for CY 2023. We solicited comment on other implementation
strategies for potential future rulemaking that are not outlined in
section VI. of this final rule.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported our proposed delayed
implementation of the rebased and revised MEI in PFS ratesetting until
the public had an opportunity to comment on the proposed changes to the
MEI, as discussed in section II.M. of this final rule.
Response: We thank the commenters for their support.
Comment: Many commenters expressed concerns with the redistributive
impacts discussed in section VI. of the proposed rule, where we
discussed the alternative considered to implement the proposed rebased
and revised MEI in PFS ratesetting through a 4-year transition for CY
2023. Many of the commenters cited other proposals and their confluence
with the proposed rebased and revised MEI as a source of their concerns
regarding the implementation of the MEI in PFS ratesetting. Most
commenters noted that the AMA has said it intends to collect practice
cost data from physician practices in the near future and urged CMS to
pause consideration of other sources for the MEI until the AMA's
efforts have concluded. A few commenters urged CMS to implement the MEI
for PFS ratesetting when appropriate using a 4-year transition to
minimize shifts and maintain stability in PFS payments.
Response: We appreciate commenters' feedback, specifically as it
relates to updating PFS ratesetting, and will consider this information
in future rulemaking. We note that we discuss comments relating to the
proposed rebased and revised MEI in section II.M. of this final rule.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2023 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2023 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of clinical labor minutes for the preservice,
service, and post service periods for each code. In addition to
increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised codes that make use of this clinical labor activity when they
are reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the complex
case, and 5 minutes as the standard for the highly complex case. These
values were based upon a review of the existing minutes assigned for
this clinical labor activity; we determined that 2 minutes is the
duration for most services and a small number of codes
[[Page 69416]]
with more complex forms of digital imaging have higher values. We also
finalized standard times for a series of clinical labor tasks
associated with pathology services in the CY 2016 PFS final rule with
comment period (80 FR 70902). We do not believe these activities would
be dependent on number of blocks or batch size, and we believe that the
finalized standard values accurately reflect the typical time it takes
to perform these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (Review patient clinical extant information and
questionnaire) in the preservice period, and CA014 (Confirm order,
protocol exam) in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, we continue to believe that in these
cases, the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, one
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2023, we are continuing to display two versions of
the Labor Task Detail public use file: one version with the old listing
of clinical labor tasks, and one with the same tasks crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2023 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in
CY 2019 and continuing through CY 2022, we conducted a market-based
supply and equipment pricing update, using information developed by our
contractor, StrategyGen, which updated pricing recommendations for
approximately 1300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
to phase in our use of the new direct PE input pricing over a 4-year
period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25
percent (CY 2021), and 100/0 percent (CY 2022) split between new and
old pricing. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2023, we proposed to update the price of eight supplies and
two equipment items in response to the public submission of invoices
following the publication of the CY 2022 PFS final rule. The eight
supply and equipment items with proposed updated prices are listed in
the valuation of specific codes section of the preamble under Table 19,
CY 2023 Invoices Received for Existing Direct PE Inputs.
We received the following comments on our proposal to update the
price of eight supplies and two equipment items in response to the
public submission of invoices following the publication of the CY 2022
PFS final rule:
[[Page 69417]]
Comment: Several commenters submitted comments to clarify that the
invoice they included in their submission that was identified as the
Lysing Reagent (SL089) supply was intended for a different supply item,
the Lysing Solution (SL039). The commenters stated that our proposed
reduction of the price for the SL089 supply appeared to be based on the
invoice they had as misidentified as being for the SL089 supply, when
it was intended for the SL039 supply. The commenters asked CMS to
disregard the earlier mistaken submission and submitted additional
invoices with updated pricing for the SL089 supply for consideration to
correct the oversight in their original submission.
Response: We appreciate the clarification from the commenters and
the updated invoices with pricing information for the SL089 supply. We
are finalizing an increase in the price of the Lysing Reagent (SL089)
supply to $5.53 based on the average of the ten submitted invoices from
the commenter. (Note: the separate discussion of the SL039 supply below
is based on a different invoice submitted by a different interested
party unconnected to the SL089 supply. We believe it is appropriate to
consider and revise the price for the SL089 supply based on the
clarification and new invoices submitted by commenters for that supply.
However, given that the invoice for SL039 submitted by these commenters
was not intended to be submitted for the SL039 supply, we did not
consider the invoice for SL039 that was mistakenly submitted by these
commenters.)
Comment: Several commenters stated their support for the proposed
pricing changes to the EP014 and EP088 equipment items and the SA117,
SK082, SL024, SL030, SL061, and SL469 supply items. The commenters
urged CMS to finalize them as proposed in the final rule.
Response: We appreciate the support for our proposed pricing from
the commenters.
In the proposed rule, we did not propose to update the price of
another eight supplies and two equipment items which were the subject
of public submission of invoices. Our rationale for not updating these
prices is detailed below:
Acetic acid 5% (SH001): We received an invoice submission
that would suggest an increase in price from 3 cents per ml to 9.5
cents per ml for the SH001 supply. However, the invoice stated that
this price was for an ``Alcian Blue 1% in 3% Acetic Acid pH 2.5''
supply and it is not clear that this represents the same supply as the
``Acetic acid 5%'' described by the SH001 supply item. We also do not
believe that the typical price for this supply has increased 200
percent in the 3 years since StrategyGen researched its pricing,
especially given that we increased the price for the SH001 supply from
1.2 cents in CY 2019 to its current price of 3 cents for CY 2022.
Cytology, lysing soln (CytoLyt) (SL039): We received an
invoice submission that would suggest an increase in price from 6 cents
per ml to 80 cents per ml for the SL039 supply. We do not believe that
the typical price for this supply has increased 1200% in the 3 years
since StrategyGen researched its pricing, especially given that we
increased the price for the SL039 supply from 3.4 cents in CY 2019 to
its current price of 6 cents for CY 2022.
Fixative (for tissue specimen) (SL068): We received an
invoice submission that would suggest an increase in price from 1.3
cents per ml to $4.87 for the SL068 supply. We believe that this was
the result of confusion on the part of the interested party regarding
the unit quantity for the SL068 supply. This item is paid on a per ml
basis and not a per unit basis; there was not enough information on the
submitted invoice to determine the price for the SL068 supply on a per
ml basis.
Ethanol, 100% (SL189): We received an invoice submission
that would suggest an increase in price from 0.33 cents per ml to 1.2
cents per ml for the SL189 supply. However, we noted that the invoice
was based on the price for a single gallon of 100% ethanol which is
typically sold in much larger quantities than a single gallon. We found
that 100% ethanol was readily available for sale online in larger unit
sizes and the current price of 0.33 cents per ml (based on the past
StrategyGen market research) appears to be accurate based on online
bulk pricing. We also found that the submitted invoices for the
ethanol, 70% (SL190), ethanol, 95% (SL248), and stain, PAP OG-6 (SL491)
supplies were also based on pricing for a single gallon. Each of these
supply items was also available for purchase in larger unit quantities
which indicated that the current pricing remained typical for these
supplies. Therefore, we did not propose to update the prices for the
SL189, SL190, SL248 or SL491 supply, as we do not believe that the
higher prices paid for smaller quantities of these supplies would be
typical.
Biohazard specimen transport bag (SM008): We received an
invoice submission that would suggest an increase in price from 8 cents
to 45 cents for the SM008 supply. However, it is not clear that the
item described on the invoice is the same item as the SM008 supply. The
invoice states only that the price is for ``Supplied Case Red Bags''
which was not enough information to determine if this would be typical
for the SM008 supply. We also do not believe that the typical price for
this supply has increased 460 percent in the 3 years since StrategyGen
researched its pricing, especially given that we increased the price
for the SM008 supply from 3.5 cents in CY 2019 to its current price of
8 cents for CY 2022.
International Normalized Ratio (INR) analysis and
reporting system w-software (EQ312): We did not receive an invoice for
this equipment item, only a letter stating that the cost of the EQ312
equipment should be increased from the current price of $19,325 to
$1,600,000. We previously finalized a policy in the CY 2011 PFS final
rule (75 FR 73205) to update supply and equipment prices through an
invoice submission process. We require pricing data indicative of the
typical market price of the supply or equipment item in question to
update the price. It is not sufficient to state a different price
without providing information to support a change in pricing. Since we
did not receive an invoice to support the higher costs asserted in the
letter, we did not propose a new price for the EQ312 equipment item.
Interested parties are encouraged to submit invoices with their public
comments or, if outside the notice and comment rulemaking process, via
email at [email protected]. We also noted that in order
to be considered a direct PE input, an equipment item must be
individually allocable to a particular patient for a particular
service. Costs associated with the implementation, maintenance, and
upgrade of equipment that is not individually allocable to a particular
patient for a particular service, or other costs associated with
running a practice, would typically be classified as forms of indirect
PE under our methodology.
Prior to the publication of the proposed rule, the same interested
parties that addressed the pricing of the EQ312 equipment item
questioned the assignment of the General Practice specialty crosswalk
for indirect PE for home Prothrombin Time (PT)/INR monitoring services.
These individuals stated that the predominant code used for PT/INR
monitoring (HCPCS code G0249) will be significantly and negatively
impacted by the continuing implementation over a 4-year period of
changes in the clinical labor rates
[[Page 69418]]
finalized in the CY 2022 PFS final rule (86 FR 65024). The individuals
requested that CMS change the crosswalk for home PT/INR monitoring
services to All Physicians or Pathology which would partially offset
the reduction that HCPCS code G0249 is facing due to changes in the
clinical labor rates.
We noted for these interested parties in the CY 2021 PFS final rule
(85 FR 84477 and 84478)that we finalized a crosswalk to the General
Practice specialty for home PT/INR monitoring services (HCPCS codes
G0248, G0249, and G0250). The data submitted by the commenters at the
time indicated that the direct-to-indirect cost percentages to furnish
home PT/INR monitoring are in the range of 31:69, similar to the ratio
associated with the General Practice specialty. We disagreed, as we did
in response to comments in the CY 2021 PFS final rule, that these home
PT/INR monitoring services should be reassigned to a different
specialty that is less reflective of the cost structure for these
services to offset reductions in payment for the services that result
from an unrelated policy proposal (the clinical labor pricing update).
We also noted that we had not received any new information about PT/INR
monitoring services since CY 2021 to indicate that Pathology would be
more accurate choices for use in indirect PE allocation but are open to
receiving new relevant information that CMS could consider in future
rulemaking. As such, we did not propose to change the assigned
specialty for PT/INR services; we direct interested parties to the
previous discussion of this topic in the CY 2021 PFS final rule (85 FR
84477 and 84478) and again in the CY 2022 PFS final rule (86 FR 65000).
Interested parties are encouraged to submit new information to support
the most accurate specialty choice to use in indirect PE allocation for
PT/INR monitoring services distinct from what has previously been
reviewed during the last two rule cycles.
Comment: A commenter submitted additional direct and indirect cost
data associated with pricing the INR analysis and reporting system w-
software (EQ312) equipment. The commenter stated that they arrived at
this amount based upon detailed review of all of the software system
and related expenses involved with furnishing home INR monitoring
services, including up front equipment and software purchases that
comprise direct equipment practice expenses, up front maintenance and
support services that comprise indirect practice expenses, and
recurring support and telecommunications services that also comprise
indirect practice expenses. The commenter submitted invoices detailing
a one-time direct cost of $69,621, a one-time indirect cost of
$84,126.31, and recurring annual costs of $963,638.52 associated with
the EQ312 equipment.
Response: We agree with the commenter that the invoices support an
increase in the purchase price of the equipment from the current
$19,325 to the price of $69,621 listed on the invoices. However, we
disagree that the one-time indirect cost of $84,126.31 or recurring
annual costs of $963,638.52 listed on the invoices would constitute
forms of direct PE which would be included in the equipment's price.
The indirect costs on the submitted invoices are for project management
and service order costs while the recurring annual costs comprise
monthly maintenance and telecommunications expenses. We agree that
these are real costs associated with the software, however they are
classified as forms of indirect PE under our current methodology. The
equipment cost formula that we use already incorporates maintenance and
interest rates costs into the per-minute pricing calculation; if we
were to include these expenses in the equipment cost as a form of
direct PE, we would be making duplicative payment for the same
expenses. We are therefore finalizing an increase in the price of the
EQ312 equipment to $69,621 but not including the indirect and recurring
annual costs in the equipment price as they are classified as forms of
indirect PE.
Comment: The same commenter reiterated their previous request made
in PFS rulemaking for CY 2021 for CMS to change the crosswalk for home
PT/INR monitoring services from the previously finalized General
Practice specialty to the All Physicians or Pathology specialty. The
commenter stated that the code used to report ongoing home PT/INR
monitoring (HCPCS code G0249) will again be significantly and
negatively impacted in CY 2023 as a result of changes in the clinical
labor rates with the corresponding budget neutrality adjustment and the
drop in the conversion factor. The commenter stated that the Pathology
specialty provides a better reflection of the indirect to direct costs
associated with home PT/INR monitoring and also reflects a more
appropriate indirect practice cost index (IPCI) for a service with very
high indirect costs, such as home PT/IN monitoring. The commenter
stated their belief that the indirect cost data captured in their
submitted invoices supports a crosswalk to the Pathology specialty
given the higher indirect costs of furnishing these services, including
the on-going software costs that are not captured in the direct PE
input; and that this specialty crosswalk change would help offset the
cuts in the proposed rate for HCPCS code G0249.
Response: We continue to believe that assignment of the Pathology
specialty for home PT/INR monitoring services as requested by the
commenters would not be appropriate. As we stated in the proposed rule,
we continue to disagree that these home PT/INR monitoring services
should be reassigned to a different specialty that is less reflective
of the cost structure for these services to offset reductions in
payment that result from an unrelated policy proposal (the clinical
labor pricing update). The commenter stated that home PT/INR monitoring
services have high indirect expenses and suggested that this supported
assignment of a specialty with a higher direct-to-indirect expense
ratio than General Practice (which has a 31 to 69 percent ratio), such
as Pathology (which has a 26 to 74 percent ratio). However, this is a
misunderstanding of the direct-to-indirect ratio for each specialty,
which is a ratio based on data from the Physician Practice Expense
Information Survey (PPIS) conducted back in 2007. The direct-to-
indirect ratio is merely a ratio, and not indicative of a specialty
having higher or lower indirect expenses in absolute terms. Higher
indirect expenses for a specialty are not correlated with a higher
percentage of indirects as compared with directs in that ratio; in
fact, the Independent Diagnostic Testing Facility specialty has both
the highest indirect expenses of any specialty, as well as a low direct
to indirect ratio (50 to 50%) precisely because IDTFs also have very
high direct expenses as well. Similarly, the Pathology specialty had
lower indirect expenses on the PPIS than the General Practice
specialty; this contradicts the commenter's contention that the high
indirect costs for home PT/INR monitoring services would justify a
change to the Pathology specialty. We continue to believe that the data
submitted by the commenters in the CY 2021 PFS final rule (85 FR 84477
and 84478) indicated that the direct-to-indirect cost percentages to
furnish home PT/INR monitoring are not reflective of the Pathology
specialty.
We note that the PE methodology, which relies on the allocation of
indirect costs based on the magnitude of direct costs, should
appropriately reflect the typical costs for the specialty the
commenters suggest. However, we are cognizant that approach may not
work
[[Page 69419]]
in all cases, particularly for newer services with costs that are not
well accounted for in our PE methodology, or services with cost
structures that do not necessarily reflect the specialties furnishing
them. Although we have previously assigned the General Practice
specialty to these codes, interested parties have provided additional
information about these services suggesting assignment to a different
specialty for purposes of allocating indirect cost. We believe that, as
we work to identify ways to update the PE methodology and our data
sources to better reflect costs for all services and changes in medical
practice, it is best to apply a consistent approach in setting rates
that does not over-allocate cost, which could result in significant
increases in payments for these services. Considering our concerns, we
will switch the specialty assignment for these services to the All
Physician specialty, consistent with how we have treated other new
services that do not quite fit our PE methodology in recent rulemaking
(see for example the discussion of HCPCS codes G2082 and G2083 in the
CY 2022 PFS final rule (86 FR 65014 and 65015) and again in this rule).
We believe this will allow for improved stability in payments, and
preserve access to this care for beneficiaries, while we work to
identify longer term solutions.
Remote musculoskeletal therapy system (EQ402): We received
an invoice submission for a price of $1,000 for the EQ402 equipment
item. Since this equipment already has a price of $1,000 we did not
propose to make any changes in the pricing; we thank the interested
party for their invoice submission confirming the current price.
The following are additional comments that we received associated
with supply and equipment pricing:
Comment: Several commenters requested the creation of a new supply
code to describe an alternate form of a basic injection pack.
Commenters stated that for many services the use of Chloraprep
(chlorhexidine) for intact skin preparation has become more typical
than Betadine (povidone-iodine solution) and that the current basic
injection pack described by supply code SA041 no longer accurately
reflects typical resource use. Commenters requested that CMS create an
alternative pack which instead includes Chloraprep (chlorhexidine) so
that specialties can select the injection pack with the most
appropriate antiseptic. Commenters requested that the new pack should
mirror the SA041 basic injection pack with the addition of the patient
prep swab, 1.5 ml chloraprep (SJ081) supply and removal of the Betadine
povidone soln (SJ041) and sponge tipped applicator (SG009) supplies.
Response: We appreciate the feedback from the commenters on the
changing nature of what supplies are typically included in basic
injection packs, and as a result, we are creating an alternate
injection pack with the new supply code SA135 which will be priced at
$14.12 as detailed in Table 5.
[GRAPHIC] [TIFF OMITTED] TR18NO22.005
After consideration of the public comments, we are finalizing the
creation of the SA135 alternate injection pack. We note that this
supply is not currently included in any CPT or HCPCS codes but has been
added to our direct PE database for future use in services.
Comment: A commenter expressed concern that the prices for the
injectable fluorescein (SH033) and lidocaine (SH049) supplies were too
low. The commenter submitted invoices for both supply items and
requested that they be used to update their respective prices.
Response: After reviewing the invoices, we are updating the price
of the fluorescein injectable (5ml uou) (SH033) supply from $38.02 to
$49.13 based on an average of prices from five submitted invoices. We
did not include the sixth invoice for the SH033 supply (with a listed
price of $64.80) in this average as it described a different type of
injectable fluorescein from the other five invoices (it described 2 mL
of a 25% solution as opposed to 5 mL of a 10% solution on the other
five invoices).
We are not updating the price of the lidocaine 2% w-epidural
injectable (Xylocaine w-epi) (SH049) supply as the two submitted
invoices were not usable for pricing. One of the invoices detailed a
3.5% type of lidocaine while the SH049 supply code specifies that it is
for 2% lidocaine. The other submitted invoice specifically noted that
it was a ``preservative free'' version of lidocaine which was more
expensive than the typical item; we do not agree that this invoice
would be accurate for establishing a new national price for the SH049
supply. We remain interested in additional information regarding
updated pricing information for the SH049 and other supply/equipment
codes; as noted below, interested parties are encouraged to submit
invoices with their public comments or, if outside the notice and
comment rulemaking
[[Page 69420]]
process, via email at [email protected].
We did not make any proposals associated with HCPCS codes G0460
(Autologous platelet rich plasma for chronic wounds/ulcers, including
phlebotomy, centrifugation, and all other preparatory procedures,
administration and dressings, per treatment) or G0465 (Autologous
platelet rich plasma (prp) for diabetic chronic wounds/ulcers, using an
FDA-cleared device (includes administration, dressings, phlebotomy,
centrifugation, and all other preparatory procedures, per treatment))
in the CY 2023 PFS proposed rule. In the CY 2021 PFS final rule, we
established contractor pricing for HCPCS code G0460 for CY 2021 (85
FR84497-84498). In the CY 2022 PFS final rule, we finalized a policy to
maintain contractor pricing for HCPCS code G0460 as we did not have
sufficient information to establish national pricing, and we did not
receive public comments on either the proposal or comment solicitation
to support establishing a national payment rate (86 FR 65019-65020). It
remains unclear to us what the typical supply inputs would be for HCPCS
code G0460 and whether they would include the use of the new 3C patch
system.
Comment: Following the publication of the CY 2023 PFS proposed
rule, we received two comments on the pricing of HCPCS codes G0460 and
G0465, and the 3C patch system supply which is topically applied for
the management of exuding cutaneous wounds, such as leg ulcers,
pressure ulcers, and diabetic ulcers and mechanically or surgically-
debrided wounds. One commenter submitted invoices associated with the
pricing of the 3C patch system (SD343) supply for which we established
a price of $625.00 in the CY 2021 PFS final rule (85 FR 84498). The
commenter requested that CMS update its supply database based on
invoices submitted for SD343 to reflect an updated price of $750.00 per
unit. The commenter also requested national pricing for HCPCS codes
G0460 and G0465, expressing concern that insufficient payment
disproportionately impacts vulnerable populations. The commenter
requested a payment rate of $1,408.90 for HCPCS G0465 in the office
setting, stating that this rate would appropriately account for the
purchase of the 3C patch, as well as the other related costs and supply
inputs required for point of care creation and administration.
Another commenter requested the establishment of new codes to allow
for quantity-specific payment when multiple patches are needed to treat
wounds of various surface sizes. Both commenters stated that many
months have passed since CMS updated NCD 270.3 in April 2021 (for
Blood-Derived Products for Chronic, Non-Healing Wounds), however, the
3C patch remains nearly inaccessible in the office and facility
settings because of insufficient payment by MACs. Both commenters
suggested that, to date, just one MAC has assigned a payment rate for
HCPCS code G0465, which the commenters believe is too low to cover the
cost to purchase and administer the patch. One commenter expressed
support for the professional fee to administer the patch in the
facility setting determined by this MAC, First Coast ($135.97), with
the appropriate geographic adjustments, and urged CMS either to apply
this rate nationally or to require MACs to set a carrier price in a
timely and transparent manner. Both commenters stated that health care
providers in the remaining MAC jurisdictions have faced denials even
when they follow the coverage guidelines specified by our NCD 270.3.
One commenter contended that, as of 2019, 27.5 percent of the
traditional Medicare beneficiaries had a diabetes diagnosis. Both
commenters highlighted that, within this population, the prevalence of
diabetes is significantly higher among Medicare FFS beneficiaries who
identify as Native American or Black/African American relative to their
white counterparts, and furthermore, these historically underserved
populations are also more likely to develop foot ulcers and infections
that require amputation. The commenters stated that the 3C Patch has
the potential to help cure these concerning health disparities and
requested that we make the 3C Patch accessible by establishing national
pricing for HCPCS codes G0460 and G0465.
Response: We do not have enough information to establish national
pricing at this time. We will consider the commenters' feedback for
future rulemaking while maintaining contractor pricing for CY 2023,
which will allow for more flexibility for contractors to establish
appropriate pricing using available information. We appreciate the
invoice submission with additional pricing information for the SD343
supply and will update our supply database for supply code SD343 at a
price of $678.57 based on an average of the submitted invoices.
(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
[email protected].
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
[[Page 69421]]
pricing was last updated created a significant disparity between CMS'
clinical wage data and the market average for clinical labor. In recent
years, a number of interested parties suggested that certain wage rates
were inadequate because they did not reflect current labor rate
information. Some interested parties also stated that updating the
supply and equipment pricing without updating the clinical labor
pricing could create distortions in the allocation of direct PE. They
argued that since the pool of aggregated direct PE inputs is budget
neutral, if these rates are not routinely updated, clinical labor may
become undervalued over time relative to equipment and supplies,
especially since the supply and equipment prices are in the process of
being updated. There was considerable interest among interested parties
in updating the clinical labor rates, and when we solicited comment on
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR
59480), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We believed it was
important to update the clinical labor pricing to maintain relativity
with the recent supply and equipment pricing updates. We proposed to
use the methodology outlined in the CY 2002 PFS final rule (66 FR
55257), which draws primarily from BLS wage data, to calculate updated
clinical labor pricing. As we stated in the CY 2002 PFS final rule, the
BLS' reputation for publishing valid estimates that are nationally
representative led to the choice to use the BLS data as the main
source. We believe that the BLS wage data continues to be the most
accurate source to use as a basis for clinical labor pricing and this
data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for our
CY 2022 clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we used the national salary data from the
Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at www.salaryexpert.com). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. We ultimately finalized the use of
median BLS wage data, as opposed to mean BLS wage data, in response to
comments in the CY 2022 PFS final rule. To account for the employers'
cost of providing fringe benefits, such as sick leave, we finalized the
use of a benefits multiplier of 1.296 based on a BLS release from June
17, 2021 (USDL-21-1094). As an example of this process, for the
Physical Therapy Aide (L023A) clinical labor type, the BLS data
reflected a median hourly wage rate of $12.98, which we multiplied by
the 1.296 benefits modifier and then divided by 60 minutes to arrive at
the finalized per-minute rate of $0.28.
After considering the comments on our CY 2022 proposals, we agreed
with commenters that the use of a multi-year transition would help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year
transition, as we have for several other broad-based updates or
methodological changes. While we recognized that using a 4-year
transition to implement the update means that we will continue to rely
in part on outdated data for clinical labor pricing until the change is
fully completed in CY 2025, we agreed with the commenters that these
significant updates to PE valuation should be implemented in the same
way, and for the same reasons, as for other major updates to pricing
such as the recent supply and equipment update. Therefore, we finalized
the implementation of the clinical labor pricing update over 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. An example of the
transition from the current to the fully-implemented new pricing that
we finalized in the CY 2022 PFS final rule is provided in Table 6.
[[Page 69422]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.006
(1) CY 2023 Clinical Labor Pricing Update Proposals
For CY 2023, we received information from one interested party
regarding the pricing of the Histotechnologist (L037B) clinical labor
type. The interested party provided data from the 2019 Wage Survey of
Medical Laboratories which supported an increase in the per-minute rate
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This
rate of $0.64 for the L037B clinical labor type is a close match to the
online salary data that we had for the Histotechnologist and matches
the $0.64 rate that we initially proposed for L037B in the CY 2022 PFS
proposed rule. Based on the wage data provided by the commenter, we
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). The proposed pricing
increase for these three clinical labor types is included in Table 7;
the CY 2023 pricing for all other clinical labor types would remain
unchanged from the pricing finalized in the CY 2022 PFS final rule.
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Comment: Several commenters noted that there was an error in the
proposed clinical labor pricing table in the CY 2023 PFS proposed rule
(87 FR 45874) where the final rate per minute for the L041A Angio
Technician clinical labor type was incorrectly listed at 0.58 rather
than the correct 0.60 as specified in the preamble text.
Response: We agree that the incorrect rate per minute for the L041A
clinical labor type was reflected in Table 5 of the proposed rule, and
have corrected this error in Table 7 of this final rule. We apologize
for any confusion that may have been caused by this mistake.
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 PFS final rule 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).
The following is a summary of the comments we received and our
responses.
Comment: Several commenters stated their support for the proposed
pricing updates to the Histotechnologist (L037B) and the Lab Tech/
Histotechnologist (L035A) clinical labor types and urged CMS to
finalize the updated pricing.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Several commenters requested that CMS update the clinical
labor description of the Angio Technician (L041A) clinical labor type
to ``Vascular Interventional Technologist.'' The commenters stated that
this updated title for the L041A clinical labor type would better align
with industry recognition of the advanced certification required to
assist physicians with minimally invasive, image-guided vascular
procedures.
Response: We appreciate the feedback and are finalizing a change in
the descriptive text of the L041A clinical labor type from ``Angio
Technician'' to ``Vascular Interventional Technologist'' as requested
by the commenter.
Comment: Several commenters disagreed with the proposed pricing for
several different technologist clinical labor types. The commenters
stated that basic certification is required for a radiologic
technologist and that there are additional advanced modality
certifications, such as for Computed Tomography (CT), Magnetic
Resonance (MR), and Vascular Intervention (VI), which require
additional educational programs and training for these advanced
modalities/disciplines. The commenters stated that the proposed pricing
for the Vascular Interventional Technologist (L041A), the Mammography
Technologist (L043A), the CT Technologist (L046A), and the MRI
Technologist (L047A) clinical labor types did not reflect the training
and certification required for these occupations. The commenters
submitted wage data from the 2022 Radiologic Technologist Wage and
Salary Survey and requested that the pricing for these four clinical
labor types be updated to reflect the wage data from the submitted
survey.
Response: When we initiated the clinical labor pricing update last
year, we lacked specific wage data for the Vascular Interventional
Technologist (L041A), the Mammography Technologist (L043A), and the CT
Technologist (L046A) clinical labor types; and relied on crosswalks for
their pricing. Based on the information contained in the 2022
Radiologic Technologist Wage and Salary Survey, we now have specific
wage data which will allow us to no longer rely on crosswalks for
pricing for these clinical labor types. Therefore, we are finalizing an
update in the pricing of these 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). For the MRI Technologist (L047A), we
were able to make use of direct BLS wage data for the occupation. In
addition, since we continue to believe that the BLS is the most
accurate source of information for wage data, we are not finalizing an
increase in the pricing of the L047A clinical labor type. As a
reminder, CY 2023 is the second year of the four-year transition to the
updated clinical labor pricing, and we will continue to transition the
prices established for these three clinical labor types over the next
two years of the update.
Comment: A commenter thanked CMS for the agency's recent work in
updating clinical labor pricing and stated that nurses and other
nonphysician providers have been drastically undervalued for many years
which could help to alleviate staffing shortages. The commenter stated
that the table of clinical labor types in the proposed rule listed
registered nurses (RNs) as their own category for labor pricing under
the L051A clinical labor code, but then also included RNs in eight
other categories of clinical labor with other practitioners. The
commenter requested having RNs identified uniquely and removing the RN
option from the other clinical labor categories, as the commenter
stated that leaving RNs in other categories would only make the
clinical labor update more confusing and could end up disadvantaging
RNs in the long term which could exacerbate the current staffing
shortage and worsen patient care.
Response: We do not agree that RNs should be removed from the other
eight clinical labor types currently listed in our direct PE database.
There is a long history of using these ``blended'' clinical labor
categories under the PFS, and together these eight clinical labor types
make up the overwhelming majority of all clinical labor (especially the
RN/LPN/MTA blend described by the L037D clinical labor code). In the
absence of alternative pricing information to value these blended
clinical labor types, we continue to believe that the proposed prices
are the most accurate valuations. We also note for the commenter that
the pricing for the RN (L051A) clinical labor type is drawn directly
from BLS wage data and the inclusion of RNs in other ``blended''
clinical labor types has no effect on the pricing of the L051A category
itself.
Comment: A commenter stated that the current RN/LPN (L042A)
clinical labor type assigned to CPT code 36516 did not accurately
reflect the costs associated with this procedure. The
[[Page 69425]]
commenter stated that CPT code 36516 is a complex extracorporeal blood
therapy procedure, conducted over a 5-1/2 to 6-hour period, that
requires extensively trained and experienced nurse operators known as
apheresis nurses. The commenter stated that the current assignment of
the RN/LPN (L042A) clinical labor type for CPT code 36516 seriously
undervalues the critical nurse labor cost component of this nearly six-
hour procedure and requested that CMS establish a new ``Apheresis
Nurse'' clinical labor type with a valuation of approximately $1.14 per
minute. The commenter also stated that there are additional supply
items not currently captured in the direct PE inputs for CPT code 36516
including a 4-liter accessory waste bag, several types of fluids, and
biohazard waste costs.
Response: We remind the commenter that we did not propose the
creation of any new clinical labor types nor did we propose any changes
in the direct PE inputs for CPT code 36516. If the commenter has reason
to believe that the RN/LPN (L042A) clinical labor type is not capturing
the typical labor costs associated with CPT code 36516 or that there
are additional supply costs not being captured in its direct PE inputs,
we encourage them to nominate CPT code 35616 as potentially misvalued
for additional review.
Comment: Several commenters stated that, to promote predictability
and stability in physician payments and mitigate the financial impacts
of significant fluctuations in physician payments that might accompany
the clinical labor pricing update, CMS should consider using a
threshold to limit the level of reductions in payments for specific
services that would occur in a single year. Several commenters noted
that in the CY 2023 Inpatient Prospective Payment System final rule,
CMS implemented a permanent 5 percent cap on the reduction in an MS-
DRG's relative weight in a given fiscal year; the commenters suggested
applying a similar cap of 5 percent, 10 percent, or 15 percent for the
Physician Fee Schedule.
Response: We agree with the commenters on the importance of
avoiding potentially disruptive changes in payment for affected
interested parties and the need to promote payment stability from year-
to-year. This is why we finalized the use of a multi-year transition
for the clinical labor update in last year's CY 2022 PFS final rule to
help smooth out the changes in payment resulting from the updated data
(86 FR 65024). We also note for the commenters that section 1848(c)(7)
of the Act, as added by section 220(e) of the PAMA, specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased-in
over a 2-year period. For additional information regarding the phase-in
of significant RVU reductions, we direct readers to the CY 2016 PFS
final rule with comment period (80 FR 70927 through 70929). Given the
mechanisms already in place to smooth payment changes and promote
stability, and considering the need to establish appropriate resource-
based valuations, we do not believe the limitation suggested by
commenters is warranted.
Comment: Several commenters stated that CMS should prioritize
stability and predictability over ongoing updates and temporarily
freeze the implementation of further policy updates. These commenters
requested that CMS pause the ongoing clinical labor pricing update to
avoid significant payment redistributions associated with the pricing
update.
Response: We finalized the implementation of the clinical labor
pricing update through the use of a 4-year transition in the CY 2022
PFS final rule (86 FR 65024). As we stated at the time, although we
recognize that payment for some services will be reduced as a result 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 two 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.
After consideration of the comments, we are finalizing the clinical
labor prices as shown in Table 8.
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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
We did not propose any technical corrections to the direct PE input
database or supporting files in the proposed rule. However, commenters
identified the following issues after we issued the CY 2023 PFS
proposed rule:
Comment: Several commenters requested that the SD332 bubble
contrast supply, an ultrasound-specific contrast agent, should be
removed from the direct PE inputs for CPT codes 76978 (Ultrasound,
targeted dynamic microbubble sonographic contrast characterization
(non-cardiac); initial lesion) and 76979 (Ultrasound, targeted dynamic
microbubble sonographic contrast characterization (non-cardiac); each
additional lesion with separate injection). Commenters stated that this
supply item does not need to be included in the direct PE inputs for
these two CPT codes because contrast agents are reported separately
using existing HCPCS Level II supply codes, such as Q9950 (Injection,
sulfur hexafluoride lipid microspheres, per ml).
Response: We appreciate the additional information from the
commenters indicating that the SD332 supply is duplicative for CPT
codes 76978 and 76979 since the supply is separately reported using
HCPCS Level II supply codes. Therefore, we are finalizing the removal
of the SD332 supply from these two CPT codes.
In the CY 2020 PFS final rule (84 FR 63102 through 63104), we
created two new HCPCS G codes, G2082 and G2083, effective January 1,
2020, on an interim final basis for the provision of self-administered
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that summed the values associated with several codes
(85 FR 84641 through 84642). Following the publication of the CY 2021
PFS final rule, interested parties expressed concerns that the
finalized PE RVU had decreased for HCPCS codes G2082 and G2083 as
compared to the proposed valuation and as compared to the previous CY
2020 interim final valuation. Interested parties questioned whether
there had been an error in the PE allocation since CMS had finalized
increases in the direct PE inputs for the services.
We reviewed the indirect PE allocation for HCPCS codes G2082 and
G2083 in response to the interested party inquiry and discovered a
technical change that was applied in error. Specifically, we
inadvertently assigned a different physician specialty than we intended
(``All Physicians'') to HCPCS codes G2082 and G2083 for indirect PE
allocation in our ratesetting process during valuation of these codes
in the CY 2020 PFS final rule, and continued that assignment into the
CY 2021 PFS proposed rule. This specialty assignment caused the PE
value for these services to be higher than anticipated for CY 2020. We
intended to revise the assigned physician specialty for these codes to
``General Practice'' in the CY 2021 PFS final rule; however, we
neglected to discuss this change in the course of PFS rulemaking for CY
2021. Since we initially applied this technical change in the CY 2021
PFS final rule without providing an explanation, we issued a correction
notice (86 FR 14690) to remove this change from the CY 2021 PFS final
rule, and to instead maintain the All Physicians specialty assignment
through CY 2021. We apologize for any confusion this may have caused.
For CY 2022, we finalized our proposal to maintain the currently
assigned physician specialty for indirect PE allocation for HCPCS codes
G2082 and G2083 to maintain payment consistency with the rates
published in the CY 2020 PFS final rule and the CY 2021 PFS proposed
rule. Although we had previously intended to assign the General
Practice specialty to these codes, interested parties have provided
additional information about these services suggesting that maintaining
the All Physicians specialty assignment for these codes will help
maintain payment stability and preserve access to this care for
beneficiaries. We solicited public comments to help us discern which
specialty would be the most appropriate to use for indirect PE
allocation for HCPCS codes G2082 and G2083. We note that the PE
methodology, which relies on the allocation of indirect costs based on
the magnitude of direct costs, should appropriately reflect the typical
costs for the specialty the commenters suggest. For example, we do not
believe
[[Page 69428]]
it would be appropriate to assign the Psychiatry specialty for these
services given that HCPCS codes G2082 and G2083 include the high direct
costs associated with esketamine supplies. The Psychiatry specialty is
an outlier compared to most other specialties, allocating indirect
costs at a 15:1 ratio based on direct costs because psychiatry services
typically have very low direct costs. Assignment of most other
specialties would result in allocation of direct costs at roughly a 3:1
ratio. We requested that commenters explain in their comments how the
indirect PE allocation would affect the payment for these services.
Specifically, to ensure appropriate payment for HCPCS codes G2082 and
G2083, we wanted to get a better understanding of the indirect costs
associated with these services, relative to other services furnished by
the suggested specialty.
As we noted in the CY 2021 PFS final rule (85 FR 84498 through
84499) and CY 2022 PFS final rule (86 FR 65042), the RAND Corporation
was studying potential improvements to our PE allocation methodology
and the data that underlie it. We were interested in exploring ways
that the PE methodology can be updated, which could include
improvements to the indirect PE methodology to address newer services
similar to those described by G2082 and G2083 which have a direct to
indirect ratio that does not match their most commonly billed
specialties. In CY 2022, we agreed with the commenters who supported
the proposal to maintain the currently assigned physician specialty
(All Physicians) for indirect PE allocation for these codes. After
consideration of the public comments, we finalized our proposal to
maintain the All Physicians specialty for indirect PE allocation for
HCPCS codes G2082 and G2083 for CY 2022.
For CY 2023, we did not make any proposals regarding the assigned
physician specialty for indirect PE allocation for HCPCS codes G2082
and G2083; 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: One commenter urged CMS to adopt a clear and recurring
process to update, on an annual basis, supply costs for codes G2082 and
G2083 with the most recently available wholesale acquisition cost (WAC)
data and to include the ``Psychiatry'' specialty type in the allocation
of the indirect PE for G2082 and G083. The commenter believed these
recommended actions directly support the following two priority CMS
initiatives: the CMS Behavioral Health Strategy and an approach to
improve the PE methodology within the PFS. The commenter stated that
the technical correction for CY 2021 to assign these HCPCS codes to the
``All Physician'' specialty preserved Medicare beneficiary access and
was an improvement over the original CMS intent to assign them to the
``General Practice'' specialty but ``demonstrated the sensitive and
intricate dependency of Medicare beneficiary access on reimbursement.''
The commenter urged CMS to provide additional insight behind its
specialty designation of ``All Physicians'' for HCPCS codes G2082 and
G2083, and argued that CMS deviated from its normal practice of using
the specialty mix contained in the claims data for these codes. The
commenter stated that, while CMS has cited concerns in applying the
actual specialty mix, CMS has not provided sufficient information or
data to suggest that the rates produced when the ``Psychiatry''
specialty is included produces an inaccurate payment. The commenter
also requested that CMS consider the implementation of policies that
allow for the construction of specialty blends in unique cases, such as
HCPCS codes G2082 and G2083, in which the agency has concerns about
applying a service's actual specialty mix. The commenter stated that,
based on utilization data published with the CY 2023 PFS proposed rule,
over 70 percent of practitioners administering esketamine are
psychiatrists. Considering that it is primarily psychiatrists
administering esketamine and CMS recognizes the imperative to improve
the indirect PE and PFS rate setting methodology for behavioral health
services, the commenter recommended a transition of specialty
designation for HCPCS codes G2082 and G2083 to its actual specialty mix
through a three-year phased-in approach. The commenter recognized CMS'
concerns about assigning the Psychiatry specialty for HCPCS codes G2082
and G2083 given the higher supply costs for these services, but
recommended that CMS adopt a specialty blend of three-fourths
``Psychiatry'' specialty type and one-fourth ``All Physician''
specialty type. The commenter believed that this specialty blend would
result in appropriate reimbursement and acknowledge the role of
psychiatrists while also addressing our concerns.
The commenter also stated that in CY 2021, CMS updated the price
for the esketamine supply item for these codes using wholesale
acquisition cost (WAC) data from the most recent available quarter, but
did not again update the price using the latest WAC data in the CY 2022
PFS final rule, or propose to update the price in the CY 2023 PFS
proposed rule. The commenter stated that, based on WAC data on
submitted invoices for the most recently available quarter, the supply
input that describes 56 mg (supply code SH109) for HCPCS code G2082
should be priced at $683.67, and the supply input describing 84 mg of
esketamine (supply code SH110) for HCPCS code G2083 should be priced at
$1025.50. The commenter urged CMS to align with its prior action and
stated intention to address input price updates in future rulemaking by
updating the supply pricing for SH109 and SH110 using WAC data
annually, and to make clear the additional data or processes interested
parties should follow to support annual updates for the esketamine
supply items for these codes.
Response: We continue to believe that the All Physicians specialty
most accurately captures the indirect PE allocation associated with
HCPCS codes G2082 and G2083. We do not assign a blended combination of
specialties for any other services and the commenters did not provide
new data to support a change in specialty assignment aside from noting
that many practitioners who report HCPCS codes G2082 and G2083 are in
the Psychiatry specialty. We continue to believe that it would not be
accurate to assign the Psychiatry specialty for HCPCS codes G2082 and
G2083 due to its outlier status among specialties, whereby Psychiatry
allocates indirect costs at a 15:1 ratio based on direct costs as
compared to most other specialties having approximately a 3:1 ratio. We
do not believe that Psychiatry would be an accurate specialty
designation for HCPCS codes G2082 and G2083 given the high direct costs
associated with esketamine (which would translate into
disproportionately high indirect PE allocation at the 15:1 ratio). We
also disagree that these services should be reassigned to a different
specialty to offset reductions in payment that result from an unrelated
policy proposal (the clinical labor pricing update).
However, to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we agree with the
commenters that we should update supply costs to reflect the wholesale
acquisition cost (WAC) data from the most recent available quarter. For
HCPCS code G2082, we are finalizing an updated price of $683.67 for the
supply input that describes 56 mg (supply code SH109) and for HCPCS
code G2083, we are finalizing an
[[Page 69429]]
updated price of $1025.50 for the supply input describing 84 mg of
esketamine (supply code SH110) based on the submitted invoices.
After consideration of the public comments, we continue to believe
that the All Physician specialty is the most accurate specialty
assignment for HCPCS codes G2082 and G2083, and we are not finalizing
any changes to the specialty assignment. However, as noted above we are
finalizing an increase in the price of the SH109 supply to $683.67 and
an increase in the price of the SH110 supply to $1025.50 to reflect the
updated market-based prices associated with esketamine. We also
received comments on other policies relating to these services that
were not addressed in the CY 2023 PFS proposed rule, and which we are
not addressing in this final rule. We appreciate the feedback from the
commenters and will take it into consideration for possible future
rulemaking.
5. Soliciting Public Comment on Strategies for Updates To Practice
Expense Data Collection and Methodology
The PE inputs used in setting PFS rates, including both the
development of PE RVUs and, historically, the relative shares among
work, PE, and malpractice RVUs across the PFS, are central in
developing accurate rates and maintaining appropriate relativity among
PFS services and overall payment among the professionals and suppliers
paid under the PFS. Consequently, the underlying PE data inputs are a
consistent point of interest among interested parties. However, unlike
other payment systems with cost reporting systems, PFS data inputs are
primarily based on exogenous proprietary data that become available as
the data are collected. Specifically, we rely on historical survey data
(almost all of which is over a decade old), some publicly available
data collected for other purposes (for example, Bureau of Labor
Statistics (BLS) wage data), recommendations from the American Medical
Association and other provider groups, and annual Medicare claims data.
a. History of Updates to PE Inputs
Each year we continue to improve accuracy, predictability, and
sustainability of updates to the PE valuation methodology to reduce the
risks of possible misvaluation and other unintended outcomes. We have
continued to develop policies geared toward providing more consistent
updates to the direct PE inputs used in PFS ratesetting, including
supply/equipment pricing and clinical labor rates. These efforts to
develop these policies should contribute to improved standardization
and transparency for all PE inputs used to update the PFS. As we
continue our work to improve the information we use in our PE
methodology, we issued a general comment solicitation to better
understand how we might improve the collection of PE data inputs and
refine the PE methodology.
In recent years, we have refined specific PE data inputs using a
combination of market research and publicly available data (for
example, market research on medical supply and equipment items and BLS
data to update clinical labor wages) to update the direct PE data
inputs used in the PFS ratesetting process. Last year, we implemented a
final transition year for supply and equipment pricing updates and
started the first year of a 4-year phase-in update to the clinical
labor rates. However, the indirect PE data inputs remain tied to legacy
information that is well over a decade old. To build on much needed
progress, we now believe indirect PE would also benefit from a refresh
that implements similar standard and routine updates. We believe that a
data refresh, and use of data sources that receive routine refreshes,
would reduce the likelihood of unpredictable shifts in payment,
especially when such shifts could be driven by the age of data
available rather than comprehensive information about changes in actual
costs.
b. Data Collection, Analysis and Findings
In light of feedback from interested parties, CMS has prioritized
stability and predictability over ongoing updates, and has taken a
measured approach to updating PE data inputs. We have worked with
interested parties and CMS contractors over a period of years to study
the landscape and identify possible strategies to reshape the PE
portion of physician payments. The fundamental issues are clear, but
thought leaders and subject matter experts have advocated for more than
one tenable approach to updating our PE methodology. Thus, we must
balance the various interests of the public, and any path forward
should allow for ongoing and routine cycles of PE updates.
Of the various PE data inputs, we believe that indirect PE data
inputs, which reflected costs such as office rent, IT costs, and other
non-clinical expenses, present the opportunity to build consistency,
transparency, and predictability into our methodology to update PE data
inputs. The primary source for indirect PE information is the Physician
Practice Information Survey (PPIS), fielded by the AMA. The survey was
most recently conducted in 2007 and 2008 (reflecting 2006 data). The
survey respondents were self-employed physicians and selected
nonphysician practitioners.
In general, interested parties have expressed the following
concerns regarding CMS's approach to indirect PE allocation:
CMS seems to rely on increasingly out-of-date data
sources, and there is a dearth of mechanisms to update empirical
inputs.
The approach exacerbates payment differentials that
possibly create inappropriate variation of reimbursement across
ambulatory places of service (for example, significantly higher
payments for the same service provided in a hospital outpatient
department versus a physician office).
CMS's method of indirect PE allocation may not accurately
reflected variation in PE across different types of services, different
practice characteristics, or evolving business models. Beyond these
issues, we have also explored other concerns with our indirect PE
allocation method in depth in previous rulemaking. For example, refer
to our previous comment solicitation and discussion of resource costs
for services involving the use of innovative technologies in our CY
2022 PFS proposed rule (86 FR 39125). PE data inputs, and the
methodological and evidence-based principles that shape use of such
information in the context of reimbursement, are discussed in depth in
a RAND Corporation (``RAND'') report prepared for CMS, entitled
Practice Expense Methodology and Data Collection Research and Analysis,
available at https://www.rand.org/pubs/research_reports/RR2166.html.\1\
---------------------------------------------------------------------------
\1\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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Various interested parties have taken issue with the use of certain
costs in our current PE allocation methodology that they do not believe
are associated with increased indirect PE. Some interested parties
argue that the costs of disposable supplies, especially expensive
supplies, and equipment are not relevant to allocating indirect PE; or
that similarly, work in the facility setting (for example, work RVUs
for surgical procedures) is not relevant to allocating indirect PE,
[[Page 69430]]
though they agree that work in the office setting may be relevant to
allocating indirect PE.\2\ However, we do not believe that there is
sufficient, if any, data or peer-reviewed evidence available to
definitively show that shifting indirect PE allocations based on the
setting of care, or based on specialty, would result in improved
allocations of PE that reflect true costs. Further, varying indirect PE
allocations based on setting of care or based on specialty might create
unintended consequences such as reduced access to care for
beneficiaries, or reduced competition and autonomy of small group
practices or individual clinicians whose revenue is based in part on
services furnished under contract in the facility setting.
---------------------------------------------------------------------------
\2\ Kazungu, Jacob S., Edwine W. Barasa, Melvin Obadha, and Jane
Chuma. ``What Characteristics of Provider Payment Mechanisms
Influence Health Care Providers' Behaviour? A Literature Review.''
The International Journal of Health Planning and Management 33, no.
4 (October 2018): e892-905. https://doi.org/10.1002/hpm.2565.
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We believe it is necessary to establish a roadmap toward more
routine PE updates, especially because potentially improper or outdated
allocation of PE across services may affect access to certain services,
which could exacerbate disparities in care and outcomes. Establishing
payments that better reflect current practice costs would mitigate
possible unintended consequences, such as labor market distortions due
to indirect cost allocations that do not reflect the current evolution
of health care practice.\3\ Interested parties have reiterated their
desire for CMS to move away from the current PE allocation approach and
continued to raise concerns with CMS's methodology and the underlying
PE data inputs. In response to these and other concerns, we continue to
review the methodology we use to establish the PE RVUs and to identify
refinements. As part of this effort, we have contracted with RAND to
develop and assess potential improvements in the current methodology
used to allocate indirect practice costs in determining PE RVUs for a
service, model alternative methodologies for determining PE RVUs, and
identify and assess alternative data sources that CMS could use to
regularly update indirect practice cost estimates.\4\
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\3\ Laugesen, Miriam J. ``Regarding `Committee Representation
and Medicare Reimbursements: An Examination of the Resource-Based
Relative Value Scale.' '' Health Services Research 53, no. 6
(December 2018): 4123-31. https://doi.org/10.1111/1475-6773.13084.
\4\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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In this final rule, we are signaling our intent to move to a
standardized and routine approach to valuation of indirect PE and we
solicited feedback from interested parties on what this may entail,
given our discussion above. We would propose the new approach to
valuation of indirect PE in future rulemaking.
We solicited comment on the following topics related to
identification of the appropriate instrument, methods, and timing for
updating specialty-specific PE data:
Potential approaches to design, revision, and fielding of
a PE survey that foster transparency (for example, transparency in
terms of the methods of survey design, the content of the survey
instrument, and access to raw results for informing PFS ratesetting);
and
Mechanisms to ensure that data collection and response
sampling adequately represent physicians and non-physician
practitioners across various practice ownership types, specialties,
geographies, and affiliations.
We also solicited comment on any alternatives to the above that
would result in more predictable results, increased efficiencies, or
reduced burdens. For example:
Use of statistical clustering or other methods that would
facilitate a shift away from specialty-specific inputs to inputs that
relate to homogenous groups of specialties without a large change in
valuation relative to the current PE allocations.
Avenues by which indirect PE can be moved for facility to
non-facility payments, based on data reflecting site of service cost
differences.
Methods to adjust PE to avoid the unintended effects of
undervaluing cognitive services due to low indirect PE.
A standardized mechanism and publicly available means to
track and submit structured data and supporting documentation that
informs pricing of supplies or equipment.
Sound methodological approaches to offset circularity
distortions, where variable costs are higher than necessary costs for
practices with higher revenue.
We also solicited comment on the cadence, frequency, and phase-in
of adjustments for each major area of prices associated with direct PE
inputs (Clinical Labor, Supplies/Equipment). We requested that
commenters address the following:
Whether CMS should stagger updates year-to-year for each
update, or establish ``milestone'' years at regular intervals during
which all direct PE inputs would be updated in the same year.
The optimal method of phasing in the aggregate effect of
adjustments, such that the impacts of updates gradually ramp up to a
full 100 percent over the course of a few years (for example, 25
percent of the aggregate adjustment in Year 1, then 50 percent of the
aggregate adjustment in Year 2, etc.).
How often CMS should repeat the cycle to ensure that
direct PE inputs are based on the most up-to-date information,
considering the burden of data collection on both respondents and
researchers fielding instruments or maintaining datasets that generate
data.
We received public comments on data collection, analysis and
findings. The following is a summary of the comments we received and
our responses.
Comment: Most commenters that responded to this RFI recommended
that CMS delay any change to update the indirect PE survey inputs. Many
commenters urged CMS to wait for AMA data collection efforts prior to
implementing changes. In responding to our RFI, the AMA RUC underscored
that CMS wrote in this year's proposed rule that the AMA PPIS continues
to be the best available source of data necessary for the purpose of
calculating indirect PE. AMA also points to the fact that CMS has
relied on AMA physician cost data for 50 years in updating the MEI and
30 years updating the RBRVS. Additionally, the RUC urged that CMS
continue to work with the AMA and various specialty societies involved
in the previous data collection effort, and wait for an updated set of
data to become available for use. The AMA indicated that it has
continued work on updates and would likely be ready by early CY 2024
with refreshed data. One commenter submitted a jointly-signed letter
that did not support the AMA RUC approaches, and described a different
means of data collection and analysis for updating the PE methodology.
In addition to emphasizing some of the same themes noted in findings
from RAND's review of the PE landscape, the letter recommended that CMS
form an expert advisory group, multidisciplinary in composition, and
backed with a dedicated research and development team of CMS staff, to
support CMS' strategic plans to update PFS ratesetting. In this letter,
the commenter also posited that indirect allocations would eventually
be unnecessary, as the methodology could be evolved toward an entirely
different means to capture actual costs of services. Overall, we
received few direct responses to many
[[Page 69431]]
of the specific prompts included in our request for information.
Response: We reiterate that we continue to believe that the current
AMA PPIS data does represent the best available source of information
at this time. However, as we continue to engage with a broad range of
perspectives from interested parties who frequently ask for CMS policy
to better reflect rapidly changing health care costs, we acknowledge,
in consideration of these perspectives and our work to analyze these
issues, that these concerns may be addressed by consistent and
transparent data refreshes.
We remain interested in possible alternatives to use of a sole
source of data. We believe that transparency and repeatability should
be key principles for examining future work to update indirect PE
inputs. We have clear agreement among interested parties that the
economic and medical landscapes have changed, and rapidly. Our intent
remains to seek data that capture such changes on a more frequent
basis, and allow for others to explore and study how best to assess and
account for changes with more rapid feedback loops. Conversely, we
understand that the competitive marketplace may create a dynamic
whereby some market participants receive revenue for the licensing and
sharing of proprietary information itself. We believe it remains
important to avoid interference with this type of business arrangement
between vendors and their customers, yet, we also believe that there is
a strong public interest to support open, transparent, and low-cost
means to conduct research on these topics. For example, we are not
aware of any independent, third-party, peer-reviewed research focused
on the characteristics of the health care labor market in light of
advancements in automation (for example, empirical analysis of how
software implementation may have a causal link to changes in the health
care labor market). Simply put, there are no available studies that
adequately answer the question, with sufficient predictive power and
adequate empirical data, of how much clinical labor is saved, or
replaced, by use of automation, in the context of furnishing
practitioner services. Further, many, if not all examinations of
automation and its effects on labor take a far broader focus than
health care workforce only, and mainly use anecdotal information, with
conclusions or hypotheses that focus on job gains/losses. We note that
many commenters highlighted themes this year focusing on labor
shortages, rather than labor surplusage. The comments that noted
refreshed survey data alone would address the need for more precise,
and up-to-date, allocations of indirect expenses seem discordant with
other comments we received about updating our PE methodology to account
for current advancements in automation, and associated software costs.
Therefore, there are a number of 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.
For these reasons, it is possible that CMS would look to using
verifiable, more objective data sets in the future to supplement or
augment survey data alone. Such action would be similar to how certain
specialty data are used in current indirect PE calculations, and
sourced from specialty societies themselves, as required by statute, in
some cases as PPIS data were not available. Alternatively, we may
explore the use of data already in the public domain. We believe that
fast-moving changes to the distribution of costs and use of evolving
technology, and more generally the innovations in how vendors support
practices, reshape indirect expenses in ways that would require
flexible but standardized methods to account for these on a more
frequent basis in our ratesetting methodology.
We reiterate our needs described in our initial discussion for this
RFI. We note that this interest to develop a roadmap for updates to our
PE methodology is underpinned by a need to have better understanding of
repeatability and reproducibility of results, as we move toward more
consistent and frequent data collection. Some commenters expressed
concerns over bias and validity. We believe some of those concerns may
be alleviated by having means to refresh data and make transparent with
more accuracy and precision how the information affects valuations for
services payable under the PFS.
Further, we note that it is possible that with the current timing
for AMA's planned updates, we would be unable to refresh data for
several years. This would result in CMS using data nearly 20 years old
to form indirect PE inputs used to set rates for services on the PFS.
As these survey data are static inputs, and leverage only the responses
gathered at the time of collection, which are applied using a
methodology without any dynamic variables, this is quite distinct from
each of the MEI and various other inputs in PE methodology.
We believe both the somewhat stale and static aspects of the PPIS,
along with expected timing for updates is significantly at tension with
the feedback we receive on a regular basis. Consistently, a broad range
of perspectives across various interested parties frequently ask for
CMS to better reflect costs in what has been a rapidly changing health
care payment landscape. The medical community and others continue to
point to shortcomings in our ratesetting methodology, which may be
improved by consistent and transparent data refreshes.
Additionally, we acknowledge that some hold disparate points of
view about the above process of updating our PE methodology. We note
that part of the public comment process aims to encourage thinking and
build consensus, or identifies a lack of consensus. We appreciate the
dialogue, multiple perspectives, and encourage that the broader
national community of health policy thought leaders, health economists,
and health systems researchers, all continue to have such conversations
with one another and with CMS. A diversity of perspectives is important
to foster a more robust set of options for the best available path
forward.
We again thank commenters for submitting feedback on our RFI. We
reiterate that our RFI does not contain any specific proposals for CY
2023. We will consider possible proposals in future rulemaking.
c. Changes to Health Care Delivery and Practice Ownership Structures,
and Business Relationships Among Clinicians and Health Care
Organizations
Market consolidation, and shifts in workforce alignment, as well as
an evolution in the type of business entities predominant in health
care markets, all suggest significant transformation in the composition
and proportions of practice expenses required to furnish care. These
evolving conditions collectively highlight the need for a comprehensive
update to PE data inputs, and possibly the PE methodology as a
whole.\5\ Ideally, more comprehensive PE data inputs and a different PE
calculation methodology would better account for indirect/overhead
costs, current trends in the delivery of health care, the use of
machine learning technology, and EHRs, and the cost differentials in
[[Page 69432]]
independent versus facility-based practices.
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\5\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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We solicited comment on current and evolving trends in health care
business arrangements, use of technology, or similar topics that might
affect or factor into indirect PE calculations. We are interested in
learning whether any PE data inputs may be obsolete, unnecessary, or
misrepresentative of the actual costs involved in operating a medical
practice.
We received public comments on current and evolving trends in
health care business arrangements, use of technology, or similar topics
that might affect or factor into indirect PE calculations. The
following is a summary of the comments we received and our responses.
Comment: A few commenters responding to our prompt to explore
avenues by which indirect PE can be moved for facility to non-facility
payments, based on data reflecting site of service cost differences,
suggested that indirect PE inputs should not be part of payment for the
facility rate of payment.
Commenters explained that because the facility bears the indirect
costs for provision of services at the facility, and the physician or
practitioner would receive indirect PE allocations for any in-office
services, the indirect PE portion of the facility fee for a physician
service is unwarranted.
Response: We note that the face value of a change that would reduce
the indirect PE portions of our current facility fees for physicians'
services to zero may have merit. We have open questions about this
feedback, which we will explore further in our ongoing research. We
believe, and related feedback from interested parties suggests, there
are two considerable shifts in today's healthcare business models.
First, many physicians and NPP's have become employed staff, versus
independent practitioners. Second, the landscape includes far more
variation in the ways that organizations interact and contract for
clinical staff and auxiliary personnel, and structure their
compensation. We would aim to better understand whether potentially
reducing to zero any indirect PE portion that is part of the facility
fee for physician services may or may not reduce competition, or have
the unintended effect of favoring certain forms of arrangements over
others.
Further, before proposing any policy, we would need to understand
whether the policy could address related open questions. Our work with
RAND to explore the relationship between different types of indirect
costs and direct cost inputs remains one of few empirical efforts to
examine the issue in-depth. In this year, and in previous years, when
we have requested similar information from the public, we continue to
receive anecdotal, if any evidence, when feedback from commenters aims
to take issue with findings in the RAND studies.
d. Unintended Consequences and Missing Information
We solicited comment on additional information that we may have not
considered or discussed above about updating and maintaining PE data
inputs, as well as any unintended impacts (or positive outcomes) that
could result from changes to the overall strategy. We are especially
interested in public comment on any concerns about beneficiaries'
access to care, possible consolidation of group practices, or burden on
small group or solo practitioners. We are also interested in public
comments on any collateral program integrity or quality issues that
could arise from potential updates. We requested that any respondents
who provide feedback ensure that the response includes discussion of
any possible health equity impacts.
We received public comments on unintended consequences and missing
information. The following is a summary of the comments we received and
our responses.
Comment: A few commenters expressed concern that topics of AI, a
related evolution of software and technology used to support provision
of services, and ties to health equity are not well-suited for the
process of updates to our annual rulemaking cycle. Commenters expressed
concerns that the public comment process alone is not sufficient to
provide information, and requested a separate RFI. We received a
similar response from many interested parties that question how CMS has
in the past, and will in the future, address definition of topics and
terms that shape our PE inputs.
Response: We encourage interested parties to continue to provide
feedback and suggestions to CMS that in general, give an evidentiary
basis to shape optimal PE data collection and methodological
adjustments over time. Submissions should discuss the feasibility and
burden associated with implementation of any suggested adjustments, and
should highlight opportunities to optimize the cadence, frequency, and
phase-in of resulting adjustments. In the interim, we will continue to
consider ways that we may engage in dialogue with interested parties to
better understand how to address possible long-term policies and
methods for PFS ratesetting.
6. Soliciting Public Comment on Strategies for Improving Global
Surgical Package Valuation
In preparation for future rulemaking, we solicited public comment
on strategies to improve the accuracy of payment for the global
surgical packages (herein referred to as ``global packages') under the
PFS. Currently, there are over 4,000 physicians' services paid as
global packages under the PFS. Global packages generally include the
surgical procedure and any services typically provided during the pre-
and postoperative periods (including evaluation and management (E/M)
services and hospital discharge services). There are three types of
global packages:
The 0-day global package, which includes the procedure and
the preoperative and postoperative physicians' services on the day of
the procedure.
The 10-day global package, which includes services on the
day of, and 10 days after, the procedure.
The 90-day global package, which includes services
furnished one day prior to the procedure, and on the day of, and 90
days immediately following the day of the procedure.
More detail about how global packages are billed and what
activities are included may be found in Chapter 12, Section 40, of the
Medicare Claims Processing Manual (Pub. 100-04).
We have applied the concept of global payment for some procedures
since the inception of the PFS on January 1, 1992 (54 FR 59502).
However, in the past decade we have engaged with interested parties
regarding numerous concerns about the accuracy and validity of the
valuation of global packages, with particular attention paid to the E/M
visits included in the services. We have made previous requests for
public feedback on global packages, including solicitations for
information or data that could be used to help support more accurate
valuations. We now wish to expand on our conversations with the public,
considering the current status of a multi-year data collection and
analysis project, as well as ongoing changes we have made to payments
for other types of patient care that may impact the global packages.
a. History of Global Valuation Discussion
In the CY 2013 PFS proposed rule (77 FR 44737 through 44738), we
discussed two reports released by the HHS Office of the Inspector
General in 2005 and
[[Page 69433]]
2012 with findings that practitioners were performing fewer E/M
postoperative visits than had been included in the valuation for these
global packages, suggesting that Medicare was paying for care that was
not being delivered. In response to the concerns raised by the OIG
reports, we solicited public feedback on methods of obtaining accurate
and current data on E/M services furnished as part of a global package.
We summarized public comment in the CY 2013 PFS final rule (77 FR 68911
through 68913).
In the CY 2015 PFS proposed rule (79 FR 40341), we delved into
barriers to accurate valuation of global packages, especially as
compared to other forms of bundled payments made under the inpatient or
outpatient prospective payment systems. In addition to the ongoing
concerns about whether E/M visits presumed to be furnished in
connection with global packages were actually being performed by the
physician receiving the global package payment, we noted issues such
as:
E/M services in the global period that occur post-
discharge are valued with PE values associated with follow-up visits in
the physician's office. Many of these follow-up visits may occur in a
hospital outpatient department where the physician may not incur many
PE costs.
The direct PE inputs often differ slightly between an E/M
service furnished in a global period and a stand-alone E/M service. For
example, follow-up visits for certain surgeries may include specialized
clinical labor such as an RN rather than a general nurse blend.
The types of physicians furnishing a specific service
dictate the direct and indirect percentages, as well as the indirect
practice cost index, in the PE methodology. Most surgical specialties
have a lower direct percentage mix, resulting in higher indirect costs
that extend to the E/M visits in the global periods.
Because the E/M visits embedded in the global package are
not reported separately and do not appear in claims data, it is
difficult to quantify the number and level of E/M services furnished in
connection with global packages under the fee-for-service system.
In some cases we have limited billing of the 10- and 90-
day global packages in conjunction with some of the payment policies
intended to encourage coordination of care through payments for non-
face-to-face services, such as transitional care management and chronic
care management, because of presumed overlap between these services.
To address these concerns, we solicited comment and finalized a
policy in the CY 2015 PFS final rule (79 FR 67586) intended to, over a
period of several years, transition all services with 10-day and 90-day
global periods to 0-day global periods. As stated in the CY 2015 PFS
final rule, we believed it would be more accurate to value the surgical
procedure-day services separately from postop E/M visits, and would
avoid potentially duplicative or unwarranted payments. For our full
discussion and rationale, refer to 79 FR 67586 through 67591.
Implementation of this policy, however, was halted by the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 110-14).
Section 523(a) of the MACRA amended section 1848(c)(8) of the Act to
prohibit the Secretary from implementing the transition policy
finalized in the CY 2015 PFS final rule. The amendments to section
1848(c)(8) of the Act also require CMS to collect additional data on
how best to value global packages and to reassess every 4 years the
continued need for this data collection. Section 1848(c)(8) of the Act
directs CMS to use the information collected to improve the accuracy of
valuation of these services under the PFS starting in CY 2019. (Refer
to the CY 2016 PFS final rule at 80 FR 70915 for additional discussion
of these requirements.)
In response to the statutory requirements as added by section
523(a) of the MACRA, we engaged in multiple discussions with interested
parties about methods of data collection and analysis, including
through public comment solicitation in the CY 2016 PFS proposed rule
(80 FR 41707) and CY 2017 PFS proposed rule (81 FR 46191), a national
listening session, and a town hall meeting. (Materials for the January
20, 2016 listening session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-01-20-MCRA-Presentation.pdf. The transcript of the town hall meeting held August
25, 2016 is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf.) In the CY 2017 PFS final rule (81 FR 80209 through
80213), we finalized a claims-based process to collect data from
practitioners on both the number and level of postoperative visits
furnished as part of the 10- and 90-day global packages. We also
contracted with RAND to support this data collection and analysis.
b. Data Collection, Analysis, and Findings
In 2019, RAND issued two reports based on its analysis of the data
collected through the data collection process we established. The
reports examined, using claims-based and survey-based data, the number
of postoperative visits furnished during the 10- and 90-day global
periods for certain high-volume procedures and the level of visits
furnished for certain procedures. (Complete details about the data
collected are discussed in the CY 2017 PFS final rule starting at 81 FR
80212, the CY 2020 PFS final rule at 84 FR 62857, and in the reports
themselves, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.)
Notably, RAND's analysis found that, according to claims-based data,
the reported number of E/M visits matched the expected number (included
for purposes of PFS valuation) for only 4 percent of reviewed 10-day
global packages and 38 percent of reviewed 90-day global packages.
Based on these analyses, RAND released a third report that analyzed the
current valuation of global packages based on the difference between
the number of postoperative E/M visits observed via the claims-based
data collection process and the expected number of such E/M visits. The
report modeled how valuation for global packages would change by
adjusting the work RVUs, physician time, and direct PE inputs to
reflect the observed number of E/M visits. The report provided
hypothetical valuations for the global packages based on these
adjustments. These three RAND reports were made available to the public
and are available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection.
The RAND reports were shared with the public, and we received
public comment about these reports in the CY 2020 PFS final rule (84 FR
62866). Public commenters raised concerns about the findings in the
reports, including questions as to whether the E/M visit data were
collected from a true representative sample of practitioners, and
various other challenges to the validity of the RAND methodology. Other
members of the public, however, were supportive of our overall efforts
to collect and analyze the data, and supplied additional data similarly
suggesting that the 10- and 90-day global packages are overvalued. In
2021, RAND responded to the CY 2020 public comments that were critical
of
[[Page 69434]]
the methodologies used in the three earlier reports in a separate
report entitled, ``Responses to Comments on RAND Global Services
Reports,'' which is available at https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/.
While some interested parties have challenged the methodology or
conclusions of the RAND reports, we have not yet received data
suggesting that postoperative E/M visits are being performed more
frequently than indicated by the data collected and analyzed in the
RAND reports. We continue to be concerned that our current valuations
of the global packages reflect certain E/M visits that are not
typically furnished in the global period, and thus, are not occurring.
We also believe that RAND has adequately responded to critiques of its
methodologies and findings. However, as part of our ongoing assessment
of our data collection process, we continue to welcome any comments
from the public on ideas for other sources of data that would help us
to assess global package valuation (including the typical number and
level of E/M services), as well as our data collection methodology and
the RAND report findings. We received some public comments in our
request for comments on possible additional data sources and on our
data collection methodology. These comments are summarized as follows:
Comment: Some commenters supported the findings and methodology of
the RAND reports. Several commenters stated that the RAND's findings
regarding E/M visit performance aligned with their own anecdotal
observations and experiences. However, other commenters expressed
skepticism of the RAND report findings and methodology, and many urged
us to continue to rely on RUC valuations of global packages (including
the number of embedded E/M visits included in the RUC surveys.) Several
commenters observed that getting truly accurate information from claims
data may be difficult; one commenter pointed out that since work done
by NPPs or clinical staff is often not reported separately, it is
difficult to get a complete picture of postoperative work. As in
previous public discussions, commenters urged CMS to continue to
examine claims data and electronic health records, or obtain
postoperative E/M information through direct surveys of practitioners.
Several commenters noted that we have spent many years performing data
collection in response to the MACRA requirements, and one commenter
requested that we cease our data collection efforts to avoid any
additional burden on practitioner. Many commenters urged us to continue
to work in collaboration with practitioners and other impacted parties
to identify sources of postoperative E/M data and to maintain
transparency about any additional collection efforts.
Response: We found that the comments we received, particularly
those critical of the RAND reports and methodology, echo the feedback
we received several years ago when we shared the RAND reports for
public comment. Please see the discussion of the RAND reports and
findings in the CY 2020 PFS final rule (84 FR 62866) and RAND's
responses to the CY 2020 public comments in the RAND report entitled,
``Responses to Comments on RAND Global Services Reports,'' which is
available at https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/. We note that we
did not receive new data that might either affirm or contradict RAND's
overall findings regarding E/M performance. We agree with commenters'
observations that we have spent many years collecting and analyzing
data regarding E/M performance in response to the MACRA requirements
and other public concerns about the valuation of globals. While we will
continue to evaluate potential sources of data regarding E/M
performance, we agree with commenters who suggest that the overall lack
of transparency within global packages can make identifying the nature
of postoperative care provision difficult and continues to call into
question the accuracy of globals that have been valued through standard
valuation processes.
c. Changes to Health Care Delivery and Payment for E/M Services
Since the inception of the PFS 30 years ago, there have been
significant changes in health care, including improvements in medical
and information technology, new models of health care delivery and
coordination between multiple clinicians furnishing care to a single
patient, and an expanding beneficiary population. (For information on
Medicare service utilization, beneficiary demographics, provider
characteristics, and payment models, please visit the resources at
data.cms.gov.) We asked to hear from the public on whether the
postoperative health care landscape has changed in ways that impact the
relevance of the global packages.
We believe that changes to health care delivery may impact proper
valuation of global services. We solicited comment on whether changes
to health care delivery, including changes in coordination of care and
use of medical technology over the past 3 decades, as well as during
the recent PHE, have impacted: the number and level of postoperative E/
M visits needed to provide effective follow-up care to patients; the
timing of when postoperative care is being provided; and who is
providing the follow-up care. We have formed hypotheses that some
beneficiaries are not receiving the number of postoperative visits that
were contemplated when valuing the global surgical packages or are not
receiving any follow-up E/M visits at all during global periods either
because the physician who performed the surgical procedure has
determined they are unnecessary (perhaps due to improvements in medical
technology or evolution in standards of care) or as the result of more
comprehensive discharge planning. It has also been suggested by some
interested parties that physicians are, in fact, performing the number
of postoperative visits that were contemplated when valuing the global
surgical packages, but the visits may, for various reasons, be
scheduled outside the global period. Others have suggested that
physicians are, without formally transferring follow-up care to another
clinician, instructing patients to follow up with another physician or
NPP (such as the patient's primary care physician or other
practitioner), and that the other clinician then furnishes and bills
for E/M services furnished for postoperative care (whether the care is
performed during or after the global period). We appreciate comments on
these ideas, and on other factors not mentioned here that could affect
the ways that postoperative E/M care is provided.
We also solicited comment on whether, or how, recent changes in the
coding and valuation of separately billable E/M services may have
impacted global packages. One change is the expansion of payment for
non-face-to-face care management services. Historically, an advantage
of global packages was that they compensated physicians for non-face-
to-face work related to the patient's transition from the hospital to
the community, or management of other health care needs following a
procedure or serious illness. Over the years, we have implemented
payment for many care management services to better reflect non-face-
to-face time spent by physicians and clinical staff on behalf of
patients with complex health care needs, including transitional care
management services in CY 2013 (77 FR 68978); chronic care
[[Page 69435]]
management in CY 2015 (78 FR 74414) and CY 2019 (83 FR 58577); complex
chronic care management in CY 2017 (81 FR 80244); and principal care
management in CY 2020 (84 FR 62962). We solicit comment on whether
global packages, and especially those with 10- and 90-day global
periods, continue to serve a purpose when physicians could otherwise
bill separately not only for the postoperative E/M visits they furnish,
but also for aspects of postoperative care management they furnish for
some patients. We also would like to hear generally what, if any,
components of preoperative or postoperative care are currently only
compensated as part of payment for global packages.
We have also heard from some interested parties who believe that
recent changes to the coding and valuation of standalone office and
outpatient E/M visits finalized in the CY 2021 PFS final rule have
skewed the relativity between these visits and the E/M visits included
in the current global package valuations (which were not modified in
response to the coding and valuation changes). In the CY 2020 PFS final
rule (84 FR 62851 through 84 FR 62854), we finalized new--and generally
increased, RVUs for the CPT-revised office and outpatient E/M code set.
Some commenters encouraged us to increase the value of the E/M visits
included in the global surgical packages commensurate with the
increased RVUs for the standalone E/M visits. However, we declined to
do so, noting that at the time that it was unclear whether it would be
appropriate to treat the E/M visits reflected in global packages as
discrete components of the package (in other words, to use a building-
block approach to calculating the value of the service, versus valuing
the services using the more holistic magnitude estimation, or possibly
another approach.) Furthermore, we cited the uncertainty as to whether
the E/M services included in valuing the global packages are typically
furnished as part of global surgery services, reasoning that if the
number and level of E/M services for global packages is not
appropriate, adopting increases in the value of E/M services in global
surgery codes would exacerbate rather than ameliorate any potential
relativity issues. (Refer to the CY 2020 PFS final rule at 84 FR 62856
through 62860 for a complete summary of comments and our responses on
the topic of increasing the value of E/M visits included in the global
packages.) We welcomed additional comments on the perceived
misalignment between the E/M visits included in global packages and
separately billable E/M services, including thoughts on how this
current tension reflects on global payment valuation and the
appropriate methodology for determining appropriate values for global
packages.
We received some public comments on whether changes to health care
delivery and payment for E/M services may impact the performance of E/M
visits or overall relevance of E/M visits. The following is a summary
of the comments we received and our responses.
Comment: Several commenters noted that while patients in general
seem in greater need of critical care, there is also (from various
commenters' perspective) either increasing opportunity or mounting
pressure on practitioners to discharge patients from hospitals and
arrange at-home care after surgeries. Many commenters stated that
postoperative care provided by the proceduralists should still be
considered a best practice. However, a few commenters agreed with some
of our hypotheses--namely that for clinical reasons patients may not
need to return for in-person postoperative care within the global
period, or that scheduling conflicts may make timely return difficult.
A few commenters also agreed that patients may, for reasons of
convenience, receive some postoperative care from community
practitioners rather than returning to the hospital where the surgical
procedure was performed. Some commenters also suggested that there may
be clinical reasons why it is better for a patient to receive
postoperative care from a practitioner or NPP other than the
proceduralist, such as in circumstances when the patient needs long-
term or specialized postoperative care outside the expertise of the
proceduralist. Overall, commenters expressed ambivalence about the
impact the PHE and use of telehealth has had on postoperative care. A
few commenters noted that some aspects of postoperative care--including
sharing of test results or consultations--can be done via telehealth,
while others described types of postoperative care that can only be
done in-person. Commenters also expressed doubt about the impact of
expanded payments for non-face-to-face services, noting that payments
for care management or other non-face-to-face services do not include
all post-surgical conditions and do not address in-person care.
Regarding our questions about the overall relevance of global
packages, some commenters stated that paying for postoperative care as
standalone visits would ensure that Medicare was only paying for the
care that was being delivered. A few commenters suggested that
postoperative care should be not only paid for separately, but paid at
a higher rate. Other commenters stated that global packages continue to
be necessary because they reduce administrative burden on practitioners
and ensure payment of care provided by NPPs and clinical staff.
Response: While we did not receive a great deal of feedback on our
specific request for information as to whether global packages are
still relevant, we believe the information we received demonstrates
that there may be variations in patients' individual postoperative care
needs. While we agree with commenters that in-person visits with the
proceduralist is the standard of care on which global packages were
based, we will continue to examine whether this specific model of
postoperative care is still necessary or relevant for all procedures.
Comment: Many commenters provided input on the valuation of the E/M
visits embedded in global packages as compared to standalone E/M
visits. Although commenters did not provide feedback on whether the
misalignment reflects on the relevance of surgical packages, many
commenters suggested that we should increase the value of global
packages to reflect the increase in standalone E/M visits (both the
office/outpatient increases finalized in CY 2020 at 84 FR 62851 through
84 FR 62854, and increases to certain hospital inpatient E/M visits
proposed in CY 2023 at 87 FR 45993.) Some commenters suggested that the
data collection requirement in the MACRA amendments to the statute does
not preclude CMS from applying such increases to all global packages.
Other commenters, however, agreed with our decision not to increase the
global packages pending our inquiry into the performance of
postoperative E/M visits.
Response: We direct commenters to the CY 2020 PFS final rule (84 FR
62851 through 84 FR 62854), where we discussed similar concerns. We
continue to disagree with commenters' interpretation of the MACRA
amendments. We note that section 1848(c)(8) of the Act, as amended by
section 523(a) of the MACRA (Pub. L. 110-14), directs CMS to use the
information collected to improve the accuracy of valuation of these
services specifically requires that we use the data we obtain through
data collection to revalue the global packages. Our data currently
suggests that at least some global packages are inaccurately, revalued,
and until we identify data that demonstrates otherwise, we do not
believe it would be appropriate to apply
[[Page 69436]]
an across-the-board adjustment to the packages that is not supported by
data. Additionally, we are also working to reconcile public
recommendations that we revalue global packages on a holistic or case-
by-case basis (discussed in greater detail in section II.B.6.d. of this
final rule) with recommendations that we apply across-the-board
increases to all global packages.
d. Strategies To Address Global Package Valuation
Consistent with the discussion above, we continue to believe that:
(1) there is strong evidence suggesting that the current RVUs for
global packages are inaccurate; (2) many interested parties agree that
the current values for global packages should be reconsidered, whether
they believe the values are too low or too high; and (3) it is
necessary to take action to improve the valuation of the services
currently valued and paid under the PFS as global surgical packages.
We would like to re-engage with the public about whether the global
packages are indeed misvalued, and if so, what would be an appropriate
approach to valuation. We have previously sought assistance from the
public on possible methods of revaluation, such as in the CY 2015 PFS
final rule (79 FR 67586).
As noted in the ``Data Collection, Analysis, and Findings'' section
above (section II.B.6.b.), RAND has provided a comprehensive roadmap
for a possible revaluation strategy. (See specifically the RAND report,
``Using Claims-Based Estimates of Postoperative Visits to Revalue
Procedures with 10- and 90-Day Global Periods,'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-. We solicited
additional input on the RAND methodology, including advantages and
drawbacks of applying the RAND methodology to revaluation (in addition
to previous feedback that was provided by the public in the CY 2020 PFS
final rule at 84 FR 62867). We also requested input on specific
alternatives, including: (1) requesting the RUC to make recommendations
on new values; or (2) another method proposed by the public.
We solicited feedback from the public on possible strategies for a
revaluation process for global services. We believe that the available
information provided in the RAND reports (discussed in section
II.B.6.b. of this final rule and available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-) indicates that there is a mismatch between
the value of the global package and work being performed. In
particular, it appears that for some services, the number of
postoperative visits typically furnished by the billing physician is
much lower than what was reflected in the global package value, and
thus we believe it may be necessary to revalue those services. (As
noted in section II.B.6.b. of this final rule, RAND's analysis found
that the reported number of E/M visits matched the expected E/M visits
for only 4 percent of reviewed 10-day global packages and 38 percent of
reviewed 90-day global packages. We referred specifically to the RAND
report, ``Claims-Based Reporting of Postoperative Visits for Procedures
with 10- or 90-Day; Global Periods--Updated Results Using Calendar Year
2019 Data'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-).
Because there are a large number and volume of services paid as global
packages, we must consider the resources needed to revalue even a
subset of the global packages, as well as the impacts across the PFS
and healthcare delivery system in general if we were to change the
values of a significant number of services at one time. We considered
various approaches we could pursue, such as: (1) revaluing all 10- and
90-day global packages at one time (perhaps with staggered
implementation dates); (2) revaluing only the 10-day global packages
(because these appear to have the lowest rate of postoperative visit
performance, per RAND's analysis of claims data); (3) revaluing 10-day
global packages and some 90-day global packages (such as those with
demonstrated low postoperative visit performance rates as identified in
RAND's analysis of these services); or (4) relying on the Potentially
Misvalued Code process to identify and revalue misvalued global
packages over the course of many years. (We noted that regardless of
whether we review particular global packages as part of a specific
revaluation strategy, the public may always nominate any global
packages to be reviewed through the Potentially Misvalued Code process;
refer to the description of the Potentially Misvalued Code process in
section II.C. of this final rule.) We solicited comment on any of the
strategies identified in this paragraph, as well as any additional
ideas members of the public may have that would address the concerns
described above about valuation of global packages. We also solicited
comment on ancillary considerations including timing considerations for
implementation of any future strategy (such as whether to have
staggered effective dates for new valuations and what criteria to use
if assigning staggered effective dates.)
We also solicited comment on additional considerations affecting
valuation of global services that may not have been thoroughly explored
in previous public comment opportunities. For instance, we are aware
that some interested parties are concerned that not enough attention
has been paid to the value of preservice work bundled into the global
payment, which could affect accurate valuation of 10- and 90-day global
packages, as well as the value of the service if it is transitioned to
a 0-day global. We solicited additional information about this concern,
as well as any other concerns about valuation not otherwise mentioned
here.
We received public comments on strategies to address global package
valuation. The following is a summary of the comments we received and
our responses.
Comment: Some commenters agreed that global surgical packages are
misvalued and encouraged CMS to revalue the packages in order to reduce
the impacts of improper valuation on the relative value scale. A few
commenters agreed that packages were misvalued, but suggested we
continue to work with impacted parties to find a method for
revaluation. Other commenters stated that they do not believe that
global packages were misvalued or, if they are misvalued, they should
be revalued on a holistic and case-by-case basis using the RUC process
or the Potentially Misvalued Code process. A few commenters suggested
that CMS and the RUC collaborate on a specific method to revalue global
packages. Commenters also noted that revaluing through the RUC process
could take a number of years and may present resource challenges.
We received diverse comments on approaches for revaluing the codes,
including revaluing all 10- and 90-day packages, revaluing some 10- and
90-day packages, or focusing just on the 10-day packages. Commenters
who recommended focusing on the 10-day packages suggested that this
would address services with lower demonstrated postoperative E/M visit
rates, and would provide us with insight about revaluation that could
then be applied to the 90-day packages as needed. Other commenters made
suggestions including phasing out global packages by not valuing new
CPT codes as globals, or changing the length
[[Page 69437]]
of global periods. While one commenter was in favor of revaluing all
packages at one time, many commenters suggested revaluing over a number
of years to avoid too much disruption to the relative value scale. One
commenter suggested we wait until after the conclusion of the PHE to
revalue any packages.
Response: We believe that the spectrum of comments demonstrates
that there is not, at this time, clear public consensus on this issue
or the preferred strategy for valuing globals. We will consider the
specific strategies proposed by the commenters and the concerns
regarding impact on the relative value scale and the resources that
would be required to revalue these codes.
e. Other Payment Structure Changes, Unintended Consequences, and
Missing Information
We solicited public comment on any other aspects of the global
payment structure (aside from the valuation of services) that
commenters believe are noteworthy. Much of the discussion over the
years has focused on whether global surgical packages are properly
valued and whether they are needed at all. We encourage commenters to
point out ways in which global surgical packages may continue to have a
positive impact on health care delivery (such as their potential to
support innovation). We also solicited suggestions on other ways that
global surgical package payments could be modified (aside from changing
their valuation) that could help improve accurate valuation or help
address other concerns about the payments (such as the lack of
transparency about what care is being provided as part of the package).
We also requested comment on additional information that we may not
have considered or discussed above about proper valuation of the global
packages, as well as any unintended impacts (or positive outcomes) that
could result from changes to how we value global services. We are
especially interested in public comment on any concerns about
beneficiaries' access to care, continuity of care, cost sharing, or
program integrity.
We received limited public comments on other payment structure
changes, unintended consequences, and missing information. The
following is a summary of the comments we received and our responses.
Comment: A few commenters opined on the consequences of unbundling
global payments. A few of these commenters raised concerns that
unbundling the packages would reduce payments to physicians or NPPs. A
few expressed concerns that beneficiaries might not want to pay the
coinsurance for standalone E/M visits (should global packages be
unbundled) and might decline postoperative care.
Response: We agree that the payments to practitioners might change
in circumstances where globals are revalued, although we do not believe
there is yet enough information to determine the financial impact
should proceduralists bill separately for postoperative care for some
procedures. We will continue to consider the potential impact of
coinsurance for globals and postoperative care for beneficiaries.
After consideration of the comments, we wish to thank the
commenters for their input. As outlined in the proposed rule, this
discussion has spanned over a decade, with participation from specialty
societies, advocacy groups, program integrity agencies, and Congress.
We had hoped through this comment solicitation to nudge discussion into
new or under-explored lanes of inquiry that would help us better
understand how global packages fit into the current health care
landscape. We appreciate the engagement we did receive with our
requests for information regarding current health care practices.
Additionally, numerous interested parties, those who have been engaged
with the discussion for many years, as well as some new voices,
provided comment that reinforced or reiterated concerns that have
emerged in prior discussions.
In this year's comment solicitation, we received a spectrum of
perspectives on: whether the globals are misvalued; if misvalued,
whether they are undervalued or overvalued; whether we should continue
to value them through our current processes or develop a new
methodology that better addresses the unique challenges posed by
bundled payments; and whether globals should be revalued individually,
in batches, or in their entirety. Looking at the totality of the
comments and keeping in mind discussion from prior years, we have
identified a few common themes on which many seem to agree. The matter
of global valuation is complex. Global packages comprise a large number
of codes, and their valuation has a significant impact on the PFS
relative value scale. Accurately valuing the work and other inputs of
the globals is critically important to ensure not only that the
practitioners providing those services are paid accurately for the work
performed, but that there is no inequitable impact on practitioners
paid outside of 10- and 90-day global packages. The diversity of
procedures paid under global packages may mean that blanket approaches
to valuation or revaluation may not achieve the desired degree of
accuracy. And, finally, while universally agreed-upon data strategies
may prove elusive, good data analysis is a critical foundation on which
to base any method for valuing these packages. We appreciate the
public's engagement on this issue, and continue to welcome additional
insights from interested parties as we consider appropriate next steps.
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, 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
[[Page 69438]]
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also considered information provided
by other interested parties. 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 (http://www.medpac.gov/docs/Fee-for-Service-Payment/Physiciandefault-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed the importance of
appropriately valuing physicians' services, noting that misvalued
services can distort the market for physicians' services, as well as
for other health care services that physicians order, such as hospital
services. In that same report, MedPAC postulated that physicians'
services under the PFS can become misvalued over time. MedPAC stated,
``When a new service is added to the physician fee schedule, it may be
assigned a relatively high value because of the time, technical skill,
and psychological stress that are often required to furnish that
service. Over time, the work required for certain services would be
expected to decline as physicians become more familiar with the service
and more efficient in furnishing it.'' We believe services can also
become overvalued when PE costs decline. This can happen when the costs
of equipment and supplies fall, or when equipment is used more
frequently than is estimated in the PE methodology, reducing its cost
per use. Likewise, services can become undervalued when physician work
increases or PE costs rise.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time-period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to 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 [email protected], with the phrase
``Potentially Misvalued Codes'' and the referencing CPT code number(s)
and/or the CPT descriptor(s) in the subject line. Physical letters for
nominations should be sent via the U.S. Postal Service to the Centers
for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security
Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination
letters must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes.'' Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 1,700
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior
[[Page 69439]]
reviews of potentially misvalued codes is included in the CY 2012 PFS
final rule with comment period (76 FR 73052 through 73055). In the same
CY 2012 PFS final rule with comment period, we finalized our policy to
consolidate the review of physician work and PE at the same time, and
established a process for the annual public nomination of potentially
misvalued services.
In the CY 2013 PFS final rule with comment period (77 FR 68892,
68896 through 68897) we built upon the work we began in CY 2009 to
review potentially misvalued codes that have not been reviewed since
the implementation of the PFS (so-called ``Harvard-valued codes''). In
the CY 2019 PFS proposed rule (73 FR 38589), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review of Work RVUs
proposed rule (76 FR 32410, 32419), we requested recommendations from
the RUC to aid in our review of Harvard-valued codes with annual
utilization of greater than 30,000 services. In the CY 2013 PFS final
rule with comment period, we identified specific Harvard-valued
services with annual allowed charges that total at least $10,000,000 as
potentially misvalued. In addition to the Harvard-valued codes, in the
CY 2013 PFS final rule with comment period we finalized for review a
list of potentially misvalued codes that have stand-alone PE (codes
with physician work and no listed work time and codes with no physician
work that have listed work time). We continue each year to consider and
finalize a list of potentially misvalued codes that have or will be
reviewed and revised as appropriate in future rulemaking.
3. CY 2023 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67548,
67606 through 67608), we modified this process whereby the public and
interested parties may nominate potentially misvalued codes for review
by submitting the code with supporting documentation by February 10th
of each year. Supporting documentation for codes nominated for the
annual review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and 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.
An interested party nominated the home-based physician visit codes:
CPT code 99344 (Home visit for the evaluation and management of a new
patient, which requires these 3 key components: A comprehensive
history; A comprehensive examination; and Medical decision making of
moderate complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting problem(s) are of high
severity. Typically, 60 minutes are spent face-to-face with the patient
and/or family), CPT code 99345 (Home visit for the evaluation and
management of a new patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the patient is
unstable or has developed a significant new problem requiring immediate
physician attention. Typically, 75 minutes are spent face-to-face with
the patient and/or family), CPT code 99349 (Home visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A detailed interval history; A
detailed examination; Medical decision making of moderate complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are moderate to high
severity. Typically, 40 minutes are spent face-to-face with the patient
and/or family), and CPT code 99350 (Home visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A comprehensive interval history; A
comprehensive examination; Medical decision making of moderate to high
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting
[[Page 69440]]
problem(s) are of moderate to high severity. The patient may be
unstable or may have developed a significant new problem requiring
immediate physician attention. Typically, 60 minutes are spent face-to-
face with the patient and/or family) as potentially misvalued.
In their submission, the nominator expressed concern that there is
no payment for transportation costs incurred when it is medically
necessary for a physician to drive to the home of the patient for a
face-to-face in-home E/M Visit, and that they are not compensated for
opportunity loss they incur by seeing fewer patients because they spend
time commuting to patients' homes, versus seeing more patients that
come to their offices. The nominator also argued that Medicare does not
compensate physicians for the work and time associated with assessing a
patient's home environment, which provides insight into a patient's
overall health and living conditions. The nominator collectively called
these non-medical factors that can affect a patient's overall health
the ``Social Determinants of Health'' (SDoH). The nominator requested
that we increase the overall RVUs for CPT codes 99344, 99345, 99349,
and 99350, by including the resources associated with: (1) the
physician's transportation costs to patients' homes; (2) lost income
opportunity for home versus in-office visits; and (3) in-home SDoH
assessment work. The nominator estimated that the adjustments to RVUs
to reflect transportation costs and opportunity costs would result in a
Medicare payment that is 67 percent higher than the current Home-based
E/M Visits payment rates, and that adjustments to account for the
physician's SDoH assessment would add an additional 55 percent increase
to the payment rates for Home-based E/M Visits. In total, the nominator
suggests that if these resources were taken into account, the payment
rates for Home-based E/M CPT codes would increase by what the nominator
estimates as a 222 percent increase from their current amounts.
The nominator included references as evidence to support their
claim that the home-based E/M CPT codes are potentially misvalued, such
as the CMS ``Medicaid Non-Emergency Medical Transportation Booklet for
Providers'' (April 2016) 6 7 and a press release from the
Better Medicare Alliance entitled, ``Report Shows Dramatic Increase in
Medicare Advantage Activity to Address Social Determinants of Health,
But Barriers Remain''.\8\
---------------------------------------------------------------------------
\6\ https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/nemt-booklet.pdf.
\7\ https://storage.aanp.org/www/documents/NP-Infographic.pdf.
\8\ https://bettermedicarealliance.org/news/report-shows-
dramatic-increase-in-medicare-advantage-activity-to-address-social-
determinants-of-health-but-barriers-remain/
#:~:text=Social%20determinants%20of%20health%20are,to%20the%20World%2
0Health%20Organization.
---------------------------------------------------------------------------
We noted that the nominator did not nominate the entire family of
home-based E/M visit codes (please see Table 9 for a list of home-based
E/M codes).
[GRAPHIC] [TIFF OMITTED] TR18NO22.011
When we establish values for codes or consider whether codes are
potentially misvalued under the PFS, we take into account the resources
involved in furnishing the specific service as described by the CPT
code. As such, historically, we do not take into account: (1) travel
costs incurred by the physician or other practitioner; (2) potential
opportunity costs to a physician or other practitioner when care is
delivered in one setting versus another; or (3) the physician or other
practitioner's work and time expended in performing activities that are
outside the scope of the specific service as described by the CPT code.
These are not considered to be resources involved in furnishing the
service, and they are not included in establishing payment rates under
the PFS in accordance with section 1848 of the Act, and, as such, do
not provide justification for potential misvaluation of those payments.
That said, in February 2021, the AMA CPT Editorial Panel deleted the
family of domiciliary codes, CPT codes 99324 to 99340, and merged the
services described by those codes into the existing family of home-
based E/M visits, CPT codes 99341 to 99350 (a range of codes that
includes CPT codes 99344, 99345, 99349, and 99350). In addition, the
AMA RUC made recommendations regarding the values for these home-based
E/M codes as discussed in section II.F. of the CY 2023 PFS proposed
rule (87 FR 45999) and in section II.F. of this final rule. Since CMS
had already received AMA RUC recommendations for these home-based E/M
visit codes, we considered those recommendations and solicited
additional public comments, recommendations, and independent analysis
as supporting evidence from all interested parties regarding the
valuations for the home-based E/M visits, including CPT codes 99344,
99345, 99349, and 99350. Because we discussed and solicited public
comment on the valuation of these codes in the proposed rule, we stated
that we were not considering these home-based E/M
[[Page 69441]]
visits as potentially misvalued for CY 2023.
An interested party has nominated the following cataract surgery
codes, CPT codes 65820 (Goniotomy--Incision to improve eye fluid flow),
66174 (Transluminal dilation of aqueous outflow canal; without
retention of device or stent), 66982 (Complex Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification), 66984 (Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification)), 66989 (Complex Extracapsular
cataract removal w/IOL insertion, complex; with insertion of
intraocular (e.g., trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without extraocular
reservoir, internal approach, one or more), and 66991 (Extracapsular
cataract removal w/IOL insertion; with insertion of intraocular (e.g.,
trabecular meshwork, supraciliary, suprachoroidal) anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, one or more), as well as the following retinal procedure
codes, CPT codes 67015 (Aspiration or release of vitreous, subretinal
or choroidal fluid, pars plana approach (posterior sclerotomy)), 67036
(Vitrectomy, mechanical, pars plana approach), 67039 (Vitrectomy,
mechanical, pars plana approach; with focal endolaser
photocoagulation), 67040 (Vitrectomy, mechanical, pars plana approach;
with endolaser panretinal photocoagulation), 67041 (Vitrectomy,
mechanical, pars plana approach; with removal of preretinal cellular
membrane (e.g., macular pucker)), 67042 (Vitrectomy, mechanical, pars
plana approach; with removal of internal limiting membrane of retina
(e.g., for repair of macular hole, diabetic macular edema), includes,
if performed, intraocular tamponade (i.e., air, gas or silicone oil)),
67043 (Vitrectomy, mechanical, pars plana approach; with removal of
subretinal membrane (e.g., choroidal neovascularization), includes, if
performed, intraocular tamponade (i.e., air, gas or silicone oil) and
laser photocoagulation), 67108 (Repair of retinal detachment; with
vitrectomy, any method, including, when performed, air or gas
tamponade, focal endolaser photocoagulation, cryotherapy, drainage of
subretinal fluid, scleral buckling, and/or removal of lens by same
technique), and 67113 (Repair of complex retinal detachment (e.g.,
proliferative vitreoretinopathy, stage C-1 or greater, diabetic
traction retinal detachment, retinopathy of prematurity, retinal tear
of greater than 90 degrees), with vitrectomy and membrane peeling,
including, when performed, air, gas, or silicone oil tamponade,
cryotherapy, endolaser photocoagulation, drainage of subretinal fluid,
scleral buckling, and/or removal of lens), as potentially misvalued
because there is currently no established non-facility payment rate for
these global 090-day surgical procedures. These codes are complex
surgical eye procedures, and they require dedicated spaces, similar to
facility-based spaces that are not typically found in an
ophthalmologist's office--such as a well-lighted and sterile surgical
theater; specific eye surgery equipment; and, possibly, clinical staff
and other medical personnel trained to assist in these surgeries and
the patient's immediate post-surgery recovery, including anesthesia
services. In the past, with concerns for patient safety and given the
intricate and delicate nature of these surgeries, we understood that
these procedures would only be performed in a well-equipped and fully
staffed medical facility. For Medicare Part B, payment for these
services is only made for procedures furnished in the facility
settings, but this nominator suggests that these cataract and retinal
procedures can be properly performed in the non-facility office,
safely, effectively, and perhaps more conveniently for patients and
physicians; and thus requests that we should establish non-facility
RVUs under the PFS to recognize the additional resources that would be
expended in the non-facility setting.
The nominator has included a list of practice expense (PE) items
involved in furnishing these services in the non-facility setting to
help us to consider establishing non-facility values for these codes.
They include the possible number and types of clinical staff and their
work time in minutes as well as a list of various equipment and
supplies typically needed to furnish the services described by the
nominated codes.
The nominator also noted that there is projected backlog for these
cataract and retinal services that may have been building up due to the
COVID-19 restrictions from the past 2 years. We solicited comment on
the merits of continuing to value these codes only in the facility
setting, as opposed to also establishing non-facility values for these
cataract and retinal surgery codes. We also solicited comment on any
appropriate safety considerations for these codes in the non-facility
setting, and whether these codes are potentially misvalued. We noted
that in last year's CY 2022 PFS final rule with comment (86 FR 65096
through 65097), we did review CPT codes 66982, 66984, 66987, 66988,
66989, 66991, and 0671T (Cataract Removal with Drainage Device
Insertion) and did not establish non-facility values for those
services, but we did note a potential rank order anomaly when
considering minimally invasive glaucoma surgeries (MIGS) and cataract
surgeries together, and suggested that the AMA RUC should consider re-
surveying all of the codes in this family.
An interested party nominated add-on CPT code 20931 (Allograft,
structural, for spine surgery only (List separately in addition to code
for primary procedure)) as a potentially misvalued service with respect
to the physician's labor for spinal surgeries involving the use of
biomechanical synthetic cage devices versus the use of structural
allograft bone as it relates to a set of CPT codes related to anterior
cervical discectomy and fusion (ACDF). Ordinarily, interested parties
nominate a primary service code as potentially misvalued, or a primary
service code and its related add-on codes, but not an add-on code
alone. The valuation of an add-on code is typically developed with
reference to some portion of the work (or other resource inputs)
involved in furnishing the primary service code. For example, the AMA
CPT 2022 Professional Edition, page 147, states ``Use code 20931 in
conjunction with codes 22319, 22532-22533, 22548-22558, 22590-22612,
22630, 22633, 22634, 22800-22812''. The primary spinal surgery codes
and the add-on CPT code 20931 have not been recently reconsidered or
reviewed by the AMA RUC or CMS, and no new or additional information
has been included with this nomination to persuade CMS that CPT code
20931 is individually potentially misvalued. This nomination of an add-
on code as potentially misvalued is similar to the nomination we
discussed in the CY 2022 PFS proposed rule (86 FR 65044) of CPT code
22551 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2) and the accompanying add-on
codes.
The nominator refers to two different methods of vertebral fusion:
one using biomechanical synthetic cage devices, the other using
structural allograft bone; and describes a typical vertebral fusion
case that uses three units of one of these products. Both of these
methods of vertebral fusion are described by CPT
[[Page 69442]]
code 22551 (includes a 90-day global period), which has a work RVU of
25.00. Both methods of vertebral fusion also involve two units of CPT
code 22552 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2, each additional interspace
(List separately in addition to code for primary procedure)), which
have a total work RVU of 13.00 (6.50 x 2), and 1 unit of CPT code 22846
(Anterior instrumentation; 4 to 7 vertebral segments (List separately
in addition to code for primary procedure)), which has a work RVU of
12.40. The vertebral fusion method employing three synthetic cage
devices with plate would involve three units of CPT code 22853
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage,
mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to intervertebral disc space
in conjunction with interbody arthrodesis, each interspace (List
separately in addition to code for primary procedure)) for a total work
RVU of 12.75 (4.25 x 3), and one unit of CPT code 20930 (Allograft,
morselized, or placement of osteopromotive material, for spine surgery
only (List separately in addition to code for primary procedure)) with
a work RVU of 0.00 (because Medicare considers this code to be bundled
into codes for other services). The nominator states that the typical
vertebral fusion employing three synthetic cage devices with plate
would total to 63.15 work RVUs.
In contrast, the nominator asserts that the vertebral fusion method
employing structural allograft bones with plate involves the same set
of services and codes (that is, one unit of CPT code 22551, two units
of CPT code 22552, and one unit of CPT code 22846), but the structural
allograft bone method includes CPT code 20931 (Allograft, structural,
for spine surgery only (List separately in addition to code for primary
procedure)), with a work RVU of 1.81, instead of CPT codes 22853 and
20930, for a total work RVU of 52.21. The nominator suggests that this
difference in total work RVUs for the two methods of vertebral fusion,
63.15 versus 52.21, is evidence that add-on CPT code 20931 is
potentially misvalued; however, we do not agree with this nominator's
method of aggregating and comparing sums of work RVUs for groups of
services that may be furnished together as being potentially misvalued,
nor consider CPT code 20931 as the source of misvaluation within this
grouping.
We understand that the nominator believes there should be an
equivalent total sum payment for all services involved in vertebral
fusion surgeries using either method, and that there should not be a
potential incentive for physicians to prefer the method that uses
synthetic cage devices because of the higher available payment amount.
The nominator asserts that the total sum payment for this kind of
spinal surgery using the structural allograft bone method is
undervalued as compared to the total sum payment for this kind of
spinal surgery using the synthetic cage method.
We note that CPT code 22853, which the commenter associates with
the synthetic cage device method of vertebral fusion, is a 45-minute
ZZZ-code (indicating an add-on code) with an IWPUT (intra-service work
(RVU) per unit of time) of 0.0944, whereas CPT code 20931, which the
commenter associates with the allograph method of vertebral fusion, is
a 20-minute ZZZ-code with an IWPUT of 0.0905. Given the much longer
intra-service time and greater IWPUT for CPT code 22853 than for CPT
code 20931, the allograph method of vertebral fusion would be expected
to have a lower total sum of work RVUs.
The nominator's description of why and how each vertebral fusion
method is potentially misvalued when compared to the other does not
present a situation that fits within our process for identifying
individual services that are potentially misvalued using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to individual
codes, or with the inter-code relativity between the RVUs assigned to
several individual codes found within a family of codes with
hierarchical relationships. We generally do not examine the summed
differences in total RVUs (as is the case presented here), based on
billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator has
provided sufficient evidence to demonstrate that CPT code 20931 itself
is misvalued, and therefore, we are not inclined to propose this code
as potentially misvalued; however, we solicited additional comment and
any independent analysis and studies (see the supporting documentation
options listed above under ``CY 2023 Identification and Review of
Potentially Misvalued Services,'' particularly in regard to any changes
in the resources to providing a service) as supporting evidence from
commenters in agreement or disagreement with this nomination.
See Table 10 for the listing of nominated potentially misvalued
codes.
[[Page 69443]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.012
We received public comments on our discussion of public nominations
for potentially misvalued codes and decision not to propose them as
potentially misvalued. The following is a summary of the comments we
received and our responses.
We received a number of public comments on the nominated home-based
E/M visit CPT codes 99344, 99345, 99349, and 99350.
Comment: Commenters were disappointed, stating that CMS did not
take into account the inclusion of the nominator's request for
consideration for: (1) travel costs incurred by the physician or other
practitioner; (2) potential opportunity costs to a physician or other
practitioner when care is delivered in the patient's home versus in the
office or at a facility; or (3) the physician or other practitioner's
work and time expended assessing a patient's home environment and/or
``Social Determinants of Health'' (SDoH) assessments. Commenters
explained that the typical home-bound patient, who requires a physician
home visit, is comparatively more frail, with multiple chronic
conditions. Some commenters suggested add-on codes, similar to the
codes for at-home COVID-19 Vaccinations, for physician transportation
costs to the patient's home.
Response: We appreciate the feedback from commenters and encourage
further discussion as we gain more experience with the new codes. As
discussed in our proposed rule, the costs identified by commenters are
not considered to be specific work, practice expense, or malpractice
expense resource inputs that are taken into account in valuation of
individual services under the PFS, so they are not included in
establishing payment rates under the PFS in accordance with section
1848 of the Act. As such, these costs do not provide justification for
potential misvaluation of the identified codes. We also noted in the CY
2023 PFS proposed rule (87 FR 45883) that the AMA RUC made
recommendations regarding the values for these home-based E/M visit
codes. Since CMS had already received AMA RUC recommendations for these
home-based E/M visit codes for this year's proposed rule, we referred
readers to the discussion and solicitation of public comments on those
recommendations in the proposed rule. We solicited additional public
comments, recommendations, and independent analysis as supporting
evidence from all interested parties regarding the valuations for the
home-based E/M visits, including CPT codes 99344, 99345, 99349, and
99350. We refer readers to section II.F. of this final rule for a
summary and our responses to those comments. With regard to the
comments requesting additional coding, we appreciate commenters'
suggestions, and, as we gain information from utilization of the newly-
reviewed codes and receive additional feedback from interested parties,
we may consider changes in future rulemaking.
Comment: One commenter stated that his Home Visit PEs are not lower
than those of an office practice, but did not offer any code-level
details to support this statement.
Response: We appreciate the perspective of interested parties, but
we would need code-level PE details to evaluate potential code
valuation issues.
We received numerous comments on the Cataract and Retinal Surgery
codes which were nominated as potentially misvalued with a request to
establish nonfacility payment rates for these complicated 090-day
global surgical procedures.
Comment: Several commenters requested that CMS revise the current
work RVU for CPT code 66174 (Transluminal dilation of aqueous outflow
canal; without retention of device or stent) and instead use the
[[Page 69444]]
higher AMA RUC-recommended work RVU value or, short of that, transition
the valuation we established in the CY 2022 PFS final rule over 3
years.
Response: We thank commenters for this comment. CPT code 66174 was
reviewed and finalized in last year's rule (85 FR 65095), and we will
not consider this code as potentially misvalued for CY 2023. We did not
identify or propose CPT code 66174 as potentially misvalued in the
proposed rule. As such, this comment is outside the scope of the
proposed rule.
Comment: Many commenters recounted the evolution of these Cataract
and Retinal Surgery codes--once exclusively performed in hospital
operating theaters, then performed in ASCs, and now perhaps maturing
into the next phase of eye care and Office-Based Surgeries (OBS).
Commenters were mainly in favor of establishing payment amounts for
these services in the non-facility office setting, which would
recognize the additional PE resources involved in furnishing the
services in those settings. Commenters also stated that there are
significant advantages to be gained when these cataract and retinal
surgery services are furnished in non-facility office settings. OBS may
offer faster scheduling and coordinating with the surgeon, patient, and
patient's family caretaker, since they bypass additional schedule
coordination, and avoid potential staffing or availability issues with
the hospital or ASC operating room. These commenters suggested that
scheduling activities may be more efficient and flexible in the OBS
setting, leading to fewer and shorter delays in delivering these
Cataract and Retinal Surgeries to alleviate the patient's urgent eye
problem (especially during recent COVID-19-related restrictions). The
commenters also suggested that office-based surgical staff are also
more likely to be familiar to the patient than a hospital operating
room or ASC staff. One commenter offered that organizations, such as
the American Association for Accreditation of Ambulatory Surgery
Facilities (AAAASF), may offer accreditation for practitioners
interested in furnishing OBS for these services, to prove they can
demonstrate they have adequate equipment, adequate sterility, adequate
backup power and lights, adequate clinical surgery personnel, and
adequate emergency personnel, should there be a need for them, compared
to hospital operating rooms or ASCs, possibly maintaining
certifications with periodic re-inspections.
Some Hospital/ASC-based commenters noted that, after decades of
ophthalmologist experience with these Cataract and Retinal Surgery
codes, they had a number of concerns about these services shifting
toward office-based surgeries compared with Hospital/ASC settings and
whether OBS can adequately address these concerns, including: (1)
Sterility controls equal or better than a hospital operating room or a
dedicated ASC operating theater; (2) Anesthesia for the OBS that is
different in the office where valium oral sedation may be used and the
patient being monitored by the physician eye surgeon, rather than in an
O.R. with general sedation via IV administered and monitored by an
anesthesiologist; (3) Equipment quality and maintenance is a concern
and in the smaller typical office setting, there may not be the backups
and redundancies that may be found in the larger facility settings,
with automatic emergency power switchovers that may not be installed
for the OBS; (4) Patient complications being detected in the pre-
screening phase, possible complications occurring during the surgical
procedure phase, and possible complications during the post-procedure
phase, are concerns for the OBS, which may not have the full facility
resources to address emergency situations arising from the office based
surgery; (5) Staff for OBS are likely to be well familiar with eye
surgeries and the patients themselves, but a general O.R. or ASC staff
might be more experienced in responding to a wider range of surgical
related complications; (6) The intricate, delicate, and complicated
surgical procedures performed by varying experienced eye surgeons
remains a concern when these procedures are performed outside of a full
facility operating theater; (7) There is considered by some commenters
to be a paucity of independent, high-quality, peer-reviewed clinical
data supporting the safety or feasibility of retina surgery performed
in an office setting, nor do they believe that there is any widespread
demand by retina specialists or patients for this OBS option.
Response: We appreciate commenters' perspectives regarding their
experience and concerns for Cataract and Retinal Surgeries being
furnished as OBS. As we continue to consider how and where these
services are furnished, and whether they are typically furnished in
different settings, information such as the comments provided by these
and other commenters are helpful. Based upon commenters' feedback, we
have concerns about these services being furnished in non-facility
settings. It is also unclear whether these services are routinely being
furnished outside of facility settings. CMS will continue to evaluate
whether these services are being furnished in non-facility settings and
will consider establishing non-facility values for these services at
that time.
Comment: The AMA RUC commented that it defers to the ophthalmology
and retinal specialty societies to determine whether these services
could be safely performed in the non-facility setting; the specialty
societies recommend against CMS moving forward with making these
services payable as OBS, citing many of the same commenters' concerns
listed earlier in this section.
Response: We appreciate the AMA RUC's response to this issue,
explaining that they defer to the specialty societies' position on this
issue.
After consideration of public comments, we will continue to gather
information concerning Cataract and Retinal Surgeries in the non-
facility office settings and their implications to Medicare payment for
future rulemaking.
We received a few public comments on the nominated CPT code 20931
(Allograft, structural, for spine surgery only (add-on code)) and other
codes related to anterior cervical discectomy and fusion (ACDF).
Comment: One commenter agreed with the nominator that CPT code
20931 is misvalued when compared to CPT code 22853 (Insertion of cage
or mesh device to spine bone and disc space during spine fusion (add-on
code)) and other codes related to anterior cervical discectomy and
fusion (ACDF), where the higher payment for CPT code 22853
inappropriately incentivizes surgeons to insert the synthetic cage
spacer over the bone allograft. However, one commenter stated that
there is no evidence that CPT code 20931 is misvalued, and that the
valuation of CPT code 20931 should not be equivalent to CPT code 22853.
Response: We thank these commenters for their feedback. As this
nomination is almost identical to a grouping of related codes for ACDF
that had been presented in the CY 2022 PFS proposed rule (86 FR 65044),
under CPT code 22551 as misvalued, and as it was discussed at that time
and reviewed again in this rule, we do not believe that the nominator
has provided sufficient evidence to demonstrate that CPT code 20931 is
misvalued nor that this code's payment should be made equivalent to CPT
code 22853. As stated earlier, our determination that one or more codes
are potentially misvalued generally revolves around the specific RVUs
assigned to individual codes, or with the inter-code relativity between
the
[[Page 69445]]
RVUs assigned to several individual codes found within a family of
codes with hierarchical relationships. We generally do not examine the
summed differences in total RVUs (as is the case presented here), based
on billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator or other
interested parties have provided sufficient evidence to demonstrate
that CPT code 20931 itself is misvalued, and therefore, we are not
inclined to propose (or adopt) this code as potentially misvalued.
After consideration of public comments, we are finalizing our
proposal not to adopt any of the nominated codes as potentially
misvalued codes. We encourage commenters who wish to nominate codes as
potentially misvalued to consider the types of supporting documentation
listed in the beginning of this section, as that information is
important for us to consider in our process for reviewing nominations
of potentially misvalued codes.
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 (Sec. 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
Telehealth Services List to one of the following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current Medicare Telehealth Services List. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits. Some examples of other clinical benefits that we consider
include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
In the CY 2021 PFS final rule (85 FR 84507), we created a third
category of criteria for adding services to the Medicare Telehealth
Services List on a temporary basis following the end of the PHE for the
COVID-19 pandemic: Category 3. This new category describes services
that were added to the Medicare Telehealth Services List during the PHE
for which there is likely to be clinical benefit when furnished via
telehealth, but there is not yet sufficient evidence available to
consider the services for permanent addition under the Category 1 or
Category 2 criteria. Services added on a temporary, Category 3 basis
will ultimately need to meet the criteria under Category 1 or 2 in
order to be permanently added to the Medicare Telehealth Services List.
To add specific services on a Category 3 basis, we conducted a clinical
assessment to identify those services for which we could foresee a
reasonable potential likelihood of clinical benefit when furnished via
telehealth. We considered the following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns for patient safety if the service is furnished as a
telehealth service.
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns about whether the provision of the service via
telehealth is likely to jeopardize quality of care.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio-video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare Telehealth Services List using
the Category 3 criterion described above. We assessed codes that were
temporarily available on the list for the duration of the PHE to
determine their appropriateness for inclusion on the Medicare
Telehealth Services List on a Category 3 basis. We have reassessed the
services that are temporarily available via telehealth for the PHE,
based on both information provided by interested parties and our own
internal review. We have assessed whether or not these services can,
outside of the circumstances of the PHE, be furnished using the full
scope of service elements via two-way, audio-video communication
technology, without jeopardizing patient safety or quality of care, and
we now believe that there are additional services that would be
appropriate for addition to the Medicare Telehealth Services List on a
Category 3 basis that we did not identify in the CY 2021 rulemaking. In
the proposed rule, we proposed to add these additional services to the
Medicare Telehealth Services List on a Category 3 basis, as further
discussed below.
[[Page 69446]]
The Medicare Telehealth Services List, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Beginning in CY 2019, we stated that for CY 2019 and onward, we
intend to accept requests through February 10, consistent with the
deadline for our receipt of code valuation recommendations from the RUC
(83 FR 59491). For CY 2023, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2022. Each request to add a service to the Medicare
Telehealth Services List must have included any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the Medicare Telehealth Services List,
requesters are advised that any information submitted as part of a
request is subject to public disclosure for this purpose. For more
information on submitting a request in the future to add services to
the Medicare Telehealth Services List, including where to submit these
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2023
Under our current policy, we add services to the Medicare
Telehealth Services List on a Category 1 basis when we determine that
they are similar to services on the existing Medicare Telehealth
Services List for the roles of, and interactions among, the
beneficiary, physician (or other practitioner) at the distant site and,
if necessary, the telepresenter. As we stated in the CY 2012 PFS final
rule with comment period (76 FR 73098), we believe that the Category 1
criterion not only streamlines our review process for publicly
requested services that fall into this category, but also expedites our
ability to identify codes for the Medicare Telehealth Services List
that resemble those services already on the Medicare Telehealth
Services List. We add services on a Category 2 basis when the service
does not fall within Category 1, and based upon our assessment of
whether the services are accurately described by the corresponding code
when delivered via telehealth and whether the use of a
telecommunications system to deliver the service produces demonstrated
clinical benefit to the patient. We add services on a temporary
Category 3 basis when the services were temporarily included on the
Medicare Telehealth Services List during the PHE, and we find that
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition under the Category 1 or Category 2
criteria.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2023. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare Telehealth Services List. We also assessed the
appropriateness of adding these services to the Medicare Telehealth
Services List on a Category 3 basis instead.
We did not propose changes to the length of time the services that
we temporarily included on a Category 3 basis will remain on the
Medicare Telehealth Services List; the services we temporarily included
on the Medicare Telehealth Services List on a Category 3 basis will
continue to be included through the end of CY 2023. In the CY 2023 PFS
proposed rule, we noted that in the event that the PHE extends well
into CY 2023, we may consider revising this policy.
We proposed to add some services to the Medicare Telehealth
Services List on a Category 3 basis through the end of 2023, some of
which we had not previously added to the Medicare Telehealth List
during the PHE, but have been added on a subregulatory basis as
provided in Sec. 410.78(f) of our regulations. For some of these
services, we received information from interested parties suggesting
potential clinical benefit. For others, we continue to believe there is
sufficient evidence of potential clinical benefit to warrant allowing
additional time for interested parties to gather data to support their
possible inclusion on the Medicare Telehealth Services List on a
Category 1 or 2 basis. The Medicare Telehealth Services List requests
for CY 2023 are listed in Table 11.
Additionally, the Consolidated Appropriations Act, 2022 (CAA, 2022)
(Pub. L. 117-103, March 15, 2022) amended section 1834(m) of the Act to
extend a number of flexibilities that are in place during the PHE for
COVID-19 for 151 days after the end of the PHE. To align the
availability of these services with those flexibilities extended under
the Act, we proposed to continue to allow certain telehealth services
that would otherwise not be available via telehealth after the
expiration of the PHE to remain on the Medicare Telehealth Services
List for 151 days after the expiration of the PHE.
BILLING CODE 4150-28-P
[[Page 69447]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.013
[[Page 69448]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.014
[[Page 69449]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.015
BILLING CODE 4150-28-C
We remind interested parties that the criterion for adding services
to the Medicare Telehealth Services List under Category 1 is that the
requested services are similar to professional consultations, office
visits, and/or office psychiatry services that are currently on the
Medicare Telehealth Services List, and that the criterion for adding
services under Category 2 is that there is evidence of clinical benefit
if provided as telehealth. As explained below, we find that none of the
requested services listed in Table 11 met the Category 1 or 2 criteria.
We received a request to permanently add CPT code S9443 (Lactation
classes, non-physician provider, per session) to the Medicare
Telehealth Services List. This service has a status code of ``I,''
which means that it is not valid for Medicare billing purposes. We
understand that this is a temporary code established by a private payor
for private payor use, and thus, it is not valid for nor payable by
Medicare. As such, this code is not separately billable under the PFS.
We generally do not add services to the Medicare Telehealth Services
List unless they are separately billable under the PFS. Outside of the
circumstances of the PHE, the Medicare Telehealth Services List only
includes services that are covered if they are furnished without the
use of telecommunication technology in-person. Because CPT code S9443
is not billable under the PFS when furnished in-person, we do not
believe it would be appropriate to allow the service to be billed
separately when furnished as a Medicare telehealth service. As noted in
the CY 2018 PFS final rule (82 FR 53011), if a service does not
describe a service typically furnished in-person, it would not be
considered a telehealth service under the applicable provisions of the
statute. We did not propose to add CPT code S9443 to the Medicare
Telehealth Services List.
Comment: A commenter requested that this code (CPT code S9443) be
added on a Category 3 basis, citing financial pressures and staff
shortages, which are affecting labor and delivery units.
Response: We thank the commenter for this comment, but as noted in
the proposed rule, this code is not separately billable under the PFS
when furnished in-person, so we do not believe that it should be
considered a telehealth service within the meaning of the statute. We
continue to believe it would be inappropriate to allow CPT code S9443
to be billed separately when furnished as a Medicare telehealth
service, and we are finalizing our proposal not to add CPT code S9443
to the Medicare Telehealth Services List.
(1) Therapy Services
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations: CPT codes
97161-97164; Therapy Personal Care services: CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services: CPT codes
97750, 97755, and 97763, to the Medicare Telehealth Services List on a
Category 1 basis.
In the CY 2022 PFS final rule (86 FR 65051), we determined that
these services did not meet the Category 1 criteria for addition to the
Medicare Telehealth Services List because they involve direct
observation and/or physical contact between the practitioner and the
patient and, in many instances, are therapeutic in
[[Page 69450]]
nature, and that they did not meet Category 2 criteria, because we
thought that the request did not provide sufficient detail to determine
whether all of the necessary elements of the service could be furnished
remotely. We continue to believe this is the case. We still do not have
sufficient information to determine whether these services meet the
Category 2 criteria. However, we noted that some of these codes,
including codes 97110, 97112, 97116, 97150, 97530, 97161-97164, 97535,
97542, 97750, and 97755 have been added to the list on a temporary
basis for the duration of the PHE.
In assessing the evidence that was supplied by interested parties
in support of adding these services to the Medicare Telehealth Services
List on a Category 2 basis, we concluded that there was not sufficient
information to determine whether all of the necessary elements of these
services could be furnished remotely. Information regarding safety,
appropriateness, and that indicates that all elements of a given CPT
code can be furnished via telehealth is still needed to assess whether
these services meet the Category 2 criteria. However, we also believe
that the therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE (including CPT codes
97150, 97530, and 97542), but are not currently included on a Category
3 basis, may continue to be furnished safely via two-way, audio-video
communication technology outside of the circumstances of the PHE.
Therefore, we proposed that CPT codes 97150, 97530, and 97542 (the
set of therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE) be added to the
Medicare Telehealth Services List through the end of CY 2023 on a
temporary, Category 3 basis, to allow time to gather additional data
that could support their possible inclusion on the list on a permanent
basis. CPT codes 97110, 97112, 97116, 97161-97168, 97535, 97750, and
97755 will continue to be available on the Medicare Telehealth Services
List on a Category 3 basis. We anticipate that keeping these services
on the Medicare Telehealth Services List on a Category 3 basis, as
proposed, through the end of CY 2023 would preserve access to care and
promote health equity, and based on information provided by interested
parties and internal review, we believe that they may safely be
furnished as telehealth outside of the circumstances of the PHE through
the end of CY 2023. However, we remind readers that the practitioners
who primarily furnish these services, physical therapists, are not,
outside the circumstances of the PHE (and the 151-day period following
the expiration of the PHE), authorized to furnish Medicare telehealth
services. We noted that, if the PHE and the 151-day period following
the expiration of the PHE both end in CY 2023, the pre-PHE rules will
take effect, and these services could no longer be furnished by
therapists as Medicare telehealth services.
Certain other requested therapy services, namely CPT codes 97537,
97763, 90901, and 98960-98962 were not on the Medicare Telehealth
Services List prior to June 16, 2022; however, we added these services
to the Medicare Telehealth Services List on a temporary basis during
the PHE, in accordance with Sec. 410.78(f). As explained below in
section II.D.1.d. of this final rule, services included on the Medicare
Telehealth Services List on a temporary basis during the PHE that have
not been added to the list on a Category 3 basis will remain on the
list for 151 days following the end of the PHE. Furthermore, we
proposed to add CPT codes 97537, 97763, 90901, and 98960-98962 to the
Medicare Telehealth Services List on a Category 3 basis through the end
of CY 2023. Our clinical analyses of these services indicate that they
can be furnished in full using two-way, audio and video technology
during the circumstances of the PHE, and information provided by
requestors indicates that there may be clinical benefit; however, there
is not yet sufficient evidence available to consider the services for
permanent addition to the Medicare Telehealth Services List under the
Category 1 or Category 2 criteria. Including these services on the
Medicare Telehealth Services List during the PHE and through CY 2023
will allow additional time for the development of evidence for CMS to
consider when evaluating these services for potential permanent
addition to the Medicare Telehealth Services List on a Category 1 or 2
basis. We continue to encourage commenters to supply additional
information in support of adding these services to the Medicare
Telehealth Services List on a permanent basis, including information
regarding the safety and appropriateness of furnishing these services
via telehealth.
Comment: Several commenters supported our addition of the listed
therapy services to the Medicare Telehealth Services List on a Category
3 basis. However, commenters stated that many of these codes should be
added permanently; commenters specifically stated that therapy
services, including CPT codes 97110, 97112, 97116, 97150, 97161-97164,
97530, 97535, 97537, 97542, 97750, 97755, 97763, 90901, 98960, 98961,
and 98962 should be added permanently, stating that these codes have
been used successfully to provide telehealth services throughout the
PHE and have shown that the same quality of care can be given with
equal or higher levels of patient satisfaction as in-person visits.
According to these commenters, the PHE has given ample data to support
that, when used appropriately, telehealth can have a positive effect on
outcomes for patients who are restricted from a full course of in-
person therapy visits, which they claim is at a lower cost of care, and
the inclusion of these therapy service codes on the Medicare Telehealth
Services List on a Category 1 or Category 2 basis would preserve access
to these services beyond the temporary extension and ease
administrative burden should Congress act in the future to make
rehabilitation services delivered via telehealth permanent.
Response: We note that all of the above-mentioned therapy services
are either currently on the Medicare Telehealth Services List on a
Category 3 basis, or we have proposed to add them on a Category 3 basis
for CY 2023, to continue to gather data with regard to likely clinical
benefit when furnished via telehealth outside of the circumstances of
the PHE. We continue to believe that the process as discussed in the CY
2021 PFS final rule (85 FR 84506 through 84509), whereby we created the
Category 3 basis for adding to or deleting services from the Medicare
Telehealth Services List is the appropriate means of potentially adding
services permanently for those services that were temporarily added
under the circumstances of the PHE, as this process allows for the
collection and evaluation of data that could potentially support
permanent inclusion following the 151-day period after the end of the
PHE. We believe our proposal, consistent with the amendments made by
provisions of the CAA, 2022, to extend the period that these services
will be available on the Medicare Telehealth Services List temporarily
for the PHE by 151 days following the end of the PHE will further
enhance the opportunity for the collection of information on the
experiences of clinicians who are furnishing telehealth services during
the PHE for COVID-19. This will also help us to determine which
services may ultimately be eligible for permanent addition under
Category 1 or Category 2 criteria, and we encourage interested parties
to use this
[[Page 69451]]
extended time period to gather data on use of services, that is more
than statements of support and more than subjective attestations of
clinical benefit, to support their potential addition in future
rulemaking.
Comment: Commenters requested clarification on whether CPT codes
for Occupational Therapy (97165, 97166, 97167, and 97168) and Speech
Therapy (92522 and 92523) were included in the list of Category 3 codes
for CY 2023, and should be added on a Category 3 basis.
Response: We clarify that these codes (CPT codes 97165-97168 and
92521-92524) are currently included on the Medicare Telehealth Services
List available on a Category 3 basis.
After consideration of public comments, we are finalizing our
proposed addition of CPT codes 90901, 97150, 97530, 97537, 97542,
97763, and 98960-98962 to the Medicare Telehealth Services List on a
Category 3 basis.
(2) Telephone E/M Services
We have also received requests to temporarily add Telephone E/M
visit codes, CPT codes 99441, 99442, and 99443 to the Medicare
Telehealth Services List on a Category 3 basis. In the March 31, 2020
interim final rule with comment period (IFC), we established separate
payment for audio-only telephone E/M services (85 FR 19264 through
19266) for the duration of the PHE for the COVID-19 pandemic. Although
these services were previously considered non-covered under the PFS, in
the context of the PHE for COVID-19 and with the goal of reducing
exposure risks associated with COVID-19 (especially in situations when
two-way, audio and video technology is not available to furnish a
Medicare telehealth service), we believed there were circumstances
where prolonged, audio-only communication between the practitioner and
the patient could be clinically appropriate, yet not fully replace a
face-to-face visit. In the May 8, 2020 COVID-19 IFC, we noted that
interested parties had informed us that use of audio-only services was
more prevalent than we had previously considered, especially because
many beneficiaries were not using video-enabled communication
technology from their homes. In other words, there were many cases
where practitioners who would ordinarily furnish audio-video telehealth
or in-person visits to evaluate and manage patients' medical concerns
were instead using audio-only interactions to manage more complex care
(85 FR 27589 through 27590). While we had previously acknowledged the
likelihood that, under the circumstances of the PHE for COVID-19, more
time would be spent interacting with the patient via audio-only
technology, we stated that the intensity of furnishing an audio-only
visit to a beneficiary during the unique circumstances of the PHE for
COVID-19 was not accurately captured by the valuation of these services
that we established in the March 31, 2020 IFC (85 FR 27590). This will
be particularly true to the extent that these audio-only services are
serving as a substitute for office/outpatient (O/O) Medicare telehealth
visits for beneficiaries not using video-enabled telecommunications
technology, which is contrary to the situation we anticipated when
establishing separate payment for them in the March 31, 2020 IFC. In
the May 8, 2020 COVID-19 IFC, we stated that, given our understanding
that these audio-only services were being furnished primarily as a
replacement for care that would otherwise be reported as an in-person
or telehealth visit using the O/O E/M codes, we established new RVUs
for the telephone E/M services based on crosswalks to the most
analogous O/O E/M codes, based on the time requirements for the
telephone codes and the times assumed for valuation for purposes of the
O/O E/M codes. Specifically, we crosswalked the levels 2-4 O/O E/Ms for
established patients, as described by CPT codes 99212, 99213, and
99214, to CPT codes 99441, 99442, and 99443, respectively.
Additionally, we stated that, given our understanding that these audio-
only services were being furnished as substitutes for O/O E/M services,
we recognized that they should be considered as telehealth services,
and added them to the Medicare Telehealth Services List for the
duration of the PHE for COVID-19 (85 FR 27590).
In the CY 2022 PFS final rule (86 FR 65055), in response to
requests that these codes be added to the Medicare Telehealth Services
List on a Category 3 basis, we stated that we were finalizing a change
to the definition of ``telecommunications system'' to allow telehealth
services for the diagnosis, evaluation, and treatment of mental health
conditions to be furnished through audio-only technology in certain
circumstances after the end of the PHE. For example, the O/O E/M codes
are on the Medicare Telehealth Services List permanently and when used
to describe care for mental health conditions, will be reportable when
furnished via audio-only technology to patients in their homes. Since
audio-only telecommunications technology can be used to furnish mental
health telehealth services to patients in their homes, the addition of
these codes to the Medicare Telehealth Services List is unnecessary for
mental health telehealth services. For telehealth services other than
mental health care, we stated that we believe that two-way, audio-video
communications technology is the appropriate standard that will apply
for telehealth services after the PHE ends. Further, we noted that
section 1834(m)(2)(A) of the Act requires that payment to a distant
site physician or practitioner that furnishes Medicare telehealth
services to an eligible telehealth individual be equal to the amount
that would have been paid under Medicare if such physician or
practitioner had furnished the service without a telecommunications
system. We believe that the statute requires that telehealth services
be so analogous to in-person care such that the telehealth service is
essentially a substitute for a face-to-face encounter. However, these
audio-only telephone E/M services are inherently non-face-to-face
services, since they are furnished exclusively through remote, audio-
only communications. Outside the circumstances of the PHE, the
telephone E/M services would not be analogous to in-person care; nor
would they be a substitute for a face-to-face encounter. Therefore, we
do not believe it will be appropriate for these codes to remain on the
Medicare Telehealth Services List after the end of the PHE and the 151-
day post-PHE extension period. Accordingly, we did not propose to keep
these telephone E/M services on the Medicare Telehealth Services List
after that period on a Category 3 basis, because the codes describe
services that can only be furnished using audio-only telecommunications
technology, and outside of the circumstances of the PHE, they do not
describe services that are a substitute for an in-person visit. While
we acknowledge that audio-only technology can be used to furnish mental
health telehealth services to patients in their homes under certain
circumstances after the PHE ends, two-way, audio-video communications
technology continues to be the appropriate standard that will apply for
Medicare telehealth services after the PHE and the 151-day extension
period. As we noted in the CY 2021 PFS final rule (85 FR 84535), we
will assign these Telephone E/M visit codes (CPT codes 99441, 99442,
and 99443) a ``bundled'' status after the end of the PHE and the 151-
day extension period, and we will post the RUC-recommended RVUs for
[[Page 69452]]
these codes in accordance with our usual practice.
We received public comments on Telephone E/M Services. The
following is a summary of the comments we received and our responses.
Comment: Many commenters urged us to continue to make payment for
Telephone E/M visit codes following 151 days after the PHE. Some
commenters stated that payment for these services should be made
permanent while others request that they be added to the Medicare
Telehealth Services List on a Category 3 basis. Commenters stated that
experience during the PHE indicated that telehealth can provide a
viable alternative to office visits. Commenters stated that, although
patient-provider communication using both audio and visual modes is
considered optimal for telehealth delivery, many patients are unable to
use the video technology required due to lack of broadband or cellular
data, technology that does not support video, or difficulty in using
video technology. Commenters cited access concerns, particularly for
patients who live in rural areas or who lack of broadband access, as
well as disparities in access to technology and in digital literacy.
A commenter noted that, in the CY 2023 PFS proposed rule, CMS
further stated that telephone E/M services are neither analogous to an
in-person E/M visit nor can the telephone E/M substitute for an in-
person E/M visit. However, as noted above, in the second IFC, CMS did
believe telephone E/Ms were serving as a substitute for in-person E/M
visits, and because of that, began to reimburse them the same rate as
in-person E/M visits. Commenters noted that this would indicate they
are analogous to an in-person service and would fit the criteria to be
on the Medicare Telehealth Services List permanently.
Response: We reiterate that we believe these audio-only telephone
E/M services are inherently non-face-to-face services, since they are
furnished exclusively through remote, audio-only communications. We
continue to believe that, outside the circumstances of the PHE, these
services will no longer serve as a substitute for in-person care that
is ordinarily furnished in a face-to-face encounter. Section 1834(m)(1)
of the Act requires that we make payment for telehealth services
``notwithstanding that the individual physician or practitioner
providing the telehealth service is not at the same location as the
beneficiary.'' Section 1834(m)(2)(A) of the Act requires that we make
payment to a physician or practitioner located at a distant site for a
telehealth service at an amount equal to the amount that the physician
or practitioner would have been paid if the service had instead been
furnished without the use of a telecommunications system. Taken
together, we believe that the statute requires that Medicare telehealth
services be analogous to in-person care such that the telehealth
service is essentially a substitute for a face-to-face encounter. We
recognize that we added the telephone E/M services to the Medicare
Telehealth Services List on a temporary basis during the PHE to address
the associated extraordinary public health and safety, and healthcare
access issues. However, outside of the circumstances of the PHE, we
continue to believe that our longstanding regulatory interpretation of
``telecommunications system'' generally precludes the use of audio-only
technology for purposes of Medicare telehealth services, with the
exception under certain circumstances of telehealth services to
diagnose, evaluate, or treat a mental health disorder (including
treatment of a diagnosed SUD or co-occurring mental health disorder).
That rule and the exception are specified in our regulation at Sec.
410.78(a)(3). At the conclusion of the PHE and the 151-day extension
period provided by the CAA, 2022, the only Medicare telehealth services
that will be permitted to be furnished using audio-only technology will
be the mental health telehealth services. When a practitioner furnishes
such an E/M service using audio-only technology, they would bill for
the same service they would bill if the service had been furnished in
person. As such, there is not a need to add the telephone-only E/M
codes to the Medicare Telehealth Services List for this purpose.
Comment: A commenter stated that, if CMS removes the telephone E/M
CPT codes 99441-99443 from the Medicare Telehealth Services List on the
152nd day after the PHE ends, CMS should then create and establish
particular values for a third and higher level of virtual check-in
service that would be similar to the telephone E/M services that have
been available during the PHE. The commenter is requesting that this
third virtual check-in code would crosswalk to CPT code 99443, and
should assign RVUs to HCPCS codes G2012 (Brief communication
technology-based service, e.g. virtual check-in, by a physician or
other qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related e/m service provided within the previous 7
days nor leading to an e/m service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion), G2252 (Brief communication technology-based service, e.g.
virtual check-in, by a physician or other qualified health care
professional who can report evaluation and management services,
provided to an established patient, not originating from a related e/m
service provided within the previous 7 days nor leading to an e/m
service or procedure within the next 24 hours or soonest available
appointment; 11-20 minutes of medical discussion), and a third
potential check-in code with crosswalks to CPT codes 99441-99443,
respectively.
Response: We appreciate the comment and may consider potential
coding revisions for future rulemaking. However, we believe that, in
light of the fact that the virtual check-in codes are intended for
practitioners to have a non-face-to-face discussion with a patient to
determine the need for care, the necessity for a longer virtual check-
in (for example, 21-30 minutes) is not clear. Moreover, if a patient
requires evaluation and management (E/M) services that are sufficiently
complicated to last longer than the 11-20 minutes considered in HCPCS
code G2252, then there are many other E/M visit codes that are already
available as Medicare telehealth.
After consideration of public comments, we are finalizing our
proposal not to add these CPT codes 99441-99443 to the Medicare
Telehealth Services List on a Category 3 basis; rather, we will retain
CPT codes 99441-99443 on the Medicare Telehealth Services List through
expiration of the 151-day period following the end of the PHE, at which
point they will revert to bundled status.
(3) GI Tract Imaging and Continuous Glucose Monitoring
We received requests to add CPT codes describing GI Tract Imaging,
CPT code 91110 (Gastrointestinal tract imaging, intraluminal (e.g.,
capsule endoscopy), esophagus through ileum, with interpretation and
report) and Ambulatory Continuous Glucose Monitoring, CPT code 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; analysis,
interpretation and report), to the Medicare Telehealth Services List on
a Category 3 basis. We believe these codes may describe services that
are inherently non-face-to-face services, (the patient need not be
[[Page 69453]]
present in order for the service to be furnished in its entirety), and
therefore, they do not describe services that are a substitute for an
in-person visit. As stated earlier, we believe that the statute
requires that telehealth services be so analogous to in-person care
such that the telehealth service is essentially a substitute for a
face-to-face encounter. For this and other reasons, we did not propose
to add these services to the Medicare Telehealth Services List on a
Category 3 basis; we do not believe these CPT codes describe services
that are a substitute for an in-person visit, and we believe that
services that are not inherently face-to-face services are not services
that can be furnished as Medicare telehealth services. Even so, we are
interested in information that would help us to understand whether
these services would meet the criteria for inclusion on the Medicare
Telehealth Services List either for the PHE, as Category 3 services, or
permanently on a Category 1 or 2 basis, given our questions as to
whether they are inherently non-face-to-face services, and therefore,
may not fit within the scope of services that could be furnished as
Medicare telehealth services. Therefore, we also solicited comment on
whether these services would involve an in-person service when
furnished without the use of a telecommunications system.
We received public comments on GI Tract Imaging and Continuous
Glucose Monitoring. The following is a summary of the comments we
received and our responses.
Comment: A commenter agreed that CPT code 91110 describes a service
that is inherently a non-face-to-face service, as the patient is not
present in order for the service to be furnished in its entirety. The
commenter described the services as involving swallowing a capsule
camera that captures images of the gastrointestinal tract, which are
recorded on the capsule and subsequently reviewed by the clinician
using special computer software. The commenter stated that the
ingestion of the capsule is the only component of this service that
requires direct observation by a health care provider. The commenter
noted that less than 10 percent of the service time/work associated
with CPT code 91110 involves any direct interaction with the patient,
and the small amount of patient interaction can be done safely and
effectively via a telehealth visit with video, per the FDA clearance.
According to one commenter, since the capsule service should only
be offered to an established patient, an in-person interaction to
administer the capsule is unnecessary and the patient can safely do so
in the home setting.
Response: We appreciate this background information from the
commenters. Given that this service describes collection,
interpretation, and reporting, we believe this code describes services
that are not inherently non-face-to-face, and therefore, they do not
describe a service that is a substitute for an in-person visit.
Additionally, the face-to-face portion of the service would require the
patient to be physically present.
Comment: Some commenters agreed with CMS' assessment that
Ambulatory Continuous Glucose Monitoring, CPT code 95251, is an
inherently non-face-to-face service, and therefore, does not describe a
service that is a substitute for an in-person visit. CPT code 95251
does not involve an in-person visit when furnished without the use of a
telecommunications system.
One commenter opposed our proposal not to add CPT code 95251 to the
Medicare Telehealth Services List on a Category 3 basis, citing the
importance of this service in treating gestational diabetes, saying CMS
should add CPT code 95251 to the list on a Category 3 basis when it is
billed with CPT codes 99213 (Established patient office or other
outpatient visit, 20-29 minutes) or 99214 (Established patient office
or other outpatient visit, 30-39 minutes) and the appropriate modifier.
Another commenter cited 2020 claims data that shows CPT code 95251 is
billed 8.2 percent and 62.6 percent of the time with CPT codes 99213
and 99214, respectively, demonstrating that this service is typically
performed face-to-face.
Response: We appreciate the comments. We continue to believe, and
commenters have confirmed, that CPT code 95251 is not a substitute for
an in-person visit, as this code describes physician analysis,
interpretation, and reporting, which does not inherently describe a
face-to-face encounter. Accordingly, this code does not describe a
service that, when conducted via telehealth, is a substitute for a
face-to-face service. As noted in the CY 2018 PFS final rule (82 FR
53011), if a service does not describe a service typically furnished
in-person, it would not be considered a telehealth service under the
applicable provisions of the statute.
After consideration of public comments, we are finalizing our
proposal not to add CPT code 91110 or CPT code 95251 to the Medicare
Telehealth Services List on a Category 3 basis.
(4) Neurostimulator Pulse Generator/Transmitter
We received requests to add codes describing the electronic
analysis of an implanted neurostimulator pulse generator/transmitter to
the Medicare Telehealth Services List. These included a request to add
CPT codes 95976 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with simple
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) and 95977
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with complex
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) permanently
on a Category 1 basis, as well as a request to add CPT codes 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain,
cranial nerve, spinal cord, peripheral nerve, or sacral nerve,
neurostimulator pulse generator/transmitter, without programming),
95983 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, first 15
[[Page 69454]]
minutes face-to-face time with physician or other qualified health care
professional), and 95984 (Electronic analysis of implanted
neurostimulator pulse generator/transmitter (e.g., contact group[s],
interleaving, amplitude, pulse width, frequency [Hz], on/off cycling,
burst, magnet mode, dose lockout, patient selectable parameters,
responsive neurostimulation, detection algorithms, closed loop
parameters, and passive parameters) by physician or other qualified
health care professional; with brain neurostimulator pulse generator/
transmitter programming, each additional 15 minutes face-to-face time
with physician or other qualified health care professional (List
separately in addition to code for primary procedure)) to the Medicare
Telehealth Services List on a temporary Category 3 basis.
The request to add CPT codes 95976 and 95977, which are codes that
describe analysis of cranial nerve neurostimulation, indicated that the
ability to fully furnish this service using two-way, audio-video
communication technology was forthcoming, but is currently unavailable.
Therefore, we did not propose to add CPT codes 95976 and 95977 to the
Medicare Telehealth Services List, because the full scope of service
elements described by these codes cannot currently be furnished via
two-way, audio-video communication technology. However, we will
consider additional evidence regarding the ability to furnish these
services as telehealth services, such as information indicating that
current technology has evolved, as it becomes available for future
rulemaking. We also did not propose to add them on a Category 1 basis
because they do not describe services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List.
With regard to CPT codes 95970, 95983, and 95984, which describe
general brain nerve neurostimulation, we have some concerns about
whether the full scope of service elements could be furnished via two-
way, audio-video communication technology, particularly since it is
unclear whether the connection between the implanted device and the
analysis/calibration equipment can be done remotely. Additionally, we
are concerned about the immediate safety of the patient if the
calibration of the neurostimulator were done incorrectly or if some
other problem occurred. However, we did include these services on the
Medicare Telehealth Services List on a temporary basis during the PHE,
and Medicare claims data suggest that these services are being provided
via telehealth. Based on this information, we believe there is some
possible clinical benefit for these services when furnished via
telehealth; however, there is not yet sufficient evidence available to
consider the services for permanent addition to the Medicare Telehealth
Services List under the Category 1 or Category 2 criteria. With that
said, CPT codes 95970, 95983, and 95984 do meet the criteria for
temporary inclusion on the Medicare Telehealth Services List on a
Category 3 basis. Therefore, we proposed to add CPT codes 95970, 95983,
and 95984 to the Medicare Telehealth Services List on a Category 3
basis, while we solicited comment on our concerns regarding patient
safety and whether these services are appropriate for inclusion on the
Medicare Telehealth Services List outside the circumstances of the PHE.
Comment: Commenters agreed with CMS that the full scope of service
elements described by CPT codes 95976 and 95977 cannot currently be
furnished via two-way, audio-video communication technology, and they
state that the agency should reconsider these services for possible
addition to the Medicare Telehealth Services List as evidence develops
regarding the ability to furnish these services as telehealth services.
Response: We appreciate commenters' support for this proposal and
are finalizing our proposal to not add these services to the Medicare
Telehealth Services List.
Comment: Commenters supported our proposal to add CPT codes 95970,
95983, and 95984 to the Medicare Telehealth Services List on a Category
3 basis. Some commenters expressed disappointment that we did not
propose to add them to the Medicate Telehealth Services List
permanently. In response to our comment solicitation regarding patient
safety concerns, a commenter noted that the technology includes safety
features, including a prominent network status indicator that appears
on both the clinician's programmer, as well as the patient's device,
and the ``Protected Recovery Program'' (PRP) feature that ensures the
patient is returned to a known state if a remote session is
interrupted. According to one commenter, systems have been successfully
in use for over a year and a half that allow for a stable, secure 2-way
telehealth connection for brain stimulator pulse generator programming.
Commenters stated that these systems route through a secure HIPAA-
compliant server and allow the managing physician qualified health care
professional (QHP) to remotely control all essential functions of the
patient device while providing real time audio and video to allow for
patient assessment and feedback. The commenter noted that CMS' concerns
regarding patient safety if the programming is incorrect or if another
problem occurred have been addressed in the development and deployment
of existing remote brain neurostimulator programming systems. The
commenter stated that these systems ensure that the patient controller
has a ``safe'' program (set of stimulation parameters). In the event of
an interruption in the remote connection, they noted that the device
automatically reverts to this ``safe'' program, so that the patient is
not left with a potentially problematic set of programming parameters.
The commenter also noted that all elements can be fully and
effectively performed by a remotely located clinician using two-way,
audio/video telecommunication technology including direct programming
of implantable neurostimulator devices, and these services are critical
to the successful therapy regimens and health outcomes of people with
Parkinson's disease.
Response: We continue to believe that these services are most
appropriately added to the Medicare Telehealth Services on a Category 3
basis. Adding them on a Category 3 basis will allow the continued
collection of information through the experiences of clinicians who are
furnishing these services via telehealth during the PHE for COVID-19,
and help us to determine whether these services may ultimately be
eligible for addition to the Medicare Telehealth Services List on a
Category 1 or Category 2 basis. We encourage interested parties to use
this extended time period to gather data on these services to support
their potential addition to the Medicare Telehealth Services List on a
Category 1 or Category 2 basis in the future.
After consideration of public comments, we are finalizing our
proposals not to add CPT codes 95976 and 95977 to the Medicare
Telehealth Services List, and to add CPT codes 95970, 95983, and 95984
to the Medicare Telehealth Services List on a Category 3 basis.
(5) Emotional/Behavior Assessment Services and Psychological or
Neuropsychological Testing and Evaluation Services
We received requests to add a number of emotional/behavior
assessment services and psychological, or neuropsychological testing
and evaluation services, described by CPT codes 97151 (Behavior
identification assessment, administered by a
[[Page 69455]]
physician or other qualified health care professional, each 15 minutes
of the physician's or other qualified health care professional's time
face-to-face with patient and/or guardian(s)/caregiver(s) administering
assessments and discussing findings and recommendations, and non-face-
to-face analyzing past data, scoring/interpreting the assessment, and
preparing the report/treatment plan), 97152 (Behavior identification-
supporting assessment, administered by one technician under the
direction of a physician or other qualified health care professional,
face-to-face with the patient, each 15 minutes), 97153 (Adaptive
behavior treatment by protocol, administered by technician under the
direction of a physician or other qualified health care professional,
face-to-face with one patient, each 15 minutes), 97154 (Group adaptive
behavior treatment by protocol, administered by technician under the
direction of a physician or other qualified health care professional,
face-to-face with two or more patients, each 15 minutes), 97155
(Adaptive behavior treatment with protocol modification, administered
by physician or other qualified health care professional, which may
include simultaneous direction of technician, face-to-face with one
patient, each 15 minutes), 97156 (Family adaptive behavior treatment
guidance, administered by physician or other qualified health care
professional (with or without the patient present), face-to-face with
guardian(s)/caregiver(s), each 15 minutes), 97157 (Multiple-family
group adaptive behavior treatment guidance, administered by physician
or other qualified health care professional (without the patient
present), face-to-face with multiple sets of guardians/caregivers, each
15 minutes), 97158 (Group adaptive behavior treatment with protocol
modification, administered by physician or other qualified health care
professional, face-to-face with multiple patients, each 15 minutes),
0362T (Behavior identification supporting assessment, each 15 minutes
of technicians' time face-to-face with a patient, requiring the
following components: administration by the physician or other
qualified health care professional who is on site; with the assistance
of two or more technicians; for a patient who exhibits destructive
behavior; completion in an environment that is customized to the
patient's behavior.), and 0373T (Adaptive behavior treatment with
protocol modification, each 15 minutes of technicians' time face-to-
face with a patient, requiring the following components: administration
by the physician or other qualified health care professional who is on
site; with the assistance of two or more technicians; for a patient who
exhibits destructive behavior; completion in an environment that is
customized to the patient's behavior.) to the Medicare Telehealth
Services List permanently on a Category 2 basis. These services are
currently on the Medicare Telehealth Services List temporarily for the
duration of the PHE. We believe that, for these services, there is
likely to be clinical benefit when furnished via telehealth, and
therefore, they meet the criteria for temporary inclusion on a Category
3 basis. We did not identify these services during our initial
assessment of services that should be temporarily available on the
Medicare Telehealth Services List on a Category 3 basis in CY 2021
rulemaking; however, we proposed to include these services on the
Medicare Telehealth Services List on a Category 3 basis, in light of
information we received from the requestors describing the potential
clinical benefit of these services when furnished via telehealth.
However, we do have concerns regarding whether, outside the
circumstances of the PHE, the full scope of service elements can occur
in a manner that does not jeopardize quality of care, whether this
patient population could be fully assessed via interactive audio-video
technology, and whether these services could be conducted in a way that
maintains the safety of the beneficiary. This patient population often
includes patients with moderate to severe challenges in oral
communication, and they may require close observation of their
movements within all of their environmental cues, which include, for
instance, smell, sound, and colors around the room. We are concerned
that two-way, audio and video communications technology would not fully
capture these behavioral nuances. We believe more time may be necessary
to develop evidence that could support the decision to add these
services to the Medicare Telehealth Services List permanently on a
Category 1 or Category 2 basis. We solicited comment on our patient
safety concerns.
We received public comments on emotional/behavior assessment and
psychological or neuropsychological testing and evaluation services.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported the addition of these services
on a Category 3 basis. Some commenters suggested that the services
should be added permanently, rather than temporarily on a Category 3
basis.
One commenter urged us to permanently add CPT codes 97151, 97152,
97153, 97154, 97155, and 97156, but did not find sufficient evidence
supporting safe, effective telehealth delivery of the services
represented by codes 97157, 97158, 0362T, or 0373T; however, the
commenter supported our proposal to add the latter four codes on a
Category 3 basis.
A few commenters responded to our concerns regarding patient
safety, quality of care, and whether the full scope of service elements
can be met via two-way audio-video communication technology. In
response to our questions about regarding whether this patient
population can be assessed fully and safely via interactive audio-video
technology and our concerns that patients with moderate to severe
communication difficulties often require close observation of their
responses to cues in their environments (for example, odors, sounds,
colors) that could not be accomplished remotely via technology, a
commenter acknowledged our concerns, but noted that the services
represented by this code set are not specific to any patient
population; rather, they noted that they are for any patient for whom
they may be medically necessary. The commenter included emerging
evidence of the efficacy of telehealth delivery of the services,
including research articles relevant to each service. The commenter
noted that no reports of significant adverse events or negative side
effects were noted in research; however, the commenter indicated that
when the assessment or treatment services targeted behaviors in
patients with developmental disabilities that carried risk of harm, the
supervising behavior analysts (QHPs) had the behavior technicians or
caregivers who delivered the services take precautions to protect
patients.
A commenter agreed there may be concern that some patients may not
be able to be fully assessed via interactive audio-visual technology;
however, they stated that the benefits of furnishing these services via
telehealth outweigh the concerns. The commenter also noted that the
decision as to the appropriateness of care should be determined by the
provider, without financial disincentives between in-person and
telehealth care. The commenter noted that there are significant
benefits to being able to provide these services via telehealth. The
commenter stated that patients with dementia or other cognitive or
psychological impairments may require the assistance of additional
parties
[[Page 69456]]
during a visit, and that providing these services remotely can allow
for inclusion of other people, including family, significant others,
and additional practitioners, who can provide substantial benefits.
According to the commenter, this is not always the case for in-person
visits, as caregivers and other family members may not be able to take
time off from work or travel to the appointments, and virtual visits
allow for the practitioner, the patient, and important family members
to be in separate locations while still being able to participate in
the visit. Additionally, the commenter noted that psychiatric patients
often have social anxiety issues, leading to limitations on leaving
safe places like their home, facility, or family, and remote visits are
important ways to ensure these patients maintain access to care.
A commenter did not support these services remaining on the
Medicare Telehealth Services List, stating such additions may pose
beneficiary safety and quality-of-care issues. The commenter urged us
to exercise extreme caution when adding additional mental-health-
related services to the Medicare Telehealth Services List on a
temporary basis, considering the unique challenges faced by persons
living with mental health conditions, and the multiple, system-wide
issues currently complicating the delivery of safe and effective mental
health care.
Response: We note that CPT codes 90853 and 96121 are already
permanently on the Medicare Telehealth Services List. Regarding CPT
codes 96130-96133, 97151-97158, 0362T, and 0373T, we continue to
believe our proposal to add these services on a Category 3 basis is
appropriate and preferable. Adding these CPT codes to the Medicare
Telehealth Services List on a Category 3 basis will allow for the
collection and evaluation of data that could potentially support
permanent inclusion on the Medicare Telehealth Services List, and we
look forward to evaluating such data in the future.
After consideration of public comments, we are finalizing our
proposal to retain CPT codes 97151-97158, 0362T, and 0373T on the
Medicare Telehealth Services List on a Category 3 basis.
c. Other Services Proposed for Addition to the Medicare Telehealth
Services List
As discussed above, there are services that are included on the
Medicare Telehealth Services List temporarily during the PHE for which
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition to the list under the Category 1 or
Category 2 criteria. In addition to the services we proposed for
addition to the Medicare Telehealth Services List on a Category 3 basis
in response to requests, we also proposed to add a number of services
to the Medicare Telehealth Services List on a Category 3 basis that are
currently included on the Medicare Telehealth Services List temporarily
during the PHE that were not specifically requested for permanent
addition. These services would be included on the Medicare Telehealth
Services List through 2023 to allow us time to evaluate data that may
support their permanent addition to the list on a Category 1 or
Category 2 basis.
The services we proposed for addition to the Medicare Telehealth
Services List temporarily on a Category 3 basis include CPT codes 90875
(Individual psychophysiological therapy incorporating biofeedback
training by any modality (face-to-face with the patient), with
psychotherapy (e.g., insight oriented, behavior modifying or supportive
psychotherapy); 30 minutes), 92012 (Ophthalmological services: medical
examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient),
92014 (Ophthalmological services: medical examination and evaluation,
with initiation or continuation of diagnostic and treatment program;
comprehensive, established patient, 1 or more visits), 92507 (Treatment
of speech, language, voice, communication, and/or auditory processing
disorder; individual), 94005 (Home ventilator management care plan
oversight of a patient (patient not present) in home, domiciliary or
rest home (e.g., assisted living) requiring review of status, review of
laboratories and other studies and revision of orders and respiratory
care plan (as appropriate), within a calendar month, 30 minutes or
more), 96105 (Assessment of aphasia (includes assessment of expressive
and receptive speech and language function, language comprehension,
speech production ability, reading, spelling, writing, e.g., by Boston
Diagnostic Aphasia Examination) with interpretation and report, per
hour), 96110 (Developmental screening (e.g., developmental milestone
survey, speech and language delay screen), with scoring and
documentation, per standardized instrument), 96112 (Developmental test
administration (including assessment of fine and/or gross motor,
language, cognitive level, social, memory and/or executive functions by
standardized developmental instruments when performed), by physician or
other qualified health care professional, with interpretation and
report; first hour), 96113 (Developmental test administration
(including assessment of fine and/or gross motor, language, cognitive
level, social, memory and/or executive functions by standardized
developmental instruments when performed), by physician or other
qualified health care professional, with interpretation and report;
each additional 30 minutes (List separately in addition to code for
primary procedure)), 96127 (Brief emotional/behavioral assessment
(e.g., depression inventory, attention-deficit/hyperactivity disorder
[ADHD] scale), with scoring and documentation, per standardized
instrument), 96170 (Health behavior intervention, family (without the
patient present), face-to-face; initial 30 minutes), 96171 (Health
behavior intervention, family (without the patient present), face-to-
face; each additional 15 minutes (List separately in addition to code
for primary service)), 97129 (Therapeutic interventions that focus on
cognitive function (e.g., attention, memory, reasoning, executive
function, problem solving, and/or pragmatic functioning) and
compensatory strategies to manage the performance of an activity (e.g.,
managing time or schedules, initiating, organizing, and sequencing
tasks), direct (one-on-one) patient contact; initial 15 minutes), 97130
(Therapeutic interventions that focus on cognitive function (e.g.,
attention, memory, reasoning, executive function, problem solving, and/
or pragmatic functioning) and compensatory strategies to manage the
performance of an activity (e.g., managing time or schedules,
initiating, organizing, and sequencing tasks), direct (one-on-one)
patient contact; each additional 15 minutes (List separately in
addition to code for primary procedure)), and 99473 (Self-measured
blood pressure using a device validated for clinical accuracy; patient
education/training and device calibration). Our analyses of these
services indicate that there is some evidence of possible clinical
benefit associated with these services when furnished via telehealth.
We believe these services can safely be furnished via real-time, audio
and visual interactive telecommunications under the circumstances of
the PHE, but there is not yet sufficient evidence available to consider
the services for permanent addition to the Medicare Telehealth Services
List under the Category 1 or Category 2 criteria.
[[Page 69457]]
Some audiology testing services are currently temporarily included
on the Medicare Telehealth Services List for the duration of the PHE.
These are CPT codes 92550 (Tympanometry and reflex threshold
measurements), 92552 (Pure tone audiometry (threshold); air only),
92553 (Pure tone audiometry (threshold); air and bone), 92555 (Speech
audiometry threshold;), 92556 (Speech audiometry threshold; with speech
recognition), 92557 (Comprehensive audiometry threshold evaluation and
speech recognition (92553 and 92556 combined)), 92563 (Tone decay
test), 92565 (Stenger test, pure tone), 92567 (Tympanometry (impedance
testing)), 92568 (Acoustic reflex testing, threshold), 92570 (Acoustic
immittance testing, includes tympanometry (impedance testing), acoustic
reflex threshold testing, and acoustic reflex decay testing), 92587
(Distortion product evoked otoacoustic emissions; limited evaluation
(to confirm the presence or absence of hearing disorder, 3-6
frequencies) or transient evoked otoacoustic emissions, with
interpretation and report), 92588 (Distortion product evoked
otoacoustic emissions; comprehensive diagnostic evaluation
(quantitative analysis of outer hair cell function by cochlear mapping,
minimum of 12 frequencies), with interpretation and report), 92601
(Diagnostic analysis of cochlear implant, patient younger than 7 years
of age; with programming), 92625 (Assessment of tinnitus (includes
pitch, loudness matching, and masking)), 92626 (Evaluation of auditory
function for surgically implanted device(s) candidacy or postoperative
status of a surgically implanted device(s); first hour), 92627
(Evaluation of auditory function for surgically implanted device(s)
candidacy or postoperative status of a surgically implanted device(s);
each additional 15 minutes (List separately in addition to code for
primary procedure)). We have received information that, during the PHE,
certain practitioners have developed the capacity to perform these
services using remote technology including specialized equipment inside
an audiometric soundproof booth. We believe that, in circumstances in
which such equipment is available at the originating site, these
services can be furnished in a way in which all of the elements of the
services are met and that there is likely to be a clinical benefit when
these services are furnished via telehealth. Therefore, we proposed to
add these services to the Medicare Telehealth Services List on a
Category 3 basis, which will allow these services to be available via
telehealth through the end of CY 2023. We solicited comments regarding
how widespread the availability of this remote technology is, and
whether interested parties believe these services can be furnished in a
way that does not jeopardize patient safety or quality of care when
these services are furnished remotely.
Additionally, as discussed in section II.F. of this final rule, we
proposed to create HCPCS codes G0316 (listed as GXXX1 in our proposed
rule)(Prolonged hospital inpatient or observation care evaluation and
management service(s) beyond the total time for the primary service
(when the primary service has been selected using time on the date of
the primary service); each additional 15 minutes by the physician or
qualified healthcare professional, with or without direct patient
contact (list separately in addition to CPT codes 99223, 99233, and
99236 for hospital inpatient or observation care evaluation and
management services). (Do not report G0316 on the same date of service
as other prolonged services for evaluation and management 99358, 99359,
993X0). (Do not report G0316 for any time unit less than 15 minutes)),
G0317 (listed as GXXX2 in our proposed rule) (Prolonged nursing
facility evaluation and management service(s) beyond the total time for
the primary service (when the primary service has been selected using
time on the date of the primary service); each additional 15 minutes by
the physician or qualified healthcare professional, with or without
direct patient contact (list separately in addition to CPT codes 99306,
99310 for nursing facility evaluation and management services). (Do not
report G0317 on the same date of service as other prolonged services
for evaluation and management 99358, 99359, 993X0,). (Do not report
G0317 for any time unit less than 15 minutes)), and G0318 (listed as
GXXX3 in our proposed rule) (Prolonged home or residence evaluation and
management service(s) beyond the total time for the primary service
(when the primary service has been selected using time on the date of
the primary service); each additional 15 minutes by the physician or
qualified healthcare professional, with or without direct patient
contact (list separately in addition to CPT codes 99345, 99350 for home
or residence evaluation and management services). (Do not report G0318
on the same date of service as other prolonged services for evaluation
and management 99358, 99359, 99417). (Do not report G0318 for any time
unit less than 15 minutes)) to describe prolonged services associated
with certain types of E/M services. These codes will be replacing
existing codes that describe prolonged services, specifically inpatient
prolonged services CPT codes 99356 (Prolonged service in the inpatient
or observation setting, requiring unit/floor time beyond the usual
service; first hour (List separately in addition to code for inpatient
or observation Evaluation and Management service)) and 99357 (Prolonged
service in the inpatient or observation setting, requiring unit/floor
time beyond the usual service; each additional 30 minutes (List
separately in addition to code for prolonged service)). These services
are similar to services currently on the Medicare Telehealth Services
List, such as CPT codes 99356 and 99357, which were added to the
Medicare Telehealth Services List on a Category 1 basis in the CY 2016
rule (80 FR 71060-71062), as well as O/O prolonged service HCPCS code
G2212 (Prolonged service in the inpatient or observation setting,
requiring unit/floor time beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service)),
which was added to the Medicare Telehealth Services List on a Category
1 basis in the CY 2021 rule (85 FR 84506). Similarly, we believe that
these proposed HCPCS G codes will be sufficiently similar to
psychiatric diagnostic procedures or O/O visits currently on the
Medicare Telehealth Services List to qualify for inclusion on the list
on a Category 1 basis. Therefore, we proposed to add proposed HCPCS
codes G0316, G0317, and G0318 to the Medicare Telehealth Services List
on a Category 1 basis.
Table 12 lists the services that we are finalizing for addition to
the Medicare Telehealth Services List on a Category 3 basis. Table 13
lists the services we are finalizing for permanent addition to the
Medicare Telehealth Services List on a Category 1 basis.
BILLING CODE 4150-28-P
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[GRAPHIC] [TIFF OMITTED] TR18NO22.017
BILLING CODE 4150-28-C
We received public comments on these other services that we
proposed for addition to the Medicare Telehealth Services List. The
following is a summary of the comments we received and our responses.
Comment: Many commenters supported the addition of many of these
services on a Category 3 basis.
Response: We appreciate the support for our proposals.
Comment: One commenter stated that ophthalmologic services (92002,
92004, 92012 and 92014) are generally covered via telehealth by other
insurance plans, including Medicare Advantage plans and the Veterans
Health Administration, and should also be available to Medicare
beneficiaries. Commenters supported the addition of CPT codes 92012 and
92014 on a Category 3 basis.
Response: We thank commenters for their support of our proposal,
and we are finalizing as proposed the addition of CPT codes 92012 and
92014 to the Medicare Telehealth Services List on a Category 3 basis.
We did not identify or propose CPT codes 92002 or 92004 as Medicare
telehealth in the proposed rule. As such, discussion of these codes is
outside the scope of this rule.
Comment: Regarding our comment solicitation related to patient
safety for audiology services, a commenter stated that there is now
strong evidence confirming that patients who receive therapy services
via telehealth have similar, or even better outcomes, compared to
patients who received traditional in-person therapy services (including
citations of studies). This commenter cited this evidence in urging us
to add these services permanently. A commenter stated that the
Veteran's Administration has shown, for many years, that audiology
services can be safely provided, via telehealth, without sacrificing
patient outcomes or quality of care, and that the technology required
to perform these procedures via telehealth, in many cases with the
assistance of an audiology assistant or technician at a remote
location, is readily available. Commenters requested that many
audiology services that are not currently available on the Medicare
Telehealth Services List be added on a Category 3 basis.
Response: We appreciate the information provided by commenters, and
we may consider this information in future rulemaking. Given support of
commenters, as well as information provided, we are finalizing the
addition of audiology CPT codes 92550, 92552, 92553, 92555, 92556,
92557, 92563, 92565, 92567, 92568, 92570, 92587, 92588, 92601, 92625,
92626, and 92627 to the Medicare Telehealth Services List on a Category
3 basis, as proposed.
Comment: Commenters supported the addition of the proposed
prolonged services HCPCS codes G0316-G0318 permanently on a Category 1
basis, stating that doing so is essential to maintaining consistency
with the new coding and payment structure for inpatient E/M services.
Response: We appreciate commenters' support for this proposal. We
are finalizing the addition of HCPCS codes G0316, G0317, and G0318 to
the Medicare Telehealth Services List on a Category 1 basis, as
proposed.
Comment: Numerous commenters requested that we add many services
that are temporarily available for the PHE to the Medicare Telehealth
Services List that are currently on the list on a temporary basis, but
that we did not propose to continue on the list to be available as
Medicare telehealth services be added on a Category 3 basis
Response: As discussed above, we identified the services we
considered appropriate for addition to the Medicare Telehealth Services
List on a Category 3 basis by conducting an internal review to assess
those services that may, outside of the circumstances of the PHE, be
furnished using the full scope of service elements for their respective
service/code via two-way, audio-video communication technology, as
though the service were provided in-person. The commenters did not
present new information indicating that our analysis was incomplete.
Furthermore, because we did not propose to add the services requested
by these commenters to the Medicare Telehealth Services List on a
Category 3 basis, we found these comments to be outside the scope of
the proposed rule.
As discussed in section II.E. of this final rule, we proposed to
create two HCPCS G-codes to describe monthly Chronic Pain Management
and Treatment services: HCPCS code G3002 (Chronic pain management and
treatment, monthly bundle including, diagnosis; assessment and
monitoring; administration of a validated pain rating scale or tool;
the development, implementation, revision, and/or maintenance of a
person-centered care plan that includes strengths, goals, clinical
needs, and desired outcomes; overall treatment management; facilitation
and coordination of any necessary behavioral health treatment;
medication management; pain and health literacy counseling; any
necessary chronic pain related crisis care; and ongoing communication
and care coordination between relevant practitioners furnishing e.g.
physical therapy and occupational therapy, complementary and
integrative approaches, and community-based care, as appropriate.
Required initial face-to-face visit at least 30 minutes provided by a
physician or other qualified health professional; first 30 minutes
personally provided by physician or other qualified health care
professional, per calendar month. (When using G3002, 30 minutes must be
met or exceeded.)) and HCPCS code G3003 (Each additional 15 minutes of
chronic pain management and treatment by a physician or other qualified
health care professional, per calendar month (List separately in
addition to code for G3002). (When using G3003, 15 minutes must be met
or exceeded.)).
Comment: As discussed in section II.E.4.(33) in the CY 2023 PFS
proposed rule, we solicited comment regarding how best the initial
visit and subsequent visits should be conducted (for example, in-
person, via telehealth, or the use of a telecommunications system, and
any implications for additional or different coding). We also
considered whether to add the CPM codes to the Medicare
[[Page 69460]]
Telehealth Services List. Many commenters asked us to add CPM services
to the Medicare Telehealth Services List. One commenter stated that the
CPM code(s) would be appropriate to add on a Category 1 basis, since
chronic pain limits patient mobility and a ``silver lining'' of the
COVID-19 pandemic is that telehealth flexibilities improved access to
pain care. This commenter continued that it can be very burdensome for
patients, especially those with ``high impact'' chronic pain, to
physically get to doctor appointments, undergo the hardship of driving,
walking distances, standing in line, and sitting for long periods in
waiting rooms, all of which may exacerbate pain that has been ongoing
for days to weeks. The commenter emphasized how important access to
telehealth is for this particular group of Medicare patients and urged
us to add it to the Medicare Telehealth Services List. One commenter
stated that telehealth should be an option, because of geographic
factors (rural dwellers are underserved) and life circumstances (child
care, transportation), which can make repeated in-person appointments
inaccessible. This commenter continued that people with chronic pain
can experience challenging issues traveling to see a clinician, and
often inquire about the availability of receiving integrative care
through telehealth. For these reasons, this commenter recommended that
we add the CPM services to the Medicare Telehealth Services List. One
commenter stated they believed that telehealth increases self-efficacy
in people living with pain. As a middle pathway, another commenter
requested that we allow providers to use their discretion when
determining if telehealth is appropriate for their patient. Another
commenter added that telehealth visits should always be with the
agreement of the patient as some people are more comfortable with face-
to-face interactions. One commenter noted telehealth is appropriate
once patients are established on their care plan, while another
commenter suggested that at minimum, telehealth be allowed for all
follow up visits.
Response: As discussed earlier in this section, we agree with the
commenter's suggestion to add CPM services to the Medicare Telehealth
Services List on a Category 1 basis. We believe that the interactions
between the furnishing practitioner and the beneficiary described by
the required face-to-face visit component of the CPM services are
sufficiently similar to professional consultations, office visits, and
office psychiatry services currently on the Medicare Telehealth
Services List for these services to be added on a Category 1 basis. By
its nature, and because of the many treatment challenges described by
these and other commenters in section II.E.4.(33), pain care is ideally
suited to telehealth, and we believe appropriate to be furnished
through interactive, real-time telecommunications technology. Like
certain other non-face-to face PFS services, there are also components
of HCPCS codes G3002 and G3003 describing care planning or care
coordination with other health care professionals that are commonly
furnished remotely using telecommunications technology, and do not
require the patient to be present/in-person with the practitioner when
they are furnished. As such, these components of HCPCS codes G3002 and
G3003 are not considered telehealth services for purposes of Medicare,
and we do not need to consider whether the non-face-to-face aspects of
HCPCS codes G3002 and G3003 are similar to other telehealth services.
We are finalizing in this rule that any of the CPM in-person components
included in HCPCS codes G3002 and G3003 may be furnished via
telehealth, as clinically appropriate, in order to increase access to
care for beneficiaries. However, we reiterate as provided in the code
descriptor that the initial CPM services visit billed under HCPCS code
G3002 must be furnished in-person without the use of telecommunications
technology. (For further clarification about the initial in person
visit requirements, please see section II.E.4.(33).)
Comment: One commenter asked that we enable the CPM codes, in
addition to being rendered through telehealth, to be furnished through
audio-only technology.
Response: We appreciate the comment. In the CY 2022 PFS final rule,
we finalized a policy to revise the definition of ``telecommunications
system'' at Sec. 410.78(a)(3) to allow the use of audio-only
technology for the diagnosis, evaluation, or treatment of mental health
conditions under certain circumstances (described in detail at 86 FR
64996, 65056 through 65060) that allow visits and other services
furnished via audio-only technology to be reported as Medicare
telehealth services, with the appropriate modifier. We acknowledge that
certain scope of service aspects of CPM may pertain to the diagnosis,
evaluation, or treatment of mental health conditions. We expect
clinicians will bill for the HCPCS code that most accurately describes
the services furnished, including in instances where the service being
furnished might determine the technological modality used to deliver
the service.
After consideration of public comments, we are finalizing our
proposal to add CPT codes 90875, 92012, 92014, 92507, 94005, 96105,
96110, 96112, 96113, 96127, 96170, 96171, 97129, 97130, and 99473 to
the Medicare Telehealth Services List on a Category 3 basis, and
finalizing our proposal to add HCPCS codes G0316, G0317, and G0318,
G3002, and G3003 to the Medicare Telehealth Services List on a Category
1 basis.
d. Services Proposed for Removal From the Medicare Telehealth Services
List After 151 Days Following the End of the PHE
As we noted in the CY 2022 PFS final rule (86 FR 65054), at the
conclusion of the PHE for COVID-19, the associated waivers and interim
policies will expire, payment for Medicare telehealth services will
once again be limited by the requirements of section 1834(m) of the
Act, and we will return to the policies established through our regular
notice-and-comment rulemaking process, through which we established and
maintain the Medicare Telehealth Services List. Services that have been
added to the Medicare Telehealth Services List on a Category 3 basis
will remain on the list through the end of CY 2023. We have explained
that under our current policy, all other services that were temporarily
added to the Medicare Telehealth Services List on an interim basis
during the PHE and have not been added to the Medicare Telehealth
Services List on a Category 1, 2, or 3 basis will not remain on the
list after the end of the PHE (85 FR 84506-84509). As explained in
section II.D.1.e. of this final rule, Division P, Title III, Subsection
A of the Consolidated Appropriations Act, 2022 (CAA, 2022), extends
some of the flexibilities implemented during the PHE for COVID-19 for
an additional 151 days after the end of the PHE, including section
301(a) of Division P, Title III, Subtitle A of the CAA, 2022, which
specifies that, for services on the Medicare Telehealth Services List
as of the date of enactment (March 15, 2022) furnished during 151 days
after the end of the PHE, the originating site for the telehealth
service can be any site in the United States at which the beneficiary
is located when the service is furnished, including the beneficiary's
home. To give full effect to this provision, we believe it is necessary
to continue to include the services on the Medicare Telehealth Services
List through the 151-day period after the end of the PHE that were
temporarily added to the list
[[Page 69461]]
during the PHE but have not since been added on a Category 3 or other
basis, and which are currently set to be removed from the list at the
end of the PHE. As such, we proposed to continue to include on the
Medicare Telehealth Services List the services that are currently set
to be removed from the list when the PHE ends (that is, those not
currently added to the list on a Category 1, 2, or 3 basis) for an
additional 151 days after the PHE ends. Table 14 lists those services
that are temporarily included on the list available for the PHE, which
we proposed to retain on the Medicare Telehealth Services List for an
additional 151 days following the end of the PHE. The services listed
in Table 14 will no longer be available on the Medicare Telehealth
Services List on the 152nd day after the end of the PHE. As previously
explained, on the 152nd day after the end of the PHE, payment for
Medicare telehealth services will once again be limited by the
requirements of section 1834(m) of the Act, as aforementioned, and
telehealth claims for these services furnished on or after the codes
are removed from the list will be denied. We proposed to align the
temporary availability of services available as Medicare telehealth
services until the end of the PHE with the 151-day extensions of
flexibilities enacted in the CAA, 2022 in order to simplify the process
of ending the PHE-related flexibilities and to minimize possible
errors.
Comment: A commenter noted that CPT code 94664 did not appear in
Table 10 of the proposed rule despite being a code that was temporarily
added for the PHE.
Response: We agree that CPT code 94664 was inadvertently omitted
from Table 10 of the proposed rule. As a code that was temporarily
added to the Medicare Telehealth Services List for the duration of the
PHE, it should have been included among codes that we proposed will
remain on the Medicare Telehealth Services List for an additional 151
days following the end of the PHE. We have corrected this error in
Table 14, and we are finalizing that CPT code 94664 will remain on the
Medicare Telehealth Services List for an additional 151 days following
the end of the PHE.
Comment: Many commenters supported our proposal to align the period
of availability for services that are temporarily available for the
duration of the PHE with the 151-day extension of certain telehealth
flexibilities associated with the CAA, 2022. Some commenters stated
that we should eliminate the temporary designation for all services on
the Medicare Telehealth Services List, making permanent all services
currently available.
Response: We thank commenters for their support of our proposal to
allow services that would be available for the duration of the PHE to
remain on the Medicare Telehealth Services List through the 151-day
period following the end of the PHE. We continue to believe that
services, including those that we added on a temporary interim basis
for the PHE for COVID-19, should be considered for permanent addition
to the Medicare Telehealth Services List through the regular annual
process we established as required by section 1834(m)(4)(F)(ii) of the
Act. While we have included some services on the Medicare Telehealth
Services List on a temporary Category 3 basis through the end of CY
2023, this was to allow for the continued development of data to
support their potential future consideration for permanent addition to
the list on a Category 1 or Category 2 basis; we review all items on
the Medicare Telehealth Services List each year as per our established
process. Interested parties may continue to use the annual submission
process to request the addition of any services to or deletion of
services from the Medicare Telehealth Services List, regardless of
whether the service was added on a temporary Category 3 basis. We note
that the services that are included on the Medicare Telehealth Services
list on a Category 3 basis will remain on the list for an additional
period beyond 151 days after the end of the PHE, which is currently
through the end of 2023. We understand that, if the PHE is in effect
for most of the year next year, the 151-day period after the PHE may
end on a date that is beyond December 31, 2023. We clarify that in this
instance, the Category 3 services would remain on the Medicare
Telehealth Services List through December 31, 2023 or 151 days after
the PHE, if later. We will consider whether any additional extensions
are needed in the future.
[[Page 69462]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.018
e. Implementation of Telehealth Provisions of the Consolidation
Appropriations Acts, 2021 and 2022
As discussed in the CY 2021 PFS final rule (85 FR 84506),
legislation enacted to address the PHE for COVID-19 provided the
Secretary with new authorities under section 1135(b)(8) of the Act, as
added by section 102 of the Coronavirus Preparedness and Response
Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020)
and subsequently amended by section 6010 of the Families First
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section
3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES
Act) (Pub. L. 116-136, March 27, 2020), to waive or modify Medicare
telehealth payment requirements during the PHE for COVID-19. We used
these authorities to establish several flexibilities to accommodate
changes in the delivery of care during the PHE. Through waiver
authority under section 1135(b)(8) of the Act, in response to the PHE
for COVID-19, we removed the geographic and site of service originating
site restrictions in section 1834(m)(4)(C) of the Act, as well as
restrictions in section 1834(m)(4)(E) of the Act on the types of
practitioners who may furnish telehealth services, for the duration of
the PHE for COVID-19. We also used waiver authority to allow certain
telehealth services to be furnished via audio-only communication
technology. At the end of the PHE for COVID-19, these waivers and
interim policies will expire, and payment for Medicare telehealth
services will once again be limited by the requirements of section
1834(m) of the Act.
Section 1834(m)(7) of the Act (as added by section 2001(a) of the
SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24,
2018)), removes the geographic restrictions under section
1834(m)(4)(C)(i) of the Act and authorizes the patient's home as a
permissible originating site, for telehealth services furnished for
purposes of treatment of a substance use disorder (SUD) or a co-
occurring mental health disorder, furnished on or after July 1, 2019,
to an individual with a SUD diagnosis. Section 123(a) of Division CC of
the Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260,
December 27, 2020) amended section 1834(m)(7)(A) of the
[[Page 69463]]
Act to broaden the scope of services for which the geographic
restrictions under section 1834(m)(4)(C)(i) of the Act do not apply and
for which the patient's home is a permissible originating site to
include telehealth services furnished for the purpose of diagnosis,
evaluation, or treatment of a mental health disorder, effective for
services furnished on or after the end of the PHE for COVID-19. Section
123(a) of the CAA, 2021 also added subparagraph (B) to section
1834(m)(7) of the Act to prohibit payment for a telehealth service
furnished in the patient's home under paragraph (7), unless the
physician or practitioner furnishes an item or service in-person,
without the use of telehealth, within 6 months prior to the first time
the physician or practitioner furnishes a telehealth service to the
beneficiary, and thereafter, at such times as the Secretary determines
appropriate. For a full discussion of our implementation of section
123(a) of the CAA, 2021, refer to our CY 2022 PFS final rule (86 FR
64996).
In the proposed rule, we proposed to implement provisions of
section 1834(m) of the Act (including the amendments made by the CAA,
2021) and provisions of the CAA, 2022 that extend certain Medicare
telehealth flexibilities adopted during the PHE for 151 days after the
end of the PHE.
Sections 301, 302, 303, 304, and 305 of Division P, Title III,
Subtitle A of the CAA, 2022 amended section 1834(m) of the Act to
generally extend certain PHE-related telehealth policies for services
that are on the Medicare Telehealth Services List as of the date of
enactment (March 15, 2021). Specifically, section 301(a) of the CAA,
2022 amended section 1834(m)(4)(C) of the Act to add a new clause
(iii), which temporarily expands the scope of telehealth originating
sites for those services to include any site in the United States where
the beneficiary is located at the time of the telehealth service,
including an individual's home, for a 151-day period beginning on the
first day after the end of the PHE for COVID-19. Section 301(a) also
amended section 1834(m)(7)(A) of the Act to apply the expanded scope of
telehealth originating site policy to include any location in the
United States in new clause (iii) of section 1834(m)(4)(C) of the Act
during the 151-day period for telehealth services furnished for the
purposes of diagnosis, evaluation, or treatment of a mental health
disorder and to individuals with a SUD diagnosis for purposes of
treatment of the SUD or a co-occurring mental health disorder for this
151-day post-PHE extension period. In addition to this provision,
section 301(b) of the CAA, 2022 amended section 1834(m)(2)(B) of the
Act to add a new clause (iii) that allows payment of an originating
site facility fee to an originating site with respect to those
telehealth services furnished during the 151-day period only if the
originating site is one that meets the geographic requirements in
section 1834(m)(4)(C)(i) of the Act, and is a setting included on the
enumerated list of originating sites under section 1834(m)(4)(C)(ii) of
the Act (other than the patient's home).
Section 302 of the CAA, 2022 amended section 1834(m)(4)(E) of the
Act to temporarily expand the definition of eligible telehealth
practitioners for the 151-day period beginning on the first day after
the end of the PHE for COVID-19 to include qualified occupational
therapists, qualified physical therapists, qualified speech-language
pathologists, and qualified audiologists.
Section 303 of the CAA, 2022 amended section 1834(m)(8) of the Act
to temporarily continue payment for telehealth services furnished by
FQHCs and RHCs for the 151-day period beginning on the first day after
the end of the COVID-19 PHE using the methodology established for
telehealth services furnished by FQHCs and RHCs during the PHE, which,
in accordance with section 1834(m)(8)(B) of the Act, is based on
payment rates that are similar to the national average payment rates
for comparable telehealth services under the PFS.
Section 304(a) of the CAA, 2022 amended section 1834(m)(7)(B)(i) of
the Act to delay the requirement for an in-person visit with the
physician or practitioner within 6 months prior to the initial mental
health telehealth service, and again at subsequent intervals as the
Secretary determines appropriate. In light of this amendment, the in-
person requirements for telehealth services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder will
again be effective on the 152nd day after the PHE ends. In addition,
section 304(b) and (c) of the CAA, 2022 modified sections 1834(y) and
1834(o)(4) of the Act, respectively, to similarly delay in-person visit
requirements for mental health visits furnished by Rural Health Clinics
and Federally Qualified Health Centers via telecommunications
technology. Therefore, we proposed to revise the regulatory text at
Sec. 410.78(b)(3)(xiv) to recognize the delay of the in-person
requirements for mental health visits furnished by RHCs and FQHCs
through telecommunication technology under Medicare until the 152nd day
after the PHE for COVID-19, to conform with the statute. See section
II.B.3. of this final rule for our proposal to implement similar
changes for RHC and FQHC mental health visits.
Finally, section 305 of the CAA, 2022 added a new paragraph (9) to
section 1834(m) of the Act to require the Secretary to continue to
provide for coverage and payment of telehealth services included on the
Medicare Telehealth Services List as of the March 15, 2022, date of
enactment that are furnished via an audio-only telecommunications
system during the 151-day period beginning on the first day after the
end of the PHE for COVID-19. The new paragraph applies only to
telehealth services specified on the Medicare Telehealth Services List
under section 1834(m)(4)(F)(i) of the Act that are designated to as
eligible to be furnished via audio-only technology as of the date of
enactment of the CAA, 2022 (that is, March 15, 2022). These are the
services for which CMS waived the requirements of section 1834(m)(1) of
the Act and the first sentence of Sec. 410.78(a)(3) for use of
interactive telecommunications systems to furnish telehealth services,
to the extent they require use of video technology, during the PHE.
Under this waiver, CMS permitted the audio-only telephone E/M services
and certain behavioral health counseling and educational services to be
furnished via audio-only equipment during the PHE for COVID-19. We
proposed to continue to make payment for services included on the
Medicare Telehealth Services List as of March 15, 2022 that are
furnished via an audio-only telecommunications system for the 151-day
period beginning on the first day after the end of the PHE. We read
section 305 of the CAA, 2022 to require that we continue to make
payment for services furnished via audio-only telecommunications
systems (each described by a HCPCS code, including their successor
codes) for the 151-day period after the end of the PHE. These services
include certain behavioral health, counseling, and educational
services. (https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf, n.d.). A list of the services that involve
audio-only interaction but are included on the Medicare Telehealth
Services List for the duration of the PHE is available at the CMS
website, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
Section 309 of Division P, Title III, Subtitle A of the CAA, 2022
authorizes the Secretary to implement the amendments described above
made by
[[Page 69464]]
sections 301 through 305 through program instruction or otherwise.
Given that the end date of the PHE is not yet known and could occur
before the rulemaking process for the CY 2023 PFS is complete, and that
the changes made by these provisions are very specific and concise, we
announced in the CY 2023 PFS proposed rule that we intended to issue
program instructions or other subregulatory guidance to effectuate the
changes described above, other than the proposed revisions to Sec.
410.78. We intend to issue these instructions in the near future. We
believe this approach will serve to ensure a smooth transition after
the end of the PHE for COVID-19.
We received public comments on our proposals to implement section
304(a) of the CAA, 2022, which amended section 1834(m)(7)(B)(i) of the
Act, regarding the requirement that an in-person visit with the
physician or practitioner must occur within 6 months prior to the
initial mental health telehealth service. The following is a summary of
the comments we received and our responses.
In-Person Requirements
Comment: Many commenters expressed general support for our
proposals to implement and effectuate changes via program instructions,
and subregulatory guidance, based on the fact that the last day of the
PHE remains uncertain, but varied in their level of concern about
whether the post-PHE transition period, of 151 days, would allow enough
flexibility. Commenters expressed concerns that a sudden shift in the
in-person visit requirements, beginning 152 days after the end of the
PHE, could create beneficiary access issues, additional strain on the
existing health care workforce shortage, and significant confusion
among clinical and administrative staff about how to align resources
and inform beneficiaries. Some commenters noted that the public will
receive only 60 days' notice before the last day of the PHE, which they
believe would not allow adequate time to coordinate in-person care
across many different settings of care and varied individual
beneficiary needs. A few commenters suggested that CMS should take the
narrowest interpretation of the intent of Congress for in-person visit
requirements prior to the initial mental health telehealth service, on
the basis that the Secretary has the authority to specify the
requirements associated with the required interval for similar follow-
up in-person visit requirements. Other commenters expressed confusion
about how individual physicians or practitioners would ensure
appropriate record keeping and overall compliance plans would be
updated to provide a means of verifying that any individual service met
the in-person visit requirements. Some commenters whose focus is on
enabling and supporting telehealth care through various health IT
solutions requested that CMS provide more specifics on timing and
possible ways to standardize the means by which individual physicians
or practitioners document compliance with in-person requirements.
We also received comments that outlined concerns or possible risks
to patient safety when patients with certain mental health conditions
were treated remotely. These commenters provided examples of high-risk
circumstances, such as possible risks associated with treating complex,
or atypical patients, via telehealth. Commenters discussed that care of
certain patients, who may have a severe or rare diagnosis, may also be
under a course of treatment, where that plan of care includes a
medication regimen that requires close monitoring. Alternatively, one
commenter mentioned that certain beneficiaries with significant complex
needs may demonstrate possible outcomes that may be superior when
delivered via telehealth versus in-person. We also received a broad
range of comments suggesting varied ways that CMS could implement the
in-person visit requirements for mental health telehealth services.
Response: We appreciate these commenters' feedback. We did not
propose to modify our established policies to implement these in-person
visit requirements (except as it pertains to the 151-day extension for
the 6-month requirement for an in-person visit for mental health
treatment). We recognize that the CAA, 2022 delays implementation of
the in-person visit requirements for mental health telehealth services
for a period of 151 days after the final day of the PHE. As explained
above and in the proposed rule, we are implementing section 304(a) of
the CAA, 2022. and further emphasize that the availability of
furnishing these services via telehealth does not preclude
practitioners from seeing patients in-person, when indicated. We will
continue to gather information on these mental health telehealth
services as they are utilized, and we will take this information into
consideration in the future for possible rulemaking.
Comment: Several commenters suggested that no in-person requirement
should be enforced at all.
Response: We appreciate commenters' feedback. The statute does
require an in-person, non-telehealth visit within 6 months prior to the
first mental health services furnished via Medicare telehealth.
However, we clarify that we do not believe this requirement applies to
beneficiaries who began receiving mental health telehealth services in
their homes during the PHE. In other words, if a beneficiary began
receiving mental health telehealth services during the PHE or during
the 151-day period after the end of the PHE, then they would not be
required to have an in-person visit within 6 months; rather, they will
be considered established and will instead be required to have at least
one in-person visit every 12 months (so long as any such subsequent
telehealth service is furnished by the same individual physician or
practitioner (or a practitioner of the same sub-specialty in the same
practice) to the same beneficiary). This means that these services
would be subject to the requirement that an in-person visit is
furnished within 12 months of each mental health telehealth service for
those services that are subject to in-person visit requirements (unless
an exception is documented by their treating practitioner). For
discussion of additional requirements for these services, please see
the discussion in the CY 2022 PFS final rule.
f. Use of Modifiers for Medicare Telehealth Services Following the End
of the PHE for COVID-19
Prior to CY 2017, Medicare telehealth services furnished via
interactive audio and video telecommunications systems were reported
using the GT modifier. In the CY 2017 PFS Final Rule, CMS finalized
creation of a new Place of Service (POS) code for Medicare telehealth,
POS ``02'' (81 FR 80199-80201). When a physician or practitioner
submits a claim for their services, including claims for telehealth
services, they include a place of service (POS) code that is used to
determine whether a service is paid using the facility or non-facility
rate. Under the PFS, there are two payment rates for many physicians'
services: the facility rate and the non-facility (or office) rate. The
PFS non-facility rate is the single amount paid to a physician or other
practitioner for services furnished in their office. The PFS facility
rate is the amount generally paid to a professional when a service is
furnished in a setting of care, like a hospital, where Medicare is
making a separate payment to a facility entity in addition to the
payment to the billing physician or practitioner. This separate
payment, often referred to as a ``facility fee,'' reflects the
facility's costs associated with the service (clinical staff, supplies,
[[Page 69465]]
and equipment) and is paid in addition to what is paid to the
professional under the PFS. POS ``02'' indicates that the service was
furnished via telehealth, and under the pre-PHE process, was then paid
at the facility payment rate.
As discussed in the March 31, 2020 IFC, (refer to 85 FR 19230), we
stated that, as physician practices suddenly transitioned a potentially
significant portion of their services from in-person to telehealth
visits in the context of the PHE for the COVID-19 pandemic, the
relative resource costs of furnishing these services via telehealth may
not significantly differ from the resource costs involved when these
services are furnished in-person. Therefore, we instructed physicians
and practitioners who bill for Medicare telehealth services to report
the POS code that would have been reported had the service been
furnished in-person. This will allow our systems to make appropriate
payment for services furnished via Medicare telehealth, which, if not
for the PHE for the COVID-19 pandemic, would have been furnished in-
person, at the same rate they would have been paid if the services were
furnished in-person. In order to effectuate this change, we finalized
on an interim basis (85 FR 19233) the use of the CPT telehealth
modifier, modifier ``95'', for the duration of the PHE for COVID-19,
which should be applied to claim lines that describe services furnished
via telehealth and that the practitioner should report the POS code
where the service would have occurred had it not been furnished via
telehealth.
We further noted that we are maintaining the facility payment rate
for services billed using the general telehealth POS code ``02'',
should practitioners choose to maintain their current billing practices
for Medicare telehealth during the PHE for the COVID-19 pandemic.
We proposed that Medicare telehealth services furnished on or
before the 151st day after the end of the PHE, in alignment with the
extensions of telehealth-related flexibilities in the CAA, 2022, will
continue to be processed for payment as Medicare telehealth claims when
accompanied with the modifier ``95.'' We further proposed that
physicians and practitioners can continue to report the place of
service code that would have been reported had the service been
furnished in-person during the 151-day period after the end of the PHE,
as finalized on an interim basis in the March 31 IFC (85 FR 19233). We
proposed that Medicare telehealth services performed with dates of
service occurring on or after the 152nd day after the end of the PHE
will revert to pre-PHE rules and will no longer require modifier ``95''
to be appended to the claim, but the appropriate place of service (POS)
indicator will need to be included on the claim to be processed for
payment as Medicare telehealth claims in order to properly identify the
place where the service was furnished. We further proposed that, for
Medicare telehealth services furnished on or after the 152nd day after
the end of the PHE, the POS indicators for Medicare telehealth will be:
POS ``02''--is redefined as Telehealth Provided Other than
in Patient's Home (Descriptor: The location where health services and
health related services are provided or received, through
telecommunication technology. Patient is not located in their home when
receiving health services or health related services through
telecommunication technology.); and
POS ``10''--Telehealth Provided in Patient's Home
(Descriptor: The location where health services and health related
services are provided or received through telecommunication technology.
Patient is located in their home (which is a location other than a
hospital or other facility where the patient receives care in a private
residence) when receiving health services or health related services
through telecommunication technology.).
We remind readers that we defined ``home'' in our CY 2022 PFS final
rule (86 FR 65059) to include, as: ``both in general and for this
purpose, a beneficiary's home can include temporary lodging, such as
hotels and homeless shelters. We also clarified that for circumstances
where the patient, for privacy or other personal reasons, chooses to
travel a short distance from the exact home location during a
telehealth service, the service is still considered to be furnished `in
the home of an individual' for purposes of section 1834(m)(4)(C)(ii)(X)
of the Act.''
In our proposed rule, we discussed that, once the flexibilities for
the geographic restrictions and the site of service waivers for
Medicare telehealth services expire (on the 152nd day after the end of
the PHE, per the CAA, 2022), POS ``02'' would once again be required
for all Medicare telehealth claims (with the exception of certain
Medicare telehealth for mental health services). In the proposed rule,
we noted that the exceptions include claims for Medicare telehealth
mental health telehealth services, clinical assessments for patients
with ESRD that are receiving home dialysis, and Medicare telehealth
treatment of an SUD or mental health services that are co-occurring
mental health disorder with substance use treatment that are furnished
to with the patient in their home (that is, the originating site is in
a private residence and not a hospital or other facility setting), in
which case POS ``10'' could be used by the billing practitioner. In our
proposed rule, we further discussed that, on or after the 152nd day
after the PHE has expired, payment for Medicare telehealth services
using either of the Medicare telehealth POS codes would be made at the
PFS facility payment rate, in accordance with established PFS policy
outside the circumstances of the PHE. We proposed to align payment for
those telehealth services described as taking place in the
beneficiary's home, using POS ``10'' for Medicare telehealth, and those
services not provided in a patient's home, using POS ``02'' for
Medicare telehealth, to be made at the same facility payment amount. We
believe that the facility payment amount best reflects the practice
expenses, both direct and indirect, involved in furnishing services via
telehealth (please see section II.B. of this final rule for further
discussion regarding practice expense).
We further proposed that, beginning January 1, 2023, a physician or
other qualified health care practitioner billing for telehealth
services furnished using audio-only communications technology shall
append CPT modifier ``93'' (Synchronous Telemedicine Service Rendered
Via Telephone or Other Real-Time Interactive Audio-Only
Telecommunications System: Synchronous telemedicine service is defined
as a real-time interaction between a physician or other qualified
health care professional and a patient who is located away at a distant
site from the physician or other qualified health care professional.
The totality of the communication of information exchanged between the
physician or other qualified health care professional and the patient
during the course of the synchronous telemedicine service must be of an
amount and nature that is sufficient to meet the key components and/or
requirements of the same service when rendered via a face-to-face
interaction) to Medicare telehealth claims (for those services for
which the use of audio-only technology is permitted under Sec.
410.78(a)(3)), to identify them as having been furnished using audio-
only technology. We noted that we have also instructed all relevant
providers, including RHCs, FQHCs, and OTPs to append Medicare modifier
``FQ'' (Medicare telehealth service was furnished using audio-only
[[Page 69466]]
communication technology) for allowable audio-only services furnished
in those settings; however, consistent with our proposal for audio-only
services furnished under the PFS, we also proposed to require all
relevant providers, including RHCs, FQHCs, and OTPs to use modifier
``93'' when billing for eligible mental health services furnished via
audio-only telecommunications technology. We believe that using
modifier ``93'', which is a CPT modifier, will simplify billing, as
this modifier is used by payers outside of Medicare. Currently, these
modifiers can only be applied to Medicare telehealth mental health
services and those telehealth services for the treatment of a SUD or a
co-occurring mental health disorder when the originating site is the
beneficiary's home.
Supervising practitioners continue to be required to append the
``FR'' modifier on any applicable telehealth claim when they provide
direct supervision for a service using virtual presence through real-
time, audio and video telecommunications technology.
Comment: Some commenters expressed concern regarding our proposed
approach to the use of modifiers for billing of Medicare telehealth
services. One commenter noted that we had inadvertently overlooked the
fact that after the transition period, facility-based providers would
not be able to bill using the POS code fields, as the CMS-1450 (UB-04)
institutional claim form does not permit use of POS code fields. The
commenter noted that this may have been an oversight.
Response: We thank commenters for offering feedback on technical
issues associated with our proposed policies for use of modifiers that
allow claims processing and billing for professional services under
Part B, which includes Medicare telehealth services. We reiterate that
151 days after the end of the PHE, Medicare telehealth services will
once again be subject to the statutory requirements in section 1834(m)
of the Act. As such, only physicians and the practitioners specified in
section 1834(m)(4)(E) of the Act will be able to serve as distant site
practitioners to furnish and bill for Medicare telehealth services, and
those services would be billed on the professional, not the
institutional, claim form. Thus, beginning on the 152nd day after the
PHE ends, only certain types of practitioners will be permitted to
furnish and bill for Medicare telehealth services, and none of those
practitioners would be ``facility-based providers.''
Comment: Many commenters requested that we continue to allow for
services that would have been furnished in a non-facility setting
outside of the circumstances of the PHE to be billed at the non-
facility rate for telehealth services following the end of the PHE.
Commenters stated that they were concerned that reverting to the
facility rate for telehealth services will lead practitioners to offer
telehealth less frequently and inhibit access. According to these
commenters, many patients in rural and underserved areas are now able
to access mental health services, often for the first time. Many
commenters emphasized their concerns that mental health services would
be particularly impacted, as there is already high demand for these
services and relatively low numbers of available practitioners.
One commenter requested that we maintain payment at the non-
facility-based rate for telehealth services furnished in office
settings through the end of 2023, stating that changing payment to the
facility rate would result in a nearly 30 percent cut for some
services, which they believed will harm access to telehealth services.
Some commenters, including MedPAC, expressed concern that payment
at the facility rate will create the unintended effects of shifting
beneficiaries toward both higher intensity and volume of virtual care
modalities that would be inappropriate for beneficiaries. In MedPAC's
comment, they offered their March 2022 MedPAC Report to Congress
(https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_v2_SEC.pdf), which noted that Medicare
spending can be sensitive to shifts in the site of care, and that the
negative impact of the pandemic on E/M services may have been more
significant in 2020 were it not for Medicare telehealth.
Some commenters, including MedPAC, provided examples and
explanations that raised questions about uncertainty of clinical
benefit and possible overpayment for Medicare telehealth and offered
evidence that many patients who used telehealth during the PHE would
prefer in-person visits, once it is safe to do so.
Response: We acknowledge the commenters' concerns. We note that
there are many nuances to this issue, and we seek to minimize confusion
and practitioner burden during the period immediately following the
PHE. We are concerned about issues raised by commenters related to
payment stability in the post-PHE period, as care delivery will
potentially be transitioning between virtual, hybrid, and in-person
models. As such, we are finalizing that we will continue to allow for
payment be made for Medicare telehealth services at the place of
service for telehealth services that ordinarily would have been paid
under the PFS, if the services were furnished in-person, through the
latter of the end of the of CY 2023 or the end of the calendar year in
which the PHE ends. For those services furnished in a facility as an
originating site, POS 02 may be used, and the corresponding facility
fee can be billed, per pre-PHE policy, beginning the 152nd day after
the end of the PHE.
Comment: Some commenters expressed concern that our proposals to
transition to the use of new modifiers would create confusion and
administrative burden, without sufficient time to allow for the
sufficient training education of clinical and administrative staff to
implement new billing practices. Others supported immediate
implementation.
Response: We appreciate commenters' feedback. We believe that the
use of these modifiers following the end of the PHE, when implemented,
will enable practitioners to better report (and allow CMS to better
understand) how they practice and when certain services are furnished
via telehealth. We do not agree that these modifiers/codes would cause
confusion; rather, they will provide clarity. Moreover, education
regarding these modifiers/codes will be made available, as necessary.
After consideration of public comments, we are finalizing our
proposals, with some modifications regarding the use of telehealth
modifiers/codes and the payment rates. Practitioners will continue to
bill with modifier 95 along with the POS code corresponding to where
the service would have been furnished in-person through the later of
the end of the year in which the PHE ends or CY 2023. As stated
earlier, for those services furnished in a facility as an originating
site, POS 02 may be used, and the corresponding facility fee can be
billed, per pre-PHE policy, beginning the 152nd day after the end of
the PHE.
Additionally, effective on and after January 1, 2023, CPT modifier
``93'' can be appended to claim lines, as appropriate, for services
furnished using audio-only communications technology in accordance with
our regulation at Sec. 410.78(a)(3). All providers, including RHCs,
FQHCs, and OTPs must append Medicare modifier ``FQ'' (Medicare
telehealth service was furnished using audio-only communication
technology) for allowable audio-only services furnished in those
settings. However,
[[Page 69467]]
consistent with our proposal for audio-only services furnished under
the PFS, we are also finalizing to require all providers including
RHCs, FQHCs, and OTPs to use modifier ``93'' when billing for eligible
mental health services furnished via audio-only telecommunications
technology. Providers have the option to use the ``FQ'' or the 93''
modifiers or both where appropriate and true, since they are identical
in meaning.
Supervising practitioners continue to be required to append the
``FR'' modifier on any applicable telehealth claim when they provide
direct supervision for a service using virtual presence through real-
time, audio and video telecommunications technology.
In response to the issues raised by commenters related to payment
stability in the post-PHE period, we are reiterating that we are
finalizing that, for Medicare telehealth services, we will continue to
maintain payment at the POS had the service been furnished in-person,
and this will allow payments to continue to be made at the non-
facility-based rate for Medicare telehealth services through the latter
of the end of CY 2023 or the end of the calendar year in which the PHE
ends.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
Under Medicare Part B, certain types of services, including
diagnostic tests, services incident to physicians' or practitioners'
professional services, and other services, are required to be furnished
under specific minimum levels of supervision by a physician or
practitioner.
For professional services furnished incident to the services of the
billing physician or practitioner (see Sec. 410.26) and many
diagnostic tests (see Sec. 410.32), direct supervision is required.
Additionally, for pulmonary rehabilitation services (see Sec. 410.47)
and for cardiac rehabilitation and intensive cardiac rehabilitation
services (see Sec. 410.49), direct supervision of a physician is
required (see also Sec. 410.27(a)(1)(iv)(D) for hospital outpatient
services).Outside the circumstances of the PHE, direct supervision
requires the immediate availability of the supervising physician or
other practitioner, but the professional need not be present in the
same room during the service. We have established this ``immediate
availability'' requirement to mean in-person, physical, not virtual,
availability (please see the April 6, 2020 IFC (85 FR 19245) and the CY
2022 PFS final rule (86 FR 65062)).
Through the March 31, 2020 COVID-19 IFC, we changed the definition
of ``direct supervision'' during the PHE for COVID-19 (85 FR 19245
through 19246) as it pertains to supervision of diagnostic tests,
physicians' services, and some hospital outpatient services, to allow
the supervising professional to be immediately available through
virtual presence using real-time audio/video technology, instead of
requiring their physical presence. In the CY 2021 PFS final rule (85 FR
84538 through 84540), we finalized continuation of this policy through
the later of the end of the calendar year in which the PHE for COVID-19
ends or December 31, 2021. In the March 31, 2020 IFC (85 FR 19246) and
in our CY 2022 PFS final rule (see 85 FR 65063), we also noted that the
temporary exception to allow immediate availability for direct
supervision through virtual presence facilitates the provision of
telehealth services by clinical staff of physicians and other
practitioners' incident to their own professional services. This is
especially relevant for services such as physical therapy, occupational
therapy, and speech language pathology services, since those
practitioners can only bill Medicare for telehealth services under
Medicare telehealth waivers that are effective only during the PHE for
COVID-19 (based on the emergency waiver authority established in
section 1135(b)(8) of the Act), and for 151 days after the final day of
the PHE for COVID-19, as specified by provisions of the CAA, 2022. We
noted that sections 1834(m)(4)(D) and (E) of the Act specify the types
of clinicians who may furnish and bill for Medicare telehealth
services. Outside of the PHE and the 151-day period after the PHE ends,
such clinicians include only physicians as defined in section 1861(r)
of the Act and practitioners described in section 1842(b)(18)(C) of the
Act. We remind readers that after December 31 of the year in which the
PHE ends, the pre-PHE rules for direct supervision at Sec.
410.32(b)(3)(ii) would apply. As noted in the CY 2022 PFS final rule
(86 FR 65062), this means the temporary exception to allow immediate
availability for direct supervision through virtual presence, which
facilitates the provision of telehealth services by clinical staff of
physicians and other practitioners incident to their professional
services, will no longer apply. As such, after the end of the calendar
year in which the PHE ends, Medicare telehealth services can no longer
be performed by clinical staff incident to the professional services of
the billing physician or practitioner who directly supervises the
service through their virtual presence.
While we did not propose to make the temporary exception to allow
immediate availability for direct supervision through virtual presence
permanent, as with last year's rulemaking (86 FR 39149 through 50), we
continue to solicit information on whether the flexibility to meet the
immediate availability requirement for direct supervision through the
use of real-time, audio/video technology should potentially be made
permanent. We also solicited comment regarding the possibility of
permanently allowing immediate availability for direct supervision
through virtual presence using real-time, audio/video technology for
only a subset of services, as we recognize that it may be inappropriate
to allow direct supervision without physical presence for some services
due to potential concerns over patient safety. As discussed in last
year's final rule (86 FR 65063), and based on gaps in the currently
available evidence, we are in need of more information as we consider
whether to make permanent a temporary exception to our direct
supervision policy.
We received public comments on expiration of PHE flexibilities for
direct supervision requirements. The following is a summary of the
comments we received and our responses.
Comment: Commenters offered a variety of perspectives and
suggestions for possible ways that CMS could modify the direct
supervision requirements. Many commenters that recommended a permanent
change to direct supervision rules supported their feedback by raising
issues such as health care workforce shortages and concern with
clinician burnout that would possibly occur from implementing the pre-
PHE direct supervision requirements. Others noted that certain NPPs,
such as PAs, and advanced practice nurse practitioners are authorized
under state law statutory requirements in many states to practice
independently under virtual supervision of a physician. Still others
based their recommendations that we establish a permanent virtual
direct supervision on a specialty-level or service-level analysis. For
example, commenters identified a certain specialty or family of codes
that would be typically low-risk for patient safety issues, and
indicated that those specialties or services would be appropriate
candidates for a permanent virtual direct supervision policy. Some
[[Page 69468]]
commenters mentioned that virtual direct supervision may also reduce
the burden and overhead costs associated with enrolling their
practitioners through multiple MAC jurisdictions.
Response: We continue to gather information on this topic, and we
appreciate the information provided by commenters. We remind readers
that, as described earlier in this section, our current temporary
policy to permit immediate availability for purposes of direct
supervision through the virtual presence of the billing clinician was
adopted to address the circumstances of the PHE for COVID-19. We
believe allowing additional time to collect information and evidence
for direct supervision through virtual presence will help us to better
understand the potential circumstances in which this flexibility could
be appropriate permanently, outside of the PHE for COVID-19. We realize
that direct supervision through virtual presence is probably not
something that we would have contemplated without our experience in
implementing this policy during the PHE, and we hope to learn more
about this in the near future. We also note that the Secretary renewed
the PHE for the COVID-19 pandemic for a 90-day period beginning on
October 13, 2022,\9\ which means that the PHE would expire on January
11, 2023, absent any further action by the Secretary regarding the PHE
for COVID-19. As such, we expect to continue to permit direct
supervision through virtual presence through at least the end of CY
2023 under our previously finalized policy which, as specified in Sec.
410.32(a)(3)(ii), continues through the end of the calendar year in
which the PHE ends. With that said, CMS will consider the comments
received from the proposed rule for potential future PFS rulemaking.
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\9\ https://aspr.hhs.gov/legal/PHE/Pages/covid19-13Oct2022.aspx.
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3. Telehealth Originating Site Facility Fee Update
Section 1834(m)(2)(B) of the Act established the initial Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00,
and specifies that for telehealth services furnished on or after
January 1 of each subsequent calendar year, the telehealth originating
site facility fee is increased by the percentage increase in the
Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the
Act. The final MEI increase for CY 2023 is 3.8 percent and is based on
the most recent historical percentage increase of the 2017-based MEI
for the second quarter of 2022.
Therefore, for CY 2023, the final payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is $28.64. The
Medicare telehealth originating site facility fee and the MEI increase
by the applicable time period are shown in Table 15.
[GRAPHIC] [TIFF OMITTED] TR18NO22.019
[[Page 69469]]
E. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the
5-year review process, revisions in RVUs were proposed and finalized
via rulemaking. In addition to the 5-year reviews, beginning with CY
2009, CMS and the RUC identified a number of potentially misvalued
codes each year using various identification screens, as discussed in
section II.C. of this final rule, Potentially Misvalued Services under
the PFS. Historically, when we received RUC recommendations, our
process had been to establish interim final RVUs for the potentially
misvalued codes, new codes, and any other codes for which there were
coding changes in the final rule with comment period for a year. Then,
during the 60-day period following the publication of the final rule
with comment period, we solicit public comment about those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we paid for services based upon the
interim final values established in the final rule. In the final rule
with comment period for the subsequent year, we consider and responded
to public comments received on the interim final values, and typically
make any appropriate adjustments and finalize those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we established interim final
values in the CY 2016 PFS final rule with comment period (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), and re-proposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
Federal Government as part of our process for establishing valuations.
Where we concur that the RUC's recommendations, or recommendations from
other commenters, are reasonable and appropriate and are consistent
with the time and intensity paradigm of physician work, we proposed
those values as recommended. Additionally, we continually engage with
interested parties, including the RUC, with regard to our approach for
accurately valuing codes, and as we prioritize our obligation to value
new, revised, and potentially misvalued codes. We continue to welcome
feedback from all interested parties regarding valuation of services
for consideration through our rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conduct a review that
includes the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the Federal
Government, as well as Medicare claims data. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we use in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could include the CPT codes that make up the bundled code
and the inputs associated with those codes. We use the building block
methodology to construct, or deconstruct, the work RVU for a CPT code
based on component pieces of the code. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. Section 1848(c)(1)(A) of the
Act specifically defines the work component as the resources that
reflect time and intensity in furnishing the service. Also, the
published literature on valuing work has recognized the key role of
time in overall work. For particular codes, we refine the work RVUs in
direct proportion to the changes in the best information regarding the
time resources involved in furnishing
[[Page 69470]]
particular services, either considering the total time or the
intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an E/M service, we believe that there is overlap between the two
services in some of the activities furnished during the preservice
evaluation and postservice time. Our longstanding adjustments have
reflected a broad assumption that at least one-third of the work time
in both the preservice evaluation and postservice period is duplicative
of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. We also include a summary of interested
party reactions to our approach when available. We noted in past
rulemaking that many commenters and interested parties have expressed
concerns over the years with our reviews of and updates to work RVUs
based on changes in the best available information regarding the time
resources involved in furnishing individual services. We have been
particularly concerned with the RUC's and various specialty societies'
objections to our approach given the significance of their
recommendations to our process for valuing services and since much of
the information we use to update the RVUs is derived from their survey
process. We are obligated under the statute to consider both time and
intensity in establishing work RVUs for PFS services. As explained in
the CY 2016 PFS final rule with comment period (80 FR 70933), we
recognize that adjusting work RVUs for changes in time is not always a
straightforward process, so we have applied various methodologies to
identify several potential work values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we sometimes use the relationship
between the ``old time'' values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we believe that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC's recommendation has appeared to
disregard or dismiss the changes in time, without a persuasive
explanation of why such a change should not be accounted for in the
overall work of the service, then we have generally used one of the
aforementioned methodologies to identify potential work RVUs, including
the methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several interested parties, including the RUC, have expressed
general objections to our use of these methodologies to adjust for
reductions in time, suggesting that our adjustments to the RUC-
recommended work RVUs are inappropriate. Other interested parties have
expressed general concerns with our refinements to RUC-recommended
values. In the CY 2017 PFS proposed rule (81 FR 46162), we requested
comments regarding potential alternatives to making adjustments that
would recognize overall estimates of work in the context of changes in
the resource of time for particular services; however, we did not
receive any specific potential alternatives. In the CY 2017 PFS final
rule (81 FR 80272 through 80277), we responded in detail to several
comments that we received regarding our approach to RUC-recommended
work times and RVUs. As described earlier in this section, crosswalks
to key reference or similar codes are one of the many methodological
approaches we have employed to identify potential values that reconcile
the RUC-recommend work RVUs with the recommended time values when the
RUC-recommended
[[Page 69471]]
work RVUs did not appear to account for significant changes in time.
We received several comments regarding our methodologies for work
valuation in response to the CY 2023 PFS proposed rule and those
comments are summarized below.
Comment: Several commenters disagreed with our reference to older
work time sources, and stated that their use led to the proposal of
work RVUs based on flawed assumptions. Commenters stated that codes
with ``CMS/Other'' or ``Harvard'' work time sources, used in the
original valuation of certain older services, were not surveyed, and
therefore, were not resource-based. Commenters also stated that it was
invalid to draw comparisons between the current work times and work
RVUs of these services to the newly surveyed work time and work RVUs as
recommended by the RUC.
Response: We agree that it is important to use the recent data
available regarding work times, and we note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also believe that our operating assumption regarding
the validity of the existing values as a point of comparison is
critical to the integrity of the relative value system as currently
constructed. The work times currently associated with codes play a very
important role in PFS ratesetting, both as points of comparison in
establishing work RVUs and in the allocation of indirect PE RVUs by
specialty. If we were to operate under the assumption that previously
recommended work times had been routinely overestimated, this would
undermine the relativity of the work RVUs on the PFS in general, in
light of the fact that codes are often valued based on comparisons to
other codes with similar work times. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, which is why we apply various methodologies
to identify several potential work values for individual codes.
However, we reiterate that we believe it would be irresponsible to
ignore changes in time based on the best data available, and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
Comment: Several commenters disagreed with the use of time ratio
methodologies for work valuation. Commenters stated that this use of
time ratios is not a valid methodology for valuation of physician
services. Commenters stated that treating all components of physician
time (preservice, intraservice, postservice and post-operative visits)
as having identical intensity is incorrect, and inconsistently applying
it to only certain services under review creates inherent payment
disparities in a payment system, which is based on relative valuation.
Commenters stated that in many scenarios, CMS selects an arbitrary
combination of inputs to apply rather than seeking a valid clinically
relevant relationship that would preserve relativity. Commenters
suggested that CMS determine the work valuation for each code based not
only on surveyed work times, but also the intensity and complexity of
the service and relativity to other similar services, rather than
basing the work value entirely on time. Commenters recommended that CMS
embrace the clinical input from practicing physicians when valid
surveys were conducted and provide a clinical rationale when proposing
crosswalks for valuation of services.
Response: We disagree and continue to believe that the use of time
ratios is one of several appropriate methods for identifying potential
work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for survey information that suggests the amount of time
involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. When our review of recommended
values reveals that changes in time are not accounted for in a RUC-
recommended work RVU, the obligation to account for that change when
establishing proposed and final work RVUs remains.
We recognize that it would not be appropriate to develop work RVUs
solely based on time given that intensity is also an element of work,
but in applying the time ratios, we are using derived intensity
measures based on current work RVUs for individual procedures. We
clarify again that we do not treat all components of physician time as
having identical intensity. If we were to disregard intensity
altogether, the work RVUs for all services would be developed based
solely on time values and that is not the case, as indicated by the
many services that share the same time values but have different work
RVUs. For example, among the codes reviewed in this CY 2023 PFS final
rule, CPT codes 22632 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; each additional
interspace), 63035 (Laminotomy (hemilaminectomy), with decompression of
nerve root(s), including partial facetectomy, foraminotomy and/or
excision of herniated intervertebral disc; each additional interspace,
cervical or lumbar), 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), and 99285 (Emergency department
visit for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making) all share the same intraservice and total work
time of 60 minutes. However, these codes had very different proposed
work RVUs of 5.22 and 3.86 and 5.50 and 4.00, respectively. These
examples demonstrate that we do not value services purely based on work
time; instead, we incorporate time as one of multiple different factors
in our review process. Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277).
We also clarify for the commenters that our review process is not
arbitrary in nature. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the
[[Page 69472]]
RUC, the HCPAC, and other public commenters, medical literature, and
comparative databases, as well as a comparison with other codes within
the PFS, consultation with other physicians and health care
professionals within CMS and the Federal Government, as well as
Medicare claims data. We also assess the methodology and data used to
develop the recommendations submitted to us by the RUC and other public
commenters and the rationale for the recommendations. In the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329), we
discussed a variety of methodologies and approaches used to develop
work RVUs, including survey data, building blocks, crosswalks to key
reference or similar codes, and magnitude estimation (see the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329) for more
information).
With regard to the commenter's concerns regarding clinically
relevant relationships, we emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
Comment: Several commenters did not agree with CMS valuing codes
based on work RVU increments. Commenters stated that this methodology
for valuing codes inaccurately treats all components of the physician
time as having identical intensity and would lead to incorrect work
valuations. Commenters stated that CMS should carefully consider the
clinical information justifying the changes in physician work intensity
provided by the RUC and other interested parties.
Response: We believe that using the incremental difference between
the work RVUs of codes is a valid methodology for setting values,
especially when valuing services within a family of revised codes where
it is important to maintain appropriate intra-family relativity.
Historically, we have frequently used an incremental methodology in
which we value a code based upon the incremental work RVU difference
between the code and another code or another family of codes. We note
that the RUC has also used the same incremental methodology on occasion
when it was unable to produce valid survey data for a service. We have
no evidence to suggest that the use of an incremental difference
between the work RVUs of codes conflicts with the statute's definition
of the work component as the resources in time and intensity required
in furnishing the service. We do consider clinical information
associated with physician work intensity provided by the RUC and other
interested parties as part of our review process, although we remind
readers again that we do not believe that it is necessary for codes to
share the same site of service, patient population, or utilization
level in order to serve as an appropriate crosswalk.
Comment: Several commenters stated that they were concerned about
CMS' lack of consideration for compelling evidence that services have
changed. Commenters stated that CMS appeared to dismiss the fact that
services may change due to technological advances, changes in the
patient population, shifts in the specialty of physicians providing
services or changes in the physician work or intensity required to
perform services. Commenters stated that CMS' failure to discuss
compelling evidence does not reflect the long history of reviewing
potentially misvalued codes, first through the statutorily mandated 5-
year review processes and more recently from continuous annual reviews.
Commenters stated that CMS has discussed compelling evidence in
rulemaking since the inception of the RBRVS and has informed public
commenters to consider compelling evidence to identify potentially
misvalued codes. Commenters requested that CMS address the compelling
evidence submitted with the RUC recommendations when the agency does
not accept the RUC's recommended work RVUs.
Response: The concept of compelling evidence was developed by the
RUC as part of its work RVU review process for individual codes. The
RUC determines whether there is compelling evidence to justify an
increase in valuation. The RUC's compelling evidence criteria include
documented changes in physician work, an anomalous relationship between
the code and multiple key reference services, evidence that technology
has changed physician work, analysis of other data on time and effort
measures, and evidence that incorrect assumptions were made in the
previous valuation of the service. While we appreciate the submission
of this additional information for review, we emphasize that the RUC
developed the concept of compelling evidence for its own review
process; an evaluation of ``compelling evidence,'' at least as
conceptualized by the RUC, is not part of our review process, as our
focus is the time and intensity of services, in accordance with the
statute. With that said, we do consider changes in technology, patient
population, and other compelling evidence criteria, as such evidence
may affect the time and intensity of a service under review. For
example, new technology may cause a service to become easier or more
difficult to perform, with corresponding effects on the time and
intensity of the service. However, we are under no obligation to adopt
the same review process or compelling evidence criteria as the RUC. We
instead focus on evaluating and addressing the time and intensity of
services when reviewing potentially misvalued codes because section
1848(c)(1)(A) of the Act specifically defines the work component as the
resources that reflect time and intensity in furnishing the service.
Comment: Several commenters raised the issue of the refinement
panel which was last reformed in CY 2016. Commenters stated that the
refinement panel was not obsolete and was not mutually exclusive with
the change to include all proposed valuations in each year's proposed
rule. Commenters stated that for 2 decades, the refinement panel
process was considered by interested parties to be an appeals process
and its elimination discontinued CMS' reliance on outside interested
parties to provide accountability through a transparent appeals
process. Commenters requested that CMS consider these issues and create
an objective, transparent and consistently applied formal appeals
process that would be open to any commenting organization.
Response: We did not propose any changes to the refinement panel
for CY 2023. As we stated in the CY 2016 PFS final rule (80 FR 70917
and 70918), the refinement panel was established to assist us in
reviewing the public comments on CPT codes with interim final work RVUs
and in balancing the interests of the specialty societies who commented
on the work RVUs with the budgetary and redistributive effects that
could occur if we accepted extensive increases in work RVUs across a
broad range of services. When developing the CY 2016 proposed rule, and
continuing to the present, we did not believe that the refinement panel
had generally served as the kind of ``appeals'' or reconsideration
process that some interested parties envisioned in their comments. We
also believe that the refinement panel was not achieving its intended
purpose. Rather than providing us with additional information, balanced
across specialty interests, to assist us in establishing work RVUs, the
refinement panel
[[Page 69473]]
process generally served to rehash the issues raised and information
already discussed at the RUC meetings and considered by CMS. In
contrast to the prior process of establishing interim final values and
using a refinement panel process that generally was not observed by
members of the public, we continue to believe that the current process
of proposing the majority of code values in a proposed rule, giving the
public the opportunity to comment on those proposed values, and then
finalizing those values in a final rule offers greater transparency and
accountability.
We also note that we did not finalize our proposal to eliminate the
refinement panel completely in CY 2016. We retain the ability to
convene refinement panels for codes with interim final values under
circumstances where additional input provided by the panel is likely to
add value as a supplement to notice and comment rulemaking. We also
remind interested parties that we have established an annual process
for the public nomination of potentially misvalued codes. This process,
described in the CY 2012 PFS final rule (76 FR 73058), provides an
annual means for those who believe that values for individual services
are inaccurate and should be readdressed through notice and comment
rulemaking to bring those codes to our attention.
In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified that terms ``reference services'', ``key reference
services'', and ``crosswalks'' as described by the commenters are part
of the RUC's process for code valuation. These are not terms that we
created, and we do not agree that we necessarily must employ them in
the identical fashion for the purposes of discussing our valuation of
individual services that come up for review. However, in the interest
of minimizing confusion and providing clear language to facilitate
feedback from interested parties, we will seek to limit the use of the
term, ``crosswalk,'' to those cases where we are making a comparison to
a CPT code with the identical work RVU. We also occasionally make use
of a ``bracket'' for code valuation. A ``bracket'' refers to when a
work RVU falls between the values of two CPT codes, one at a higher
work RVU and one at a lower work RVU.
We look forward to continuing to engage with interested parties and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 16 contains a list of codes and
descriptors for which we proposed work RVUs; this includes all codes
for which we received RUC recommendations by February 10, 2022. The
finalized work RVUs, work time and other payment information for all CY
2023 payable codes are available on the CMS website under downloads for
the CY 2023 PFS final rule at (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the Federal Government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 18 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of
PE RVUs, we address certain proposed refinements that would be common
across codes. We also address the refinements to particular codes that
we are finalizing in section II.B. of this rule. We note that for each
refinement of the RUC-recommended direct PE inputs that we are
finalizing, we indicate the potential impact on direct costs for that
service. We also note that, on average, in any case where the impact on
the direct cost for a particular refinement is $0.35 or less, the
refinement has no impact on the PE RVUs. This calculation considers
both the impact on the direct portion of the PE RVU, as well as the
impact on the indirect allocator for the average service. We also noted
that many of the refinements listed in Table 17 result in changes under
the $0.35 threshold and would be unlikely to result in a change to the
RVUs.
We note that the final direct PE inputs for CY 2023 are displayed
in the CY 2023 direct PE input files, available on the CMS website
under the downloads for the CY 2023 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the final CY 2023 PE RVUs
as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general
[[Page 69474]]
guidelines regarding appropriate equipment time inputs. We appreciate
the RUC's willingness to provide us with these additional inputs as
part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time will also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also noted that we believe these same assumptions will
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question will be available if the
room is not being occupied by a particular patient. For additional
information, we referred readers to our discussion of these issues in
the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this final rule, Determination
of PE RVUs, for more information regarding the collaborative work of
CMS and the RUC in improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2023, we received invoices for several new supply and
equipment items. Tables 19 and 20 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final rule, Determination of Practice Expense Relative
Value Units, we encourage interested parties to review the prices
associated with these new and existing items to determine whether these
prices appear to be accurate. Where prices appear inaccurate, we
encourage interested parties to submit invoices or other information to
improve the accuracy of pricing for these items in the direct PE
database by February 10th of the following year for consideration in
future rulemaking, similar to our process for consideration of RUC
recommendations.
We remind interested parties that due to the relativity inherent in
the development of RVUs, reductions in existing prices for any items in
the direct PE database increase the pool of direct PE RVUs available to
all other PFS services. Tables 19 and 20 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that interested parties will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that interested
parties are more likely to have better pricing information for items
used more frequently. A single invoice may not be reflective of typical
costs and we encourage interested parties to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we include the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
[[Page 69475]]
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the list of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are
subject to the OPPS cap; are displayed in the public use files for the
PFS proposed and final rules for each year. The public use files for CY
2023 are available on the CMS website under downloads for the CY 2023
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule with comment period (78 FR 74261 through
74263).
Effective January 1, 2007, section 5102(b)(1) of the Deficit
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section
1848(b)(4) of the Act to require that, for imaging services, if--(i)
The technical component (TC) (including the TC portion of a global fee)
of the service established for a year under the fee schedule without
application of the geographic adjustment factor, exceeds (ii) The
Medicare OPD fee schedule amount established under the prospective
payment system (PPS) for hospital outpatient (HOPD) services under
section 1833(t)(3)(D) of the Act for such service for such year,
determined without regard to geographic adjustment under paragraph
(t)(2)(D) of such section, the Secretary shall substitute the amount
described in clause (ii), adjusted by the geographic adjustment factor
[under the PFS], for the fee schedule amount for such TC for such year.
As required by the section 1848(b)(4)(A) of the Act, for imaging
services furnished on or after January 1, 2007, we cap the TC of the
PFS payment amount for the year (prior to geographic adjustment) by the
Outpatient Prospective Payment System (OPPS) payment amount for the
service (prior to geographic adjustment). We then apply the PFS
geographic adjustment to the capped payment amount. Section
1848(b)(4)(B) of the Act defines imaging services as imaging and
computer-assisted imaging services, including X-ray, ultrasound
(including echocardiography), nuclear medicine (including PET),
magnetic resonance imaging (MRI), computed tomography (CT), and
fluoroscopy, but excluding diagnostic and screening mammography. For
more information regarding the history of the cap on the TC of the PFS
payment amount under the DRA (the ``OPPS cap''), we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69659 through
69662).
For CY 2023, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined above
for purposes of this cap. Beginning for CY 2023, we proposed to include
the following services on the list of codes to which the OPPS cap
applies: CPT codes 0493T (Contact near-infrared spectroscopy studies of
lower extremity wounds (e.g., for oxyhemoglobin measurement)), 0640T
(Noncontact near-infrared spectroscopy studies of flap or wound (e.g.,
for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue
oxygenation [StO2]); image acquisition, interpretation and report, each
flap or wound), 0641T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); image acquisition only, each
flap or wound), 0642T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); interpretation and report
only, each flap or wound), 0651T (Magnetically controlled capsule
endoscopy, esophagus through stomach, including intraprocedural
positioning of capsule, with interpretation and report), 0658T
(Electrical impedance spectroscopy of 1 or more skin lesions for
automated melanoma risk score), 0689T (Quantitative ultrasound tissue
characterization (non-elastographic), including interpretation and
report, obtained without diagnostic ultrasound examination of the same
anatomy (e.g., organ, gland, tissue, target structure)), 0690T
(Quantitative ultrasound tissue characterization (non-elastographic),
including interpretation and report, obtained with diagnostic
ultrasound examination of the same anatomy (e.g., organ, gland, tissue,
target structure) (List separately in addition to code for primary
procedure)), 0694T (3-dimensional volumetric imaging and reconstruction
of breast or axillary lymph node tissue, each excised specimen, 3-
dimensional automatic specimen reorientation, interpretation and
report, real-time intraoperative), 0700T (Molecular fluorescent imaging
of suspicious nevus; first lesion), 0701T (Molecular fluorescent
imaging of suspicious nevus; each additional lesion (List separately in
addition to code for primary procedure)), and 76883 (Ultrasound,
nerve(s) and accompanying structures throughout their entire anatomic
course in one extremity, comprehensive, including real-time cine
imaging with image documentation, per extremity). As CPT codes 0493T,
0642T, 0651T, 0658T, and 76883 are not within the statutory scope of
services to which the OPPS cap applies, as they cannot be split into
professional and technical components, or they only describe the
professional component (PC), we thus proposed to add these codes to the
OPPS DRA caps list in error. Therefore, we are not finalizing our
proposal to add them to the list of services to which the OPPS cap
applies. We believe that the remaining codes, CPT codes 0640T, 0641T,
0689T, 0690T, 0694T, 0700T, and 0701T, meet the definition of imaging
services under section 1848(b)(4)(B of the Act, and thus, should be
subject to the OPPS cap. Therefore, we are finalizing our proposal to
add CPT codes 0640T, 0641T, 0689T, 0690T, 0694T, 0700T, and 0701T to
the list of services to which the OPPS cap applies, and we are not
finalizing our proposal to add CPT codes 0493T, 0642T, 0651T, 0658T,
and 76883 to the OPPS cap list.
4. Valuation of Specific Codes for CY 2023
(1) Anterior Abdominal Hernia Repair (CPT Codes 15778, 49591, 49592,
49593, 49594, 49595, 49596, 49613, 49614, 49615, 49616, 49617, 49618,
49621, 49622, and 49623)
In April 2021, the RUC reviewed an existing code that describes
hernia repair, CPT code 49565 (Repair recurrent incisional or ventral
hernia; reducible). CPT code 49565 was identified as being performed
less than 50 percent of the time in the inpatient setting and being
primarily performed in the outpatient setting. Interested
[[Page 69476]]
parties requested referral to CPT to update the code's descriptor. In
response to the disparate site of service and request to update the
code's descriptor, CPT created new codes with 000-day global periods to
describe this type of service. The codes within this family are
differentiated by 3 characteristics: whether the hernia is initial or
recurrent, whether it is reducible or strangulated, and the total
length of the hernia. CPT also created two new codes that describe
parastomal hernia repair and an add-on code for removal of mesh.
The RUC recommendations differentiate the post-operative periods
for the codes within this family by whether there is a same-day
discharge, overnight stay with a visit on the same date, or whether the
patient is admitted to the hospital. We disagree with many of the RUC-
recommended work RVUs for the codes within this family that have a
post-operative overnight stay built into their valuation. More
specifically, we disagree with the RUC-recommended work RVUs for such
codes because the RUC did not completely apply the 23-hour policy
calculation (finalized in the CY 2011 PFS final rule (75 FR 73226)) in
formulating its recommendations. Additionally, we disagree with the
RUC-recommended work RVUs for the CPT codes in this family for which
the RUC considered the patient to be admitted during the post-operative
period because the RUC did not apply the 23-hour policy when
formulating its recommendations.
As we noted in the CY 2011 PFS final rule (75 FR 73226), the work
RVUs for services that are typically performed in the outpatient
setting and require a hospital stay of less than 24 hours may in some
cases involve multiple overnight stays while the patient is still
considered to be an outpatient for purposes of Medicare payment.
Because such services are typically furnished in the outpatient
setting, they should not be valued to include inpatient post-operative
E/M visits. The level of discharge day management services included in
the valuation of such services should similarly not reflect an
inpatient discharge and should therefore be reduced. And finally, as
discussed in CY 2011 rulemaking, the intraservice time from the
inpatient level E/M postoperative visit should be reallocated to the
immediate postservice time of the service. The 23-hour policy
calculation, when fully applied to the calculation of a work RVU, is
used to reduce the value of discharge day management services, remove
the inpatient E/M visits, and reallocate the intraservice time to the
immediate post-service period. See the CY 2011 PFS final rule (75 FR
73226) for additional in-depth explanation of the 23-hour policy.
For the codes with an overnight stay and an E/M visit on the same
date built into their valuation, we believe the RUC only partially
applied the 23-hour policy when it applied the policy to the immediate
post service times, but not to the calculation of the work RVUs.
Instead, we believe the 23-hour policy should be fully applied to the
codes in this family that describe outpatient services for which there
is an overnight stay during the post-operative period, regardless of
the number of nights that a patient stays in the hospital. The services
to which the 23-hour policy is usually applied would typically involve
a patient stay in a hospital for less than 24 hours, which often means
the patient may stay overnight in the hospital. On occasion, the
patient may stay in the hospital longer than a single night; however,
in both cases (one night or more than one night), the patient is
considered to be a hospital outpatient, not an inpatient, for Medicare
purposes. In short, we do not believe that the work that is typically
associated with an inpatient service should be included in the work
RVUs for the outpatient services to which the 23-hour policy applies.
The RUC recommended a work RVU of 8.0 for CPT code 15778
(Implantation of absorbable mesh or other prosthesis for delayed
closure of defect(s) (ie, external genitalia, perineum, abdominal wall)
due to soft tissue infection or trauma). CPT code 15778 was surveyed
with having one subsequent hospital visit, CPT code 99232 (subsequent
hospital care/day 25 minutes) and 25 minutes of immediate post service
time. For purposes of calculating the recommended work RVU of 8.0, the
RUC considered CPT code 15778 to describe an inpatient service, while
we consider CPT code 15778 to describe an outpatient service for
purposes of Medicare billing. As noted above, we do not believe that
work that is typically associated with an inpatient service should be
included in the work RVUs for the outpatient services to which the 23-
hour policy applies. Therefore, the valuation for this code should not
include inpatient work in the post-operative period. See the CY 2022
PFS final rule (86 FR 65090) for further discussion on the 23-hour
policy as it relates to outpatient billing. We believe the 23-hour
policy should be fully applied to CPT code 15778, and we disagree with
the RUC-recommended work RVU of 8.0.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we instead proposed a work
RVU of 7.05 for CPT code 15778 and a reallocation of the time
associated with the intra-service portion of the inpatient hospital
visit to the immediate postservice time of CPT code 15778.
The steps for the 23-hour policy calculation are as follows:
Step (1): CPT code 15778 does not have a hospital
discharge day management service; therefore, we will skip this step*.
Step (2): 8.0-1.39** = 6.61.
Step (3): 6.61 + (20 minutes x 0.0224)*** = 7.05 RVUs.
*Value associated with \1/2\ hospital discharge day management
service
**Value associated with an inpatient hospital visit, CPT code
99232.
***Value associated with the reallocated intraservice time
multiplied by the postservice intensity of the 23-hour stay code.
The following CPT codes have a post-operative period that is
considered an overnight stay with a visit on the same date: CPT codes
49592 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
incarcerated or strangulated), 49593 (Repair of anterior abdominal
hernia(s) (ie, epigastric, incisional, ventral, umbilical, spigelian),
any approach (ie, open, laparoscopic, robotic), initial, including
placement of mesh or other prosthesis, when performed, total length of
defect(s); 3 cm to 10 cm, reducible), 49594 (Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), initial,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
49595 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); greater than 10
cm, reducible), 49614 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s);
less than 3 cm, incarcerated or strangulated), and 49615 (Repair of
anterior abdominal hernia(s) (ie,
[[Page 69477]]
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s); 3
cm to 10 cm, reducible). The RUC recommended a work RVU of 9.0 for CPT
code 49592, 10.80 for CPT code 49593, 14.0 for CPT code 495944, 14.88
for CPT code 49595, 10.79 for CPT code 49614, and 12.0 for CPT code
496159. CPT codes 49592, 495933, 49614, and 49615 were surveyed with
one subsequent inpatient hospital visit at a level of CPT code 99231
(subsequent hospital care/day 15 minutes). The RUC applied the 10
minutes of intraservice time from CPT code 99231 to the immediate
postservice time of these codes, resulting in a total immediate
postservice time of 30 minutes for these codes. CPT codes 49594 and
49595 were surveyed with a subsequent inpatient hospital visit at a
level of CPT code 99232. The RUC applied the 20 minutes of intraservice
time from CPT code 99232 to the immediate postservice time of both
codes, resulting in a total immediate postservice time of 40 minutes.
Much like our concerns regarding the RUC-recommended work RVU for
CPT code 15778, we do not believe that the RUC fully applied the 23-
hour policy calculation when calculating the work RVUs for these codes
and we disagree with the RUC-recommended RVUs. While the RUC removed
the 99231 and 99232 inpatient visits included in the post-operative
period for these codes, the RUC did not subtract the values of these
visits from the work RVUs before making their work RVU recommendations.
In the CY 2011 PFS final rule (75 FR 73226), we stated that we do not
believe that the post-procedure hospital visits for outpatient services
should be at the inpatient level since the typical case is an
outpatient who would be ready to be discharged from the hospital in 23
hours or less. However, we agree with the RUC that the intra-service
time of the inpatient hospital visit may be included in the valuation
for 23-hour stay codes. Therefore, we believe that step 2 of the 23-
hour hour policy calculation, which involves deducting the RVUs of the
inpatient hospital visits from the starting work RVU value and
subsequently reallocating the time associated with the intra-service
portion of the inpatient hospital visits to the immediate postservice
time of the 23-hour stay code, should be fully applied when calculating
the work RVUs for CPT codes 49592, 49593, 49594, 49595, 49614, and
49615.
Using the 23-hour policy calculation described above and in the CY
2011 PFS final rule, we proposed work RVUs of 8.46 for CPT code 49592,
10.26 for CPT code 49593, 13.46 for CPT code 49594, 13.94 for CPT code
49595, 10.25 for CPT code 49614, and 11.46 for CPT code 49615.
The following CPT codes have a post-operative period that the RUC
considers to be admitted to a hospital: CPT code 49596 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49616 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s); 3
cm to 10 cm, incarcerated or strangulated), 49617(Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), recurrent,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); greater than 10 cm, reducible), 49618 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
recurrent, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49621 (Repair of parastomal hernia, any approach (ie,
open, laparoscopic, robotic), initial or recurrent, including placement
of mesh or other prosthesis, when performed; reducible), and 49622
(Repair of parastomal hernia, any approach (ie, open, laparoscopic,
robotic), initial or recurrent, including placement of mesh or other
prosthesis, when performed; incarcerated or strangulated). The RUC
recommended a work RVU of 18.67 for CPT code 49596, 15.55 RVUs for CPT
code 49616, 16.03 RVUs for CPT code 49617, 22.67 RVUs for CPT code
49618, 13.70 RVUs for CPT code 49621, and 17.06 RVUs for CPT code
49622. CPT codes 49596 and 496182 were surveyed and recommended with
one subsequent inpatient hospital visit at a level of CPT code 99233
(subsequent hospital care/day 35 minutes). The RUC recommendations
include an immediate postservice time of 25 minutes for CPT code 49596
and 30 minutes for CPT code 49618. CPT codes 49616, 49617, and 49622
were surveyed and recommended with one subsequent inpatient hospital
visit at a level of CPT code 99232. The RUC recommendations include an
immediate postservice time of 25 minutes for 49616, 28 minutes for CPT
code 49617, and 25 minutes for CPT code 49622. CPT code 49621 was
surveyed and recommended with one subsequent inpatient hospital visit
at a level of CPT code 99231 and an immediate postservice time of 25
minutes.
For purposes of calculating the recommended work RVUs, the RUC
considered these CPT codes to describe an admitted inpatient service,
while we consider the CPT codes to describe outpatient services for
purposes of billing. Therefore, we believe that inpatient work in the
post-operative period should not be included in the valuation. We
believe the 23-hour policy should be applied to these codes. Using the
23-hour policy calculation described above and in the CY 2011 PFS final
rule, we proposed a work RVU of 18.67 for CPT code 49596, 15.55 RVUs
for CPT code 49616, 16.03 RVUs for CPT code 49617, 22.67 RVUs for CPT
code 49618, 13.70 RVUs for CPT code 49621, and 17.06 RVUs for CPT code
49622. We are also proposing revised immediate postservice times for
the reallocation of the time associated with the intraservice portion
of the inpatient hospital visit. We proposed immediate post service
times of 40 minutes for CPT code 49596, 35 minutes for CPT code 49616,
38 minutes for CPT code 49617, 45 minutes for CPT code 49618, 30
minutes for CPT code 49621, and 35 minutes for CPT code 49622.
The following CPT codes have a post-operative period that the RUC
considers to be a same day discharge: CPT code 49591 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); less than 3 cm, reducible) and
49613 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), recurrent, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
reducible). The RUC-recommended a work RVU of 6.27 for CPT code 49591
and 7.75 for CPT code 49613. We disagree with the RUC-recommended RVU
for CPT code 495911 because it falls above the median value for codes
with similar
[[Page 69478]]
times. We proposed a work RVU of 5.96 RVUs based on the intraservice
time ratio, which is the ratio of 90 minutes of intraservice time of a
current hernia repair code--CPT code 49560 (Repair initial incisional
or ventral hernia; reducible) and the 45 minutes of intraservice time
for CPT code 49591. The proposed work RVU of 5.96 is also supported by
reference CPT code 93453 (Combined right and left heart catheterization
including intraprocedural injection(s) for left ventriculography,
imaging supervision and interpretation, when performed). CPT code 93453
has a work RVU of 5.99, the same intraservice time as CPT code 49591(45
minutes), and a slightly higher total time of 113 minutes.
For CPT code 49613, we disagree with the RUC- recommended work RVU
of 7.75, as it is above the median range compared to codes with similar
times. We proposed a work RVU of 7.42 RVUs for CPT code 49613 based off
of the intraservice time ratio of 100 minutes of intraservice time for
a current hernia repair code--CPT code 49565 (Repair recurrent
incisional or ventral hernia; reducible), compared to the 60 minutes of
intraservice time for CPT code 49613. The proposed work RVU of 7.42 is
also supported by reference CPT code 52353 (Cystourethroscopy, with
ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral
catheterization is included)). CPT code 52353 has a work RVU of 7.50
with the same intraservice time of 60 minutes and a very similar total
time of 133 minutes.
CPT code 49623 (Removal of total or near-total non-infected mesh or
other prosthesis at the time of initial or recurrent anterior abdominal
hernia repair or parastomal hernia repair, any approach (ie, open,
laparoscopic, robotic)) is an add-on code. The RUC recommended a work
RVU of 5.0 for CPT code 49623. The RUC recommendation is higher than
the work RVUs for many other CPT add-on codes with similar times. We
proposed a work RVU of 2.61 RVUs for CPT code 49623, based on the
reverse building block methodology. The proposed work RVU of 2.61 is
also supported by reference CPT code 15774 (Grafting of autologous fat
harvested by liposuction technique to face, eyelids, mouth, neck, ears,
orbits, genitalia, hands, and/or feet; each additional 25 cc injectate,
or part thereof (List separately in addition to code for primary
procedure)), which has a work RVU of 2.50 and the same total time of 45
minutes.
We reviewed the RUC-recommended direct PE inputs for all of the
codes within this family. We disagree with the RUC's recommendations of
66 total minutes of clinical staff time for CPT codes 49591 and 49613,
60 total minutes of clinical staff time for CPT codes 49592, 49593,
49594, 49595, 49596, 49614, 49615, 49616, 49617, 49618, 49621, and
49622, and 20 total minutes of clinical staff time for CPT code 15778.
In the CY 2023 PFS proposed rule, we noted that the RUC recommended
090-day pre-service times for all of these codes despite surveying all
of the services as 000-day services. In the CY 2022 PFS final rule (86
FR 65090), we stated we continue to believe that setting and
maintaining clinical labor time and valuation standards provides
greater consistency among codes that share clinical labor tasks and
could improve relativity of values among codes. Therefore, we believe
that the standard clinical labor packages that are in accordance with
the surveyed global period continue to be the most appropriate for
purposes of clinical labor valuation.
The RUC recommendations for CPT codes 49591 and 49613, and CPT
codes 49592, 49593, 49594, 49595, 49596, 49614, 49615, 49616, 49617,
49618, 49621, and 49622, include the standard for 090-day preservice
times for clinical labor activities, which is 60 minutes. For 49591 and
49613 in particular, the RUC also recommended an additional 6 minutes
in the post service period to conduct patient communications. We
disagree with the RUC-recommended 090-day times as these CPT codes were
surveyed by the RUC as 000-day services and should have times
consistent with 000- day services. Therefore, we proposed the standard
clinical labor times for a 000-day extensive package for a total pre-
service clinical staff time of 30 minutes for CPT codes 49591 through
49622 with an additional standard 3 minutes of post-service patient
communications for 49591 and 49613. CPT code 49623 is an add-on code
and does not have RUC-recommended direct PE inputs.
For CPT code 15778, the RUC recommendation is 20 minutes of
clinical staff activities, which is standard for an emergent procedure
package. We do not agree that the service described by CPT code 15778
should be considered an emergent procedure. Therefore, we proposed the
minimal clinical staff package minus pre-service education for CPT code
15778, for a total of 12 clinical staff time minutes.
Comment: We received public comments for this code family that did
not support our proposed RVUs. Commenters stated that they do not agree
with our ``systemic and formulaic'' reduction in work RVUs by the use
of the Reverse Building Block (RBB) methodology. The commenters also
stated that our use of the RBB in the context of the 23-hour policy is
duplicative and results in inappropriately low valuations, in contrast
to their preferred method of magnitude estimation.
Response: We believe that there are multiple appropriate
methodologies for calculating work RVUs, including the RBB method, time
ratios, increments, and survey data. We finalized in the CY 2011 PFS
final rule (75 FR 73328 through 73329), the RBB formula for applying
the 23-hour policy to the work RVUs and the times of the outpatient
service and the same-day E/M codes. We do not believe that it is
duplicative to apply the full 23-hour policy to CPT codes when the RUC
recommendations do not account for the appropriate reduction in work
RVUs; this is relevant for some of the codes in this family as well as
the Intracranial Laser Interstitial Thermal Therapy (LITT) family (CPT
Codes 61736 and 61737) discussed in the CY 2022 PFS final rule (86 FR
65090). We continue to believe the entire 23-hour policy calculation,
as finalized in the CY 2011 PFS final rule, should be completely and
consistently applied where applicable.
Comment: Commenters noted several concerns regarding the
application of the 23-hour policy to this code family. Commenters
stated that they disagree with the additional application of the 23-
hour policy to the CPT codes that the RUC has considered as overnight
with a visit on the same date because they believe that this has
already been accounted for during the survey process magnitude
estimation. Commenters noted that they do not believe that the 23-hour
policy should be applied to the codes that the RUC has considered as
admitted because the patient will likely become an inpatient.
Additionally, the commenters expressed concern that we have added CPT
codes 49596, 49616, 49617, 49618, 49621, and 49622 to the Hospital
Outpatient Prospective Payment System's Inpatient Only List and the
volume being reallocated to the new CPT codes are from inpatient
predecessor codes, CPT codes 49561 and 49566, which is contradictory.
One commenter noted that the post-operative care will be occurring on
the same day as the service and they believe that we did not account
for this. Commenters also noted concern about contradictory policies
regarding the newly revised E/M CPT codes, 99232, 99233, 99238, and
99239, which they noted now represents the same physician work whether
inpatient or outpatient. Commenters opined that the revision to the E/M
[[Page 69479]]
codes renders the 23-hour policy invalid. One commenter also expressed
concern about our assertion that the 23-hour policy can encompass
scenarios where the patient stays multiple overnights in the hospital,
as this is contradictory to our ``Two-Midnight rule'' regarding
inpatient versus outpatient status.
Response: As stated previously, we believe that it is not
duplicative to apply the full 23-hour policy calculation to the CPT
codes that the RUC has considered as overnight with a visit on the same
date. It is not evident from the RUC recommendations provided to us
that the final work RVU was appropriately reduced (per the CY 2011 PFS
final rule formula) consistent with the second step of the 23-hour
calculation. Therefore, we believe the entire calculation should be
applied to the CPT codes that the RUC has considered as overnight with
a visit on the same date. We acknowledge that we proposed to add the
CPT codes that the RUC has considered as admitted to the Hospital
Outpatient Prospective Payment System's Inpatient Only List for 2023.
However, we believe that doing so is not inconsistent with our
proposals for this family. The RUC recommendations include a request to
treat these CPT codes as 000-day global services. As such, regardless
of the inpatient status of the patients, we continue to believe that
000-day global service code families allow for separately billable
post-operative E/M visits. Therefore, we believe it is still
appropriate to subtract the value of the post-operative E/M visit that
the RUC recommended as bundled into the valuations of the codes from
the valuation of the codes. We also acknowledge that the RUC
recommendations include the post-operative work occurring on the same
day of the service. In light of that, we intend to reallocate the
intraservice time from the removed post-operative E/M visit to the
immediate post-service time of the service, as proposed. We believe
that the proposed revisions for CPT codes 99221-99223 and 99231-99233
are not inconsistent with our 23-hour policy as it applies to this code
family; the RUC recommendations referenced in this rule (from April
2021) explicitly identify many of the codes in this family as being
subject to our 23-hour policy. Consistent with discussions in the CY
2011 and CY 2022 PFS final rules cited above, we agree with the RUC
that these codes are subject to the 23-hour policy, and we believe it
is appropriate to fully apply the 23-hour policy to several of the
codes within this family. We again note that the RUC recommendations
request this family be 000-day global services, as such, this allows
for separately billable E/M visits regardless of the patient's
admission status.
We note that we also discussed 000-day global services and
separately billable E/M visits in the CY 2022 PFS final rule relative
to CPT codes 21315 and 21320 (86 FR 65074). We note that we acknowledge
commenter's concerns regarding policy implications as a result of
adopting the E/M inpatient/observation revisions and will take that
into consideration for future rulemaking. Also consistent with the CY
2011 and CY 2022 final rules, we disagree with the commenter's concerns
regarding multiple overnights and the application of the 23-hour
policy. We stated in the CY 2022 final rule cited above that the 23-
hour policy can encompass several scenarios, including multiple
overnight stays (87 FR 45860). We did not propose any changes to the
previously finalized 23-hour policy nor a policy regarding ``Two-
Midnights''. Therefore, we believe it is still consistent to fully
apply the 23-hour policy to the codes within this family that the RUC
considers overnight with a visit on the same date and admitted.
Comment: One commenter stated that they have concerns with our CY
2011 PFS final rule policy (75 FR 73226) to reallocate the intraservice
time of the inpatient level E/M postoperative visit to the immediate
postservice time of the service. The commenter noted that the E/M
services furnished post operatively are separate and distinct from the
main surgical procedure and there is no difference in work to provide a
separate E/M service furnished to a postoperative patient by the
surgeon compared to another provider. Additionally, the commenter
stated that we have not provided a rationale or evidence for this
policy and the components of it, such as the intraservice vs. total
time and the chosen intensity. The commenter also noted that this
policy of reallocating the intraservice time from the inpatient level
E/M postoperative visit to the immediate postservice time of the
service is discriminatory to surgeons and the 23-hour policy overall is
flawed and not in line with statute.
Response: We acknowledge that some commenters had concerns
regarding various aspects of our 23-hour policy and CMS's full
application of the policy to the CPT codes in this family. We refer
readers to our discussion regarding the policy and its application in
the CY 2011 and CY 2022 PFS final rules, cited above. Since we did not
propose any changes to our 23-hour policy, its application or
calculation, we are not finalizing any changes to the policy for CY
2023.
Comment: Commenters disagreed with our proposed valuation
methodologies for several specific codes within the family. For CPT
codes 49591 and 49613, commenters disagreed with our use of the
intraservice time ratio as a valuation methodology. Commenters noted
that using ratios treats all components of physician time as having
identical intensities. Commenters also noted that we did not adequately
account for the bundled work of the placement of mesh, that previously
was reported separately. Commenters also disagreed with our chosen
supporting reference codes, as they noted their clinical nature and
intensity is not appropriate for purposes of comparison. For CPT code
49623, commenters disagreed with our use of the RBB methodology as the
service is currently not described by an existing CPT code and is
instead reported using an unlisted code or with modifier -22.
Response: We continue to believe that intraservice time ratios are
a valid and appropriate tool for determining work RVUs. We reiterate
that, consistent with the statute, we are required to value the work
RVU based on the relative resources involved in furnishing the service,
which include time and intensity. In accordance with the statute, we
believe that changes in time and intensity must be accounted for when
developing work RVUs. When our review of recommended values reveals
that changes in the resource of time are not accounted for in a RUC-
recommended RVU, the obligation to account for that change when
establishing the proposed and final work RVUs remains. For more details
on our methodology for developing work RVUs, we direct readers to the
discussion on time ratios as discussed above in this Valuation of
Specific Codes section.
For CPT codes 49591 and 49613, we believe that the RUC recommended
work RVUs are overvalued compared to similar codes with similar
intraservice times. We also do not believe that our supporting
reference codes must have similar clinical characteristics for purposes
of comparison due to the inherent relativity of the PFS. Also, for CPT
code 49591, we found multiple other supporting reference codes that
have similar and even lower intraservice and total times, but RVUs much
lower than the RUC recommended value for this code. For example, CPT
code 33289 (Transcatheter implantation of wireless pulmonary artery
pressure sensor for long-term hemodynamic monitoring, including
deployment and calibration of
[[Page 69480]]
the sensor, right heart catheterization, selective pulmonary
catheterization, radiological supervision and interpretation, and
pulmonary artery angiography, when performed) was reviewed by the RUC
in 2018. This CPT code has 40 minutes of intraservice time, 111 minutes
of total time, a work RVU of 6.0 and a nearly identical intensity of
0.115 as compared to the RUC derived intensity of 0.113 for their
recommended work RVU value for this code. Therefore, we believe a work
RVU of 5.96 for CPT code 49591 is an appropriate valuation based on CPT
codes with similar times and intensities. For CPT code 49613, we
disagree that our supporting reference code (CPT code 52353) is
inappropriate for purposes of comparison. In addition to the similar
times, it also has an intensity of 0.101 that is very close to the RUC
derived intensity of 0.105 for their recommendation for this code.
Therefore, we believe a work RVU of 7.42 for CPT code 49613 is an
appropriate valuation based on CPT codes with similar times and
intensities.
For CPT code 49623, we disagree that it is inappropriate to use the
RBB to reach a work RVU valuation. We believe that there are multiple
valuation methodologies that we can use to calculate work RVUs for CPT
codes, all of which align with the statutory requirement to value work
RVUs based on the relative resources involved in furnishing the
service, which include time and intensity. However, we agree with
commenters that there are other more appropriate CPT codes that could
be used in the RBB calculation for purposes of comparison. For example,
CPT code 11008 (Removal of prosthetic material or mesh, abdominal wall
for infection (e.g., for chronic or recurrent mesh infection or
necrotizing soft tissue infection) (List separately in addition to code
for primary procedure)) has a total time of 60 minutes and an RVU of
5.0. Using CPT code 11008 in the RBB calculation yields a work RVU of
3.75 for CPT code 49623. We believe that CPT code 11008 is a more
appropriate code to use within the RBB calculation for CPT code 49623.
We also support a work RVU of 3.75 with a reference code, CPT code
63048 (Laminectomy, facetectomy and foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s], [e.g., spinal or lateral recess stenosis]), single vertebral
segment; each additional segment, cervical, thoracic, or lumbar (List
separately in addition to code for primary procedure)), which has the
same total time of 45 minutes and work RVU of 3.47. Therefore, we are
finalizing a work RVU of 3.75 for CPT code 49623.
Comment: Commenters did not support our proposed practice expense
(PE) clinical staff time packages for this code family. Commenters
disagreed with using a 000/010-day extensive package and believe that
the 090-day clinical staff time package is still appropriate because
the change to a 000-day global period from a 090-day global period was
requested by the RUC to account for the variable post-operative care
and not the procedural clinical staff work that is associated with it.
One commenter also noted that in April 2022, the RUC created a new
clinical staff time package for 000/010-day global period codes that
had previously been 090-day global period codes. Commenters also
requested that we accept the RUC's recommendation to use the standard
emergent procedure package, with 20 minutes of clinical staff
activities e for CPT code 15778.
Response: As stated in the CY 2023 PFS proposed rule (87 FR 45909),
we continue to believe that maintaining clinical labor standards
provides greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. We
reviewed the individual codes in question and concluded that the use of
000-day or 010-day global period standards for ``Extensive use of
Clinical Staff'' would be most typical and consistent in these cases.
Upon further clinical review, we also continue to believe that the most
appropriate clinical staff package for CPT code 15778 is the minimal
staff package minus pre-service education. We are pleased to learn that
the RUC has developed a new clinical staff package for CPT codes that
are transitioning from a 90-day global period. This clinical staff
package was not included in the recommendations submitted for this code
family.
After consideration of the public comments, we are finalizing the
work RVU values for this code family as proposed, with the exception of
CPT code 49623, as indicated above. We are also finalizing all PE
inputs as proposed.
(2) Removal of Sutures or Staples (CPT Codes 15851, 15853, and 15854)
In October 2021, the CPT Editorial Panel approved the deletion of
CPT code 15850 and revised CPT code 15851 (Removal of sutures or
staples requiring anesthesia (ie, general anesthesia, moderate
sedation)), and created two new related CPT add-on codes, 15853 and
15854, to describe Removal of sutures or staples requiring anesthesia
(i.e., general anesthesia, moderate sedation). The RUC reviewed the
three codes: 15851, 15853 and 15854 at the January 2022 RUC meeting.
After reviewing CPT code 15851, we proposed the RUC-recommended
work RVU of 1.10 for CPT code 15851. CPT codes 15853 (Removal of
sutures OR staples not requiring anesthesia (List separately in
addition to E/M code)), and 15854 (Removal of sutures OR staples not
requiring anesthesia (List separately in addition to E/M code) are
valued by the RUC as PE-only codes. The RUC did not recommend any work
inputs for these two add-on codes and we did not propose any work RVU
refinements.
We also proposed the RUC-recommended direct PE inputs for CPT codes
15851, 15853, and 15854 without refinement.
Comment: One commenter expressed support for our proposed
valuations for the family of codes that describe the removal of sutures
or staples.
Response: We appreciate the commenter's support, and we are
finalizing our proposal of the RUC-recommended direct PE inputs for CPT
codes 15851, 15853, and 15854 without refinement.
(3) Arthrodesis Decompression (CPT Codes 22630, 22632, 22633, 22634,
63052, and 63053)
In October 2020, the CPT Editorial Panel approved the revision of
four codes describing arthrodesis and the addition of two new add-on
codes, CPT codes 63052 (Laminectomy, facetectomy, or foraminotomy
(unilateral or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[s] [e.g., spinal or lateral recess stenosis]),
during posterior interbody arthrodesis, lumbar; single vertebral
segment (List separately in addition to code for primary procedure))
and 63053 (Laminectomy, facetectomy, or foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s] [e.g., spinal or lateral recess stenosis]), during posterior
interbody arthrodesis, lumbar; each additional segment (List separately
in addition to code for primary procedure)), to report laminectomy,
facetectomy, or foraminotomy during posterior interbody arthrodesis,
lumbar to more appropriately identify the decompression that may be
separately reported. In January 2021, the RUC reviewed the survey
results for the two new codes and expressed concern that the four base
codes had not been surveyed along with the two new add-
[[Page 69481]]
on codes. The RUC recommended that the entire family be resurveyed and
presented for review at its April 2021 meeting. The RUC suggested that
until new values could be established, interim values be established
for CPT codes 63052 and 63053, which CMS revised for CY 2022 based on
the survey data and RUC review available to us at the time of the
development of the CY 2022 PFS proposed rule. We have noted in similar
circumstances, such as the minimally invasive glaucoma surgery (MIGS)
procedures with cataract surgery discussed in the CY 2022 PFS final
rule (86 FR 65097), that it is best for entire code families to be
surveyed at the same time. We also noted that we finalized a policy in
the CY 2015 PFS final rule (79 FR 67602 through 67609) to make all
changes in the work and MP RVUs and the direct PE inputs for new,
revised, and potentially misvalued services under the PFS by proposing
and then finalizing such changes through notice and comment rulemaking,
as opposed to initially finalizing changes on an interim final basis.
For CPT codes 22630 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; lumbar), 22633
(Arthrodesis, combined posterior or posterolateral technique with
posterior interbody technique including laminectomy and/or discectomy
sufficient to prepare interspace (other than for decompression), single
interspace; lumbar), 22634 (Arthrodesis, combined posterior or
posterolateral technique with posterior interbody technique including
laminectomy and/or discectomy sufficient to prepare interspace (other
than for decompression), single interspace; each additional interspace
and segment (List separately in addition to code for primary
procedure)), 63052, and 63053, we disagreed with the RUC-recommended
work RVUs of 22.09, 26.80, 7.96, 5.70, and 5.00, respectively, because
these values do not account for the surveyed changes in time, and we
proposed a work RVU of 20.42 for CPT code 22630, a work RVU of 24.83
for CPT code 22633, a work RVU of 7.30 for CPT code 22634, the current
work RVU of 4.25 for CPT code 63052 and a work RVU of 3.78 for CPT code
63053. For CPT code 22632 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; each additional interspace
(List separately in addition to code for primary procedure)), we agreed
with the RUC-recommended maintenance of the current work RVU of 5.22,
as there were no surveyed changes in time.
We proposed a work RVU of 20.42 for CPT code 22630 based on the
reverse building block methodology to account for the surveyed 8-minute
decrease in total time, 10-minute decrease in pre-service time, 30-
minute decrease in intraservice time, and 2-minute decrease in
immediate post-service time. We believe that since the two components
of work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, it would be inappropriate to maintain the current work RVU
given the significant decrease in intraservice time without adequate
justification of increased intensity. There are currently three CPT
code 99231 (Subsequent hospital care/day 15 minutes) and four CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits bundled in
CPT code 22630's 090-day global period and valuation. The RUC
recommended that the post-operative period for CPT code 22630 change to
include two CPT code 99232 (subsequent hospital care/day 25 minutes),
one CPT code 99231, one CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter.), and two CPT code 99213 visits. The currently bundled post-
operative visits total to 6.16 work RVUs, whereas the RUC-recommended
changes to the post-operative visits total 6.98 work RVUs, resulting in
a 0.82 work RVU increase (if no other changes occurred to CPT code
22630). The proposed work RVU of 20.42 for CPT code 22630 maintains the
same IWPUT of 0.067 and maintains the 0.82 work RVU difference between
the current and RUC-recommended post-operative period. We believe this
proposed work RVU is more accurate than the RUC-recommended work RVU
because there was no obvious or explicitly stated rationale in the
RUC's recommendations for the change in intensity of intraservice time,
and there was a 30-minute decrease in intraservice time for CPT code
22630. We believe that since the two components of work are time and
intensity, absent an obvious or explicitly stated rationale for why the
relative intensity of a given procedure has increased, it would have
been inappropriate to propose the RUC-recommended work RVU for CPT code
22630.
Similarly, we proposed a work RVU of 24.83 for CPT code 22633,
based on the reverse building block methodology, to account for the
surveyed 56-minute decrease in total time, 20-minute decrease in
intraservice time, and 33-minute decrease in post-operative time. The
reverse building block methodology accounts for the time and intensity
of post-operative work through long-established and agreed-upon times
and intensities for bundled post-operative visits, and accurately
adjusts for the changes occurring in the post-operative period. There
is currently one post-operative CPT code 99232, two CPT code 99233
(Subsequent hospital care/day 35 minutes), and three CPT code 99213
visits bundled in CPT code 22633's valuation. The RUC recommended that
the post-operative period for CPT code 22633 change to include two CPT
code 99232, one CPT code 99231, one CPT code 99214 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making. When using
time for code selection, 30-39 minutes of total time is spent on the
date of the encounter.), and two CPT code 99213 visits. The currently
bundled post-operative visits total to 8.30 work RVUs, whereas the RUC-
recommended changes to the post-operative visits total 6.98 work RVUs,
resulting in a 1.32 work RVU decrease (if no other changes occurred to
CPT code 22633). Using the reverse building block methodology, the
proposed work RVU of 24.83 maintains the same IWPUT of 0.080 and the
1.32 work RVU difference between the current and RUC-recommended post-
operative period. We believe this proposed work RVU is more accurate
than the RUC-recommended work RVU because there was no obvious or
explicitly stated rationale in the RUC's recommendations for the change
in intensity of intraservice time, and there was a 20-minute decrease
in intraservice time for CPT code 22633. We believe that since the two
components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, it would have
[[Page 69482]]
been inappropriate to propose the RUC-recommended work RVU decrease of
0.95, which is only about three-quarters of the established decrease in
work RVU of 1.32 and intensity from the changes in the post-operative
period alone. We also considered the apparent decrease in intraservice
time and the lack of an adequate justification for increased intensity
to arrive at our proposed work RVU of 24.83 for CPT code 22633.
We proposed a work RVU of 7.30 for CPT code 22634 based on a
comparison to its base code, CPT code 22633. We used the proposed work
RVU of 24.83 for the parent CPT code (22633) as the numerator and the
current work RVU for CPT code 22633 of 27.75 as the denominator, and
multiplied that fraction by the current work RVU of 8.16 for CPT code
22634 to arrive at a proportionate proposed work RVU of 7.30 for CPT
code 22634 ((24.83/27.75) * 8.16) = 7.30). The proposed work RVU
accounts for the decrease in intraservice time and is well bracketed by
CPT code 34820 (Open iliac artery exposure for delivery of endovascular
prosthesis or iliac occlusion during endovascular therapy, by abdominal
or retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 7.00 work RVUs with an
intraservice time of 60 minutes, and CPT code 34833 (Open iliac artery
exposure with creation of conduit for delivery of endovascular
prosthesis or for establishment of cardiopulmonary bypass, by abdominal
or retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 8.16 work RVUs with an
intraservice time of 72 minutes.
CPT codes 63052 and 63053 were new add-on codes to report
decompression when performed in conjunction with posterior interbody
arthrodesis at the same interspace for CY 2022. The proposed work RVU
for CPT code 63052 would maintain the current work RVU, despite a
surveyed change in time. In the CY 2022 PFS final rule, we finalized a
work RVU of 4.25 for CPT code 63052 for CY 2022 based on a crosswalk to
CPT code 22853 (Insertion of interbody biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to intervertebral
disc space in conjunction with interbody arthrodesis, each interspace
(List separately in addition to code for primary procedure)), which has
a work RVU of 4.25 and an intraservice time of 45 minutes. Despite a
surveyed 5-minute intraservice time increase for CPT code 63052, we
believe the crosswalk to CPT code 22853 is still valid, given that only
3 months passed between the two surveys, as it now has the same
intraservice time as CPT code 63052, is a spinal procedure, and is an
add-on code to the same base codes as CPT code 63052. Commenters on the
CY 2022 PFS proposed rule supported the bracket of key reference
service CPT code 22552 (Arthrodesis, anterior interbody, including disc
space preparation, discectomy, osteophytectomy and decompression of
spinal cord and/or nerve roots; cervical below C2, each additional
interspace (List separately in addition to code for primary procedure))
and MPC CPT code 34812 (Open femoral artery exposure for delivery of
endovascular prosthesis, by groin incision, unilateral (List separately
in addition to code for primary procedure)), and therefore, we noted
that the final work RVU of 4.25 for CY 2022 was supported by the
commenters (86 FR 65092). CPT code 22552 has a work RVU of 6.50 and an
intraservice time of 45 minutes, and commenters noted that CPT code
22552 has a higher intensity as anticipated for a surgical procedure in
comparison with a lumbar procedure. CPT code 34812 has a work RVU of
4.13 and 40 minutes of intraservice time, and commenters noted that
this code involves open femoral artery exposure by groin incision and
closure of the wound, typically for separately reported delivery of an
endovascular prosthesis for an asymptomatic infrarenal abdominal aortic
aneurysm. In comparison, exposure and closure for CPT code 63052 are
performed as part of the primary arthrodesis code and the intraservice
time includes higher intensity bony and soft tissue resection, and
therefore, although both codes require the same time, the physician
work and intensity of CPT code 63052 is greater than CPT code 34812.
In the CY 2022 PFS final rule, we finalized a work RVU of 3.19 for
CPT code 63053 for CY 2022 based on an intraservice time ratio between
CPT codes 63052 and 63053 ((30 minutes/40 minutes) * 4.25 = 3.19). We
believe this intraservice time ratio between the two CPT codes is still
valid, given that only 3 months passed between the two surveys, and
therefore, we proposed a work RVU of 3.78 based on the surveyed time
changes for CPT codes 63052 and 63053 ((40 minutes/45 minutes) * 4.25 =
3.78) in order to maintain consistency with previous analysis of time
and intensity of these two add-on codes. Due to the lack of an obvious
or explicitly stated rationale in the RUC's April recommendations for
the change in intensity between the January 2021 and April 2021
surveys, we relied on the changes in surveyed time to calculate the
proposed work RVUs for CPT codes 63052 and 63053.
We proposed the RUC-recommended PE inputs for CPT codes 22630 and
22633.
Comment: Some commenters disagreed with our proposed work RVUs for
CPT codes 22630 and 22633, stating that the changes in time for these
CPT codes are attributed to changes in technology that reduced operator
time but increased the intensity of the services provided within that
time. The commenters stated that routine use of fluoroscopy to obtain
intraoperative films may decrease the time required for these
procedures, but the surgeon is using that data in real-time to
determine the positioning and safety of hardware placement. The
commenters also stated that using high-speed electric drills eliminates
the routine need to change out air pressure tanks required for
pneumatic drills, but the differences in torque and handling change the
``feel'' of a procedure involving a high-speed drill close to the
spinal nerves. The commenters stated that the decreases in
intraoperative time is due to reduction in time devoted to low-risk and
less intense portions of the procedures (for example, waiting on a
radiology technician to obtain an intraoperative cross-table lateral
film; waiting for X-ray films to be developed after a flat plate film
was taken and waiting for air tanks to be changed out for a pneumatic
drill). The commenters contended that the decrease in intraservice time
is matched by a related increase in the intensity of the procedure
itself, as the lower intensity aspects of the procedure have been
eliminated, leaving the high-risk elements of the procedures to be
provided in less time with greater intensity.
Response: We note that we proposed a work RVU of 20.42 for CPT code
22630 based on the reverse building block methodology to account for
the surveyed 8-minute decrease in total time, 10-minute decrease in
pre-service time, 30-minute decrease in intraservice time, and 2-minute
decrease in immediate post-service time. We believed it would be
inappropriate to maintain the current work RVU for CPT code 22630 given
the significant decrease in intraservice time and the absence of an
adequate justification of increased intensity. However, after
consideration of the commenters' rationale for decreased time and
increased intensity, we are finalizing the RUC recommended work RVUs of
22.09 and 26.80 for CPT codes 22630 and
[[Page 69483]]
22633, respectively, as we believe the RUC recommended work RVUs
adequately account for the changes in resources. We appreciate the
commenters additional input regarding intensity, but remind interested
parties that both time and intensity changes must be addressed in the
summary of recommendations. We remind interested parties that, since
the two components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. If the RUC's recommendations
appear to disregard or dismiss the changes in time, without a
persuasive explanation of why such a change should not be accounted for
in the overall work of the service, then we generally use one of the
methodologies discussed above to identify potential work RVUs,
including the methodologies intended to account for the changes in the
resources involved in furnishing the procedure.
We note that we proposed a work RVU of 7.30 for CPT code 22634
based on a comparison to our proposed work RVU for its base code, CPT
code 22633, which we are not finalizing. Given that we have decided to
finalize the RUC recommended work RVU of 26.80 for CPT code 22633, in
order to maintain for relativity within the family, we are also
finalizing the RUC recommended work RVU of 7.96 for CPT code 22634.
Comment: A few commenters urged CMS to finalize the RUC recommended
work RVUs for CPT codes 63052 and 63053, stating that the intraservice
time for CPT code 63035 increased by five minutes to a total of 45
minutes and that the time spent performing this procedure is
essentially all high-risk. The commenters asserted that the lower
intensity surgical exposure activities were already completed with the
base code, so the physician work of CPT code 63052 involves only the
high intensity, dangerous aspects of neural element and spinal cord
decompression. Similarly, some commenters disagreed with our use of an
intraservice time ratio to value CPT code 63053. Commenters stated that
this approach ignores magnitude estimation and stated that the second
survey included more respondents who routinely perform this procedure.
Commenters stated that the new survey from April 2021, which included
all six codes in the family, generated an intraservice time of 40
minutes, a difference of five minutes between CPT codes 63052 and
63053, which is believed to be a more accurate reflection of the
difference in work between laminectomy/facetectomy/foraminotomy with
decompression of the first segment and an additional segment versus the
January 2021 survey, which generated an intraservice time difference of
ten minutes between CPT codes 63052 and 63053.
Response: We agree with the commenters that an intraservice time
difference of 5 minutes between CPT codes 63052 and 63053 is a
reflection of the difference in work between laminectomy/facetectomy/
foraminotomy with decompression of the first segment and an additional
segment, and therefore, we proposed the RUC recommended physician time
values for CPT codes 63052 and 63053. However, we continue to believe
that, despite a surveyed 5-minute intraservice time increase for CPT
code 63052, the crosswalk to CPT code 22853 is still valid to support a
work RVU of 4.25 for CPT code 63052, given that only 3 months passed
between the two surveys, that it now has the same intraservice time as
CPT code 22853, are both spinal procedures, and are both add-on codes
to the same base codes. We reiterate that commenters on the CY 2022 PFS
proposed rule supported the bracket of key reference service CPT code
22552 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2, each additional interspace
(List separately in addition to code for primary procedure)) and MPC
CPT code 34812 (Open femoral artery exposure for delivery of
endovascular prosthesis, by groin incision, unilateral (List separately
in addition to code for primary procedure)), and therefore, we noted
that the final work RVU of 4.25 for CY 2022 was supported by the
commenters (86 FR 65092). CPT code 22552 has a work RVU of 6.50 and an
intraservice time of 45 minutes, and commenters noted that CPT code
22552 has a higher intensity as anticipated for a surgical procedure
and in comparison with a lumbar procedure. CPT code 34812 has a work
RVU of 4.13 and 40 minutes of intraservice time, and commenters noted
that this code involves open femoral artery exposure by groin incision
and closure of the wound, typically for separately reported delivery of
an endovascular prosthesis for an asymptomatic infrarenal abdominal
aortic aneurysm. In comparison, exposure and closure for CPT code 63052
are performed as part of the primary arthrodesis code and the
intraservice time includes higher intensity bony and soft tissue
resection, and therefore, although both codes require the same time,
the physician work and intensity of CPT code 63052 is greater than CPT
code 34812. Therefore, we are finalizing a work RVU of 4.25 for CPT
code 63052.
We remind commenters that in the CY 2022 PFS final rule, we
finalized a work RVU of 3.19 for CPT code 63053 for CY 2022 based on an
intraservice time ratio between CPT codes 63052 and 63053 ((30 minutes/
40 minutes) * 4.25 = 3.19). We continue to believe this intraservice
time ratio between the two CPT codes is still valid, given that only 3
months passed between the two surveys, and therefore, we are finalizing
a work RVU of 3.78 based on the surveyed time changes for CPT codes
63052 and 63053 ((40 minutes/45 minutes) * 4.25 = 3.78) in order to
maintain consistency with previous analysis of time and intensity of
these two add-on codes. We reiterate that, due to the lack of an
obvious or explicitly stated rationale in the RUC's April
recommendations for the change in intensity between the January 2021
and April 2021 surveys, we relied on the changes in surveyed time to
calculate the work RVU for CPT code 63053.
We are finalizing the RUC-recommended PE inputs for CPT codes 22630
and 22633, as proposed.
(4) Total Disc Arthroplasty (CPT Codes 22857 and 22860)
In September 2021, the CPT Editorial Panel created CPT Category I
code 22860 to describe Total disc arthroplasty (artificial disc),
anterior approach, including discectomy to prepare interspace (other
than for decompression); second interspace, lumbar (List separately in
addition to code for primary procedure) and replace CPT Category III
code 0163T (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression), each additional interspace, lumbar (List separately in
addition to code for primary procedure)), which prompted CPT codes
22860 and 22857 (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression); single interspace, lumbar) to be surveyed for the
January 2022 RUC meeting. At the January 2022 RUC meeting, the
specialty societies indicated, and the RUC agreed, that the survey
results for both CPT codes 22857 and 22860 were erroneous and that the
codes should be resurveyed for the April 2022 RUC meeting. Therefore,
we proposed to maintain the RUC-recommended work RVU of 27.13 for
[[Page 69484]]
CPT code 22857 and contractor pricing for CPT code 22860 for CY 2023.
We will revisit the valuations of CPT codes 22857 and 22860 in future
rulemaking when we review the April 2022 RUC recommendations, based on
our annual review process discussed in the background section of this
final rule.
We did not receive comments on our proposals for this code family
and we are finalizing the values as proposed.
(5) Insertion of Spinal Stability Distractive Device (CPT Codes 22869
and 22870)
For CPT codes 22869 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without open decompression or fusion,
including image guidance when performed, lumbar; single level) and
22870 (Insertion of interlaminar/interspinous process stabilization/
distraction device, without open decompression or fusion, including
image guidance when performed, lumbar; second level (List separately in
addition to code for primary procedure)), we proposed to maintain the
current work RVUs of 7.03 and 2.34, respectively. We proposed the RUC-
recommended direct PE inputs for CPT code 22869 without refinement.
We did not receive comments on our proposals for this code family
and we are finalizing the values as proposed.
(6) Knee Arthroplasty (CPT Codes 27446 and 27447)
CPT codes 27446 (Arthroplasty, knee, condyle and plateau; medial OR
lateral compartment) and 27447 (Arthroplasty, knee, condyle and
plateau; medial AND lateral compartments with or without patella
resurfacing (total knee arthroplasty)) were reviewed by the RUC in
April 2021. We previously reviewed CPT code 27447 in the CY 2021 PFS
final rule; (see 85 FR 84609 and 84610 for our previous discussion).
The RUC proposed a revised survey instrument to ask about additional
pre-operative time and resources spent on pre-optimization patient
work. The RUC agreed that the pre-service planning activities are being
performed routinely for the typical patient but the inclusion of this
work is not reflected in the 090-day global period structure. The RUC
indicated that separate planning codes may be developed, or current
codes such as the prolonged service codes may be reported for these
activities.
We proposed the RUC-recommended work RVU of 17.13 for CPT code
27446. The survey 25th percentile actually showed an increase in work
RVU even though there was a decrease in total time. One post facility
visit, CPT code 99232 (Subsequent hospital care/day 25 minutes), was
removed and replaced with CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter) a post-operative visit in the office. Given a decrease in
the total time spent and a lower level post-operative visit, it is
reasonable that the work RVU went down. There was no change in the
global period.
For CPT code 27447, the RUC reaffirmed the same valuation that it
recommended for the CY 2021 PFS rulemaking cycle. Since we did not
receive any new information regarding this code, we did not propose to
change our previously finalized values (see 85 FR 84609 and 84610 for
our previous discussion of this code in the CY 2021 PFS final rule). We
proposed to maintain a work RVU of 19.60 for CPT code 27447, the value
that we previously finalized through rulemaking. We proposed the RUC-
recommended direct PE inputs for CPT code 27446 and we proposed to
maintain the direct PE inputs for CPT code 27447.
Comment: One commenter, representing interested parties who furnish
these services, agreed with the RUC recommendation, but noted that CPT
code 27447 has been undervalued since its reduction in 2021 and noted
the current work RVU is based on the AMA RUC's recommendations
following the 2019 survey. This commenter and other interested parties
previously argued to maintain the then current work RVU of 20.72, which
was lower than the survey median. The commenter claimed that CPT codes
27447 and 27130 are undervalued due to the RUC and CMS utilizing
different percentiles from surveys to assign the work RVUs and
recommended that CMS adopt a policy to base work RVUs uniformly on the
same percentile of physician survey results as the RUC. We did not make
any proposals for CPT code 27130.
The commenter appreciated CMS discussing the concept of pre-
optimization time for these services in the proposed rule and provided
further clarification with regard to the RUC survey. The commenter
noted that the RUC specifically rejected a proposal for a revised
survey instrument to ask about additional pre-operative time and
resources spent on pre-optimization patient work. Additionally, the use
of current prolonged services, CPT codes 99358 and 99359 was suggested;
however, it was noted that these codes could not be used in conjunction
with CPT codes 27446 and 27447, given the standard of practice includes
preservice time over several days and not one single day, as stated in
the code descriptor for CPT codes 27446 and 27447. The commenter noted
it continues to work with the AMA and CPT to clarify if there are
existing codes to bill for pre-optimization time.
The commenter was in support of the proposed RVUs for PE and
malpractice for CPT code 27447. The commenter generally supported
increased payment rates to facilities for arthroplasty due to the
extreme complexity of the procedure, innovations in the standard of
care and outcomes, and to recognize increased costs through the COVID-
19 public health emergency (PHE). Nevertheless, the ongoing annual
increases in Medicare facility payments for arthroplasty present a
stark contrast with severely decreasing Medicare physician payments for
arthroplasty.
Response: We thank the commenter for their support of our proposal
and appreciate the commenters continued engagement with the AMA and the
CPT to clarify if there are existing codes to bill for pre-optimization
time. We are finalizing the values as proposed for CPT codes 27446 and
27447.
(7) Endovascular Pulmonary Arterial Revascularization (CPT Codes 33900,
33901, 33902, 33903, and 33904)
At the February 2021 meeting of the CPT Editorial Panel, CPT
approved a new family of Category I CPT codes to describe percutaneous
endovascular repair of pulmonary artery stenosis (PAS) by stent
replacement. CPT codes 33900 through 33904 were surveyed by the RUC at
the October 2021 RUC meeting.
We disagree with the RUC-recommended work RVU of 14.0 for CPT code
33900 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 11.03 for CPT code 33900. A work RVU of 11.03 is supported by a
bracket of reference CPT codes, including CPT code 61650 and CPT code
61640. CPT code 61650 (Endovascular intracranial prolonged
administration of pharmacologic agent(s) other than for thrombolysis,
arterial, including catheter placement, diagnostic angiography, and
imaging guidance;
[[Page 69485]]
initial vascular territory) has a work RVU of 10.0 and the same
intraservice time of 90 minutes and the same total time of 206 minutes.
CPT code 61640 (Balloon dilatation of intracranial vasospasm,
percutaneous; initial vessel) has a work RVU of 12.32 and an
intraservice time of 90 minutes and a higher total time of 233 minutes.
There are no direct PE inputs for CPT Code 33900.
We disagree with the RUC-recommended work RVU of 18.0 for CPT code
33901 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 14.50. A work RVU of 14.50 is supported by a reference CPT
code--CPT code 11005. CPT code 11005 (Debridement of skin, subcutaneous
tissue, muscle and fascia for necrotizing soft tissue infection;
abdominal wall, with or without fascial closure) has a work RVU of
14.24 and the same intraservice time of 120 minutes and nearly the same
total time of 235 minutes.
There are no direct PE inputs for CPT Code 33901.
We disagree with the RUC-recommended work RVU of 17.33 for CPT code
33902 (Percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 14.0. A work RVU of 14.0 is supported by a reference CPT code--
CPT code 61640. CPT code 61640 (Balloon dilatation of intracranial
vasospasm, percutaneous; initial vessel) has a work RVU of 12.32 and
the same intraservice time of 90 minutes and a higher total time of 233
minutes.
There are no direct PE inputs for CPT Code 33902.
We disagree with the RUC-recommended work RVU 20.0 for CPT code
33903 (percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. Although we disagree with the RUC-recommended
work RVU, we concur that the relative difference in work between CPT
codes 33901 and 33903 is equivalent to the RUC-recommended interval of
2.0 RVUs. Therefore, we proposed a work RVU of 16.50 for CPT code
33903, based on the recommended interval of 2.0 additional RVUs above
our proposed work RVU of 14.50 for CPT code 33901. A work RVU of 16.50
is also supported by a reference code--CPT code 11005. CPT code 11005
(Debridement of skin, subcutaneous tissue, muscle and fascia for
necrotizing soft tissue infection; abdominal wall, with or without
fascial closure) has a work RVU of 14.24 and the same intraservice time
of 120 minutes and a higher total time of 265 minutes.
There are no direct PE inputs for CPT Code 33903.
We disagree with the RUC-recommended RVU of 7.27 for CPT code 33904
(Percutaneous pulmonary artery revascularization by stent placement,
each additional vessel or separate lesion, normal or abnormal
connections (list separately in addition to code for primary procedure)
(use 33904 in conjunction with 33900, 33901, 33902, 33903)). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 5.53. A work RVU of 5.53 is supported by a reference code--CPT
code 57267. CPT code 57267 (Insertion of mesh or other prosthesis for
repair of pelvic floor defect, each site (anterior, posterior
compartment), vaginal approach (List separately in addition to code for
primary procedure) has a work RVU of 4.88 and the same time of 45
minutes.
There are no direct PE inputs for CPT code 33904.
Comment: Commenters disagree with our proposed valuations for all
of the codes within this family. Commenters asserted that we failed to
properly justify the decrease for each CPT code because we did not
provide a clinical rationale. One commenter stated that the RUC
intentionally did not use the survey 25th percentile value because the
RUC believes the clinical nature is vastly different than currently
described by similar coding and more intense. Therefore, commenters
noted that we should accept the RUC-recommended survey median values.
For CPT codes 33900, 33901, 33902, and 33904, commenters disagreed with
our chosen supporting reference codes. They noted that the CPT codes
are not clinically similar and the CPT codes that the RUC recommended
are more appropriate for purposes of comparison. Commenters also noted
that we did not maintain the RUC recommended relativity within the code
family that accounts for the change from unilateral to bilateral
anatomically. For CPT code 33903, a commenter disagreed with our use of
the incremental methodology. The commenter noted that using increments
forms a linear relationship between RVUs, which is not appropriate.
Response: We disagree with commenters that supporting reference
codes must have similar clinical characteristics to be appropriate for
purposes of reaching valuations. We believe that the inherent
relativity of the PFS is such that all codes can be used for purposes
of comparison, while considering time and intensity. We maintain that
the RUC recommended work RVU values for CPT codes 33900-33904 are
overvalued relative to codes with similar times and intensities. For
example, CPT code 11004 (Debridement of skin, subcutaneous tissue,
muscle and fascia for necrotizing soft tissue infection; external
genitalia and perineum), has a work RVU of 10.80, an intraservice time
of 90 minutes and a total time of 280 minutes. This is the same
intraservice time and a significantly higher total time than CPT code
33900 and is almost 3 RVUs less than the RUC recommended value of 14.0
for this CPT code. We also disagree that we did not maintain relativity
within the family. We believe that our proposed RVUs account for the
recommended changes in time within the family as the procedure changes
from unilateral to bilateral and is further supported by our reference
codes with similar times. For example, for CPT code 33903, we used the
incremental difference between the RUC recommended values for CPT codes
33901 and 33903 (2 RVUs) to reach our proposed value of 16.50 RVUs for
CPT code 33903. This value is higher than the 25th percentile and
accounts for the change in intensity from unilateral to bilateral. We
also believe the use of an incremental difference between codes is a
valid methodology for setting values, especially in valuing services
within a family where it is important to maintain appropriate intra-
family relativity. Historically, we have frequently utilized an
incremental methodology in which we value a code based upon its
incremental difference between another code or another family of codes.
We note that the RUC has also used the same incremental methodology on
occasion when it was unable to produce valid survey data for a service.
We are finalizing our work RVUs for this family as proposed.
(8) Percutaneous Arteriovenous Fistula Creation (CPT Codes 36836 and
36837)
In October 2021, the CPT Editorial Panel created CPT codes 36836
(Percutaneous arteriovenous fistula creation, upper extremity, single
access
[[Page 69486]]
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) and 36837
(Percutaneous arteriovenous fistula creation, upper extremity, separate
access sites of 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) to
describe the creation of an arteriovenous fistula in an upper extremity
via a percutaneous approach. Previously, CPT coding did not account for
percutaneous arteriovenous access creation, as current the CPT codes
only describe an open surgical approach. Given that new technologies
have been developed that allow for less invasive approaches that
utilize percutaneous image-guided methods to approximate a target
artery and vein using magnets or mechanical capture, we created HCPCS
codes G2170 (Percutaneous arteriovenous fistula creation (avf), direct,
any site, by tissue approximation using thermal resistance energy, and
secondary procedures to redirect blood flow (e.g., transluminal balloon
angioplasty, coil embolization) when performed, and includes all
imaging and radiologic guidance, supervision and interpretation, when
performed) and G2171 (Percutaneous arteriovenous fistula creation
(avf), direct, any site, using magnetic-guided arterial and venous
catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed) in July 2020 that describe two
approaches to percutaneous arteriovenous access creation. The RUC
intends for CPT codes 36836 and 36837, which represent two percutaneous
approaches to creating arteriovenous access for End-Stage Renal Disease
(ERSD) patients during hemodialysis, to replace HCPCS codes G2170 and
G2171, and has requested both G2170 and G2171 be deleted. For CY 2023,
the RUC recommended a work RVU of 7.50 for CPT code 36836, and a work
RVU of 9.60 for CPT code 36837.
We disagreed with the RUC-recommended RVUs for CPT codes 36836 and
36837. We found that the recommended work RVUs were high when compared
to other codes with similar time values. The RUC-recommended RVU of
7.50 for 36836 is the second highest RVU for codes with 55 to 65
minutes of intraservice time and 94 to 114 minutes of total time, with
RVUs ranging from 2.45 to 8.84. Similarly, the RUC-recommended RVU of
9.60 for 36837 is the third highest RVU for codes with 65 to 85 minutes
of intraservice time and 109 to 129 minutes of total time, with RVUs
ranging from 4.69 to 10.95. Therefore, we proposed a work RVU of 7.20
for CPT code 36836, and a work RVU of 9.30 for CPT code 36837.
We disagreed with the RUC-recommended work RVU of 7.50 for CPT code
36836 and proposed an RVU of 7.20 that is based on the intra-service
time ratio calculation using the second reference code from the RUC
survey, CPT code 36905 (Percutaneous transluminal mechanical
thrombectomy and/or infusion for thrombolysis, dialysis circuit, any
method, including all imaging and radiological supervision and
interpretation, diagnostic angiography, fluoroscopic guidance, catheter
placement(s), and intraprocedural pharmacological thrombolytic
injection(s); with transluminal balloon angioplasty, peripheral
dialysis segment, including all imaging and radiological supervision
and interpretation necessary to perform the angioplasty). The proposed
RVU of 7.20 is based on the intra-service time ratio using the RUC-
recommended 60 minutes intra-service time for CPT code 36836 divided by
75 minutes of intra-service time for CPT code 36905, then multiplying
by the RVU of 9.00 for CPT code 36905 ((60/75) x 9.00 = 7.20). We chose
to use the second reference code from the RUC survey, CPT code 36905,
in this calculation because its intra-service time and total time
values were closer to the time values proposed by the RUC for CPT code
36836. We noted that the RUC-recommended RVU of 7.50 is one of the
highest values within the range of reference codes we reviewed with the
same intra-service time and similar total time. The proposed work RVU
of 7.20 is supported by the reference CPT codes we compared to CPT code
36836 with the same 60 minutes of intra-service time and similar total
time as CPT code 36836; reference CPT code 47541 (Placement of access
through the biliary tree and into small bowel to assist with an
endoscopic biliary procedure (e.g., rendezvous procedure),
percutaneous, including diagnostic cholangiography when performed,
imaging guidance (e.g., ultrasound and/or fluoroscopy), and all
associated radiological supervision and interpretation, new access) has
a work RVU of 6.75, and reference CPT code 33991 (Insertion of
ventricular assist device, percutaneous, including radiological
supervision and interpretation; left heart, both arterial and venous
access, with transseptal puncture) has a work RVU of 8.84. Again, we
believe 7.20 is a more appropriate value overall than 7.50 when
compared to the range of codes with the same intra-service time and
similar total time.
Although we disagreed with the RUC-recommended work RVU of 9.60 for
CPT code 36837, we concur that the relative difference in work between
CPT codes 36836 and 36837 is equivalent to the RUC-recommended interval
of 2.10 RVUs. We believe the use of an incremental difference between
these CPT codes is a valid methodology for setting values, especially
in valuing services within a family of codes where it is important to
maintain an appropriate intra-family relativity. Therefore, we proposed
a work RVU of 9.30 for CPT code 36837, based on the RUC-recommended
interval of 2.10 RVUs above our proposed work RVU of 7.20 for CPT code
36836.
For the direct PE inputs, we solicited additional information on
two equipment items and four supply items. For two of those four supply
items, we requested a justification for their inclusion as direct PE
inputs. The RUC submitted invoices for two new equipment inputs; one
for a Wavelinq EndoAVF generator (EQ403) used for CPT code 36837, and
the other for an Ellipsys EndoAVF generator (EQ404) used for CPT code
36836. We solicited comments and requested information that may inform
us why the Wavelinq generator (EQ403) is so much more expensive on its
invoice as compared with the Ellipsys generator (EQ404) since the
former costs $18,580 and the latter costs $3,000.
In addition, the RUC included supply items SD149 (catheter, balloon
inflation device) and SD152 (catheter, balloon, PTA) as direct PE
inputs for CPT codes 36836 and 36837. We solicited comments and
requested information that may inform us if supply items SD149 and
SD152 are typical, and how often they are used, for CPT codes 36836 and
36837. Also, the RUC included supply items SF056 (detachable coil) and
SF057 (non-detachable embolization coil) as direct PE inputs for CPT
code 36837 (one each for SF056 and two each for SF057). We solicited
comments and requested
[[Page 69487]]
information that may provide us with a justification for keeping supply
items SF056 and SF057 as direct PE inputs for CPT code 36837. We need
to know if both of these supply items are typical and how often they
are used for CPT code 36837. If these supply inputs are not typical for
these procedures, we believe that they should be removed from the
direct PE inputs.
We proposed to delete HCPCS codes G2170 and G2171 and replace them
with CPT codes 36836 and 36837 as recommended by the RUC.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters agreed with our proposal to delete HCPCS
codes G2170 and G2171, and replace them with CPT codes 36836 and 36837.
One of the commenters also stated that they preferred CMS setting the
rates for percutaneous creation of an arteriovenous fistula through
rulemaking, rather than relying on contractor pricing. Other commenters
stated that the contractor-priced payments for HCPCS codes G2170 and
G2171 varied widely among the different Medicare Administrative
Contractors (MACs), ranging approximately from $6,100 to $12,000
(rounded).
Response: We thank the commenters for their support. We are
finalizing our proposal to delete HCPCS codes G2170 and G2171, and
replacing them with CPT codes 36836 and 36837. We are establishing the
RVUs for CPT codes 36836 and 36837 in this final rule, so the payments
for these codes will not be contractor-priced, in contrast to the
payments for HCPCS codes G2170 and G2171.
Comment: Several commenters disagreed with our proposed RVU of 7.20
for CPT code 36836 and RVU of 9.30 for CPT code 36837. Several
commenters also disagreed with our methodologies for the valuation of
the proposed RVUs and stated they do not appropriately reflect the
complexity and intensity of physician work associated with these
services. Therefore, they post that the statutorily-required intensity
component of the work RVU and its role in the valuation of these
procedures was overlooked. The commenters preferred that we accept the
RUC-recommended RVU of 7.50 for CPT code 36836 and RVU of 9.60 for CPT
code 36837 instead. The commenters stated that the proposed RVU is
unworkable given the time it takes to perform these procedures and PE
involved and that CMS's proposed RVU will cause barriers to patient
access to these procedures, and will have a disproportionate impact on
patients from underrepresented minority groups. However, there was one
commenter that stated even the RUC-recommended RVU of 9.60 for CPT code
36837 was too low. Many commenters stated that CMS is using flawed
methodologies for the valuation of codes for 2023, such as the building
block methodology, incremental methodology, code comparisons, and time
ratio methodology. This includes the intra-service time ratio
calculation that informs the proposed work RVU of 7.20 for CPT code
36836 and the incremental methodology used for the proposed RVU of 9.30
for CPT code 36837. Also, the commenters stated that CMS did not
provide any rationale or transparency as to how they arrived at the
reductions applied to CPT codes 36836 and 36837. The commenters stated
that CMS proposes an inconstant combination of inputs to apply, and
that this selection process has the appearance of seeking an arbitrary
value from the vast array of possible mathematical calculations, rather
than seeking a valid, clinically relevant relationship that would
preserve relativity between codes.
Response: We continue to believe that the RVU of 7.20 for CPT code
36836, and the RVU of 9.30 for CPT code 36837, are appropriate RVUs for
these procedures. We found that the RUC-recommended work RVUs were high
for these codes when compared to other codes with similar time values.
The RUC-recommended RVU of 7.50 for 36836 is the second highest RVU for
codes with 55 to 65 minutes of intraservice time and 94 to 114 minutes
of total time, with RVUs ranging from 2.45 to 8.84. Similarly, the RUC-
recommended RVU of 9.60 for 36837 is the third highest RVU for codes
with 65 to 85 minutes of intraservice time and 109 to 129 minutes of
total time, with RVUs ranging from 4.69 to 10.95.
We disagreed with the RUC-recommended work RVU of 7.50 for CPT code
36836 and proposed an RVU of 7.20 that is based on the intra-service
time ratio calculation using the second reference code from the RUC
survey, CPT code 36905. In our effort to remain transparent, we
provided the following rationale: The proposed RVU of 7.20 is based on
the intra-service time ratio using the RUC-recommended 60 minutes
intra-service time for CPT code 36836 divided by 75 minutes of intra-
service time for CPT code 36905, then multiplying by the RVU of 9.00
for CPT code 36905 ((60/75) x 9.00 = 7.20). We chose to use the second
reference code from the RUC survey, CPT code 36905, in this calculation
because its intra-service time and total time values were closer to the
time values proposed by the RUC for CPT code 36836. We noted that the
RUC-recommended RVU of 7.50 is one of the highest values within the
range of reference codes we reviewed with the same intra-service time
and similar total time. The proposed work RVU of 7.20 is supported by
the reference CPT codes we compared to CPT code 36836 with the same 60
minutes of intra-service time and similar total time as CPT code 36836;
reference CPT code 47541 has a work RVU of 6.75, and reference CPT code
33991 has a work RVU of 8.84. We continue to believe that the use of
time ratios is one of several appropriate methods for identifying
potential work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for information provided by surveys that suggests the amount of
time involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. When our review of recommended
values reveals that changes in the resource of time are not accounted
for in a RUC-recommended RVU, the obligation to account for that change
when establishing proposed and final work RVUs remains. We recognize
that it would not be appropriate to develop work RVUs solely based on
time given that intensity is also an element of work, but in applying
the time ratios, we are using derived intensity measures based on
current work RVUs for individual procedures. Were we to disregard
intensity altogether, the work RVUs for all services would be developed
based solely on time values and that is definitively not the case, as
indicated by the many services that share the same time values but have
different work RVUs. Furthermore, we reiterate that we use time ratios
to identify potentially appropriate work RVUs, and then use other
methods (including estimates of work from CMS medical personnel and
crosswalks to key reference or similar codes) to validate these RVUs.
For more details on our methodology for developing work RVUs, we direct
readers to the discussion CY 2017 PFS final rule (81 FR 80272 through
80277). Again, for CPT code 36836, we believe 7.20 is a more
appropriate value overall than 7.50 when compared to the range
[[Page 69488]]
of codes with the same intra-service time and similar total time.
For CPT code 36837, although we disagreed with the RUC-recommended
work RVU of 9.60, we did concur that the relative difference in work
between CPT codes 36836 and 36837 is equivalent to the recommended
interval of 2.10 RVUs. Therefore, we proposed a work RVU of 9.30 for
CPT code 36837, based on the recommended interval of 2.10 RVUs above
our proposed work RVU of 7.20 for CPT code 36836. We continue to
believe the use of an incremental difference between these CPT codes is
a valid methodology for setting values, especially in valuing services
within a family of codes where it is important to maintain an
appropriate intra-family relativity. Historically, we have frequently
utilized an incremental methodology in which we value a code based upon
its incremental difference between another code or another family of
codes. We note that the RUC has also used the same incremental
methodology on occasion when it was unable to produce valid survey data
for a service. Again, for CPT code 36837, we believe a work RVU of 9.30
based on an incremental increase of 2.10 RVUs above CPT code 36836 is a
more appropriate value than 9.60.
Comment: A few commenters stated that the proposed RVU of 7.20 for
CPT code 36836 and RVU of 9.30 for CPT code 36837 fall below the RUC
survey 25th percentile values of 7.50 and 9.60 respectively. Commenters
also stated that we need to provide a significant justification when we
propose an RVU that is below the 25th percentile.
Response: We remind the commenters that we used an intraservice
time ratio, described above, to develop the proposed RVU of 7.20 for
CPT code 36836, and that we used a 2.10 incremental increase from the
proposed RVU of 7.20 for CPT code 36836 for CPT code 36837, resulting
in an RVU of 9.30. The time ratio methodology and the incremental
methodology are both valid methodologies for developing the RVUs that
we propose, and there is no rule stating that the RVU cannot go below
the survey 25th percentile. In addition to the time ratio and
incremental methodologies, we also use other methods for developing
RVUs, such as the building block methodology and code comparisons. For
more details on our methodology for developing work RVUs, we direct
readers to the discussion CY 2017 PFS final rule (81 FR 80272 through
80277).
Comment: Several commenters responded to our request for additional
information for four direct PE supply items (SD149 (catheter, balloon
inflation device), SD152 (catheter, balloon, PTA), SF056 (detachable
coil), and SF057 (non-detachable embolization coil)) and two new direct
PE equipment items (EQ403 (Wavelinq EndoAVF generator) and EQ404
(Ellipsys EndoAVF generator)). Supply items SD149 and SD152 are direct
PE inputs for CPT codes 36836 and 36837, and supply items SF056 and
SF057 are direct PE inputs for CPT code 36837. Equipment item EQ403 is
a direct PE input for CPT code 36837, and equipment item EQ404 is a
direct PE input for CPT code 36836. For the four supply items, we had
requested a justification for their inclusion as direct PE inputs and
asked if these supply items are typical and how often they are used.
For the two new equipment items, we had requested information that may
inform us why the EQ403 is so much more expensive on its invoice as
compared with the EQ404, since the former costs $18,580 and the latter
costs $3,000.
Response: We thank the commenters for responding to our request for
information. The majority of commenters that responded to our request
for information stated that all four of these supply items are typical
and should be included as direct PE inputs for CPT codes 36836 and
36837 as recommended by the RUC. One commenter stated they believe the
typical direct PE input for CPT code 36837 is for one SF056 and that
SF057 is not a typical use, and also stated that they could not find
evidence of typical use (50 percent or greater) for supplies SD149 and
SD152 during CPT procedure code 36837.
A few commenters responded to our request for more information on
the costs for EQ403 and EQ404. The commenters stated that the specialty
societies submitted invoice pricing for supplies and equipment to the
RUC, and that they do not have any influence on the prices that vendors
set for their products. Some commenters described how each of these
equipment items are used. Another commenter stated that typically, the
WavelinQTM EndoAVF generator (E0403) can be acquired through
direct purchase or financed through an agreement where the provider
agrees to purchase a predetermined number of WavelinQTM
catheters (SD350). The price of the generator (EQ403) can change
depending on how many catheters the provider agrees to purchase and/or
the type of purchase agreement the provider chooses.
Again, we thank the commenters for responding to our request for
information. The majority of the commenters stated that PE supply items
SD149 and SD152 are typical direct PE inputs for CPT codes 36836 and
36837; and supply items SF056 and SF057 are typical direct PE inputs
for CPT code 36837. After reviewing the information provided by the
commenters, we are finalizing the direct PE supply items SD149, SD152,
SF056, and SF057 for CPT codes 36836 and 36837 as recommended by the
RUC without refinement. We are finalizing direct PE equipment items
EQ403 and EQ404 for CPT codes 36836 and 36837 as recommended by the RUC
without refinement.
Comment: One commenter was concerned that the proposed work RVU for
CPT code 36837 did not include the reimbursement for the coil
embolization supply items. The commenter stated that coil embolization
at the time of WavelinQ procedure is critical to the success of the
arteriovenous fistula. The commenter stated that embolization is a very
important step in the success of the procedure and should be taken into
account in the fee schedule.
Response: The work RVU is only for the activity of the physician
for a procedure code. Supply items SF056 (detachable coil) and SF057
(non-detachable embolization coil) are direct PE inputs for CPT code
36837, and the payment for these supply items is included in the PE
RVU. Therefore, the coil embolization supply items are reimbursed and
are taken into account in the physician fee schedule, though not in the
work RVU.
Comment: A few commenters requested that CMS separately identify
and pay for high-cost disposable supplies priced at more than $500
using appropriate HCPCS codes, instead of including these high-cost
supplies as direct PE inputs for CPT codes 36836 and 36837. These
supply items should then be reviewed annually and updated.
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).
Comment: One commenter submitted an additional invoice associated
with
[[Page 69489]]
the pricing of the EllipsysTM Vascular Access Catheter,
(SD351) supply. The commenter stated that Medtronic recently has been
compelled by rising costs to implement price increases across their
portfolio world-wide. Among the many contributing factors,
manufacturing labor costs have increased by nine percent, and key
materials that are used in making our products are exhibiting double-
digit cost increases. One commenter stated that starting in July of
2022, they revised their standard pricing for the EllipsysTM
catheter sold to physicians' offices to reflect rising costs and to
achieve parity with prices for catheters in other sites of service
(that is, hospital outpatient departments and ASCs). The commenter
stated that the price to physician office customers the
EllipsysTM catheter is now $8,950, and submitted an invoice
to support this assertion.
Response: We appreciate the submission of additional pricing
information this commenter for the SD351 supply. We note that the RUC
submitted invoices for this supply item with their recommendations
based on information gathered from the specialties that perform this
service. While we acknowledge that pricing for the item in question may
have changed, we are interested in additional review by other
interested parties before finalizing an increase in the price. The
submitted invoice would represent an increase from $6000 to $8950 for
the SD351 supply, an extraordinary increase in the span of 6 months
since the service was reviewed at the January 2022 RUC meeting. We will
review the valuations for this service when they are revised by the RUC
to reflect the additional costs described by this commenter, including
any increases in the price of the SD351 supply, and consider for future
updates to this service.
Comment: One commenter expressed concern that CMS is using only a
single invoice of $6,000 for SD351 (EllipsysTM Vascular
Access Catheter) and noted this pricing is unrepresentative for this
device. The commenter urged CMS to work with the manufacturers to
collect additional invoices to arrive at more appropriate pricing for
SD351.
Response: We often request that practitioners send us additional
invoices for supplies and equipment, which we then use to establish the
PE inputs and PE RVUs for specific services. We did receive an
additional invoice for SD351 but as noted above, the RUC submitted
invoices for this supply item with their recommendations based on
information gathered from the specialties that perform this service. We
will consider the additional invoice and this new information in future
rulemaking.
Comment: A few commenters stated that the direct PE inputs for
equipment for CPT code 36836 should reflect the use of EL011 (room,
angiography) rather than EL016 (room, ultrasound, vascular). One of
these commenters noted that although CPT code 36836 is done under
ultrasound, the typical location for this procedure is in an
angiography room given the angioplasty performed after the fistula
creation more than 90 percent of the time. Another commenter stated
that CMS' proposal to use an ultrasound room rather than an angiography
room in the development of the PE values for CPT code 36836 is
incorrect in their view, as CPT code 36836 typically infers inclusion
of a balloon angioplasty among the performed procedures, and in their
experience the appropriate venue when a balloon angioplasty is
performed is always an angiography room.
Response: We disagree with the commenters and believe that EL016
(room, ultrasound, vascular) is the appropriate direct PE equipment
input for CPT code 36836. We reviewed the equipment inputs on the
Practice Expense Summary of Recommendation for the non-facility
setting, and the PE spreadsheet, provided by the RUC for CPT codes
36836 and 36837. The RUC-recommended EL016 for CPT code 36836, and we
agree with the RUC recommendation. Please consider presenting any
direct PE equipment input changes for CPT code 36836 to the AMA RUC for
review.
After consideration of the public comments, we are finalizing the
work RVU values for the Percutaneous Arteriovenous Fistula Creation
code family (CPT codes 36836 and 36837) as proposed. We are finalizing
the direct PE inputs for CPT codes 36836 and 36837 without refinement.
Also, we are deleting HCPCS codes G2170 and G2171 as proposed.
(9) Energy Based Repair of Nasal Valve Collapse (CPT Codes 30468 and
30469)
In September 2021, the CPT Editorial Panel created CPT code 30469
(Repair of nasal valve collapse with low energy, temperature-controlled
(i.e., radiofrequency) subcutaneous/submucosal remodeling) which is
currently reported with an unlisted code. For the January 2022 RUC
meeting, both CPT code 30468 (Repair of nasal valve collapse with
subcutaneous/submucosal lateral wall implant(s)) and CPT code 30469
were reviewed. For CY 2023, the RUC recommended no change to the
current work RVU of 2.80 for CPT code 30468, and a work RVU of 2.70 for
CPT code 30469.
The RUC reviewed the specialty society request to affirm the recent
RUC valuations for CPT code 30468, which was surveyed and valued by the
RUC in January 2020 for CY 2021. The RUC agreed, so for CY 2023, the
RUC is not recommending any change to the current work RVU of 2.80 for
CPT code 30468. In addition, the PE Subcommittee reviewed the direct PE
inputs and made modifications to the pre-service clinical staff time to
CPT code 30468 in accordance with current standards. There was a
previous oversight in valuing the direct PE inputs for CPT code 30468.
Therefore, 3 minutes of clinical staff time has been added to CPT code
30468 for clinical activity CA005 (complete pre-procedure phone calls
and prescription).
We proposed to maintain the current work RVU of 2.80 for CPT code
30468 as recommended by the RUC. We also proposed the RUC-recommended
direct PE inputs for CPT code 30468, which now includes clinical
activity code CA005, without refinement.
For CPT code 30469, the RUC recommended a work RVU of 2.70 based on
a direct work RVU crosswalk from CPT code 31295 (Nasal/sinus endoscopy,
surgical, with dilation (e.g., balloon dilation); maxillary sinus
ostium, transnasal or via canine fossa). We disagreed with the RUC-
recommended work RVU of 2.70. Therefore, we proposed a work RVU of 2.44
for CPT code 30469, which is the same RVU as CPT code 31297 (Nasal/
sinus endoscopy, surgical, with dilation (e.g., balloon dilation);
sphenoid sinus ostium) and has the same 20 minutes of intra-service
time and similar total time. We noted that CPT code 31295, which the
RUC used as a direct crosswalk for the work RVU for CPT code 30469, has
the same 20 minutes of intra-service time and 56 minutes of total time
as CPT code 31297. We believe the RUC should have used CPT code 31297
as the crosswalk for CPT code 30469. Both CPT codes 31295 and 31297
were reviewed in 2017 and are in the same code family. The proposed
work RVU of 2.44 is supported by the reference CPT codes we compared to
CPT code 30469 with the same 20 minutes of intra-service time and
similar total time as CPT code 30469; reference CPT code 31233 (Nasal/
sinus endoscopy, diagnostic; with maxillary sinusoscopy (via inferior
meatus or canine fossa puncture)) with an RVU of 2.18, and CPT code
31295 with an RVU of 2.70. Again, we believe 2.44 is a more appropriate
value overall than 2.70
[[Page 69490]]
when compared to the range of codes with the same intra-service time
and similar total time.
We proposed the RUC-recommended direct PE inputs for CPT code 30469
without refinement.
The following is a summary of the comments we received and our
responses.
Comment: A few comments supported our proposal to maintain the
current work RVU of 2.80 for CPT code 30468.
Response: We thank the commenters for their support, and we are
finalizing the RUC-recommended RVU of 2.80 for CPT code 30468 as
proposed.
Comment: A few comments disagreed with our proposed work RVU of
2.44 for CPT code 30469. The commenters stated that we did not consider
the intensity for CPT code 30469, and that the intensity was a closer
match to the RUC-recommended crosswalk CPT code 31295, instead of our
proposed comparator code of CPT code 31297. One commenter stated that
CPT code 30469 has greater intensity because it involves multiple
applications in anatomic locations subject to damage which would worsen
the patient's condition. Also, commenters were concerned with
maintaining relativity between CPT codes 30468 and 30469, and also
stated that the proposed RVU of 2.44 for CPT code 30469 falls below the
survey 25th percentile for CPT code 30469.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another, and we still believe that CPT
code 31297 is a valid comparator to CPT code 30469, which has the same
20 minutes of intra-service time and similar total time as CPT code
30469. We also noted that CPT code 31295, which the RUC used as a
direct crosswalk for the work RVU for CPT code 30469, has the same 20
minutes of intra-service time and 56 minutes of total time as CPT code
31297. We do not agree with the commenter that we did not consider the
intensity for CPT code 30469, and would like to note that the intensity
represented by the IWPUT of 0.0853 for CPT code 32197 is similar to the
IWPUT of 0.0874 for the 2nd reference code used in the RUC survey,
which is CPT code 31238 (Nasal/sinus endoscopy, surgical; with control
of nasal hemorrhage). For relativity purposes, we note that there were
different codes with similar time values the RUC could have used
besides CPT code 31295. We continue to believe that the proposed work
RVU of 2.44 is supported by the reference CPT codes we compared to CPT
code 30469 with the same 20 minutes of intra-service time and similar
total time as CPT code 30469; reference CPT code 31233 with an RVU of
2.18, and CPT code 31295 with an RVU of 2.70. Also, we point out that
the RUC-recommended RVU of 2.70 was below the 25th percentile on two of
the three survey entries provided on the RUC Summary Report for CPT
code 30469, and that the lowest 25th percentile value for these three
entries was 2.25, which is below our proposed value of 2.44. Therefore,
we are finalizing the work RVU of 2.44 as proposed for CPT code 30469.
After consideration of the public comments, we are finalizing the
work RVUs for the Energy Based Repair of Nasal Valve Collapse code
family (CPT codes 30468 and 30469) as proposed. We are also finalizing
the direct PE inputs for codes 30468 and 30469 as proposed, without
refinement.
(10) Drug Induced Sleep Endoscopy (DISE) (CPT Code 42975)
In October 2020, the CPT Editorial Panel created CPT code 42975
(Drug-induced sleep endoscopy, with dynamic evaluation of velum,
pharynx, tongue base, and larynx for evaluation of sleep-disordered
breathing, flexible, diagnostic) to report drug induced sleep endoscopy
(DISE) flexible, diagnostic. At the January 2021 RUC Meeting, the RUC
requested that this service be resurveyed for the April 2021 RUC
Meeting using a standard 000-day survey template. For CY 2023, the RUC
recommended a work RVU of 1.95 for CPT code 42975.
We disagreed with the RUC-recommended work RVU of 1.95 for CPT code
42975 and proposed a work RVU of 1.58. We believe the RVU should be
lower than the RUC recommendation of 1.95 to reflect the decrease in
total time from 68 minutes to 50 minutes. The proposed RVU of 1.58 is
based on the total time ratio calculation using the RUC-recommended 50
minutes total time for CPT code 42975 divided by the 48 minutes of
total time for CPT code 43197 (Esophagoscopy, flexible, transnasal;
diagnostic, including collection of specimen(s) by brushing or washing,
when performed (separate procedure)), then multiplying by the RVU of
1.52 for CPT code 43197 ((50/48) x 1.52 = 1.58). We found that CPT code
43197 has the same intra-service time and similar total time as CPT
code 42975. Also, CPT code 43197 is a similar endoscopic procedure as
CPT codes 42975 and 31579 (Laryngoscopy, flexible or rigid telescopic,
with stroboscopy). We noted that CPT code 31579 is the first key
reference code in the RUC survey. The proposed work RVU of 1.58 is
supported by the reference CPT codes we compared to CPT code 42975 with
the same 15 minutes of intra-service time and similar total time as CPT
code 42975; reference CPT code 43200 (Esophagoscopy, flexible,
transoral; diagnostic, including collection of specimen(s) by brushing
or washing, when performed (separate procedure)) with an RVU of 1.42,
and CPT code 62272 (Spinal puncture, therapeutic, for drainage of
cerebrospinal fluid (by needle or catheter)) with an RVU of 1.58.
Again, we believe the proposed RVU of 1.58 is a more appropriate value
overall than 1.95 when compared to the range of codes with the same
intra-service time and similar total time.
We proposed the RUC-recommended direct PE inputs for CPT code 42975
without refinement.
The following is a summary of the comments we received and our
responses.
Comment: A few commenters disagreed with our proposed RVU of 1.58
for CPT code 42975, and want us to accept the RUC-recommended RVU of
1.95 instead. The commenters stated that they did not understand our
rationale that the RVU should be reduced due to the decrease in total
time between the two surveys for the January 2021 and April 2021 RUC
meetings, especially since an interim RVU of 1.90 was previously
accepted by CMS for the 2022 PFS. The commenters stated it is important
to note that the interim value accepted by CMS for the 2022 PFS was
based on inaccurate survey data, as the immediate post-service time was
not captured appropriately in the initial survey of CPT code 42975.
Upon resurvey, respondents gave identical intra time and post procedure
time. The only difference was the removal of 18 minutes of post time
(for the half day discharge management visit) that was included in
total time approved on an interim basis in January 2021, which
represents the reduction of total time from the January 2021 (68
minutes) to the April 2021 (50 minutes) total time for CPT code 42975.
Based on this, the commenters did not understand CMS' rationale that
the work RVU should be reduced due to the decrease in total time
between the two surveys, and argued that the first survey was
invalidated due to the use of the incorrect tool. Respondents therefore
were asked about post procedure visits/time, and indicated that a
discharge management visit occurs. The standard time for a half day
discharge management was then recommended by
[[Page 69491]]
one of the specialty societies. The only change in data for the April
survey was that respondents were not asked about a discharge management
visit, and therefore, they did not indicate that one occurred. Their
pre, intra, and immediate post times were almost identical. Therefore,
the commenters believe that the RUC-recommended RVU of 1.95 is
justified and is appropriate as compared to the key reference services
selected and the broader fee schedule of codes with similar times and
intensity.
Response: We appreciate the RUC resurveying CPT code 42975. This
allowed us to review CPT code 42975 again and revalue it for 2023. We
note that when CPT code 42975 was initially valued in January 2021, an
incorrect survey instrument was used, thus requiring CPT code 42975 to
be resurveyed in April 2021. In January 2021, the RUC questioned the 18
minutes for the \1/2\ discharge day management used by the specialty
society to value CPT code 42975, and determined that it was not
necessary for this code. When CPT code 42975 was resurveyed for the
April 2021 RUC meeting, the total time showed the decrease of 18
minutes due to the removal of the \1/2\ discharge day management. Thus,
the total time for CPT code 42975 dropped from 68 minutes to 50
minutes. Therefore, we continue to believe the RVU should be lower than
the RUC recommendation of 1.95 to reflect the decrease in total time
from 68 minutes to 50 minutes. The proposed RVU of 1.58 is based on the
total time ratio calculation using the RUC-recommended 50 minutes total
time for CPT code 42975 divided by the 48 minutes of total time for CPT
code 43197, then multiplying by the RVU of 1.52 for CPT code 43197
((50/48) x 1.52 = 1.58). We found that CPT code 43197 has the same
intra-service time and similar total time as CPT code 42975. Also, CPT
code 43197 is a similar endoscopic procedure as CPT codes 42975 and
31579. We noted that CPT code 31579 is the first key reference code in
the RUC survey. The proposed work RVU of 1.58 is supported by the
reference CPT codes we compared to CPT code 42975 with the same 15
minutes of intra-service time and similar total time as CPT code 42975;
reference CPT code 43200 with an RVU of 1.42, and CPT code 62272 with
an RVU of 1.58. Again, we continue to believe the proposed RVU of 1.58
is a more appropriate value overall than 1.95 when compared to the
range of codes with the same intra-service time and similar total time.
Therefore, we are finalizing the work RVU of 1.58 for code 42975 as
proposed.
Comment: One commenter disagreed with our use of a total time ratio
to develop the proposed RVU of 1.58 for CPT code 42975, and stated that
it neglects to capture the level of intensity. The commenter stated
that the methodologies CMS used for the valuation of specific codes for
2023 is flawed, including the total time ratio calculation that informs
the proposed work RVU of 1.58 for CPT code 42975.
Response: We disagree with the commenter and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
In accordance with the statute, we believe that changes in time and
intensity must be accounted for when developing work RVUs. When our
review of recommended values reveals that changes in the resource of
time are not accounted for in a RUC-recommended RVU, the obligation to
account for that change when establishing the proposed and final work
RVUs remains. We recognize that it would not be appropriate to develop
work RVUs solely based on time given that intensity is also an element
of work, but in applying the time ratios, we are using derived
intensity measures based on current work RVUs for individual
procedures. Were we to disregard intensity altogether, the work RVUs
for all services would be developed based solely on time values and
that is definitively not the case, as indicated by the many services
that share the same time values but have different work RVUs.
Furthermore, we reiterate that we use time ratios to identify
potentially appropriate work RVUs, and then use other methods
(including estimates of work from CMS medical personnel and crosswalks
to key reference or similar codes) to validate these RVUs. For more
details on our methodology for developing work RVUs, we direct readers
to the discussion in the CY 2017 PFS final rule (81 FR 80272 through
80277).
Comment: One commenter stated that the proposed RVU of 1.58 for CPT
code 42975 falls below the RUC survey 25th percentile of 1.95, and that
we need to provide a significant justification when we propose an RVU
that is below the 25th percentile.
Response: We disagree with the commenter and would like to remind
the commenter that we used a total time ratio, described above, to
develop the proposed RVU of 1.58 for CPT code 42975. A total time ratio
is one of several valid methodologies we use for developing the RVUs
that we propose, and there is no rule stating that the work RVU cannot
go below the survey 25th percentile. We believe that changes in work
time should be reflected in changes to the work RVU, and note that the
total time decreased for CPT code 42975 when it was resurveyed in April
2021.
After consideration of the public comments, we are finalizing the
work RVU for the Drug Induced Sleep Endoscopy (DISE) code family (CPT
code 42975) as proposed. We are finalizing the direct PE inputs for
code 42975 as proposed, without refinement.
(11) Endoscopic Bariatric Device Procedures (CPT Codes 43235, 43290,
and 43291)
In February 2021, the CPT Editorial Panel created CPT codes 43290
(Esophagogastroduodenoscopy, flexible, transoral; with deployment of
intragastric bariatric balloon) and 43291 (Esophagogastroduodenoscopy,
flexible, transoral; with removal of intragastric bariatric balloon(s))
for endoscopic bariatric device procedures to the
esophagogastroduodenoscopy (EGD) code family. CPT code 43235
(Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing, when performed
(separate procedure)) is the base code for the EGD family and was
surveyed with the new endoscopic bariatric device procedures, 43290 and
43291. All three of these CPT codes were reviewed at the April 2021 RUC
meeting. For CY 2023, the RUC recommended an RVU of 3.11 for CPT code
43290, an RVU of 2.80 for CPT code 43291, and maintaining the current
work RVU of 2.09 for CPT code 43235.
We proposed the RUC-recommended work RVU of 3.11 for CPT code
43290, the RUC-recommended work RVU of 2.80 for CPT code 43291, and
maintaining the current work RVU of 2.09 for CPT code 43235 for this
code family.
We proposed the direct PE inputs for CPT code 43235 without
refinement. However, we proposed refinements to the direct PE inputs
for CPT codes 43290 and 43291.
For CPT code 43290, we proposed refinements to the direct PE inputs
for
[[Page 69492]]
clinical labor activity codes CA001 (complete pre-service diagnostic
and referral forms) and CA011 (provide education/obtain consent). We
proposed to refine CA001 from 5 minutes to the standard 3 minutes since
no explanation was provided to support 5 minutes for this clinical
labor activity. We proposed to refine CA011 from 15 minutes to 10
minutes since it was not clear why this much time for education is
needed, and we do not believe that the recommended 15 minutes would be
typical for the procedure. Also, when we looked at other procedures
with clinical labor activity code CA011 we did not find many procedures
with more than 12 minutes for this activity. Therefore, we proposed to
refine the clinical labor activity times for CA001 and CA011 for CPT
code 43290 as described above, and to accept the remaining RUC-
recommended direct PE inputs without refinement.
For CPT code 43291, we proposed a refinement to the direct PE input
for clinical labor activity code CA016 (prepare, set-up and start IV,
initial positioning and monitoring of patient) from 10 minutes to the
standard 2 minutes. In the PE Summary of Recommendations for non-
facility direct PE inputs provided by the RUC, the RUC recommended 8
minutes above the standard 2 minutes for CA016 and stated this clinical
labor activity was identical to the 10 minutes for positioning the
patient as CPT code 43260 (Endoscopic retrograde
cholangiopancreatography (ERCP); diagnostic, including collection of
specimen(s) by brushing or washing, when performed (separate
procedure)). However, our study of this code family could not find 10
minutes of non-facility direct PE inputs for clinical labor activity
CA016. Also, CPT code 43260 is only performed in a facility and does
not have any non-facility clinical labor times. Therefore, we proposed
to refine the clinical labor activity time for CA016 for CPT code 43291
as described above, and to accept the remaining RUC-recommended direct
PE inputs without refinement. This proposed reduction of 8 minutes to
the CA016 clinical labor activity also carried over to the equipment
times for the suction machine (Gomco) (EQ235), the scope video system
(monitor, processor, digital capture, cart, printer, LED light)
(ES031), and the multi-channeled flexible digital scope, esophagoscopy
gastroscopy duodenoscopy (EGD) (ES087) which we proposed to reduce by
the same 8 minutes.
The following is a summary of the comments we received and our
responses.
We did not receive comments on the proposed work RVUs for CPT codes
43235, 43290, and 43291. Therefore, we are finalizing the work RVU of
2.09 for CPT code 43235, the RVU of 3.11 for code 43290, and the RVU of
2.80 for code 43291 as proposed. We did receive comments on the direct
PE inputs for CPT codes 43290 and 43291, and those comments and
responses are below.
Comment: We received a few comments regarding the PE inputs for CPT
code 43290 in the non-facility setting. The commenters requested that
we accept the RUC-recommended clinical labor times for CA001 and CA011
in the non-facility setting. The commenters stated that the RUC agreed
that the ``Extensive Use of Clinical Staff'' package should be used for
CA001 to allow 5 minutes for CPT code 43290. Also, the commenters
stated that additional minutes above the standard for CA011 were needed
for CPT code 43290 due to the extent of the patient instruction
required, and stated 15 minutes should be allowed.
Response: We continue to disagree with the RUC-recommended direct
PE inputs for clinical labor activity codes CA001 and CA011 for CPT
code 43290. We reviewed the Practice Expense Summary of Recommendation
for the facility and non-facility settings. We continue to believe that
3 minutes for CA001, and 10 minutes for CA011, in the non-facility
setting is appropriate. Although the RUC recommended 5 minutes for
CA001 in the non-facility setting, we note that that the RUC
recommended only 3 minutes for CA001 in the facility setting, and not
the 5 minutes that would be the standard for the ``Extensive Use of
Clinical Staff'' in the facility and non-facility settings. After
reviewing the comments, we are still not convinced that the information
provided would support the need for 5 minutes for CA001 in the non-
facility setting. Also, for clinical labor activity CA011, we continue
to believe that 10 minutes is appropriate and that the recommended 15
minutes would not be typical for the procedure. When we looked at other
procedures with clinical labor activity code CA011, we did not find
many procedures with more than 12 minutes for this activity. After
reviewing the comments, we remain unconvinced that the information
provided would support the need for 15 minutes for CA011 in the non-
facility setting. Therefore, we are finalizing the clinical labor
activity times for CA001 and CA011 for CPT code 43290 as proposed.
Comment: The commenters stated that 10 minutes was needed for CA016
for CPT code 43291, instead of the standard 2 minutes, for positioning
the patient because no other procedure in this code family is performed
in this position, which is why extra time is required. The commenters
stated that clinical labor time needed to position the patient is
identical to that of CPT code 43260 and described the process as
follows: patient is placed face up with their head resting on a pad
positioner or pillow and their neck in a neutral position, patient's
arms are positioned to maintain a neutral thumb-up or supinated
position and may be tucked at their sides or abducted to less than 90
degrees on arm boards, then the patient is intubated while supine and
staff must then move the patient into left lateral position.
Response: After reviewing the comments, we are still not convinced
that the information provided would support the need for 10 minutes for
CA016 for CPT code 43291. We continue to believe that the standard 2
minutes for CA016 is appropriate. We remind the commenters that in our
study of CPT code 43260, we could not find 10 minutes of non-facility
direct PE inputs for clinical labor activity CA016 as suggested. Also,
we remind the commenters that CPT code 43260 is only performed in the
facility setting and does not have any non-facility clinical labor
times. Therefore, we are finalizing the clinical labor activity time
for CA016 for CPT code 43291 as proposed.
After consideration of the public comments, we are finalizing the
work RVU values for the Endoscopic Bariatric Device Procedures code
family (CPT codes 43235, 43290, and 43291) as proposed. We are
finalizing the direct PE inputs for CPT code 43235 as proposed, without
refinement. We are finalizing the direct PE inputs for CPT codes 43290
and 43291 as proposed.
(12) Delayed Creation Exit Site From Embedded Catheter (CPT Code 49436)
CPT code 49436 (Delayed creation of exit site from embedded
subcutaneous segment of intraperitoneal cannula or catheter) was
finalized as potentially misvalued in the CY 2022 PFS final rule (86 FR
64996) and the code was found to be appropriate to value for the non-
facility/office setting. The RUC only reviewed the PE inputs for this
service at the January 2022 meeting. The RUC recommended 5 minutes for
Clinical Activity Code CA013, line 34 in the non-facility/office
setting on the RUC-recommended PE spreadsheet. We disagreed with the
RUC-recommended
[[Page 69493]]
time, and proposed the standard time of 2 minutes, as an adequate
rationale was not provided for the additional time in the global space.
The proposed reduction of 3 minutes to the CA013 clinical labor
activity also carries over to the equipment times, which we proposed to
reduce by the same 3 minutes. Otherwise, we agreed with the RUC-
recommended clinical labor times for activity codes CA011 and CA018,
and we proposed the remaining refinements as recommended.
The RUC did not recommend any work inputs for this code and we did
not propose any work RVU refinements.
We received three comments regarding our proposed direct PE input
refinements for CPT code 49436 in response to the CY 2023 PFS proposed
rule and those comments are summarized below.
Comment: Two commenters stated that the rationale for the
additional 3 minutes under the CA013 clinical labor activity was
included in the PE Summary of Recommendations (SOR), which lists the
supply items needed to set up the procedure room. The commenters stated
that the 36 supply items are mostly sterile and will take at least 3
more minutes to set up than the standard 2 minutes allocated for an E/M
service. Another commenter requested that we reevaluate and finalize
the RUC-recommended 5 minutes.
Response: We continue to disagree with the RUC-recommended 5
minutes for Clinical Activity Code CA013. The PE SOR did not provide a
sufficient rationale for the additional time, and commenters did not
provide new data to justify the additional time. This procedure is
performed during an office visit, and we believe that the standard 2
minutes adequately accounts for the preparation of supplies, when
compared to similar codes in the global space and non-facility/office
setting.
After consideration of the public comments, we are finalizing 2
minutes for CA013 as proposed. The proposed reduction of 3 minutes to
the CA013 clinical labor activity also carries over to the formula used
to calculate equipment times, which we are finalizing to reduce by the
same 3 minutes. We agreed with the RUC-recommended clinical labor times
for activity codes CA011 and CA018, and we are finalizing the remaining
refinements as proposed and recommended.
(13) Percutaneous Nephrolithotomy (CPT Codes 50080 and 50081)
In September 2021, the CPT Editorial Panel revised the descriptors
to CPT codes 50080 (Percutaneous nephrolithotomy or pyelolithotomy,
lithotripsy stone extraction, antegrade ureteroscopy, antegrade stent
placement and nephrostomy tube placement, when performed, including
imaging guidance; simple (e.g., stone[s] up to 2 cm in a single
location of kidney or renal pelvis, nonbranching stones)) and 50081
(Percutaneous nephrolithotomy or pyelolithotomy, lithotripsy stone
extraction, antegrade ureteroscopy, antegrade stent placement and
nephrostomy tube placement, when performed, including imaging guidance;
complex (e.g., stone[s] 2 cm, branching stones, stones in
multiple locations, ureter stones, complicated anatomy)), that in
recent claims data were identified via the site of service anomaly
screen, to be performed less than 50 percent of the time in the
inpatient setting, but both codes have 090 day global periods, which
include post-op inpatient hospital E/M services as a component of their
value, typical of major surgery codes. The revised code descriptors
also include image guidance and nephrostomy tube placement, which were
not present in the old descriptors, and were reported as procedures
that were separate from CPT codes 50081 and 50082. These codes have not
been reviewed for nearly 30 years.
CPT code 50080 currently has a work RVU of 15.74 with 117 minutes
of intra-service time and 359.5 minutes of total time. The RUC
recommended a work RVU of 13.50, 90 minutes of intra-service time, and
244 minutes of total time for CPT code 50080, which represents a
reduction from the current values. However, the recommended intra-
service times dropped by 76.9 percent from the current intra-service
time and the RUC recommended work RVU is reduced only by 85.9 percent.
Therefore, we disagree with the RUC recommended work RVU and we
proposed a work RVU of 12.11 for CPT code 50080 with the RUC
recommended 90 minutes of intra-service time and 244 minutes of total
time. We noted that our proposed work RVU for CPT code 50080 falls
between CPT code 36830 (Creation of arteriovenous fistula by other than
direct arteriovenous anastomosis (separate procedure); nonautogenous
graft (e.g., biological collagen, thermoplastic graft)), with a work
RVU of 12.03 and the same intra-service time of 90 minutes, and CPT
code 36818 (Arteriovenous anastomosis, open; by upper arm cephalic vein
transposition), with a work RVU of 12.39 and the same intra-service
time of 90 minutes (and both with similar total times to CPT code
50080).
CPT code 50081 currently has a work RVU of 23.50 with 42 minutes of
pre-service evaluation time, 0 minutes of pre-service positioning time,
25 minutes of pre-service scrub/dress/wait time, 195 minutes of intra-
service time, 27 minutes of immediate post-service time, and 507.5
minutes of total time. The RUC recommended 22.00 work RVUs with 40
minutes of pre-service evaluation time, 3 minutes positioning time, 10
minutes scrub/dress/wait time, 140 minutes of intra-service time, 44
minutes of immediate post-service time, for a sum of 302 minutes of
total time. The RUC-recommended intra-service time and total time for
CPT code 50081 are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs. Though
the RUC recommended a work RVU of 22.00 that is less than the current
23.50 work RVU, a substantial reduction in time should be better
reflected in the work RVU.
The RUC recommended 13.50 work RVUs for CPT code 50800 and 22.00
for CPT code 50081, with an incremental difference between the two
codes of 8.50 work RVUs (22.00 - 13.50 = 8.50). We proposed a work RVU
of 20.61 for CPT code 50081, based on the proposed CPT code 50080's
work RVU of 12.11 plus the RUC-recommended incremental difference 8.50
work RVUs between CPT code 50080 and CPT code 50081(12.11 + 8.50 =
20.61).
We proposed the direct PE inputs as recommended by the RUC for both
codes in the family.
Comment: We received several comments concerning CPT codes 50080
and 50081, all opposing our proposed work RVUs for these services.
Commenters pointed out that CPT codes 50080 and 50081 are not the same
services that they were when they were last reviewed. They noted that
both codes have retained their current work RVUs since CY 2010 and that
they now encompass several other procedures that previously could have
been separately billable, which has increased their intensity and
complexity. These additions include imaging supervision and
interpretation, antegrade stent placement, nephrostomy tube placement
and antegrade ureteroscopy as have been included in their new
descriptors.
Response: We acknowledge that it has been many years since these
two CPT codes were last reviewed and percutaneous nephrolithotomy's
technologies and methodologies have changed, which may have added
complexities to the service, but at the same time, there have been
improvements in methods and
[[Page 69494]]
efficiencies through research and evaluations of better and best
practices. We see evidence of this just in the change in the physician
intra-services times for CPT code 50080 with what was 117 minutes, but
is now 90 minutes, even with the addition of those services now added
to the new descriptor (compared to the previous descriptor for CPT code
50080; Percutaneous nephrostolithotomy or pyelostolithotomy, with or
without dilation, endoscopy, lithotripsy, stenting, or basket
extraction; up to 2 cm.). Similarly, with the change in the physician
intra-services times for CPT code 50081 with what was 195 minutes, but
is now 140 minutes, even with the addition of those services now added
to the new descriptor (compared to the previous descriptor for CPT code
50081; Percutaneous nephrostolithotomy or pyelostolithotomy, with or
without dilation, endoscopy, lithotripsy, stenting, or basket
extraction; over 2 cm). The skills and trainings of the physicians have
certainly become more efficient in performing the main task and the
additional tasks now bundled into CPT codes 50080 and 50081 using less
intra-service time and total time for these procedures.
Comment: Commenters suggested that CMS should consider CPT codes
50080 and 50081 as entirely new codes with their new descriptors
describing their bundling and that the old codes are not really
comparable to all of the tasks performed in the new code and thus CMS
should place more weight in the most recent results from these codes'
surveyed work RVUs and their surveyed times, specifically the 25th
percentile results.
Response: We do agree that the new descriptors for CPT codes 50080
and 50081 are more detailed and more specific about what is now bundled
in with the entirety of the service but the fundamental core of these
services are still the same and they are not completely new and
different enough to make them incomparable. We still believe that the
reductions in physician work times should generally result in
reductions in of the work RVUs, as we have proposed. If those
additional tasks of imaging supervision and interpretation, antegrade
stent placement, nephrostomy tube placement and antegrade ureteroscopy
were separately paid from CPT codes 50080 and 50081, those separate
claim codes and their typical units of service were not included in the
AMA RUC recommendations for consideration to value the bundled service.
Having those CPT codes, their work RVUs, and their intra-service
minutes would have been useful when we were valuing these services.
Commenters reiterated that these services, these additional tasks, are
now part of the bundled codes, which lead us to re-review the AMA RUC
recommendations. From our re-review of the AMA RUC recommendations, we
do note that in the text material accompanying the RUC recommendation
for CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour
physician or other qualified health care professional time) codes or
language was struck from the text material. It is unclear if the
reference to CPT code 76000 was intentionally deleted, but we note that
CPT code 76000 has a work RVU value of 0.30 and an intra-service time
of 10.0 minutes and a total time of 20.0 minutes.
Comment: Commenters objected to CMS' selection of comparator codes.
Commenters stated that the comparator codes chosen by CMS (for CPT code
50080 which falls between CPT codes 36830 and 36818) do not have
similar clinical anatomical basis to CPT codes 50080 and 50081, and
that our comparator codes have not taken into account similar levels of
work intensities.
Response: We believe our selected comparator codes are relevant in
the PFS relative value system and that all services are appropriately
subject for comparison to each other. By statute, we are required to
consider times and intensities as they are related to work when
reviewing and valuating all CPT and HCPCS services.
After review and consideration of all comments on our proposals for
CPT codes 50080 and 50081, we believe that the value of CPT code 76000
is not entirely accounted for in our original proposed valuations and
we are adding Fluoroscopy's 0.30 work RVUs to both CPT codes 50080 and
50081, since this work was omitted from our proposed valuations. We are
finalizing 12.41 work RVUs (12.11 + 0.30) for CPT code 50080 and 20.91
work RVUs (12.11 + 8.50 + 0.30) for CPT code 50081 for CY 2023. We are
also finalizing the direct PE inputs as proposed and as recommended by
the RUC for both of these codes.
(14) Laparoscopic Simple Prostatectomy (CPT Codes 55821, 55831, 55866,
and 55867)
In October 2021, the CPT Editorial Panel added CPT placeholder code
55867 (Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) and prompted this family of
Laparoscopic Simple Prostatectomy codes for survey and review for the
January 2022 RUC meeting.
The RUC recommended a work RVU of 15.18 for CPT code 55821
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); suprapubic, subtotal, 1 or 2 stages) with 33 minutes of
pre-service evaluation time, 3 minutes positioning time, 10 minutes
scrub/dress/wait time, 120 minutes of intra-service time, and 25
minutes of immediate post-service time, for a sum of 329 minutes of
total time. CPT code 55821 currently has a work RVU value of 15.76 with
102.0 minutes of intra-service time and 399.5 minutes of total time.
After reviewing this code and relative similar codes in the PFS, we
proposed the RUC-recommended work RVU of 15.18 with 315 minutes of
total time.
The RUC recommended a work RVU of 15.60 for CPT code 55831
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); retropubic, subtotal), with 40 minutes of pre-service
evaluation time, 3 minutes positioning time, 10 minutes scrub/dress/
wait time, 120 minutes of intra-service time, 25 minutes of immediate
post-service time, for a sum of 329 minutes of total time. CPT code
55831 currently has a work RVU value of 17.19 with 114.0 minutes of
intra-service time and 422.5 minutes of total time. The RUC notes an
additional degree of difficulty with this retropubic incision approach
(behind the pubis) compared to the suprapubic approach. After reviewing
this code and relative similar codes in the PFS, we proposed the RUC
recommended work RVU of 15.60 with 322 minutes of total time.
The RUC recommended a work RVU of 22.46 for CPT code 55866
(Laparoscopy, surgical prostatectomy, retropubic radical, including
nerve sparing, includes robotic assistance, when performed) with 40
minutes of pre-service evaluation time, 15 minutes positioning time, 12
minutes scrub/dress/wait time, 180 minutes of intra-service time, 50
minutes of immediate post-service time, for a sum of 362 minutes of
total time. CPT code 55866 currently has a work RVU value of 26.80 with
180 minutes of intra-service time and 422 minutes of total time. The
RUC notes that this procedure removes the entire prostate with robotic
assistance, and the complexity of nerve sparing when operating with a
cancerous
[[Page 69495]]
prostate, increases the medical complexity and intensity of this
procedure. After reviewing this code and relative similar codes in the
PFS, we proposed the RUC recommended work RVU of 22.46 with 362 minutes
of total time to CPT code 55866.
The RUC recommended a work RVU of 19.53 for CPT code 55867
(Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) with 40 minutes of pre-service
evaluation time, 8 minutes positioning time, 11 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 50 minutes of immediate
post-service time, for a sum of 354 minutes of total time. The RUC
offers CPT code 42420 (Excision of parotid tumor or parotid gland;
total, with dissection and preservation of facial nerve) with a work
RVU of 19.53, 180 minutes of intra-service time and 383 minutes of
total time)) as a crosswalk to CPT code 55867. After reviewing this
code and relative similar codes in the PFS, we proposed the RUC-
recommended work RVU of 19.53 with 354 minutes of total time to CPT
code 55867.
We proposed the RUC-recommended direct PE inputs for CPT codes
55821, 55831, 55866, and 55867 without refinement.
CMS received two comments for CPT codes 55821, 55831, 55866, and
55867.
Comment: Both comments for these Laparoscopic Simple Prostatectomy
codes indicated support for CMS to accept the RUC-recommended work RVUs
and the direct PE inputs adjustments.
Response: We thank commenters for taking time to submit comments
expressing support for our proposals to accept the RUC-recommendations
for CPT codes 55821, 55831, 55866, and 55867.
We are finalizing the RUC-recommended work RVUs and direct PE
inputs for these Laparoscopic Simple Prostatectomy codes.
(15) Lumbar Laminotomy With Decompression (CPT Codes 63020, 63030, and
63035)
In October 2018, CPT code 63030 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, lumbar) was identified by the AMA as having an anomalous
site of service when compared to Medicare utilization data. The
Medicare data from 2014 through 2017 indicated that CPT code 63030 was
performed less than 50 percent of the time in the inpatient setting,
yet included inpatient hospital evaluation and management (E/M)
services within its global period. In January 2019, the RUC recommended
that this code be reviewed in 2 years (January 2021) to determine if
previous changes to differentiate percutaneous, endoscopic, and open
spine procedures were effective to correct reporting of this service.
In December 2020, the Relativity Assessment Workgroup noted that CPT
code 63030 continues to be primarily reported in the outpatient
setting, but still includes inpatient hospital visits in its valuation.
The specialty society indicated that there is still confusion about
this code, and therefore, the RUC recommended that CPT code 63030 be
referred to the CPT Editorial Panel to revise the descriptor to
mitigate the incorrect reporting in the outpatient setting, but the CPT
Editorial Panel did not accept the code change application to
differentiate inpatient (63030) versus outpatient (630X0) at the
September 2021 CPT meeting. Since this is a site of service issue, CPT
code 63030 was surveyed with the code family for the January 2022 RUC
meeting.
For CPT codes 63020 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, cervical), 63030, and 63035 (Laminotomy (hemilaminectomy),
with decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; each
additional interspace, cervical or lumbar (List separately in addition
to code for primary procedure)), we disagree with the RUC's recommended
work RVUs of 15.95, 13.18, and 4.00, respectively, because they do not
account for the surveyed changes in time for CPT codes 63020, 63030,
and 63035, and the full application of the 23-hour policy to CPT code
63030. We proposed a work RVU of 14.91 for CPT code 63020, a work RVU
of 12.00 for CPT code 63030, and a work RVU of 3.86 for CPT code 63035.
The RUC recommended 40 minutes pre-service evaluation, 20 minutes
pre-service positioning, 15 minutes pre-service scrub/dress/wait time,
90 minutes intraservice time, 30 minutes immediate post-service time,
and one CPT code 99232 (subsequent hospital care/day 25 minutes), one
CPT code 99231 (Subsequent hospital care/day 15 minutes), one CPT code
99238 (Hospital discharge day management; 30 minutes or less), one CPT
code 99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter.), and two CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits in the post-
operative period. This results in a 15-minute decrease in the pre-
service period, a 30-minute decrease in intraservice time, a 5-minute
decrease in immediate post-service time, and a 17-minute increase in
the post-operative period. The proposed work RVU of 14.91 is based on
the total time ratio calculation using the RUC-recommended 379 minutes
of total time divided by the current total time of 412 minutes for CPT
code 63020, then multiplying by the current work RVU of 16.20 for CPT
code 63020 ((379 minutes/412 minutes) * 16.20 = 14.90). We noted that
this is a direct crosswalk to CPT code 27057 (Decompression
fasciotomy(ies), pelvic (buttock) compartment(s) (e.g., gluteus medius-
minimus, gluteus maximus, iliopsoas, and/or tensor fascia lata muscle)
with debridement of nonviable muscle, unilateral), which has a work RVU
of 14.91, identical intraservice and immediate post-service time of 90
minutes and 30 minutes, respectively, and only 10 more minutes of total
time. We believe this work RVU more adequately accounts for the
decrease in total and intraservice time than the RUC recommended work
RVU, and we noted that we considered the reverse building block
methodology, which would result in a work RVU of 14.30, but we believed
that it decreased the valuation of CPT code 63020 too much, considering
the shift in post-operative work to include a longer, more intense
office/outpatient visit (CPT code 99214).
We disagree with the RUC-recommended work RVU for CPT code 63030.
More specifically, we disagree with the RUC recommended work RVU for
CPT code 63030 because the RUC did not completely apply the 23-hour
policy calculation (finalized in the CY 2011 PFS final rule (75 FR
73226)) in formulating its recommendations.
[[Page 69496]]
Additionally, we disagree with the RUC recommended work RVU for this
code for which the RUC considered the patient to be admitted during the
post-operative period because the RUC did not fully apply the 23-hour
policy when formulating their recommendations. As we noted in the CY
2011 PFS final rule (75 FR 73226), and as we discuss earlier in this
section of this final rule (``(1) Anterior Abdominal Hernia Repair (CPT
codes 15778, 49591, 49592, 49593, 49594, 49595, 49596, 49613, 49614,
49615, 49616, 49617, 49618, 49621, 49622, and 49623''), the work RVUs
for services that are typically performed in the outpatient setting and
require a hospital stay of less than 24 hours may in some cases involve
multiple overnight stays while the patient is still considered to be an
outpatient for purposes of Medicare payment. Because such services are
typically furnished in the outpatient setting, they should not be
valued to include inpatient post-operative E/M visits. The level of
discharge day management services included in the valuation of such
services should similarly not reflect an inpatient discharge and should
therefore be reduced. And finally, as discussed in CY 2011 rulemaking,
the intraservice time from the inpatient level E/M postoperative visit
should be reallocated to the immediate postservice time of the service.
The 23-hour policy calculation, when fully applied to the calculation
of a work RVU, is used to reduce the value of discharge day management
services, remove the inpatient E/M visits, and reallocate the
intraservice time to the immediate post-service period. We refer
readers to the 2011 PFS final rule (75 FR 73226) for an in-depth
explanation of the 23-hour policy.
For CPT code 63030, we believe the RUC only partially applied the
23-hour policy when it applied the policy to the immediate post service
time, but not to the calculation of the work RVU. Instead, we believe
the 23-hour policy should be fully applied to this code that describes
outpatient services for which there is an overnight stay during the
post-operative period, regardless of the number of nights that a
patient stays in the hospital. The services to which the 23-hour policy
is usually applied would typically involve a patient stay in a hospital
for less than 24 hours, which often means the patient may stay
overnight in the hospital. On occasion, the patient may stay in the
hospital longer than a single night; however, in both cases (one night
or more than one night), the patient is considered to be a hospital
outpatient, not an inpatient, for Medicare purposes. In short, we do
not believe that the work that is typically associated with an
inpatient service should be included in the work RVUs for the
outpatient services to which the 23-hour policy applies, especially
considering the previously discussed site of service anomaly for CPT
code 63030.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we are instead proposing a
work RVU of 12.00 for CPT code 63030.The steps are as follows:
Step (1): 13.18 - 0.64 * = 12.54.
Step (2): 12.54 - 0.76 ** = 11.78.
Step (3): 11.78 + (10 minutes x 0.0224) *** = 12.00 RVUs.
* Value associated with \1/2\ hospital discharge day management
service.
** Value associated with an inpatient hospital visit, CPT code
99231.
*** Value associated with the reallocated intraservice time
multiplied by the post-service intensity of the 23-hour stay code.
The RUC recommended the maintenance of the current work RVU of
13.18 because there was no change in intraservice time and the 37-
minute decrease in total time is largely due to the change in immediate
post-service time and post-operative period from the application of the
23-hour policy. We noted that the proposed work RVU of 12.00 is higher
than the other valuations that we considered, including the total time
ratio work RVU of 11.75 ((305 minutes/342 minutes) * 13.18 = 11.75) and
the reverse building block work RVU of 11.45. We noted that the
proposed work RVU of 12.00 is well-bracketed by two 90-minute
intraservice timed 090-day CPT codes 28725 (Arthrodesis; subtalar),
with a work RVU of 11.22, and 58720 (Salpingo-oophorectomy, complete or
partial, unilateral or bilateral (separate procedure)), with a work RVU
of 12.16.
We noted that, in the summary of recommendations (SOR) submitted to
CMS by the RUC, the specialty societies assert that the surveyed total
time would be the same as the current total time if the 23-hour policy
was not fully applied to the immediate post-service time and post-
operative period, with only a shift of work from facility to office,
but we noted that this is not true. The surveyed total time is 339
minutes, but the RUC recommended 40 minutes for the pre-service
evaluation time rather than the specialty societies' surveyed 45
minutes. If the RUC had recommended the survey times, with the pre-
service evaluation refinement, the reverse building block work RVU
would be 12.62, still less than the RUC-recommended work RVU of 13.18,
effectively accounting for the shift from facility to office post-
operative visits.
For CPT code 63035, we proposed a work RVU of 3.86 based on the
reverse building block methodology to account for the 11-minute
increase in intraservice time. We noted that this proposed value is
between the surveyed 25th percentile value of 3.50 and the RUC-
recommended work RVU of 4.00. We noted that the proposed work RVU is
well-bracketed by two 60-minute add-on CPT codes--CPT code 50706 and
63231. CPT code 50706 (Balloon dilation, ureteral stricture, including
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all
associated radiological supervision and interpretation (List separately
in addition to code for primary procedure)), has a work RVU of 3.80,
and CPT code 63621 (Stereotactic radiosurgery (particle beam, gamma
ray, or linear accelerator); each additional spinal lesion (List
separately in addition to code for primary procedure)), has a work RVU
of 4.00.
For the direct PE inputs, we proposed to remove the 125 minutes of
equipment time for EQ168 (light, exam) for CPT codes 63020 and 63030
because the RUC contested the typicality of its use to assess the wound
and remove staples. Because it is a standard piece of equipment in a
neurosurgeon and orthopedic exam room, and the RUC questioned its
typicality, we proposed 0 minutes for EQ168 for CPT codes 63020 and
63030.
We received several comments regarding our proposed work RVUs and
two comments regarding our proposed refinement to direct PE input EQ168
(light, exam) for CPT codes 63020, 63030, and 63035 in response to the
CY 2023 PFS proposed rule and those comments are summarized below.
Comment: Commenters urged CMS to use valid survey data to establish
work RVUs when possible, instead of a calculated value supported by
another code with no clinical relevancy. The commenters disagreed with
our proposed work RVU of 14.91 for CPT code 63020, stating that the RUC
recommended the survey 25th percentile work RVU using magnitude
estimation from a valid survey of physicians who perform this service
and that it appropriately accounts for the decrease in intraservice
time, and therefore, it did not need to be decreased further.
Commenters also disagreed with the work RVU crosswalk from CPT code
27057 to CPT code 63020, stating that CPT code 27057 is a rarely
performed procedure for a significantly different patient population,
thus making it an
[[Page 69497]]
inappropriate comparison that discounts the time, work, and intensity
required to perform CPT code 63020. Commenters stated that CPT code
63020 requires removal of bone, along with dissection around nerve
roots and the spinal cord, whereas CPT code 27057 only requires the
soft tissue work of a fasciotomy. Commenters also stated that the
physician work described by CPT code 27057 does not entail the same
intensity of work required by CPT code 63020, does not include
significant risk of paralysis, and does not require routine use of
fluoroscopy and image guidance to perform the procedure. Commenters
stated that positioning for CPT code 63020 requires use of the Mayfield
headrest and is more complex than a routine prone positioning for CPT
code 27057. Commenters stated that CPT code 27057 includes gluteal
muscle debridement, which is tedious and time consuming, but not as
complex as work involving the resection of bone and retraction of
spinal nerves.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes that describe
clinically similar services are sometimes stronger comparator codes, we
do not agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate code
comparison or an appropriate crosswalk. As noted above, we proposed a
crosswalk to CPT code 27057 with the support of the total time ratio.
We believe that time ratios are a valid and appropriate tool for
determining work RVUs. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
In accordance with the statute, we believe that changes in time and
intensity must be accounted for when developing work RVUs. When our
review of recommended values reveals that changes in the resource of
time are not accounted for in a RUC-recommended RVU, the obligation to
account for that change when establishing proposed and final work RVUs
remains. For more details on our methodology for developing work RVUs,
we direct readers to the discussion on time ratios as discussed above
in this Valuation of Specific Codes section.
Regarding the commenters' assertion that the RUC-recommended work
RVU, which is only a decrease of 0.25 work RVUs from the current
valuation of CPT code 63020, accounts for the 15-minute decrease in the
pre-service period, a 30-minute decrease in intraservice time, a 5-
minute decrease in immediate post-service time, and a 17-minute
increase in the post-operative period, and did not need to be further
decreased, we reiterate that, although we do not imply that the
decrease in time as reflected in survey values must always equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity, absent an
obvious or explicitly stated rationale for why the relative intensity
of a given procedure has increased, it would be inappropriate to use
the RUC-recommended work RVU to value CPT code 63020 given the
significant decrease in intraservice time and the absence of an
adequate justification of increased intensity. The RUC-recommended work
RVU yields an IWPUT of 0.077, whereas the current IWPUT is 0.059. The
RUC-recommended work RVU would yield an IWPUT increase of 0.018 with no
obvious or explicitly stated rational for an increased intensity. If
the RUC's recommendations appear to disregard or dismiss the changes in
time, without a persuasive explanation of why such a change should not
be accounted for in the overall work of the service, then we generally
use one of the methodologies discussed above to identify potential work
RVUs, including the methodologies intended to account for the changes
in the resources involved in furnishing the procedure such as a total
time ratio.
We continue to believe our proposed work RVU of 14.91 for CPT code
63020 based on the total time ratio calculation and a direct crosswalk
to CPT code 27057, which has a work RVU of 14.91, identical
intraservice and immediate post-service time of 90 minutes and 30
minutes, respectively, and only 10 more minutes of total time, more
adequately accounts for the decrease in total and intraservice time
than the RUC recommended work RVU.
We note that while CPT code 63020 requires removal of bone, along
with dissection around nerve roots and the spinal cord whereas CPT code
27057 requires the soft tissue work of a fasciotomy, does not include
significant risk of paralysis, and does not require routine use of
fluoroscopy and image guidance to perform the procedure, CPT code
27057's vignette and service description describes a 75-year old female
who is febrile with leukocytosis who is taken to the operating room
emergently for fasciotomy(ies) and debridement of necrotic muscle. We
note that the typical patient is at risk of acute renal failure and
life-threatening rhabdomyolysis. We note that, while we understand that
the positioning for CPT code 63020 requires use of the Mayfield
headrest and is more complex than a routine prone positioning for CPT
code 27057, that difference is accounted for in the difference in pre-
service positioning time of 8 minutes, which has longstanding, well-
established standardized WPUT of 0.0224 which factors into the reverse
building block work RVU of 14.30. Therefore, we continue to believe a
direct crosswalk to CPT code 27057 is appropriate to value CPT code
63020 and are finalizing a work RVU of 14.91 for CPT code 63020.
Comment: The commenters disagreed with our proposed work RVU of
12.00 for CPT code 63030, stating that there is concern about
contradictory policies regarding the newly revised E/M CPT codes that
combined inpatient and observation (outpatient) services. They believe
this renders the 23-hour policy invalid.
Response: We believe that adopting the revisions for CPT codes
99221-99223 and 99231-99233 is not inconsistent with our 23-hour policy
as it applies to this code family. In this instance, we are reviewing
RUC-recommendations that explicitly identify CPT code 63030 as being
subject to our 23-hour policy. Consistent with discussions in the CY
2011 and CY 2022 PFS final rules cited above, we agree with the RUC
that this code is subject to the 23-hour policy, and we believe it is
appropriate to fully apply the 23-hour policy to CPT code 63030. We
note that we acknowledge commenters' concerns regarding policy
implications as a result of adopting the E/M inpatient/observation
revisions and will take that into consideration for future rulemaking.
Additionally, we note that we did not propose any changes to the
previously finalized 23-hour policy in the proposed rule, and we
believe it is still consistent to apply the 23-hour policy, as was
recommended by the RUC, for CPT code 63030. We also remind commenters
that the 23-hour policy calculation, when fully applied to the
calculation of a work RVU, is used to reduce the value of discharge day
management services, remove the inpatient E/M visits, and reallocate
the intraservice time to the immediate post-service period. We refer
readers to the 2011 PFS final rule (75 FR 73226) for an in-depth
explanation of the 23-hour policy. For CPT code 63030, we believe the
RUC only partially applied the 23-hour policy when it applied the
policy to the immediate post service time, but not to the calculation
of the work RVU. Instead, we continue to believe the 23-hour policy
should be fully applied to this code that describes
[[Page 69498]]
outpatient services for which there is an overnight stay during the
post-operative period, regardless of the number of nights that a
patient stays in the hospital. In short, we continue to believe that
the work that is typically associated with an inpatient service should
not be included in the work RVUs for the outpatient services to which
the 23-hour policy applies, especially considering the previously
discussed site of service anomaly for CPT code 63030. Therefore, we are
finalizing our proposed work RVU of 12.00 for CPT code 63030.
Comment: Commenters disagreed with our proposed work RVU of 3.86
for CPT code 63035, stating that it was a Harvard valued code with time
and work values that were generated from the base code, CPT code 63030.
Commenters expressed that the Harvard survey did not include all the
surgical specialties that now perform the service, with only 17
responses from neurosurgeons. Therefore, the commenters stated that the
previous intraservice time should not be used to arrive at a calculated
value. The commenters also expressed concern that CMS did not address
the compelling evidence provided by the RUC, and urged CMS to address
this rationale.
Response: We believe that it is important to use the recent data
available regarding work times, and we note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also believe that our operating assumption regarding
the validity of the existing values as a point of comparison is
critical to the integrity of the relative value system as currently
constructed. The work times currently associated with codes play a very
important role in PFS ratesetting, both as points of comparison in
establishing work RVUs and in the allocation of indirect PE RVUs by
specialty. If we were to operate under the assumption that previously
recommended work times had been routinely overestimated, this would
undermine the relativity of the work RVUs on the PFS in general, in
light of the fact that codes are often valued based on comparisons to
other codes with similar work times. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, which is why we apply various methodologies
to identify several potential work values for individual codes.
However, we reiterate that we believe it would be irresponsible to
ignore changes in time based on the best data available, and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
We remind commenters that the concept of compelling evidence was
developed by the RUC as part of its work RVU review process for
individual codes. The RUC determines whether there is compelling
evidence to justify an increase in valuation. The RUC's compelling
evidence criteria include documented changes in physician work, an
anomalous relationship between the code and multiple key reference
services, evidence that technology has changed physician work, analysis
of other data on time and effort measures, and evidence that incorrect
assumptions were made in the previous valuation of the service. While
we appreciate the submission of this additional information for review,
we emphasize that the RUC developed the concept of compelling evidence
for its own review process; an evaluation of ``compelling evidence,''
at least as conceptualized by the RUC, is not part of our review
process, as our focus is the time and intensity of services, in
accordance with the statute. With that stated, we do consider changes
in technology, patient population, and other compelling evidence
criteria, as such evidence may affect the time and intensity of a
service under review. For example, new technology may cause a service
to become easier or more difficult to perform, with corresponding
effects on the time and intensity of the service. However, we are under
no obligation to adopt the same review process or compelling evidence
criteria as the RUC. We instead focus on evaluating and addressing the
time and intensity of services when valuing codes because section
1848(c)(1)(A) of the Act specifically defines the work component as the
resources that reflect time and intensity in furnishing the service.
Therefore, we are finalizing a work RVU of 3.86 for CPT code 63035 as
proposed.
Comment: Two commenters disagreed with our proposal to remove 125
minutes of equipment time for EQ168 (light, exam) for CPT codes 63020
and 63030, stating that they believe the exam light is needed to check
for possible seroma and to examine and take out stitches. The
commenters urged CMS not to remove the exam light expense from these
code values.
Response: We proposed to remove the 125 minutes of equipment time
for EQ168 (light, exam) for CPT codes 63020 and 63030 because the RUC
contested the typicality of its use to assess the wound and remove
staples. Because it is a standard piece of equipment in a neurosurgeon
and orthopedic exam room, and the RUC questioned its typicality, we
proposed 0 minutes for EQ168 for CPT codes 63020 and 63030. We note
that we found five other 090-day codes in the CPT code 630XX series,
CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda equina and/or
nerve root[s], [eg, spinal or lateral recess stenosis]), single
vertebral segment; cervical), 63046 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; thoracic), 63047 (Laminectomy,
facetectomy and foraminotomy (unilateral or bilateral with
decompression of spinal cord, cauda equina and/or nerve root[s], [eg,
spinal or lateral recess stenosis]), single vertebral segment; lumbar),
63050 (Laminoplasty, cervical, with decompression of the spinal cord, 2
or more vertebral segments), and 63051 (Laminoplasty, cervical, with
decompression of the spinal cord, 2 or more vertebral segments; with
reconstruction of the posterior bony elements (including the
application of bridging bone graft and non-segmental fixation devices
[eg, wire, suture, mini-plates], when performed)) that do not have time
allotted to EQ168, despite their inclusion of ``Monitor wounds and
remove sutures/staples'' in their post-service descriptions, therefore
we do not believe this is a typical equipment input. Since we have not
received new information that contradicts the findings in the RUC
Database to indicate that the use of this equipment is typical, we are
finalizing 0 minutes for EQ168 for CPT codes 63020 and 63030 as
proposed.
[[Page 69499]]
(16) Somatic Nerve Injections (CPT Codes 64415, 64416, 64417, 64445,
64446, 64447, 64448, 76942, 77002, and 77003)
In May 2021, the CPT Editorial Panel revised the descriptors and
billing instructions for CPT codes 64415 (Injection(s), anesthetic
agent(s) and/or steroid; brachial plexus, including imaging guidance,
when performed), 64416 (Injection(s), anesthetic agent(s) and/or
steroid; brachial plexus, continuous infusion by catheter (including
catheter placement), including imaging guidance, when performed), 64417
(Injection(s), anesthetic agent(s) and/or steroid; axillary nerve,
including imaging guidance, when performed), 64445 (Injection(s),
anesthetic agent(s) and/or steroid; sciatic nerve, including imaging
guidance, when performed), 64446 (Injection(s), anesthetic agent(s)
and/or steroid; sciatic nerve, continuous infusion by catheter
(including catheter placement), including imaging guidance, when
performed), 64447 (Injection(s), anesthetic agent(s); femoral nerve,
including imaging guidance, when performed), 64448 (Injection(s),
anesthetic agent(s) and/or steroid; femoral nerve, continuous infusion
by catheter (including catheter placement), including imaging guidance,
when performed), 77002 (Fluoroscopic guidance for needle placement),
77003 (Fluoroscopic guidance and localization of needle or catheter tip
for spine or paraspinous diagnostic or therapeutic injection procedures
(epidural or subarachnoid)) and 76942 (Ultrasonic guidance for needle
placement, imaging supervision and interpretation). These codes were
then surveyed by the RUC in October 2021.
We last finalized values for CPT codes 64415, 64416, 64417, 64445,
64446, 64447, and 64448 in the CY 2020 PFS final rule (84 FR 62744
through 62745). In May 2018, the CPT Editorial Panel approved the
revision of descriptors and guidelines for codes in the somatic nerve
injection family. At its October 2018 meeting, the RUC recommended work
RVU and PE inputs for a number of somatic nerve injection codes,
including CPT codes 64415, 64416, 64417, 64445, 64446, 64447, and
64448. (Note that in 2018, the codes did not include ``including
imaging guidance, when performed'' in their descriptors.) During the
October 2018 RUC presentation for this family of services, the
specialty societies stated that CPT codes 64415, 64416, 64417, 64446,
66447, and 64448 were reported with the imaging code CPT code 76942
more than 50 percent of the time. In reviewing this family of services
in the CY 2020 PFS final rule, our finalized work and PE values for the
codes did not consider the simultaneous performance of injection and
imaging (84 FR 62744). In May 2021, the CPT Editorial Panel revised the
codes to include ``with imaging, when performed'' in the descriptors.
When presenting its CY 2023 valuation recommendations, the RUC
pointed out that the current values and times for CPT codes 64415,
64416, 64417, 64445, 64446, 64447, and 64448 reflect only the work and
time of the injection. The revised codes, however, include both
injection and imaging. In order to make an equitable comparison between
the RUC recommendations and the current values, the RUC suggested we
compare the RUC recommendations to values that combined the current
work and estimated time of the injection codes and the imaging code
with which they are being bundled, CPT code 76942. We agreed with this
approach and thank the RUC for providing combined work RVUs and
estimated combined times, which we considered as part of the RUC's
recommendations.
As part of its recommendations, the RUC reaffirmed its prior
recommendations for a number of codes that were previously reviewed or
reaffirmed in the CY 2020 PFS final rule, including: CPT codes 64400
(Injection(s), anesthetic agent(s); trigeminal nerve, each branch
(i.e., ophthalmic, maxillary, mandibular)), 64408 (Injection(s),
anesthetic agent(s), and/or steroid; vagus nerve), 64420 (Injection(s),
anesthetic agent(s) and/or steroid; intercostal nerve, single level),
64421 (Injection(s), anesthetic agent(s) and/or steroid; intercostal
nerves, each additional level (List separately in addition to code for
primary procedure)), 64425 (Injection(s), anesthetic agent(s) and/or
steroid; ilioinguinal, iliohypogastric nerves), 64430 (Injection(s),
anesthetic agent(s) and/or steroid; pudendal nerve), 64435
(Injection(s), anesthetic agent(s) and/or steroid; paracervical
(uterine) nerve), 64449 (Injection(s), anesthetic agent(s) and/or
steroid; lumbar plexus, posterior approach, continuous infusion by
catheter (including catheter placement)), and 64450 (Injection(s),
anesthetic agent(s); other peripheral nerve or branch) (84 FR 62744
through 62745); CPT code 64451 (Injection(s), anesthetic agent(s) and/
or steroid; nerves innervating the sacroiliac joint, with image
guidance (ie, fluoroscopy or computed tomography) (84 FR 62740); and
CPT code 64454 (Injection(s), anesthetic agent(s) and/or steroid;
genicular nerve branches including imaging guidance, when performed)
(84 FR 62749). The RUC also reaffirmed its recommendation for CPT code
64455 (Injection(s), anesthetic agent(s) and/or steroid; plantar common
digital nerve(s) (e.g., Morton's neuroma)), which was reviewed and
valued in the CY 2019 PFS final rule (83 FR 58542). The codes the RUC
wishes to reaffirm for CY 2023 have not been revised by the CPT
Editorial Panel and were not resurveyed by the RUC since their prior
valuation. Since we did not receive new information regarding these
codes, we acknowledged the RUC's reaffirmation but we did not review
the values of these codes in the proposed rule. In the proposed rule,
we also noted that the RUC-reaffirmed values for CPT codes 64435 (work
RVU of 0.75), 64450 (work RVU of 0.75), 64451 (work RVU of 1.52), and
64454 (work RVU of 1.52) are the same as the current work RVUs that we
finalized in the CY 2020 PFS final rule. The RUC reaffirmed work RVU of
0.94 for CPT code 64405 is the current work RVU, which was finalized in
the CY 2019 PFS final rule (83 FR 59542) and reaffirmed in the CY 2020
final rule, and the RUC-reaffirmed work RVU of 1.10 for CPT code 64418
is the current work RVU value finalized in the CY 2018 PFS final rule
(82 FR 53054) and reaffirmed in the CY 2020 PFS final rule. The RUC
reaffirmed a work RVU of 0.75 for CPT code 64455 which is the current
work RVU we finalized in the CY 2019 PFS final rule (83 FR 58542).
For CY 2023, we proposed the RUC-recommended work RVUs for CPT
codes 64417 (work RVU of 1.31), 64447 (work RVU of 1.34), 64448 (work
RVU of 1.68), 77002 (work RVU of 0.54), 77003 (work RVU of 0.60), and
76942 (work RVU of 0.67).
For CPT code 64415, we disagreed with the RUC-recommended work RVU
of 1.50 and proposed a work RVU of 1.35, based on the intraservice time
ratio calculated using the ``combined'' values for CPT code 64415 and
the imaging CPT code 76942 provided by the RUC. (The combined work RVU
the RUC offered for comparison was 2.02 (the sum of the work RVUs for
both codes: CPT code 64415 is 1.35 and CPT code 76942 is 0.67), and an
estimated intraservice time of 15 minutes and total time of 43
minutes.) This proposed work RVU of 1.35 for CPT code 64415 is
supported by a crosswalk to CPT code 11982 (Removal, non-biodegradable
drug delivery implant), which has a work RVU of 1.34, an identical
service time, and a total time that is two minutes lower than CPT code
64415. This value is further supported by a bracket of CPT codes: CPT
code 64486
[[Page 69500]]
and CPT code 33285. CPT code 64486 (Transversus abdominis plane (TAP)
block (abdominal plane block, rectus sheath block) unilateral; by
injection(s) (includes imaging guidance, when performed)) has a work
RVU of 1.27 and identical intraservice and total time values to CPT
code 64415, and CPT code 33285 (insertion, subcutaneous cardiac rhythm
monitor, including programming) has a work RVU of 1.53, an intraservice
time of 10 minutes and a total time of 40 minutes.
We noted that when compared to the current time file information
for CPT code 64415, the RUC-recommended intraservice time decreased
from 12 to 10 minutes (16.7 percent reduction) and RUC-recommended
total time decreased from 40 to 35 minutes (12.5 percent reduction).
However, the RUC-recommended work RVU increased by 0.15 which is an
11.1 percent increase. Although we do not imply that the decrease in
time as reflected in survey values must always equate to a one-to-one
or linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should not be
met with significant increases to work RVUs without adequate
justification. Additionally, while we do acknowledge that adding
imaging does bundle some additional work into the code, we do not
believe that the recoding of the services in this family has resulted
in a significant increase in their intensity, only a change in the way
in which they will be reported, and through the bundling of some of
these frequently reported services, it is reasonable to expect that the
new coding system will achieve efficiencies via elimination of
duplicative assumptions of the resources involved in furnishing
particular services. We believe the new coding assigns more accurate
work times, and thus, reflects efficiencies in resource costs that
existed but were not reflected in the services as they were previously
reported. If the addition of imaging guidance had made the new CPT
codes significantly more intense to perform, we believe that this would
have been reflected in the surveyed work times, which in the case of
CPT code 64415 actually decreased from the predecessor code. Thus, we
are disinclined to ignore the impact of decreased times on the work
RVU. We believe our proposed value of 1.35 appropriately reflects both
the additional work and the decrease of time.
We considered proposing a work RVU of 1.27 for CPT code 64415,
using CPT code 64486 as a comparison code, since it has the same
intraservice and total times as the revised CPT code 64415. However,
CPT code 64486, with a work RVU of 1.27, has a lower work RVU than the
current work RVU of 64415 (1.35.) We are in general agreement with the
RUC that it is important to acknowledge that there is some additional
work that comes with adding imaging to this procedure.
For CPT code 64416, we disagreed with the RUC-recommended work RVU
of 1.80 and instead proposed a work RVU of 1.65. While we disagreed
with the RUC's recommended work RVU, we did agree with the RUC's
proposed increment of +0.30 between CPT codes 64415 and 64416. (The RUC
recommendation for CPT code 64415 was 1.50, and the recommendation for
CPT code 64416 was 1.80.) We found persuasive the RUC's observation
that the current increment between CPT codes 64415 and 64416 is
unusually small when compared to other sets of related codes in the
family. Typically, the codes that add catheter placement in addition to
the injection are 0.30-0.36 work RVUs higher than the codes for an
injection in the same nerve group or region. Retaining such a narrow
interval of 0.15 between CPT codes 64415 and 64416 would create a rank
order anomaly within the family in light of adjustments to some of the
other codes' work RVUs. Our proposed work RVU of 1.65 for CPT code
64416 is supported by a bracket of CPT codes: CPT code 64448 and CPT
code 36573. CPT code 64448 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) bilateral; by injections
(includes imaging guidance, when performed)) has a work RVU of 1.60, 15
minutes intraservice time and 40 minutes total time, and CPT code 36573
(Insertion of peripherally inserted central venous catheter (PICC),
without subcutaneous port or pump, including all imaging guidance,
image documentation, and all associated radiological supervision and
interpretation required to perform the insertion; age 5 years or older)
has a work RVU of 1.70, 15 minutes intraservice time and 40 minutes
total time.
We noted that, when compared to the current time file, the RUC-
recommended intraservice time for CPT code 64416 decreased from 20 to
15 minutes (25 percent reduction) and the RUC-recommended total time
decreased from 49 to 44 minutes (10.2 percent reduction). However, the
RUC recommended a 0.32 increase in the work RVU, which is a 21.6
percent increase. We noted that the RUC-recommended work RVU of 1.80
would give CPT code 64416 the highest work RVU of the surveyed codes,
and would make it among the highest valued codes in the family. We do
not believe the RUC-recommended work RVU appropriately accounts for the
reductions in the surveyed total time for the procedure, and did not
receive specific information explaining why, despite the decrease in
time, the value should receive such a significant increase relative to
the other surveyed codes. As stated previously, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased significantly, decreases in time should be
reflected in the revised work RVUs. As noted in our discussion of CPT
code 64415 above, if the addition of imaging guidance had made the new
CPT codes significantly more intense to perform, we believe that this
would have been reflected in the surveyed work times, which in the case
of CPT code 64416, are now actually lower. We believe our proposed work
RVU of 1.65 corrects the increment between CPT code 64415 and 64416,
while also acknowledging that, the addition of imaging notwithstanding,
the times for CPT code 64416 have noticeably decreased.
For CPT code 64445, we disagreed with the RUC-recommended work RVU
of 1.39 and instead proposed a work RVU of 1.28, based on the
intraservice time ratio calculated using the ``combined'' values for
CPT code 64445 and the imaging CPT code 76942 provided by the RUC. (The
combined work RVU the RUC offered for comparison was 1.67 (the sum of
the work RVUs for both codes: CPT code 64445 is 1.00 and CPT code 76942
is 0.67), and an estimated intraservice time of 13 minutes and total
time of 27 minutes.) This proposed value of 1.28 is supported by a
comparison to CPT code 64486 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) unilateral; by
injection(s) (includes imaging guidance, when performed)), which has a
work RVU of 1.27 and intraservice time of 10 minutes and total time of
35 minutes. The value is also supported by a low bracket of CPT code
58100 (Endometrial sampling (biopsy) with or without endocervical
sampling (biopsy), without cervical dilation, any method (separate
procedure)), with a work RVU of 1.21, identical intraservice time and
almost identical total time, and a high bracket
[[Page 69501]]
of CPT code 11982 (Removal, non-biodegradable drug delivery implant),
with a work RVU of 1.34, identical intraservice time and a higher total
time of 33 minutes.
We noted that the RUC-recommended intraservice time and total time
for CPT code 64445 are identical to the current intraservice and total
times in the time file for CPT code 64445. However, the RUC recommended
a 0.39 increase to the work RVU. We do not imply that the lack of
change to the intraservice and total times means that the work RVU
cannot be increased. We believe that since the two components of work
are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, the RUC-proposed increase in the work RVU does not seem
justified. As noted in our discussion of CPT code 64415 above, if the
addition of imaging guidance had made the new CPT codes significantly
more intense to perform, we believe that this would have been reflected
in the surveyed work times, which in the case of CPT code 64445, are
the same as the predecessor code.
We considered proposing a work RVU of 1.10 for CPT code 64445,
using CPT code 30901 (Control nasal hemorrhage, anterior, simple
(limited cautery and/or packing) any method) as a comparison code, with
a work RVU of 1.10 and identical intraservice and total times as CPT
code 64445. However, we believed this would cause a rank order anomaly
within the family. For example, CPT code 64418 (Injection(s),
anesthetic agent(s) and/or steroid; suprascapular nerve) also has a
work RVU of 1.10, but does not include imaging. Again, we generally
agree with the RUC that it is important to acknowledge the additional
work that comes with adding imaging to this procedure, and to ensure
that this additional work is reflected within the relative values of
the family, but we still proposed a work RVU of 1.28 for CPT code
64445.
For CPT code 64446, we disagreed with the RUC-recommended work RVU
of 1.75 and instead proposed a work RVU of 1.64. This recommended work
RVU is 0.36 higher than the proposed work RVU for CPT code 64445
(1.28). We noted that the current increment between the current values
of 64445 and 64446 (1.00 and 1.36, respectively) is 0.36. The RUC
recommendations for these codes (1.39 and 1.75) preserved this
increment. Since the same imaging activity is being added to both
codes, we agree with preserving the relationship between the values of
CPT codes 64445 and 64446. Our proposed work RVU of 1.64 for CPT code
64446 is supported by a bracket of CPT codes: CPT code 64448 and 36573.
CPT code 64448 (Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) bilateral; by injections (includes
imaging guidance, when performed)) has a work RVU of 1.60, 15 minutes
intraservice time and 40 minutes total time, and CPT code 36573
(Insertion of peripherally inserted central venous catheter (PICC),
without subcutaneous port or pump, including all imaging guidance,
image documentation, and all associated radiological supervision and
interpretation required to perform the insertion; age 5 years or older)
has a work RVU of 1.70, 15 minutes intraservice time and 40 minutes
total time. (We noted that this is the same bracket we suggested to
support the proposed value for CPT code 64416. As revised, the
intraservice and total times for CPT codes 64416 and 64446 are the
same.)
We noted that, compared to the time file for CPT code 64446, the
RUC-recommended intraservice time stayed the same (15 minutes) and the
total time increased from 40 to 44 minutes (10 percent increase). The
RUC-recommended work RVU for CPT code 64446, is 0.39 higher than the
current RVU, a 28.7 percent increase. We believe the RUC-recommended
work RVU increase is disproportionate to the change in time.
Additionally, we noted that the RUC-recommended times result in CPT
code 64416 and CPT code 64446 having identical intraservice and total
times. We believe it best preserves rank order within the family to
assign CPT code 64416 and CPT code 64446 similar work RVUs.
We proposed the direct PE inputs as recommended by the RUC for all
of the codes in the Somatic Nerve Injections family.
We would like to correct a typographical error. We note that in
several places in the CY 2023 proposed rule at 87 FR 45919, the number
``64488'' in CPT code 64488 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) bilateral; by injections
(includes imaging guidance, when performed) was misidentified as
``64448.''
Comment: A number of commenters expressed support of our proposed
work RVUs for CPT codes 64417, 64447, 64448, 77002 77003, and 76942.
Response: We thank the commenters for their support.
Comment: Several commenters expressed concerns about all of our
proposed values (including those that aligned with the RUC-recommended
valuations), which they did not believe reflected the combined work of
both the injection and the imaging. Commenters indicated that the
addition of imaging makes the injection procedure more efficient and
improves success rates for patients. They also noted that somatic nerve
injections are important treatments for pain management and can be an
alternative to opioid prescription.
Response: We agree with commenters that somatic nerve injections
are a valuable pain management service. However, under allowing the
codes (which were frequently being performed simultaneously) meant that
there was duplication in payments for components of the practitioner's
time, effort, and PE when performing; what was essentially a combined
procedure was being billed as though it was two standalone procedures.
We agreed with, and appreciated the CPT and RUC's decision to revise
and revalue the codes to reflect a bundling of the somatic nerve
injection and imaging procedures.
Comment: Commenters disagreed with our proposed work RVUs for CPT
codes 64415, 64416, 64445 and 64446 and urged us to accept the RUC
recommendations. Commenters disagreed with some of the codes we
selected to use as brackets or crosswalks to support our proposed
valuations on the basis that the codes we selected did not include
imaging.
Response: We disagree that some of the codes used as brackets or
crosswalks were inappropriate simply because they did not include
imaging. We continue to believe that the nature of the PFS relative
value system is such that all services are appropriately subject to
comparisons to one another. Although codes that describe clinically
similar services are sometimes stronger comparator codes, we do not
agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate code
comparison or an appropriate crosswalk.
Comment: Some commenters disagree with our use of time ratios to
calculate proposed RVUs for CPT codes 64415 and 64445, stating that
they believed the intraservice time ratio did not consider the combined
work of both the injections and the imaging described by the revised
code descriptors.
Response: We disagree that our use of time ratio calculations was
inappropriate. As stated in the proposed rule, we specifically used the
RUC's projected ``combined'' RVU and intraservice time for CPT codes
64415 and 64445 when performing our intraservice time ratio
calculations. It
[[Page 69502]]
was our understanding that the RUC provided this information to
demonstrate values reflecting the combined work of the revised codes.
Comment: Some commenters disagree with our use of increments to
support our proposed values for CPT codes 64416 and 64446.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes.
Comment: Commenters reiterated that CPT codes 64415, 64416, 64445,
and 64446 (revised to add imaging) now describe work that is more
intense than the previous codes (which described injections without the
imaging). Commenters stated that the RUC recommendations better
reflected the intensity of this new work.
Additionally, several commenters provided detailed clinical
information explaining that injections to the sciatic nerve (which are
described in CPT codes 64445 and 64446) are more intense than
injections to the femoral artery (CPT codes 64447 and 64448.) Several
commenters also provided clinical information demonstrating that
injections to the brachial plexus (which are described by CPT codes
64415 and 64416) are more intense than injections to the sciatic nerve
(which are described by CPT codes 64445 and 64446.)
Response: As explained in the proposed rule, we believed that our
proposed RVUs for CPT codes 64415, 64416, 64445, and 64446 acknowledged
the increased work of the codes while also reflecting their respective
changes in time. However, we consider clinical information associated
with physician work intensity provided by the RUC and other interested
parties as part of our review process, and we found the additional
clinical information helpful by providing greater insight into relative
intensity within this code family. We note that to determine work RVUs,
we must look at both time and intensity. We must also consider
relativity: if two codes have the same work time, but one code has a
higher intensity, relativity dictates that the higher-intensity code
gets more RVUs.
For CPT code 64445 (injection of sciatic nerve, with imaging, if
performed), we proposed a work RVU of 1.28; the code had a surveyed
intraservice time of 10 minutes. For CPT code 64447 (injection of
femoral artery, with imaging, if performed), we had proposed a work RVU
of 1.34; the code has an intraservice time of 8 minutes. In light of
the additional information that injections to the sciatic nerve are
more intense than injections to the femoral nerve (coupled with the
fact that CPT code 64445 has a longer intraservice time than CPT code
64447), we now agree that the RUC recommendation of 1.39 for CPT code
64445 better supports relativity.
For CPT code 64446 (injection of sciatic nerve with catheter
placement, with imaging, if performed), we had proposed a work RVU of
1.64; the code has 15 minutes of intraservice time. We proposed a work
RVU of 1.68 for CPT code 64448 (injection of femoral nerve with
catheter placement, with imaging, if performed); the code has an
intraservice time of 15 minutes. In light of the additional information
that sciatic nerve injections are more intense than femoral injections
(coupled with the fact that CPT codes 64446 and 64448 have the same
intraservice time), we now agree that the RUC recommendation of 1.75
for CPT code 64446 better supports relativity.
For CPT code 64415 (injection to the brachial plexus, with imaging,
if performed), we proposed a work RVU of 1.35; the code has an
intraservice time of 10 minutes. As noted above, we now agree with a
work RVU of 1.39 for CPT code 64445 (injection of sciatic nerve, with
imaging, if performed); the code also has 10 minutes of intraservice
time. In light of the additional information that brachial nerve
injections are more intense than sciatic nerve injections (coupled with
the fact that CPT codes 64415 and 64445 have the same intraservice
time), we now agree that the RUC recommendation of 1.50 for CPT code
64415 better supports relativity.
For CPT code 64416 (injection to the brachial plexus with catheter
placement, with imaging, if performed), we proposed a work RVU of 1.65;
the code has an intraservice time of 15 minutes. As noted above, we now
agree with a work RVU of 1.75 for CPT code 64446 (injection of sciatic
nerve with catheter placement, with imaging, if performed); the also
code has 15 minutes of intraservice time. In light of the additional
information that brachial nerve injections are more intense than
sciatic nerve injections (coupled with the fact that CPT codes 64416
and 64446 have the same intraservice time), we now agree that the RUC
recommendation of 1.80 for CPT code 64416 better supports relativity.
Based on the comments, we are finalizing the work RVUs for CPT
codes 64417, 64447, 64448, 77002, 77003, and 76942. and the PE inputs
for all codes, as proposed. We are finalizing the RUC recommended work
RVU of 1.50 for CPT code 64415; 1.80 for CPT code 64416; 1.39 for CPT
code 64445; and 1.75 for CPT code 64446.
(17) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714,
69716, 69717, 69719, 69726, 69727, 69729, 69730, and 69728)
In October 2020, the CPT Editorial Panel deleted two codes used for
mastoidectomy and replaced them with four new codes for magnetic
transcutaneous attachment to external speech processor. The CPT
Editorial Panel made additional revisions to differentiate
implantation, removal, and replacement of the implants. The RUC
submitted interim recommendations to CMS for six codes in this family
following the January 2021 RUC meeting, and we proposed and finalized
the recommended work RVU for all six of these codes in the CY 2022 PFS
final rule (86 FR 65099 through 65100). For CY 2023, the CPT Editorial
Panel established three additional new codes and the coding structure
of the family was changed to describe the different techniques more
appropriately for transcutaneous passive implant procedures that vary
in time and intensity depending on the indication for the procedure,
device chosen, and patient anatomy. The nine codes in the family were
surveyed again for the January 2022 RUC meeting and new recommendations
were submitted to CMS.
We proposed the RUC-recommended work RVU for six of the nine codes
in the Transcutaneous Passive Implant-Temporal Bone family. We proposed
a work RVU of 9.03 for CPT code 69716 (Implantation, osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor within the mastoid and/or resulting in removal of less
than 100 mm2 surface area of bone deep to the outer cranial cortex), a
work RVU of 9.97 for CPT code 69729 (Implantation, osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor, outside of the mastoid and resulting in removal of
greater than or equal to 100 mm2 surface area of bone deep to the outer
cranial cortex), a work RVU of 9.46 for CPT code 69719 (Revision/
replacement (including removal of existing device), osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor, within the mastoid and/or involving a bony defect
less than 100 mm2 surface area of bone
[[Page 69503]]
deep to the outer cranial cortex), a work RVU of 10.25 for CPT code
69730 (Revision/replacement (including removal of existing device),
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor, outside the mastoid and involving a bony
defect greater than or equal to 100 mm2 surface area of bone deep to
the outer cranial cortex), a work RVU of 7.38 for CPT code 69727
(Removal, entire osseointegrated implant, skull; with magnetic
transcutaneous attachment to external speech processor, within the
mastoid and/or involving a bony defect less than 100 mm2 surface area
of bone deep to the outer cranial cortex), and a work RVU of 8.50 for
CPT code 69728 (Removal, entire osseointegrated implant, skull; with
magnetic transcutaneous attachment to external speech processor,
outside the mastoid and involving a bony defect greater than or equal
to 100 mm2 surface area of bone deep to the outer cranial cortex).
We disagreed with the RUC's recommended work RVU for the other
three codes in the family for the procedures describing percutaneous
attachment to external speech processor. We disagreed with the RUC's
recommended work RVU of 8.00 for CPT code 69714 (Implantation,
osseointegrated implant, skull; with percutaneous attachment to
external speech processor) and we instead proposed a work RVU of 6.68
based on a crosswalk to CPT code 38305 (Drainage of lymph node abscess
or lymphadenitis; extensive). In reviewing CPT code 69714, we noted
that the recommended intraservice time is decreasing from 40 minutes to
30 minutes (25 percent reduction), and the recommended total time is
decreasing from 182 minutes to 146 minutes (20 percent reduction);
however, the RUC-recommended work RVU is only decreasing from 8.69 to
8.00, which is a reduction of just over 8 percent. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 69714, we
believed that it was more accurate to propose a work RVU of 6.68 based
on a crosswalk to CPT code 38305 to account for these decreases in the
surveyed work time.
We also disagreed with the recommended work RVU of 8.00 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family. At the recommended work RVU of 8.00, the
intensity of CPT code 69714 is increasing by nearly 50 percent as
compared with the survey conducted last year, and the resulting
intensity of the service would be significantly higher than any of the
other codes in the family. We did not agree that this intensity would
be typical given that the percutaneous form of implant described by CPT
code 69714 should have the lowest intensity of the three types
described in this code family. The implantation procedure described by
this code should also typically have lower intensity than the revision/
replacement procedures elsewhere in the family. We believed that the
intensity of CPT code 69714 is more accurately described at our
proposed work RVU of 6.68 based on a crosswalk to CPT code 38305. This
code shares the same intraservice time of 30 minutes as CPT code 69714
and has a higher total time of 186 minutes; we agreed that CPT code
69714 is more intense than CPT code 38305 which was offset by our
crosswalk code having an additional office visit in its global period.
We disagreed with the RUC's recommended work RVU of 8.48 for CPT
code 69717 (Revision/replacement (including removal of existing
device), osseointegrated implant, skull; with percutaneous attachment
to external speech processor) and we instead proposed a work RVU of
7.91 based on a crosswalk to CPT code 46262 (Hemorrhoidectomy, internal
and external, 2 or more columns/groups; with fistulectomy, including
fissurectomy, when performed). In reviewing CPT code 69717, we noted
that although the intraservice time remains essentially unchanged
(decreasing from 45 minutes to 44 minutes), the recommended total time
is decreasing from 187 minutes to 159 minutes (15 percent reduction).
However, the RUC-recommended work RVU was only decreasing from 8.80 to
8.48, which is a reduction of less than 4 percent. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 69717, we
believed that it was more accurate to propose a work RVU of 7.91 based
on a crosswalk to CPT code 46262 to account for these decreases in the
surveyed work time.
We also disagreed with the recommended work RVU of 8.48 because it
resulted in a higher intensity than the other two revision/replacement
codes (CPT codes 69719 and 69730) in this family. CPT code 69717
describes the percutaneous form of implant which should have the lowest
intensity of the three revision/replacement codes in this family,
however at the recommended work RVU of 8.48 it would have the highest
intensity of this group. While the intensity at the recommended work
RVU for CPT code 69717 is nowhere near the anomalous nature of the
intensity at the recommended work RVU for CPT code 69714, we still
believed that the intensity would be more typical at the proposed work
RVU of 7.91. This proposed valuation restores the relationship between
the three revision/replacement codes by placing the intensity of CPT
code 69717 slightly lower than CPT codes 69719 and 69730. Therefore, we
believed that the intensity of CPT code 69717 was more accurately
described at our proposed work RVU of 7.91 based on a crosswalk to CPT
code 46262. This code has nearly the same intraservice time of 45
minutes as CPT code 69717 and has a higher total time of 179 minutes;
we agreed that CPT code 69717 is more intense than CPT code 46262 which
was offset by our crosswalk code having an additional office visit in
its global period.
We disagreed with the RUC's recommended work RVU of 7.50 for CPT
code 69726 (Removal, entire osseointegrated implant, skull; with
percutaneous attachment to external speech processor) and we instead
proposed a work RVU of 6.36 based on a crosswalk to CPT code 67912
(Correction of lagophthalmos, with implantation of upper eyelid lid
load (e.g., gold weight)). In reviewing CPT code 69726, we noted that
the recommended intraservice time was increasing from 30 minutes to 35
minutes (17 percent increase), and the recommended total time was
increasing from 148 minutes to 150 minutes (1 percent increase);
however, the RUC-recommended work RVU was increasing from 5.93 to 7.50,
which was an increase of just over 26 percent. Although we did not
imply that the increase in time as reflected in survey values must
equate to a one-to-one or linear increase in the valuation of work
RVUs, we believed that since the two components of work are time and
intensity, modest increases in time should be appropriately reflected
in modest increases to work RVUs. In the case of CPT code 69726, we
believed that it was more accurate to propose a work RVU of 6.36 based
on a crosswalk
[[Page 69504]]
to CPT code 67912 to account for these increases in the surveyed work
time.
We also disagree with the recommended work RVU of 7.50 because it
resulted in an intensity which is anomalously high in relationship to
the rest of the code family and created a rank order anomaly within the
work RVUs. CPT code 69726 describes the percutaneous form of the
removal procedure which should have the lowest intensity of all nine
codes in this family. However, the intensity of CPT code 69726 at the
recommended work RVU of 7.50 would be the second-highest in the family,
even higher than CPT code 69730 which describes the revision/
replacement procedure with magnetic transcutaneous attachment resulting
in removal of greater than or equal to 100 square mm surface area of
bone. We did not agree that this would be typical and we believed that
the intensity would be more accurate at our proposed work RVU of 6.36.
We also noted that the recommended work RVU of 7.50 for CPT code 69726
creates a rank order anomaly within the family as it would be higher
than the recommended work RVU of 7.38 for CPT code 69727 which
describes a more complex procedure and has higher surveyed work times.
Therefore, we believed that the work and intensity of CPT code 69726
were more accurately described at our proposed work RVU of 6.36 based
on a crosswalk to CPT code 67912. This code has nearly the same
intraservice time of 40 minutes as CPT code 69726 and has a higher
total time of 166 minutes; we agreed that CPT code 69726 is more
intense than CPT code 69726 which was offset by our crosswalk code
having an additional office visit in its global period.
We proposed the direct PE inputs as recommended by the RUC for all
nine codes in the Transcutaneous Passive Implant-Temporal Bone family.
Comment: Several commenters disagreed with CMS' use of the current
work RVUs and work times when reviewing the codes in the Transcutaneous
Passive Implant-Temporal Bone family. Commenters stated that CMS was
comparing work RVUs and work times to an interim recommendation that
was made interim due to a flawed survey process. Commenters stated that
the RUC reviewed this family of services and determined that they
needed to be resurveyed with a revised Reference Service List (RSL) to
encompass a larger range of relative values, specifically to include
the lower end of the RVU spectrum. Commenters stated that CMS should
not use the interim recommendations as a base to arrive at new work
RVUs for the codes in this family.
Response: We disagree with the commenters that it was inappropriate
to use the current work RVUs and work times that were active for CY
2022 when evaluating the codes in the Transcutaneous Passive Implant-
Temporal Bone family. As we stated earlier in the Methodology for
Establishing Work RVUs portion of this section, we believe that our
operating assumption regarding the validity of the existing values as a
point of comparison is critical to the integrity of the relative value
system as currently constructed. The work times currently associated
with codes play a very important role in PFS ratesetting, both as
points of comparison in establishing work RVUs and in the allocation of
indirect PE RVUs by specialty. If we were to operate under the
assumption that previously recommended work times had been routinely
overestimated, this would undermine the relativity of the work RVUs on
the PFS in general, in light of the fact that codes are often valued
based on comparisons to other codes with similar work times. Instead,
we believe that it is crucial that the code valuation process take
place with the understanding that the existing work times that have
been used in PFS ratesetting are accurate. Even if the work RVUs and
work RVUs for the codes in the Transcutaneous Passive Implant-Temporal
Bone family were recommended to CMS on an interim basis, they were used
for payment throughout CY 2022 and are appropriately subject to
comparisons when evaluating the updated recommendations for CY 2023. We
also note that we proposed and finalized those interim work RVUs and
work times as recommended by the RUC without refinement.
Furthermore, the use of older work RVUs and older work times that
predate the interim recommendations from CY 2022 would not have changed
the analysis that we performed indicating that several of the codes in
the Transcutaneous Passive Implant-Temporal Bone family were overvalued
as recommended by the RUC. For example, CPT code 69714 previously had a
work RVU of 14.45 and an intraservice work time of 90 minutes before
its CY 2022 interim review. If we were to use these values as the basis
for our review, the recommended intraservice time would decrease from
90 minutes to 30 minutes (67 percent reduction) however, the RUC-
recommended work RVU would only decrease from 14.45 to 8.00, which is a
reduction of just under 45 percent. Regardless of whether the starting
point of comparison is the interim CY 2022 values or the historic CY
2007 values, we continue to believe that several of the codes in this
family are more accurately described using our proposed work RVUs.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 6.68 for CPT code 69714 and stated that CMS should instead
finalize the RUC-recommended work RVU of 8.00. Commenters disagreed
that the recommended intensity for CPT code 69714 was too high and
stated that the code describes an intense and complex surgery on a
highly sensitive sensory organ, operating in a small space where
millimeters of difference lead to cerebrospinal fluid leak and
intracranial vascular injury. Commenters disagreed with the CMS
crosswalk to CPT code 38305 and stated that CPT code 69714 requires
more physician work as it is a more intense service than CPT code
38305, which instead describes the less intense work of draining a
lymph node abscess. Commenters also stated that CPT code 38305 was last
reviewed 22 years ago and is not widely performed, and therefore,
should not be used as a crosswalk code.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 6.68 is a more accurate choice for CPT
code 69714. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69714
found that the typical intraservice time required to perform the
procedure had significantly decreased (from both the historic and
interim work time values) and we believe that this decrease in work
time should be reflected in a corresponding decrease in the work RVU.
Even if the decrease in work time was due to greater efficiencies in
delivering the service, this decrease in work time should be reflected
in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 38305 is an appropriate choice as a crosswalk for CPT code
69714. CPT code 38305 describes the extensive drainage of a lymph node
abscess or lymphadenitis procedure; we stated in the proposed rule that
we agreed that CPT code 69714 is more intense than CPT code 38305 which
is offset by our crosswalk code having an additional office visit in
its global period. We also emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are
[[Page 69505]]
appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
We also disagreed with the recommended work RVU of 8.00 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family. At the recommended work RVU of 8.00, the
intensity of CPT code 69714 is increasing by nearly 50 percent as
compared with the survey conducted last year (and by more than 60
percent as compared with the historic pre-interim survey intensity),
and the resulting intensity of the service would be significantly
higher than any of the other codes in the family. We do not agree that
this intensity would be typical given that the percutaneous form of
implant described by CPT code 69714 should have the lowest intensity of
the three types described in this code family. The implantation
procedure described by this code should also typically have lower
intensity than the revision/replacement procedures elsewhere in the
family. Aside from stating that CPT code 69714 describes an intense
surgery and pointing out that it had a higher intensity than CPT code
69717 at the proposed work RVU, commenters did not respond to our
analysis that the recommended work RVU of 8.00 resulted an anomalously
high intensity. As such, we continue to believe that the proposed work
RVU of 6.68 for CPT code 69714 is a more accurate choice than the RUC-
recommended work RVU of 8.00.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 7.91 for CPT code 69717 and stated that CMS should instead
finalize the RUC-recommended work RVU of 8.48. Commenters stated that
for the procedures described by CPT code 69717, the practitioner must
work with a variety of delicate structures in a very small space just
behind the ear which makes these procedures very intense and complex to
perform. Commenters stated that the work per unit time as recommended
by the RUC for CPT code 69717 was already lower than CPT codes 69719
and 69730. Commenters disagreed with the CMS crosswalk to CPT code
46262 and stated that CPT code 69717 requires more physician work than
CPT code 46262. Commenters also stated that CPT code 46262 was last
reviewed 22 years ago and is not widely performed, and therefore,
should not be used as a crosswalk code.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 7.91 is a more accurate choice for CPT
code 69717. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69717
found that the typical intraservice time required to perform the
procedure had significantly decreased (from both the historic and
interim work time values) and we believe that this decrease in work
time should be reflected in a corresponding decrease in the work RVU.
Even if the decrease in work time was due to greater efficiencies in
delivering the service, this decrease in work time should be reflected
in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 46262 is an appropriate choice as a crosswalk for CPT code
69717. CPT code 46262 describes a hemorrhoidectomy with fistulectomy
which requires a similar level of risk and complexity to the patient;
we stated in the proposed rule that we agreed that CPT code 69717 is
more intense than CPT code 46262 which is offset by our crosswalk code
having an additional office visit in its global period. We also
emphasize that we continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes that describe
clinically similar services are sometimes stronger comparator codes, we
do not agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate crosswalk.
We also disagreed with the recommended work RVU of 8.48 because it
results in a higher intensity than the other two revision/replacement
codes (CPT codes 69719 and 69730) in this family. CPT code 69717
describes the percutaneous form of implant which should have the lowest
intensity of the three revision/replacement codes in this family,
however at the recommended work RVU of 8.48 it would have the highest
intensity of this group. While the intensity at the recommended work
RVU for CPT code 69717 is nowhere near the anomalous nature of the
intensity at the recommended work RVU for CPT code 69714, we still
believe that the intensity would be more typical at the proposed work
RVU of 7.91. Commenters stated that the work per unit time as
recommended by the RUC for CPT code 69717 was already lower than CPT
codes 69719 and 69730 but otherwise did not respond to our discussion
of the intensity of the code and how it related to the other revision/
replacement codes in this family. As such, we continue to believe that
the proposed work RVU of 7.91 for CPT code 69717 is a more accurate
choice than the RUC-recommended work RVU of 8.48.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 6.36 for CPT code 69726 and stated that CMS should instead
finalize the RUC-recommended work RVU of 7.50. Commenters stated that
for CPT code 69726, the practitioner must work with a variety of
delicate structures in a very small space just behind the ear which
makes these procedures very intense and complex to perform. Commenters
disagreed with the CMS crosswalk to CPT code 67912 and stated that CMS
should not apply this crosswalk because CPT code 67912 is an
infrequently performed service that has not been reviewed by the RUC or
CMS in 20 years, has disparate times from the survey code, and
typically involves less physician work.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 6.36 is a more accurate choice for CPT
code 69726. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69726
found that the typical intraservice time required to perform the
procedure had significantly decreased and we believe that this decrease
in work time should be reflected in a corresponding decrease in the
work RVU. Even if the decrease in work time was due to greater
efficiencies in delivering the service, this decrease in work time
should be reflected in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 67912 is an appropriate choice as a crosswalk for CPT code
69726. CPT code 67912 describes a correction of lagophthalmos, with
implantation of upper eyelid lid load; we acknowledged in the proposed
rule that the work times were not an exact match with CPT code 69726
but closely matched the intraservice and total times. We also stated in
the proposed rule that we agreed that CPT code 69726 is more intense
than CPT code 69726 which is offset by our crosswalk code having an
additional office visit in its global period. We also emphasize that we
[[Page 69506]]
continue to believe that the nature of the PFS relative value system is
such that all services are appropriately subject to comparisons to one
another. Although codes that describe clinically similar services are
sometimes stronger comparator codes, we do not agree that codes must
share the same site of service, patient population, or utilization
level to serve as an appropriate crosswalk.
We also disagreed with the recommended work RVU of 7.50 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family and creates a rank order anomaly within the
work RVUs. CPT code 69726 describes the percutaneous form of the
removal procedure which should have the lowest intensity of all nine
codes in this family. However, the intensity of CPT code 69726 at the
recommended work RVU of 7.50 would be the second-highest in the family,
even higher than CPT code 69730 which describes the revision/
replacement procedure with magnetic transcutaneous attachment resulting
in removal of greater than or equal to 100 square mm surface area of
bone. We did not agree that this would be typical and we believe that
the intensity would be more accurate at our proposed work RVU of 6.36.
We also noted in the proposed rule that the recommended work RVU of
7.50 for CPT code 69726 created a rank order anomaly within the family
as it would be higher than the recommended work RVU of 7.38 for CPT
code 69727 which describes a more complex procedure and has higher
surveyed work times. Commenters did not respond to our discussion of
the anomalously high intensity of CPT code 69727 at the recommended
work RVU or explain why it should create a rank order anomaly within
the family. As such, we continue to believe that the proposed work RVU
of 6.36 for CPT code 69726 is a more accurate choice than the RUC-
recommended work RVU of 7.50.
After consideration of the comments, we are finalizing the work
RVUs for all nine codes in the Transcutaneous Passive Implant-Temporal
Bone family as proposed. We did not receive any comments on the direct
PE inputs and we are also finalizing them as proposed.
(18) Contrast X-Ray of Knee Joint (CPT Code 73580)
CPT code 73580 (Radiologic examination, knee, arthrography,
radiological supervision and interpretation) was first identified via
the high-volume growth screen in 2008. In 2021, the Relativity
Assessment Workgroup (RAW) noted that code 73580 was never surveyed and
remains CMS/Other sourced, and recommended that it be surveyed. CPT
code 73580 was then surveyed. We proposed the RUC-recommended work RVU
of 0.59. We also proposed the RUC-recommended direct PE inputs without
refinement.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed the RUC-recommended work RVU of 0.59 for
CPT code 73580. We are finalizing as proposed the RUC-recommended
direct PE inputs without refinement.
(19) 3D Rendering With Interpretation and Report (CPT Code 76377)
We nominated this code in the CY 2020 PFS final rule as potentially
misvalued, stating that we believe it is of the same family as CPT code
76376 (3D rendering with interpretation and reporting of computed
tomography, magnetic resonance imaging, ultrasound, or other
tomographic modality with image postprocessing under concurrent
supervision; not requiring image postprocessing on an independent
workstation), which was reviewed at the April 2018 RUC meeting. CMS
requested that CPT code 76377 also be reviewed to maintain relativity
within the code family (84 FR 62625). The specialty societies maintain
that these services are more accurately viewed as separate code
families. Furthermore, the RUC cites changes in technique and patient
population as compelling evidence to maintain a physician work RVU of
0.79 despite a 5-minute recommended reduction in physician total time
compared to the current physician time.
We proposed the RUC recommended work RVU of 0.79 for CPT code
76377; however, we reiterate that we continue to believe that CPT code
76376 and 76377 would be more appropriately viewed as belonging to the
same code family and we request that they be surveyed together.
We proposed the RUC-recommended direct PE inputs without
refinement.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed the RUC-recommended work RVU of 0.79 for
CPT code 76377. We are finalizing as proposed the RUC-recommended
direct PE inputs without refinement.
(20) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
Since their creation in 2011, CPT codes 76881 (Ultrasound, complete
joint (i.e., joint space and peri-articular soft-tissue structures),
real-time with image documentation) and 76882 (Ultrasound, limited,
joint or other nonvascular extremity structure(s) (e.g., joint space,
peri-articular tendon[s], muscle[s], nerve[s], other soft-tissue
structure[s], or soft-tissue mass[es]), real-time with image
documentation) have been reviewed numerous times as New Technology/New
Services by the Relativity Assessment Workgroup (RAW). In October 2016,
the RAW reviewed these codes and agreed with the specialty societies
that the dominant specialties providing the complete (CPT code 76881)
versus the limited (CPT code 76882) ultrasound of extremity services
were different than originally thought, causing variation in the
typical PE inputs. The RAW recommended referral to the Practice Expense
Subcommittee for review of the direct PE inputs and the CPT Editorial
Panel to clarify the introductory language regarding the reference to
one joint in the complete ultrasound. The PE Subcommittee reviewed the
direct PE inputs for CPT codes 76881 and 76882 and adjusted the
clinical staff time at the January 2017 RUC meeting, and the CPT
Editorial Panel editorially revised CPT codes 76881 and 76882 to
clarify the distinction between complete and limited studies and
revised the introductory guidelines to clarify reference to one joint
in the complete ultrasound procedure in June 2017. In October 2021, the
CPT Editorial Panel approved the addition of CPT code 76883 for
reporting real-time, complete neuromuscular ultrasound of nerves and
accompanying structures throughout their anatomic course, per
extremity, and the revision of CPT code 76882 to add focal evaluation.
CPT codes 76881 and 76882 were identified as part of the neuromuscular
ultrasound code family with CPT code 76883 and surveyed for the January
2022 RUC meeting.
For CPT codes 76881, 76882, and 76883, we disagreed with the RUC-
recommended work RVUs of 0.90, 0.69, and 1.21, respectively, as we
believed they did not account for the surveyed time changes or
appropriate comparisons for the new add-on code, CPT code 76883, and
proposed a work RVU of 0.54 for CPT code 76881, a work RVU of 0.59 for
CPT code 76882, and a work RVU of 0.99 for CPT code 76883.
CPT code 76881 represents a complete evaluation of a specific joint
in an extremity. This service requires ultrasound examination of all
the following joint elements: joint space (for example, effusion),
peri-articular soft-tissue structures that surround the joint (that is,
muscles, tendons, other soft-tissue structures), and any identifiable
abnormality. In some circumstances, additional evaluations such as
dynamic imaging or stress maneuvers may be
[[Page 69507]]
performed as part of the complete evaluation. The RUC recommended 5
minutes of pre-service time, 20 minutes of intraservice time, and 5
minutes of post-service time, based on the survey. The RUC discussed
the 5-minute increase in intraservice time and determined that the
increase relates to the change in the dominant specialty provider since
the creation of the code, as previously there was 15 minutes of
intraservice time for the radiologist to scan and/or review the
sonographer-obtained images. Now, the rheumatologist is performing the
scanning and it takes 20 minutes for the typical patient. For
rheumatology, physicians typically scan the patients with portable
ultrasound devices rather than utilizing sonographers as originally
described in the 2010 survey. The RUC noted that this code is reported
with an office E/M visit 58.9 percent and a non-facility office E/M
visit 66.3 percent of the time; the RUC stated that CPT code 76881 is
imaging-specific so the physician work described would not overlap with
the E/M service, but we disagreed, as the descriptions of pre-service
and post-service work directly overlap. The description of pre-service
work for CPT code 76881 states ``Review pertinent clinical information.
Review any prior applicable imaging studies.'' Pre-service work for CPT
code 99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter.), the most common E/M
code reported with CPT code 76811, includes ``Review interval
correspondence, referral notes, medical records, and diagnostic data
generated since the last visit.'' Post-service work of CPT code 76881
is described as ``Discuss significant findings with the referring
physician. Review and sign final report,'' whereas the post-service
work for CPT code 99214 includes ``Arrange diagnostic testing and
referral if necessary. Document the encounter in the medical record,
spending time to further refine the differential diagnosis, workup, or
treatment plan as necessary. Coordinate care by discussing the case
with other physicians and members of the health care team and write
letters of referral if necessary. Perform electronic data capture and
reporting to comply with quality payment program and other electronic
mandates. Review and analyze interval testing results and refine the
differential diagnosis, workup, and treatment plan based on these
results. Order additional testing based on these results. Communicate
results and plan modifications with patient and/or family.'' We
believed there was overlap in pre-service and post-service work between
the E/M visit and CPT code 76881, and therefore, we proposed 0 minutes
for the pre-service and post-service time rather than the RUC-
recommended 5 minutes of pre-service and post-service time. The
proposed work RVU of 0.54 was the reverse building block valuation
based on the removal of the 5 minutes of pre-service and post-service
time, with a long-standing intensity of 0.0224 (10 minutes * 0.0224
work/minute = 0.224 work RVUs). The proposed work RVU accounted for the
0.224 work RVU decrease as a result of the removal of pre-service and
post-service time, and the increase of 5 minutes of intraservice time,
while maintaining the same IWPUT of 0.027, as there was no discussed
change in intensity. The specialty societies and the RUC asserted that
there was an increase of 5 minutes as a result of the intraservice work
changing due to a change in dominant specialty providing the service
(from radiology to rheumatology), but did not present a change in
intensity. We noted that the specialty societies used CPT code 76700
(Ultrasound, abdominal, real time with image documentation; complete)
with a work RVU = 0.81, 11 minutes of intra-service time, and 21
minutes total time, as a reference code because it has identical pre-
and post-service time but less intra-service time than the surveyed
code and is a clinically similar ultrasound code. We noted that this is
not an appropriate reference code as it is billed alone 72.8 percent of
the time, and therefore, the valuation of CPT code 76700 accounts for
pre- and post-service work that would not overlap with an E/M visit
like we believed the pre- and post-service work did for CPT code 76881.
CPT code 76882 represents a limited evaluation of a joint or focal
evaluation of a structure(s) in an extremity other than a joint (for
example, soft-tissue mass, fluid collection, or nerve[s]). This
evaluation includes assessment of a specific anatomic structure(s) (for
example, joint space only [effusion] or tendon, muscle, and/or other
soft-tissue structure[s] that surround the joint) that does not assess
all the elements included in CPT code 76881, although it does include
all surrounding anatomy and any associated pathology or contralateral
comparison as indicated. The RUC discussed the four-minute increase in
intraservice time and determined that the increase relates to the
change in dominant supplier of this service since the creation of the
code, as there is currently 11 minutes of intraservice time that
included scanning performed only by the podiatrist, and now the
radiologist works with the sonographer to obtain and interpret the
images in addition to the physician performing additional scanning as
needed. Because radiologists no longer use portable ultrasound devices
as originally described in the 2010 survey or in the 2017 PE update,
the RUC and specialty societies assert that the physician work (time)
has changed due to supervision of the sonographer in addition to the
radiologist performing the scanning. The specialty societies and RUC
also noted that ultrasound technology has evolved immensely since 2010,
including proliferation of high-frequency ultrasound probes dedicated
to musculoskeletal imaging, as well as producing images with higher
fidelity and more detail, whereby the number and quality of images that
can be reviewed and the pathology to evaluate have greatly increased
since 2010. Therefore, the typical patient requires 15 minutes of
intraservice time. While we agreed with the RUC that 15 minutes of
intraservice time is warranted for CPT code 76882, we noted that there
was no information indicating a change in intensity, and therefore, for
CPT code 76882, we proposed the reverse building block work RVU of 0.59
to account for the 4-minute increase in intraservice time and the
maintenance of the current IWPUT of 0.024.
We noted that commenters may raise concern about a potential rank
order anomaly with the proposed work RVUs of 0.54 and 0.59 for CPT
codes 76881 and 76882, respectively, but we noted that the IWPUT of
each code adequately reflects the increased intensity of intraservice
work for the complete ultrasound (CPT code 76881; IWPUT = 0.027) versus
the limited/focal ultrasound (CPT code 76882; IWPUT = 0.024), and the
lesser work RVU of 0.54 for CPT code 76881 stemmed from the removal of
the presumed overlapping pre- and post-service time with the E/M visits
that are typically performed. The RUC noted that consistency of
intensity measures is demonstrated across the range of codes ascending
from the limited code (CPT code 76881) to the new, most complex code
(CPT code 76883). By proposing work RVUs that maintain the current
IWPUTs, we maintained relativity both among the neuromuscular
ultrasound family, as well as the larger family of ultrasound
[[Page 69508]]
imaging codes. We also noted that the difference between the RUC-
recommend IWPUTs and our proposed IWPUTs for CPT codes 76881 and 76882
was the same, where CPT code 76882 had an IWPUT that is 0.003 less than
the IWPUT of CPT code 76881.
CPT code 76883 will be available for CY 2023 to report real-time,
complete neuromuscular ultrasound of nerves and accompanying structures
throughout their anatomic course, per extremity. This code will entail
examination of a nerve throughout its length, within one extremity,
including evaluation of multiple areas for potential nerve compression,
measurement of cross-sectional areas, evaluation of echogenicity,
vascularity, mobility including dynamic maneuvers when indicated,
evaluation for any associated muscular denervation, with comparison to
unaffected muscles or nerves within that extremity as needed. CPT code
76883 also requires permanently recorded images and cine loop and a
written report containing a description of each of the elements
evaluated. The RUC recommended 7 minutes of pre-service time, 25
minutes of intra-service time and 7 minutes of post-service time as
supported by the survey. The RUC clarified that this service would not
typically be reported with an office E/M visit. The RUC arrived at a
recommended work RVU of 1.21 by comparing the pre-, intra-, and post-
service times to those of CPT code 76881, which we proposed to modify
due to presumed overlapping work in the pre- and post-service time with
E/M visits. When we compared the proposed times of 0 minutes of pre-
service time, 20 minutes of intraservice time, and 0 minutes of post-
service time, and a work RVU of 0.54 for CPT code 76881, and the
proposed times of 7 minutes of pre-service time, 25 minutes of
intraservice time, and 7 minutes of post-service time for CPT code
76883, we arrived at a reverse building block work RVU of 0.99.
For the direct PE inputs, we proposed to remove the 2 minutes of
clinical labor time for CA006 (Confirm availability of prior images/
studies), the 1 minute of clinical labor time for the CA007 (Review
patient clinical extant information and questionnaire), and the 2
minutes for CA011 (Provide education/obtain consent) for CPT code 76881
because these RUC recommendations describe clinical labor activities
that presumably overlapped with the E/M visit that is typically billed
with CPT code 76881. We proposed the direct PE inputs as recommended by
the RUC for CPT codes 76882 and 76883.
We received several comments regarding our proposed work RVUs, pre-
and post-service time, and direct PE input refinements for CPT codes
76881, 76882, and 76883 in response to the CY 2023 PFS proposed rule
and those comments are summarized below.
Comment: Some commenters stated that the pre- and post-service work
of CPT code 76881 should not be removed simply because it may be billed
in conjunction with an E/M code. One commenter stated that if a
rheumatologist decides to order the more expensive MRI instead of
performing an ultrasound, the pre- and post- ordering time is quick,
whereas, for musculoskeletal ultrasound (MSKU), the pre-service time
includes detailed review of other studies and discussion with the
patient that are not normally included as part of the E/M visit. The
post-service work includes labelling, storing, documenting the results.
The commenter stated that none of this would be part of the normal E/M
coding for a visit. Another commenter stated that the physician work
associated with an E/M visit is separate and distinct from the
physician work associated with the imaging services reported by CPT
code 76882. Furthermore, the commenter asserted that the E/M visit and
ultrasound require different cognitive and technical skills by the
rendering physician. When these services are performed in the same
encounter, the physician work is neither overlapping nor duplicative,
and should be separately accounted for.
Response: After review of the commenters' statements, CPT code
76881's pre- and post-service descriptions, and similar imaging codes
that are typically reported with an E/M visit which allow for pre- and
post-service time, we agree with the commenters' assertion that the 5
minutes of pre- and post-service time is appropriate for CPT code
76881. We also agree that, while the service descriptions of the E/M
visit and CPT code 76881 may match, CPT code 76881's activities likely
reflect image-specific activities that do not overlap with the E/M
visit's activities; therefore, we are finalizing physician work time as
the RUC recommended, with 5 minutes of pre-service evaluation time and
5 minutes of immediate post-service time.
Comment: Some commenters stated that these CPT codes are typically
furnished by rheumatologists with the following direct PE inputs: (1)
expensive, high quality, high frequency ultrasound machines with power
Doppler capability rather than an inexpensive, handheld/portable device
as included in the direct PE inputs; (2) a sonographer specially
trained in MSKU rather than a physician or a standard x-ray technician
as included in the direct PE inputs; and (3) a dedicated exam/imaging
room in which to perform this service. One commenter submitted
responses and synthesized conclusions from a limited survey of direct
PE inputs typical of rheumatologists. More commenters noted that the
RUC decided to reduce the PE portion of the technical component of CPT
code 76881 by over 90 percent, phased in over time. The commenters
continued by stating that there is another proposed decrease to 0.27 PE
RVUs for CY 2023 based on a flawed assumption regarding the type of
ultrasound services provided in the non-facility setting. The
commenters stated that many clinics maintain and use a dedicated
ultrasound room, a non-portable ultrasound room and a PACS system, as
well as two dedicated sonographers. The commenters stated that even
practices that use portable ultrasound units will utilize a dedicated
ultrasound room and PACS system, and employ, or contract the services
of, a sonographer or other highly trained, typically highly
credentialed, clinical staff. One commenter stated that the January
2022 RUC recommendations indicate rheumatology as the dominant
specialty in the non-facility setting, but they incorrectly assumed
that portable ultrasound is the typical equipment used by
rheumatologists. This commenter stated that, of the 88 providers who
submitted surveys for CPT code 76881 or the 100 providers that
submitted surveys for CPT code 76882, no information was provided
regarding the level of rheumatologists' input, and therefore, the
commenter asserted that there is no way of knowing if rheumatologists
were appropriately queried, despite the acknowledgement that they are
the dominant specialty for CPT code 76881. This commenter submitted an
attachment that claims that the dedicated medical sonographer's labor
cost per hour is $47.50 and that they spent $80,017.24 on ultrasound
technology and $3,003.00 in maintenance of the ultrasound technology
per year. Another commenter stated that rheumatology was not part of
the PE survey in 2017 and none of the RUC members who sat on the PE
subcommittee in 2017 performed MSKU in their offices at the time of the
survey. The commenter stated that we stated that the ``transition
period [to phase in the cuts year over year as finalized for CY 2018]
would allow us to obtain more stakeholder input on the appropriate PE
inputs and specialty assumptions for these
[[Page 69509]]
services,'' and that we expected to consider this for future
rulemaking. The commenter noted that their comments on the CY 2019 PFS
proposed rule were deemed out of scope and that no further action was
taken to obtain PE values.
Response: We appreciate the commenters' survey collection efforts
to reflect rheumatologists' costs in performing CPT codes 76881, 76882,
and 76883, and the concern regarding the accounting of rheumatologists'
typical clinal labor and equipment in the January 2022 RUC
recommendations. We share the commenters concerns that the recommended
PE inputs may not fit within the family of services as currently valued
given concerns raised by commenters. In consideration of commenters'
concerns and survey data, including early feedback on how the PE inputs
for these services may not be reflective of what will be considered
typical in how these services may be furnished, we encourage the RUC
and other interested parties to reconsider the PE inputs of the
neuromuscular ultrasound family, including the new code, in the near
term.
We note that we did not make any proposals related to CPT codes
76881 or 76882 in the CY 2019 PFS proposed rule, therefore the comments
were appropriately deemed out of scope at that time, and at that time,
rheumatology was not the dominant specialty, therefore, we would have
considered PE inputs of the dominant specialty to be typical when
performing these CPT codes at that time. We encourage the commenters to
coordinate with the RUC to provide the survey data to facilitate a
reconsideration of PE inputs given the shift in dominant specialty and
recent changes that were made by the RUC PE Subcommittee.
Because the RUC has standardized procedures for PE and physician
surveys, and the fact that the surveyors' results differ so drastically
from the RUC recommendations, we encourage the RUC and other interested
parties to reconsider the PE inputs of the neuromuscular ultrasound
family, which we would consider in future rulemaking if submitted.
While the submission of the survey data is appreciated, we note that no
invoices were submitted, and therefore, we encourage collaboration with
the RUC PE subcommittee and the submission of specific invoices to
support the surveys' results and robust data to show the typicality of
these PE inputs.
Comment: One commenter asserted that they utilize a dedicated
diagnostic medical sonographer with specific musculoskeletal training,
high quality machines that cost around $40 thousand each (based on a
recent purchase of a GE LOGIQTM E ultrasound machine for a
Veteran Affairs Hospital that cost $44,110 after a government
discount), and a dedicated ultrasound scanning room due to patient
draping requirements and machine optimization.
Response: We appreciate the commenters' input regarding CPT codes
76881, 76882, and 76883. We encourage the RUC and other interested
parties to reconsider the PE inputs of the neuromuscular ultrasound
family, as they differ significantly from the RUC recommended direct PE
inputs as submitted for the CY 2023 PFS proposed rule. After a
reconsideration by the RUC and interested parties regarding the PE
inputs, we would be interested in engaging with interested parties to
obtain invoices to support accurate pricing for PE inputs that may be
altered for this family of codes.
Comment: Many commenters urged CMS to pause all proposed reductions
to CPT codes 76881 and 76882 to allow collaboration between the RUC and
interested parties' on how rheumatologists currently utilize or plan to
utilize MSKU since the rheumatology community has never been surveyed
by the RUC on their typical PE investments in their ultrasound
programs. Commenters stated that rheumatologists were not included in
the 2017 survey when PE cuts were recommended by the RUC and finalized
for CY 2018.
Response: We believe it is imperative that the RUC and interested
parties reconsider the PE inputs for CPT codes 76881, 76882, and 76883
in the near term, as commenters have submitted survey responses that
differ significantly from the RUC recommended direct PE inputs. There
are also significant discrepancies between the RUC assumption that
rheumatologists typically scan patients themselves, versus varying
commenters agreeing with this assumption, and some arguing that
rheumatologists utilize a highly trained sonographer to scan patients.
There are also significant commenter and RUC discrepancies regarding
typical equipment used for these CPT codes. We note that in the CY 2018
PFS final rule (82 FR 53058 through 53059), we sought comment on
whether a portable ultrasound unit would be a more accurate PE input
for CPT codes 76881 and 76882, given that the dominant specialty for
both of these services was podiatry based on available 2016 Medicare
claims data. At that time, we did not finalize our proposal to include
an ultrasound room, and instead finalized the RUC recommended
equipment, with the exception of the ultrasound room, which we replaced
with a portable ultrasound unit based on the RUC's determination, as
expressed through its recommendations for CY 2018, that a portable unit
is the equipment type that is typical for podiatry, which was the
dominant specialty furnishing CPT code 76882 at the time. Commenters
disagreed with our proposals and RUC recommendations, stating that the
shift of PE from CPT code 76881 to CPT code 76882 was based on
inaccurate assumptions regarding the typical equipment used in
furnishing these services. These commenters noted that the equipment
used to furnish the two procedures is identical and that the RUC-
recommended direct PE inputs for CPT code 76881, which were developed
based on the assumption that the dominant specialty furnishing the
service is podiatry, do not reflect the equipment inputs utilized by
rheumatologists such as an ultrasound room and PACS workstation. Given
the changes in dominant specialty for these CPT codes from 2010 to
2017, and again from 2017 to 2022, we recommend that the RUC and
interested parties reconsider the PE inputs for each code based on the
dominant specialty for each CPT code, based on the most recent year's
Medicare claims data, and consideration of survey responses submitted
to CMS in response to the CY 2023 PFS proposed rule.
Comment: Many commenters expressed the importance of MSKU in
controlling the prescribing of expensive biologic medications,
streamlining patient care, reducing delays in patient care that result
from scheduling alternative imaging tests (not on the initial
encounter) and subsequent follow up visits to act on the tests results,
and obtaining sensitive, safe non-traumatic images for pediatric
patients. Commenters stated that MSKU benefits patients and families by
allowing them to see their anatomy in real time, which aids the
patients' confidence in their physician and diagnosis. Commenters also
stated that MSKU aids minorities and underserved areas where access to
MSKU extends the ability to care for patients who may otherwise not be
able to travel for MRI or CT services due to cost or additional time
required to schedule and attend subsequent visits for the imaging and
follow up, which can extend the time to initiate treatment by months.
Response: We appreciate the commenters' input on the value of CPT
codes 76881, 76882, and 76883, and agree with the commenters that these
services play an integral part in high
[[Page 69510]]
quality, cost effective, expedient imaging, diagnosis, and care for a
variety of patient populations. For this reason, we believe it is
imperative that the RUC and interested parties reconsider the PE inputs
for CPT codes 76881, 76882, and 76883 in the near term.
In order to maintain relativity among this family of codes after
being compelled by the commenters' assertion that the pre- and post-
service time for CPT code 76881 does not overlap with an E/M visit, and
finalizing the RUC-recommended work RVU and PE inputs for CPT code
76881, we are also finalizing the RUC recommended work RVUs and PE
inputs for CPT codes 76882 and 76883. Therefore, for CPT codes 76881,
76882, and 76883, we are finalizing work RVUs of 0.90, 0.69, and 1.21,
respectively. As mentioned above, we are finalizing 5 minutes of pre-
service evaluation time and 5 minutes of immediate post-service time
for CPT code 76881. Similarly, we are finalizing the inclusion of 2
minutes of clinical labor time for CA006 (Confirm availability of prior
images/studies), 1 minute of clinical labor time for the CA007 (Review
patient clinical extant information and questionnaire), and 2 minutes
for CA011 (Provide education/obtain consent) for CPT code 76881 for the
direct PE inputs, as recommended by the RUC, because we are compelled
by the commenters' assertion that these activities are imaging-specific
and do not overlap with an E/M visit. We are finalizing the direct PE
inputs as recommended by the RUC for CPT codes 76882 and 76883, as
proposed. We reiterate our recommendation that the RUC and interested
parties reconsider the PE inputs in the near term. We also remind
interested parties that we have established an annual process for the
public nomination of potentially misvalued codes. This process provides
an annual means for those who believe that values for individual
services are inaccurate and should be readdressed through notice and
comment rulemaking to bring those codes to our attention, as detailed
in section II.C. of this final rule. 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. While this process is
available to interested parties, we encourage the RUC and other
interested parties to reconsider the PE inputs of the neuromuscular
ultrasound family as a whole, including the new code, in the near term,
as we have already reviewed comments for this final rule and survey
data that may indicate that the PE inputs for these services may not be
reflective of what will be considered typical in how these services may
be furnished.
(21) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472,
90473, and 90474)
Especially in the context of the current PHE for COVID-19, it is
evident that consistent beneficiary access to vaccinations is vital to
public health. As discussed in the CY 2021 PFS proposed rule (85 CFR
50162), many interested parties raised concerns about the reductions in
payment rates for the preventive vaccine administration services that
had occurred over the past several years. The codes for immunization
administration services include CPT codes 90460, 90471, and 90473, as
well as the three Healthcare Common Procedural Coding System (HCPCS)
codes that describe the services to administer the Part B preventive
vaccinations other than the COVID-19 vaccine: G0008 (influenza), G0009
(pneumococcal), and G0010 (HBV). Until CY 2019, we generally had
established payment rates for these immunization administration
services based on a direct crosswalk to the PFS payment rate for CPT
code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular). Because we proposed
and finalized reductions in valuation for the crosswalk code for CY
2018, and because the reductions in overall valuation for that code
have been subject to the multi-year phase-in of significant reductions
in RVUs, the payment rate for these vaccine administration codes has
been concurrently reduced. Further, because the reduction in RVUs for
the crosswalk code, CPT code 96372, was significant enough to be
required to be phased in over several years under section 1848(c)(7) of
the Act, the reductions in overall valuation for the vaccine
administration codes were likewise subject to reductions over several
years. As we noted in Table 21 of the CY 2022 PFS proposed rule (86 FR
39222), the national payment rate for administering these preventive
vaccines has declined more than 30 percent since 2015.
We have attempted to address the reduction in payment rates for the
Part B preventive vaccine administration HCPCS G-codes in the last
three PFS rulemaking cycles. In the CY 2020 PFS final rule, we
acknowledged that it is in the public interest to ensure appropriate
resource costs are reflected in the valuation of the immunization
administration services that are used to deliver these vaccines, and
noted that we planned to review the valuations for these services in
future rulemaking. For CY 2020, we maintained the CY 2019 national
payment amount for immunization administration services described by
HCPCS codes G0008, G0009 and G0010 (84 FR 62798).
In the CY 2021 PFS proposed rule, we proposed to crosswalk CPT
codes 90460, 90471, and 90473, as well as HCPCS codes G0008, G0009 and
G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein)
(85 FR 50163). In the proposed rule, we noted that CPT code 36000 is a
service with a similar clinical vignette, and that the additional
clinical labor, supply, and equipment resources associated with
furnishing CPT code 36000 were similar to costs associated with these
vaccine administration codes. We also noted that this crosswalk would
have resulted in a payment rate for vaccine administration services
that is approximately the same as the CY 2017 rate that was in place
prior to the revaluation of CPT code 96372 (the original crosswalk
code). In the CY 2021 PFS final rule, we did not finalize the proposed
policy, and instead finalized a policy to maintain the CY 2019 payment
amount for CPT codes 90460-90474, as well as HCPCS codes G0008, G0009
and G0010 (85 FR 84628). In the final rule, we also noted that we
continued to seek additional information that specifically identifies
the resource costs and inputs that should be considered to establish
payment for vaccine administration services on a long-term basis.
For the CY 2022 rulemaking cycle, we requested feedback from
interested parties that would support the development of an accurate
and stable payment rate for administration of the preventive vaccines
described in section 1861(s)(10) of the Act (influenza, pneumococcal,
HBV, and COVID-19) for physicians, NPPs, mass immunizers and certain
other providers and suppliers. We invited commenters to submit their
detailed feedback to a series of questions and requests that we
believed would assist us in establishing payment rates for these
services that could be appropriate for use on a long-term basis; we
direct readers to the full discussion of this topic in the CY 2022 PFS
final rule (86 FR 65179 through 65193). For CY 2022, we finalized a
uniform payment rate of $30 for the administration of an influenza,
pneumococcal or HBV vaccine covered under the Medicare Part B
preventive vaccine benefit at section 1861(s)(10) of the Act. We
explained that since the
[[Page 69511]]
administration of the preventive vaccines described under section
1861(s)(10) of the Act is not included within the statutory definition
of physicians' services, the payment rates we established for these
services in the CY 2022 PFS final rule are independent of the PFS, and
will be updated as necessary independently of the valuation of any
specific codes under the PFS (86 FR 65186). We discuss the current
payment policy for administration of preventive vaccines and our
proposals for CY 2023 in section II.H. of this final rule.
We note that as we considered payment policies to ensure adequate
access to the Part B preventive vaccines, including consideration of
resource costs, the RUC surveyed and reviewed CPT codes 90460-90474 at
the April 2021 meeting and submitted recommendations to CMS for our
consideration in the CY 2023 rulemaking cycle.
We proposed the RUC-recommended work RVU for all six codes in the
Immunization Administration family. We proposed a work RVU of 0.24 for
CPT code 90460 (Immunization administration through 18 years of age via
any route of administration, with counseling by physician or other
qualified health care professional; first or only component of each
vaccine or toxoid administered), a work RVU of 0.18 for CPT code 90461
(Immunization administration through 18 years of age via any route of
administration, with counseling by physician or other qualified health
care professional; each additional vaccine or toxoid component
administered), a work RVU of 0.17 for CPT code 90471 (Immunization
administration (includes percutaneous, intradermal, subcutaneous, or
intramuscular injections); 1 vaccine (single or combination vaccine/
toxoid)), a work RVU of 0.15 for CPT code 90472 (Immunization
administration (includes percutaneous, intradermal, subcutaneous, or
intramuscular injections); each additional vaccine (single or
combination vaccine/toxoid)), a work RVU of 0.17 for CPT code 90473
(Immunization administration by intranasal or oral route; 1 vaccine
(single or combination vaccine/toxoid)), and a work RVU of 0.15 for CPT
code 90474 (Immunization administration by intranasal or oral route;
each additional vaccine (single or combination vaccine/toxoid)).
For the direct PE inputs, we proposed to remove 1 minute of
clinical labor time for the CA008 (Perform regulatory mandated quality
assurance activity (pre-service)) activity for CPT codes 90460 and
90471-90474. The RUC recommendations describe these activities as
``Checking historical and current temperatures for vaccine
refrigerator; recording temperatures; reporting temperatures; vaccine
inventorying; ordering vaccines; completing required Vaccines for
Children (VFC) paperwork; receiving vaccines; inspecting/logging
vaccines and putting them in the vaccine refrigerator; creating lot
numbers in EHR.'' Checking refrigerator temperatures, vaccine
inventorying, and filling out vaccine paperwork are administrative
tasks which are not individually allocable to a particular patient for
a particular service. We removed this 1 minute of clinical labor time
as these administrative tasks are forms of indirect PE. We also refined
the equipment times for CPT codes 90460 and 90471-90474 to conform to
our established policies for non-highly technical equipment.
In consideration of the information provided in the recommendation
for these services, we proposed the RUC's recommended work RVUs and
direct PE inputs (with minor refinements) for these vaccine
administration services. However, we continue to seek additional
information from commenters that specifically identifies the resource
costs and inputs that should be considered to establish payment for
these vaccine administration services on a long-term basis, consistent
with our policy objectives for ensuring maximum access to immunization
services.
Comment: Many commenters stated that they supported the proposal of
the RUC-recommended work RVUs for all six codes in the Immunization
Administration family.
Response: We appreciate the support for our proposed work RVUs from
the commenters.
Comment: A commenter stated that they supported the proposal of the
RUC-recommended work RVUs and thanked CMS for its emphasis on the
importance and value of vaccines. The commenter also stated that CMS
should adopt a site-neutral approach for all Part B vaccines and apply
the OPPS payment rate in all sites of service. The commenter stated
that the vaccine administration service is remarkably similar across
all of the intramuscular injected Part B vaccines; the commenter stated
that it is essentially the same service regardless of the type of
vaccine, across all of the various sites of service and that the
infrastructure and necessary supplies and staff are fundamentally the
same regardless of where a vaccine is administered. The commenter
stated that annual updates to the vaccine administration payment rates
based on OPPS claims data is a reliable and data-based method for
updating the payment rate which would prevent the issues that have
occurred in the past with the crosswalk to CPT code 96372.
Response: We appreciate the support for our proposed work RVUs from
the commenter. We did not propose and we are not finalizing the OPPS
payment rates for the Immunization Administration codes as we do not
have data at the moment that indicates these services are identical
regardless of the site of service and type of provider. We note for the
commenter that we proposed work RVUs and direct PE inputs for the
Immunization Administration codes to ensure that they would be
resource-based and not dependent on crosswalks to other CPT codes for
valuation.
Comment: One commenter disagreed with the proposed valuation of the
Immunization Administration codes and stated that the proposed payment
rates were insufficient to cover the resource costs associated with
providing these services. The commenter stated that the RUC methodology
does not result in adequate payment rates for these vaccine
administration services and requested that CMS assign the $30 Part B
vaccine administration payment rate to the Part D vaccine
administration services as well. The commenter stated that there was no
policy rationale for a large difference in payment rates between the
proposed Part B vaccine administration payment rate and the proposed
payments rates for the Part D vaccine administration services and
requested that CMS finalize a payment of $30 for CPT codes 90460,
90461, 90471, 90472, 90473, and 90474.
Response: We disagree with the commenter that the RUC methodology
used to value the Immunization Administration codes does not result in
adequate payment rates for these services. We remind the commenter that
under Medicare Part B, the statute requires CMS to value physician
services using a resource-based system based on the time and intensity
of the services involved. (See section 1848(c)(1)(A) of the Act.) We
believe that the RUC recommended values for these codes, with minor
refinements to the direct PE inputs to conform with our standard
equipment time methodology, are reasonable and will establish resource-
based payments for these services as required by the statute.
Comment: Several commenters disagreed with the proposal to remove 1
minute of clinical labor time for the CA008 (Perform regulatory
mandated
[[Page 69512]]
quality assurance activity (pre-service)) activity for CPT codes 90460
and 90471-90474 as a form of indirect PE. Commenters stated that
clinical staff immunization confirmation protocols have changed since
the Immunization Administration codes were last valued due to the
explosion in the number of new vaccines introduced since 2009.
Commenters stated that practitioners typically give orders for the
antigen but not the particular brand and presentation, and determining
which of these vaccine products to use is a clinical staff decision
based on the patient's age and vaccination history and potentially
complicated by restrictions. Commenters stated that some vaccines have
different dosing requirements based on age, and that while in some
cases it is acceptable to use the alternative brand in stock if the
original brand is not known, in other cases using only the brand from
the original dose is acceptable. Commenters stated that each time a
vaccine is administered clinical staff must follow these immunization
confirmation protocols, and therefore, the commenters believe that
these clinical staff activities are appropriately attributed to direct
PE.
Response: We appreciate the additional information provided by the
commenters describing the decisions that the clinical staff must make
when carrying out these regulatory mandated quality assurance
activities. Based on this additional information, we agree that these
quality assurance activities constitute a form of clinical judgment
that is individually allocable to the Immunization Administrative
services as a form of direct PE. We are therefore not finalizing our
proposal and will restore the 1 minute of clinical labor time for the
CA008 activity for CPT codes 90460 and 90471-90474.
Comment: Several commenters disagreed with the proposal to refine
the equipment times for CPT codes 90460 and 90471-90474 to conform to
the established CMS policies for non-highly technical equipment.
Commenters stated that in February 2008, the RUC recommended and CMS
finalized the use of total clinical staff time as the time of medical
equipment use for the service of vaccine administration. Commenters
stated that this established an exemption specific to the service of
vaccine administration and that CMS should finalize the RUC's equipment
time recommendations for each piece of medical equipment as established
by this 2008 exemption.
Response: We disagree with the commenters and continue to believe
that the equipment times for CPT codes 90460 and 90471-90474 should
conform to the established policies for non-highly technical equipment.
While the commenters are correct that we finalized the RUC-recommended
direct PE inputs for these codes in the CY 2009 PFS final rule (73 FR
69736), we did not establish an exemption to the standard equipment
times for the Immunization Administration codes. We did not apply the
established policies for non-highly technical equipment during our CY
2009 review of these codes solely because those established policies
had not been developed yet; the higher equipment times for CPT codes
90460 and 90471-90474 are an artifact of the age of their last review
date, not an exemption to our standard policies. As we have noted with
regards to the standardization of clinical labor tasks, we believe that
setting and maintaining standard equipment time formulas helps provide
greater consistency among codes and improves relativity across the
wider fee schedule. Updating older equipment times and bringing them
into accordance with the established equipment time formulas is a
standard part of our review process and the Immunization Administration
codes are no exception to that rule. We continue to believe that the
equipment times for CPT codes 90460 and 90471-90474 should conform to
the established policies for non-highly technical equipment in order to
maintain relativity between codes.
After consideration of the comments, we are finalizing the work
RVUs inputs for all six codes in the Immunization Administration family
as proposed. We are finalizing the direct PE inputs as proposed aside
from restoring 1 minute of clinical labor time for the CA008 activity
for CPT codes 90460 and 90471-90474 as described above.
(22) Orthoptic Training (CPT Codes 92065 and 92066)
In October 2019, the RUC identified CPT code 92065 (Orthoptic and/
or pleoptic training, with continuing medical direction and evaluation;
performed by a physician or other qualified health care professional)
as needing review because it was Harvard Valued (that is, the value of
the code had not been reviewed since the implementation of the
Resource-Based Relative Value Scale (RBRVS)) and its utilization
surpassed 30,000 in each of several recent years. At its January 2020
meeting, during review of CPT code 92065, the RUC noted that the use of
``and/or'' in the descriptor defined different patient populations and
treatment techniques and recommended that the code be reviewed by the
CPT Editorial Panel (CPT) in order to create two separate codes.
Additionally, based upon review and analysis of survey data, specialty
societies decided to submit a new code change application for the
February 2021 CPT meeting.
During the February 2021 meeting, CPT noted that the services of
CPT code 92065 are delivered in two different ways: directly by the
practitioner and by a technician under the supervision of the
practitioner. In response to this observation, CPT suggested that two
codes be created to identify who furnishes the orthoptic service.
Identifying in the code descriptor who furnishes the services would
ensure more accurate valuation of both the work and the PE associated
with the service. The CPT formally revised code 92065 and created new
CPT code 92066 to describe orthoptic services furnished under the
supervision of a physician or qualified health care professional.
During its April 2021 meeting, the RUC revalued the work associated
with the services of CPT code 92065 (Orthoptic training; performed by a
physician or other qualified health care professional) and valued the
PE inputs for new CPT code 92066 (Orthoptic training; performed by a
physician or other qualified health care professional under supervision
of a physician or other qualified health care professional). CPT code
92066 is valued as a PE-only code.
After reviewing CPT code 92065, we proposed to accept the RUC-
recommended work RVU of 0.71. We also proposed to accept the RUC-
recommended direct PE inputs for CPT code 92065. We proposed to accept
the RUC-recommended direct PE inputs for CPT code 92066 as well.
Comment: We received a few comments in response to our proposals
for CPT codes 92065 and 92066. Commenters expressed support of our
proposal to accept the RUC-recommended work RVUs and the direct PE
inputs adjustments.
Response: We thank commenters for taking time to submit their
support of the RUC-recommendations for CPT codes 92065 and 92066.
We are finalizing the RUC-recommended work RVU of 0.71 for CPT
codes 92065 and the RUC-recommended direct PE inputs for both CPT codes
92065 and 92066.
(23) Dark Adaptation Eye Exam (CPT Code 92284)
CPT code 92284 (Dark adaptation examination with interpretation and
report) was identified in July 2020 as Harvard Valued with a
utilization of over 30,000 claims. In January 2021, the
[[Page 69513]]
RUC recommended that the code be surveyed for the April 2021 RUC
meeting. The RUC reviewed the survey results for the procedure and
noted that the 25th percentile work value of 0.45 was greater than the
code's current value. The RUC recommended a work RVU of 0.14, based on
a direct work RVU crosswalk from CPT code 76514 (Ophthalmic ultrasound,
diagnostic; corneal pachymetry, unilateral or bilateral (determination
of corneal thickness)). We disagreed with the RUC-recommended work RVU
of 0.14 for CPT code 92284. We found that the recommended work RVU did
not adequately reflect reductions in physician time, since this
diagnostic screening is usually completed during an E/M visit and
largely consists of interpreting machine generated results. Instead, we
proposed a work RVU of 0.00 for CPT code 92284, which is comparable to
other ophthalmic screening tests; such as 99172 (Visual function
screening, automated or semi-automated bilateral quantitative
determination of visual acuity, ocular alignment, color vision by
pseudoisochromatic plates, and field of vision (may include all or some
screening of the determination[s] for contrast sensitivity, vision
under glare)) and 99173 (Screening test of visual acuity, quantitative,
bilateral). Alternatively, we considered using a total-time methodology
with a work RVU of 0.03 and a reverse building block methodology with a
work RVU of 0.06. We solicited comments and requested information that
may inform why CPT code 92284 should include additional valuation as
this procedure is included in an E/M visit.
For the direct PE inputs, we proposed to refine the equipment time
for the lens set (EQ165) from 24 minutes to 15 minutes and motorized
table (EF030) from 24 minutes to 15 minutes. The reduction in time for
both equipment types is proposed to match the RUC-recommended 15
minutes in Clinical Activity Code CA021. We solicited public comment to
provide further rationale for the additional 9 minutes recommended.
We received a few comments regarding our proposed work RVUs and
direct PE inputs for CPT code 92284 in response to the CY 2023 PFS
proposed rule and those comments are summarized below.
Comment: Commenters disagreed with the comparison to CPT codes
99172 and 99173, stating that these reference codes assume there is no
physician work involved with the service, and therefore, do not serve
as appropriate clinical comparisons to the surveyed CPT code 92284.
Instead, these commenters agree with the RUC-recommended crosswalk to
CPT code 76514 as a closer clinical comparison, based on work RVU,
intra-service time, and intensity of physician/optometrist work
involved with this service.
Commenters did not support the proposed alternative methodologies,
stating that the total-time and reverse building block methodologies do
not appropriately value the physician work and total time required in
CPT code 92284. In addition, the commenters stated that use of these
alternative methodologies would mean that we are choosing an
inconsistent combination of inputs to apply, and that this selection
process has the appearance of seeking an arbitrary value from the vast
array of possible mathematical calculations, rather than seeking a
valid, clinically relevant relationship that would preserve relativity.
One commenter acknowledged that we noted the physician work largely
consists of interpreting machine-generated results, stating that they
agreed with the RUC-recommended intraservice time of 3 minutes, which
was a reduction from the surveyed intraservice time of 15 minutes. The
commenter noted that this represents a change in technology which
allows technicians to administer the test, a change with which most
survey respondents were not familiar. Another commenter asked that we
consider upholding the RUC recommendations for all CPT codes covered in
this rule, especially CPT code 92284.
Response: We disagree with commenters and continue to believe that
CPT codes 99172 and 99173 are appropriate comparator codes for CPT code
92284. These reference codes also account for the screening nature of
CPT code 92284, which is usually performed in conjunction with an E/M
visit that accounts for the physician work. We continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
We also clarify for the commenters that our review process is not
arbitrary in nature and includes a variety of methodologies and
approaches used to develop work RVUs, including the use of building
block and total-time methodologies. Our reviews of recommended work
RVUs and time inputs generally include, but have not been limited to, a
review of information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the Federal
Government, as well as Medicare claims data.
When considering the intraservice time, we do not agree with the
commenter, and continue to believe that complex work is not performed
to analyze the machine generated results. In our review, we focus on
evaluating and addressing the time and intensity of services, but we
are under no obligation to adopt the same review process or compelling
evidence criteria as the RUC. While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. We also have reason to believe that the new
technology has led to greater efficiencies in the service which, under
the resource-based nature of the RVU system, lends further support for
a reduction in the work RVU.
Comment: Commenters urged CMS to accept the RUC-recommended direct
PE inputs for CPT code 92284 and provided additional rationale to
explain the additional 9 minutes of equipment time for the lens set
(EQ165) and motorized table (EF030). Commenters stated that in addition
to the 15 minutes that the equipment is in use during performance of
the test, there is an additional 9 minutes of clinical activities where
the equipment is unavailable for use with another patient. These
activities all occur in the room with the testing equipment, lens set,
and table.
Response: We appreciate the additional information provided by the
commenters to clarify the equipment time. We are persuaded by the
comments that explained the standard default equipment formula was used
and RUC PE direct input benchmarks for clinical staff time were used
for CA011, CA013, CA014, and CA024, which results in 24 minutes when
combined with the 15 minutes of CA021. Therefore, we are not finalizing
our proposed refinement to the equipment time for the lens set (EQ165)
and motorized table (EF030), and will finalize the RUC-recommended time
of 24 minutes.
After careful consideration of the public comments, we are
finalizing a work RVU of 0.00 for CPT code 92284 as proposed. For the
direct PE inputs,
[[Page 69514]]
we are not finalizing our proposed refinements to the equipment time
and are instead finalizing the RUC-recommended direct PE inputs for CPT
code 92284.
(24) Anterior Segment Imaging (CPT Code 92287)
For CPT code 99287 (Anterior segment imaging with interpretation
and report; with fluorescein angiography), we proposed the RUC-
recommended work RVU of 0.40.
We proposed the RUC-recommended direct PE inputs for CPT code 92287
without refinement.
Comment: Commenters supported our proposed valuation for CPT code
92287.
Response: We acknowledge and appreciate the support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.40 and the RUC-recommended direct PE
inputs for CPT code 92287 as proposed.
(25) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243,
93244, 93245, 93246, 93247, and 93248)
In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to
adopt the RUC's work RVU recommendations for CPT codes 93241 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation), 93242 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93243 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93244 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation),
93245 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; includes
recording, scanning analysis with report, review and interpretation),
93246 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; recording
(includes connection and initial recording)), 93247 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; scanning analysis with
report), and 93248 (External electrocardiographic recording for more
than 7 days up to 15 days by continuous rhythm recording and storage;
review and interpretation).
We noted that the recommendations for this family of codes
contained one new supply item, the ``extended external ECG patch,
medical magnetic tape recorder'' (SD339). We did not receive a
traditional invoice to establish a price for this supply item. Instead,
we received pricing information from two sources: a weighted median of
claims data with the cost of the other direct PE inputs removed, and a
top-down approach calculating the cost of the supply per service based
on summing the total costs of the health care provider and dividing by
the total number of tests furnished. The former methodology yielded a
supply price of approximately $440 while the latter methodology
produced an estimated supply price of $416.85. Interested parties also
submitted a series of invoices from the clinical study marketplace with
a price of $595, which we rejected as we typically require an invoice
representative of commercial market pricing to establish a national
price for a new supply or equipment item.
After consideration of the information, we proposed to employ a
crosswalk to an existing supply for use as a proxy price until we
received pricing information to use for the ``extended external ECG
patch, medical magnetic tape recorder'' item. We proposed to use the
``kit, percutaneous neuro test stimulation'' (SA022) supply as our
proxy item at a price of $413.24. We believed the kit to be the closest
match from a pricing perspective to employ as a proxy until we would be
able to arrive at an invoice that is representative of commercial
market pricing. We welcomed the submission of invoices or other
additional information for use in pricing the ``extended external ECG
patch, medical magnetic tape recorder'' supply. In response to our
proposal, we received conflicting information from commenters and in
the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized
contractor pricing for CY 2021 for the four codes that included this
supply input (CPT codes 93241, 93243, 93245, and 93247) to allow
additional time to receive more pricing information.
We noted that interested parties have continued to engage with CMS
and the MACs on payment for this service. We remained concerned that we
continued to hear that the supply costs as initially considered in our
CY 2021 PFS proposal were much higher than they should be. At the same
time, we also heard that the resource costs, as reflected in the
contractor-based payments, do not adequately cover the incurred cost
for the SD339 supply that is used to furnish these services. In
consideration of continued access to these services for Medicare
beneficiaries, we once again solicited public comments and information
in the CY 2022 PFS proposed rule (86 FR 39179) to support CMS' future
rulemaking to establish a uniform national payment that appropriately
reflects the PE inputs that are used to furnish these services. During
the comment period, we received invoices and additional information for
use in pricing the SD339 supply from the commenters.
Based on this information, we finalized an updated price of $200.15
for the ``extended external ECG patch, medical magnetic tape recorder''
(SD339) supply in the CY 2022 PFS final rule based on the average of
the ten invoices we received (86 FR 65125). We believed that the
invoice data for this supply item, which ranged from a minimum price of
$179.80 to a maximum price of $241.99, suggested that our updated price
of $200.15 was more accurate than the suggested crosswalk to the SD214
supply at a price of $325.98. We believed that considering a potential
impact to payment for other services under the PFS, a proposal to
establish national payment for these services based on this new pricing
information should take into account broader feedback from interested
parties. Therefore, we did not finalize national pricing at this time
and finalized our proposal to maintain contractor pricing for CPT codes
93241, 93243, 93245, and 93247 for CY 2022.
For CY 2023, we received a series of additional invoices for the
SD339 supply from two impacted parties. Each of the invoices priced the
supply item at either $265.00 or $226.38; we therefore proposed to
average together these prices and establish a proposed price of $245.69
for the SD339 supply. We noted that we believe that this represents the
most typical price for the supply based on the invoice data that has
been provided over the past 2 years. We also proposed national pricing
for CPT codes 93241, 93243, 93245, and 93247 for CY 2023 now that the
SD339 supply has an established price. The proposed CY 2023 RVUs for
these CPT codes are displayed in Addendum B on the CMS website under
downloads for the CY 2023 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Comment: Many commenters stated their support for the proposal of
national pricing for CPT codes 93241,
[[Page 69515]]
93243, 93245, and 93247. Commenters detailed the clinical benefits of
external extended ECG monitoring, such as offering easy access to
patients by having inventory readily available at the point of care,
being able to return the device in a postage paid box thus preventing a
return trip to the hospital or doctor's office, and having the option
for a monitor that provides greater than 24-48 hours of data that
providers need access to for clinical decision making. Commenters
stated that the proposal of national pricing would help to provide
greater stability in payment for these services and ensure continued
access to care for beneficiaries.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters submitted additional invoices
associated with the pricing of the ``extended external ECG patch,
medical magnetic tape recorder'' (SD339) supply. Commenters stated that
they believe these additional invoices would help better capture the
market-based costs associated with the SD339 supply.
Response: We appreciate the submission of invoices with additional
pricing information from the commenters in helping to determine the
most accurate price for the SD339 supply. We averaged together the
price of the new invoices with the invoices that we had previously
received prior to the publication of the CY 2023 PFS proposed rule.
After averaging together these 21 invoices, we are finalizing an
updated price of $260.35 for the SD339 supply.
Comment: Several commenters stated that they supported the proposal
of national pricing and the proposed price of $245.69 for the SD339
supply; however they noted that the result does not adequately reflect
the cost of delivering these services by independent diagnostic testing
facilities (IDTFs). Commenters stated that KPMG, in conjunction with
AdvaMed, performed and presented a detailed cost analysis to CMS and
individual MACs requesting a reevaluation of the PE inputs. Commenters
stated that this analysis segregated costs into three categories: (1)
cost of goods sold including costs directly related to the devices,
supplies, production overhead and shipping; (2) direct labor, including
manufacturing a product or provision of a service and clinical
services; and (3) other indirect costs (IT support, finance, rent), and
stated that all three categories were necessary to fully account for
and understand the resources expended by an IDTF to provide LT-ECG
services. Commenters also stated that these three categories did not
consider the consumption of non-device assets used in the delivery of
LT-ECG (for example, software and processing) or the costs associated
with the purchase of capital equipment, regulatory, and research and
development expenses. This cost analysis summed to $300.68 for the
total cost of providing LT-ECG services, including capital expenditures
and research and development costs; a separate commenter submitted a
related cost analysis that summed to $283.89. Commenters requested that
the Extended External ECG Monitoring services be priced in accordance
with the updated costs from the AdvaMed/KPMG analysis as the CMS
proposed pricing does not adequately account for all the costs
associated with manufacturing and delivery of the associated monitoring
services (for example, software and processing) that are necessary for
efficient and effective delivery of services.
Response: We appreciate the presentation of these additional cost
analyses from the commenters for use in pricing the Extended External
ECG Monitoring codes. However, we did not propose to use these external
cost analyses in valuing these codes and they do not fit easily within
the framework of how our PE methodology operates. As the commenters
noted, these cost analyses include delivery, software, and processing
expenses which are typically considered to be forms of indirect PE
under our methodology. These indirect expenses would not be included in
the invoice pricing of the SD339 supply which we sought comment upon in
the proposed rule. The commenters also explicitly stated that their
cost analyses for providing Extended External ECG Monitoring services
included costs associated with research and development, which are not
costs that we include when determining the price of a service under our
PE methodology, as they are not connected to the furnishing of the
service itself.
More broadly, our PE allocation currently makes use of a ``bottom
up'' methodology that sums the typical and medically necessary
resources associated with each service and uses them to calculate the
PE RVU. The cost analyses submitted by the commenters are forms of a
``top down'' analysis which have not been used as the basis of our PE
methodology since we finalized the changes to the current system in CY
2007. (For a detailed explanation of the direct PE methodology,
including examples, we refer readers to the 5-year review of work RVUs
under the PFS and proposed changes to the PE methodology CY 2007 PFS
proposed notice (71 FR 37242) and the CY 2007 PFS final rule with
comment period (71 FR 69629).) This is not to say that the cost
analyses submitted by the commenters are irrelevant to the process of
valuing the Extended External ECG Monitoring services, as they can be a
useful tool in determining accurate market-based pricing. However, they
cannot be directly utilized to determine the most accurate price for
the SD339 supply, especially given that these cost analyses include
additional expenses such as delivery, processing, and research/
development costs which would not typically be considered direct
expenses under our PE methodology.
We also note that the AdvaMed/KPMG cost analysis submitted by the
commenters with a total cost of $300.68 for the Extended External ECG
Monitoring services includes research and development costs of $38.50
in its total expenses. As stated above, our PE methodology does not
recognize research and development costs when determining the prices of
services, only those resources individually allocable to the service
which are both typical and medically necessary. When these are removed,
the resulting total cost of $262.18 closely matches our proposed
pricing for the External ECG Monitoring services. We believe that these
cost analyses ultimately reinforce the accuracy of our proposals after
excluding the costs which would not be included under our PE
methodology.
Comment: A commenter had a series of questions regarding the
invoices used to establish the pricing for the SD339 supply. The
commenter outlined six different scenarios asking whether these
invoices constituted health insurance claims, entire technical services
billed by IDTFs, individual single-use patches, and several related
scenarios. The commenter requested additional information about the
invoices used for pricing the SD339 supply based on these different
scenarios.
Response: As detailed above, we received 21 invoices which we
averaged together under our typical pricing methodology which resulted
in a price of $260.35 for the SD339 supply. We reviewed each invoice
and determined that the price was associated with an individual
extended external ECG patch, not health insurance claims or entire
technical services. We did separately receive ``top down'' cost
analyses from several commenters, as discussed above, but these were
not invoices for the SD339 supply, and therefore, we did not include
them as part of the averaged invoice price.
Comment: A commenter asked CMS to explain why the CY 2023 proposed
[[Page 69516]]
rule used a new batch of invoices to price the SD339 supply which
superseded rather than added to the CY 2022 final rule's batch of
invoices for the same supply. The commenter stated that CMS did not
explain what about the new invoices was superior and more likely to be
representative and valid of national costs for the SD339 supply. The
commenter requested that CMS provides more detail about what the
invoice data they have received are, and why CMS has included or
excluded when specifying the input.
Response: When we use invoices to update supply and equipment
pricing, we find ourselves typically working with a small amount of
submitted invoice data. It is not uncommon to use a single invoice to
update supply and equipment pricing for lack of additional invoices
associated with the item in question. The limited amount of invoice
data sometimes results in making use of invoices across different
calendar years in order to get a more representative sample of market-
based pricing. However, our preference is always to use more recent
pricing information whenever possible since it will be more reflective
of current market-based pricing for the item in question.
In the case of the SD339 supply, we received a large quantity of
invoices (21 in total) from multiple different interested parties.
Because we had an abundance of invoice data associated with this
supply, we averaged together the invoices from the CY 2023 cycle and
did not need to include the older invoices from the CY 2022 cycle. We
did not include them for the simple reason that they constituted older
pricing which was less reflective of current market pricing. We
typically do not exclude any invoices in making supply and equipment
pricing determinations, however we do not believe that it would be
accurate to use older, outdated data when we have readily available
invoices which are more current.
Comment: A commenter stated that an underlying problem for
establishing appropriate payment rates for External Extended ECG
Monitoring is the IDTF model itself, which does not easily fit into the
CMS methodology for paying for physician services. The commenter stated
that the current PE methodology is based on outdated data from the 2006
PPI Survey performed by the American Medical Association and mostly
focuses on expenses related to the traditional physician office which
the commenter stated that they did not believe to be comprehensive or
accurate. The commenter urged CMS to develop a survey appropriate for
IDTFs, especially IDTFs that perform remote monitoring, which would
capture unique components of the IDTF cost structure such as expenses
related to research and development and unique challenges and
regulatory requirements related to AI and software as a service (SaaS).
Response: We agree with the commenter on the need for comprehensive
and accurate data for use in our PE methodology. We continue to be
interested in potential approaches that can be used to update aspects
of the PE methodology, which is why we solicited comments on Strategies
for Updates to Practice Expense Data Collection and Methodology in the
PE section of the rule. We direct readers to section II.B.5. of this
final rule for the full discussion of this topic along with additional
comments that we received.
After consideration of the comments, we are finalizing national
pricing for CPT codes 93241, 93243, 93245, and 93247 along with an
updated price of $260.35 for the SD339 supply.
(26) Cardiac Ablation (CPT Codes 93653, 93654, 93655, 93656, and 93657)
The technologies and clinical practices associated with Cardiac
Ablation Services have changed enough over the past decade (since 2011
when they were first developed) that the specialty societies
recommended referring theses codes to the CPT Editorial Panel to have
the code descriptors for Cardiac Ablation Services updated to create
new and more complete descriptors reflecting the fact that many of
these services are commonly performed together and should be
incorporated and bundled. From the survey results presented to CMS last
year, the RUC advisory committee believes that many of the survey
respondents may not have realized that the code descriptors had been
substantially revised and that they may not have read the updated code
descriptors thoroughly enough to understand that services that are
separately billed, were now combined into the existing codes (since CPT
did not issue new codes for the revised descriptors). Since then, the
RUC has re-surveyed these Cardiac Ablation codes in April 2021 for re-
review. In the interim, the work RVUs for the newly bundled CPT codes
were maintained at their current values until the new recommendations
were presented for CY 2023.
The RUC re-surveyed and reviewed CPT code 93653 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; treatment of
supraventricular tachycardia by ablation of fast or slow
atrioventricular pathway, accessory atrioventricular connection, cavo-
tricuspid isthmus or other single atrial focus or source of atrial re-
entry), and recommends a work RVU of 15.00 with 31 minutes of pre-
service evaluation time, 3 minutes positioning time, 15 minutes scrub/
dress/wait time, 120 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 199 minutes of total time.
CPT code 93653 currently has a work RVU value of 14.75 with 23 minutes
of pre-service evaluation time, 1 minutes positioning time, 5 minutes
scrub/dress/wait time, 180 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 239 minutes of total time.
The time and the physician's work of CPT add-on code 93613
(Intracardiac electrophysiologic 3-dimensional mapping (List separately
in addition to code for primary procedure) with a work RVU of 5.23 and
90 minutes of total time, and CPT add-on code 93621 (Comprehensive
electrophysiologic evaluation including insertion and repositioning of
multiple electrode catheters with induction or attempted induction of
arrhythmia; with left atrial pacing and recording from coronary sinus
or left atrium (List separately in addition to code for primary
procedure)) with a work RVU of 1.50 and 20 minutes of total time are
bundled within CPT code 93653. When all three codes are separately
considered, they currently sum up to 21.48 work RVUs, much greater than
the 15.00 work RVUs that the RUC has recommended. These codes also add
up to much more physician total time than the RUC-recommended 199
minutes.
After reviewing this code and relative similar codes in the PFS, we
proposed a comparator CPT code 37229 (Revascularization, endovascular,
open or percutaneous, tibial, peroneal artery, unilateral, initial
vessel; with atherectomy, includes angioplasty within the same vessel,
when performed) with a work RVU of 13.80 and a similar intra-service
time of 120 minutes and similar pre-service evaluation, pre-service
positioning, pre-service scrub/dress/wait times, and
[[Page 69517]]
immediate post-service times, for a sum of 188 minutes of total time
for a 000 day global period, compared to the RUC-recommended 199
minutes of total time for CPT code 93653. We proposed a work RVU of
13.80 for the bundled CPT code 93653.
The RUC re-surveyed and reviewed CPT code 93654 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; with treatment of
ventricular tachycardia or focus of ventricular ectopy including left
ventricular pacing and recording, when performed), and recommends a
work RVU of 18.10 with 40 minutes of pre-service evaluation time, 3
minutes positioning time, 15 minutes scrub/dress/wait time, 200 minutes
of intra-service time, 33 minutes of immediate post-service time, for a
sum of 291 minutes of total time. CPT code 93654 currently has a work
RVU value of 19.75 with 23 minutes of pre-service evaluation time, 1
minutes positioning time, 5 minutes scrub/dress/wait time, 240 minutes
of intra-service time, 40 minutes of immediate post-service time, for a
sum of 309 minutes of total time. CPT code 93654 is currently and
continues to be a bundled code. The RUC recommended intra-service times
and total times for CPT code 93654 are less than the current times for
this code, and the RUC-recommended work RVUs are also less than the
current work RVUs. Though the RUC recommended a work RVU of 18.10, it
is still a relatively high value compared to the existing 19.75 value.
The RUC recommended a work RVU of 15.00 for CPT code 93653, and 18.10
for CPT code 93654, with a relative increment between them of 3.10 work
RVUs. We proposed to maintain the relative increment RVU difference of
3.10 between CPT code 93653 and CPT code 93654, so because we proposed
a work RVU of 13.80 for CPT code 93653, we proposed a work RVU of 16.90
(13.80 plus 3.10) for CPT code 93654, with 200 minutes of intra-service
time and 291 minutes of total time.
CPT add-on code 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)) has a current work RVU of 5.50 with a physician
intra-service time of 60 minutes as finalized last year, from a
previous value of 7.50 work RVUs with 90 minutes of physician intra-
service time. The RUC recommended the re-surveyed intraservice time of
60 minutes and 7.00 work RVUs. The primary change to CPT code 93655 is
the reduction of the intraservice time of about 67 percent, which we
use as a guide to determine a work RVU. We compared CPT add-on code
22854 (Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to vertebral
corpectomy(ies) (vertebral body resection, partial or complete) defect,
in conjunction with interbody arthrodesis, each contiguous defect (List
separately in addition to code for primary procedure)), also with 60
minutes of intraservice and total time and a work RVU of 5.50 to CPT
add-on code 93655 and we believed that it is a more accurate valuation
than the RUC's work RVU comparison to CPT add-on code 93592
(Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)) with a work RVU of 8.00 and an intra-service and
total time of 60 minutes, and to CPT add-on code 34820 (Open iliac
artery exposure for delivery of endovascular prosthesis or iliac
occlusion during endovascular therapy, by abdominal or retroperitoneal
incision, unilateral (List separately in addition to code for primary
procedure)) with a work RVU of 7.00 and an intra-service and total time
of 60 minutes. After reviewing this code and relative similar codes in
the PFS, we proposed to maintain the current work RVU for CPT code
93655 of 5.50 with a physician intra-service time of 60 minutes, as
finalized last year (86 FR 65108).
The RUC re-surveyed and reviewed CPT code 93656 (Comprehensive
electrophysiologic evaluation including transseptal catheterizations,
insertion and repositioning of multiple electrode catheters with
intracardiac catheter ablation of atrial fibrillation by pulmonary vein
isolation, including intracardiac electrophysiologic 3-dimensional
mapping, intracardiac echocardiography including imaging supervision
and interpretation, induction or attempted induction of an arrhythmia
including left or right atrial pacing/recording, right ventricular
pacing/recording, and His bundle recording, when performed), and
recommends a work RVU of 17.00 with 35 minutes of pre-service
evaluation time, 3 minutes positioning time, 15 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 30 minutes of immediate
post-service time, for a sum of 263 minutes of total time. CPT code
93656 currently has a work RVU of 19.77 with 23 minutes of pre-service
evaluation time, 1 minute positioning time, 5 minutes scrub/dress/wait
time, 240 minutes of intra-service time, 40 minutes of immediate post-
service time, for a sum of 309 minutes of total time. CPT code 93656
has bundled within it, the time and the physician's work of CPT add-on
code 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List
separately in addition to code for primary procedure) with a work RVU
of 5.23 and 90 minutes of total time and CPT add-on code 93662
(Intracardiac echocardiography during therapeutic/diagnostic
intervention, including imaging supervision and interpretation (List
separately in addition to code for primary procedure)) with a work RVU
of 1.44 and 25 minutes of total time. When all three codes are
separately considered, they sum up to 26.44 work RVUs, which is much
greater than the 17.00 work RVUs that is recommended and has much more
physician total time than the RUC recommended 263 total time minutes.
The RUC recommended intra-service times and total times for CPT
code 93656 that are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs. Though
the RUC recommended a work RVU of 17.00, it is still a high value
compared to the existing 19.77. The RUC recommended the work RVU for
CPT code 93653 as 15.00, and for CPT code 93656 as 17.00, with a
relative increment between them of 2.00 work RVUs. As a better
valuation for CPT code 93656, we proposed a work RVU of 13.80 for CPT
code 93653 plus the relative increment RVU difference of 2.00 that the
RUC is maintaining between CPT code 93653 and CPT code 93656 (15.00
subtracted from 17.00 equals 2.00). This would value CPT code 93656 at
15.80 (13.80 plus 2.00) work RVUs for 180 minutes of intra-service time
and 263 minutes of total time, which we propose for CY 2023.
CPT add-on code 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
[[Page 69518]]
code for primary procedure)) has a current work RVU of 5.50 with a
physician intra-service time of 60 minutes as finalized last year (86
FR 65108). The previous work RVU was 7.50 with 90 minutes of physician
intraservice time. The RUC recommended the re-surveyed intra-service
time of 60 minutes and 7.00 work RVUs. The primary change to CPT add-on
code 93657 is the reduction of the intra-service time from before the
re-survey and the current RUC-recommended time, from 90 minutes to 60
minutes, which is a reduction of about 67 percent, and which we used as
a guide to determine an appropriate work RVU. We compare CPT add-on
code 22854 (Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to vertebral
corpectomy(ies) (vertebral body resection, partial or complete) defect,
in conjunction with interbody arthrodesis, each contiguous defect (List
separately in addition to code for primary procedure)), also with 60
minutes of intra-service and total time, and a work RVU of 5.50, to CPT
add-on code 93657, and believe that this is a more accurate comparison
for valuation than the RUC's work RVU comparison to CPT add-on code
93592 (Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)) with a work RVU of 8.00 and an intra-service and
total time of 60 minutes, and to CPT add-on code 34820 (Open iliac
artery exposure for delivery of endovascular prosthesis or iliac
occlusion during endovascular therapy, by abdominal or retroperitoneal
incision, unilateral (List separately in addition to code for primary
procedure)) with a work RVU of 7.00 and an intra-service and total time
of 60 minutes. After reviewing this code and relative similar codes in
the PFS, we proposed to re-affirm the current work RVU of 5.50 with a
physician intraservice time of 60 minutes for CPT add-on code 93657, as
finalized last year (86 FR 65108).
The RUC did not recommend, and we did not propose, direct PE inputs
for CPT codes 93653-93657.
We received many comments concerning CMS' proposed work RVUs for
these Cardiac Ablation CPT codes 93653, 93654, 93655, 93656, and 93657.
Comment: Commenters were uniformly against the CMS proposed work
RVUs for these codes and urged CMS to accept the AMA RUC-recommended
values supported by a robust survey. Commenters argued that the CMS
proposed work RVUs for these services are inappropriately low for the
long lengths of time required to perform these services, and also
neglect to account for the higher intensity of the physician's work
with a live beating heart.
Response: Since CY 2011, when these codes were first developed and
valued, there is no doubt that cardiac ablation technologies and
clinical practices have changed and matured, and thus, these codes were
brought to our attention by the AMA RUC for an overdue review. Over the
last decade, there have been improvements in the related technologies,
new informative results from ongoing research in cardiac ablation, and
physicians who have improved their skills and experience and training,
all contributing to better methodologies that are refined, to an
improved new standard for cardia ablation. They are now performing
these services faster, more efficiently, more safely, and more
effectively, with better outcomes. This also includes the elimination
of duplications of effort, procedure overlaps, and ineffective past
practices. Of course, on the other hand, some new techniques and
methodologies may require performing concurrent procedures making the
better service more complex and more demanding. With all this said, we
do agree that cardiac ablation is a complicated and comparatively
intensive set of procedures that does take a good amount of time to
complete, and that the subsequent changes over the last 10 years have
recognized the need to now bundle these services to reflect current
typical practices.
At present, the cardiac ablation base CPT codes and their
accompanying CPT codes that are paying separately, sum to a total work
RVU of 21.48. CPT code 93653 paying 14.75 work RVUs; with CPT code
93613 paying 5.23 work RVUs; and CPT code 93621 paying 1.50 work RVUs.
Since the AMA CPT Panel and the RUC are recommending the bundling of
these three service codes into CPT code 93653, their recommended work
RVUs for CPT code 93653 is 15.00, and is 69.8 percent of the original
summed value of 21.48. We further refined the newly bundled work to
13.80 work RVUs and that is 64.2 percent of the original summed value,
reflecting what we perceived as improvements and efficiencies gained in
how these procedures are now furnished.
Comment: Commenters disagreed with the CMS proposed work RVUs for
the cardiac ablation add-on codes and urged CMS to accept the AMA RUC-
recommended values.
Response: We remind commenters that those work RVU values were
accepted and finalized in last year's rule (86 FR 65108). We accepted
the RUC-recommended reductions in physician time from 90 minutes to 60
minutes of intra-service and total time, with a final work RVU of 5.50
for CPT code 93655. We accepted the RUC-recommended reductions in
physician time from 90 minutes to 60 minutes of intra-service and total
time, with a final work RVU of 5.50 for CPT code 93657, and we see no
reason change those final values.
We note that it is challenging to make definitive conclusions about
comparisons of relative intensity of work for the same unit of time,
especially without seeing objective or competing viewpoints for some or
most of the procedures that currently have similar valuations. In
developing the PFS, CMS works to mitigate any perceived or explicit
bias against or for any organ system or type of services, which may
distort actual importance to beneficiaries' health and safety. We also
note that levels of intensity can be mathematically different with the
shifting of pre-service minutes or immediate post service minutes, to
or from intra-service minutes, where intensity values are derived.
After review and consideration of all comments on our proposals for
CPT codes 93653, 93654, and 93656, we are persuaded by these comments,
and we are finalizing RUC-recommended values of 15.00, 18.10, and
17.00, respectively. CPT add-on codes 93655 and 93657 both remain
finalized at 5.50 work RVUs from last year.
(27) Pulmonary Angiography (CPT Codes 93569, 93573, 93574, 93575,
93563, 93564, 93565, 93566, 93567, and 93568)
In May 2021, the CPT Editorial Panel revised CPT code 93568
(Injection procedure during cardiac catheterization including imaging
supervision, interpretation, and report; for nonselective pulmonary
arterial angiography (List separately in addition to code for primary
procedure) which resulted in the creation of four new related CPT add-
on codes. CPT add-on codes 93563 to 93567 were surveyed with the four
new codes, as part of the same code family.
The RUC surveyed and reviewed CPT code 93563 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective coronary angiography during
congenital heart catheterization (List separately in
[[Page 69519]]
addition to code for primary procedure)), and recommends a work RVU of
1.11 for 15 minutes of intra-service and total time for this add-on
service. The current work RVU is 1.11 for 25 minutes of intra-service
and total time, so there is a reduction of 10 minutes in physician
time. With the reduction of physician time, it is typical that there
would be some reduction in the work RVUs. After reviewing this code and
relative similar codes in the PFS, we believe a better comparator add-
on code would be CPT code 64494 (Injection(s), diagnostic or
therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves
innervating that joint) with image guidance (fluoroscopy or CT), lumbar
or sacral; second level (List separately in addition to code for
primary procedure)), with a work RVU of 1.00 for 15 minutes of intra-
service and total time. CPT code 64494 is a good comparator in terms of
both the new physician time and due to the proportional work RVU, as
compared to CPT code 93563. Therefore, we proposed a work RVU of 1.00
and 15 minutes of intra-service and total time for add-on CPT code
93563.
The RUC surveyed and reviewed CPT code 93564 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective opacification of
aortocoronary venous or arterial bypass graft(s) (e.g., aortocoronary
saphenous vein, free radial artery, or free mammary artery graft) to
one or more coronary arteries and in situ arterial conduits (e.g.,
internal mammary), whether native or used for bypass to one or more
coronary arteries during congenital heart catheterization (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 1.13 for 18 minutes of intra-service and total time for
this add-on service. The current work RVU is 1.13 for 25 minutes of
intra-service and total time, so there is a reduction of 7 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 31632 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
transbronchial lung biopsy(s), each additional lobe (List separately in
addition to code for primary procedure)) with a work RVU of 1.03 for 18
minutes of intra-service and total time. CPT code 31632 is a good
comparator in terms of both the new physician time and due to the
proportional work RVU, as compared to CPT code 93564. Therefore, we
proposed a work RVU of 1.03 and 18 minutes of intra-service and total
time for add-on CPT code 93564.
The RUC surveyed and reviewed CPT code 93565 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective left ventricular or left
atrial angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU as compared
to CPT code 93565. Therefore, we proposed a work RVU of 0.50 and 10
minutes of intra-service and total time for add-on CPT code 93565.
The RUC surveyed and reviewed CPT code 93566 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective right ventricular or right
atrial angiography (List separately in addition to code for primary
procedure)) and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU, as
compared to CPT code 93566. Therefore, we proposed a work RVU of 0.50
and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93567 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for supravalvular aortography (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 0.97 for 10 minutes of intra-service and total time for
this add-on service. The current work RVU is 0.97 for 15 minutes of
intra-service and total time, so there is a reduction of 5 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 74248 (Radiologic small
intestine follow-through study, including multiple serial images (List
separately in addition to code for primary procedure for upper GI
radiologic examination)) with a work RVU of 0.70 for 10 minutes of
intra-service and total time. CPT code 74248 is a good comparator code
in terms of both the new physician time and due to the proportional
work RVU, as compared to CPT code 93567. Therefore, we proposed a work
RVU of 0.70 and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93568 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for nonselective pulmonary arterial
angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.88 for 13 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.88 for 20 minutes of intra-service and total time, so there is a
reduction of 7 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we agree with the RUC recommendation and proposed a work RVU of
0.88 with 13 minutes of intra-service and total time for add-on CPT
code 93568.
For the first of the related four new add-on codes to this family,
CPT code 93569 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary arterial angiography, unilateral (List separately
in addition to code for primary procedure)), the RUC recommended a work
RVU of 1.05 for 11 minutes of
[[Page 69520]]
intra-service and total time for this add-on service. The RUC noted
that the typical patient for this service is pediatric. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 78434 (Absolute quantitation
of myocardial blood flow (AQMBF), positron emission tomography (PET),
rest and pharmacologic stress (List separately in addition to code for
primary procedure)) with a work RVU of 0.63 for 11 minutes of intra-
service and total time. CPT code 78434 is a good comparator code in
terms of both the physician time, and due to the proportional work RVU,
as compared to CPT code 93569. Therefore, we proposed a work RVU of
0.63 and 11 minutes of intra-service and total time for add-on CPT code
93569.
For the second of the related four new add-on codes to this family,
CPT code 93573 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary arterial angiography, bilateral (List separately in
addition to code for primary procedure)), the RUC recommended a work
RVU of 1.75 for 18 minutes of intra-service and total time for this
add-on service. The RUC noted that the typical patient for this service
is pediatric and that this service is bilateral. After reviewing this
code and relative similar codes in the PFS, we believe a better
comparator add-on code would be HCPCS code G0289 (Arthroscopy, knee,
surgical, for removal of loose body, foreign body, debridement/shaving
of articular cartilage (chondroplasty) at the time of other surgical
knee arthroscopy in a different compartment of the same knee (List
separately in addition to code for primary procedure)) with a work RVU
of 1.48 for 20.5 minutes of intra-service and total time and that this
service is bilateral. G0289 has 2.5 minutes of additional physician
intra-service time, so we adjusted the comparator work RVU from 1.48 to
1.30. Therefore, we proposed 1.30 work RVUs for 18 minutes of intra-
service and total time for add-on CPT code 93573.
For the third of the related four new add-on codes to this family,
CPT code 93574 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary venous angiography of each distinct pulmonary vein
during cardiac catheterization. (List separately in addition to code
for primary procedure)), the RUC recommended a work RVU of 1.84 for 20
minutes of intra-service and total time for this add-on service. The
RUC noted that the typical patient for this service is pediatric. After
reviewing this code and relative similar codes in the PFS, we believe a
better comparator add-on code would be CPT code 93598 (Measurement of
output of blood from heart, performed during cardiac catheterization
for evaluation of congenital heart defects (List separately in addition
to code for primary procedure)) with a work RVU of 1.44 for 20 minutes
of intra-service and total time. CPT code 93598 is a good comparator
code in terms of both the physician time, and due to the proportional
work RVU, as compared to CPT code 93574. Therefore, we proposed 1.44
work RVUs for 20 minutes of intra-service and total time for add-on CPT
code 93574.
For the last of the related four new add-on codes to this family,
CPT code 93575 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary angiography of major aortopulmonary collateral
arteries (MAPCAs) arising off the aorta or its systemic branches, each
distinct vessel)), the RUC recommended a work RVU of 1.92 for 20
minutes of intra-service and total time for this add-on service. The
RUC describes this service and the physician's work as very time-
intensive and complicated, and the typical patient for this service is
pediatric. We agree with the RUC recommendations and proposed a work
RVU of 1.92 with 20 minutes of intra-service and total time for add-on
CPT code 93575.
The RUC did not recommend, and we did not propose, direct PE inputs
for CPT codes 93563-93575.
Numerous comments were submitted concerning this family of
pulmonary angiography codes all against the CMS-proposed RVU values.
Comment: Commenters noted that CMS is equating reductions in
physician times with reductions in work RVUs, with this family of
codes, without regard to the intensity or complexity of these pulmonary
procedures, or that some of these codes are primarily typical with
pediatrics and congenital heart disease. Commenters recommended that
CMS reconsider their proposed values as being too low and to accept the
AMA RUC recommended values.
Response: As commenters know, we are obligated to take into account
changes in physician times and intensity with changes in work RVUs. We
appreciate all of the time and efforts commenters place into their
extensive comments in responding to our proposals and we do review
these comments in detail to improve our proposals where warranted. When
we observe reductions in physician times and no significant change to
the procedure's description of work and no change in the procedure's
work RVU, or we see recommendations of increases in the procedure's
work RVU, we wonder how the intensity of the procedure has changed.
Improvements in these procedure's technologies and physicians' training
in new skills and methods do contribute to faster, and more efficient
outcomes and would result in the reduction of a procedure's work time.
At the same time, where duplicate and overlapping efforts are
eliminated, new techniques can also introduce complexities that would
contribute to the work's intensity without the addition of work time.
However, these add-on codes reduce physician work times, and the nature
of the PFS relative value system is such that all services are subject
to comparisons to one another.
However, we do agree with the commenters' point regarding CPT code
93569 and our proposed work RVU value of 0.63. Our proposed work RVU
creates a rank order anomaly within this family of codes whose patients
are pediatrics. The AMA RUC-recommended work RVUs between CPT code
93569 and CPT code 93573 reflect about a 67 percent difference between
the two codes. Our proposed work RVU for CPT code 93569 of 0.63 is
about a 106 percent higher than our proposed work RVU of 1.30 for CPT
code 93573, which created a large difference. To correct this error and
to maintain that RUC-recommended interval difference between these two
codes, we are finalizing a corrected work RVU of 0.78 for CPT code
93569, by applying that RUC-recommended interval difference between CPT
codes 93569 and 93573 (1.30 divided by 1.67 = 0.78). This aligns with
the intra-service minutes difference between CPT codes 93569 (11
minutes) and 93573 (18 minutes) and the comparator CPT code 58110
(Endometrial sampling (biopsy) performed in conjunction with colposcopy
(List separately in addition to code for primary procedure)), with
similar physician intra-service minutes and a similar work RVU of 0.77.
After review and consideration of all comments on our proposals for
these Pulmonary Angiography codes, we are finalizing all work RVUs as
proposed except for CPT code 93569, whose work RVU we are adjusting
from 0.63 to 0.78 for CY 2023.
[[Page 69521]]
(28) Quantitative Pupillometry Services (CPT Code 95919)
The CPT Editorial Panel approved a new Category I CPT code to
replace the sunset Category III (CPT code 0341T Quantitative
pupillometry with interpretation and report, unilateral or bilateral)
and 92499 (Unlisted ophthalmological service or procedure for reporting
this service).
We did not propose the RUC-recommended work RVU of 0.25 for CPT
code 95919, as we believe this is an overestimation based on a
comparison to other codes with similar time values, particularly the
key reference code CPT code 92081 (Visual field examination, unilateral
or bilateral, with interpretation and report; limited examination
(e.g., tangent screen, Autoplot, arc perimeter, or single stimulus
level automated test, such as Octopus 3 or 7 equivalent). In the
interest of maintaining relativity with similarly timed codes, we are
instead proposing a work RVU of 0.18 with a crosswalk to CPT code 92504
(Binocular microscopy (separate diagnostic procedure)). We noted that
this value falls between the work RVUs of 0.17 for CPT code 94010
(Spirometry, including graphic record, total and timed vital capacity,
expiratory flow rate measurement(s), with or without maximal voluntary
ventilation) and 0.20 for CPT code 77081 (Dual-energy X-ray
absorptiometry (DXA), bone density study, 1 or more sites; appendicular
skeleton (peripheral) (e.g., radius, wrist, heel)); both codes have
identical intraservice times and similar total times.
We proposed the RUC-recommended direct PE inputs without
refinement.
Comment: Commenters did not support our proposed work RVU of 0.18
rather than the RUC-recommended 0.25. A commenter asserted that the RUC
survey results are robust and that CMS did not furnish evidence that
this service is appropriately valued below the 25th survey percentile.
Another commenter stated that CPT code 92504 is a less appropriate
crosswalk than the RUC's crosswalk of CPT code 72190 as it does not
match the pre/intra/post times and because it was last revalued in
2010.
Response: The RUC-recommended RVU of 0.25 was high in comparison to
the range of RVUs for the comparison CPT codes with the same intra-
service time and similar total times, and therefore, we believe that
CPT code 92504 is a valid crosswalk. We continue to believe that,
particularly given that this service is likely to be performed multiple
times in a single day, the RUC-recommended value represents a slight
overestimation of intensity. We acknowledge that the work times were
not an exact match with CPT code 92504 but closely matched the
intraservice and total times, and we continue to believe that this is
an appropriate crosswalk.
We are finalizing as proposed a work RVU of 0.18 for CPT code 95919
and the RUC-recommended direct PE inputs without refinement.
(29) Caregiver Behavior Management Training (CPT Codes 96202 and 96203)
CPT code 96202 (Multiple-family group behavior management/
modification training for guardians/caregivers of patients with a
mental or physical health diagnosis, administered by physician or other
qualified health care professional (without the patient present), face-
to-face with multiple sets of guardians/caregivers; initial 60 minutes)
and its add-on code, CPT code 96203 (Multiple-family group behavior
management/modification training for guardians/caregivers of patients
with a mental or physical health diagnosis, administered by physician
or other qualified health care professional (without the patient
present), face-to-face with multiple sets of guardians/caregivers; each
additional 15 minutes (List separately in addition to code for primary
service)), are new codes created by the CPT Editorial Panel during its
February 2021 meeting. The two codes are to be used to report the total
duration of face-to-face time spent by the physician or other qualified
health professional providing group training to guardians or caregivers
of patients. Although the patient does not attend the group trainings,
the goals and outcomes of the sessions focus on interventions aimed at
improving the patient's daily life. According to the CPT Summary of
Recommendations, during the face-to-face service time, caregivers are
taught how to structure the patient's environment to support and
reinforce desired patient behaviors, to reduce the negative impacts of
the patient's diagnosis on the patient's daily life, and to develop
highly structured technical skills to manage patient behavior. As a
means of identifying work values for CPT codes 96202 and 96203, three
specialty societies sent surveys to a random sample of a subset of
their members. Based upon survey results and after discussion, the RUC
recommended a work RVU of 0.43 per identified patient service for CPT
code 96202. The RUC noted that this recommendation is based upon a
median group size of six caregivers and includes 10 minutes pre-time,
60 minutes intra-time, and 20 minutes post-time for a total time of 90
minutes. For CPT code 96203, the 15-minute add-on code, the RUC
recommended a work RVU of 0.12, which is also based upon a median group
size of six. After reviewing the caregiver training codes, we stated in
the proposed rule that CPT codes 96202 and 96203 are not payable under
the PFS. We noted that in past rulemaking, we have explained that we
read section 1862(a)(1)(A) of the Act to limit Medicare coverage and
payment to items and services that are reasonable and necessary for the
diagnosis and treatment of an individual Medicare beneficiary's illness
or injury or that improve the functioning of an individual Medicare
beneficiary's malformed body member. For example, in the CY 2013 PFS
final rule (77 FR 68979), when discussing payment for the non-face-to-
face care management services that are part of E/M services, we stated
that Medicare does not pay for services that are furnished to parties
other than the beneficiary. We listed as an example, communication with
caregivers. Because the codes for caregiver behavior management
training describe services furnished exclusively to caregivers rather
than to the individual Medicare beneficiary, we did not review the RUC-
recommended valuation of these codes or propose to establish RVUs for
these codes for purposes of PFS payment. However, recognizing our focus
on ensuring equitable access to reasonable and necessary medical
services, we requested public comment about the services described by
these two codes. First, we sought comment on the ways in which a
patient may benefit when a caregiver learns strategies to modify the
patient's behavior. We also sought comment on how current Medicare
policies regarding these caregiver training services may impact
Medicare beneficiary health. Finally, we sought comment about how the
services described by these codes might be bundled into Medicare
covered services as incident to services or as practitioner work that
is part of some care management codes.
Below is a summary of the comments received.
Comment: Most commenters recommended that CMS pay for caregiver
behavioral management training services and to use the RUC-recommended
values for purposes of payment. Several appreciated CMS displaying the
RUC-recommended values. Several commenters asked CMS to reconsider its
position on the caregiver behavior management training codes, noting
that there is extensive
[[Page 69522]]
empirical support for caregiver behavior management training, and that
these services are a component of the standard of care for treatment of
several health behavior issues. Many commenters asserted that although
the patient is not present when this training is provided, these codes
have many specific, direct benefits for the patient. The RUC commented
that these codes allow for reporting the physician/QHP work and/or time
associated with the evidence-based behavioral management/modification
training of parent/caregivers, which is performed in tandem with the
diagnostic and intervention services furnished directly to the
``identified patient'' that support the patient's optimal level of
function.
Some commenters asserted that CMS' proposed application of section
1862(a)(1)(A) of the Act was not appropriate given the well-established
evidence of the direct effect the provision of these services on the
health outcomes associated with specific chronic conditions, including
a reduction in disruptive and problematic behaviors for children with
ADHD, improved weight management for individuals with obesity, and
better management of patients with dementia.
One commenter noted that if the patient's presence is a requirement
for these services, it becomes a barrier to this care for patients with
particular health conditions. One commenter indicated that these
services are specifically intended to prepare caregivers to implement
necessary elements of care plans. This commenter also suggested that
not paying for these services would contribute to health inequities
issue because in many cases the patients at issue have dementia and
other disorders that place them at great social and economic
disadvantage.
Commenters also noted that there are other CPT codes, several paid
separately under the PFS, that describe services that do not include
direct contact with the patient but are still considered integral to
the patient's care, including care management services and
interprofessional consultations.
Commenters also expressed broad support for the role of caregivers
in the health of individuals, indicating that the caregiver's play a
critical role in supporting patient care and that caregiver engagement
is an important part of the individual patient's plan of care. Other
commenters noted that these services when delivered in groups without
the patient present have clear advantages over services delivered
individually. The commenters suggested that caregiver engagement will
help reduce costs and improve access to care. Other commenters stated
these services enable caregivers to better address the patient's needs
and provide assistance to perform activities of daily living and family
caregivers who play a huge role in the patient's long-term care; and
many family caregivers are supporting patients with complex care, and
expressed fear of making a mistake, with concern being the greatest for
managing medications, using meters and monitors, and performing wound
care. Several commenters noted that caregiver behavior training is
evidence-based and providing training will promote improved outcomes.
A few commenters suggested that CMS might consider adding a
caregiver training element to the appropriate chronic care management
code and would be pleased to explore with CMS how to implement this
service.
Response: We appreciate the response from commenters. We
acknowledge the important role that caregivers can have in overall
care, especially for Medicare beneficiaries. We also acknowledge the
idea that broadly increasing the resources provided to caregivers could
have beneficial results on general well-being in addition to reductions
in the need for medical or institutional interventions.
However, under section 1862(a)(1)(A) of the Act, Medicare payment
is generally limited to those items and services that are reasonable
and necessary for the diagnosis or treatment of illness or injury or
that improve the functioning of a malformed body member. We sought
feedback on the ways in which a patient may benefit when a caregiver
learns strategies to modify the patient's behavior. We also sought
comment regarding how Medicare policies regarding these caregiver
training services may impact Medicare beneficiary health.
Commenters responded by explaining how the training services
provided directly to the caregiver treat beneficiary's health
conditions. Commenters also explained how the lack of access to these
standard treatments would have a disproportionately negative effect on
beneficiaries with particular conditions and the practitioners who
treat them. Commenters have highlighted that behavioral management/
modification training of parents/caregivers, when furnished in tandem
with other diagnostic and intervention services related to specific
treatment, can be integral to the treatment of a beneficiary's specific
condition. Commenters have also pointed out that to the extent that
this service is integral to evolving standards of care for people with
certain conditions, lack of payment for this service under the PFS
would likely result in an inappropriate payment disparity that would
have a detrimental impact on access to care for particular
beneficiaries and the physicians and other qualified health care
professionals that treat them.
We note that in the proposed rule we reiterated that Medicare does
not pay for services that are furnished to parties other than the
beneficiary. Over the past decade or more, in specific circumstances,
we have made payment for some care furnished to beneficiaries through
direct involvement of parents, guardians, or caregivers, as well as
through interactions with other medical professionals or clinical staff
rather than the beneficiary in-person. These circumstances include when
the lack of coding and payment for services historically not paid for
separately give rise to inappropriate payment disparities that do not
reflect the relative resources involved in furnishing treatment, given
the changes in medical practice that have led to more care
coordination/team-based care, and the idea that the resources involved
in those aspects of care are not adequately reflected in current
coding/payment. In these cases, we have created coding and separate
payment for services such as transitional care management (77 FR
68978), chronic care management (79 FR 67715), behavioral health
integration services (81 FR 80226), and virtual check-in services (83
FR 59483). In some cases, we have also specifically made payment for
services provided directly to caregivers when, in current practice and
in specific circumstances, they are an integral part of ongoing
treatment for some patients (81 FR 80331). In the CY 2017 PFS final
rule, we noted that we believe that CPT codes 96160 and 96161, Patient,
Caregiver-focused Health Risk Assessment codes, describe services that,
in particular cases, can be necessary components of services furnished
to Medicare beneficiaries. We recognized that in current medical
practice, practitioner interaction with caregivers is an integral part
of treatment for some patients. Accordingly, the descriptions for
several payable codes under the PFS include direct interactions between
practitioners and caregivers. We agreed with commenters, that there are
circumstances where this service is an essential part of a service to a
Medicare beneficiary. Therefore, we assigned active payment status to
both codes for CY 2017.
Based on public comments, we believe there could be circumstances,
captured in the medical record, where
[[Page 69523]]
separate payment for these services may be appropriate. We will
continue to consider and contemplate which circumstances or services
and for which beneficiaries it would be appropriate to furnish and
receive payment for these types of services in future notice and
comment rulemaking.
We appreciate the thoughtful feedback submitted by the public on
this matter. We intend to address these codes more thoroughly during
the CY 2024 rulemaking process as we review other coding and valuation
changes.
(30) Cognitive Behavioral Therapy Monitoring (CPT code 98978).
See the Remote Therapeutic Monitoring (RTM) section II.I. of this
final rule for a review of new device code, CPT code 98978.
(31) Code Descriptor Changes for Annual Alcohol Misuse and Annual
Depression Screenings (HCPCS Codes G0442 and G0444)
Interested parties have raised concerns with the portion of the
code descriptors that require a certain number of minutes to bill for
the HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and
G0444 (Annual depression screening, 15 minutes). Over the past several
years, AAFP and the ACP have requested that CMS revise the code
descriptors to state ``up to 15 minutes'' instead of the current ``15
minutes,'' allowing practitioners to efficiently furnish the service.
As currently described, claims for the service are said to be denied by
MACs in instances where records suggest that a full 15 minutes was not
reached by the practitioner when furnishing the service. Both codes
were high in volume for 2019 and 2020, with over 700,000 reported
services in our Medicare claims data.
Medicare Part B coverage for such screenings originated from a
national coverage determination (NCD) from 2011 and 2012. We believe
that these screenings may not require a full 15 minutes to perform for
the typical patient, so we believed that it would be appropriate to
propose to revise the descriptors to specify that screening times of 5
to 15 minutes would be the typical range to furnish these services.
This will establish a lower time limit for both HCPCS codes G0442 and
G0444. Therefore, we proposed to modify the descriptor for HCPCS code
G0442 to read ``Annual alcohol misuse screening, 5 to 15 minutes'' and
for HCPCS code G0444 to read ``Annual depression screening, 5 to 15
minutes.''
We received a number of comments concerning the adjustments to the
descriptors of HCPCS codes G0442 and G0444.
Comment: Commenters were all in favor of the descriptor changes
made for these codes and for the clarification of these services. The
commenters universally expressed their support and a few recommended
that CMS should re-review the valuations for these services to ensure
proper payment.
Response: We thank commenters for their supporting comments on the
descriptor adjustments to HCPCS codes G0442 and G0444. When substantial
descriptor changes are made to some CPT codes, that does signal to CMS
to re-review all aspects of a service and to possibly align for proper
payment. These descriptor changes were to HCPCS codes and they do not
change the currently established payments for them. They are just a
clarification for the claims process to smooth out any possible
misunderstanding of conditions of payment and our original intent in
allowing payments for these services.
After review and consideration of all comments regarding our
proposals for HCPCS codes G0442 and G0444, we are finalizing our
descriptor changes as proposed, to ``Annual alcohol misuse screening, 5
to 15 minutes'' for HCPCS code G0442 and to ``Annual depression
screening, 5 to 15 minutes.'' for HCPCS code G0444.
(32) Insertion, and Removal and Insertion of New 180-Day Implantable
Interstitial Glucose Sensor System (HCPCS Codes G0308 and G0309)
For the CY 2021 PFS final rule (85 FR 84645), we established
national pricing for 3 Category III CPT codes that describe continuous
glucose monitoring. Category III CPT codes 0446T (Creation of
subcutaneous pocket with insertion of implantable interstitial glucose
sensor, including system activation and patient training), 0447T
(removal of implantable interstitial glucose sensor from subcutaneous
pocket via incision), and 0448T (removal of implantable interstitial
glucose sensor with creation of subcutaneous pocket at different
anatomic site and insertion of new implantable sensor, including system
activation) describe the services related to the insertion, removal,
and removal and insertion of an implantable interstitial glucose sensor
from a subcutaneous pocket. The implantable interstitial glucose
sensors are part of systems that can allow real-time glucose
monitoring, provide glucose trend information, and signal alerts for
detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia). The direct PE
inputs for CPT code 0446T include a 90-day supply item, SD334
(implantable interstitial glucose sensor), and a 90-day smart
transmitter proxy equipment item, EQ392 (heart failure patient
physiologic monitoring equipment package). The direct PE inputs for CPT
code 0448T include only the 90-day SD334 interstitial glucose sensor.
For CY 2022, based on requests from interested parties for CMS to
allow beneficiaries critical access to a newly approved 180-day
continuous glucose monitoring system, CMS established two new HCPCS
codes to describe the new 180-day monitoring service. Specifically, CMS
established HCPCS code G0308 (Creation of subcutaneous pocket with
insertion of 180-day implantable interstitial glucose sensor, including
system activation and patient training) and G0309 (removal of
implantable interstitial glucose sensor with creation of subcutaneous
pocket at different anatomic site and insertion of new 180-day
implantable sensor, including system activation). The newly approved
180-day continuous glucose monitoring system extends the monitoring
period from the previous 90 days to allow for a longer monitoring
period between replacement of the sensor. We believe it is important
for beneficiaries to have continued access to this service during the
transition from a 90- to 180-day monitoring period where the 90-day
sensor may become obsolete. Therefore, effective July 1, 2022, HCPCS
codes G0308 and G0309 are contractor priced. We solicited information
and invoices from interested parties on the costs of the 180-day
interstitial glucose supply and 180-day smart transmitter equipment
direct PE inputs for HCPCS codes G0308 and G0309 to ensure proper
payment for these physician's services, for consideration of national
payment amounts for CY 2023. We noted that the 90-day supply item,
SD334, is currently priced at $1,500 based on information we received
from interested parties. The 90-day smart transmitter, EQ392, is
currently priced at $1,000 and assigned a time value of 25,290 minutes
derived from 60 minutes per hour times 24 hours per day times 90 days
per billing quarter divided by 1 minute of equipment use of every 5
minutes of time. HCPCS code G0308 includes the smart transmitter and
interstitial glucose sensor and HCPCS code G0309 includes the
interstitial glucose sensor only.
Comment: Commenters supported our creation of G codes G0308 and
G0309 to describe the new 180-day interstitial continuous glucose
monitor. Commenters also requested that we
[[Page 69524]]
delete the G codes effective January 1, 2023 and revalue CPT codes
0446T and 0448T to include direct PE costs for the new sensor and
transmitter, since the current 90-day sensor and transmitter has become
obsolete. We also received invoices and pricing information from a
commenter to support their requested PE revaluation.
Response: We agree with commenters that we should delete G codes,
G0308 and G0309, effective January 1, 2023 to ensure accurate payment
for the new 180-day Continuous Glucose Monitoring device. We also agree
to revalue the PE inputs for the existing CPT codes, 0446T and 0448T.
The invoices that we received from a commenter list a supply increase
(SD334) from $1,500 to $3,000, which would be a supply input for both
0446T and 0448T. The invoices also list the equipment (EQ392) as having
an increase in equipment minutes, but not a change in the cost of the
transmitter itself. The increase in equipment minutes applies only to
CPT code 0446T. The physician work remains the same for both codes,
therefore there is no change to work RVUs.
In consideration of the comments and invoices received, we are
finalizing changes to codes G0308, G0309, 0446T, and 0448T. G codes
G0308 and G0309 will be deleted effective January 1, 2023. CPT codes
0446T and 0448T will have supply input SD334 valued at $3,000. CPT code
0446T equipment EQ392 will have equipment minutes equal to 60 minutes *
24 hours * 30 days * 6 months/1 out of every 5 minutes = 51,840
minutes.
(33) Chronic Pain Management and Treatment (CPM) Bundles (HCPCS G3002
and G3003, Formerly GYYY1 and GYYY2, Respectively)
(a) Background and Proposal
In the CY 2022 PFS proposed rule (86 FR 39104, 39179 through
39181), we solicited comments on and explored refinements to the PFS
that would appropriately value chronic pain management and treatment
(CPM) for the purpose of future rulemaking. In our solicitation, we
described Federal efforts for more than a decade to effectively address
pain management as a response to the nation's overdose crisis,\10\ such
as the National Pain Strategy \11\ and the HHS Pain Management Best
Practices Inter-Agency Task Force (PMTF) Report.\12\ As we noted in our
CY 2022 comment solicitation, several sections of the Support for
Patients and Communities Act of 2018 \13\ (SUPPORT Act) describe
actions the Department of Health and Human Services has been directed
to take to improve pain care, such as section 2003, which amended
Medicare's Annual Wellness Visit \14\ to include a review of factors
for evaluation related to pain for patients using opioid medications;
section 6086, the Dr. Todd Graham Pain Management Study; \15\ and
section 6032, which required CMS to furnish a Report to Congress and
develop a related Action Plan to review coverage and payment policies
in Medicare and Medicaid related to the treatment of opioid use
disorder and for non-opioid therapies to help manage acute and chronic
pain.\16\ In the section 6032 Report and the Action Plan, CMS included
a recommendation to explore the possibility of establishing a new
bundled payment under the Medicare Physician Fee Schedule for
integrated multimodal pain care that could include certain elements
such as diagnosis, a person-centered plan of care, care coordination,
medication management, and other aspects of pain care.
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\10\ https://www.hhs.gov/overdose-prevention/.
\11\ https://www.iprcc.nih.gov/sites/default/files/documents/NationalPainStrategy_508C.pdf.
\12\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
\13\ https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf.
\14\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
\15\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\16\ https://www.cms.gov/sites/default/files/2022-4/SUPPORT%206032%20Action%20Plan_Final_061521_Clean.pdf.
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As described in Goal 3 of CMS' 2022 Behavioral Health Strategy \17\
(Strategy), CMS intends to improve the care experience for individuals
with acute and/or chronic pain, expand access to evidence-based
treatments for acute and chronic pain, and increase coordination
between primary and specialty care through payment episodes,
incentives, and payment models. In late 2019, the CMS Office of Burden
Reduction & Health Informatics launched the ``Chronic Pain Stakeholder
Engagement,'' which focused on understanding access to covered
treatment and services for people living with pain. \18\ CMS recently
released information gathered from interested parties through this
Engagement using qualitative research methods and the human-centered
design process, to uncover provider burden, and identify opportunities
to improve access to covered services by illustrating the experiences
of people living with, and treating, chronic pain. The intent of this
project was to highlight the most prominent barriers people with pain
face in accessing care, and the factors influencing clinicians that can
affect people with chronic pain, the quality of their care, and their
quality of life.
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\17\ https://www.cms.gov/cms-behavioral-health-strategy.
\18\ https://www.cms.gov/About-CMS/OBRHI.
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In the context of the Biden-Harris' Administration's commitment to
equity,\19\ and the inclusion of equity as a pillar of CMS' Strategic
Vision,\20\ disparities exist in pain treatment due to bias in
treatment, language barriers, cultural norms, and socioeconomic status.
We are also aware that pain is a factor in suicidality and suicide,
prioritized in the Surgeon General's Call to Action to Implement the
National Strategy for Suicide Prevention \21\ and in HHS' work to
implement ``988'',\22\ the new national dialing code for suicide and
crisis assistance that was implemented nationally this year.
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\19\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
\20\ https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
\21\ https://www.hhs.gov/sites/default/files/sprc-call-to-action.pdf.
\22\ https://www.samhsa.gov/find-help/988.
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In coordination with all of these initiatives, we also have
continued to explore refinements to the PFS that would appropriately
value CPM. In the CY 2022 PFS proposed rule, we sought comment on
whether we should approach CPM through a standalone code or E/M add-on
coding, and about the specific activities that are involved in CPM, how
we might value such a code or service, the settings where this care is
provided, the types of practitioners that furnish this care, and
whether the service or any components of it could or should be
furnished as ``incident to'' \23\ services under the direction of the
billing practitioner by other members of the care team (86 FR 39182).
We received just under 2,000 comments on this comment solicitation,
including comments from provider associations, federations, and
societies that represent health care professionals; organizations that
educate, connect, and advocate for people with pain; State-based health
care organizations, medical societies and associations; cancer care
centers; health care companies; device manufacturers; pain care
providers; and people living with pain. Almost all commenters were
supportive of our efforts to carefully consider an approach to coding
and payment for care for CPM. Many commenters supported the creation of
separate coding and payment for CPM under the PFS. We summarized
[[Page 69525]]
these comments, expressed appreciation for the commenters' attention to
informing our approach to payment and coding for comprehensive CPM
services, and thanked the commenters for their comments in the CY 2022
PFS final rule (86 FR 65129).
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\23\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se0441.pdf.
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Generally, commenters agreed that efforts are needed to effectively
support the complex needs of beneficiaries with chronic pain.
Commenters emphasized that there are numerous conditions giving rise to
chronic pain and that people presenting with chronic pain respond
variably to various treatment modalities, and often require longer
office visit times, and longer follow-up coordinating care with social
workers and case managers, mental and behavioral health support,
communications with emergency department physicians and nurses, and
numerous medication adjustments. One commenter stated that
beneficiaries with complex chronic pain conditions may require a lot of
time for correct dosing of medications and counseling, and that such
time is not captured effectively using existing E/M codes. This
commenter also believed that separate coding and payment for chronic
pain management could help with better understanding of the treatment
of chronic pain than when the service is reported with existing visit
codes and would allow for valuation based on the resources involved in
furnishing these specific services to people with chronic pain,
enhancing the likelihood of appropriate payment, especially for non-
face-to-face time involved with the service.
A few commenters expressed preference for using existing E/M codes
and the creation of codes to be used in conjunction with E/M codes. One
commenter suggested that CMS either clarify or modify existing codes so
they can support services for patients with chronic pain or significant
acute pain, as well as beneficiaries with a chronic disease and a
behavioral health condition, stating that using the existing codes
would avoid any concerns about overpayment for patients with both a
chronic disease and pain, while also making it more feasible for small
practices to employ care management staff and provide customized care
management services for all the patients who need them.
One commenter who was agreeable with various approaches to payment
suggested that the guidelines for Cognitive Assessment and Care Plan
Services code 99483 include ``chronic pain syndromes'' in the
``assessment of factors that could be contributing to cognitive
impairment'' and that these codes could be reported by physicians who
consult with a pain specialist about their patient's pain. This
commenter also suggested that Transitional Care Management could also
potentially include pain management following inpatient care to help
prevent acute pain from progressing to chronic pain. Other commenters
also likened CPM services to chronic care management services. We
believe that chronic care management codes, which, except for Principal
Care Management, specify that the chronic condition being managed is
expected to last at least one year or until death, would not properly
describe the condition of many beneficiaries with chronic pain, which
could potentially improve with treatment and intervention, or recur
after improvement. For example, the 11th revision of the World Health
Organization's International Classification of Diseases and Related
Health Problems define chronic pain as persistent or recurring pain
lasting longer than 3 months.\24\
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\24\ https://icd.who.int/en.
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Commenters included feedback about other specific activities
involved in the management of patients with chronic pain in addition to
those we specified in the comment solicitation. Commenters also
identified codes that CMS might examine as models for payment, either
as stand-alone timed codes or monthly bundles. Commenters suggested
which practitioners should be able to bill such CPM codes, which
practitioners should be able to furnish CPM services incident to the
services of a physician or other practitioner, and expressed views on
adding CPM services to the Medicare Telehealth Services List and
obtaining beneficiary consent for CPM services.
We agree with commenters who believe that E/M codes may not reflect
all the services and resources required to furnish comprehensive,
chronic pain management to beneficiaries living with pain. While we
agree in principle that it might be appropriate to establish bundled
all-inclusive coding with monthly payment for a broader set of CPM
services, we do not have data at the present time on the full scope of
services and resource inputs involved in care for patients with chronic
pain to support development of a proposed monthly bundled all-inclusive
rate. We do believe that E/M codes do not appropriately reflect the
time and other potential resources involved in furnishing comprehensive
CPM for beneficiaries with chronic pain. Beginning in the CY 2014 PFS
final rule (78 FR 74414 through 74427), we recognized that the
resources involved in furnishing comprehensive care to patients with
multiple chronic conditions are greater than those required to support
care in a typical E/M service. In response, we finalized a separately
payable HCPCS code G0316 (Chronic Care Management (CCM) services
furnished to patients with multiple (2 or more) chronic conditions
expected to last at least 12 months, or until the death of the patient;
20 minutes or more per in 30 days of chronic care management services
provided by clinical staff and directed by a physician or other
qualified health care practitioner). The following year, in the CY 2015
PFS final rule (79 FR 67715 through 67730), we refined aspects of the
existing CCM policies and adopted separate payment for CCM services
under CPT code 99490 (Chronic care management services (CCM), at least
20 minutes of clinical staff time directed by a physician or other
qualified health professional, per calendar month, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient; Chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; Comprehensive care
plan established, implemented, revised, or monitored). In the CY 2017
PFS final rule (81 FR 80244), we adopted CPT codes 99487 (Complex
chronic care management (CCCM) services with the following required
elements: Multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient, chronic conditions
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored, moderate or high
complexity medical decision making; first 60 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month) and 99489 (CCCM services with the
following required elements: Multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient,
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, comprehensive
care plan established, implemented, revised, or monitored, moderate or
high complexity medical decision making; each additional 30 minutes of
clinical staff time directed by a physician or other qualified health
care professional,
[[Page 69526]]
per calendar month (List separately in addition to code for primary
procedure)). Then, in the CY 2019 PFS final rule (83 FR 59577), we
adopted a new CPT code, 99491 (CCM services, provided personally by a
physician or other qualified health care professional, at least 30
minutes of physician or other qualified health care professional time,
per calendar month, with the following required elements: Multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient; chronic conditions place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline; comprehensive care plan established, implemented,
revised, or monitored), to describe at least 30 minutes of CCM services
performed personally by a physician or NPP. In the CY 2020 PFS final
rule (84 FR 62690), we established payment for an add-on code to CPT
code 99490 by creating HCPCS code G2058 (CCM services, each additional
20 minutes of clinical staff time directed by a physician or other
qualified healthcare professional, per calendar month). We also created
two new HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694),
representing comprehensive services for a single high-risk disease
(that is, principal care management). In the CY 2021 PFS final rule (85
FR 84639), we finalized a RUC-recommended replacement code for HCPCS
code G2058 with the identical descriptor, CPT code 99439, and assigned
the same valuation as for G2058. For CY 2022, the RUC resurveyed the
CCM code family, including CCCM and Principal Care Management (PCM),
and added five new CPT codes: 99437 (CCM services each additional 30
minutes by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure)), 99424 (PCM services for a single high-risk disease first
30 minutes provided personally by a physician or other qualified health
care professional, per calendar month), 99425 (PCM services for a
single high risk disease each additional 30 minutes provided personally
by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure), 99426 (PCM, for a single high-risk disease first 30 minutes
of clinical staff time directed by physician or other qualified health
care professional, per calendar month), and 99427 (PCM services, for a
single high-risk disease each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure)).
The CCM/CCCM/PCM code family now includes five sets of codes, each
set with a base code and an add-on code. The sets vary by the degree of
complexity of care (that is, CCM, CCCM, or PCM), who directly performs
the services (that is, clinical staff, or the physician or NPP), and
the time spent furnishing the services. The RUC-recommended values for
work RVUs and direct PE inputs for these codes in CY 2022 were derived
from a recent RUC specialty society survey. We proposed to accept the
RUC-recommended values, considered public comments, and finalized the
proposed values for the 10 CCM/CCCM/PCM codes.
In consideration of the supportive comments we received last year
in response to our comment solicitation, clinical expertise within CMS,
and internal input from CMS staff and from our HHS operating division
partners, we proposed to create separate coding and payment for CPM
services beginning January 1, 2023. We recognize that there is
currently no existing CPT code that specifically describes the work of
the clinician who performs comprehensive, holistic CPM. We also believe
the resources involved in furnishing CPM services to beneficiaries with
chronic pain are not appropriately recognized under current coding and
payment mechanisms. As noted above, we do not believe that E/M codes
and values appropriately reflect time involved in furnishing CPM for
beneficiaries with chronic pain. CMS has authority under section 1848
of the Act to establish codes that describe services furnished by
clinicians and suppliers that bill for physicians' services, and to
establish payment amounts for those services that reflect the relative
value of the resources involved in furnishing them. We also expect that
creating separate coding and payment for CPM will help facilitate the
development of data regarding the prevalence and impact of chronic pain
in the Medicare population, where conditions including osteoarthritis,
cancer, and other similar conditions that cause pain over extended
periods of time are common.\25\ Such information can assist us in
identifying potential coding and valuation refinements to ensure
appropriate payment for these services. We also believe that the
comprehensive care management involved in CPM services may potentially
prevent or reduce the need for acute services, such as those due to
falls \26\ and emergency department care \27\ associated with chronic
pain--for example, sickle cell disease or migraine pain--and also have
the potential to reduce the need for treatment for concurrent
behavioral health disorders, including substance use disorders. There
is some evidence that addressing chronic pain early in its course may
result in averting the development of ``high-impact'' chronic pain \28\
in some individuals; these people report more severe pain, more
difficulty with self-care, and higher health care use than others with
chronic pain.
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\25\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CC_Main.
\26\ https://www.cdc.gov/falls/facts.html.
\27\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\28\ https://www.sciencedirect.com/science/article/pii/S1526590018303584?via%3Dihub.
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There are various definitions for chronic pain from, for example,
the Centers for Disease Control and Prevention \29\ and the National
Institutes of Health,\30\ and in the Institute of Medicine's (IOM)
``Relieving Pain in America: A Blueprint for Transforming Prevention,
Care, Education, and Research'',\31\ and in the World Health
Organization International Classification of Disease Edition 11,--most
define chronic pain consistently, with some variation, as pain that
persists longer than 3 months. The CDC, for example, has defined
chronic pain within its 2016 opioid prescribing Guideline as ``pain
that typically lasts >3 months or past the time of normal tissue
healing, and can be the result of an underlying medical disease or
condition, injury, medical treatment, inflammation, or an unknown
cause.'' For clarity and operational use, we proposed to define chronic
pain as ``persistent or recurrent pain lasting longer than 3 months.''
We welcomed comments from the public regarding whether this was an
appropriate definition of chronic pain, or whether we should consider
some other interval or description to define chronic pain. We were also
interested in hearing from commenters about how the chronic nature of
the person's pain should be documented in the medical record.
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\29\ https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf.
\30\ https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.
\31\ https://www.ncbi.nlm.nih.gov/books/NBK92525/#ch1.s3.
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We posited a monthly payment approach may also be more financially
straightforward from the standpoint of
[[Page 69527]]
beneficiaries receiving treatment for chronic pain, particularly with
respect to applicable coinsurance, which is generally 20 percent of the
payment amount, after the annual Part B deductible amount is met.\32\
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\32\ https://www.medicare.gov/what-medicare-covers/what-part-b-covers.
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Beginning for CY 2023, we proposed to create two HCPCS G-codes to
describe monthly CPM services. The codes and descriptors for the
proposed G-codes are:
HCPCS code G3002: Chronic pain management and treatment,
monthly bundle including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and/or maintenance of a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes; overall treatment management; facilitation and
coordination of any necessary behavioral health treatment; medication
management; pain and health literacy counseling; any necessary chronic
pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.
physical therapy and occupational therapy, and community-based care, as
appropriate. Required initial face-to-face visit at least 30 minutes
provided by a physician or other qualified health professional; first
30 minutes personally provided by physician or other qualified health
care professional, per calendar month. (When using G3002, 30 minutes
must be met or exceeded.)
HCPCS code G3003: Each additional 15 minutes of
chronic pain management and treatment by a physician or other qualified
health care professional, per calendar month. (List separately in
addition to code for G3002. When using G3003, 15 minutes must be met or
exceeded.)
We were interested in hearing from commenters regarding our
proposed inclusion of ``administration of a validated pain assessment
rating scale or tool,'' as an element of the proposed CPM services, and
including it within the descriptor of the proposed HCPCS code G3002. We
also solicited comment on whether a repository or list of such tools
would be helpful to practitioners delivering CPM services.
We proposed to include, as an element of the CPM codes, the
development of and/or revisions to a person-centered care plan that
included goals, clinical needs, and desired outcomes, as outlined above
and maintained by the practitioner furnishing CPM services.
We proposed to include health literacy counseling as an element of
the CPM codes, because we believe it will enable beneficiaries with
chronic pain to make well-informed decisions about their care,
increases pain knowledge, and strengthens self-management skills.
Health literacy is the degree to which individuals have the ability to
find, understand, and use information and services to inform health-
related decisions and actions for themselves and others.\33\ Adequate
health literacy may improve the person's capability to take
responsibility for their health, including pain-related health issues
such as adherence to treatment regimens and medication administration,
and have a positive influence on health outcomes, and health
disparities. CMS' Network of Quality Improvement and Innovation
Contractors have used health literacy counseling to improve health
counseling,\34\ and health literacy counseling has been used to treat
arthritis.\35\ We noted in the proposed rule that we were interested in
hearing from commenters about how pain and health literacy counseling
is or may be effectively used as a service element to help
beneficiaries with chronic pain make well-informed decisions about
their own care, weigh risks and benefits, make decisions, and take
actions that are best for them and their health.
---------------------------------------------------------------------------
\33\ https://health.gov/healthypeople/priority-areas/health-
literacy-healthy-people-
2030#:~:text=Health%20literacy%20is%20a%20central,well-
being%20of%20all.%E2%80%9D.
\34\ https://qi.ipro.org/health-equity/health-literacy/.
\35\ https://www.ahrq.gov/health-literacy/improve/precautions/1stedition/tool3.html.
---------------------------------------------------------------------------
For HCPCS code G3002, we proposed to include an initial face-to-
face visit of at least 30 minutes, provided by a physician or other
qualified health professional, to a beneficiary who has chronic pain,
as defined above, or is being diagnosed with chronic pain that has
lasted more than 3 months at the time of the initial visit. After
consultation with our medical officers, we believe the management of a
new patient with chronic pain would involve an initial face-to-face
visit of at least 30 minutes due to the complexity involved with the
initial assessment. We believe follow-up or subsequent visits could be
non-face to face. HCPCS code G3003 describes an additional 15 minutes
of CPM and treatment by a physician or other qualified health care
professional, per calendar month (listed separately in addition to
G3002). We solicited comment on the appropriateness of the proposed 30-
minute duration per calendar month for G3002, and also on the proposed
duration and frequency for G3003. We also solicited comment on whether
we should consider specifying a longer duration of time for G3002 (for
example, one hour--or 45 minutes). Similarly, we solicited comment on
whether we should consider specifying a longer duration of time for
G3003 (for example, 20-minute increments). We also welcomed comment on
our proposal to permit billing of CPM services for beneficiaries who
have already been diagnosed with chronic pain, and for people who are
being diagnosed with chronic pain during the visit.
We welcomed comments regarding how best the initial visit and
subsequent visits should be conducted (for example, in-person, via
telehealth, or the use of a telecommunications system, and any
implications for additional or different coding). We also considered
whether to add the CPM codes to the Medicare Telehealth Services List,
based on our review of any information provided through the public
comments and our analysis of how these new services may be
appropriately furnished to Medicare beneficiaries. We also requested
comment regarding whether there are components of the proposed CPM
services that do not necessarily require face-to-face interaction with
the billing practitioner, such as care that could be provided by
auxiliary staff incident to the billing practitioner's services. For
any components that could be furnished incident to the services of the
billing practitioner, we requested comment on whether these could be
appropriately furnished under the general supervision of the billing
physician or non-physician practitioner (NPP), for example,
administration of a pain rating scale or tool, or elements of care
coordination, as we have provided for certain care management services.
We believe that most CPM services would be billed by primary care
practitioners who are focused on long-term management of their patients
with chronic pain. As calls for improved pain management have increased
in recent years, this has resulted in better education and training of
primary care practitioners and heightened awareness of the need for
pain care nationally. We believe the codes we proposed for CPM services
will create appropriate payment for physicians and other practitioners
(beyond primary care practitioners) that reflects the time and
resources involved in attending comprehensively to the needs of
beneficiaries with chronic pain. As the IOM ``Blueprint'' report noted,
even people who need consultation with a pain specialist
[[Page 69528]]
should benefit from the sustained involvement of a primary care
practitioner who is able to help coordinate care across the full
spectrum of health care providers, as such coordination ``helps prevent
people from seeking relief from multiple providers and treatment
approaches that may leave them frustrated and angry and worse off both
physically and mentally, and from falling into a downward spiral of
disability, withdrawal, and hopelessness.'' \36\ The Blueprint stated
that this type of fragmentation hinders the development of a strong,
mutually trusting relationship with a single health professional who
takes responsibility, and that this established relationship is one of
the keys to successful pain treatment. We anticipated that if these
proposed codes are finalized, primary care practitioners will employ a
variety of person-centered pain management strategies, such as those
suggested in the PMTF Report and illustrated in CMS' CPM graphic \37\
including medications, therapies, exercise, behavioral health
approaches, complementary and integrative health, and community-based
care based on the complexity, goals, and characteristics of each person
they serve with chronic pain and according to the person-centered plan
of care. It is also important to note that, in many parts of the
country, people have access only to their primary care practitioner for
chronic pain care.\38\ We understand, however, the need or desire that
some individuals with chronic pain have to be seen on an ongoing basis
for CPM by a pain specialist who has received special training and/or
certification to meet the needs of the most complex and challenging
patients with chronic pain.
---------------------------------------------------------------------------
\36\ https://www.ncbi.nlm.nih.gov/books/NBK91497/.
\37\ https://www.cms.gov/files/document/cms-chronic-pain-journey-map.pdf.
\38\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
---------------------------------------------------------------------------
Therefore, we proposed to permit billing by another practitioner
after HCPCS code G3002 has already been billed in the same calendar
month by a different practitioner. In these situations, we anticipate
that there could be occasional instances where care of an individual
with chronic pain is transferred to a pain specialist or other
specialist during the same month they received the CPM services from a
primary care practitioner, for ongoing care. In these or other
situations (such as when the beneficiary elects to choose a different
physician or practitioner to furnish CPM services), we would anticipate
G3002 and potentially G3003 could be billed by another practitioner
during the same month, for the same beneficiary. We believe that it
would be unlikely for G3002 to be billed more than twice per month
under such circumstances and proposed placing a limit on the number of
times the code could be billed per beneficiary per calendar month, at a
maximum of twice per calendar month. We solicited comment on our
proposal to permit billing by another practitioner after the G3002 has
already been billed in the same month by a different practitioner, and
on the number of times the code could be appropriately billed per
month, per beneficiary.
We proposed to require that the beneficiary's verbal consent to
receive CPM services at the initiating visit be documented in the
beneficiary's medical record, as not all Medicare beneficiaries with
chronic pain eligible to receive these separately billable CPM services
may understand or want to receive these services, and the beneficiary
should be aware that they are receiving them. At the initial visit, the
beneficiary with chronic pain should be educated regarding what the CPM
services are, how often they may generally expect to receive the
services, and have an explanation of any cost sharing that may apply in
their particular situation. Practitioners have informed us that
beneficiary cost sharing is a significant barrier to provision of
similar care management services, such as CCM services, and we
solicited comment on how best to effectively educate both practitioners
and beneficiaries with chronic pain about the existence of, and the
benefits and value of, the proposed CPM services. We solicited comment
regarding whether the initiating visit is the appropriate time for
billing practitioners to obtain beneficiary verbal consent, if consent
should be given at each visit, and also if beneficiary consent should
be sought by the practitioners with whom CPM billing practitioners
coordinate other Medicare services under the CPM plan of care, or even
more broadly.
We believe there might be some potential for duplicative payment
for services allocated to the same patient concurrent with certain
other Medicare care management services, such as CCM or behavioral
health integration (BHI) services; however, we believe the proposed CPM
codes have features that would mitigate such circumstances, such as the
elements of the service that specifically address the beneficiary's
pain--for example, the administration of a validated pain rating scale
or tool. We welcomed comments regarding what, if any, Medicare services
we should consider that could not be billed by the same practitioner
for the same patient concurrent with any other Medicare services, to
avoid duplication of payment, and help limit financial burden to the
Medicare beneficiary with chronic pain. We noted that we would expect
to refine these codes as needed through future rulemaking as we receive
more information how the codes are being used, and how they are
implemented in practice.
To the extent that components of the proposed CPM codes are also
components of other care management services, we reiterate our policy
against double-counting time and require that the time used in
reporting CPM services may not represent time spent in any other
reported service. We proposed that the CPM codes could be billed in the
same month as a care management service, such as CCM, or BHI. We
believe there are circumstances in which it is reasonable and necessary
to provide both services in a given month, based on the needs of the
Medicare beneficiary with chronic pain, for example, when the
beneficiary has both chronic pain, and a mental disorder(s), or
multiple chronic conditions. We also proposed that the CPM codes would
be able to be billed for the same Medicare patient in the same month as
another bundled service such as HCPCS Codes G2086-G2088, which describe
bundled payments under the PFS for opioid use disorders. We noted that
patient consent would need to be obtained for both of the bundled
services such as, for example, CPM and BHI, and all other requirements
to report CPM and to report the other service or services would need to
be met. We invite comments on these billing proposals and their
appropriateness in the context of CPM.
Finally, we questioned commenters whether we should consider
creating additional coding and payment to address acute pain. We are
interested in information regarding a definition for acute pain,
standalone or E/M coding, the specific activities that could be
furnished, how we might value and price such a code or service, the
settings where care should be provided, the types of practitioners that
should furnish acute pain care, if the service or any components should
be furnished as ``incident to'' services under the direction of the
billing practitioner or by other members of the care team, and other
information that might help us in proposing such a code or codes.
[[Page 69529]]
(b) Valuation of Chronic Pain Management Services
Consistent with the valuation methodology for other services under
the PFS, proposed HCPCS codes G3002 and G3003 would be valued based on
what we believe to be a typical case, and we understand that, based on
variability in patient needs, some patients will require more
resources, and some fewer. The proposed CPM codes would separately pay
for a specified set of CPM elements furnished during a month, including
the administration of validated rating scales, establishment and review
of a person-centered care plan that includes goals, clinical needs, and
desired outcomes, and other elements as described in the proposed code
descriptors. To value CPM, we compared the proposed services to codes
that involve care management. In doing so, we concluded that the CPM
services were similar in work (time and intensity) to that of PCM in
that both the PCM codes and proposed CPM codes reflect services that
have similar complexities, possible comorbidities, require cognitive
time on the part of the practitioner, and may involve coordination of
care across multiple practitioners.
For HCPCS code G3002, we developed proposed inputs using a
crosswalk to CPT code 99424 (Principal care management services, for a
single high-risk disease, with the following required elements: One
complex chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/decompensation, functional decline, or death; the
condition requires development, monitoring, or revision of disease-
specific care plan; the condition requires frequent adjustments in the
medication regimen and/or the management of the condition is unusually
complex due to comorbidities; ongoing communication and care
coordination between relevant practitioners furnishing care; first 30
minutes provided personally by a physician or other qualified health
care professional, per calendar month.), which is assigned a work RVU
of 1.45. Additionally, for G3002 we proposed to use a crosswalk to the
direct PE inputs associated with CPT code 99424. We believe that the
work and PE described by this crosswalk code is analogous to the
services described in G3002, because G3002 includes similar care plan,
medication management, unusually complex clinical management; care
coordination between relevant practitioners furnishing care; and time
for care provided personally by a physician or other qualified health
care professional, as described in CPT code 99424.
We proposed to value G3003 at a work RVU of 0.50, using a crosswalk
to CPT code 99425 (each additional 30 minutes provided personally by a
physician or other qualified health care professional, per calendar
month) (List separately in addition to code for G3002), which is
assigned a work RVU of 1.00. However, the required minimum number of
minutes described in G3003 is half of the number of minutes in CPT code
99425. For HCPCS code G3003, we proposed to use a crosswalk to half of
the direct PE inputs associated with CPT code 99425. We believe that
the work and PE described by this crosswalk code is analogous to the
services described in G3003, because G3003 includes similar activities
as described in CPT code 99425.
We proposed that G3002 can only be billed when the full 30 minutes
of service time has been met or exceeded. Additionally, we proposed
that the add-on code (G3003) can only be billed when the full 15
minutes of service time is met or exceeded.
Our proposed valuation of CPM services includes services that are
personally performed by a physician (or other appropriate billing
practitioner, such as a nurse practitioner (NP) or physician assistant
(PA)) described by certain E/M visit codes that apply to a new patient
in various settings. Accordingly, we proposed that G3002/G3003 must be
furnished by the physician (or other appropriate billing practitioner)
and could not be billed on the same date of service as CPT codes 99202-
99215 (Office/outpatient visits new), since these codes reflect face-
to-face services furnished by the physician or other billing
practitioner for related, separately billable services that are being
furnished to a patient the practitioner has not previously seen. We
believe it would be unlikely the practitioner is prepared to address
the complex pain needs of a new patient on the same day he or she is
seen for a general visit, or a visit where the person is being seen for
some other illness or condition. We do not believe that the services
included in G3002/G3003 would significantly overlap with CCM services;
Transitional Care Management (TCM) services; or BHI services, which
have various clinical purposes separate from CPM. We do believe there
is likely overlap in the Medicare beneficiary population eligible to
receive CCM, TCM, BHI, and the proposed CPM services, but we believe
there are distinctions in the nature and extent of the assessments,
care coordination, medication management, and care planning for CPM to
allow concurrent billing for services that are medically reasonable and
necessary, and that it is particularly important to allow for the
provision of needed services, including behavioral health services, to
beneficiaries with chronic pain. We solicited comment on whether we
have appropriately identified the codes Medicare should not pay if
furnished during the same day as the proposed CPM codes, and if there
are circumstances where multiple care planning codes could be furnished
without overlap or other situations, such as where the practitioner is
seeing a new patient.
We noted that the proposed CPM codes would be limited to
beneficiaries in office or other outpatient or domiciliary settings. We
will consider for future rulemaking separately identifying and paying
for CPM services furnished to beneficiaries in any appropriate setting
of care, in recognition of the prevalence and burden of pain across all
settings of care, and the associated time and service complexity to
provide care for chronic pain. We appreciate comments on other settings
where CPM services could be provided.
(c) Request for Comment
We believe there could be circumstances in which a beneficiary
receiving CPM services needs referrals or recommendations, based on a
clinician's assessment, for services or interventions that are not
included as elements of the CPM services, such as for community-based
care or physical and occupational therapy. We welcomed comments on the
care coordination that may occur between relevant practitioners
furnishing services, such as complementary and integrative care, and on
the community-based care element included in the descriptors for
proposed G3002 and G3003.
We also asked commenters to weigh in on how documentation of the
performance of the elements of CPM services might best be addressed in
medical recordkeeping. We solicited general comment on whether there
are any elements of CPM services outlined in this proposal that the
public and interested parties believe are not typically furnished in
connection with comprehensive chronic pain management, or any proposed
elements of the CPM services that should be removed or altered. We
solicited comment on whether there are elements
[[Page 69530]]
of CPM services that we have not identified and should be added to the
code descriptors.
Additionally, we solicited comment on which, if any, CPM elements
could be furnished as ``incident to'' services, and whether to add
G3002 and G3003 to the list of services for which we allow general
supervision as described in our regulation at Sec. 410.26(b)(5). We
welcomed comments from the public for future rulemaking regarding what
elements of the CPM services could be furnished under general
supervision, or direct supervision. For example, facilitation and
coordination of any necessary behavioral health treatment, chronic pain
related crisis care, and ongoing communication and care coordination
between relevant practitioners furnishing care might be appropriate
activities to be considered under general supervision.
The proposed CPM codes may involve arrangements where the physician
or other health professional might work in collaboration with other
health care providers or members of a care team, such as a
psychologist, dental practitioner, or social worker, where these
individuals might furnish certain elements of the service bundle under
the direction of the physician or qualified health practitioner, such
as assessments, person-centered care planning, referrals to community-
based care, and other activities, as appropriate. We requested comments
on if, and how, we should structure the proposed CPM code and payment
for these services to account for these types of arrangements that
could include team-based care.
We received over 150 unique comments on our proposal from national
health care organizations including provider associations, federations,
and societies that represent health care professionals; organizations
that educate, connect, and advocate for people with pain; State-based
health care organizations, medical societies and associations; cancer
care centers; health care companies; hospice and palliative care
organizations; device manufacturers; pain care providers; and people
living with pain and their caregivers. Almost all commenters were
supportive of our proposal. We also received several comments mainly
from psychologists or psychology associations, requesting we adopt
additional coding without medication management in the code descriptor,
as medication management in most states is outside the scope of a
psychologist's license. The following is a summary of the comments we
received and our responses.
Comment: Commenters living with chronic pain and their caregivers
shared poignant stories about the importance of the proposed codes. One
person observed that in recent years, since the release of the Centers
for Disease Control and Prevention's (CDC) Guideline for Prescribing
Opioids, for people taking opioid medications or for those who were
forced to stop taking medications, the relationship between providers
and patients has become fraught, tense, and stigmatizing, even risky
for physicians and for all these reasons, many clinicians have refused
to treat chronic pain patients or have terminated chronic pain patients
from their practices, with growing numbers of pain patients unable to
find anyone to treat them, even if they do not use opioid medications.
The spouse of a person living with chronic pain told of repeated trips
to a local hospital seeking emergency treatment that worsened, instead
of improved, her care, in part because the couple believed clinicians
at the hospital were fearful of prescribing opioids and did not have
access to, or ignored, the recommendations of the patient's longtime
clinicians, who included several pain specialists. A beneficiary who
lives with chronic pain stated that she hoped the change in codes would
motivate clinicians to focus more attention on people with pain, as
after many years of seeing provider inexperience first-hand, along with
the accompanying administrative demands and paperwork pain care
demands, she believed having a special billing code will be a ``giant
step'' forward for people with pain, potentially allowing more people
like her with painful conditions to continue to contribute to society,
including through employment. A person living with chronic pain stated
he liked what he saw in the code proposal because he hoped it would
open the doors to more doctors who would provide pain care, including
appropriate medication management, because he thinks doctors are still
fearful of Federal and State prescribing guidelines. Another person
living with pain stated the CPM services are ``so needed by people like
me.''
One commenter noted that they would expect that the amount of pain
care required and the cost to Medicare to be large and increasing,
especially given the aging American population and the prevalence of
age-associated chronic pain conditions in Medicare like arthritis,
cancer, and diabetic neuropathy; the same commenter stated that pain
management is complex, and there are no existing codes that account for
all the tasks required to care for a patient with chronic pain, and
that a standalone code will signal to physicians that, when patients
have complaints of pain, it is critical to take them seriously.
Conversely, another commenter was not supportive of the new codes as
they believe that physicians will continue to bill evaluation and
management (E/M) codes to avoid adding to their administrative burden.
One commenter requested that we ``pause'' implementation of the
codes, further engage with interested parties, and make additional
clarifications within the code to address valuation, descriptors, and
guidance. Another commenter noted that they do not support including
the CPM codes in the applicable list used for accountable care
organizations beneficiary assignment, citing that managing chronic pain
does not routinely follow the overall health of the patient, and is
typically managed by clinicians with specific skills beyond primary
care. One commenter questioned if a single bundled code was adequate to
address the breadth of conditions that patients may experience, as well
as the variety of treatment and management approaches. One commenter
urged us to consider that for some people, a visit with a practitioner
might focus not just on pain management, but also whole-person care.
The same commenter noted that, although they appreciated our efforts to
simplify billing requirements for the CCM codes, uptake appears to be
low in part due to administrative burden, and they expressed concerns
that similar challenges would apply to the CPM codes, which could
entail documentation of services rendered in an E/M service. The
commenter asked us if we could determine a pathway to make billing more
streamlined, perhaps through billing using the G89.xx ICD-10 series. A
commenter thanked us for improving access to pain care, including
through prevention and treatment for substance use disorders (SUD). A
different commentator congratulated us on, through creation of the
codes, helping to prevent some individuals from developing SUD. One
commenter noted the codes would prompt more practitioners to welcome
Medicare beneficiaries with chronic pain into their practices, and
encourage practitioners already treating Medicare beneficiaries who
have pain to spend the time to help them manage their condition within
a trusting, supportive, and ongoing care partnership.
Response: We thank all the commenters who expressed enthusiastic
support of the proposed new HCPCS
[[Page 69531]]
codes for CPM services, and we appreciate the attention to informing
our approach in shaping this policy that we believe will provide
improved access to holistic and comprehensive pain management for
people with Medicare. A few commenters disagreed with our proposal. One
commenter stated that our proposal is not substantially different than
existing codes, while another questioned whether one code was
sufficient to address the breadth of conditions patients experiencing
chronic pain face. We do not agree that there is an existing code that
specifically describes the work of the clinician in performing the
specific tasks described in the code descriptor for HCPCS code G3002.
We anticipate that the CPM codes will be used to address the full range
of chronic pain conditions that impact Medicare patients. We look
forward to gaining more knowledge through data, and clinician and
beneficiary experience as use of the CPM codes becomes more frequent.
Comment: We received a few comments regarding our proposal to
define chronic pain as ``persistent or recurrent pain lasting longer
than 3 months.'' Most commenters agreed with our proposed definition.
We received several suggestions related to the specification of 3
months duration, including one month, 90 days, and the addition of
``expected to last longer'' to our definition. A few others suggested
we broaden the definition generally, to ensure that patients with
cancer, neuropathic pain, psychogenic pain, and headaches would also
benefit from this proposal to create HCPCS codes that describe CPM
services, while another commenter congratulated us on using language
that it noted was inclusive of all types of pain treatment. One
commenter asked us to integrate acute pain and biopsychosocial factors
into our definition, and stated that risk indicators of pain are
apparent early, potentially limiting robust interventions for the
prevention of chronic pain. One commenter opined that our definition of
chronic pain was overly broad and did not address the many types of
conditions that pain patients may experience. A commenter who agreed
with our definition noted that in the International Classification of
Disease, 11th edition (ICD-11),\39\ chronic pain has its own diagnosis,
independent of an underlying disease or condition. Still, another
commenter, who also agreed with our definition, noted there are ICD-10
diagnostic codes for chronic pain, the G89.xx series. Another commenter
agreed that the proposed definition is largely in line with their
understanding, adding more context to include, ``persistent or
recurrent pain without a serious progression or exacerbation of an
underlying pathologic condition and without tolerability over time.''
Another commenter stated that at a high level, they believe the metric
of ``time'' is not the dispositive component to define a chronic pain
diagnosis, but the definition should instead take into account a
complex series of associated factors like amount of suffering or
hindrance of function, and that not all recurrent pain should be
considered chronic pain; instead chronic pain as a diagnosis should be
utilized for an individual who does not understand how to manage or
live their life with their current, recurring, episodic symptoms.
---------------------------------------------------------------------------
\39\ https://icd.who.int/en.
---------------------------------------------------------------------------
Response: We appreciate all the commenters' suggestions and
observations. As we described in the proposed rule, we reviewed
definitions from the Centers for Disease Control and Prevention, the
National Institutes of Health, the World Health Organization,\40\ and
in the Institute of Medicine's ``Relieving Pain in America: A Blueprint
for Transforming Prevention, Care, Education, and Research.'' For
operational ease and consistency with the proposed rule and various
sources, we are finalizing as proposed the definition of chronic pain
as ``persistent or recurrent pain lasting longer than 3 months.''
---------------------------------------------------------------------------
\40\ https://painconcern.org.uk/new-classification-for-chronic-
pain/
#:~:text=Chronic%20primary%20pain%20is%20defined,explained%20by%20ano
ther%20chronic%20condition.
---------------------------------------------------------------------------
Comment: One commenter recommended we focus on improving care for
all pain, such as acute pain, as well as pain related to cancer, sickle
cell disease, and for people in palliative care, with another commenter
also agreeing that additional codes could focus on people with
palliative and cancer pain. This commenter noted that increased support
for comprehensive acute pain management could also reduce the number of
patients who progress from acute to chronic pain. This sentiment was
echoed by other commenters, who suggested an additional pain code for
acute care that would incorporate massage therapy and other
complementary and integrative services for both in-patient and
outpatient visits, as is seen in some large health systems. Several
other commenters generally supported the inclusion or addition of acute
pain management in this or other codes. One commenter suggested that
after we gain experience with the use of the codes for chronic pain, we
consider their application to acute pain management. A few commenters
did not support additional coding and payment for acute pain
management, as they believed these circumstances are adequately handled
via existing E/M coding and payment.
Response: As we mentioned in the proposed rule, we understand there
is some evidence that addressing chronic pain early in its course, such
as when the person is experiencing acute pain, may result in averting
the development of ``high-impact'' chronic pain in some individuals and
that these people report more severe pain, more difficulty with self-
care, and higher health care use than others with chronic pain. We
considered, in the development of this code, whether or not to include
acute pain, and elected not to include it in the CPM services
descriptor. We will continue to consider how best to approach
management of acute pain through coding and payment.
In our proposal, we required an initial face-to-face visit of at
least 30 minutes provided by a physician or other qualified health
professional with the first 30 minutes personally provided by the
physician or other qualified health professional, per calendar month
for HCPCS code G3002. We noted that HCPCS codes GYYY1 and GYYY2 were
placeholder codes and that the final code number will be HCPCS code
G3002 and G3003, respectively. We proposed, for HCPCS code G3003, an
additional fifteen minutes of CPM services by a physician or other
qualified health professional, per calendar month, and we proposed
limiting the application of HCPCS code G3003 to up to three units of an
additional 15 minutes of CPM services, per calendar month (listed
separately in addition to proposed HCPCS code G3002). We sought comment
on both the proposed duration of 30 minutes for HCPCS code G3002, and
the duration and the limit on HCPCS code G3003.
Comment: Most commenters agreed that our proposal for 30 minutes
for HCPCS code G3002 was reasonable and adequate for the treatment and
management of the first visit for a person with chronic pain and that
fifteen-minute intervals for subsequent time-based intervals is
adequate.
One commenter expressed a concern that neither code allowed for
adequate time, and that the codes should allow for at least an hour for
the first visit and 45 minutes for subsequent visits, especially to
allow for the intensity of clinical time that would be likely
[[Page 69532]]
needed to diagnose and treat a new patient. The same commenter urged
us, because the myriad of situations that could apply based on the
complexity of treating pain overall in the Medicare population, to
consider additional flexibilities in the duration of time for the codes
based on each person with pain's situation. Another commenter noted
that the time required to coordinate with other specialists, referrals,
therapies, and trial different treatments is ``considerable'' to create
and modify an individual treatment plan for each patient. Another
commenter suggested that twice a month billing for proposed HCPCS code
G3002 is insufficient for completion of the list of requirements, and
recommended that four visits per month be allowed to ensure that the
element list is completed. A separate commenter echoed this sentiment,
suggesting there be no limitation on the number of times per month this
code can be billed, citing the multitude of providers seen by some
patients. Another commenter recommended we consider extending the
length of visits from 45 minutes (30 minutes for proposed HCPCS code
G3002, 15 minutes for proposed G3003) to 60 minutes to account for the
complexity of pain care. A commenter noted that 30 minutes was too high
a threshold for appointments beyond the initial visit, and recommended
that subsequent visits only have a limit of 15 minutes after which
billing is allowed. One commenter stated that we should not put any
limits on the number of times proposed HCPCS code G3003 can be billed
each month. A commenter requested that the frequency and duration of
permitted CPM visits be flexible enough to account for the variety of
practice types--from primary care to specialized clinics offering
intensive and integrated chronic pain management services, and this
commenter also noted that patients have different intensities of need,
with some requiring longer appointments, or at greater frequency, while
some have lower needs, stating that 30 minute and 15 minute durations
of HCPCS codes G3002 and G3003 respectively, as well as the frequency,
may be too limited to adequately account for the challenging demands of
chronic pain management. Another commenter stated that 30 minutes seems
reasonable but flexibility is important as chronic pain conditions vary
and sometimes more than 30 minutes may be needed, especially for a
first visit. Another commenter requested clarification related to the
frequency of allowed billing for CPM codes, as some services such as
comprehensive palliative care require a wide range of care.
Response: We appreciate the commenters' overall support of our
proposal to set the duration of HCPCS code G3002 at 30 minutes, to
accommodate both the specified elements of the monthly bundle, and the
complex needs of the person with chronic pain, and we are finalizing
HCPCS code G3002 for 30 minutes duration. We agree with the commenters
who observed that additional flexibilities are needed to account for
the numerous situations that could apply to each person with pain's
clinical situation, and the factors that might go into the clinician's
determination regarding how much time is appropriate to spend treating
a person with chronic pain, and also how many and what type of
clinicians might need to also furnish care during a particular month.
Although we expect that in most instances the person with chronic pain
would see one clinician on a regular basis who is performing a lead
role in managing that individual's pain, we can also foresee limited
circumstances where a beneficiary may need to have their care
transferred to a pain specialist, or other specialist in the same
month, and the pain specialist or other specialist may also bill HCPCS
code G3002 for the same beneficiary, in the same month. There may also
be situations where the person with chronic pain needs to see two
different clinicians managing their pain on a regular basis, for
example, a cancer specialist and a rheumatologist, with both billing
the CPM code(s). We would not expect many beneficiaries living with
chronic pain would typically be seeing more than one or two physicians
or qualified health professionals in a month who might be performing
HCPCS code G3002; in part, because of the burden of care described by
chronic pain patients and their caregivers, and also because
beneficiaries incur cost-sharing expenses for these services and other
care they receive--typically 20 percent of the Medicare payment amount
after the annual Medicare Part B deductible amount is met.
Based on the comments, especially those that encouraged us to
increase billing flexibilities to account for the unique needs of each
person with chronic pain, we have reconsidered the proposed limit on
billing G3003 to three times per month, and are finalizing in this rule
flexibility to bill the second code, for each additional 15 minutes of
care, an unlimited number of times, as medically necessary, per month,
after HCPCS code G3002 has been billed. We will be monitoring use of
the codes going forward to understand more about how they are being
used.
Comment: One commenter asked if our proposal required the physician
to meet with the patient each month or only once in the initial month
of the service, as the commenter noted that monthly visits with the
physician are not likely to be necessary for some people receiving
ongoing chronic pain management. Another commenter stated that a
monthly visit may be onerous for cancer patients who are already
receiving time-intensive care. A commenter pointed out that it could
take year or more of regular visits to develop, coordinate, and revise
a treatment plan optimal in managing the patient's chronic pain; the
same commenter stated that a patient might drop back to bi-monthly,
quarterly, bi-annually, and annual visits so long as pain is being
effectively managed. Another commenter requested clarification
regarding if all the elements in the descriptor would be required each
month.
Response: We agree with the commenters who noted that each person
with chronic pain may not need to receive the monthly bundle every
month; rather, using a person-centered approach, one which optimizes
care according to individual circumstances and preferences, requires
variability in how often services are appropriately rendered.
Therefore, the CPM services for the HCPCS code G3002 may not be
rendered more than once per month by each individual practitioner
billing the code for each beneficiary, but could be rendered less than
twelve times per year, depending on the specific needs of the person
with chronic pain.
Comment: Some commenters requested clarification on our proposal
that the first time HCPCS code G3002 is billed that initial visit must
be in person, or if subsequent monthly visits must be ``face-to-face,''
or in person. Several commenters recommended that we not make in-person
first time visits an absolute requirement, so as to accommodate for
mobility difficulties for people living a long-distance from the
physician's office. Other commenters recommended that ``face-to-face''
components be available via both video and telecommunication technology
to support access. Several commenters stated that we needed to clarify
that the code required that only the very first visit be in-person, and
that follow-up visits could be delivered in-person, or by telehealth. A
different commenter's concern was that HCPCS code G3002 seemingly
requires an ``initial'' face-to-face visit of at least 30 minutes, and
while the commenter did
[[Page 69533]]
not object to one required initial face-to-face visit at the onset of
CPM treatment, they thought that CMS potentially requiring an in-person
visit monthly is unnecessary, overburdensome, and would exacerbate
health care disparities. One commenter noted an initial visit with the
patient could be supported by telehealth. Another commenter noted that
patients should be seen in the office for the initial visit, at least
until they are regulated on their pain medicines. An additional
commenter requested clarification as to whether a practitioner could
bill these codes both for patients that have an established history of
chronic pain, and those that are being diagnosed as having chronic pain
for the first time.
Response: We thank the commenters for their comments, but we are
finalizing the requirement that the first time HCPCS code G3002 is
billed, the physician or qualified health practitioner must see the
beneficiary in-person, where both individuals are in a clinical setting
such as a primary care practitioner's office or other applicable
setting. We believe that an in-person visit at the onset of care will
benefit both the clinician's accuracy in administering the elements of
the HCPCS code G3002 bundle of services, and help at the beginning of
care to foster a successful therapeutic relationship between the
clinician and the person with chronic pain. One commenter told us
doctor-patient relationships in pain management have become so
``fraught, mistrustful, and corrosive'' that they have led to a crisis,
as illustrated by CMS' own Journey Map of the Chronic Pain
Experience,\41\ which, in their view, accurately demonstrates the
current ``dysfunctional and damaging state'' of pain care. These
reports support our decision to require that the physician or other
qualified health professional meet with the beneficiary in person for
the first time. We acknowledge that for some people living with chronic
pain who may live far from the clinician's office, or who have issues
with transportation, or whose pain is exacerbated by activity, even
getting to a clinician in-person for a first visit may be challenging.
We are not requiring that each subsequent visit, whether these be
monthly or at some other periodicity be held in-person, but rather
leaving that determination to the discretion and preference of the
clinician and the beneficiary as they are best positioned to together
determine how to develop and maintain the care partnership to
effectively manage pain.
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\41\ https://www.cms.gov/files/document/cms-chronic-pain-journey-map.pdf.
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Comment: A commenter stated that while patients earlier in their
journey managing chronic pain may have care primarily coordinated by a
primary care practitioner, others progressing to high-impact chronic
pain may have their care mainly coordinated via a pain management
specialist; this commenter suggested we allow the codes to be billed at
a maximum twice per month to account for the difference in specialty
primarily managing a patient's care. This commenter also suggested we
add pain management specialists to the list of examples of care that a
patient might need (for example, physical and occupational therapy,
etc.).
Response: We agree with the commenter that it is possible that a
beneficiary living with chronic pain might need to see more than one
clinician type who is enabled to bill for the CPM services--as the
commenter noted, one likely scenario might be a person who sees a
primary care practitioner, and a pain specialist (for the purposes of
this rule, we are not defining ``pain specialist''). As described in
the proposed rule, we believe it is unlikely that most beneficiaries
with pain would want, or need to, see more than a few physicians or
other qualified health professionals in the same month to manage their
pain, and administer the elements of the CPM services for various
reasons, including the reasons commenters who urged us to add the CPM
services to the telehealth list have flagged. We also believe that the
beneficiary would likely object to, or could even by confused by,
having large numbers of clinicians managing their chronic pain.
Although we are not restricting the numbers of clinicians who can bill
HCPCS code G3002, we will be monitoring its use going forward to better
understand more about the types of practitioners and patients using the
CPM codes and services.
Comment: A few commenters requested clarification as to whether the
person being seen for the first time with proposed HCPCS code G3002 had
to have already been diagnosed with a chronic pain diagnosis, or a
condition that causes chronic pain. One commenter stated we should
include both people who both meet the definition of chronic pain on the
first visit, and also people who have adequate medication documentation
or concerns that would likely attest they have met the definition of
chronic pain, to create an equitable care environment.
Response: We are clarifying that the beneficiary, at the first
visit, need not have an established history or diagnosis of chronic
pain, or be diagnosed with a condition that causes or involves chronic
pain; rather, it is the clinician's responsibility to establish,
confirm, or reject a chronic pain and/or pain-related diagnosis when
the beneficiary first presents for care and the clinician is using
HCPCS code G3002.
Comment: Several commenters questioned if clinicians are required
to furnish all appropriate elements of the code bundle in each
encounter for HCPCS code G3002, including medication management. One
commenter stated that we should allow clinicians flexibility for any of
the services listed, in any order and over any time period to best
manage the person's pain condition(s) and that should allow for
omission of certain ones when they are not appropriate or not desired
by the patient (for example, medication management, behavioral
counseling). Another commenter stated that its stakeholders were
concerned that HCPCS code G3002 seems to indicate that all listed
services must be completed to bill for the code.
Response: We are clarifying that clinicians will be required to
furnish all appropriate elements of the code bundle, but also
clarifying that we do not expect that all elements of the code bundle
will be appropriate for every patient. Therefore, we can confirm that
if medication management is appropriate for a specific patient, then a
clinician who bills HCPCS code G3002 will be required to furnish
medication management to that patient. As described later in this
preamble, we will be finalizing the descriptor of HCPCS code G3002 as
follows, with the two modifications shown in italics: Chronic pain
management and treatment, monthly bundle including, diagnosis;
assessment and monitoring; administration of a validated pain rating
scale or tool; the development, implementation, revision, and/or
maintenance of a person-centered care plan that includes strengths,
goals, clinical needs, and desired outcomes; overall treatment
management; facilitation and coordination of any necessary behavioral
health treatment; medication management; pain and health literacy
counseling; any necessary chronic pain related crisis care; and ongoing
communication and care coordination between relevant practitioners
furnishing care, for example, physical therapy and occupational
therapy, complementary and integrative approaches, and community-based
care, as appropriate. We believe that the services enumerated as
examples accurately summarize the
[[Page 69534]]
components of some elements of key care for people with Medicare living
with pain.
Comment: Many commenters requested that we remove medication
management from the code descriptors. One commenter stated it
appreciated medication management being included in the code descriptor
and that careful evaluation of all medications, including use of
American Geriatrics Society Beers Criteria[supreg], should be included
as part of the CPM service, urging us to keep the element of medication
management in the descriptor finalized for this code.
Response: We continue to believe that medication management is an
essential element of pain care, and we are not removing it from the
code descriptors for HCPCS codes G3002 and G3003. A 2022 Congressional
Budget Office publication \42\ indicated nationwide per capita use of
prescription drugs has increased in recent years, as has Medicare Part
D enrollee use, from an average of 48 prescriptions per year in 2009 to
54 prescriptions per year in 2018. In addition, between 2017-2018,
nearly 58 percent of U.S. adults used a dietary supplement \43\ in the
past 30 days, and the percentage of adults using these supplements
increases with age; \44\ nutritional supplements are used by some
people for the treatment of pain.\45\ Although we are not explicitly
defining medication management for the purposes of HCPCS codes G3002
and G3003, we believe that medication management would customarily
include, as part of this element, a review of prescription drugs, over-
the-counter medications, supplements, natural treatments, and/or any
other substances the person with chronic pain might be using for any
purpose. Medicare's Annual Wellness Visit requires the clinician to
collect and document use or exposure to ``medications and supplements,
including calcium and vitamins \46\.'' Common prescription medications
used for pain include acetaminophen, non-steroidal anti-inflammatory
drugs, anticonvulsants, antidepressants, musculoskeletal agents,
antianxiety medications, and opioids. Americans also use dietary
supplements for a range of purposes, including the treatment of
pain.\47\ \48\ Some individuals with pain may also be using substances
such as cannabis and other plant-based treatments for
pain.49 50 Bearing this information in mind, we believe
medication management by the eligible physician or qualified health
professional would be an applicable element of the HCPCS code G3002 for
most beneficiaries with chronic pain.
---------------------------------------------------------------------------
\42\ https://www.cbo.gov/publication/
57772#:~:text=Use%20of%20prescription%20drugs%20among,year%E2%80%94a%
2013%20percent%20increase.
\43\ https://ods.od.nih.gov/factsheets/list-all/.
\44\ https://www.cdc.gov/nchs/products/databriefs/db399.htm#section_3.
\45\ https://www.nccih.nih.gov/health/providers/digest/nutritional-approaches-for-musculoskeletal-pain-and-inflammation.
\46\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
\47\ https://ods.od.nih.gov/.
\48\ https://www.fda.gov/food/dietary-supplements.
\49\ https://www.cdc.gov/marijuana/health-effects/chronic-pain.html.
\50\ https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment/living-review.
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Comment: One commenter stated that massage therapy, therapeutic
exercise programs, and complementary and integrative services (like
acupuncture, tai chi, yoga, and mindfulness meditation) should be
referenced in the code, even if currently not covered by Medicare, and
that clinicians should be allowed to bill for the range of treatments
listed in the HHS PMTF Report, even though the Medicare program may not
pay for those services. One commenter noted that care coordination
could include not just complementary and integrative care, but also
prescribing of durable medical equipment. One commenter stated we
should try to remove barriers to more ``alternative'' therapies.
Response: The PMTF Report recommends a range of treatments and
therapies that could be used for successful pain management including
medications, restorative therapies (for example, therapeutic exercise,
massage therapy), interventional procedures (for example, nerve blocks,
joint injections), behavioral health approaches (for example, cognitive
behavioral therapy), and complementary and integrative health
approaches. The latter include, as described in the Report,
acupuncture, massage and manipulative therapies, mindfulness-based
stress reduction, yoga, tai chi, and spirituality. HHS's 2010 National
Pain Strategy \51\ (NPS) also mentions complementary and integrative
care, focusing mostly on access difficulties for patients with chronic
pain, including insurance coverage. Since the NPS was published,
Medicare has finalized a coverage decision to cover acupuncture for
chronic low back pain.\52\ NIH's National Center for Complementary and
Integrative Health continues to evaluate various approaches,\53\ as is
the cross-cutting NIH HEAL Initiative[supreg] \54\. The HHS Agency for
Healthcare Research and Quality has also performed some work in this
area.\55\
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\51\ https://www.iprcc.nih.gov/sites/default/files/documents/NationalPainStrategy_508C.pdf.
\52\ https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=295.
\53\ https://www.nccih.nih.gov/health/providers/digest/mind-and-body-approaches-for-chronic-pain-science.
\54\ https://heal.nih.gov/funding/awarded.
\55\ https://www.ahrq.gov/topics/complementary-and-alternative-medicine.html.
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First, we are clarifying that we are not requiring in the code
descriptor that a clinician refer a beneficiary to services; that
determination should be made between the clinician and the beneficiary.
We understand that clinicians customarily refer beneficiaries,
including those who have chronic pain, to a range of treatments based
on their individual circumstances, and according to the person-centered
plan of care.
Second, based on the commenter's suggestion and on our proposal
within the CY 2023 PFS proposed rule, where we solicited comment
regarding interest in chronic pain management services and specifically
mentioned specialty care coordination such as complementary and
integrative pain care; recent coverage in Medicare for acupuncture for
chronic low back pain; \56\ and evidence that may point to efficacy for
some individuals with chronic pain using complementary and integrative
approaches, we have elected to revise the code descriptor for HCPCS
code G3003 by adding ``complementary and integrative approaches'' to
the code descriptor as examples of approaches that a clinician could
take in coordinating pain care across a range of treatments and
therapies for a beneficiary. However, we are not requiring that a
clinician make a referral to such care, nor are we requiring that the
clinician only refer Medicare beneficiaries to services currently
covered by Medicare. We are finalizing the addition of ``complementary
and integrative approaches'' to the descriptor for HCPCS code G3003. In
context, the addition will read as follows: ``. . . any necessary
chronic pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.,
physical therapy and occupational therapy, complementary and
integrative approaches, and community-based care, as appropriate.''
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\56\ https://www.medicare.gov/coverage/acupuncture.
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Comment: Several commenters supported the requirement for the
development, implementation, revision, and maintenance of a person-
centered
[[Page 69535]]
care plan that includes strengths, goals, clinical needs, and desired
outcomes by the practitioner furnishing CPM services. A commenter asked
that we recognize the role nurses play in person-centered planning. One
commenter supported this element of the CPM services, and stated that
person-centered care planning is not only key for people living with
chronic pain, but also for others living with serious illness, and that
the person-centered care plan and specifically these elements in the
CPM service should become required for people with serious illness. One
commenter expressed concern that current billing codes compensate
providers the same regardless of the severity of the beneficiary's
condition or time spent with the provider.
Response: We are correcting the code descriptor to more clearly
indicate that we do not expect the clinician to develop, implement,
revise, and maintain the person-centered care plan, that is, performing
each of these activities each time HCPCS codes G3002 or G3003 is
billed; rather, the status of the person-centered plan may vary based
upon the individual circumstances of the beneficiary with chronic pain.
Thus, we are finalizing a revision to the HCPCS code G3002 descriptor
to clarify this element as ``the development, implementation, revision,
and/or maintenance of a person-centered care plan that includes
strengths, goals, clinical needs, and desired outcomes''. We do not
agree, based on the revisions to proposed concurrent billing policies
and revisions in the descriptors that we are finalizing for HCPCS codes
G3002 and G3003, as described above and below, that there will be
insufficient flexibility to address the severity or breadth of needs
that a Medicare beneficiary living with chronic pain might have. We
believe that both the ``and/or'' edit that we are finalizing as part of
the code descriptor, and the additional flexibilities for payment,
discussed below, are sufficient to address the unique needs of each
beneficiary with chronic pain.
Comment: Several commenters opined on the inclusion of pain and
health literacy counseling, which we included as a proposed element of
the HCPCS code G3002 descriptor, to help beneficiaries with chronic
pain make well-informed decisions about their own care, weigh risks and
benefits, make decisions, and take actions that are best for them.\57\
One commenter recommended we instead use the term ``self-care
management,'' and noted that this term is more broadly inclusive of
health literacy counseling. Another commenter stressed the important
role nurses have in ensuring patients are fully informed by educating
and advocating on behalf of patients as they navigate the care
continuum. Another commenter stressed that the receipt of integrative
pain care would involve the practitioner taking into account the
``whole person'' in managing pain, especially important in light of the
importance of care coordination coupled with the goals of health
literacy. (We note that we recently emphasized the importance of health
literacy in our 2022-2032 CMS Framework for Health Equity.\58\) The
Framework's fourth priority is to ``advance language access, health
literacy, and the provision of culturally-tailored services,'' and
states that ``Medicare-enrolled individuals with low health literacy
experience increased hospital admissions and visits to emergency
departments, as well as higher medical costs and lower access to
care.'' Another commenter stated that in their experience, health
literacy counseling is most efficiently done through networks of
chronic pain support groups led by specially trained individuals who
have received training and education by pain leaders, and that it is a
fundamental and essential component in learning to cope with chronic
pain, which is devastating and challenging. The commenter further
observed that we could improve health outcomes by providing funding to
non-profit groups that specialize in chronic pain management to help
grow these type of educational and skill-based support groups. Another
commenter supported this requirement, adding that this should be able
to be provided via telehealth to reduce barriers to entry. A commenter
noted that health literacy, especially with medication adherence, is
valuable to people with chronic pain using multiple medications, as
often these patients lack a comprehensive understanding of all their
medications, which can deter adherence; if they had better resources to
help them understand them, adherence would increase.
---------------------------------------------------------------------------
\57\ https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/health-literacy.
\58\ https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
---------------------------------------------------------------------------
Response: We agree that pain and health literacy counseling is an
important element of care for people with chronic pain and appreciate
the commenters' suggestions about how it can contribute to improved
health outcomes. We thank the commenters, and we are finalizing pain
and health literacy counseling as an element of the HCPCS code G3002
descriptor, as proposed. As we gain experience with the CPM codes we
may consider additional options to increase the availability of pain
and health literacy counseling for Medicare beneficiaries.
Comment: Many commenters opined on our proposal to include
administration of a validated pain assessment rating scale or tool as
an element of code descriptor of HCPCS code G3002. Several commenters
noted that pain subjectivity can make pain management a difficult task,
and that the use of validated pain assessment tools can illuminate and
inform a fuller picture of the person's condition, as well as the
person's care plan. One commenter stated that pain scales can be
beneficial, but they need to be tailored to each person, and that
function and quality of life are also important elements to monitor.
The same commenter recommended the use of the National Quality Forum's
patient-reported measure, Patients' Experience of Receiving Desired
Help for Pain to achieve this. Another commenter stated something
similar, indicating that we should explore ways to address the
inconsistencies in pain measurement due to influences like geography
and cultural norms. Among the many comments related to bias in pain
assessment, one commenter urged us to consider the biases of assessment
tools when proposing a validated pain scale. One commenter vehemently
opposed the inclusion of a validated pain assessment scale citing
concerns with pain bias, proprietary systems, and established outcomes
beyond such scales, which they noted together create a case to avoid
requirements for providers to use scales that have not received
widespread support. The commenter also expressed concerns with pain
bias that has developed over time in pain scales, especially for women,
older adults, and ethnic groups, where the scales were not removed from
use even after bias was documented, potentially worsening health equity
issues. This commenter continued, stating that there is disagreement
over the use of pain scales and that no single scale has been adopted
as a common scale, in part because of proprietary issues. A different
commenter agreed with the assessments of bias in traditionally
marginalized populations, offering that objective pain scales and
objective benchmarked pain data be used. This commenter defined
benchmarked objective pain data including a pain database on adults, a
database on women and pain, an
[[Page 69536]]
orthopedic pain database, or an older adult pain database.
Additionally, we received comments related to the ``well-documented
bias against historically-disadvantaged groups'' in pain assessment,
and suggestions that the best tools for chronic pain also focus on pain
interference, impact on function, activities of daily living, emotional
and psychological health, and the patient's perception of their own
quality of life. Regarding specific tools, one commenter agreed with
administration of a validated pain assessment rating scale or tool, and
stated that we should not limit the acceptable tools; rather we should
enable practitioners to select the most appropriate tool for staff to
administer as part of the person-centered CPM care plan, and that a
reference repository or list of potential tools would be helpful. The
same commenter asked that we not be prescriptive in requiring a
particular scale or tool. Another commenter recommended the
consideration of the use of outcome and quality-of-life measures as
opposed to reductionistic tools that only measure one aspect of pain. A
different commenter supported our proposal to use a validated tool,
suggesting the PROMIS-8A, but urging us to make a list of validated
tools available, and also avoid requiring use of a specific tool.
Another commenter expressed concern about unintended consequences of
using a pain rating scale or tool for validation and suggested the
addition of a measurement that uses objective measures. A commenter
noted that a pain scale is a reliable and valid way to understand the
extent of how pain is impacting the person, but should not be the sole
measure to show improvement. Further, a commenter recommended we
undertake more inquiry before mandating the use of any specific tool or
registry and assemble a stakeholder group, issue a Request for
Information, or use some other means to conduct a landscape analysis of
validated tools. One commenter noted that the use of a validated pain
assessment tool should be excluded and be available as a separate add-
on code. This commenter also noted that such a step would incentivize a
multidimensional assessment of physical, social, and emotional
functioning.
Response: We recognize that periodic assessment of the experience
of pain is an essential element of pain care in the immediate sense and
over time, as chronic pain may be enduring as a symptom of disease or a
long-term disease in and of itself. We also note that no prescribed set
nor single pain assessment measure will be required in the
administration of HCPCS code G3002 or G3003, because no particular tool
or tool set can assess the complex nature of the experience of pain
across all individuals, nor appropriately guide its treatment. We
regularly collaborate with other HHS operating divisions including
working with the National Institutes of Health (NIH) on the NIH
HEAL[supreg] Initiative (Helping to End Addiction Long-term), which
includes more than 30 large scale pain and substance use disorder
programs. The NIH HEAL Initiative and the NIH Pain Consortium pain
research agendas engage nearly all NIH Institutes, Centers, and
Offices. The ambitious and crosscutting nature of the NIH HEAL
Initiative[supreg] and trans-agency interactions of the NIH Pain
Consortium require engagement from experts across disciplines and
sectors and with other HHS operating divisions including CMS. Much of
this NIH research effort focuses on preclinical, translational and
clinical research aimed to improve pain management.\59\ We have been
working with NIH to create and disseminate an accessible, curated, and
dynamic set of Pain Assessment resources for clinicians seeking
instruments to assess their patients' pain and pain-related symptoms
(such as sleep disruption, loss of function, and behavioral health).
The resources are carefully selected as validated and meaningful tools
to inform clinicians and patients in shared decision making as to the
most effective pain management plan for each person. Recognizing that
while many tools are validated in certain populations, they may need
refinement to address cultural sensitivities in populations with health
disparities. We will leverage efforts of the NIH HEAL Initiative to
continue to include appropriately updated tools for these populations
as they evolve. We are finalizing the inclusion of administration of a
validated pain rating scale or tool in the HCPCS code G3002 descriptor.
We will continue to consider opinions and feedback from clinicians and
people with pain as to the use of The Pain Assessment Resource and more
generally, validated screening tools, and collaborate with our NIH
operating division partners to leverage their work in this area and
ensure that the Pain Assessment Resource is comprehensive, inclusive
across disciplines, and up to date over time. A link to the resource is
available at https://www.painconsortium.nih.gov/resource-library/resources-pain-assessment.
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\59\ https://heal.nih.gov/about.
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Comment: We received numerous comments on components of the
proposed CPM services that do not necessarily require a ``face-to-
face'' or in-person visit with the practitioner, such as care that
could be provided by auxiliary staff ``incident to'' the services of
the physician or other qualified health care practitioner. A few
commenters requested clarification on which specific aspects of the
code could be furnished without face-to-face care. We also received
many comments requesting a general supervision requirement, rather than
a direct supervision requirement, with commenters citing provider
shortages as barriers to care. Another commenter suggested that the
initial visit would not have to be face-to-face so long as an in-person
visit occurred shortly after the CPM initiation, and prior to the
prescribing of controlled substance medications for pain. One commenter
stated that other clinical staff in the practice should be able to
follow up and interact with patients. Another commenter stated that
relevant components that could be non-face-to-face could include
questions about medication and improvements related to medication,
social determinants of health, or history of substance use disorders,
or crime, as well as coordination of any necessary behavioral health
treatment, and pain and health literacy counseling. A commenter stated
that most components of the proposed CPM services do not require face-
to-face interaction with the billing practitioner such as overall
treatment management, medication management, pain and health literacy
counseling, and care management which can provided by clinical staff
incident-to a billing practitioner under general supervision, and that
these providers' ability to furnish care has proved to increase access
to medically necessary care, and helped relieve some of the burden for
billing practitioners while still ensuring patients are receiving high-
quality care. A commenter noted that registered nurse care managers
could provide CPM services as incident to services, under the general
supervision of a physician or other qualified health professional.
Another commenter stated that the definition provided of ``provided by
a physician or other qualified health care professional'' was limiting,
and suggested that we use, ``clinical staff time directed by a
physician or other qualified health care professional.'' Another
commenter requested that CMS consider creating separate billing codes
to reflect time spent by physicians and
[[Page 69537]]
clinical staff as is done in the chronic care management (CCM) code.
Response: We agree with the commenters and believe that certain
elements of the proposed bundle, such as care planning or care
coordination with other health care professionals, would not likely
require face-to-face care. These might include activities such as
telephone calls, medical records review, and coordination and
information exchange with other health care providers. We are also not
requiring that subsequent visits for which a physician or other
qualified health professional bills HCPCS code G3002 or G3003 be for
services that were provided to a beneficiary face-to-face. However, the
initial visit for HCPCS code G3002 must be a face-to-face visit.
Comment: A few commenters applauded our efforts to support team-
based care for Medicare beneficiaries with chronic pain. One commenter
stated that chronic pain management may involve arrangements with
psychologists as part of team-based care. Another commenter stated that
since there is no disease-modifying or curative therapy for chronic
pain, best managing chronic pain requires multi-modal interventions and
coordination across a patient's care team, and coordinating care with
other practitioners and providers such as integrative medicine,
physical therapists, psychiatry, and hospital programs.
Response: We agree with the commenters about team-based care, which
leads to better outcomes for beneficiaries, and better experience for
staff, and improves all aspects of care delivery. Team-based care
positively effects the person's care experience, such as office visit
cycle time, care access, preventive screening, self-management, goal
setting and action planning, and medication management. Team-based care
also improves process and workflows, helping to ensure staff are
working at the top of their capabilities, and sharing in
accountability.\60\
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\60\ https://innovation.cms.gov/files/x/tcpi-changepkgmod-nextsteps.pdf.
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Comment: A few commenters requested that the structure of the CPM
codes include payment for the time interdisciplinary providers spend in
consultation with one another. Additionally, this commenter noted
concern that requesting coordination with ``relevant providers'' was
not specific enough, and would not require inclusion of the range of
services available to treat chronic pain. One commenter stated that we
should ensure that reimbursement is revenue neutral, to continue to
encourage practitioners to treat chronic pain.
Response: We are not requiring in the code elements that the
clinician billing CPM codes coordinate and communicate with other
relevant practitioners, as these actions would vary based on the
beneficiary with chronic pain's circumstances. Nor is the list of
services we have used as examples meant to be inclusive of every type
of care a person with chronic pain could require in the course of
individualized treatment for chronic pain. We do expect that
communication and care coordination between providers of all types
would be of benefit to the beneficiary with pain and we leave the
extent of that communication and coordination to the discretion of the
physician or qualified health professional billing the CPM codes, as
appropriate.
Comment: Several commenters requested that we recognize CPM
services for all practitioners who may bill E/M visits, including
oncologists. One commenter noted we had stated the new codes can be
billed by a ``physician or other qualified health care professional''
and agreed that physicians, including primary care physicians, board
certified pain management specialists, neurologists, anesthesiologists,
board-certified headache specialists, rheumatologists, osteopaths, and
other physician specialists that focus on pain conditions should be
able to bill the new CPM codes; the commenter asked us to clarify what
types of practitioners can bill for proposed HCPCS code G3002 and
G3003. A commenter noted that we stated our anticipation that the CPM
codes would most frequently be billed by primary care providers. This
commenter specified that cancer specialists also spend considerable
time managing acute and chronic pain, with this sentiment being echoed
by providers of palliative and hospice care, as well as nurse
anesthetists, all concerned and asking for clarification regarding
whether they ``counted'' as approved providers. A commenter requested
more support and increased access for innovative alternative treatment
to opioids (ALTO) programs, which have been shown in a few states to
reduce opioid prescriptions in emergency department settings. One
commenter stated that, if we identify specialties expected to furnish
the CPM services, geriatrics should be included. Two commenters
recommended that Rural Health Centers and Federally Qualified Health
Centers be allowed separate payment for these codes. One commenter
requested that the code be inclusive of the broad range of providers
that treat pain, as each patient should be able to access the provider
best suited to primarily manage their pain. A commenter stated that,
while we stated we believe primary care providers might most often use
the codes, cancer specialists spend considerable time managing both
acute and chronic pain associated with cancer, and we should explicitly
state that CPM services can be billed by any clinician with E/M
services in their scope, including oncologists and pain management
specialists. Two commenters stated we should make rehabilitation
therapists eligible to bill the code, and, if they are part of the care
team, they should share in the reimbursement proportionally among
practitioners rendering care. One commenter asked that we include
marriage and family therapists as providers who can render CPM
services. A commenter recommended HCPCS code G3002 be billable by other
Medicare providers like doctors of chiropractic. Another commenter
encouraged us to include massage therapists under Medicare Part C in
coding and billing changes to capture services that are provided as
part of complementary and integrative pain care.
Response: We appreciate the commenters' thoughts about the broad
range of provider types that might furnish care that effectively
addresses the many aspects of chronic pain, and note that we are not
limiting the types of physician specialties, or the types of qualified
health professionals, who can furnish CPM services, as long as they can
furnish all of the service elements of HCPCS code G3002, including
prescribing medication as needed, within their scope of practice in the
State in which the services are furnished.
Comment: Several commenters urged us to consider the contributions
of interdisciplinary teams including physical and occupational
therapists, social workers, massage therapists, pharmacists, and
athletic trainers when creating rules for incident to billing. Two
commenters requested that CMS use the term, ``clinical staff'' as is
used in other codes to ensure inclusion of different provider types.
One commenter noted that members of the interdisciplinary team are
needed to provide person-centered, holistic pain management and that
incident to billing will support team-based care, and that we should
consider separate billing for physician time versus other clinical
staff time; another commenter also made this request. A different
commenter noted
[[Page 69538]]
that limitations on ``incident to'' billing has been limiting for the
creation of collaborative, interdisciplinary teams. A commenter asked
us to address ``incident to'' with greater clarity, to explain if the
CPM services could be provided in a domiciliary or home setting, which
is not the same as a provider's office or clinic, including under
general supervision. One commenter noted that component activities of
CPM services can be appropriately provided as ``incident to'' physician
services, as well as by hospital staff under the Medicare Part B
outpatient benefits. The commenter further stated that since staff who
implement CPM care plan services are either office or facility-based,
payment for the services should be recognized under both the PFS and
the Outpatient Hospital Prospective Payment System. One commenter
stated that clinicians such as social workers, pharmacists, and
chaplains could be very helpful to address aspects of chronic pain
through incident to billing. Another commenter recommended CMS focus on
a simpler way to capture and reimburse for CPM services. For example,
CMS might explore whether E/M codes billed with an ICD-10 diagnosis
code for chronic pain from the G89.xx series, in which a person-
centered plan of care for pain is documented, could be eligible for
monthly billing of a G3003-type code (for example, each 15 minutes of
CPM care plan services implementing an individualized CPM plan
inclusive of staff monitoring patient's adherence and response to the
plan, coordinating services and communicating with other practitioners
and providers). This G3003-type code would acknowledge and pay for the
component activities of CPM care plan services that are appropriately
provided ``incident to'' physician services by practitioner-employed
office staff or by hospital staff under the outpatient hospital
benefits.
Response: We note that this rule generally addresses payment for
physicians' services under the PFS. Comments regarding other payment
systems not addressed in the proposed rule are outside the scope of
this rulemaking. The billing practitioner should report the place of
service for the location where they would ordinarily provide face-to-
face chronic pain management services to the beneficiary. We thank
commenters for their feedback and may consider further development of
the CPM codes to recognize components that could be furnished by
auxiliary personnel incident to the services of the billing
practitioner, and components that could be primarily performed by
clinical staff, in the future. We note that auxiliary personnel is
defined at Sec. 410.26(a)(1) as any individual who is acting under the
supervision of a physician (or other practitioner), regardless of
whether the individual is an employee, leased employee, or independent
contractor of the physician (or other practitioner) or of the same
entity that employs or contracts with the physician (or other
practitioner), has not been excluded from the Medicare, Medicaid, and
all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in which the services are
being furnished. We did not propose to change this definition of
auxiliary personnel in the proposed rule, and therefore, the comments
asking CMS to modify the definition of auxiliary services are outside
the scope of this rulemaking. Additionally, we note that all
requirements for services furnished incident to a physician's (or
practitioner's) professional services listed at Sec. 410.26 continue
to apply. We will keep the commenters' concerns in mind when
considering any further development of the CPM codes in the future.
Comment: Many commenters asked us to clarify if the proposed CPM
services would be available for billing/reporting in conjunction with
remote patient monitoring (CPT code 99091), remote physiologic
monitoring (CPT codes 99453, 99454, 9457, 99458), or remote therapeutic
monitoring (CPT codes 98975, 98976, 98977, 98980, 98981 and as proposed
GRTM1/2/3/4 codes. One commenter also requested clarification
surrounding what virtual presence/remote supervision is permitted, who
can order these services, what documentation is required, and whether
billing is permitted for individual services in addition to the
management components of CPM. A commenter noted that patients with
chronic pain may also benefit from remote therapy monitoring to monitor
their pain levels, medication adherence, and response to prescribed
therapy regimens.
Response: HCPCS codes G3002 and G3003, and the services describing
remote patient monitoring, remote physiologic monitoring, and remote
therapeutic monitoring, are distinct types of services, although there
may be some overlap in eligible patient populations. There may be some
circumstances where it is reasonable and necessary to provide both
services in a given month. Thus, HCPCS codes G3002 and G3003, could be
billed for the same patient in the same month as the Remote Physiologic
Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) services. All
applicable requirements for the individual codes must be met, per the
elements of each individual code, for both types of remote monitoring
and CPM services. Additionally, the time and effort cannot be counted
more than once when billing CPM codes concurrently with RPM or RTM.
Billing practitioners should remember that cost sharing applies to each
service independently. If all requirements to report each service are
met, without time or effort being counted more than once, then CPM and
RPM or RTM may be billed.
Comment: Several commenters stated they were concerned about low
payment, and other payment issues related to the proposed CPM codes,
which we had valued in our proposal based on our conclusion that the
CPM services were similar in work (time and intensity) to that of
Principal Care Management (PCM) service. One commenter observed that in
order for physicians to be willing to treat chronic pain patients,
especially primary care physicians, we need to make physician payments
for the new CPM codes higher than primary care and PCM visits to avoid
lower payment for CPM than for a standard follow-up clinical visit for
primary care (CPT code 99214 for 30 min clinical visit). The commenter
was very concerned that unless we considered raising these rates before
the new CPM codes go into effect, physicians will not use them to
accomplish the intended improvements in pain care that Medicare
patients so desperately need, and that the use of other codes not
specific to pain will impair our ability to accurately track data
regarding chronic pain, and care outcomes, in the Medicare program.
Another commenter had similar concerns, recommending that the valuation
of the new codes be on par with current office and outpatient E/M
codes. A different commenter noted that it had significant concerns
with our proposal to disallow use of the codes on the same day as a
``general'' visit like an E/M visit where the person is being seen for
a separate illness or condition, and that this would be a grave mistake
that would hamper the delivery of truly integrative pain care. This
commenter also added that this move would exacerbate disparities at a
time when CMS is working to promote health
[[Page 69539]]
equity, urging us to allow same day E/M billing. Another commenter
requested clarification regarding the interaction with other service
codes to ensure that this code enhances rather than inhibits physician
encounters. A different commenter stated that people living with
chronic pain are likely to have at least one or more comorbidities that
are being treated along with their pain, and often these health
concerns are, in fact, addressed by one singular practitioner on the
same day. The same commenter noted that requiring people to be seen on
different days that they come for other health care services will
significantly reduce numbers of people with pain who are willing, or
able, to receive CPM services, including people who are older adults,
disabled, homeless, lack reliable/affordable transportation, cannot
take time off work, and/or are unable to secure child care--among other
issues. The commenter stated mandating repeated in-person visits would
be arduous for disabled people already poorly served by public
transportation, a problem that characterizes many smaller cities,
suburbs, and rural communities. Another commenter stated that our
proposed code valuation will prohibit use of the codes or make them go
unused, as they pay less than CPT code 99214, or result in less
payment, causing providers to reconsider the number of pain patients
they care for. Additionally, the commenter expressed fears that for
providers already wary of rendering care to people with chronic pain,
the valuation of the codes would further disincentivize them from
treating these patients, not only paying less, but requiring more work.
The commenter described a ``worst case'' scenario where if the codes
became ``required'' for people receiving CPM services (for example, use
of a 99xxx code was deemed fraudulent) it anticipated that many
clinicians would cease seeing patients with chronic pain because of the
low valuation, and required services that appear ``extraordinarily
laborious.'' This commenter included several real life scenarios from
clinicians working at the front lines of pain; stating that if we
really wish to support the use of CPM, the valuation should be at least
(emphasis added) comparable to CPT code 99213 or 99214, but to truly
incentivize (emphasis added) adoption and utilization of CPM services,
we should consider significantly increased reimbursement to allow CPM
services to grow sufficiently to meet anticipated demand. A different
commenter noted primary care providers will be disinclined to prescribe
opioids due to this payment rule. The commenter expressed concern that
these patients will then have to find pain management clinics, which
are not present in all communities. A commenter stated a similar
opinion, discussing that primary care providers are afraid of
prescribing opioids and that patients are suffering as a result.
Another commenter noted that they would like the code to differentiate
between a patient who is now meeting the threshold for chronic pain
from those patients with a previous diagnosis of chronic pain, who is
simply seeing a new provider. This commenter noted that a person is an
expert in their own condition, and sharing all of that information with
a new provider is often very time-consuming, whereas someone with new
chronic pain may not have as much information to share. This commenter
recommended ``substantial'' time for both scenarios. One commenter
requested clarity on the interaction between the E/M and CPM codes to
avoid any inadvertent misuse by providers, and recommended that CMS
consider creating a modifier to attach to the CPM codes to prevent
double payments. Another commenter was concerned that the proposed CPM
codes could lead to an underutilization of important non-opioid pain
management options because providers are not clear on the rules around
the use of these codes. One commenter opined that there should not be
any concurrent billing restrictions imposed on CPM services, which
would force patients to pick between certain services and care. Another
commenter noted that the current valuation and payment are
disproportionate to the work required of HCPCS code G3002, and noted
that this code more closely aligns with what is included in a level 4
or 5 E/M service. A different commenter echoed previous statements
regarding concern that the valuation of HCPCS codes G3002 (formerly
GYYY1) and G3003 (formerly GYYY2) and RVUs will create disincentives to
care for patients with chronic pain. The commenter suggested separating
HCPCS code G3002 into two codes: one code for face-to-face that is
valued higher than a standard E/M visit, and a second for coordination
undertaken by the physician or other qualified healthcare professional
outside of face-to-face care (similar to CCM and PCM codes). Another
commenter suggested two add-on codes for HCPCS code G3003 because these
patients can be complex, and may require intense coordination. An
additional commenter suggested adding a GYYY3 and GYYY4 code. HCPCS
code G3002 (formerly GYYY1) would remain and HCPCS code G3003 (formerly
GYYY2) would be half the resource inputs of G3002. GYYY3 would be a new
code for subsequent visits after the initial visit with a 15-minute
threshold instead of a 30-minute threshold, and GYYY4 would be another
new code for administration of the validated pain measurement as an
add-on for HCPCS codes G3002 or G3003. One commenter stated that the
code should be treated as an E/M and fall into the category as a visit,
billed in FFS clinics and related to RHCs and FQHCs paid for as per the
current methodology. The commentator suggested using a payment
``crosswalk'' of 99213 and 99214 tied to proposed HCPCS codes G3002 and
G3003, including a modifier of 30-40 percent to compensate providers
adequately for the labor involved in CPM services. One commenter stated
that it believed clinicians billing for CPM services would face
substantial decreases in work RVUs generated relative to current
reimbursement compared to outpatient E/M codes and is unclear on how
both codes could be billed. Another commenter stated that they believed
the reimbursement proposed is inappropriately low, and urged us to
adjust the proposed RVUs of 1.45 for HCPCS code G3002 and 0.5 for HCPCS
code G3003 in the final rule. This commenter noted the work intended in
this code will require significant time investment by physicians,
qualified health professionals, and clinical staff. The same commenter
noted HCPCS code G3002 should be crosswalked with CPT code 99414 at
1.92 work RVUs and HCPCS code G3003 be crosswalked with CPT code 99212
at 0.7 work RVUs. Another commenter stated we are undervaluing HCPCS
code G3002 by crosswalking it to CPT code 99424, which has 1.45 RVUs. A
similar 30-minute new patient office visit (CPT code 99203) is valued
at 1.6 RVUs. This commenter also stated that an established patient
visit (CPT code 99214) is valued at 1.92 RVUs. This commenter
recommended CPT codes 99495 and 99496 for better crosswalks. Another
commenter requested clarification on whether it is permissible for the
same practitioner to bill a service like interventional pain management
during the same month the clinician bills for the CPM services. Another
commenter noted that E/M codes 99214 and 99213 already allow for time-
based, face to face encounters with providers, have similar or greater
work RVUs, and less limitations and requirements as compared to those
specified in the code
[[Page 69540]]
descriptors for G3002 and G3003. This commenter recommends increasing
the time allotment to 45 and 20 minutes for HCPCS codes G3002 and
G3003, respectfully. The same commenter also expressed concern that
providers would be less likely to utilize the CPM codes in favor of
those they are already using and allowing for an increase in time
allotment would correct this issue, according to this commenter.
Response: It is not our intent to either underpay, or create
incentives for clinicians to use other codes that would constrain the
use of the new codes. However, in the absence of experience with these
new codes, we must base our projections reasonably on our experience
with existing codes that we believe bear some relationship to the new
proposed codes, such as the PCM code. Therefore, in light of the
crosswalk to CPT codes 99424 and 99425, we are finalizing as proposed
the work RVUs of 1.45 for HCPCS code G3002 and 0.5 for HCPCS code
G3003. We will monitor use of the CPM codes to better determine if the
payment rates and billing flexibilities are appropriate. In the
proposed rule, we outlined our concerns about duplicate, or overlap
billing in situations where the eligible clinician might bill certain
E/M codes on the same day the CPM service(s) are rendered. Based on the
commenters' concerns, we have reconsidered our approach to billing CPM
services. We believe that, due to the complexities of pain treatment,
there could be beneficiaries seeing a clinician for the first time, or
in a subsequent visit, who could also need to be seen by the clinician
for the CPM service(s) on the same day, or for a subsequent visit. The
code sets for E/M services are organized into various categories and
levels; the more complex the visit, the higher level of the code the
clinician would bill within the appropriate category. Clinicians must
make certain that the codes selected are appropriate for the services
furnished, and that they fulfill the requirements to bill an E/M
service.\61\ Many Medicare beneficiaries have multiple chronic
conditions,\62\ and many of these conditions could involve chronic
pain. We believe it is reasonable to assume that in many instances, the
clinician could be spending time with the Medicare patient discussing
health and wellness related to a variety of conditions that person may
be experiencing, or expect to experience, and that interaction might
not have a focus on the chronic pain aspects of the person's care.
Additionally, if the person with pain has made the effort--which could
be considerable, as commenters have noted, to get to an appointment
with a clinician, it makes sense from a burden standpoint--allowing for
the burden on both the clinician, and the person with Medicare, to
permit billing for both the E/M service, and the CPM service(s) on the
same day. Therefore, if all requirements to report each service are
met, without time or effort being counted more than once, then both E/M
and CPM may be billed on the same day.
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\61\ https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/eval-mgmt-serv-guide-icn006764.pdf.
\62\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Chartbook_Charts.
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Comment: Two commenters requested that we revisit existing guidance
and regulations to allow pharmacies to bill Medicare for opioid-based
compounded drugs. Another commenter urged CMS to reconsider the issue
of reimbursement for medication used in intrathecal pumps. One of these
commenters also requested that the compounded medications delivered to
the physician's office for insertion into an implanted pump be
reimbursed as an incident-to drug or Durable Medical Equipment,
depending on the billing entity.
Response: We appreciate the commenters' thoughts about compounded
drugs and reimbursement for medication used in intrathecal pumps;
however, these comments are out of the scope of our proposals for CPM
services.
Comment: Many commenters asked us to add CPM services to the
Medicare Telehealth Services List. One commenter asked that we enable
the CPM codes, in addition to being rendered through telehealth, to be
furnished through audio-only technology. We address these comments in
section II.D.1.c. of this final rule, Other Services Proposed for
Addition to the Medicare Telehealth Services List.
Comment: One commenter suggested we include screening services in
the CPM bundle to identify, reduce, and prevent hazardous or harmful
alcohol and drug use, which the commenter characterized as common in
people with SUD in residential treatment settings living with chronic
pain. An additional commenter echoed the request for screening to
identify, reduce, and prevent hazardous or harmful alcohol and drug use
generally. This commenter also encouraged the inclusion of ordering of
tests and Durable Medical Equipment, as well as consultations with
other providers and communication with pharmacies be included. One
commenter suggested the inclusion of nutrition screening and nutrition
therapy in the code descriptions, as people with chronic pain often
have complex dietetic and nutritional needs. Another provider group
recommended that the term ``prognosis'' be added to the ``diagnosis''
in the bundle description as an option.
Response: As outlined in the proposed rule and in the CPM code
descriptors, we expect clinicians to facilitate and coordinate any
necessary behavioral health treatment, and other relevant care
associated with HCPCS codes G3002 and G3003, such as complementary and
integrative approaches and/or community-based care. This includes, as
described in the CMS Behavioral Health Strategy,\63\ multiple elements
including access to prevention and treatment services for SUD, mental
health services, crisis intervention and pain care to enable care that
is well-coordinated and effectively integrated. Under the Strategy, we
have defined behavioral health as ``encompassing a beneficiary's whole
emotional and mental well-being, which includes, but is not limited to,
the prevention and treatment of mental disorders and substance use
disorders.'' ``Whole-person care'' is defined as ``the whole of a
beneficiary's needs including physical health, behavioral health, long-
term services and supports (home and community-based services, and
institutional care), and health-related social needs.''
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\63\ cms.gov/cms-behavioral-health-strategy.
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Comment: One commenter suggested we ensure that the proposed CPM
codes are reimbursable in the beneficiary's home, and all other
settings where primary care, mental health care, and SUD care can
occur. Another commenter recommended inclusion of residential treatment
facilities, long term care facilities, and homes as settings in which
billing can occur.
Response: We appreciate the commenter's suggestion that we ensure
that the proposed CPM codes are payable for services delivered in the
beneficiary's home, and all other settings where primary care, mental
health care, and SUD care can occur. We note that CPM is priced in both
facility and non-facility settings, and we are not limiting the place
of service for CPM, other than as discussed above (the initial visit
must be in-person). The billing practitioner should report the place of
service for the location where they would ordinarily provide face-to-
face chronic pain management services to the beneficiary
Comment: Several commenters stated that the elements of the
proposed CPM codes favor prescriptions by medical
[[Page 69541]]
providers, instead of prioritizing non-pharmacological strategies for
pain management, including those developed by psychologists, that may
be safe and effective for many patients. One commenter further stated
that the creation of additional bundled codes that do not include
medication management will allow for greater flexibility in treatment
and allow psychologists to provide pain management services and
practice to the top of their license when participating in team-based
comprehensive chronic pain treatment. Another commenter suggested that
physical and occupational therapists should be able to bill the codes,
stating that these practitioners' practice integrates an understanding
of a patient's or client's prescription and non-prescription regimen
with consideration of its impact on health, function, movement, and
disability, and that it is within the physical therapist's professional
scope of practice to administer and store medication to facilitate
outcomes of physical therapist patient and client management. The same
commenter asked that we require, in the code descriptor, that
physicians and other non-physician practitioners must refer appropriate
chronic pain patients to physical and/or occupational therapy prior to
being reimbursed for the codes. A few commenters requested that CMS
create a code for providers who do not bill for E/M codes. One
commenter stated that physical therapists and psychologists are not
qualified to perform all the necessary services we have outlined, such
as thorough pain assessments and diagnoses, medication management,
crisis care, etc. and suggested we establish a path whereby non-
physician professionals can bill a chronic pain code for services that
are part of an overall treatment plan. Two commenters suggested that
education be provided to physician providers to increase the
consultation of physical and occupational therapists, also stating that
physical therapists are significantly underutilized in community and
rural settings.
Response: We acknowledge and support the important work of
psychologists and occupational and physical therapists in the care of
people with Medicare, including beneficiaries with chronic pain. We
believe that this code describes a distinct PFS service that is
reasonable and necessary in the diagnosis and treatment of the person
with chronic pain, and that medication management, as described in the
preamble text above, is a key element of such care and of the proposed
HCPCS code G3002; therefore, we are including it as a code element.
We understand that cognitive behavior therapy (CBT), as one
example, is a common treatment provided by psychologists, including to
people with chronic pain.64 65 66 Medicare covers
psychotherapy, as well as other services that support mental health and
wellness.\67\ Chronic pain can be linked, in some people, to mental
health conditions, such as anxiety and depression.\68\ Psychotherapy is
billed with Current Procedural Terminology (CPT) codes \69\ that
reflect the amount of time spent with the patient, and family may or
may not be present during these therapy sessions. To bill these CPT
codes, the psychotherapist must provide a mental health diagnosis using
an International Classification of Diseases (ICD) code and/or
Diagnostic and Statistical Manual (DSM) code.
---------------------------------------------------------------------------
\64\ https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.
\65\ https://www.va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf.
\66\ https://www.nih.gov/news-events/nih-research-matters/meditation-cognitive-behavioral-therapy-ease-low-back-pain.
\67\ https://www.cms.gov/files/document/mln1986542-medicare-mental-health.pdf.
\68\ https://health.gov/healthypeople/objectives-and-data/browse-objectives/chronic-pain.
\69\ https://www.ama-assn.org/practice-management/cpt.
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While clinical psychologists (CPs) do not have prescription
authority in all States and are therefore, not authorized to bill the
Medicare program for any of the CPT codes that include medication
management components, there are CPT codes that CPs can bill for
treating Medicare patients who are diagnosed with chronic pain. Hence,
the Health and Behavior Assessment and Intervention (HBAI) range of CPT
codes are intended to be used for psychological assessment and
treatment, when the primary diagnosis is a medical condition, such as
chronic pain.
This family of codes was revised in 2020, when a new set of codes
to describe these HBAI treatment services went into effect.\70\ Health
behavior assessment under these HBAI services is conducted through
health-focused clinical interviews, behavioral observation and clinical
decision-making and includes evaluation of the person's responses to
disease, illness or injury, outlook, coping strategies, motivation and
adherence to medical treatment. Health behavior interventions under
these HBAI services are provided individually, to a group (two or more
patients), and/or to the family, with or without the patient present,
and include promotion of functional improvement, minimization of
psychological and/or psychosocial barriers to recovery, and management
of and improved coping with medical conditions. The HBAI codes apply to
services that address psychological, behavioral, emotional, cognitive,
and interpersonal factors in the treatment/management of people
diagnosed with physical health issues. Use of HBAI codes requires a
physical health diagnosis (ICD-10) to be the primary diagnosis. The
HBAI codes capture services related to physical health, such as
adherence to medical treatment, symptom management, health-promoting
behaviors, health-related risky behaviors, and adjustment to physical
illness. The HBAI codes and the Psychotherapy codes cannot be billed
contemporaneously. We believe HBAI codes are well-suited to the
provision of CBT, as appropriate, to people with chronic pain when the
person does not have a concurrent mental disorder.
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\70\ https://www.apaservices.org/practice/reimbursement/health-codes/health-behavior.
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For HCPCS codes G3002 and G3003, we are finalizing the codes for
use by physicians and other qualified health professionals. However, we
will consider if there is a benefit to modifying these codes and/or
creating new codes that can potentially support broader chronic pain
management by other practitioner types, including those who may not be
prescribers in the scope of practice in the State in which they
practice and are an important part of the care team for beneficiaries
with chronic pain, in future rulemaking, such as clinical
psychologists, or doctors of chiropractic. We do not agree that
clinicians should be required to make referrals to occupational and
physical therapists; although, as we stated in the proposed rule, and
in the code descriptor, we do expect that there will be ``ongoing
communication and care coordination between relevant practitioners
furnishing care, for example physical therapy and occupational therapy
. . . as appropriate.''
Comment: Several commenters opined on our proposal to require
verbal consent at the initiating visit, or at the initiating visit and
subsequent visits, to help make sure that people with Medicare living
with chronic pain want the services, are aware they may need them, and
that they also receive an explanation of any cost sharing that may
apply in their particular situation. All commenters were supportive of
our proposal. One commenter stated that, although it supported
requiring consent, it noted that consent should be obtained at the
third visit, so patients could be given an opportunity to work with the
[[Page 69542]]
physician a few times, but at the first visit the physician should
still be required to educate patients regarding CPM services, explain
their frequency/purpose/value, and any cost-sharing that may apply, so
patients can better understand the model which is different according
to the commenter from the disjointed, fragmented, solitary struggle for
effective pain care that the vast majority of pain patients presently
experience, and that in this manner, patients would have an opportunity
to understand CPM services better. The commenter also stated consent
should be discussed, including any costs with family/unpaid caregivers.
The same commenter stated we need not require consent at each visit,
and suggested that we should support practitioners referred by the CPM
billing practitioner to also seek the patient's consent, to emphasize
in part that they are working as a team. A different commenter stated
that in implementing the new codes, we should establish requirements
similar to CCM services, for example, requiring that providers document
that all components of the service are met and that informed consent,
inclusive of cost-sharing, has been obtained. Another commenter urged
us to allow consent to be obtained and documented by members of the
care team in addition to the physician/qualified health profession. One
commenter believes that verbal consent should be obtained upon
enrollment (at the first visit) and not at every visit, which would
create inefficiencies. The spouse of a person living with longtime
chronic pain observed that ``patient consent, consultation should
always be a part of primary care as patients are typically ignored,
especially in pain management.'' A commenter stated that consent, for
some people with dementia or other cognitive health issues, might have
to be obtained through a legal representative outside of the face to
face initiating visit.
Response: We are appreciative of the comments regarding consent, as
we believe the person with chronic pain should be educated regarding
what the CPM services are, how often they may be generally expected to
receive the services at this initial visit, and receive an explanation
of any cost sharing that may apply in their particular situation; this
is an important element of person-centered care and self-determination.
We disagree with the commenter who suggested we obtain verbal consent
after the first visit. Similar to how the Medicare Chronic Care
Management service is administered, we believe the physician or
qualified health care practitioner should get the person's consent for
services before the practitioner bills for them. This helps to ensure
that beneficiaries are engaged and are aware of their treatment and
cost sharing responsibilities, and helps prevent duplicate billing. If
the beneficiary does not provide consent or if other conditions for
payment are not met, the practitioner cannot bill Medicare. As outlined
in this preamble, referrals may be made to providers who are not
rendering a Medicare covered service(s), or who may not be enrolled in
Medicare, such as acupuncturists, massage therapists, psychiatrists,
dieticians, dentists, and providers of community-based services, which
could include companies that make environmental modifications, adult
day health programs, direct support workers, and others, and we do not
believe that requiring consent from providers who are not billing for
the CPM codes is necessary or practicable. We agree that providers
should document in the record that the beneficiary has given consent
for the services, although we are not requiring that the clinician
document that ``each element'' of the code has been delivered, since
that would vary based upon the person's needs. We are thankful for the
commenter who noted that consent, for some beneficiaries, may have to
be obtained from a legally responsible person, such as for people with
chronic pain who have dementia, an intellectual or developmental
disability, or any other type of cognitive disorder; those arrangements
vary under State law.
Comment: One commenter recommended that we focus and support
continued communication and care coordination for the CPM services,
which it stated has been a long-time struggle for chronic pain care,
but an essential element, especially in underserved communities.
Response: We agree that care coordination and communication between
all clinicians and other providers furnishing care to beneficiaries
living with chronic pain is an essential element, including for people
with pain living in underserved communities.
Comment: A few commenters stated that payers and providers should
look at quality care and meaningful improvements in function and
quality of life (beyond use of a validated pain rating scale or tool).
One commenter stressed the importance of utilization and outcome
measures that can assess efficacy and cost-effectiveness such as
hospitalizations, emergency department and urgent care visits,
specialist utilization and procedures, number of prescription
medications, and other health care data. Another appreciated our
interest in growing the available data related to the prevalence and
impact of chronic pain in the Medicare population, and requested that
once we collect data, this data be deidentified and made available to
the public to assist interested parties in the development and
refinement of programs. Another commenter requested that we provide a
mechanism for quality outcomes measurement based on the provided
service to shed light on pain experienced by the Medicare population,
what works best, and what provides improved health outcomes, in part to
reduce the need for specialty care and hospitalization. One commenter
noted the importance of medication adherence, and data regarding
medication adherence specific to chronic pain, including to avoid
unnecessary hospitalizations, adverse events, and deaths.
Response: We agree with the commenters that quality and data
collection are foundational components to delivering value as part of
the overall care journey, and help ensure optimal care and best
outcomes for people of all ages and backgrounds, and across service
delivery systems/settings, and payer types, as described in our CMS
National Quality Strategy.\71\ We are aware that there are scant
measures that examine chronic pain and medication adherence for chronic
pain, and trust that government and interested parties will continue to
explore options in measure development, testing, and endorsement to
improve measurement in chronic pain care. However, because we did not
make any proposals regarding the link between quality and CPM codes,
these comments are out of the scope of our proposed rule.
---------------------------------------------------------------------------
\71\ https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality.
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Comment: Several commenters wanted to ensure that use of the CPM
codes would not limit or interfere with the beneficiary's access to
other medical or pharmacy benefits.
Response: We appreciate the comment and can confirm that its use
will not interfere with other medically necessary Medicare benefits.
Comment: Many commenters requested more specifics related to the
administrative requirements and potential burdens the use of the CPM
codes would place on providers. Commenters urged CMS to work to ensure
the documentation requirements not be overly burdensome. This was
echoed by a commenter with chronic
[[Page 69543]]
pain who noted that physicians seem ``overwhelmed with today's
paperwork and administrative demands.''
Response: In 2020, we established our Office of Burden Reduction
and Health Informatics,\72\ to unify our efforts to reduce regulatory
and administrative burden, and advance interoperability and national
standards. We are continuing to engage beneficiaries and the clinical
community to better understand their experiences, form solutions, and
infuse CMS with a customer-focused mindset. We will be interested to
get feedback from clinicians about burden, once the CPM codes are
implemented in practice.
---------------------------------------------------------------------------
\72\ https://www.cms.gov/About-CMS/OBRHI.
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Comment: A few commenters recommended CMS reduce potentially
prohibitive payment methods, including prior authorization and cost
sharing to improve access to chronic pain management. These commenters
also suggested increasing access for non-opioid methods of pain
management, such as physical therapy and behavioral health care.
Another commenter also requested further clarification of cost sharing
requirements, as many people with chronic pain have disabilities, with
concern about limited access to pain management.
Response: The various interventions described in the PMTF Report's
pain management ``Toolbox'' attest that individualized care consists of
diagnostic evaluation that results in an integrative, person-centered
care plan that includes all necessary treatment options, that we hope
clinicians will consider when they treat Medicare beneficiaries with
chronic pain. Regarding cost-sharing, as described above, standard Part
B cost-sharing will apply to the CPM services. In some instances,
people who are low income or disabled and are dually eligible Medicare
and Medicaid beneficiaries, for example, will have different cost-
sharing from beneficiaries who are enrolled in Medicare, only. We
emphasize that the CPM codes do not require prior authorization.
Comment: One commenter expressed concern and confusion over our use
of the word ``bundle'' in the proposed rule, which they interpreted as
payment that contemplated paying other involved providers in an episode
of care environment. The commenter further stated that payment-based
``bundling'' is already a fast-growing and promising form of pain care
that should be correctly labeled.
Response: We apologize for any confusion by our use of the word
``bundle.'' The proposed CPM codes are not bundles as the commenter
contemplates, but rather codes similar to the CCM codes, or the code
for Cognitive Assessment and Care Planning Services, 99483, that denote
the elements of the code itself. By ``bundle,'' we were just referring
to all of the elements contained within the CPM code descriptors.
Comment: One commenter stated that caregivers and trusted family
members are also part of the team providing support to people with
chronic pain, and recommended including these individuals in the CPM
services, which it noted is especially important for people who have
communication or cognitive issues. Another commenter stated that
caregiver participation for these individuals is especially important
as they are often directly affected by the person's pain and can help
in making its perception better, or worse.
Response: We agree that the role of caregivers is of critical
importance across Medicare as caregivers provide a broad range of
mostly unpaid assistance with diverse health-related activities
provided by a friend, family member, partner, or neighbor to a care
recipient. The caregiver has a significant personal relationship with
the care recipient, and care may be episodic, daily, occasional, or of
short or long duration. Caregivers assist in basic personal care
activities such as eating and bathing; household management activities,
such as shopping and meal preparation; and other activities, such as
managing medications, attending medical encounters, and coordinating
financial and other activities, such as handling insurance and paying
bills. Caregivers may also be involved in managing complex health care
and assistive technology activities at home and in navigating care
transitions between settings of care. We are pointing out that Medicare
makes payment for CPT code 96161 (Administration of caregiver-focused
health risk assessment instrument (e.g., depression inventory) for the
benefit of the patient, with scoring and documentation, per
standardized instrument). However, as noted in the descriptors for
HCPCS codes G3002 and G3003, CPM services must be furnished by a
physician or other qualified health practitioner.
Comment: One commenter stated that in implementing the CPM
services, it is important for CMS to take a balanced approach between
administrative burden and program integrity, and that use of the codes
should be considered along with potential risk of ``bad actors'' to
inappropriately use them. The same commenter indicated that we should
prevent multiple group practices from concurrently billing for this
service for the same patient during the same time period as this would
eliminate duplicative services and payment. A different commenter
echoed that sentiment, concerned with ``doctor shopping,'' leading to
billing denials and driving up provider costs. Another commenter viewed
this problem differently, discussing that some patients will travel for
answers, or based on the availability of chronic pain providers in
their areas, may need to see their primary care provider first, then
may see other providers. This commenter was concerned that providers
would not specifically know when this code was billed by previous
providers, risking rejection even after services were provided. This
commenter recommended eliminating the limits on monthly billing.
Response: As with implementation of any new billing code, we will
be monitoring its use going forward, not just for data and other
purposes, but also for program integrity reasons. For HCPCS code G3002
and G3003, we would not generally expect multiple group practices to be
concurrently billing for a service that is to be rendered once per
month, per practitioner, per beneficiary. As noted previously, we will
be gathering data on the clinicians billing for and patients receiving
the services described by these CPM codes, and we may consider making
changes to these codes in future rulemaking, if necessary.
Comment: One commenter asked us to consider whether or not our
proposal to create new codes for CPM is the best course, or if we
should reconsider and expand the CCM codes. Another commenter
elaborated on issues with the CCM codes, stating these are confusing to
clinicians, involve administrative and documentation burden, which
discourages uptake, and that it hopes this scenario will not develop
with the CPM codes.
Response: We appreciate the comments about CCM vs. CPM; we did
consider differences in the CCM codes, which we explained in the
proposed rule, and believe the best course is to finalize the CPM codes
and monitor their use in practice.
Comment: One commenter stated that evidence shows that many people
with chronic pain, especially people from communities of color, have
low trust in the health care system, based on previous discrimination
and follow up. Another commenter stated that it is very important we
improve pain management for members of racial and ethnic minorities,
given both the rising
[[Page 69544]]
rates of drug overdose deaths among these populations and disparities
in the identification and effective management of pain.
Response: As we outlined in the proposed rule, we are aware of
disparities in chronic pain care and seek to address these disparities
in part through finalization of the CPM codes.
Comment: A commenter asked that we consider a ``MedLearn'' article
or Educational Transmittal to help providers understand more about the
CPM services including who can bill, documentation, potential
restrictions with other codes, etc. Several other commenters suggested
provider communication such as a Medicare Learning Network article or
similar blog post to summarize comments and the final rule. Another
commenter suggested that we convene all essential stakeholders in
public meetings, organized by the Agency, to hear stakeholder input
about the best way to move forward to encourage rather than limit non-
opioid pain management.
Response: We appreciate these suggestions from the commenters and
are considering how best we can educate providers about use of the new
codes, working with our HHS operating division partners.
Comment: A few commenters stated that CPM services should be able
to be billed concurrently with CCM, Behavioral Health Integration, or
Primary Care Management. Another commenter noted that CPM services
might disincentivize the provision of CPM services to the most complex
patients in part because neurologists routinely bill certain codes for
safety purposes, and the CPM proposal, which prohibited same day
billing of certain other codes, would impair care.
Response: We thank the commenters for sharing their feedback. As
noted in the CY 2023 PFS proposed rule, we believe there are
distinctions in the nature and extent of the assessments, care
coordination, medication management, and care planning for CPM to allow
concurrent billing for services that are medically reasonable and
necessary, and that it is particularly important to allow for the
provision of needed services, including behavioral health services to
beneficiaries with chronic pain. Therefore, if all requirements to
report each service are met then CPM may be billed in the same month as
CCM, TCM, and BHI services. We reiterate that the time spent in
providing CPM services may not represent time spent in providing any
other reported service.
Comment: A commenter questioned how the CPM codes relate to the
proposal in the CY 2023 OPPS proposed rule that would add the Facet
Joint Interventions service category to the prior authorization list.
This commenter noted that it seems incongruous for CMS to be
encouraging chronic pain management with this CPM code while
discouraging it in another.
Response: We thank the commenter for the comment; however, the
discussion of the new prior authorization proposal in the CY 2023 OPPS
proposed rule is beyond the scope of this CY 2023 PFS rule.
To further assist clinicians and interested parties in
understanding more about how we anticipate the CPM services might be
used, members of our clinical team have prepared the following
scenarios to illustrate how the codes might be used in practice.
Scenario 1: An individual clinician sees a new patient who
is seeking to establish care (for example, a general internist sees a
patient who is new to her practice and has a history of chronic pain).
The internist/clinician would need to review the patient's history,
including current and prior medications and treatments tried, and
perform an examination to ascertain the source of the patient's
symptoms as well as an initial functional assessment and develop a care
management plan as part of the visit).
++ This scenario would also likely involve some aspect of
medication management, may include referrals to behavioral health
clinicians, substance use disorder, and/or pain management specialists,
and would most certainly involve scheduling a follow-up appointment
with the internist, which could occur in 1-2 weeks or in several months
(or somewhere in between) depending on the needs of the patient.
++ While other clinicians are involved either through referrals or
to support other elements of the CPM services, it is expected that
generally only one or two clinicians would bill HCPCS code G3002/G3003,
asserting that they are providing the CPM services.
Scenario 2: An individual clinician sees an established
patient who is well known and has a stable care plan and on maintenance
medications (that is, a family physician sees a patient for routine
care to update the care management plan and perform a functional
assessment to ensure that the treatment plan is still supporting the
patient's goals of care).
++ As we stated above, it would be unusual for no medications or
supplements to be involved in the majority of cases of the management
of chronic pain. This may or may not mean the patient is on a chronic
opioid or other medication, and medication management is an almost
universal component of chronic pain management care--even for very
stable patients.
++ Medication management does not only involve management of
medications that the patient is currently taking, but the ability to
recognize when a new medication or over the counter treatment should be
considered as an adjunct to other treatment, to discuss that
recommendation in the context of shared decision-making and to initiate
the pharmacotherapeutic plan of care.
++ Coordination of care (be it the person's behavioral health
treatment or pain management care in general) is critical, and we
mention in the proposed rule language that coordination is expected
``as an element of the CPM codes, the development of and/or revisions
to a person-centered care plan that includes goals, clinical needs, and
desired outcomes, as outlined above and maintained by the practitioner
furnishing CPM services.'' However, not all psychologists are trained
or authorized to coordinate such care as a primary care clinician is
trained, as we have explained.
Scenario 3: An individual clinician provides care to a
patient with multiple chronic conditions (for example, a family
physician sees a patient with a history of chronic low back pain,
obesity, diabetes, and chronic renal insufficiency and routinely must
manage multiple concerns at the same visit).
++ This clinician would likely perform routine functional
assessments of this patient, medication management, ongoing clinical
assessments of their diabetes and kidney function, and discussion of
what their options are when it comes to managing their pain in the
context of these other conditions. As such, without knowing the history
of this patient's conditions, their current medications, past
treatments that have been successful or failures, the clinician cannot
properly manage this patient's chronic pain (for example. changes in
medication must be made in the context of this patients' kidney
function). Additionally, the clinician may wish to offer the patient
non-pharmacologic options for the treatment of their chronic low back
pain, which may include referrals to chiropractic, acupuncture,
physical therapy, massage, cognitive behavioral therapy or other
integrative or complementary/integrative treatments, all of which would
be reasonable discussions to take place in the context of billing HCPCS
codes G3002 and G3003, as appropriate.
[[Page 69545]]
Scenario 4: One individual clinician transfers care of a
patient to another individual clinician in the course of the month (for
example, a family physician refers to a pain management specialist who
then takes over the pain care aspects of a patient with chronic pain).
++ This situation could necessitate two different practitioners
billing HCPCS code G3002 during that first month; the lead clinician
could change to someone else on an infrequent and limited basis,
In summary, we are finalizing code descriptors for HCPCS codes
G3002 and G3003, with two modifications to HCPCS code G3002 shown in
italics, below.
HCPCS code G3002 (Chronic pain management and treatment, monthly
bundle including, diagnosis; assessment and monitoring; administration
of a validated pain rating scale or tool; the development,
implementation, revision, and/or maintenance of a person-centered care
plan that includes strengths, goals, clinical needs, and desired
outcomes; overall treatment management; facilitation and coordination
of any necessary behavioral health treatment; medication management;
pain and health literacy counseling; any necessary chronic pain related
crisis care; and ongoing communication and care coordination between
relevant practitioners furnishing care, e.g. physical therapy and
occupational therapy, complementary and integrative approaches, and
community-based care, as appropriate. Required initial face-to-face
visit at least 30 minutes provided by a physician or other qualified
health professional; first 30 minutes personally provided by physician
or other qualified health care professional, per calendar month. (When
using G3002, 30 minutes must be met or exceeded.))
HCPCS code G3003 (Each additional 15 minutes of chronic pain
management and treatment by a physician or other qualified health care
professional, per calendar month. (List separately in addition to code
for G3002. When using G3003, 15 minutes must be met or exceeded.))
In response to public comments, we are finalizing our proposed
policies pertaining to HCPCS codes G3002 and G3003, with a few
modifications, as follows:
We are defining chronic pain as persistent or recurrent
pain lasting longer than 3 months, as proposed;
We are requiring that the first time HCPCS code G3002 is
billed, the physician or qualified health practitioner must see the
beneficiary in-person. Both individuals must be in a clinical setting
such as a primary care practitioner's office or other applicable
setting, as proposed;
A physician or other qualified health practitioner may
bill HCPCS code G3003, for each additional 15 minutes of care, an
unlimited number of times, as medically necessary, per month, after
HCPCS code G3002 has been billed, as revised;
A work RVU of 1.45 for HCPCS code G3002 and a work RVU of
0.5 for HCPCS code G3003, as proposed;
That any of the CPM in-person components included in HCPCS
codes G3002 and G3003 may be furnished via telehealth, as clinically
appropriate, in order to increase access to care for beneficiaries, as
revised;
That HCPCS codes G3002 and G3003 may be furnished and
billed by physicians and other qualified health professionals, as
proposed; and
That both E/M and CPM may be billed on the same day if all
requirements to report each service are met, and time spent providing
CPM services does not represent time spent for providing any other
reported service, as proposed.
In response to comments expressing lack of clarity about certain
proposed policies pertaining to HCPCS codes G3002 and G3003, we are
clarifying in this final rule that:
The beneficiary, at the first visit, need not have an
established history or diagnosis of chronic pain, or be diagnosed with
a condition that causes or involves chronic pain; but that rather, it
is the clinician's responsibility to establish, confirm, or reject a
chronic pain and/or pain-related diagnosis when the beneficiary first
presents for care and the clinician first reports HCPCS code G3002;
That clinicians will be required to furnish all
appropriate elements of the code bundle, but that we do not expect that
all elements of the code bundle will be appropriate for every patient;
That we are not requiring in the code descriptor that a
clinician refer a beneficiary to other services; that determination
should be made between the clinician and the beneficiary; and finally
That CPM services would be available for billing/reporting
in conjunction with remote patient monitoring, remote physiologic
monitoring, or remote therapeutic monitoring if all requirements to
report each service are met, and time spent providing CPM services does
not represent time spent for any other furnished and billed service.
(34) Revisions to the ``Incident to'' Physicians' Services Regulation
for Behavioral Health Services
In the CY 2014 PFS final rule with comment period (78 FR 74425
through 74427), we created an exception to our ``incident to''
regulation at Sec. 410.26(b)(5) under which ``incident to'' services
generally must be furnished under direct supervision. Specifically, we
finalized a policy to require general, rather than direct, supervision
when chronic care management services are furnished incident to the
billing physician's or NPP's services outside of the practice's normal
business hours by clinical staff. In the CY 2017 PFS final rule (81 FR
80255), we finalized a revision to our regulation under Sec.
410.26(b)(5) to require a general, rather than direct, level of
supervision for designated care management services, and established
that we would designate care management services through notice and
comment rulemaking.
We understand that circumstances related to the PHE for COVID-19
have likely contributed to an increase in the demand for behavioral
health services while also exacerbating existing barriers to
beneficiaries' access to needed behavioral health services. For
example, the American Psychological Association (APA) conducted a
survey in 2020 and a follow-up survey in 2021 to better understand the
impact of the COVID-19 pandemic on mental health treatment and the work
of practicing psychologists. In the 2021 follow-up survey, many
psychologists reported increases in the demand for treatment of anxiety
and depression. They reported the greatest increases in treating
anxiety disorders (84 percent, up from 74 percent), depressive
disorders (72 percent, up from 60 percent), and trauma- and stress-
related disorders (62 percent, up from 50 percent). Other diagnoses
with large increases included sleep-wake disorders, obsessive-
compulsive and related disorders, and substance-related and addictive
disorders.\73\
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\73\ https://www.apa.org/pubs/reports/practitioner/covid-19-2021.
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Additionally, according to HRSA's National Center for Health
Workforce Analysis, by 2025, shortages are projected nationally for a
variety of behavioral health practitioners, including psychiatrists;
clinical, counseling, and school psychologists; mental health and
substance use social workers; school counselors; and
[[Page 69546]]
marriage and family therapists.\74\ Currently, there is no separate
benefit category under the statute that recognizes the professional
services of licensed professional counselors (LPCs) and Licensed
Marriage and Family Therapists (LMFTs). Therefore, payment for the
services of LPCs and LMFTs can only be made under the PFS indirectly
when an LPC or LMFT performs services as auxiliary personnel incident
to, the services, and under the direct supervision, of the billing
physician or other practitioner. According to the American Counseling
Association, there are more than 140,000 licensed professional
counselors (LPCs) in the U.S., and the Medicare program's reimbursement
for mental health treatment services delivered by this professional
group could address provider shortages.\75\ Additionally, according to
the U.S. Bureau of Labor Statistics, there were approximately 54,800
Marriage and Family Therapists (MFTs) as of May 2021.\76\
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\74\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\75\ https://www.counseling.org/government-affairs/federal-issues/medicare-reimbursement.
\76\ https://www.bls.gov/oes/current/oes211013.htm.
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In the 2022 CMS Behavioral Health Strategy,\77\ CMS included a goal
to improve access to and quality of mental health care services. In
light of the current needs among Medicare beneficiaries for improved
access to behavioral health services, and the existing workforce
shortages impeding access to needed treatment for behavioral health, we
have considered regulatory revisions that may help to reduce existing
barriers and make greater use of the services of LPCs and LMFTs. We
noted that CMS does not have authority to create a statutory benefit
category for practitioner types. Therefore, we proposed to amend the
direct supervision requirement under our ``incident to'' regulation at
Sec. 410.26 to allow behavioral health services to be furnished under
the general supervision of a physician or NPP when these services or
supplies are provided by auxiliary personnel incident to the services
of a physician or NPP. We are limiting the scope of this proposal to
behavioral health services at this time due to increased needs for
behavioral health treatment and workforce shortages in this field. We
believe that this proposed change will facilitate utilization and
extend the reach of behavioral health services. We believe that any
risk associated with this proposed change would be minimal, since the
auxiliary personnel providing the services would need to meet all of
the applicable requirements to provide incident to services, including
any applicable licensure requirements imposed by the State in which the
services are being furnished, as described in Sec. 410.26(a)(1).
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We received a high volume of public comments on these proposals.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters stated that they applaud CMS' proposed
revisions to the ``Incident to'' Physicians' Services regulation for
behavioral health services. Commenters stated that this proposal will
help expand access to, and coordination of mental health services in
rural and underserved areas where masters' level practitioners
represent a substantial segment of the mental health providers in the
area and doctoral-level clinicians such as psychologists are few, and
for some patients a long distance away. Further, allowing the
supervision of auxiliary staff such as licensed professional counselors
(LPCs) and marriage and family therapists (MFTs) without requiring a
continuous, direct physical presence would enable more patients to
receive services. Commenters also described that these provisions will
better engage the full panoply of behavioral health care providers in
meeting the needs of Medicare beneficiaries, while further promoting
beneficiary choice to select the type of behavioral health provider
that best suits their mental health needs. Many commenters also noted
that these proposed revisions are essential in light of the fact that
the COVID-19 pandemic has exacerbated rates of depression, loneliness,
and suicide among the elderly population.
Several commenters did not fully support changing the supervisory
requirements from ``direct'' to ``general'' because they noted that
most LPCs and LMFTs possess enough professional knowledge and training
on mental health and addiction to not be under any level of supervision
by a physician or NPP and requested that CMS add a separate benefit
category for LPCs and LMFTs, whom the commenters state comprise 40
percent of the behavioral health workforce, in order to increase access
to behavioral health services for Medicare beneficiaries. However, many
commenters noted that they recognize that without Congressional action,
CMS's ability to expand Medicare beneficiaries' access to LPCs and
LMFTs is limited and stated they support all steps CMS can take to
increase beneficiary access to these practitioners within its
regulatory authority.
A few commenters noted that many mental health counselors practice
in settings where they are not employed by or working directly with
physicians or NPPs and would not be able to take advantage of this
flexibility. Other commenters noted that the proposal to allow LPCs and
LMFTs to furnish behavioral health services under general supervision
is an important step to more effectively deploy behavioral health
professionals to practice at the top of their license, stating that
LPCs could be well positioned to treat patients for conditions
including depression and anxiety, thereby creating greater capacity for
clinical psychologists and other providers with more advanced training
to treat patients with conditions that require more complex care.
Commenters also described that with this new flexibility, primary care
practices may be able to leverage a broader range of behavioral health
professionals in the delivery of team-based integrated primary care,
and therefore, design their workflows in ways to better address the
needs of their patients.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing our
proposal to amend the direct supervision requirement under our
``incident to'' regulation at Sec. 410.26 to allow behavioral health
services to be furnished under the general supervision of a physician
or NPP when these services or supplies are provided by auxiliary
personnel incident to the services of a physician or NPP.
Comment: Many commenters requested that CMS specify which services
are considered ``behavioral health services,'' and would be eligible to
be furnished under general supervision under our proposal. A few
commenters urged CMS to define ``behavioral health services'' under the
broadest terms possible for the purposes of this provision.
Response: We do not define behavioral health services by HCPCS
codes; we did not propose to do so, and we believe individual
practitioners are in the best position to determine whether particular
treatments or diagnostic services are behavioral health services.
However, we generally understand a behavioral health service to be any
service furnished for the diagnosis, evaluation, or treatment of a
mental health disorder, including substance use disorders (SUD). We
note that in the CY 2022 PFS final rule (86 FR 65061), we stated that
SUD services
[[Page 69547]]
are considered mental health services for the purposes of the expanded
definition of ``interactive telecommunications system.'' Additionally,
in the CY 2010 PFS final rule (74 FR 61787), we referenced that the
outpatient mental health treatment limitation, which was phased out as
of 2014, applied to outpatient treatment of a mental, psychoneurotic,
or personality disorders, identified under the International
Classification of Diseases (ICD) diagnosis code range 290-319. These
are the types of behavioral health services that would be eligible to
be furnished by auxiliary personnel under the general supervision of a
physician or certain other nonphysician practitioners who are
authorized under their statutory benefit category to have integral,
although incidental, services provided incident to their own
professional services. Services could include, but are not limited to
services such as psychotherapy, Screening, Brief Intervention, and
Referral to Treatment (SBIRT) services, psychiatric diagnostic
evaluations, and other services furnished primarily for the treatment
or diagnosis of mental health or SUD disorders.
Comment: Many commenters sought clarification regarding which types
of clinicians may serve as auxiliary personnel under this policy. A few
commenters pointed out that terminology for clinicians who furnish
behavioral health care varies across states and requested that CMS
include all independently licensed providers in each state. One
commenter noted an example, that Washington State does not have an LPC
credential, but the equivalent independent license in Washington is a
Licensed Mental Health Counselor, or LMHC, and noted that states that
have alternative titles for comparable credentials would benefit
greatly by being able to use these clinicians to furnish services under
general supervision for Medicare beneficiaries and requested that CMS
consider expanding this proposal to include all those providers with
comparable state-issued licenses. Some commenters encouraged inclusion
of other mid-level clinicians who provide behavioral health treatment
services, such as certified addictions counselors. Other commenters
pointed out a range of clinicians that participate in furnishing
behavioral health treatment, including occupational therapists,
psychiatric pharmacists, and peer support specialists. Another
commenter pointed out that physician assistants are qualified to help
address workforce shortages and access to behavioral health treatment.
Many commenters also highlighted the importance of peer support
services, which commenters stated are designed to value lived
experience and to empower an individual to direct their own recovery
with dignity, noting that integrating peer support services in clinical
settings increases engagement in care and improves both physical and
mental outcomes, and requested clarification as to whether peer support
specialists could be considered auxiliary personnel. A few commenters
noted that under Medicare's partial hospitalization program, CMS
defaults to State licensure laws on which providers are eligible to
provide care, and therefore, encouraged CMS to adopt, for the purposes
of this provision, deference to State licensure laws where the care is
taking place.
Response: We note that the definition of auxiliary personnel at
Sec. 410.26(a)(1) defines auxiliary personnel as any individual who is
acting under the supervision of a physician (or other practitioner),
regardless of whether the individual is an employee, leased employee,
or independent contractor of the physician (or other practitioner) or
of the same entity that employs or contracts with the physician (or
other practitioner), has not been excluded from the Medicare, Medicaid
and all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in which the services are
being furnished. We note that we did not propose any changes to the
existing regulatory definition of auxiliary personnel in Sec. 410.26,
and therefore, we are not making any changes to this definition in this
rule. All requirements for services furnished incident to a physician's
or NPP's professional services listed at Sec. 410.26 continue to
apply. Many of the clinician types mentioned by commenters could
satisfy this definition.
Comment: Several commenters requested that CMS create a mechanism
for licensed psychologists to bill Medicare for the services furnished
by advanced psychology trainees under a licensed psychologist's
supervision, noting this is allowed by many State Medicaid programs.
The commenters stated that clinical psychology interns have 1,000 to
2,000 hours of clinical experience prior to beginning their internship,
but under current Medicare rules, they are not able to independently
bill Medicare, which leaves psychology training programs without a
steady source of funding and prevents trainees from gaining valuable
experience working with older patients and patients with disabilities.
Additionally, several commenters requested that CMS include behavioral
health providers who are in the process of seeking full licensure, such
as associate marriage and family therapists and State licensed
associate counselors, as auxiliary personnel. The commenters noted that
these are individuals who have met their state's graduate education and
exam requirements but have not yet met the supervised experience
requirement.
Response: We thank the commenters for their feedback; however, we
note that these comments are outside of the scope of our proposed
change to the required level of supervision for behavioral health
services furnished incident to a physician, NPP, or CP, because we did
not propose any changes to Medicare payment rules regarding interns or
postdoctoral students.
Comment: A few commenters stated they opposed the expansion of NPPs
scope of practice beyond their State license, education, and training.
One commenter stated that while they recognize the important services
these practitioners provide on the care team, Medicare patients--most
of whom have multiple chronic conditions, in addition to complex
behavioral health issues--should have access to primary care and
specialty physician services. They stated they believe that NPPs should
be under the direct supervision of a licensed physician and work within
the care team. Several commenters urged CMS to defer to State laws and
leave the scope of practice to the State legislatures and State
licensing boards. Another commenter noted that scope of practice is
determined by one's licensure in the State and supervision can ensure
safe delivery of that care. One commenter encouraged CMS to conduct
data collection and research on the care provided by LPCs and LMFTs
prior to expanding the policy to other providers to ensure patients are
receiving the best quality care to meet their needs. A few commenters
stated they oppose any supervisory changes that undermine the oversight
of physician-led health care teams. One commenter expressed concern
that under general supervision, the supervising clinician usually
provides oversight to a larger number of non-medical behavioral health
clinicians, which creates an obstacle to providing immediate feedback
when needed and suggested that guardrails are needed to ensure that
appropriate psychiatric consultation is available.
[[Page 69548]]
Response: The change to the level of supervision for ``incident
to'' behavioral health services from direct to general does not alter
the longstanding regulatory definition of auxiliary personnel.
Accordingly, any individual who qualifies as auxiliary personnel under
the ``incident to'' regulations at Sec. 410.26, which requires
services to be furnished in accordance with applicable State law, will
continue to qualify as such, regardless of the required level of
supervision assigned to the services. The definition of general
supervision requires the services to be furnished under the physician's
(or other practitioner's) overall direction and control. These
requirements must be met for the physician or practitioner to bill for
the behavioral health service. In the case where State law and scope of
practice are silent about whether an individual serving in the capacity
of auxiliary personnel is licensed/authorized to provide a given
behavioral health service, the supervision level for the provision of
the behavioral health service will default to the standard direct
supervision requirement for ``incident to'' services. Additionally, in
order for payment to be made under Medicare Part B for the services and
supplies incident to the services of a physician or other practitioner,
the service must be an integral, though incidental, part of the service
of the physician or practitioner in the course of diagnosis or
treatment of an injury or illness, in accordance with Sec. 410.26(b).
For this to be met, we would expect there to be a course of treatment
established by the physician or practitioner and in which the physician
or practitioner is actively participating and managing.
Comment: Several commenters expressed support for CMS allowing
behavioral health services to be furnished under general supervision in
the RHC and FQHC settings as well, and a few commenters encouraged CMS
to utilize its regulatory authority to amend the FQHC ``incident to''
regulations and FQHC mental health visit to include an encounter
performed by an LPC and LMFT to generate a billable visit in Medicare
to better align with Medicaid.
Response: We appreciate these suggestions from the commenters. We
note that for CY 2023, the proposed change to the level of supervision
for ``incident to'' behavioral health services from direct to general
was applicable only to services payable under the PFS, which means
services furnished in the RHC and FQHC settings were not addressed in
the relevant proposal in the CY 2023 PFS proposed rule (87 FR 46062
through 46068). We may consider changes to the regulations regarding
services furnished at RHCs and FQHCs in the future. Additionally, we
note that the types of practitioners' services that can be considered
RHC and FQHC services are specified in section 1861(aa)(1) and (3) of
the Act, respectively, and do not include the services of LPCs and
LMFTs.
Comment: One commenter suggested that CMS require a claims modifier
when services are billed ``incident to'' which could indicate the type
of personnel who performed the service (for example, LPC, LMFT,
clinical psychologist, clinical social worker). The commenter stated
that because this proposal would relax the supervision policy for
behavioral health services billed as ``incident to'' services,
transparency is necessary to understand the impacts of this change,
evaluate the quality of behavioral health care provided, monitor the
use of services, and inform future improvements.
Response: We thank the commenter for this suggestion. We may
consider a claims modifier for billing ``incident to'' services broadly
for future rulemaking.
Comment: Several commenters raised potential impacts for
beneficiaries who are dually eligible for Medicare and Medicaid. A few
commenters urged CMS to clarify that LPCs may be reimbursed by the
Medicaid program for services they provide to dually-eligible Medicare
beneficiaries, without documentation of a Medicare claim denial or,
alternatively, create a protocol to provide such a denial so that the
Medicaid program will process the claim.
Response: We thank commenters for this information and feedback,
but we note that this rule focuses on supervision, not which party will
be reimbursed for furnishing behavioral health services. We note that
this policy is limited to the change in the required level of
supervision for behavioral health services furnished by auxiliary
personnel incident to the services of a physician or NPP, and
therefore, we do not anticipate that this policy would have an effect
on the processing of crossover claims for beneficiaries who are dually
eligible for Medicare and Medicaid.
(35) New Coding and Payment for General Behavioral Health Integration
(BHI) Billed by Clinical Psychologists (CPs) and Clinical Social
Workers (CSWs)
In the CY 2017 PFS final rule (81 FR 80230), we established G-codes
to describe monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99492-99494,
which we established for payment under the PFS in the CY 2018 PFS final
rule (82 FR 53077 and 53078). Additionally, we created a fourth G-code
to describe services furnished using other models of BHI in the primary
care setting, which was replaced by CPT code 99484 in the CY 2018 PFS
final rule (82 FR 53077 and 53078).
We stated in the CY 2017 PFS final rule (81 FR 80236) that we
recognized that the psychiatric CoCM is prescriptive and that much of
its demonstrated success may be attributable to adherence to a set of
elements and guidelines of care. We finalized a code set to pay
accurately for care furnished using this specific model of care, given
its widespread adoption and recognized effectiveness. However, we
stated we recognized that there are primary care practices that are
incurring, or may incur, resource costs inherent to treatment of
patients with similar conditions based on BHI models of care other than
the psychiatric CoCM that may benefit beneficiaries with behavioral
health conditions, and therefore, finalized a General BHI code which
may be used to report a range of models of BHI services, and that we
expected this code to be refined over time as we receive more
information about other BHI models in use.
In the CY 2018 PFS final rule (82 FR 53078), we stated that we had
received inquiries from interested parties about whether professionals
who were not eligible to report the approved initiating visit codes for
BHI services to Medicare might nonetheless serve as a primary hub for
BHI services. For example, interested parties have suggested that a CP
might serve as the primary practitioner that integrates medical care
and psychiatric expertise. For purposes of future rulemaking, we sought
comment on the circumstances under which this model of care is
happening and whether additional coding would be needed to accurately
describe and value other models of care. A few commenters suggested
that CMS create separate codes to describe behavioral health care
management services that could be billed by CPs and NPPs who are not
authorized to bill Medicare for E/M services. One commenter suggested
that CMS include psychiatric diagnostic evaluation services that can be
furnished and billed by CPs as eligible initiating visits. Commenters
also
[[Page 69549]]
described other models of care that are in use, including the STAR-VA
model and a model used in outpatient health care settings where a
clinical social worker (CSW) not only furnishes psychiatric care but
also assists with psychosocial aspects of medical care.
In the CY 2017 PFS final rule (81 FR 80239), we stated that we had
received a few comments suggesting that in addition to the qualifying
E/M services (or an AWV or IPPE), the initiating visit services for BHI
should include in-depth psychological evaluations delivered by a CP
including CPT codes 90791, 96116 or 96118, which include care plan
development. In this final rule, we established that the same services
that qualify as the initiating visit for CCM would also qualify as
initiating services for BHI, which do not include in-depth
psychological evaluation by a CP and which were not, in their entirety,
within the scope of CPs' practice, and therefore, CPs would not be able
to report the General BHI code directly (although a psychiatrist may be
able to do so) (81 FR 80239).
In the 2022 CMS Behavioral Health Strategy,\78\ we included a goal
to improve access to and quality of mental health care services, and
included an objective to ``increase detection, effective management
and/or recovery of mental health conditions through coordination and
integration between primary and specialty care providers.'' As
previously noted in this proposed rule, we understand that
circumstances related to the COVID-19 PHE have likely contributed to an
increase in the demand for behavioral health services while also
exacerbating existing barriers in beneficiaries' access to needed
behavioral health services. In light of the feedback we have received
and considering the increased needs for mental health services, we
proposed to create a new G code describing General BHI performed by CPs
or CSWs to account for monthly care integration where the mental health
services furnished by a CP or CSW are serving as the focal point of
care integration. Specifically, we proposed to create HCPCS code GBHI1
(Care management services for behavioral health conditions, at least 20
minutes of clinical psychologist or clinical social worker time, per
calendar month, with the following required elements: initial
assessment or follow-up monitoring, including the use of applicable
validated rating scales; behavioral health care planning in relation to
behavioral/psychiatric health problems, including revision for patients
who are not progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination with and/or
referral to physicians and practitioners who are authorized by Medicare
law to prescribe medications and furnish E/M services, counseling and/
or psychiatric consultation; and continuity of care with a designated
member of the care team.) We proposed to value this service under the
proposed HCPCS code GBHI1 based on a direct crosswalk to the work
values and direct PE inputs for CPT code 99484 (Care management
services for behavioral health conditions, at least 20 minutes of
clinical staff time, directed by a physician or other qualified health
care professional, per calendar month, with the following required
elements: initial assessment or follow-up monitoring, including the use
of applicable validated rating scales; behavioral health care planning
in relation to behavioral/psychiatric health problems, including
revision for patients who are not progressing or whose status changes;
facilitating and coordinating treatment such as psychotherapy,
pharmacotherapy, counseling and/or psychiatric consultation; and
continuity of care with a designated member of the care team), because
the services described by GBHI1 closely mirror those described by CPT
code 99484. Therefore, we believe that this crosswalk is an appropriate
valuation of the level, time, and intensity of the proposed service
described by HCPCS code GBHI1. CPs are authorized under their statutory
benefit category at section 1861(ii) of the Act to furnish ``qualified
psychologist services'' to include ``such services and such services
and supplies furnished as an incident to his service furnished by a
clinical psychologist (as defined by the Secretary) which the
psychologist is legally authorized to perform under State law (or the
State regulatory mechanism provided by State law) as would otherwise be
covered if furnished by a physician or as an incident to a physician's
service.'' Additionally, the statutory benefit category for CSWs at
Section 1861(hh)(2) of the Act defines ``clinical social worker
services'' as ``services performed by a clinical social worker (as
defined in paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a hospital
and other than services furnished to an inpatient of a skilled nursing
facility which the facility is required to provide as a requirement for
participation) which the clinical social worker is legally authorized
to perform under State law (or the State regulatory mechanism provided
by State law) of the State in which such services are performed as
would otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.'' Based on the
authorizations under the CP and CSW statutory benefit categories, CPs
are authorized to furnish and bill for services that are provided by
clinical staff incident to their professional services when the
``incident to'' requirements specified in Sec. 410.26 of our
regulations are met, and would be authorized to do the same when
furnishing services described by proposed HCPCS code GBHI1, whereas
CSWs would only be able to bill Medicare for services they furnish
directly and personally. The proposed work value for HCPCS code GBHI1
is 0.61 (based on a direct crosswalk to CPT code 99484). We solicited
comment on whether this proposed value accurately reflects the resource
costs involved in furnishing these models of care, or whether
additional coding may be needed, for example, separate coding for CPs
and CSWs. We also solicited comment on the proposed requirements for
billing GBHI1, including any applicable ``incident to'' requirements,
and the role and responsibilities of CSWs and CPs.
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In the CY 2017 PFS final rule (81 FR 80239), we finalized the
requirement of an initiating visit for the BHI codes for new patients
or beneficiaries not seen within a year of commencement of BHI
services. We stated that the initiating visit would establish the
beneficiary's relationship with the billing practitioner (most aspects
of the BHI services would be furnished incident to the billing
practitioner's professional services), ensure the billing practitioner
assesses the beneficiary prior to initiating care management processes,
and provide an opportunity to obtain beneficiary consent. We noted that
the existing eligible initiating visit codes are not, in their
entirety, within the scope of the CP's practice. Given that, we
proposed to allow a psychiatric diagnostic evaluation (CPT code 90791)
to serve as the initiating visit for GBHI1. We welcome comment on
whether we should consider additional codes to qualify as the
initiating visit.
In the CY 2017 PFS final rule (81 FR 80235), we established that
CCM and BHI services could be billed during the same month for the same
beneficiary if all the requirements to bill each service are separately
met. We are also proposing that HCPCS code GBHI1 could be billed during
the same month as CCM and TCM services, provided
[[Page 69550]]
that all requirements to report each service are met and time and
effort are not counted more than once. The patient consent requirements
would apply to each service independently.
In the CY 2017 PFS final rule (81 FR 80235), we established that
the BHI services may be furnished incident to the billing
professional's services under general supervision because we do not
believe it is clinically necessary that the professionals on the team
who provide services other than the treating practitioner (namely, the
behavioral health care manager and the psychiatric consultant) to have
the billing practitioner immediately available to them at all times, as
would be required under a higher level of supervision. We believe this
is also the case for the service described by GBHI1. Therefore,
consistent with other care management codes paid under the PFS, we
proposed to add HCPCS code GBHI1 to the list of designated care
management services for which we allow general supervision.
We received public comments on new coding and payment for general
behavioral health integration (BHI) billed by Clinical Psychologists
(CPs) and Clinical Social Workers (CSWs). The following is a summary of
the comments we received and our responses.
Comment: Many commenters supported our proposed coding and payment
for BHI that would recognize psychologists' role in integrated care.
The commenters expressed support for recognizing multiple evidence-
based models of integrated care, stating this allows psychologists the
flexibility required to support the behavioral health needs of the
broader community. Other commenters noted that by providing access to
behavioral health and health behavior services within primary care
settings, BHI services can be particularly helpful in addressing
treatment disparities affecting members of racial and ethnic
minorities, and those living in underserved and vulnerable communities
with inadequate access to mental and behavioral health specialists. A
few commenters stated this proposal will provide additional flexibility
to primary care practices to design their workflows to best suit the
needs of beneficiaries and the care team's capacities. Commenters noted
that the establishment of this code will also help to recognize
psychologists' role in integrated care and allow psychologists the
flexibility required to support the behavioral health needs of the
broader community. Other commenters pointed out that a potential
advantage of the proposed service code is that HCPCS code GBHI1
appropriately adds additional autonomy to CP and CSW clinical practice,
which has the potential to improve job satisfaction and retention.
Additionally, commenters stated that allowing for reimbursement of
measurement-based care, interprofessional coordination, and care
management services may incentivize more CPs and CSWs to participate in
the Medicare behavioral health clinician network, which would in turn
increase patient access to care management services and behavioral
health treatment driven by validated outcome measurements. Commenters
also expressed support for allowing these services to be furnished
under general supervision.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing this
code as proposed. We note that the code GBHI1 was a placeholder code
and that the final code number will be HCPCS code G0323 (Care
management services for behavioral health conditions, at least 20
minutes of clinical psychologist or clinical social worker time, per
calendar month. (These services include the following required
elements: Initial assessment or follow-up monitoring, including the use
of applicable validated rating scales; behavioral health care planning
in relation to behavioral/psychiatric health problems, including
revision for patients who are not progressing or whose status changes;
facilitating and coordinating treatment such as psychotherapy,
coordination with and/or referral to physicians and practitioners who
are authorized by Medicare to prescribe medications and furnish E/M
services, counseling and/or psychiatric consultation; and continuity of
care with a designated member of the care team.))
Additionally, we are finalizing our proposal to add HCPCS code
G0323 to the list of designated care management services for which we
allow general supervision.
Comment: Several commenters stated they agreed with CMS that CPT
code 90791 (psychiatric diagnostic evaluation) could appropriately
serve as the initiating visit, noting that psychologists and social
workers are not able to bill E/M services. A few commenters also
requested that CPT code 96156, health behavior assessment and
reassessment, also serve as an allowable initiating visit for the newly
proposed BHI code. Another commenter urged CMS to broaden the types of
visits that can serve as an initiating visit for HCPCS code GBHI1,
stating that a visit with a primary care provider or social worker
would also be appropriate initial visit types and that limiting the
initiating visit to a psychiatric diagnostic evaluation undermines CMS'
intent to expand access to wraparound services for individuals
receiving mental health services.
Response: We appreciate the commenters suggestion about considering
other CPT codes such as 96156 (health behavior assessment, or
reassessment), as well as E/M visit codes in addition to CPT code 90791
(psychiatric diagnostic evaluation) to serve as the initiating visit
for GBHI1. However, when considering that CPs and CSWs cannot bill the
program for E/M visits because they are not licensed by the States to
furnish such services and, that the range of health behavior assessment
and intervention codes are for billing primarily for physical illnesses
rather than psychiatric illnesses, we believe that 90791 is the best
option that aligns with the services that CPs and CSWs are authorized
to furnish under State law and scope of practice. Accordingly,
recognizing a code for which CPs and CSWs can bill as an initiating
visit for HCPCS code G0323 offers them greater access and opportunity
to furnish integrated care management services.
Comment: A few commenters expressed concern about the medical
management of patients in models of care without psychiatric
involvement and suggested that the ability to receive immediate advice
on prescribing from a psychiatrist or child psychiatrist, as is the
case in the existing evidence-based psychiatric CoCM model, should be a
mandatory element in all other collaborative care models to ensure
patient safety and high-quality patient care. A commenter also pointed
to the existing interprofessional consultation codes (CPT codes 99446-
99449, 99451-99452) and urged CMS to emphasize the importance of
consultative relationships between psychiatrists, primary care
physicians, clinical psychologists, and clinical social workers in
order to ensure high-quality care.
Response: We thank the commenters for this feedback. In the CY 2017
PFS final rule (81 FR 80236 through 80238), we noted that we created
the General BHI code in order to allow payment for models of integrated
care other than the psychiatric collaborative care (CoCM) code. We
agree with the comment regarding the importance of consultative
relationships between various members of the care team, including
psychiatrists, primary care physicians, clinical psychologists, and
clinical social workers.
[[Page 69551]]
Comment: Many commenters supported the proposed valuation based on
a crosswalk to CPT code 99484. A few commenters opposed the proposed
valuation, stating that CPT code 99484 describes clinical staff time
and is valued assuming the service is performed by a behavioral health
care manager and that those assumptions do not accurately reflect the
cost when the service is performed by a clinical psychologist or
clinical social worker. Another commenter stated they do not believe
this proposed value accurately reflects the resource costs involved in
furnishing these models of care as the amount of time needed to
complete the required elements will take far longer than 20 minutes per
month and there is a substantial amount of work that occurs outside of
the office. The commenter urged CMS to consider a code that permits
multiple billable units of 20 minutes per unit per month capped at 10
units per month to better acknowledge the amount of time it takes to
adequately perform the required elements, as well as the critical
effort that occurs outside the office visit.
Response: We thank the commenters for this feedback. After
consideration of the comments, for CY 2023, we are finalizing the value
of HCPCS code G0323 as proposed, however we may consider changes in how
this code is valued for future rulemaking. We note that the commenter's
suggestion regarding codes that permit multiple billable units of 20
minutes per unit per month is outside of the scope of the proposal.
Comment: A few commenters requested that CMS clarify whether HCPCS
code GBHI1 may be billed in conjunction with codes describing remote
monitoring services. The commenter stated they support the new code but
sought clarification on whether HCPCS code GBHI1 could be billed in
conjunction with the following services: remote patient monitoring (CPT
code 99091), remote physiologic monitoring (CPT codes 99453, 99454,
99457, 99458), or remote therapeutic monitoring (CPT codes 98975,
98976, 98977, 98980, 98981 and as proposed GRTM1/2/3/4) codes.
Response: HCPCS code G0323, and the services describing remote
patient monitoring, remote physiologic monitoring, and remote
therapeutic monitoring, are distinct types of services, although there
may be some overlap in eligible patient populations. There may be some
circumstances where it is reasonable and necessary to provide both
services in a given month. The BHI codes, including HCPCS code G0323,
could be billed for the same patient in the same month as the RPM or
RTM services. All applicable requirements for the individual codes must
be met, including obtaining informed consent from the beneficiary, for
both the remote monitoring and BHI. In this circumstance, appropriate
billing in a given month means that time and effort cannot be counted
more than once when using BHI codes with RPM or RTM. Billing
practitioners should remember that cost sharing applies to each service
independently. If all requirements to report each service are met,
without time or effort being counted more than once, both may be
billed.
Comment: Several commenters requested that CMS clarify that
providers of peer support services (also known as peer support
specialists and peer recovery specialists) may bill as part of
behavioral health integration codes including the new GBHI1 code and
collaborative care codes.
Response: While there is no statutory benefit category under
Medicare law that authorizes direct billing and payment to peer support
specialists for their professional services under the Medicare Part B
program, it may be possible for peer support specialists to provide
their services in an ``incident to'' capacity. That is, if a peer
support specialist meets the definition of auxiliary personnel as
defined under the ``incident to'' regulations at Sec. 410.26, then
they could be eligible to provide behavioral health services within
their scope of practice in accordance with State law under the
supervision of a physician or certain nonphysician practitioners.
Comment: One commenter suggested that CMS should consider use of
telehealth visits to meet the initiating visit criteria as this would
serve to increase access in alignment with CMS' stated goal. Another
commenter encouraged CMS to monitor utilization of the code if
finalized and noted that the type of work described is resource
intensive and needs to be valued accordingly. Another commenter stated
they supported the proposed crosswalk, but it was unclear to them
whether the current valuation is accurate, stating that CPT code 99484
will be reviewed by the RUC at their September 2022 meeting.
Response: We may consider these commenters' suggestions for future
rulemaking. Additionally, we intend to monitor utilization of this code
and any subsequent changes to the valuation of CPT code 99484 in order
to determine whether we may need to re-visit the valuation through
future rulemaking.
Comment: One commenter encouraged CMS to consider broadening the
scope of services in this code to include coordination of social care.
The commenter stated that the behavioral health care manager will be
more successful in getting individuals successfully engaged in
treatment if they are able to attend to basic resources and social
needs by referring to relevant social services and programs and that
counting minutes spent coordinating mental health treatment but not
minutes spent helping address other concerns is burdensome for
clinicians and does not make sense clinically when it is all part of a
typical evidence-based clinical social work interventions that result
from a comprehensive psychosocial assessment and collaborative planning
process to work toward the overarching goal (in this case, improved
behavioral health).
Response: We appreciate the commenters suggested consideration of
making payment for coordination of social services. We did not propose
to include coordination of social care in HCPCS code G0323, so for this
reason we will not be finalizing such a change. As we continue to
consider ways to expand access to behavioral health services, we may
consider this for future rulemaking.
Comment: A few commenters stated they support additional coding to
promote integration and recommended that CMS develop a bundled payment
for behavioral health services that would include wraparound services
and could be used in value-based payment arrangements.
Response: We appreciate these suggestions. While they are out of
scope for this proposed rule, we may consider additional coding to
promote integration and payment through future rulemaking.
(36) Request for Information: Medicare Part B Payment for Services
Involving Community Health Workers (CHWs)
The American Public Health Association (APHA) defines a community
health worker as a ``frontline public health worker who is a trusted
member of and/or has an unusually close understanding of the community
served. This trusting relationship enables the worker to serve as a
liaison/link/intermediary between health/social services and the
community to facilitate access to services and improve the quality and
cultural competence of service delivery.'' Community Health Workers are
classified as a workforce category by the Department of Labor. The
Community Health Worker Core
[[Page 69552]]
Consensus Project (C3) lists the following ten roles of CHWs: \79\
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\79\ St John, J.A., Mayfield-Johnson, S.L., & Hern[aacute]ndez-
Gordon, W.D. (2021). Introduction: Why Community Health Workers
(CHWs)? In Promoting the Health of the Community (pp. 3-10).
Springer, Cham.
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Cultural mediation among individuals, communities, and
health and social service systems.
Providing culturally appropriate health education and
information.
Care coordination, case management, and system navigation.
Providing coaching and social support.
Advocating for individuals and communities.
Building individual and community capacity.
Providing direct service.
Implementing individual and community assessments.
Conducting outreach.
Participating in evaluation and research.
Findings from randomized controlled trials indicate that particular
CHW interventions reduce chronic disease disparities in low income,
racial and ethnic minority communities, such as type 2 diabetes,
hypertension, HIV/AIDS, and obesity.\80\ \81\ \82\ \83\ \84\ We are
also interested in better addressing the social needs of beneficiaries;
for example, in the FY 2023 IPPS/LTCH proposed rule, we proposed new
measures under the Hospital Inpatient Quality Reporting Program
pertaining to assessing social determinants of health. The CHW skillset
may position this workforce to address these social needs. In light of
the significant benefits that services involving CHWs can potentially
offer the health of Medicare beneficiaries, including a reduction in
health disparities, we are interested in learning more about how
services involving CHWs are furnished in association with the specific
Medicare benefits established by the statute.
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\80\ Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA.
Community Health Worker Support for Disadvantaged Patients With
Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public
Health. 2017;107(10):1660-1667. doi:10.2105/AJPH.2017.303985.
\81\ Cooper L.A., Roter D. L., Carson K. A., et al. A randomized
trial to improve patient-centered care and hypertension control in
underserved primary care patients. J Gen Intern Med.
2011;26(11):1297-1304.
\82\ Spencer MS, Rosland AM, Kieffer EC, Sinco BR, Valerio M,
Palmisano G, et al. Effectiveness of a community health worker
intervention among African American and Latino adults with type 2
diabetes: a randomized controlled trial. Am J Public Health. 2011
Dec;101(12):2253-60.
\83\ Brown LD, Vasquez D, Lopez DI, Portillo EM. Addressing
Hispanic Obesity Disparities Using a Community Health Worker Model
Grounded in Motivational Interviewing. Am J Health Promot.
2022;36(2):259-268.
\84\ Kenya, S., Jones, J., Arheart, K. et al. Using Community
Health Workers to Improve Clinical Outcomes Among People Living with
HIV: A Randomized Controlled Trial. AIDS Behav 17, 2927-2934 (2013).
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Over the past several years, we have worked to develop payment
mechanisms under the PFS to improve the accuracy of valuation and
payment for the services furnished by physicians and other health care
professionals, especially in the context of evolving models of care.
For example, physicians and other eligible practitioners are able to
report care management services and behavioral health integration
services based on tasks personally provided by clinical staff under
their supervision. Some of the elements of the comprehensive care plans
referenced in the description of care management services include
medication management, community/social services ordered, and
coordination with other agencies, which are also some of the services
personally provided by CHWs.
Section 1862(a)(1)(A) of the Act generally excludes from coverage
services that are not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member. We are interested in learning whether and how
CHWs, as auxiliary personnel of physicians and hospitals, may provide
reasonable and necessary services to Medicare beneficiaries under the
appropriate supervision of health care professionals that are
responsible more broadly for medical care, including behavioral health
care. We are also looking to understand whether and how services
involving CHWs are accounted for under the existing CCM codes or other
care management or behavioral health integration services, including
whether the employment and supervision arrangements ordinarily adopted
within the industry would meet the requirements that allow for billing
by supervising professionals or providers, including RHCs and FQHCs.
For example, do CHWs tend to be employees of physicians or of the same
entities that employ physicians? Are physicians or other medical
professionals supervising their interaction with patients in a manner
consistent with direct supervision--for example, immediate availability
in the same location?
We noted that CHWs are employed in a number of sectors, including
local government, community-based organizations, and social services
sectors. Therefore, the health care providers working with CHWs may
have established nontraditional relationships with these organizations
outside of the health sector. We are interested in learning how
payments between health care provider organizations, and community-
based organizations, local governments, and social service
organizations, account for the costs of services provided by CHWs, and
how health care provider organizations ensure that the funding amount
is sufficient to cover the costs of the full range of CHW services. We
also solicited comment on whether and to what extent CHW services are
provided in association with preventive services, including those
covered by Medicare.
Physicians and certain other health care practitioners are
authorized to bill Medicare for services furnished incident to their
professional services by auxiliary personnel. Our regulation at Sec.
410.26 requires that auxiliary personnel who perform services incident
to the services of the billing physician or other practitioner must be
acting under the supervision of the billing practitioner, and must meet
any applicable requirements, including licensure, imposed by the State
in which the services are furnished. We understand that there is wide
variation in State standards for CHWs. In addition, the training that
CHWs receive is typically provided by employers but varies widely in
terms of its breadth and scope.\85\ We are trying to understand how
CHWs might also be recognized as auxiliary personnel in the Medicare
context, and are therefore interested in learning how States may have
determined whether and under what circumstances CHWs have the necessary
qualifications to perform services that would improve the health of
Medicare beneficiaries and others being treated by supervising
professionals or providers.
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\85\ Fasting, D., Mayfield-Johnson, S.L., St. John, J.A., &
Hern[aacute]ndez-Gordon, W.D. (2021). In Promoting the Health of the
Community (pp. 43-52). Springer, Cham.
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We received several public comments in response to our request for
information about Medicare Part B Payment for Services Involving
Community Health Workers (CHWs). We appreciate the thoughtful feedback
submitted by the public on this matter and may consider these comments
in future rulemaking.
(37) Recognition of the Nurse Portfolio Credentialing Commission (NPCC)
The Medicare program established qualifications under regulations
at Sec. 410.75 for NPs and, under Sec. 410.76 for clinical nurse
specialists (CNS). Both the NP and CNS qualification regulations
require that NPs and CNSs be certified as a NP or a CNS by a
[[Page 69553]]
recognized national certifying body that has established standards for
NPs and/or CNSs, and that a listed certifying body must be approved by
the Secretary. An identical list of Medicare recognized and approved
national certifying bodies for NPs and CNSs is included under Chapter
15, section 200 and 210 of the Medicare Benefit Policy Manual, pub.
100-02.
The organizations listed under program manual instructions as
recognized national certifying bodies for NPs and CNSs are as follows:
American Academy of Nurse Practitioners;
American Nurses Credentialing Center;
National Certification Corporation for Obstetric,
Gynecologic and Neonatal Nursing Specialties;
Pediatric Nursing Certification Board (previously named
the National Certification Board of Pediatric Nurse Practitioners and
Nurses);
Oncology Nurses Certification Corporation;
AACN Certification Corporation; and
National Board on Certification of Hospice and Palliative
Nurses.
The Nurse Portfolio Credentialing Commission (NPCC) has requested
to have its organization added to the lists of recognized national
certifying bodies for NPs and CNSs who specialize in clinical genetics/
genomics and are awarded the Advanced Clinical Genomics Nurse (ACGN)
credential. The NPCC's request to CMS describes the NPCC as a non-
profit organization, established in 2018 by genetics/genomics nurse
leaders as the only organization that now offers new credentials to
advanced practice registered nurses (APRNs) who specialize in genetics/
genomics, a nursing specialty recognized by the American Nurses
Association.
Additionally, the NPCC's letter states that its organization
evolved directly from the American Nurses Credentialing Center (a
listed, CMS-recognized national certifying body) and the Genetic
Nursing Credentialing Commission, which are the organizations that
awarded new genetics/genomics nursing credentials from 2001 to 2018.
However, as of 2019, the American Nurses Credentialing Center (ANCC)
stopped offering new credentialing to genetics nurses and instead
offers only renewal credentialing to nurses who specialize in genetics.
Since 2019, the NPCC has awarded the ACGN credential to 32 APRNs from
17 States.
Now, with the NPCC being the only organization that offers new
credentialing to nurses in genetics, the NPCC is concerned that the
absence of its organization from the current list of recognized
national certifying bodies appropriate for NPs and CNSs presents a
barrier and a disadvantage for newly credentialed APRNs. Specifically,
the NPCC is concerned that newly NPCC credentialed NPs and CNSs seeking
enrollment under Medicare would be denied on the basis that they do not
meet Medicare's certification requirement unless the NPCC is listed as
a recognized national certifying body appropriate for NPs and CNSs who
specialize in genetics/genomics. The website for the NPCC is available
at https://www.nurseportfolio.org.
When considering previous requests to add other organizations to
the list of recognized national certifying bodies for NPs and CNSs, we
stated that it is not our intention to be overly restrictive in our
program requirements and consequently prevent qualified NPs and CNSs
who specialize in areas of medicine other than those certified by the
ANCC from participating in the Medicare program as NPs or CNSs and from
rendering care to patients in need of specialized services (see 71 FR
69707). Accordingly, we proposed to add the NPCC organization to the
list of recognized national certifying bodies in manual instructions
for NPs at section 200 and CNSs at section 210 of the Medicare Benefit
Policy Manual, pub. 100-02. We requested public comments on this
proposal.
The following is a summary of the public comments received on our
proposal concerning the NPCC, along with our response to these
comments.
Comment: One commenter stated that its organization is concerned
that the addition of the NPCC to the list of recognized national
certifying bodies for NPs and CNSs would create confusion between the
national certifying bodies for NPs and CNSs that are already listed
under program manual instructions and, the NPCC. The commenter
described the NPCC as a type of credentialing organization that
provides an additional credential in advanced clinical genomics to
demonstrate expertise in a specific specialty area to already certified
and licensed NPs and CNSs. Therefore, the commenter asserted that since
the list of recognized national certifying bodies in program manual
instructions lists the organizations that provide the certification
necessary to practice under Medicare as a NP or a CNS in accordance
with Medicare regulations, it does not support adding the NPCC, which
offers a specialty credential that goes beyond the requisite
qualification requirements for NPs and CNSs.
Response: We appreciate the commenters concern about creating
confusion by adding the NPCC to the list of recognized national
certifying bodies for NPs and CNSs. When establishing this list of
recognized national certifying bodies for NPs and CNSs, we were
cautious about being overly restrictive in our program requirements and
consequently preventing qualified NPs and CNSs who specialize in areas
of medicine other than those certified by the American Nurses
Credentialing Corporation (ANCC) from participating in the Medicare
program as NPs or CNSs and from rendering care to patients in need of
specialized services. Accordingly, the current list recognizes
organizations that certify NPs and CNSs with specialties in obstetrics,
gynecology, neonatal nursing, pediatrics, oncology, hospice and
palliative care. It is our intent to exercise this same caution when
considering additional prospects given the current severe shortage of
health care professionals such as NPs and CNSs available to render care
to patients, particularly those who are certified and furnish
specialized services. Since the ANCC no longer offers new credentialing
to genetics nurses, the NPCC is the only organization that offers new
credentialing for this nurse specialty. Therefore, our consideration to
recognize and list the NPCC is to prevent the potential for such
genetics nurses from being denied enrollment in the Medicare program.
Comment: Another commenter stated that CMS should recognize the
NPCC as a national certifying body for NPs and CNSs.
Response: We appreciate the support of our proposal. After
considering the public comments on the NPCC proposal, we are finalizing
our proposal to recognize and add the NPCC to the list of national
certifying bodies that is housed in our program manual instructions in
the Medicare Benefit Policy Manual, pub. 100-02, at Chapter 15, section
200 for NPs and, 210 for CNSs.
(38) Request for Information: Medicare Potentially Underutilized
Services
Medicare provides payment for many kinds of services that support
beneficiaries in promoting health and well-being and that may also, in
some cases, reduce unnecessary spending within the health care system
by decreasing the need for more expensive kinds of care. Some examples
of these services may include patient
[[Page 69554]]
educational services, like Diabetes Self-Management Training or
preventive services, like the Annual Wellness Visit.
We solicited comments on ways to identify specific services and to
recognize possible barriers to improved access to these kinds of high
value, potentially underutilized services by Medicare beneficiaries. We
also solicited regarding how we might best mitigate some of these
obstacles, including for example, through examining conditions of
payment or payment rates for these services or by prioritizing
beneficiary and provider education investments.
We discussed that ``high value'' health services have been
described as those ``services that provide the best possible health
outcomes at the lowest possible cost.'' \86\ The American College of
Physicians states that high value services seek ``to improve health,
avoid harms, and eliminate wasteful practices.'' \87\ However, we
described that we believe that some high value Medicare services may be
potentially underutilized by beneficiaries. In some cases, limited use
of these kinds of services occurs disproportionately in underserved
communities.
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\86\ ``Michigan Program on Value Enhancement.'' Institute for
Healthcare Policy & Innovation (28 Apr. 2022). https://ihpi.umich.edu/featured-work/michigan-program-value-enhancement.
\87\ High value care. ACP. (n.d.). (May 9, 2022). https://www.acponline.org/clinical-information/high-value-care.
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Disparities in health and healthcare persist despite decades of
research and widespread efforts to improve health outcomes in the
United States.\88\ Certain populations, including groups experiencing
racial disparity, people with disabilities, individuals dually eligible
for Medicare and Medicaid, and those living in rural and underserved
areas are more likely to experience challenges accessing healthcare
services, lower quality of care, and below average health outcomes when
compared to the general population.89 90 91 Many known
factors impede efficient and equitable healthcare, including workforce
challenges, transportation issues, healthcare costs, language barriers,
a lack of health literacy, and confusion about health insurance
coverage and processes.\92\ Additional factors include social
determinants of health and community-level burdens that contribute to
the exacerbation of health disparities. For example, disparities in
cancer screening and treatment across racial and ethnic groups have
been well documented. Research demonstrates that minority populations
are less likely to receive cancer screening tests than their white
counterparts and, consequently, are more likely to be diagnosed with
late-stage cancer.\93\ Additionally, racial and ethnic minorities with
positive test results are more likely to experience delays in receiving
the diagnostic tests that would serve to confirm cancer diagnoses.\94\
We are committed to building solutions that will help close gaps in
healthcare quality, access, and outcomes.\95\
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\88\ Office of Minority Health. (2021, January, page 3). Paving
the Way to Equity: A Progress Report. Centers for Medicaid and
Medicare Services. https://www.cms.gov/files/document/paving-way-equity-cms-omh-progress-report.pdf.
\89\ Agency for Health Care Research and Quality (AHRQ). (2021,
June). 2019 National Healthcare Quality and Disparities Report.
AHRQ. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr19/index.html.
\90\ Executive Order No. 13985, 86 FR 7009 (2021, January 20).
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/. For the
purposes of this RFI, we are using the definitions of equity and
underserved communities established in Executive Order 13985, ``The
term `equity' means the consistent and systematic fair, just, and
impartial treatment of all individuals, including individuals who
belong to underserved communities that have been denied such
treatment, such as Black, Latino, and Indigenous and Native American
persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) persons; persons with disabilities;
persons who live in rural areas; and persons otherwise adversely
affected by persistent poverty or inequality.'' The term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life.
\91\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health & Human. Services. Second
Report to Congress on Social Risk Factors and Performance in
Medicare's Value-Based. Purchasing Program. 2020. https://aspe.hhs.gov/reports/second-report-congress-social-risk-medicares-value-based-purchasing-programs.
\92\ Lahr, M., Henning-Smith, C., Rahman, A., Hernandez, A.
(2021, January). Barriers to Health Care Access for Rural Medicare
Beneficiaries: Recommendations from Rural Health Clinics. University
of Minnesota Rural Health Research Center.