[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Proposed Rules]
[Pages 40482-41289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16041]



[[Page 40481]]

Vol. 84

Wednesday,

No. 157

August 14, 2019

Part II

Book 2 of 3 Books

Pages 40481-41289





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 403, 410, 415, 416, et al.



Medicare Program; CY 2020 Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Changes to Part B Payment Policies; 
Medicare Shared Savings Program Requirements; Medicaid Promoting 
Interoperability Program Requirements for Eligible Professionals; 
Establishment of an Ambulance Data Collection System; Updates to the 
Quality Payment Program; Medicare Enrollment of Opioid Treatment 
Programs and Enhancements to Provider Enrollment Regulations Concerning 
Improper Prescribing and Patient Harm; and Amendments to Physician 
Self-Referral Law Advisory Opinion Regulations; Proposed Rules

Federal Register / Vol. 84 , No. 157 / Wednesday, August 14, 2019 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 410, 414, 415, 416, 418, 424, 425, 489, and 498

[CMS-1715-P]
RIN 0938-AT72


Medicare Program; CY 2020 Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Changes to Part B Payment Policies; 
Medicare Shared Savings Program Requirements; Medicaid Promoting 
Interoperability Program Requirements for Eligible Professionals; 
Establishment of an Ambulance Data Collection System; Updates to the 
Quality Payment Program; Medicare Enrollment of Opioid Treatment 
Programs and Enhancements to Provider Enrollment Regulations Concerning 
Improper Prescribing and Patient Harm; and Amendments to Physician 
Self-Referral Law Advisory Opinion Regulations

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses: Changes to the physician 
fee schedule (PFS); other changes to Medicare Part B payment policies 
to ensure that payment systems are updated to reflect changes in 
medical practice, relative value of services, and changes in the 
statute; Medicare Shared Savings Program quality reporting 
requirements; Medicaid Promoting Interoperability Program requirements 
for eligible professionals; the establishment of an ambulance data 
collection system; updates to the Quality Payment Program; Medicare 
enrollment of Opioid Treatment Programs and enhancements to provider 
enrollment regulations concerning improper prescribing and patient 
harm; and amendments to Physician Self-Referral Law advisory opinion 
regulations.

DATES: Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on September 27, 2019.

ADDRESSES: In commenting, please refer to file code CMS-1715-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1715-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1715-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

FURTHER INFORMATION CONTACT:
    Jamie Hermansen, (410) 786-2064, for any issues not identified 
below.
    Michael Soracoe, (410) 786-6312, for issues related to practice 
expense, work RVUs, conversion factor, and impacts.
    Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-
4735, for issues related to malpractice RVUs and geographic practice 
cost indicies (GPCIs).
    Larry Chan, (410) 786-6864, for issues related to potentially 
misvalued services under the PFS.
    Lindsey Baldwin, (410) 786-1694, or Emily Yoder, (410) 786-1804, 
for issues related to telehealth services.
    Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694, 
for issues related to Medicare coverage of opioid use disorder 
treatment services furnished by opioid treatment programs (OTPs).
    Lindsey Baldwin, (410) 786-1694, for issues related to bundled 
payments under the PFS for substance use disorders.
    Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, 
for issues related to the comment solicitation on opportunities for 
bundled payments under the PFS.
    Regina Walker-Wren, (410) 786-9160, for issues related to physician 
supervision for physician assistant (PA) services and review and 
verification of medical record documentation.
    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane 
Grayson, (410) 786-6583, or Christiane LaBonte, (410) 786-7237, for 
issues related to care management services.
    Kathy Bryant, (410) 786-3448, for issues related to coinsurance for 
colorectal cancer screening tests.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or 
Christiane LaBonte, (410) 786-7237, for issues related to payment for 
evaluation and management services.
    Kathy Bryant, (410) 786-3448, for issues related to global surgery 
data collection.
    Thomas Kessler, (410) 786-1991, for issues related to ambulance 
physician certification statement.
    Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542, 
for issues related to the ambulance fee schedule-BBA of 2018 
requirements for Medicare ground ambulance services data collection 
system.
    Linda Gousis, (410) 786-8616, for issues related to intensive 
cardiac rehabilitation.
    David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-
3816, for issues related to the Medicaid Promoting Interoperability 
Program.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) Quality Measures.
    Katie Mucklow, (410) 786-0537, or Diana Behrendt, (410) 786-6192, 
for issues related to open payments.
    Cheryl Gilbreath, (410) 786-5919, for issues related to home 
infusion therapy benefit.
    Joseph Schultz, (410) 786-2656, for issues related to Medicare 
enrollment of opioid treatment programs, and enhancements to provider 
enrollment regulations concerning improper prescribing and patient 
harm.
    Jacqueline Leach, (410) 786-4282, for issues related to Deferring 
to State Scope of Practice Requirements: Ambulatory Surgical Centers 
(ASC).
    Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring 
to State Scope of Practice Requirements: Hospice.
    [email protected], for issues related to Advisory 
Opinions on Application of the Physician Self-referral law.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Megan Hyde, (410) 786-3247, for inquiries related to Alternative 
Payment Models (APMs).

SUPPLEMENTARY INFORMATION:

Addenda Available Only Through the Internet on the CMS Website

    The PFS Addenda along with other supporting documents and tables 
referenced in this proposed rule are available on the CMS website at 
http://www.cms.gov/Medicare/Medicare-Fee-

[[Page 40483]]

for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. Click on the link on the left side of the screen titled, 
``PFS Federal Regulations Notices'' for a chronological list of PFS 
Federal Register and other related documents. For the CY 2020 PFS 
proposed rule, refer to item CMS-1715-P. Readers with questions related 
to accessing any of the Addenda or other supporting documents 
referenced in this proposed rule and posted on the CMS website 
identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2019 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and make other policy changes, including proposals to 
implement certain provisions of the 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, 
applicable to services furnished in CY 2020 and thereafter. In 
addition, this proposed rule includes proposals related to payment 
policy changes that are addressed in section III. of this proposed 
rule. We are requesting public comments on all of the proposals being 
made in this proposed rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major proposed rule, we are proposing to establish RVUs for 
CY 2020 for the PFS to ensure that our payment systems are updated to 
reflect changes in medical practice and the relative value of services, 
as well as changes in the statute. This proposed rule also includes 
discussions and proposals regarding several other Medicare Part B 
payment policies, Medicare Shared Savings Program quality reporting 
requirements, Medicaid Promoting Interoperability Program requirements 
for eligible professionals, the establishment of an ambulance data 
collection system, updates to the Quality Payment Program, Medicare 
enrollment of Opioid Treatment Programs and enhancements to provider 
enrollment regulations concerning improper prescribing and patient 
harm; and amendments to Physician Self-Referral Law advisory opinion 
regulations. This proposed rule addresses:

 Practice Expense RVUs (section II.B.)
 Malpractice RVUs (section II.C.)
 Geographic Practice Cost Indices (GPCIs) (section II.D.)
 Potentially Misvalued Services Under the PFS (section II.E.)
 Telehealth Services (section II.F.)
 Medicare Coverage for Opioid Use Disorder Treatment Services 
Furnished by Opioid Treatment Programs (section II.G.)
 Bundled Payments Under the PFS for Substance Use Disorders 
(section II.H.)
 Physician Supervision for Physician Assistant (PA) Services 
(section II.I.)
 Review and Verification of Medical Record Documentation 
(section II.J.)
 Care Management Services (section II.K.)
 Coinsurance for Colorectal Cancer Screening Tests (section 
II.L.)
 Therapy Services (section II.M.)
 Valuation of Specific Codes (section II.N.)
 Comment Solicitation on Opportunities for Bundled Payments 
Under the PFS (section II.O.)
 Payment for Evaluation and Management (E/M) Services (section 
II.P.)
 Ambulance Coverage Services--Physician Certification Statement 
(section III.A.)
 Ambulance Fee Schedule--Medicare Ground Ambulance Services 
Data Collection System (section III.B.)
 Intensive Cardiac Rehabilitation (section III.C.)
 Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs) (section III.D.)
 Medicare Shared Savings Program Quality Measures (section 
III.E.)
 Open Payments (section III.F.)
 Home Infusion Therapy Benefit (section III.G.)
 Medicare Enrollment of Opioid Treatment Programs and 
Enhancements to Existing General Enrollment Policies Related to 
Improper Prescribing and Patient Harm (section III.H.)
 Deferring to State Scope of Practice Requirements (section 
III.I.)
 Advisory Opinions on the Application of the Physician Self-
Referral Law (section III.J.)
 Updates to the Quality Payment Program (section III.K.)
2. Summary of Costs and Benefits
    We have determined that this major proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VI. of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, practice expense (PE), and malpractice (MP), which are adjusted 
for geographic cost variations. These values are multiplied by a 
conversion factor (CF) to convert the relative value units (RVUs) into 
payment rates. The concepts and methodology underlying the PFS were 
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. 
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus 
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 
5, 1990) (OBRA '90). The final rule published in the November 25, 1991 
Federal Register (56 FR 59502) set forth the first fee schedule used 
for payment for physicians' services.
    We note that throughout this major proposed rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for the services they furnish to Medicare 
beneficiaries.
1. Development of the RVUs
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was

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implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other public commenters, and the 
rationale for their recommendations. In the CY 2011 PFS final rule with 
comment period (75 FR 73328 through 73329), we discussed a variety of 
methodologies and approaches used to develop work RVUs, including 
survey data, building blocks, crosswalk to key reference or similar 
codes, and magnitude estimation. More information on these issues is 
available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and 
required us to develop resource-based PE RVUs for each physicians' 
service beginning in 1998. We were required to consider general 
categories of expenses (such as office rent and wages of personnel, but 
excluding MP expenses) comprising PEs. The PE RVUs continue to 
represent the portion of these resources involved in furnishing PFS 
services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33, enacted on August 5, 1997) (BBA of 1997) delayed implementation 
of the resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA of 1997 provided for a 4-year transition 
period from the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some resource costs are borne by the 
facility. Medicare's payment to the facility (such as the outpatient 
prospective payment system (OPPS) payment to the HOPD) would reflect 
costs typically incurred by the facility. Thus, payment associated with 
those specific facility resource costs is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and published in the Federal 
Register (65 FR 65376) as part of a November 1, 2000 final rule. The 
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 
and 68 FR 63196) extended the period during which we would accept these 
supplemental data through March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA of 1997 amended section 1848(c) of the 
Act to require that we implement resource-based MP RVUs for services 
furnished on or after CY 2000. The resource-based MP RVUs were 
implemented in the PFS final rule with comment period published 
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and 
physician-owned insurers' MP insurance premium data from all the 
states, the District of Columbia, and Puerto Rico. For more information 
on MP RVUs, see section II.C. of this proposed rule, Determination of 
Malpractice Relative Value Units.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently. We completed 5-year 
reviews of work RVUs that were effective for calendar years 1997, 2002, 
2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.

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    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC identified and reviewed a number of potentially misvalued codes 
on an annual basis based on various identification screens. This annual 
review of work and PE RVUs for potentially misvalued codes was 
supplemented by the amendments to section 1848 of the Act, as enacted 
by section 3134 of the Affordable Care Act, that require the agency to 
periodically identify, review and adjust values for potentially 
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
    As described in section VI. of this proposed rule, the Regulatory 
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of 
the Act, if revisions to the RVUs cause expenditures for the year to 
change by more than $20 million, we make adjustments to ensure that 
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component. Please refer to the CY 2017 PFS final rule with comment 
period for a discussion of the last GPCI update (81 FR 80261 through 
80270).
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS's Office of 
the Actuary (OACT). The formula for calculating the Medicare PFS 
payment amount for a given service and fee schedule area can be 
expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI 
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
    Section 1848(b)(2)(B) of the Act specifies that the fee schedule 
amounts for anesthesia services are to be based on a uniform relative 
value guide, with appropriate adjustment of an anesthesia CF, in a 
manner to ensure that fee schedule amounts for anesthesia services are 
consistent with those for other services of comparable value. 
Therefore, there is a separate fee schedule methodology for anesthesia 
services. Specifically, we establish a separate CF for anesthesia 
services and we utilize the uniform relative value guide, or base 
units, as well as time units, to calculate the fee schedule amounts for 
anesthesia services. Since anesthesia services are not valued using 
RVUs, a separate methodology for locality adjustments is also 
necessary. This involves an adjustment to the national anesthesia CF 
for each payment locality.

B. Determination of PE RVUs

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding MP expenses, as specified in section 1848(c)(1)(B) of the 
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a 
resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the 5-year review of work relative value 
units under the PFS and proposed changes to the practice expense 
methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 
PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of

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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 called ``CY 2020 PFS Proposed Rule PE/HR'' on the 
CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2020, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2018. These specialties are Medical Toxicology and 
Hematopoietic Cell Transplantation and Cellular Therapy. We are 
proposing to use proxy PE/HR values for these new specialties, as there 
are no PPIS data for these specialties, by crosswalking the PE/HR as 
follows from specialties that furnish similar services in the Medicare 
claims data:
     Medical Toxicology from Emergency Medicine; and
     Hematopoietic Cell Transplantation and Cellular Therapy 
from Hematology/Oncology.
    These updates are reflected in the ``CY 2020 PFS Proposed Rule PE/
HR'' file available on the CMS website under the supporting data files 
for the CY 2020 PFS proposed 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 on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     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.
     Next, 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

[[Page 40487]]

furnished together as a global service. When services have separately 
billable PC and TC components, the payment for the global service 
equals the sum of the payment for the TC and PC. To achieve this, we 
use a weighted average of the ratio of indirect to direct costs across 
all the specialties that furnish the global service, TCs, and PCs; that 
is, we apply the same weighted average indirect percentage factor to 
allocate indirect expenses to the global service, PCs, and TCs for a 
service. (The direct PE RVUs for the TC and PC sum to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct readers to the file called ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2020 PFS proposed 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 proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to a RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use 
the most recent year of claims data to determine which codes are low 
volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we 
instead use the expected specialty that we identify on a list developed 
based on medical review and input from expert stakeholders. We display 
this list of expected specialty assignments as part of the annual set 
of data files we make available as part of notice and comment 
rulemaking and consider recommendations from the RUC and other 
stakeholders on changes to this list on an annual basis. Services for 
which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) are unaffected by the list of expected 
specialty assignments. We also finalized in the CY 2018 PFS final rule 
(82 FR 52982 through 59283) a policy to apply these service-level 
overrides for both PE and MP, rather than one or the other category.
    For CY 2020, we are proposing to clarify the expected specialty 
assignment for a series of cardiothoracic services. Prior to the 
creation of the expected specialty list for low volume services in CY 
2018, we previously finalized through rulemaking a crosswalk to the 
thoracic surgery specialty for a series of cardiothoracic services that 
typically had fewer than 100 services reported each year (see, for 
example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we 
noted that for many of the affected codes, the expected specialty list 
for low volume services incorrectly listed a crosswalk to the cardiac 
surgery specialty instead of the thoracic surgery specialty. We are 
proposing to update the expected specialty list to accurately reflect 
the previously finalized crosswalk to thoracic surgery for these 
services. The affected codes are shown in Table 1.

             Table 1--Proposed Updates to Expected Specialty
------------------------------------------------------------------------
                         CY 2019 expected       Updated CY 2020 expected
     CPT code               specialty                  specialty
------------------------------------------------------------------------
33414.............  Cardiac Surgery..........  Thoracic Surgery.
33468.............  Cardiac Surgery..........  Thoracic Surgery.
33470.............  Cardiac Surgery..........  Thoracic Surgery.
33471.............  Cardiac Surgery..........  Thoracic Surgery.
33476.............  Cardiac Surgery..........  Thoracic Surgery.
33478.............  Cardiac Surgery..........  Thoracic Surgery.
33502.............  Cardiac Surgery..........  Thoracic Surgery.
33503.............  Cardiac Surgery..........  Thoracic Surgery.
33504.............  Cardiac Surgery..........  Thoracic Surgery.
33505.............  Cardiac Surgery..........  Thoracic Surgery.
33506.............  Cardiac Surgery..........  Thoracic Surgery.
33507.............  Cardiac Surgery..........  Thoracic Surgery.
33600.............  Cardiac Surgery..........  Thoracic Surgery.
33602.............  Cardiac Surgery..........  Thoracic Surgery.
33606.............  Cardiac Surgery..........  Thoracic Surgery.
33608.............  Cardiac Surgery..........  Thoracic Surgery.
33610.............  Cardiac Surgery..........  Thoracic Surgery.
33611.............  Cardiac Surgery..........  Thoracic Surgery.
33612.............  Cardiac Surgery..........  Thoracic Surgery.
33615.............  Cardiac Surgery..........  Thoracic Surgery.
33617.............  Cardiac Surgery..........  Thoracic Surgery.
33619.............  Cardiac Surgery..........  Thoracic Surgery.
33620.............  Cardiac Surgery..........  Thoracic Surgery.
33621.............  Cardiac Surgery..........  Thoracic Surgery.
33622.............  Cardiac Surgery..........  Thoracic Surgery.
33645.............  Cardiac Surgery..........  Thoracic Surgery.
33647.............  Cardiac Surgery..........  Thoracic Surgery.
33660.............  Cardiac Surgery..........  Thoracic Surgery.
33665.............  Cardiac Surgery..........  Thoracic Surgery.
33670.............  Cardiac Surgery..........  Thoracic Surgery.
33675.............  Cardiac Surgery..........  Thoracic Surgery.
33676.............  Cardiac Surgery..........  Thoracic Surgery.
33677.............  Cardiac Surgery..........  Thoracic Surgery.
33684.............  Cardiac Surgery..........  Thoracic Surgery.
33688.............  Cardiac Surgery..........  Thoracic Surgery.
33690.............  Cardiac Surgery..........  Thoracic Surgery.
33692.............  Cardiac Surgery..........  Thoracic Surgery.
33694.............  Cardiac Surgery..........  Thoracic Surgery.
33697.............  Cardiac Surgery..........  Thoracic Surgery.
33702.............  Cardiac Surgery..........  Thoracic Surgery.
33710.............  Cardiac Surgery..........  Thoracic Surgery.
33720.............  Cardiac Surgery..........  Thoracic Surgery.
33722.............  Cardiac Surgery..........  Thoracic Surgery.
33724.............  Cardiac Surgery..........  Thoracic Surgery.
33726.............  Cardiac Surgery..........  Thoracic Surgery.
33730.............  Cardiac Surgery..........  Thoracic Surgery.
33732.............  Cardiac Surgery..........  Thoracic Surgery.
33735.............  Cardiac Surgery..........  Thoracic Surgery.
33736.............  Cardiac Surgery..........  Thoracic Surgery.

[[Page 40488]]

 
33737.............  Cardiac Surgery..........  Thoracic Surgery.
33750.............  Cardiac Surgery..........  Thoracic Surgery.
33755.............  Cardiac Surgery..........  Thoracic Surgery.
33762.............  Cardiac Surgery..........  Thoracic Surgery.
33764.............  Cardiac Surgery..........  Thoracic Surgery.
33766.............  Cardiac Surgery..........  Thoracic Surgery.
33767.............  Cardiac Surgery..........  Thoracic Surgery.
33768.............  Cardiac Surgery..........  Thoracic Surgery.
33770.............  Cardiac Surgery..........  Thoracic Surgery.
33771.............  Cardiac Surgery..........  Thoracic Surgery.
33774.............  Cardiac Surgery..........  Thoracic Surgery.
33775.............  Cardiac Surgery..........  Thoracic Surgery.
33776.............  Cardiac Surgery..........  Thoracic Surgery.
33777.............  Cardiac Surgery..........  Thoracic Surgery.
33778.............  Cardiac Surgery..........  Thoracic Surgery.
33779.............  Cardiac Surgery..........  Thoracic Surgery.
33780.............  Cardiac Surgery..........  Thoracic Surgery.
33781.............  Cardiac Surgery..........  Thoracic Surgery.
33782.............  Cardiac Surgery..........  Thoracic Surgery.
33783.............  Cardiac Surgery..........  Thoracic Surgery.
33786.............  Cardiac Surgery..........  Thoracic Surgery.
33788.............  Cardiac Surgery..........  Thoracic Surgery.
33800.............  Cardiac Surgery..........  Thoracic Surgery.
33802.............  Cardiac Surgery..........  Thoracic Surgery.
33803.............  Cardiac Surgery..........  Thoracic Surgery.
33813.............  Cardiac Surgery..........  Thoracic Surgery.
33814.............  Cardiac Surgery..........  Thoracic Surgery.
33820.............  Cardiac Surgery..........  Thoracic Surgery.
33822.............  Cardiac Surgery..........  Thoracic Surgery.
33824.............  Cardiac Surgery..........  Thoracic Surgery.
33840.............  Cardiac Surgery..........  Thoracic Surgery.
33845.............  Cardiac Surgery..........  Thoracic Surgery.
33851.............  Cardiac Surgery..........  Thoracic Surgery.
33852.............  Cardiac Surgery..........  Thoracic Surgery.
33853.............  Cardiac Surgery..........  Thoracic Surgery.
33917.............  Cardiac Surgery..........  Thoracic Surgery.
33920.............  Cardiac Surgery..........  Thoracic Surgery.
33922.............  Cardiac Surgery..........  Thoracic Surgery.
33924.............  Cardiac Surgery..........  Thoracic Surgery.
33925.............  Cardiac Surgery..........  Thoracic Surgery.
33926.............  Cardiac Surgery..........  Thoracic Surgery.
35182.............  Cardiac Surgery..........  Thoracic Surgery.
------------------------------------------------------------------------

    We note that the cardiac surgery and thoracic surgery specialties 
are similar to one another, sharing the same PE/HR data for PE 
valuation and nearly identical MP risk factors for MP valuation. As a 
result, we do not anticipate this proposal having a discernible effect 
on the valuation of the codes listed above. For additional discussion 
on this issue, we refer readers to section II.C of this proposed rule, 
Malpractice. The complete list of expected specialty assignments for 
individual low volume services, including the assignments for the codes 
identified in Table 1, is available on our website under downloads for 
the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    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 
called ``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 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 proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this proposed rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable

[[Page 40489]]

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.

       Table 2--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
     Specialty code                    Specialty description
------------------------------------------------------------------------
49......................  Ambulatory surgical center.
50......................  Nurse practitioner.
51......................  Medical supply company with certified
                           orthotist.
52......................  Medical supply company with certified
                           prosthetist.
53......................  Medical supply company with certified
                           prosthetist[dash]orthotist.
54......................  Medical supply company not included in 51, 52,
                           or 53.
55......................  Individual certified orthotist.
56......................  Individual certified prosthetist.
57......................  Individual certified
                           prosthetist[dash]orthotist.
58......................  Medical supply company with registered
                           pharmacist.
59......................  Ambulance service supplier, e.g., private
                           ambulance companies, funeral homes, etc.
60......................  Public health or welfare agencies.
61......................  Voluntary health or charitable agencies.
73......................  Mass immunization roster biller.
74......................  Radiation therapy centers.
87......................  All other suppliers (e.g., drug and department
                           stores).
88......................  Unknown supplier/provider specialty.
89......................  Certified clinical nurse specialist.
96......................  Optician.
97......................  Physician assistant.
A0......................  Hospital.
A1......................  SNF.
A2......................  Intermediate care nursing facility.
A3......................  Nursing facility, other.
A4......................  HHA.
A5......................  Pharmacy.
A6......................  Medical supply company with respiratory
                           therapist.
A7......................  Department store.
A8......................  Grocery store.
B1......................  Supplier of oxygen and/or oxygen related
                           equipment (eff. 10/2/2007).
B2......................  Pedorthic personnel.
B3......................  Medical supply company with pedorthic
                           personnel.
B4......................  Rehabilitation Agency.
B5......................  Ocularist.
C1......................  Centralized Flu.
C2......................  Indirect Payment Procedure.
C5......................  Dentistry.
------------------------------------------------------------------------

     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).

[[Page 40490]]

     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 3 details the manner in which the 
modifiers are applied.

     Table 3--Application of Payment Modifiers to Utilization Files
------------------------------------------------------------------------
                                             Volume
      Modifier           Description       adjustment    Time adjustment
------------------------------------------------------------------------
80,81,82............  Assistant at      16%............  Intraoperative
                       Surgery.                           portion.
AS..................  Assistant at      14% (85% * 16%)  Intraoperative
                       Surgery--Physic                    portion.
                       ian Assistant.
50 or LT and RT.....  Bilateral         150%...........  150% of work
                       Surgery.                           time.
51..................  Multiple          50%............  Intraoperative
                       Procedure.                         portion.
52..................  Reduced Services  50%............  50%.
53..................  Discontinued      50%............  50%.
                       Procedure.
54..................  Intraoperative    Preoperative +   Preoperative +
                       Care only.        Intraoperative   Intraoperative
                                         Percentages on   portion.
                                         the payment
                                         files used by
                                         Medicare
                                         contractors to
                                         process
                                         Medicare
                                         claims.
55..................  Postoperative     Postoperative    Postoperative
                       Care only.        Percentage on    portion.
                                         the payment
                                         files used by
                                         Medicare
                                         contractors to
                                         process
                                         Medicare
                                         claims.
62..................  Co-surgeons.....  62.5%..........  50%.
66..................  Team Surgeons...  33%............  33%.
------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    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 
proposed rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + 
interest rate)-life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous 
(that is, usage=1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed 
rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that would support an alternative rate.

[[Page 40491]]

    Maintenance: This factor for maintenance was finalized 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 
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 do not believe that 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 do not believe that we have sufficient 
information at present to propose a variable maintenance factor for 
equipment cost per minute pricing. We 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). We 
are not proposing any changes to these interest rates for CY 2020. The 
Interest rates are listed in Table 4.

                   Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                               Interest
               Price                    Useful life years      rate (%)
------------------------------------------------------------------------
<$25K..............................  <7....................         7.50
$25K to $50K.......................  <7....................         6.50
>$50K..............................  <7....................         5.50
<$25K..............................  7+....................         8.00
$25K to $50K.......................  7+....................         7.00
>$50K..............................  7+....................         6.00
------------------------------------------------------------------------

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2020 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2020 PFS 
proposed 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 67640-67641), 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 
postservice 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.'' Exam completed in RIS system 
to generate billing process and to populate images into Radiologist 
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through 
80186), we finalized a policy to establish a range of appropriate 
standard minutes for the clinical labor activity, ``Technologist QCs 
images in PACS, checking for all images, reformats, and dose page.'' 
These standard minutes will be applied to new and revised codes that 
make use of this clinical labor activity when they are reviewed by us 
for valuation. We finalized a policy to establish 2 minutes as the 
standard for the simple case, 3 minutes as the standard for the 
intermediate case, 4 minutes as the standard for the complex case, and 
5 minutes as the standard for the highly complex case. These values 
were based upon a review of the existing minutes assigned for this 
clinical labor activity; we determined that 2 minutes is the duration 
for most services and a small number of codes with more complex forms 
of digital imaging have higher values.

[[Page 40492]]

    We also finalized standard times for clinical labor tasks 
associated with pathology services in the CY 2016 PFS final rule with 
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver 
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble 
other light microscopy slides, open nerve biopsy slides, and clinical 
history, and present to pathologist to prepare clinical pathologic 
interpretation'', 1 minute for ``Clean room/equipment following 
procedure'', 1 minute for ``Dispose of remaining specimens, spent 
chemicals/other consumables, and hazardous waste'', and 1 minute for 
``Prepare, pack and transport specimens and records for in-house 
storage and external storage (where applicable).'' We do not believe 
these activities would be dependent on number of blocks or batch size, 
and we believe that these 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 59463-59464).
    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 2020, 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 2020 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Equipment Recommendations for Scope Systems
    During our routine reviews of direct PE input recommendations, we 
have regularly found unexplained inconsistencies involving the use of 
scopes and the video systems associated with them. Some of the scopes 
include video systems bundled into the equipment item, some of them 
include scope accessories as part of their price, and some of them are 
standalone scopes with no other equipment included. It is not always 
clear which equipment items related to scopes fall into which of these 
categories. We have also frequently found anomalies in the equipment 
recommendations, with equipment items that consist of a scope and video 
system bundle recommended, along with a separate scope video system. 
Based on our review, the variations do not appear to be consistent with 
the different code descriptions.
    To promote appropriate relativity among the services and facilitate 
the transparency of our review process, during the review of the 
recommended direct PE inputs for the CY 2017 PFS proposed rule, we 
developed a structure that separates the scope, the associated video 
system, and any scope accessories that might be typical as distinct 
equipment items for each code. Under this approach, we proposed 
standalone prices for each scope, and separate prices for the video 
systems and accessories that are used with scopes.
(1) Scope Equipment
    Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 
46177), we proposed standardizing refinements to the way scopes have

[[Page 40493]]

been defined in the direct PE input database. We believe that there are 
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and 
rigid scopes would typically be paired with one of the scope video 
systems, while the non-video scopes would not. The flexible scopes can 
be further divided into diagnostic (or non-channeled) and therapeutic 
(or channeled) scopes. We proposed to identify for each anatomical 
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. We proposed to classify the existing 
scopes in our direct PE database under this classification system, to 
improve the transparency of our review process and improve appropriate 
relativity among the services. We planned to propose input prices for 
these equipment items through future rulemaking.
    We proposed these changes only for the reviewed codes for CY 2017 
that made use of scopes, along with updated prices for the equipment 
items related to scopes utilized by these services. We did not propose 
to apply these policies to codes with inputs reviewed prior to CY 2017. 
We also solicited comment on this separate pricing structure for 
scopes, scope video systems, and scope accessories, which we could 
consider proposing to apply to other codes in future rulemaking. We did 
not finalize price increases for a series of other scopes and scope 
accessories, as the invoices submitted for these components indicated 
that they are different forms of equipment with different product IDs 
and different prices. We did not receive any data to indicate that the 
equipment on the newly submitted invoices was more typical in its use 
than the equipment that we were currently using for pricing.
    We did not make further changes to existing scope equipment in CY 
2017 to allow the RUC's PE Subcommittee the opportunity to provide 
feedback. However, we believed there was some miscommunication on this 
point, as the RUC's PE Subcommittee workgroup that was created to 
address scope systems stated that no further action was required 
following the finalization of our proposal. Therefore, we made further 
proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) 
to continue clarifying scope equipment inputs, and sought comments 
regarding the new set of scope proposals. We considered creating a 
single scope equipment code for each of the five categories detailed in 
this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. Under the current classification 
system, there are many different scopes in each category depending on 
the medical specialty furnishing the service and the part of the body 
affected. We stated our belief that the variation between these scopes 
was not significant enough to warrant maintaining these distinctions, 
and we believed that creating and pricing a single scope equipment code 
for each category would help provide additional clarity. We sought 
public comment on the merits of this potential scope organization, as 
well as any pricing information regarding these five new scope 
categories.
    After considering the comments on the CY 2018 PFS proposed rule, we 
did not finalize our proposal to create and price a single scope 
equipment code for each of the five categories previously identified. 
Instead, we supported the recommendation from the commenters to create 
scope equipment codes on a per-specialty basis for six categories of 
scopes as applicable, including the addition of a new sixth category of 
multi-channeled flexible video scopes. Our goal was to create an 
administratively simple scheme that would be easier to maintain and 
help to reduce administrative burden. In 2018, the RUC convened a Scope 
Equipment Reorganization Workgroup to incorporate feedback from expert 
stakeholders with the intention of making recommendations to us on 
scope organization and scope pricing. Since the workgroup was not 
convened in time to submit recommendations for the CY 2019 PFS 
rulemaking cycle, we delayed proposals for any further changes to scope 
equipment until CY 2020 in order to incorporate the feedback from the 
aforementioned workgroup.
(2) Scope Video System
    We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 
46177) to define the scope video system as including: (1) A monitor; 
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a 
printer. We believe that these equipment components represent the 
typical case for a scope video system. Our model for this system was 
the ``video system, endoscopy (processor, digital capture, monitor, 
printer, cart)'' equipment item (ES031), which we proposed to re-price 
as part of this separate pricing approach. We obtained current pricing 
invoices for the endoscopy video system as part of our investigation of 
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a 
digital capture device to the endoscopy video system (ES031) in the CY 
2017 PFS final rule (81 FR 80188). We finalized our proposal to price 
the system at $33,391, based on component prices of $9,000 for the 
processor, $18,346 for the digital capture device, $2,000 for the 
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did 
not finalize, a proposal to add an LED light source into the cost of 
the scope video system (ES031), which would remove the need for a 
separate light source in these procedures. We also described a proposal 
to increase the price of the scope video system by $1,000 to cover the 
expense of miscellaneous small equipment associated with the system 
that falls below the threshold of individual equipment pricing as scope 
accessories (such as cables, microphones, foot pedals, etc.). With the 
addition of the LED light (equipment code EQ382 at a price of $1,915), 
the updated total price of the scope video system would be set at 
$36,306.
    We did not finalize this updated pricing to the scope video system 
in CY 2018, but we did propose and finalize the updated pricing for CY 
2019 to $36,306 along with changing the name of the ES031 equipment 
item to ``scope video system (monitor, processor, digital capture, 
cart, printer, LED light)'' to reflect the fact that the use of the 
ES031 scope video system is not limited to endoscopy procedures.
(3) Scope Accessories
    We understand that there may be other accessories associated with 
the use of scopes. We finalized a proposal in the CY 2017 PFS final 
rule (81 FR 80188) to separately price any scope accessories outside 
the use of the scope video system, and individually evaluate their 
inclusion or exclusion as direct PE inputs for particular codes as 
usual under our current policy based on whether they are typically used 
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2020
    The Scope Equipment Reorganization Workgroup organized by the RUC 
submitted detailed recommendations to CMS for consideration in the CY 
2020 rule cycle, describing 23 different types of scope equipment, the 
HCPCS codes associated with each scope type, and a series of invoices 
for scope pricing. We

[[Page 40494]]

appreciate the information provided by the workgroup and continue to 
welcome additional comments and feedback from stakeholders. Based on 
the recommendations from the workgroup, we are proposing to establish 
23 new scope equipment codes (see Table 5).

           Table 5--CY 2020 Proposed New Scope Equipment Codes
------------------------------------------------------------------------
                         Proposed scope
       CMS code            equipment      Proposed price     Number of
                          description                        invoices
------------------------------------------------------------------------
ES070................  rigid scope,       ..............               0
                        cystoscopy.
ES071................  rigid scope,       ..............               0
                        hysteroscopy.
ES072................  rigid scope,       ..............               0
                        otoscopy.
ES073................  rigid scope,       ..............               0
                        nasal/sinus
                        endoscopy.
ES074................  rigid scope,       ..............               0
                        proctosigmoidosc
                        opy.
ES075................  rigid scope,            $3,966.08               5
                        laryngoscopy.
ES076................  rigid scope,            14,500.00               1
                        colposcopy.
ES077................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        hysteroscopy.
ES078................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        nasopharyngoscop
                        y.
ES079................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        bronchoscopy.
ES080................  non-channeled           21,485.51               7
                        flexible digital
                        scope,
                        laryngoscopy.
ES081................  channeled          ..............               0
                        flexible digital
                        scope,
                        cystoscopy.
ES082................  channeled          ..............               0
                        flexible digital
                        scope,
                        hysteroscopy.
ES083................  channeled          ..............               0
                        flexible digital
                        scope,
                        bronchoscopy.
ES084................  channeled               18,694.39               5
                        flexible digital
                        scope,
                        laryngoscopy.
ES085................  multi-channeled         17,360.00               1
                        flexible digital
                        scope, flexible
                        sigmoidoscopy.
ES086................  multi-channeled         38,058.81               6
                        flexible digital
                        scope,
                        colonoscopy.
ES087................  multi-channeled    ..............               0
                        flexible digital
                        scope,
                        esophagoscopy
                        gastroscopy
                        duodenoscopy
                        (EGD).
ES088................  multi-channeled         34,585.35               5
                        flexible digital
                        scope,
                        esophagoscopy.
ES089................  multi-channeled    ..............               0
                        flexible digital
                        scope, ileoscopy.
ES090................  multi-channeled    ..............               0
                        flexible digital
                        scope,
                        pouchoscopy.
ES091................  ultrasound         ..............               0
                        digital scope,
                        endoscopic
                        ultrasound.
ES092................  non-video                5,078.04               4
                        flexible scope,
                        laryngoscopy.
------------------------------------------------------------------------

    We note that we did not receive invoices for many of the new scope 
equipment items. There also was some inconsistency in the workgroup 
recommendations regarding the non-channeled flexible digital scope, 
laryngoscopy (ES080) equipment item and the non-video flexible scope, 
laryngoscopy (ES092) equipment item. These scopes were listed as a 
single equipment item in some of the workgroup materials and listed as 
separate equipment items in other materials. We are proposing to 
establish them as separate equipment items based on the submitted 
invoices, which demonstrated that these were two different types of 
scopes with distinct price points of approximately $17,000 and $5,000 
respectively.
    We noted a similar issue with the submitted invoices for the rigid 
scope, laryngoscopy (ES075) equipment item. Among the eight total 
invoices, five of them were clustered around a price point of 
approximately $4,000 while the other three invoices had prices of 
roughly $15,000 apiece. The invoices indicated that these prices came 
from two distinct types of equipment, and as a result we are proposing 
to consider these items separately. We are proposing to use the initial 
five invoices to establish a proposed price of $3,966.08 for the rigid 
scope, laryngoscopy (ES075) equipment item. We note that this is a 
close match for the current price of $3,178.08 used by the endoscope, 
rigid, laryngoscopy (ES010) equipment, which is the closest equivalent 
scope equipment. The other three invoices appear to describe a type of 
stroboscopy system rather than a scope, and they have an average price 
of $14,737. This is a reasonably close match for the price of our 
current stroboscoby system (ES065) equipment, which has a CY 2020 price 
of $17,950.28 as it transitions to a final CY 2022 destination price of 
$16,843.87 (see the 4-year pricing transition of the market-based 
supply and equipment pricing update discussed later in this section for 
more information). We believe that these invoices reinforce the value 
established by the market-based pricing update for the stroboscoby 
system carried out last year, and we are not proposing to update the 
price of the ES065 equipment at this time. However, we are open to 
feedback from stakeholders if they believe it would be more accurate to 
assign a price of $14,737 to the stroboscoby system based on these 
invoice submissions, as opposed to maintaining the current pricing 
transition to a CY 2022 price of $16,843.87.
    For the eight new scope equipment items where we have submitted 
invoices for pricing, we are proposing to replace the existing scopes 
with the new scope equipment. We received recommendations from the 
RUC's scope workgroup regarding which HCPCS codes make use of the new 
scope equipment items, and we are proposing to make this scope 
replacement for approximately 100 HCPCS codes in total (see Table 6).
BILLING CODE 4120-01-P

[[Page 40495]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.000


[[Page 40496]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.001


[[Page 40497]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.002


[[Page 40498]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.003

BILLING CODE 4120-01-C
    In all but three cases, we are proposing for the new scope 
equipment item to replace the existing scope with the identical amount 
of equipment time. For CPT codes 92612 (Flexible endoscopic evaluation 
of swallowing by cine or video recording), 92614 (Flexible endoscopic 
evaluation, laryngeal sensory testing by cine or video recording), and 
92616 (Flexible endoscopic evaluation of swallowing and laryngeal 
sensory testing by cine or video recording), the current scopes in use 
are the FEES video system (ES027) and the FEESST video system (ES028). 
Since we are proposing the use of a non-channeled flexible digital 
scope that requires a corresponding scope video system, we are adding 
the ES080 equipment at the same equipment time

[[Page 40499]]

to these three procedures rather than replacing the ES027 and ES028 
equipment. In all other cases, we are proposing to replace the current 
scope equipment listed in Table 6 with the new scope equipment, while 
maintaining the same amount of equipment time.
    We identified inconsistencies with the workgroup recommendations 
for a small number of HCPCS codes. CPT code 45350 (Sigmoidoscopy, 
flexible; with band ligation(s) (e.g., hemorrhoids)) was recommended to 
include a multi-channeled flexible digital scope, flexible 
sigmoidoscopy (ES085), however, we noted that this CPT code does not 
include any scopes among its current direct PE inputs. CPT code 31595 
was recommended to include a non-channeled flexible digital scope, 
laryngoscopy (ES080) but it no longer exists as a CPT code after having 
been deleted for CY 2019. CPT code 43232 (Esophagoscopy, flexible, 
transoral; with transendoscopic ultrasound-guided intramural or 
transmural fine needle aspiration/biopsy(s)) was recommended to include 
a multi-channeled flexible digital scope, esophagoscopy (ES088), but it 
does not include a scope amongst its direct PE inputs any longer 
following clarification from the same workgroup recommendations that 
CPT code 43232 is never performed in the nonfacility setting. In all 
three of these cases, we are not proposing to add one of the new scope 
equipment items to these procedures.
    We did not receive pricing information along with the workgroup 
recommendations for the other 15 new scope equipment items. For CY 
2020, we are proposing to establish new equipment codes for these 
scopes as detailed in Table 5. However, due to a lack of pricing 
information, we are not proposing to replace existing scope equipment 
with the new equipment items as we did for the other eight new scope 
equipment items for CY 2020. We welcome additional feedback from 
stakeholders regarding the pricing of these scope equipment items, 
especially the submission of detailed invoices with pricing data. We 
are proposing to transition the scopes for which we do have pricing 
information over to the new equipment items for CY 2020, and we look 
forward to engaging with stakeholders to assist in pricing and then 
transitioning the remaining scopes in future rulemaking.
c. Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2019 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We are proposing to correct these inconsistencies 
as described below and reflected in the CY 2020 proposed direct PE 
input database displayed on the CMS website under downloads for the CY 
2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2020, we are proposing to address the following 
inconsistencies:
     The RUC's Scope Equipment Reorganization Workgroup 
recommended deletion of the non-facility inputs for CPT codes 43231 
(Esophagoscopy, flexible, transoral; with endoscopic ultrasound 
examination) and 43232 (Esophagoscopy, flexible, transoral; with 
transendoscopic ultrasound-guided intramural or transmural fine needle 
aspiration/biopsy(s)). The gastroenterology specialty societies stated 
that these services are never performed in the non-facility setting. 
After our own review of these services, we agree with the workgroup's 
recommendation, and we are proposing to remove the non-facility direct 
PE inputs for these two CPT codes.
     In rulemaking for CY 2018, we reviewed a series of CPT 
codes describing nasal sinus endoscopy surgeries. At that time, we 
sought comments on whether the broader family of nasal sinus endoscopy 
surgery services should be subject to the special rules for multiple 
endoscopic procedures instead of the standard multiple procedure 
payment reduction. We received very few comments in response to our 
solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated 
that we would continue to explore this option for future rulemaking. We 
are proposing to apply the special rule for multiple endoscopic 
procedures to this family of codes beginning in CY 2020. This proposal 
would treat this group of CPT codes consistently with other similar 
endoscopic procedures when codes within the CPT code family are billed 
together with another endoscopy service in the same family. Similar to 
other similar endoscopic procedure code families, we are proposing that 
CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral 
(separate procedure)) would be the base procedure for the remainder of 
nasal sinus endoscopies. The codes affected by this proposal are as 
follows (see Table 7).

 Table 7--Proposed Nasal Sinus Endoscopy Codes Subject to Special Rules
                   for Multiple Endoscopic Procedures
------------------------------------------------------------------------
               CPT code                         Short descriptor
------------------------------------------------------------------------
31231................................  Nasal endoscopy dx.
31233................................  Nasal/sinus endoscopy dx.
31235................................  Nasal/sinus endoscopy dx.
31237................................  Nasal/sinus endoscopy surg.
31238................................  Nasal/sinus endoscopy surg.
31239................................  Nasal/sinus endoscopy surg.
31240................................  Nasal/sinus endoscopy surg.
31241................................  Nsl/sins ndsc w/artery lig.
31253................................  Nsl/sins ndsc total.
31254................................  Nsl/sins ndsc w/prtl ethmdct.
31255................................  Nsl/sins ndsc w/tot ethmdct.
31256................................  Exploration maxillary sinus.
31257................................  Nsl/sins ndsc tot w/sphendt.
31259................................  Nsl/sins ndsc sphn tiss rmvl.
31267................................  Endoscopy maxillary sinus.
31276................................  Nsl/sins ndsc frnt tiss rmvl.
31287................................  Nasal/sinus endoscopy surg.
31288................................  Nasal/sinus endoscopy surg.
31290................................  Nasal/sinus endoscopy surg.
31291................................  Nasal/sinus endoscopy surg.
31292................................  Nasal/sinus endoscopy surg.
31293................................  Nasal/sinus endoscopy surg.
31294................................  Nasal/sinus endoscopy surg.
31295................................  Sinus endo w/balloon dil.
31296................................  Sinus endo w/balloon dil.
31297................................  Sinus endo w/balloon dil.
31298................................  Nsl/sins ndsc w/sins dilat.
------------------------------------------------------------------------

    Special rules for multiple endoscopic procedures would apply if any 
of the procedures listed in Table 7 are billed together for the same 
patient on the same day. We apply the multiple endoscopy payment rules 
to a code family before ranking the family with other procedures 
performed on the same day (for example, if multiple endoscopies in the 
same family are reported on the same day as endoscopies in another 
family, or on the same day as a non-endoscopic procedure). If an 
endoscopic procedure is reported together with its base procedure, we 
do not pay separately for the base procedure. Payment for the base 
procedure is included in the payment for the other endoscopy. For 
additional information about the payment adjustment under the special 
rule for multiple endoscopic services, we refer readers to the CY 1992 
PFS final rule where this policy was established (56 FR 59515) and to 
Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available 
on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf).
d. 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

[[Page 40500]]

requests to update equipment and supply price and equipment useful life 
inputs through annual rulemaking, beginning with the CY 2012 PFS 
proposed rule. For CY 2020, we are proposing the following price 
updates for existing direct PE inputs.
    We are proposing to update the price of one supply and one 
equipment item in response to the public submission of invoices. As 
these pricing updates were each part of the formal review for a code 
family, we are proposing that the new pricing take effect for CY 2020 
for these items instead of being phased in over 4 years. For the 
details of these proposed price updates, please refer to Table 22, 
Proposed CY 2020 Invoices Received for Existing Direct PE Inputs in 
section II.N., Proposed Valuation of Specific Codes, of this proposed 
rule.
    We are also proposing to update the name of the EP001 equipment 
item from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image 
Analyzer'' due to clarification from stakeholders regarding the typical 
use of this equipment.
(1) Market-Based Supply and Equipment Pricing Update
    Section 220(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) provides that the Secretary may collect or 
obtain information from any eligible professional or any other source 
on the resources directly or indirectly related to furnishing services 
for which payment is made under the PFS, and that such information may 
be used in the determination of relative values for services under the 
PFS. Such information may include the time involved in furnishing 
services; the amounts, types and prices of PE inputs; overhead and 
accounting information for practices of physicians and other suppliers, 
and any other elements that would improve the valuation of services 
under the PFS.
    As part of our authority under section 1848(c)(2)(M) of the Act, we 
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE 
inputs (DPEI) for supply and equipment pricing for CY 2019. These 
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing 
recommendations for approximately 1300 supplies and 750 equipment items 
currently used as direct PE inputs. This report is available as a 
public use file displayed on the CMS website under downloads for the CY 
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     Federal Register, current DPEI data, historical proposed 
and final rules prior to CY 2018, and other resources; that is, AMA RUC 
reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability.
    (1) If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of equipment and a more precise reference for 
the RP.
    (2) If no data were available for commercial products, the current 
CMS prices were used as the RP.
    GSA prices were not used to calculate the StrategyGen recommended 
prices, due to our concern that the GSA system curtails the number and 
type of suppliers whose products may be accessed on the GSA Advantage 
website, and that the GSA prices may often be lower than prices that 
are available to non-governmental purchasers. After reviewing the 
StrategyGen report, we proposed to adopt the updated direct PE input 
prices for supplies and equipment as recommended by StrategyGen.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicated that there was no 
statistically significant difference between the estimated commercial 
prices and the current CMS prices for both equipment and supplies. This 
cumulative stable pricing for medical equipment and supplies appears 
similar to the pricing impacts of non-medical technology advancements 
where some historically high-priced equipment (that is, desktop PCs) 
has been increasingly substituted with current technology (that is, 
laptops and tablets) at similar or lower price points. However, while 
there were no statistically significant differences in pricing at the 
aggregate level, medical specialties would experience increases or 
decreases in their Medicare payments if CMS were to adopt the pricing 
updates recommended by StrategyGen. At the service level, there may be 
large shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum RVU reduction for codes that are not new or revised to 19 
percent in any individual calendar year.
    We believe that it is important to make use of the most current 
information available for supply and equipment pricing instead of 
continuing to rely on pricing information that is more than a decade 
old. Given the potentially significant changes in payment that would 
occur, both for specific services and more broadly at the specialty 
level, in the CY 2019 PFS proposed rule we proposed to phase in our use 
of the new direct PE input pricing over a 4-year period using a 25/75 
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), 
and 100/0 percent (CY 2022) split between new and old pricing. This 
approach is consistent with how we have previously incorporated 
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment 
period when changing to the ``bottom-

[[Page 40501]]

up'' PE methodology (71 FR 69641). This transition period will not only 
ease the shift to the updated supply and equipment pricing, but will 
also allow interested parties an opportunity to review and respond to 
the new pricing information associated with their services.
    We proposed to implement this phase-in over 4 years so that supply 
and equipment values transition smoothly from the prices we currently 
include to the final updated prices in CY 2022. We proposed to 
implement this pricing transition such that one quarter of the 
difference between the current price and the fully phased-in price is 
implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the transition from the current 
to the fully-implemented new pricing is provided in Table 8.

            Table 8--Example of Direct PE Pricing Transition
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current Price...............                  $100
Final Price.................                   200  ....................
    Year 1 (CY 2019) Price..                   125  \1/4\ difference
                                                     between $100 and
                                                     $200.
    Year 2 (CY 2020) Price..                   150  \1/3\ difference
                                                     between $125 and
                                                     $200.
    Year 3 (CY 2021) Price..                   175  \1/2\ difference
                                                     between $150 and
                                                     $200.
    Final (CY 2022) Price...                   200  ....................
------------------------------------------------------------------------

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we proposed to fully implement those 
prices with no transition since there are no current prices for these 
supply and equipment items. These new supply and equipment codes would 
immediately be priced at their newly established values. We also 
proposed that, for existing supply and equipment codes, when we 
establish prices based on invoices that are submitted as part of a 
revaluation or comprehensive review of a code or code family, they will 
be fully implemented for the year they are adopted without being phased 
in over the 4-year pricing transition. The formal review process for a 
HCPCS code includes a review of pricing of the supplies and equipment 
included in the code. When we find that the price on the submitted 
invoice is typical for the item in question, we believe it would be 
appropriate to finalize the new pricing immediately along with any 
other revisions we adopt for the code valuation.
    For existing supply and equipment codes that are not part of a 
comprehensive review and valuation of a code family and for which we 
establish prices based on invoices submitted by the public, we proposed 
to implement the established invoice price as the updated price and to 
phase in the new price over the remaining years of the proposed 4-year 
pricing transition. During the proposed transition period, where price 
changes for supplies and equipment are adopted without a formal review 
of the HCPCS codes that include them (as is the case for the many 
updated prices we proposed to phase in over the 4-year transition 
period), we believe it is important to include them in the remaining 
transition toward the updated price. We also proposed to phase in any 
updated pricing we establish during the 4-year transition period for 
very commonly used supplies and equipment that are included in 100 or 
more codes, such as sterile gloves (SB024) or exam tables (EF023), even 
if invoices are provided as part of the formal review of a code family. 
We would implement the new prices for any such supplies and equipment 
over the remaining years of the proposed 4-year transition period. Our 
proposal was intended to minimize any potential disruptive effects 
during the proposed transition period that could be caused by other 
sudden shifts in RVUs due to the high number of services that make use 
of these very common supply and equipment items (meaning that these 
items are included in 100 or more codes).
    We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer time frame will allow more opportunities for public 
comment and submission of additional, applicable data. We welcomed 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration.
    We received many comments regarding the market-based supply and 
equipment pricing proposal following the publication of the CY 2019 PFS 
proposed rule. For a full discussion of these comments, we direct 
readers to the CY 2019 PFS final rule (83 FR 59475-59480). In each 
instance in which a commenter raised questions about the accuracy of a 
supply or equipment code's recommended price, the StrategyGen 
contractor conducted further research on the item and its price with 
special attention to ensuring that the recommended price was based on 
the correct item in question and the clarified unit of measure. Based 
on the commenters' requests, the StrategyGen contractor conducted an 
extensive examination of the pricing of any supply or equipment items 
that any commenter identified as requiring additional review. Invoices 
submitted by multiple commenters were greatly appreciated and ensured 
that medical equipment and supplies were re-examined and clarified. 
Multiple researchers reviewed these specified supply and equipment 
codes for accuracy and proper pricing. In most cases, the contractor 
also reached out to a team of nurses and their physician panel to 
further validate the accuracy of the data and pricing information. In 
some cases, the pricing for individual items needed further 
clarification due to a lack of information or due to significant 
variation in packaged items. After consideration of the comments and 
this additional price research, we updated the recommended prices for 
approximately 70 supply and equipment codes identified by the 
commenters. Table 9 in the CY 2019 PFS final rule lists the supply and 
equipment codes with price changes based on feedback from the 
commenters and the resulting additional research into pricing (83 FR 
59479-59480).
    After consideration of the public comments, we finalized our 
proposals associated with the market research study to update the PFS 
direct PE inputs for supply and equipment pricing. We continue to 
believe that implementing the proposed updated prices with a 4-year 
phase-in will improve payment

[[Page 40502]]

accuracy, while maintaining stability and allowing stakeholders the 
opportunity to address potential concerns about changes in payment for 
particular items. We continue to welcome feedback from stakeholders on 
the proposed updated supply and equipment pricing, including the 
submission of additional invoices for consideration.
    For CY 2020, we received invoice submissions for approximately 30 
supply and equipment codes from stakeholders as part of the second year 
of the market-based supply and equipment pricing update. These invoices 
were reviewed by the StrategyGen contractor and the submitted invoices 
were used in many cases to supplement the pricing originally proposed 
for the CY 2019 PFS rule cycle. The contractor reviewed the invoices, 
as well as prior data for the relevant supply/equipment codes to make 
sure the item in the invoice was representative of the supply/equipment 
item in question and aligned with past research. Based on this 
research, we are proposing to update the prices of the following supply 
and equipment items:
BILLING CODE 4120-01-P

[[Page 40503]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.004

BILLING CODE 4120-01-C
    For most supply and equipment items, there was an alignment between 
the research carried out by the StrategyGen contractor and the 
submitted invoice. The updated CY 2020 pricing was calculated using an 
average between the previous market research and the newly submitted 
invoices in these cases. In some cases the submitted invoices were not 
representative of market prices, such as for the centrifuge with rotor 
(EP007) equipment item where the invoice price of $8,563 appeared to be 
an outlier. We did not use the invoices to calculate our pricing 
recommendation in these situations and instead continued to rely on our 
prior pricing data. In other instances, such as for the kit, probe, 
cryoablation, prostate (Galil-Endocare)

[[Page 40504]]

(SA099) supply item, our research indicated that the submitted invoice 
price was more representative of the commercial price than our CY 2019 
research and pricing. We are proposing the new invoice prices for these 
supply and equipment items due to our belief in their greater accuracy.
    For some of the remaining supply and equipment items, such as the 
five-gallon paraffin (EP031) equipment and the Olympus DP21 camera 
(EP089) equipment, we maintained the extant pricing for CY 2019 due to 
a lack of sufficient data to update the pricing. In these situations 
where we did not have an updated price for CY 2019, we believe that the 
newly submitted invoices are more representative of the current 
commercial prices that are being paid on the market. We are again 
proposing the new invoice prices for these supply and equipment items 
due to our belief in their greater accuracy.
    In addition, we were alerted by stakeholders that the price of the 
EM visit pack (SA047) supply did not match the sum of the component 
prices of the supplies included in the pack. After reviewing the prices 
of the individual component supplies, we agree with the stakeholders 
that there was a discrepancy in the previous pricing of this supply 
pack. We are proposing to update the price of the EM visit pack to 
$5.47 to match the sum of the prices of the component supplies, and 
proposing to continue to transition towards this price over the 
remaining years of the phase-in period.
    We finalized a policy last year to phase in the new supply and 
equipment pricing over 4 years so that supply and equipment values 
transition smoothly from their current prices to the final updated 
prices in CY 2022. We finalized our proposal to implement this pricing 
transition such that one quarter of the difference between the current 
price and the fully phased in price was implemented for CY 2019, one 
third of the difference between the CY 2019 price and the final price 
is implemented for CY 2020, and one half of the difference between the 
CY 2020 price and the final price is implemented for CY 2021, with the 
new direct PE prices fully implemented for CY 2022. An example of the 
transition from the current to the fully-implemented new pricing is 
provided in Table 8. For CY 2020, one third of the difference between 
the CY 2019 price and the final price will be implemented as per the 
previously finalized policy.
    The full list of updated supply and equipment pricing as it will be 
implemented over the 4-year transition period will be made available as 
a public use file displayed on the CMS website under downloads for the 
CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(2) Invoice Submission
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2020, we noted that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. 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 would 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.
(3) Adjustment to Allocation of Indirect PE for Some Office-Based 
Services
    In the CY 2018 PFS final rule (82 FR 52999 through 53000), we 
established criteria for identifying the services most affected by the 
indirect PE allocation anomaly that does not allow for a site of 
service differential that accurately reflects the relative indirect 
costs involved in furnishing services in nonfacility settings. We also 
finalized a modification in the PE methodology for allocating indirect 
PE RVUs to better reflect the relative indirect PE resources involved 
in furnishing these services. The methodology, as described, is based 
on the difference between the ratio of indirect PE to work RVUs for 
each of the codes meeting eligibility criteria and the ratio of 
indirect PE to work RVU for the most commonly reported visit code. We 
refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000) 
for a discussion of our process for selecting services subject to the 
revised methodology, as well as a description of the methodology, which 
we began implementing for CY 2018 as the first year of a 4-year 
transition. For CY 2020, we are proposing to continue with the third 
year of the transition of this adjustment to the standard process for 
allocating indirect PE.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that each service paid under 
the PFS be composed of three components: Work, PE, and malpractice (MP) 
expense. As required by section 1848(c)(2)(C)(iii) of the Act, 
beginning in CY 2000, MP RVUs are resource based. Section 
1848(c)(2)(B)(i) of the Act also requires that we review, and if 
necessary adjust, RVUs no less often than every 5 years. In the CY 2015 
PFS final rule with comment period, we implemented the third review and 
update of MP RVUs. For a comprehensive discussion of the third review 
and update of MP RVUs, see the CY 2015 proposed rule (79 FR 40349 
through 40355) and final rule with comment period (79 FR 67591 through 
67596). In the CY 2018 proposed rule (82 FR 33965 through 33970), we 
proposed to update the specialty-level risk factors used in the 
calculation of MP RVUs, prior to the next required 5 year update (CY 
2020), using the updated MP premium data that were used in the eighth 
Geographic Practice Cost Index (GPCI) update for CY 2017; however the 
proposal was ultimately not finalized for CY 2018.
    We consider the following factors when we determine MP RVUs for 
individual PFS services: (1) Specialty-level risk factors derived from 
data on specialty-specific MP premiums incurred by practitioners; (2) 
service-level risk factors derived from Medicare claims data of the 
weighted average risk factors of the specialties that furnish each 
service; and (3) an intensity/complexity of service adjustment to the 
service-level risk factor based on either the higher of the work RVU or 
clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs 
were only updated once every 5 years, except in the case of new and 
revised codes.
    As explained in the CY 2011 PFS final rule with comment period (75 
FR 73208), MP RVUs for new and revised codes effective before the next 
5-year review of MP RVUs were determined either by a direct crosswalk 
from a similar source code or by a modified crosswalk to account for 
differences in work RVUs between the new/revised code and the source 
code. For the modified crosswalk approach, we adjusted (or scaled) the 
MP RVU for the new/revised code to reflect the difference in work RVU 
between the source code and the new/revised work RVU (or, if greater, 
the difference in the

[[Page 40505]]

clinical labor portion of the fully implemented PE RVU) for the new 
code. For example, if the proposed work RVU for a revised code was 10 
percent higher than the work RVU for its source code, the MP RVU for 
the revised code would be increased by 10 percent over the source code 
MP RVU. Under this approach, the same risk factor was applied for the 
new/revised code and source code, but the work RVU for the new/revised 
code was used to adjust the MP RVUs for risk.
    In the CY 2016 PFS final rule with comment period (80 FR 70906 
through 70910), we finalized a policy to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services (using Medicare claims data), and to adjust MP RVUs for risk 
for intensity and complexity (using the work RVU or clinical labor 
RVU). We also finalized a policy to modify the specialty mix assignment 
methodology (for both MP and PE RVU calculations) to use an average of 
the three most recent years of data instead of a single year of data. 
Under this approach, for new and revised codes, we generally assign a 
specialty-level risk factor to individual codes based on the same 
utilization assumptions we make regarding specialty mix we use for 
calculating PE RVUs and for PFS budget neutrality. We continue to use 
the work RVU or clinical labor RVU to adjust the MP RVU for each code 
for intensity and complexity. In finalizing this policy, we stated that 
the specialty-level risk factors would continue to be updated through 
notice and comment rulemaking every 5 years using updated premium data, 
but would remain unchanged between the 5-year reviews.
    Section 1848(e)(1)(C) of the Act requires us to review, and if 
necessary, adjust the GPCIs at least every 3 years. For CY 2020, we are 
conducting the statutorily required 3-year review of the GPCIs, which 
coincides with the statutorily required 5-year review of the MP RVUs. 
We note that the MP premium data used to update the MP GPCIs are the 
same data used to determine the specialty-level risk factors, which are 
used in the calculation of MP RVUs. Going forward, we believe it would 
be logical and efficient to align the update of MP premium data used to 
determine the MP RVUs with the update of the MP GPCI. Therefore, we are 
proposing to align the update of MP premium data with the update to the 
MP GPCIs, that is, we are proposing to review, and if necessary update 
the MP RVUs at least every 3 years, similar to our review and update of 
the GPCIs. If we align the two updates, we would conduct the next 
statutorily-mandated review and update of both the GPCI and MP RVU for 
implementation in CY 2023. We are proposing to implement the fourth 
comprehensive review and update of MP RVUs for CY 2020 and are seeking 
comment on these proposals.
2. Methodology for the Proposed Revision of Resource-Based Malpractice 
RVUs
a. General Discussion
    We calculated the proposed MP RVUs using updated malpractice 
premium data obtained from state insurance rate filings. The 
methodology used in calculating the proposed CY 2020 review and update 
of resource-based MP RVUs largely parallels the process used in the CY 
2015 update; however, we are proposing to incorporate several 
methodological refinements, which are described below in this proposed 
rule. The MP RVU calculation requires us to obtain information on 
specialty-specific MP premiums that are linked to specific services, 
and using this information, we derive relative risk factors for the 
various specialties that furnish a particular service. Because MP 
premiums vary by state and specialty, the MP premium information must 
be weighted geographically and by specialty. We calculated the proposed 
MP RVUs using four data sources: Malpractice premium data presumed to 
be in effect as of December 31, 2017; CY 2018 Medicare payment and 
utilization data; higher of the CY 2020 proposed work RVUs or the 
clinical labor portion of the direct PE RVUs; and CY 2019 GPCIs. We 
will use the higher of the CY 2020 final work RVUs or clinical labor 
portion of the direct PE RVUs in our calculation to develop the CY 2020 
final MP RVUs while maintaining overall PFS budget neutrality.
    Similar to the CY 2015 update, the proposed MP RVUs were calculated 
using specialty-specific malpractice premium data because they 
represent the expense incurred by practitioners to obtain malpractice 
insurance as reported by insurers. For CY 2020, the most current 
malpractice premium data available, with a presumed effective date of 
no later than December 31, 2017, were obtained from insurers with the 
largest market share in each state. We identified insurers with the 
largest market share using the National Association of Insurance 
Commissioners (NAIC) market share report. This annual report provides 
state-level market share for entities that provide premium liability 
insurance (PLI) in a state. Premium data were downloaded from the 
System for Electronic Rates & Forms Filing Access Interface (SERFF) 
(accessed from the NAIC website) for participating states. For non-
SERFF states, data were downloaded from the state-specific website (if 
available online) or obtained directly from the state's alternate 
access to filings. For SERFF states and non-SERFF states with online 
access to filings, the 2017 market share report was used to select 
companies. For non-SERFF states without online access to filings, the 
2016 market share report was used to identify companies. These were the 
most current data available during the data collection and acquisition 
process.
    Malpractice insurance premium data were collected from all 50 
States, and the District of Columbia. Efforts were made to collect 
filings from Puerto Rico; however, no recent filings were submitted at 
the time of data collection and therefore filings from the previous 
update were used. Consistent with the CY 2015 update, no filings were 
collected for the other U.S. territories: American Samoa, Guam, Virgin 
Islands, or Northern Mariana Islands. Malpractice premiums were 
collected for coverage limits of $1 million/$3 million, mature, claims-
made policies (policies covering claims made, rather than those 
covering losses occurring, during the policy term). A $1 million/$3 
million liability limit policy means that the most that would be paid 
on any claim is $1 million and the most that the policy would pay for 
claims over the timeframe of the policy is $3 million. Adjustments were 
made to the premium data to reflect mandatory surcharges for patient 
compensation funds (PCF, funds used to pay for any claim beyond the 
state's statutory amount, thereby limiting an individual physician's 
liability in cases of a large suit) in states where participation in 
such funds is mandatory.
    Premium data were included for all physician and NPP specialties, 
and all risk classifications available in the collected rate filings. 
Although premium data were collected from all states, the District of 
Columbia, and previous filings for Puerto Rico were utilized, not all 
specialties had distinct premium data in the rate filings from all 
states. In previous updates, specialties for which premium data were 
not available for at least 35 states, and specialties for which there 
were not distinct risk groups (surgical, non-surgical, and surgical 
with obstetrics) among premium data in the rate filings, were 
crosswalked to a similar specialty, either conceptually or based on 
available premium data. This resulted in not using those premium data 
because

[[Page 40506]]

the 35 state threshold was not met. In this proposed CY 2020 update, we 
note that the proposed methodological improvement discussed below in 
this proposed rule expands the specialties and amount of filings data 
used to develop the proposed risk factors, which are used to develop 
the proposed MP RVUs.
b. Proposed Methodological Refinements
    For the CY 2020 update, we are proposing the following 
methodological improvements to the development of MP premium data:
    (1) Downloading and using a broader set of filings from the largest 
market share insurers in each state, beyond those listed as 
``physician'' and ``surgeon'' to obtain a more comprehensive data set.
    (2) Combining minor surgery and major surgery premiums to create 
the surgery service risk group, which yields a more representative 
surgical risk factor. In the previous update, only premiums for major 
surgery were used in developing the surgical risk factor.
    (3) Utilizing partial and total imputation to develop a more 
comprehensive data set when CMS specialty names are not distinctly 
identified in the insurer filings, which sometimes use unique specialty 
names.
    In instances where insurers report data for some (but not all) 
specialties that explicitly corresponded to a CMS specialty, where 
those data were missing, we propose to use partial imputation based on 
available data to establish what the premiums would likely have been 
had that specialty been delineated in the filing. In instances where 
there are no data corresponding to a CMS specialty in the filing, we 
propose to use total imputation to establish premiums.
    For example, if a specialty of Sleep Medicine is listed on the 
insurer's rate filing, this rate will be matched to the CMS specialty 
Sleep Medicine (C0). However, if the Sleep Medicine specialty is not 
listed on the insurer's rate filing, under our proposed methodology, 
the insurer's rate filing for General Practice would be matched to the 
CMS specialty of Sleep Medicine (C0). In this example, we believe 
General Practice is likely to be consistent with the rate that a Sleep 
Medicine provider would be charged by that insurer. This proposed 
methodological improvement means that instead of discarding specialty-
specific information from some insurers' filings because other insurers 
lacked that same level of detail, we would instead impute the missing 
rates at the insurer/specialty level in an effort to utilize as much of 
the information from the filings as possible.
    We are seeking comment on these proposed methodological 
improvements. Additional technical details are available in our interim 
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs 
for the Medicare Physician Fee Schedule,'' on our website. It is 
located under the supporting documents section for the CY 2020 PFS 
proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
c. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the 
specialty-weighted approach used in the CY 2015 final rule with comment 
period (79 FR 67591), along with the above proposed methodological 
improvements. The specialty-weighted approach bases the MP RVUs for a 
given service on a weighted average of the risk factors of all 
specialties furnishing the service. This approach ensures that all 
specialties furnishing a given service are reflected in the calculation 
of the MP RVUs. The steps for calculating the proposed MP RVUs are 
described below.
    Step (1): Compute a preliminary national average premium for each 
specialty.
    Insurance rating area malpractice premiums for each specialty are 
mapped to the county level. The specialty premium for each county is 
then multiplied by its share of the total U.S. population (from the 
U.S. Census Bureau's 2013-2017 American Community Survey (ACS) 5-year 
estimates). This is in contrast to the method used for creating 
national average premiums for each specialty in the 2015 update; in 
that update, specialty premiums were weighted by the total RVU per 
county, rather than by the county share of the total U.S. population. 
We refer readers to the CY 2016 PFS final rule with comment period (80 
FR 70909) for a discussion of why we have adopted a weighting method 
based on share of total U.S. population. This calculation is then 
divided by the average MP GPCI across all counties for each specialty 
to yield a normalized national average premium for each specialty. The 
specialty premiums are normalized for geographic variation so that the 
locality cost differences (as reflected by the 2019 GPCIs) would not be 
counted twice. Without the geographic variation adjustment, the cost 
differences among fee schedule areas would be reflected once under the 
methodology used to calculate the MP RVUs and again when computing the 
service specific payment amount for a given fee schedule area.
    Step (2): Determine which premium service risk groups to use within 
each specialty.
    Some specialties had premium rates that differed for surgery, 
surgery with obstetrics, and non-surgery. These premium classes are 
designed to reflect differences in risk of professional liability and 
the cost of malpractice claims if they occur. To account for the 
presence of different classes in the malpractice premium data and the 
task of mapping these premiums to procedures, we calculated distinct 
risk factors for surgical, surgical with obstetrics, and nonsurgical 
procedures where applicable. However, the availability of data by 
surgery and non-surgery varied across specialties. Historically, no 
single approach accurately addressed the variability in premium class 
among specialties, and we previously employed several methods for 
calculating average premiums by specialty. These methods are discussed 
below.
    Developing Distinct Service Risk Groups: We determined that there 
were sufficient data for surgery and non-surgery premiums, as well as 
sufficient differences in rates between classes for 15 specialties 
(there were 10 such specialties in the CY 2015 update). These 
specialties are listed in Table 10. Additionally, as described in the 
proposed methodological refinements, in some instances, we combined 
minor surgery and major surgery premiums to create a premium to develop 
the surgery service risk group, rather than discard minor surgery 
premium data as was done in the previous update. Therefore, we 
calculated a national average surgical premium and non-surgical premium 
for those specialties. For all other specialties (those that are not 
listed in Table 10) that typically do not distinguish premiums as 
described above, a single risk factor was calculated, and that 
specialty risk factor was applied to all services performed by those 
specialties.
    This is consistent with prior practice; however, we have refined 
the nomenclature to more precisely describe that some specialties are 
delineated into service risk groups, as is the case for surgical, non-
surgical, and surgical with obstetrics, and some specialties are not 
further delineated into service risk subgroups and are instead referred 
to as ``All''--meaning that all services performed by that specialty 
receive the same risk factor.

[[Page 40507]]



   Table 10--Proposed Specialties Subdivided Into Service Risk Groups
------------------------------------------------------------------------
      Service risk groups                      Specialties
------------------------------------------------------------------------
Surgery/No Surgery.............  Otolaryngology (04), Cardiology (06),
                                  Dermatology (07), Gastroenterology
                                  (10), Neurology (13), Ophthalmology
                                  (18), Urology (34), Geriatric Medicine
                                  (38), Nephrology (39), Endocrinology
                                  (46), Podiatry (48), Emergency
                                  Medicine (93).
Surgery/No Surgery/OB..........  General Practice (01), Family Practice
                                  (08), OB/GYN (16).
------------------------------------------------------------------------

    Step (3): Calculate a risk factor for each specialty.
    The relative differences in national average premiums between 
specialties are expressed in our methodology as a specialty-level risk 
factor. These risk factors are calculated by dividing the national 
average premium for each specialty by the national average premium for 
the specialty with the lowest premiums for which we had sufficient and 
reliable data, which remains allergy and immunology (03). For 
specialties with rate filings that are indicative of sufficient 
surgical and non-surgical premium data, we recognized those service-
risk groups (that is, surgical, and non-surgical) as risk groups of the 
specialty and we calculated both a surgical and non-surgical risk 
factor. Similarly, for specialties with rate filings that distinguished 
surgical premiums with obstetrics, we recognized that service-risk 
subgroup of the specialty and calculated a separate surgical with 
obstetrics risk factor.
(a) Technical Component (TC) Only Services
    We note that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for 
independent diagnostic testing facilities (IDTFs) that we used in the 
CY 2010 update. Those data were obtained from a survey conducted by the 
Radiology Business Management Association (RBMA) in 2009; we ultimately 
used those data to calculate an updated TC specialty risk factor. We 
applied the updated TC specialty risk factor to suppliers of TC-only 
services. In the CY 2015 final rule with comment period (79 FR 67595), 
RBMA voluntarily submitted updated MP premium information collected 
from IDTFs in 2014, and requested that we use the data for calculating 
the CY 2015 MP RVUs for TC-only services. We declined to utilize the 
data and stated that we believe further study is necessary and we would 
consider this matter and propose any changes through future rulemaking. 
We continue to believe that data for a broader set of TC-only services 
are needed, and are working to acquire a broader set of data.
    For CY 2020, we propose to assign a risk factor of 1.00 for TC-only 
services, which corresponds to the lowest physician specialty-level 
risk factor. We assigned the risk factor of 1.00 to the TC-only 
services because we do not have sufficient comparable professional 
liability premium data for the full range of clinicians that furnish 
TC-only services. In lieu of comprehensive, comparable data, we propose 
to assign 1.00, the lowest physician specialty-level risk factor 
calculated using the updated premium data, as the default minimum risk 
factor. However, we seek information on the most comparable and 
appropriate proxy for the broader set of TC-only services for future 
use, as well as any empirical information that would support assignment 
of an alternative risk factor for these services.
    Table 11 shows the proposed risk factors by specialty type and 
service risk group.
BILLING CODE 4120-01-P

[[Page 40508]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.005


[[Page 40509]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.006

BILLING CODE 4120-01-C
    Step (4): Calculate malpractice RVUs for each CPT/HCPCS code.
    Resource-based MP RVUs were calculated for each CPT/HCPCS code that 
has work or PE RVUs. The first step was to identify the percentage of 
services furnished by each specialty for each respective CPT/HCPCS 
code. This

[[Page 40510]]

percentage was then multiplied by each respective specialty's risk 
factor as calculated in Step 3. The products for all specialties for 
the CPT/HCPCS code were then added together, yielding a specialty-
weighted service specific risk factor reflecting the weighted 
malpractice costs across all specialties furnishing that procedure. The 
service specific risk factor was multiplied by the greater of the work 
RVU or clinical labor portion of the direct PE RVU for that service, to 
reflect differences in the complexity and risk-of-service between 
services.
    Low volume service codes: As we discussed above in this proposed 
rule, for low volume services code, we finalized the proposal in the CY 
2018 PFS final rule (82 FR 53000 through 53006) to apply the list of 
expected specialties instead of the claims-based specialty mix for low 
volume services to address stakeholder concerns about the year to year 
variability in PE and MP RVUs for low volume services (which also 
includes no volume services); these are defined as codes that have 100 
allowed services or fewer. These service-level overrides are used to 
determine the specialty for low volume procedures for both PE and MP.
    In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also 
finalized our proposal to eliminate general use of an MP-specific 
specialty-mix crosswalk for new and revised codes. However, we 
indicated that we would continue to consider, in conjunction with 
annual recommendations, specific recommendations regarding specialty 
mix assignments for new and revised codes, particularly in cases where 
coding changes are expected to result in differential reporting of 
services by specialty, or where the new or revised code is expected to 
be low-volume. Absent such information, the specialty mix assumption 
for a new or revised code would derive from the analytic crosswalk in 
the first year, followed by the introduction of actual claims data, 
which is consistent with our approach for developing PE RVUs.
    For CY 2020, we are soliciting public comment on the list of 
expected specialties. We also note that the list has been updated to 
include a column indicating if a service is identified as a low volume 
service for CY 2020, and therefore, whether or not the service-level 
override is being applied for CY 2020. The proposed list of codes and 
expected specialties is available on our website under downloads for 
the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Step (5): Rescale for budget neutrality.
    The statute requires that changes to fee schedule RVUs must be 
budget neutral. Thus, the last step is to adjust for relativity by 
rescaling the proposed MP RVUs so that the total proposed resource 
based MP RVUs are equal to the total current resource based MP RVUs 
scaled by the ratio of the pools of the proposed and current MP and 
work RVUs. This scaling is necessary to maintain the work RVUs for 
individual services from year to year while also maintaining the 
overall relationship among work, PE, and MP RVUs.
    Specialties Excluded from Ratesetting Calculation: In section II.B. 
of this proposed rule, Determination of Practice Expense Relative Value 
Units, we discuss specialties that are excluded from ratesetting for 
the purposes of calculating PE RVUs. We are proposing to treat those 
excluded specialties in a consistent manner for the purposes of 
calculating MP RVUs. We note that all specialties are included for 
purposes of calculating the final BN adjustment. The list of 
specialties excluded from the ratesetting calculation for the purpose 
of calculating the PE RVUs that we are proposing to also exclude for 
the purpose of calculating MP RVUs is available in section II.B. of 
this proposed rule, Determination of Practice Expense Relative Value 
Units. The proposed resource based MP RVUs are shown in Addendum B, 
which is available on the CMS website under the downloads section of 
the CY 2020 PFS rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    Because a different share of the resources involved in furnishing 
PFS services is reflected in each of the three fee schedule components, 
implementation of the resource-based MP RVU update will have much 
smaller payment effects than implementing updates of resource-based 
work RVUs and resource-based PE RVUs. On average, work represents about 
50.9 percent of payment for a service under the fee schedule, PE about 
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change 
in PE RVUs or work RVUs for a service would result in a change in 
payment of about 11 to 13 percent. In contrast, a corresponding 25 
percent change in MP values for a service would yield a change in 
payment of only about 1 percent. Estimates of the effects on payment by 
specialty type can be found in section VI. of this proposed rule, 
Regulatory Impact Analysis.
    Additional information on our proposed methodology for updating the 
MP RVUs is available in the ``Interim Report for the CY 2020 Update of 
GPCIs and MP RVUs for the Medicare Physician Fee Schedule,'' which is 
available on the CMS website under the downloads section of the CY 2020 
PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

D. Geographic Practice Cost Indices (GPCIs)

1. Background
    Section 1848(e)(1)(A) of the Act requires us to develop separate 
Geographic Practice Cost Indices (GPCIs) to measure relative cost 
differences among localities compared to the national average for each 
of the three fee schedule components (that is, work, practice expense 
(PE), and malpractice (MP)). We discuss the localities established 
under the PFS below in this section. Although the statute requires that 
the PE and MP GPCIs reflect full relative cost differences, section 
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only 
one-quarter of the relative cost differences compared to the national 
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 
1.5 work GPCI floor for services furnished in Alaska beginning January 
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE 
GPCI floor for services furnished in frontier states (as defined in 
section 1848(e)(1)(I) of the Act) beginning January 1, 2011. 
Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor 
for the work GPCIs, which was set to expire at the end of 2017. Section 
50201 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123, enacted February 9, 2018) amended the statute to extend the 1.0 
floor for the work GPCIs through CY 2019 (that is, for services 
furnished no later than December 31, 2019).
    Section 1848(e)(1)(C) of the Act requires us to review and, if 
necessary, adjust the GPCIs at least every 3 years. Section 
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed 
since the date of the last previous GPCI adjustment, the adjustment to 
be applied in the first year of the next adjustment shall be \1/2\ of 
the adjustment that otherwise would be made. Therefore, since the 
previous GPCI update was implemented in CYs 2017 and 2018, we are 
proposing to phase in \1/2\ of the latest GPCI adjustment in CY 2020.

[[Page 40511]]

    We have completed a review of the GPCIs and are proposing new GPCIs 
in this proposed rule. We also calculate a geographic adjustment factor 
(GAF) for each PFS locality. The GAFs are a weighted composite of each 
PFS localities work, PE and MP expense GPCIs using the national GPCI 
cost share weights. While we do not actually use GAFs in computing the 
fee schedule payment for a specific service, they are useful in 
comparing overall areas costs and payments. The actual effect on 
payment for any actual service would deviate from the GAF to the extent 
that the proportions of work, PE and MP RVUs for the service differ 
from those of the GAF.
    As noted above, section 50201 of the BBA of 2018 extended the 1.0 
work GPCI floor for services furnished only through December 31, 2019. 
Therefore, the proposed CY 2020 work GPCIs and summarized GAFs do not 
reflect the 1.0 work floor. However, as required by sections 
1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor for Alaska 
and the 1.0 PE GPCI floor for frontier states are permanent, and 
therefore, applicable in CY 2020. See Addenda D and E to this proposed 
rule for the CY 2020 proposed GPCIs and summarized proposed GAFs 
available on the CMS website under the supporting documents section of 
the CY 2020 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Payment Locality Background
    Prior to 1992, Medicare payments for physicians' services were made 
under the reasonable charge system. Payments under this system largely 
reflected the charging patterns of physicians, which resulted in large 
differences in payment for physicians' services among types of 
services, physician specialties and geographic payment areas.
    Local Medicare carriers initially established 210 payment 
localities, to reflect local physician charging patterns and economic 
conditions. These localities changed little between the inception of 
Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we 
undertook a study that culminated in a comprehensive locality revision 
(based on locality resource cost differences as reflected by the GPCIs) 
that we implemented in 1997. The development of the current locality 
structure is described in detail in the CY 1997 PFS final rule (61 FR 
34615) and the subsequent final rule with comment period (61 FR 59494). 
The revised locality structure reduced the number of localities from 
210 to 89, and increased the number of statewide localities from 22 to 
34.
    Section 220(h) of the Protecting Access to Medicare Act (PAMA) 
(Pub. L. 113-93, enacted April 1, 2014) required modifications to the 
payment localities in California for payment purposes beginning with 
2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through 
80268) we established 23 additional localities, increasing the total 
number of PFS localities from 89 to 112. The 112 payment localities 
include 34 statewide areas (that is, only one locality for the entire 
state) and 75 localities in the other 16 states, with 10 states having 
two localities, two states having three localities, one state having 
four localities, and three states having five or more localities. The 
remainder of the 112 PFS payment localities are comprised as follows: 
The combined District of Columbia, Maryland, and Virginia suburbs; 
Puerto Rico; and the Virgin Islands. We note that the localities 
generally represent a grouping of one or more constituent counties.
    The current 112 fee schedule areas are defined alternatively by 
state boundaries (for example, Wisconsin), metropolitan areas (for 
example, Metropolitan St. Louis, MO), portions of a metropolitan area 
(for example, Manhattan), or rest-of-state areas that exclude 
metropolitan areas (for example, Rest of Missouri). This locality 
configuration is used to calculate the GPCIs that are in turn used to 
calculate locality adjusted payments for physicians' services under the 
PFS.
    As stated in the CY 2011 PFS final rule with comment period (75 FR 
73261), changes to the PFS locality structure would generally result in 
changes that are budget neutral within a state. For many years, before 
making any locality changes, we have sought consensus from among the 
professionals whose payments would be affected. We refer readers to the 
CY 2014 PFS final rule with comment period (78 FR 74384 through 74386) 
for further discussion regarding additional information about locality 
configuration considerations.
3. GPCI Update
    As required by the statute, we developed GPCIs to measure relative 
cost differences among payment localities compared to the national 
average for each of the three fee schedule components (that is, work, 
PE, and MP). We describe the data sources and methodologies we use to 
calculate each of the three GPCIs below in this section. Additional 
information on the CY 2020 GPCI update is available in an interim 
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs 
for the Medicare Physician Fee Schedule,'' on our website located under 
the supporting documents section for the CY 2020 PFS proposed rule at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
    The work GPCIs are designed to reflect the relative cost of 
physician labor by Medicare PFS locality. As required by statute, the 
work GPCI reflects one quarter of the relative wage differences for 
each locality compared to the national average.
    To calculate the work GPCIs, we use wage data for seven 
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to 
the national average, as a proxy for physicians' wages. Physicians' 
wages are not included in the occupation categories used in calculating 
the work GPCI because Medicare payments are a key determinant of 
physicians' earnings. Including physician wage data in calculating the 
work GPCIs would potentially introduce some circularity to the 
adjustment since Medicare payments typically contribute to or influence 
physician wages. That is, including physicians' wages in the physician 
work GPCIs would, in effect, make the indices, to some extent, 
dependent upon Medicare payments.
    The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based 
on professional earnings data from the 2000 Census. However, for the CY 
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage 
and earnings data were not available from the more recent Census 
because the ``long form'' was discontinued. Therefore, we used the 
median hourly earnings from the 2006 through 2008 Bureau of Labor 
Statistics (BLS) Occupational Employment Statistics (OES) wage data as 
a replacement for the 2000 Census data. The BLS OES data meet several 
criteria that we consider to be important for selecting a data source 
for purposes of calculating the GPCIs. For example, the BLS OES wage 
and employment data are derived from a large sample size of 
approximately 200,000 establishments of varying sizes nationwide from 
every metropolitan area and can be easily accessible to the public at 
no cost. Additionally, the BLS OES is updated regularly, and includes a 
comprehensive set of occupations and industries (for example, 800 
occupations in 450 industries). For the CY 2014 GPCI update, we used 
updated BLS OES data (2009 through 2011) as a

[[Page 40512]]

replacement for the 2006 through 2008 data to compute the work GPCIs; 
and for the CY 2017 GPCI update, we used updated BLS OES data (2011 
through 2014) as a replacement for the 2009 through 2011 data to 
compute the work GPCIs.
    Because of its reliability, public availability, level of detail, 
and national scope, we believe the BLS OES data continue to be the most 
appropriate source of wage and employment data for use in calculating 
the work GPCIs (and as discussed below, the employee wage component and 
purchased services component of the PE GPCI). Therefore, for the 
proposed CY 2020 GPCI update, we used updated BLS OES data (2014 
through 2017) as a replacement for the 2011 through 2014 data to 
compute the work GPCIs.
b. Practice Expense (PE) GPCIs
    The PE GPCIs are designed to measure the relative cost difference 
in the mix of goods and services comprising PEs (not including MP 
expenses) among the PFS localities as compared to the national average 
of these costs. Whereas the physician work GPCIs (and as discussed 
later in this section, the MP GPCIs) are comprised of a single index, 
the PE GPCIs are comprised of four component indices (employee wages; 
purchased services; office rent; and equipment, supplies and other 
miscellaneous expenses). The employee wage index component measures 
geographic variation in the cost of the kinds of skilled and unskilled 
labor that would be directly employed by a physician practice. Although 
the employee wage index adjusts for geographic variation in the cost of 
labor employed directly by physician practices, it does not account for 
geographic variation in the cost of services that typically would be 
purchased from other entities, such as law firms, accounting firms, 
information technology consultants, building service managers, or any 
other third-party vendor. The purchased services index component of the 
PE GPCI (which is a separate index from employee wages) measures 
geographic variation in the cost of contracted services that physician 
practices would typically buy. For more information on the development 
of the purchased service index, we refer readers to the CY 2012 PFS 
final rule with comment period (76 FR 73084 through 73085). The office 
rent index component of the PE GPCI measures relative geographic 
variation in the cost of typical physician office rents. For the 
medical equipment, supplies, and miscellaneous expenses component, we 
believe there is a national market for these items such that there is 
not significant geographic variation in costs. Therefore, the 
equipment, supplies and other miscellaneous expense cost index 
component of the PE GPCI is given a value of 1.000 for each PFS 
locality.
    For the previous update to the GPCIs (implemented in CY 2017), we 
used 2011 through 2014 BLS OES data to calculate the employee wage and 
purchased services indices for the PE GPCI. As discussed previously in 
this section, because of its reliability, public availability, level of 
detail, and national scope, we continue to believe the BLS OES is the 
most appropriate data source for collecting wage and employment data. 
Therefore, in calculating the proposed CY 2020 GPCI update, we used 
updated BLS OES data (2014 through 2017) as a replacement for the 2011 
through 2014 data for purposes of calculating the employee wage 
component and purchased service index component of the PE GPCI. In 
calculating the proposed CY 2020 GPCI update, for the office rent index 
component of the PE GPCI we used the most recently available, 2013 
through 2017, American Community Survey (ACS) 5-year estimates as a 
replacement for the 2009 through 2013 ACS data.
c. Malpractice Expense (MP) GPCIs
    The MP GPCIs measure the relative cost differences among PFS 
localities for the purchase of professional liability insurance (PLI). 
The MP GPCIs are calculated based on insurer rate filings of premium 
data for $1 million to $3 million mature claims-made policies (policies 
for claims made rather than losses occurring during the policy term). 
For the CY 2017 GPCI update, we used 2014 and 2015 malpractice premium 
data. The proposed CY 2020 MP GPCI update reflects premium data 
presumed in effect as of December 30, 2017. We note that we finalized a 
few technical refinements to the MP GPCI methodology in CY 2017, and 
refer readers to the CY 2017 PFS final rule (81 FR 80270) for 
additional discussion.
d. GPCI Cost Share Weights
    For CY 2020 GPCIs, we are proposing to continue to use the current 
cost share weights for determining the PE GPCI values and locality 
GAFs. We refer readers to the CY 2014 PFS final rule with comment 
period (78 FR 74382 through 74383), for further discussion regarding 
the 2006-based MEI cost share weights revised in CY 2014 that we also 
finalized for use in the CY 2017 GPCI update.
    The proposed GPCI cost share weights for CY 2020 are displayed in 
Table 12.

      Table 12--Proposed Cost Share Weights for CY 2020 GPCI Update
------------------------------------------------------------------------
                                                        Proposed CY 2020
         Expense category              Current cost    cost share weight
                                     share weight (%)         (%)
------------------------------------------------------------------------
Work..............................             50.866             50.866
Practice Expense..................             44.839             44.839
    --Employee Compensation.......             16.553             16.553
    --Office Rent.................             10.223             10.223
    --Purchased Services..........              8.095              8.095
    --Equipment, Supplies, Other..              9.968              9.968
Malpractice Insurance.............              4.295              4.295
                                   -------------------------------------
    Total.........................            100.000            100.000
------------------------------------------------------------------------

e. PE GPCI Floor for Frontier States
    Section 10324(c) of the Affordable Care Act added a new 
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 
PE GPCI floor for physicians' services furnished in frontier states 
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of 
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for 
physicians' services furnished in states determined to be frontier 
states. In general, a frontier state is one in which at least 50 
percent of the counties are ``frontier counties,'' which are those that

[[Page 40513]]

have a population per square mile of less than 6. For more information 
on the criteria used to define a frontier state, we refer readers to 
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75 
FR 50160 through 50161). There are no changes in the states identified 
as Frontier States for the CY 2020 PFS proposed rule. The qualifying 
states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada. 
In accordance with statute, we would apply a 1.0 PE GPCI floor for 
these states in CY 2020.
f. Methodology for Calculating GPCIs in the U.S. Territories
    Prior to CY 2017, for all the island territories other than Puerto 
Rico, the lack of comprehensive data about unique costs for island 
territories had minimal impact on GPCIs because we used either the 
Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and 
Northern Mariana Islands) or used the unadjusted national averages (for 
the Virgin Islands). In an effort to provide greater consistency in the 
calculation of GPCIs given the lack of comprehensive data regarding the 
validity of applying the proxy data used in the States in accurately 
accounting for variability of costs for these island territories, in 
the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a 
policy to treat the Caribbean Island territories (the Virgin Islands 
and Puerto Rico) in a consistent manner. We do so by assigning the 
national average of 1.0 to each GPCI index for both Puerto Rico and the 
Virgin Islands. We refer readers to the CY 2017 PFS final rule for a 
comprehensive discussion of this policy.
g. California Locality Update to the Fee Schedule Areas Used for 
Payment Under Section 220(h) of the Protecting Access to Medicare Act
    Section 220(h) of the PAMA added a new section 1848(e)(6) to the 
Act that modified the fee schedule areas used for payment purposes in 
California beginning in CY 2017. Prior to CY 2017, the fee schedule 
areas used for payment in California were based on the revised locality 
structure that was implemented in 1997 as previously discussed. 
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that 
the fee schedule areas used for payment in California must be 
Metropolitan Statistical Areas (MSAs) as defined by the Office of 
Management and Budget (OMB) as of December 31 of the previous year; and 
section 1848(e)(6)(A)(ii) of the Act required that all areas not 
located in an MSA must be treated as a single rest-of-state fee 
schedule area. The resulting modifications to California's locality 
structure increased its number of localities from 9 under the current 
locality structure to 27 under the MSA-based locality structure; 
although for the purposes of payment the actual number of localities 
under the MSA-based locality structure is 32. We refer readers to the 
CY 2017 PFS final rule (81 FR 80267) for a detailed discussion of this 
operational consideration.
    Section 1848(e)(6)(D) of the Act defined transition areas as the 
fee schedule areas for 2013 that were the rest-of-state locality, and 
locality 3, which was comprised of Marin County, Napa County, and 
Solano County. Section 1848(e)(6)(B) of the Act specified that the GPCI 
values used for payment in a transition area are to be phased in over 6 
years, from 2017 through 2022, using a weighted sum of the GPCIs 
calculated under the new MSA-based locality structure and the GPCIs 
calculated under the current PFS locality structure. That is, the GPCI 
values applicable for these areas during this transition period are a 
blend of what the GPCI values would have been for California under the 
current locality structure, and what the GPCI values would be for 
California under the MSA-based locality structure. For example, in CY 
2020, which represents the fourth year, the applicable GPCI values for 
counties that were previously in rest-of-state or locality 3 and are 
now in MSAs are a blend of \2/3\ of the GPCI value calculated for the 
year under the MSA-based locality structure, and \1/3\ of the GPCI 
value calculated for the year under the current locality structure. The 
proportions continue to shift by \1/6\ in each subsequent year so that, 
by CY 2021, the applicable GPCI values for counties within transition 
areas are a blend of \5/6\ of the GPCI value for the year under the 
MSA-based locality structure, and \1/6\ of the GPCI value for the year 
under the current locality structure. Beginning in CY 2022, the 
applicable GPCI values for counties in transition areas are the values 
calculated solely under the new MSA-based locality structure. For 
clarity, we reiterate that this incremental phase-in is only applicable 
to those counties that are in transition areas that are now in MSAs, 
which are only some of the counties in the 2013 California rest-of 
state locality and locality 3.
    Additionally, section 1848(e)(6)(C) of the Act establishes a hold 
harmless for transition areas beginning with CY 2017 whereby the 
applicable GPCI values for a year under the new MSA-based locality 
structure may not be less than what they would have been for the year 
under the current locality structure. There are a total of 58 counties 
in California, 50 of which are in transition areas as defined in 
section 1848(e)(6)(D) of the Act. The eight counties that are not 
within transition areas are: Orange; Los Angeles; Alameda; Contra 
Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
    For the purposes of calculating budget neutrality and consistent 
with the PFS budget neutrality requirements as specified under section 
1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by 
calculating the national GPCIs as if the current localities are still 
applicable nationwide; then, for the purposes of payment in California, 
we override the GPCI values with the values that are applicable for 
California consistent with the requirements of section 1848(e)(6) of 
the Act. This approach is consistent with the implementation of the 
GPCI floor provisions that have previously been implemented--that is, 
as an after-the-fact adjustment that is implemented for purposes of 
payment after both the GPCIs and PFS budget neutrality have already 
been calculated.
    Additionally, section 1848(e)(1)(C) of the Act requires that, if 
more than 1 year has elapsed since the date of the last previous GPCI 
adjustment, the adjustment to be applied in the first year of the next 
adjustment shall be \1/2\ of the adjustment that otherwise would be 
made. However, since section 1848(e)(6)(B) of the Act provides for a 
gradual phase in of the GPCI values under the new MSA-based locality 
structure for California, specifically in one-sixth increments over 6 
years, if we were to also apply the requirement to phase in \1/2\ of 
the adjustment in year 1 of the GPCI update then the first year 
increment would effectively be \1/12\. Therefore, in CY 2017, we 
finalized a policy that the requirement at section 1848(e)(1)(C) of the 
Act to phase in \1/2\ of the adjustment in year 1 of the GPCI update 
would not apply to counties that were previously in the rest-of-state 
or locality 3 and are now in MSAs that are subject to the blended 
phase-in as described above in this section. We reiterate that this is 
only applicable through CY 2021 since, beginning in CY 2022, the GPCI 
values for such areas in an MSA would be fully based on the values 
calculated under the new MSA-based locality structure for California. 
For a comprehensive discussion of this provision, transition areas, and 
operational considerations, we refer readers to the CY 2017 PFS final 
rule (81 FR 80265 through 80268).

[[Page 40514]]

h. Refinements to the GPCI Methodology
    In the process of calculating GPCIs for the purposes of this 
proposed rule, we identified two technical refinements to the 
methodology that yield improvements over the current method; these 
refinements are applicable to the work GPCI and the employee wage index 
and purchased services index components of the PE GPCI. We are 
proposing to weight by total employment when computing county median 
wages for each occupation code which addresses the fact that the 
occupation wage can vary by industry within a county. Additionally, we 
are also proposing to use a weighted average when calculating the final 
county-level wage index; this removes the possibility that a county 
index would imply a wage of 0 for any occupation group not present in 
the county's data. These proposed methodological refinements yield 
improved mathematical precision. Additional information on the GPCI 
methodology and the proposed refinements are available in the interim 
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs 
for the Medicare Physician Fee Schedule'' on our website located under 
the supporting documents section of the CY 2020 PFS proposed rule at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
i. Proposed GPCI Update Summary
    As explained above in the Background section above, the periodic 
review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of 
the Act. At each update, the proposed GPCIs are published in the PFS 
proposed rule to provide an opportunity for public comment and further 
revisions in response to comments prior to implementation. The proposed 
CY 2020 updated GPCIs for the first and second year of the 2-year 
transition, along with the GAFs, are displayed in Addenda D and E to 
this proposed rule available on our website under the supporting 
documents section of the CY 2020 PFS proposed rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

E. 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 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.N. of this proposed rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the RUC, MedPAC, 
and other stakeholders. For many years, the RUC has provided us with 
recommendations on the appropriate relative values for new, revised, 
and potentially misvalued PFS services. We review these recommendations 
on a code-by-code basis and consider these recommendations in 
conjunction with analyses of other data, such as claims data, to inform 
the decision-making process as authorized by law. We may also consider 
analyses of work time, work RVUs, or direct PE inputs using other data 
sources, such as Department of Veteran Affairs (VA), National Surgical 
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons 
(STS), and the Merit-based Incentive Payment System (MIPS) data. In 
addition to considering the most recently available data, we assess the 
results of physician surveys and specialty recommendations submitted to 
us by the RUC for our review. We also consider information provided by 
other stakeholders. We conduct a review to assess the appropriate RVUs 
in the context of contemporary medical practice. We note that section 
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available and requires us to take into 
account the results of consultations with organizations representing 
physicians who provide the services. In accordance with section 1848(c) 
of the Act, we determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-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 declines. 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 rises.
    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

[[Page 40515]]

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, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well. Individuals and stakeholder groups may submit codes for review 
under the potentially misvalued codes initiative to CMS in one of two 
ways. Nominations may be submitted to CMS via email or through postal 
mail. Email submissions should be sent to the CMS emailbox 
[email protected], with the phrase ``Potentially 
Misvalued Codes'' in the subject line. Physical letters for nominations 
should be sent via the U.S. Postal Service to the Centers for Medicare 
and Medicaid Service, 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 
approximately 1,700 potentially misvalued codes to refine work RVUs and 
direct PE inputs. We have assigned appropriate work RVUs and direct PE 
inputs for these services as a result of these reviews. A more detailed 
discussion of the extensive prior reviews of potentially misvalued 
codes is included in the Medicare Program; Payment Policies Under the 
Physician Fee Schedule, Five-Year Review of Work Relative Value Units, 
Clinical Laboratory Fee Schedule: Signature on Requisition, and Other 
Revisions to Part B for CY 2012; Final Rule (76 FR 73052 through 73055) 
(hereinafter referred to as the CY 2012 PFS final rule with comment 
period). In the CY 2012 PFS final rule with comment period (76 FR 73055 
through 73958), we finalized our policy to consolidate the review of 
physician work and PE at the same time, and established a process for 
the annual public nomination of potentially misvalued services.
    In the Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the 
Requirement for Termination of Non-Random Prepayment Complex Medical 
Review and Other Revisions to Part B for CY 2013 (77 FR 68892) 
(hereinafter referred to as the CY 2013 PFS final rule with comment 
period), we built upon the work we began in CY 2009 to review 
potentially misvalued codes that have not been reviewed since the 
implementation of the PFS (so-called ``Harvard-valued codes''). In the 
Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2009; and Revisions to 
the Amendment of the E-Prescribing Exemption for Computer Generated 
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter 
referred to the CY 2009 PFS proposed rule), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services. 
In the CY 2013 PFS final rule with comment period, we identified 
specific Harvard-valued services with annual allowed charges that total 
at least $10,000,000 as potentially misvalued. In addition to the 
Harvard-valued codes, in the CY 2013 PFS final rule with comment period 
we finalized for review a list of potentially misvalued codes that have 
stand-alone PE (codes with physician work and no listed work time and 
codes with no physician work that have listed work time).
    In the Medicare Program; Revisions to Payment Policies under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2016 final 
rule with comment period (80 FR 70886) (hereinafter referred to as the 
CY 2016 PFS final rule with comment period), we finalized for review a 
list of potentially misvalued services, which included eight codes in 
the neurostimulators analysis-programming family (CPT codes 95970-
95982). We also finalized as potentially misvalued 103 codes identified 
through our screen of high expenditure services across specialties.
    In the Medicare Program; Revisions to Payment Policies under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2017; 
Medicare Advantage Bid Pricing Data Release; Medicare Advantage and 
Part D Medical Loss Ratio Data Release; Medicare Advantage Provider 
Network Requirements; Expansion of Medicare Diabetes Prevention Program 
Model; Medicare Shared Savings Program Requirements final rule (81 FR 
80170) (hereinafter referred to as the CY 2017 PFS final rule), we 
finalized for review a list of potentially misvalued services, which 
included eight codes in the end-stage renal disease home dialysis 
family (CPT codes 90963-90970). We also finalized as potentially 
misvalued 19 codes

[[Page 40516]]

identified through our screen for 0-day global services that are 
typically billed with an evaluation and management (E/M) service with 
modifier 25.
    In the CY 2018 PFS final rule, we finalized arthrodesis of 
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the 
use of comment solicitations with regard to specific codes, we also 
examined the valuations of other services, in addition to, new 
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2020 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 
through 67608), we modified this process whereby the public and 
stakeholders may nominate potentially misvalued codes for review by 
submitting the code with supporting documentation by February 10th of 
each year. Supporting documentation for codes nominated for the annual 
review of potentially misvalued codes may include the following:
     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 that year's final rule, we finalize our 
list of potentially misvalued codes.
a. Public Nominations
    We received three submissions that nominated codes for review under 
the potentially misvalued code initiative, prior to our February 10, 
2019 deadline. In addition to three public nominations, CMS also 
nominated one additional code for review.
    One commenter requested that CMS consider CPT code 10005 (Fine 
needle aspiration biopsy, including ultrasound guidance; first lesion) 
and CPT code 10021 (Fine needle aspiration biopsy, without imaging 
guidance; first lesion) for nomination as potentially misvalued. We 
note that these two CPT codes were recently reviewed within a family of 
13 similar codes. Our review of these codes and our rationale for 
finalizing the current values are discussed extensively in the CY 2019 
PFS final rule (83 FR 59517). For CPT code 10021, the RUC recommended a 
32 percent reduction from its previous physician time and a 5 percent 
reduction in the work RVU. The commenter disagreed with this change and 
stated that there was a change in intensity of the procedure now as 
compared to what it was in 1995 when this code was last evaluated. The 
commenter also stated that there was a change in intensity of the work 
performed due to use of more complicated equipment, more stringent 
specimen sampling that allow for extensive examination of smaller and 
deeper lesions within the body. The commenter disagreed with the CMS' 
crosswalked CPT code 36440 (Push blood transfusion, patient 2 years or 
younger) and presented CPT codes 40490 (Biopsy of lip) and 95865 
(Needle measurement and recording of electrical activity of muscles of 
voice box) as more appropriate crosswalks.
    Another commenter requested that CMS consider HCPCS code G0166 
(External counterpulsation, per treatment session) as potentially 
misvalued. This code was reviewed for the CY 2019 PFS final rule (83 FR 
59578), and the work RVU and direct PE inputs as recommended by the AMA 
RUC were finalized by CMS. We finalized the valuation of this code with 
no refinements. However, the commenter noted that the PE inputs that 
were considered for this code did not fully reflect the total resources 
required to deliver the service. We will review the commenter's 
submission of additional new data and public comments received in 
combination with what was previously presented in the CY 2019 PFS final 
rule.
    CMS nominated CPT code 76377 (3D rendering with interpretation and 
reporting of computed tomography, magnetic resonance imaging, 
ultrasound, or other tomographic modality with image postprocessing 
under concurrent supervision; requiring image postprocessing on an 
independent workstation) as potentially misvalued. 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) was reviewed by the 
AMA RUC at the April 2018 RUC meeting. However, CPT code 76377, which 
is very similar to CPT code 76376, was not reviewed, and is likely now 
misvalued, in light of the similarities between the two codes. The 
specialty societies noted that the two codes are different because they 
are utilized by different patient populations (as evidenced by the ICD-
10 diagnoses); however, we view both codes to be similar enough that 
CPT code 76377 should be reviewed to maintain relativity in the code 
family.
    We are proposing the aforementioned public and CMS nominated codes 
as potentially misvalued and welcome public comment on these codes.
    Another commenter provided information to CMS in which they stated 
that the work involved in furnishing services represented by the 
office/outpatient evaluation and management (E/M) code set (CPT codes 
99201-99215) has changed sufficiently to warrant revaluation. 
Specifically, the commenter stated that these codes have not been 
reviewed in over 12 years and in that time have suffered passive 
devaluation as more and more procedures and other services have been 
added to the CPT code set, which are subsequently valued in a budget 
neutral manner, through notice and comment rulemaking, on the Medicare 
PFS. The commenter also stated that re-evaluation of these codes is 
critical to the success

[[Page 40517]]

of CMS' objective of advancing value-based care through the 
introduction of advanced alternative payment models (APMs) as these 
APMs rely on the underlying E/M codes as the basis for payment or 
reference price for bundled payments.
    We acknowledge the points made by the commenter, and continue to 
consider the best ways to recognize the significant changes in 
healthcare practice as discussed by the commenter. We agree, in 
principle, that the existing set of office/outpatient E/M CPT codes may 
not be correctly valued. In recent years, we have specifically 
considered how best to update and revalue the E/M codes, which 
represent a significant proportion of PFS expenditures, and have also 
engaged in ongoing dialogue with the practitioner community. In the CY 
2019 PFS proposed and final rules, in part due to these ongoing 
stakeholder discussions, we proposed and finalized changes to E/M 
payment and documentation requirements to implement policy objectives 
focused on reducing provider documentation burden (83 FR 59625). 
Concurrently, the CPT Editorial Panel, under similar burden reduction 
guiding principles, convened a workgroup and proposed to refine and 
revalue the existing E/M office/outpatient code set. We thank the 
commenter for the views represented in their comment. As stated earlier 
in this section, we agree in principle that the existing set of office/
outpatient E/M CPT codes may not be correctly valued, and therefore, we 
will continue to consider opportunities to revalue these codes, in 
light of their significance to payment for services billed under 
Medicare.
    Table 13 lists the HCPCS and CPT codes that we are proposing as 
potentially misvalued.

     Table 13--HCPCS and CPT Codes Proposed as Potentially Misvalued
------------------------------------------------------------------------
            CPT/HCPCS code                     Short description
------------------------------------------------------------------------
10005................................  Fna bx w/us gdn 1st les.
10021................................  Fna bx w/o img gdn 1st les.
76377................................  3d render w/intrp postproces.
G0166................................  Extrnl counterpulse, per tx.
------------------------------------------------------------------------

F. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act

    As discussed in this rule and in prior rulemaking, several 
conditions must be met for Medicare to make payment for telehealth 
services under the PFS. For further details, see the full discussion of 
the scope of Medicare telehealth services in the CY 2018 PFS final rule 
(82 FR 53006) and in 42 CFR 410.78 and 414.65.
1. Adding Services to the List of Medicare Telehealth Services
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a process for adding services to or deleting services from 
the list of Medicare telehealth services in accordance with section 
1834(m)(4)(F)(ii) of the Act. This process provides the public with an 
ongoing opportunity to submit requests for adding services, which are 
then reviewed by us. Under this process, we assign any submitted 
request to add to the list of telehealth services 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 list of telehealth services. 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 list of telehealth services. 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 clinical benefit 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.
    The list of telehealth services, including the proposed additions 
described later in this section, can be located on the CMS website at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Historically, requests to add services to the list of Medicare 
telehealth services had to be submitted and received no later than 
December 31 of each calendar year to be considered for the next 
rulemaking cycle. However, 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. For example, to be considered during PFS 
rulemaking for CY 2021, requests to add services to the list of 
Medicare telehealth services must be submitted and received by February 
10, 2020. Each request to add a service to the list of Medicare 
telehealth services must include 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 list of Medicare telehealth services, requesters should be 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 to add services to the list of Medicare telehealth services, 
including where to mail these requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
2. Requests To Add Services to the List of Telehealth Services for CY 
2020
    Under our current policy, we add services to the telehealth list on 
a Category 1 basis when we determine that they are similar to services 
on the existing telehealth list for the roles of,

[[Page 40518]]

and interactions among, the beneficiary, physician (or other 
practitioner) at the distant site and, if necessary, the telepresenter. 
As we stated in the CY 2012 PFS final rule with comment period (76 FR 
73098), we believe that the Category 1 criteria not only streamline our 
review process for publicly requested services that fall into this 
category, but also expedite our ability to identify codes for the 
telehealth list that resemble those services already on this list.
    We did not receive any requests from the public for additions to 
the Medicare Telehealth list for CY 2020. We believe that the vast 
majority of services under the PFS that can be appropriately furnished 
as Medicare telehealth services have already been added to the list.
    However, there are three HCPCS G-codes describing new services 
being proposed in section II.H. of this rule for CY 2020 which we 
believe are sufficiently similar to services currently on the 
telehealth list to be added on a Category 1 basis. Therefore, we are 
proposing to add the face-to-face portions of the following services to 
the telehealth list on a Category 1 basis for CY 2020:
     HCPCS code GYYY1: Office-based treatment for opioid use 
disorder, including development of the treatment plan, care 
coordination, individual therapy and group therapy and counseling; at 
least 70 minutes in the first calendar month.
     HCPCS code GYYY2: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; at least 60 minutes in a subsequent calendar 
month.
     HCPCS code GYYY3: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; each additional 30 minutes beyond the first 120 
minutes (List separately in addition to code for primary procedure).
    Similar to our addition of the required face-to-face visit 
component of TCM services to the Medicare Telehealth list in the CY 
2014 PFS final rule with comment period (78 FR 74403), since HCPCS 
codes GYYY1, GYYY2, and GYYY3 include face-to-face psychotherapy 
services, we believe that the face-to-face portions of these services 
are sufficiently similar to services currently on the list of Medicare 
telehealth services for these services to be added under Category 1. 
Specifically, we believe that the psychotherapy portions of the bundled 
codes are similar to the psychotherapy codes described by CPT codes 
90832 and 90853, which are currently on the Medicare telehealth 
services list. We note that like certain other non-face-to-face PFS 
services, the other components of HCPCS codes GYYY1-3 describing care 
coordination 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, we do not need to 
consider whether the non-face-to-face aspects of HCPCS codes GYYY1-3 
are similar to other telehealth services. Were these components of 
HCPCS codes GYYY1-3 separately billable, they would not need to be on 
the Medicare telehealth list to be covered and paid in the same way as 
services delivered without the use of telecommunications technology.
    As discussed in the CY 2019 PFS final rule (83 FR 59496), we note 
that section 2001(a) of the SUPPORT Act (Pub. L. 115-271, October 24, 
2018) amended section 1834(m) of the Act, adding a new paragraph (7) 
that removes the geographic limitations for telehealth services 
furnished on or after July 1, 2019, for individuals diagnosed with a 
substance use disorder (SUD) for the purpose of treating the SUD or a 
co-occurring mental health disorder. Section 1834(m)(7) of the Act also 
allows telehealth services for treatment of a diagnosed SUD or co-
occurring mental health disorder to be furnished to individuals at any 
telehealth originating site (other than a renal dialysis facility), 
including in a patient's home. Section 2001(a) of the SUPPORT Act 
additionally amended section 1834(m) of the Act to require that no 
originating site facility fee will be paid in instances when the 
individual's home is the originating site. We believe that adding HCPCS 
codes GYYY1, GYYY2, and GYYY3 will complement the existing policies 
related to flexibilities in treating SUDs under Medicare Telehealth.
    We note that we welcome public nominations for additions to the 
Medicare telehealth list. More information on the nomination process is 
posted under the Telehealth section of the CMS website, which can be 
accessed at the following web address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.

G. Medicare Coverage for Opioid Use Disorder Treatment Services 
Furnished by Opioid Treatment Programs (OTPs)

1. Overview
    Opioid use disorder (OUD) and deaths from prescription and illegal 
opioid overdoses have reached alarming levels. The Centers for Disease 
Control and Prevention (CDC) estimated 47,000 overdose deaths were from 
opioids in 2017 and 36 percent of those deaths were from prescription 
opioids.\1\ OUD has become a public health crisis. On October 26, 2017, 
Acting Health and Human Services Secretary, Eric D. Hargan declared a 
nationwide public health emergency on the opioid crisis as requested by 
President Donald Trump.\2\ This public health emergency was renewed by 
Secretary Alex M. Azar II on January 24, 2018, April 24, 2018, July 23, 
2018, and October 21, 2018, January 17, 2019 and most recently, on 
April 19, 2019.\3\
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    \1\ https://www.cdc.gov/drugoverdose/data/index.html.
    \2\ https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.
    \3\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioid-19apr2019.aspx.
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    The Medicare population, including individuals who are eligible for 
both Medicare and Medicaid, has the fastest growing prevalence of OUD 
compared to the general adult population, with more than 300,000 
beneficiaries diagnosed with OUD in 2014.\4\ An effective treatment for 
OUD is known as medication-assisted treatment (MAT). The Substance 
Abuse and Mental Health Services Administration (SAMHSA) defines MAT as 
the use of medication in combination with behavioral health services to 
provide an individualized approach to the treatment of substance use 
disorder, including opioid use disorder (42 CFR 8.2). Currently, 
Medicare covers medications for MAT, including buprenorphine, 
buprenorphine-naloxone combination products, and extended-release 
injectable naltrexone under Part B or Part D, but does not cover 
methadone. Medicare also covers counseling and behavioral therapy 
services that are reasonable and necessary and furnished by 
practitioners that can bill and receive payment under Medicare.
---------------------------------------------------------------------------

    \4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2535238.
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    Historically, Medicare has not covered methadone for MAT because of 
the unique manner in which this drug is dispensed and administered. 
Medicare Part B covers physician-administered drugs, drugs used in

[[Page 40519]]

conjunction with durable medical equipment, and certain other 
statutorily specified drugs. Medicare Part D covers drugs that are 
dispensed upon a prescription by a pharmacy. Methadone for MAT is not a 
drug administered by a physician under the incident to benefit like 
other MAT drugs (that is, implanted buprenorphine or injectable 
extended-release naltrexone) and therefore has not previously been 
covered by Medicare Part B. Methadone for MAT is also not a drug 
dispensed by a pharmacy like certain other MAT drugs (that is 
buprenorphine or buprenorphine-naloxone combination products) and 
therefore is not covered under Medicare Part D. Methadone for MAT is a 
schedule II controlled substance that is highly regulated because it 
has a high potential for abuse which may lead to severe psychological 
or physical dependence. As a result, methadone for MAT can only be 
dispensed and administered by an opioid treatment program (OTP) as 
provided under section 303(g)(1) of the Controlled Substances Act (21 
U.S.C. 823(g)(1)) and 42 CFR part 8. Additionally, OTPs, which are 
healthcare entities that focus on providing MAT for people diagnosed 
with OUD, were not previously entities that could bill and receive 
payment from Medicare for the services they furnish. Therefore, there 
has historically been a gap in Medicare coverage of MAT for OUD since 
methadone (one of the three FDA-approved drugs for MAT) has not been 
covered.
    Section 2005 of the Substance Use-Disorder Prevention that Promotes 
Opioid Recovery and Treatment for Patients and Communities Act (the 
SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) added a new 
section 1861(jjj) to the Act, establishing a new Part B benefit 
category for OUD treatment services furnished by an OTP beginning on or 
after January 1, 2020. Section 1861(jjj)(1) of the Act defines OUD 
treatment services as items and services furnished by an OTP (as 
defined in section 1861(jjj)(2)) for treatment of OUD. Section 2005 of 
the SUPPORT Act also amended the definition of ``medical and other 
health services'' in section 1861(s) of the Act to provide for coverage 
of OUD treatment services and added a new section 1834(w) to the Act 
and amended section 1833(a)(1) of the Act to establish a bundled 
payment to OTPs for OUD treatment services furnished during an episode 
of care beginning on or after January 1, 2020.
    OTPs must have a current, valid certification from SAMHSA to 
satisfy the Controlled Substances Act registration requirement under 21 
U.S.C. 823(g)(1). To obtain SAMHSA certification, OTPs must have a 
valid accreditation by an accrediting body approved by SAMHSA, and must 
be certified by SAMHSA as meeting federal opioid treatment standards in 
42 CFR 8.12. There are currently about 1,700 OTPs nationwide.\5\ All 
states except Wyoming have OTPs. Approximately 74 percent of patients 
receiving services from OTPs receive methadone for MAT, with the vast 
majority of the remaining patients receiving buprenorphine.\6\
---------------------------------------------------------------------------

    \5\ https://dpt2.samhsa.gov/treatment/directory.aspx.
    \6\ https://wwwdasis.samhsa.gov/dasis2/nssats.htm.
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    Many payers currently cover MAT services for treatment of OUD. 
Medicaid \7\ is one of the largest payers of medications for substance 
use disorder (SUD), including methadone for MAT provided in OTPs.\8\ 
OUD treatment services and MAT are also covered by other payers such as 
TRICARE and private insurers. TRICARE established coverage and payment 
for MAT and OUD treatment services furnished by OTPs in late 2016 (81 
FR 61068). In addition, as discussed in the ``Patient Protection and 
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 
2020'' proposed rule, many qualified health plans covered MAT 
medications for plan year 2018 (84 FR 285).
---------------------------------------------------------------------------

    \7\ Medicaid provides health care coverage to 65.9 million 
Americans, including low-income adults, children, pregnant women, 
elderly adults and people with disabilities. Medicaid is 
administered by states, according to federal requirements, and is 
funded jointly by states and the federal government. States have the 
flexibility to administer the Medicaid program to meet their own 
state needs within the Medicaid program parameters set forth in 
federal statute and regulations. As a result, there is variation in 
how each state implements its programs.
    \8\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
---------------------------------------------------------------------------

    In the CY 2019 PFS final rule (83 FR 59497), we included a Request 
for Information (RFI) to solicit public comments on the implementation 
of the new Medicare benefit category for OUD treatment services 
furnished by OTPs established by section 2005 of the SUPPORT Act. We 
received 9 public comments. Commenters were generally supportive of the 
new benefit and expanding access to OUD treatment for Medicare 
beneficiaries. We received feedback that the bundled payments to OTPs 
should recognize the intensity of services furnished in the initiation 
stages, durations of care, the needs of patients with more complex 
needs, costs of emerging technologies, and use of peer support groups. 
We also received feedback that costs associated with care coordination 
among the beneficiary's practitioners should be included in the bundled 
payment given the myriad of health issues beneficiaries with OUD face. 
We considered this feedback as we developed our proposals for 
implementing the new benefit category for OUD treatment services 
furnished by OTPs and the proposed bundled payments for these services.
    To implement section 2005 of the SUPPORT Act, we are proposing to 
establish rules to govern Medicare coverage of and payment for OUD 
treatment services furnished in OTPs. In the following discussion, we 
propose to establish definitions of OUD treatment services and OTP for 
purposes of the Medicare Program. We also propose a methodology for 
determining Medicare payment for such services provided by OTPs. We are 
proposing to codify these policies in a new section of the regulations 
at Sec.  410.67. For a discussion about Medicare enrollment 
requirements and the proposed program integrity approach for OTPs, we 
refer readers to section III.H. Medicare Enrollment of Opioid Treatment 
Programs, in this proposed rule.
2. Proposed Definitions
a. Opioid Use Disorder Treatment Services
    The SUPPORT Act amended section 1861 of the Act by adding a new 
subsection (jjj)(1) that defines ``opioid use disorder treatment 
services'' as the items and services that are furnished by an OTP for 
the treatment of OUD, as set forth in subparagraphs (A) through (F) of 
section 1861(jjj)(1) of the Act which include:
     Opioid agonist and antagonist treatment medications 
(including oral, injected, or implanted versions) that are approved by 
the Food and Drug Administration (FDA) under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 355) for use in the 
treatment of OUD;
     Dispensing and administration of such medications, if 
applicable;
     Substance use counseling by a professional to the extent 
authorized under state law to furnish such services;
     Individual and group therapy with a physician or 
psychologist (or other mental health professional to the extent 
authorized under state law);
     Toxicology testing; and
     Other items and services that the Secretary determines are 
appropriate (but in no event to include meals or transportation).
    As described previously, section 1861(jjj)(1)(A) of the Act defines 
covered OUD treatment services to include oral,

[[Page 40520]]

injected, and implanted opioid agonist and antagonist medications 
approved by FDA under section 505 of the FFDCA for use in the treatment 
of OUD. There are three drugs currently approved by the FDA for the 
treatment of opioid dependence: Buprenorphine, methadone, and 
naltrexone.\9\ FDA notes that all three of these medications have been 
demonstrated to be safe and effective in combination with counseling 
and psychosocial support and that those seeking treatment for an OUD 
should be offered access to all three options as this allows providers 
to work with patients to select the medication best suited to an 
individual's needs.\10\ Each of these medications is discussed below in 
more detail.
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    \9\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \10\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
---------------------------------------------------------------------------

    Buprenorphine is FDA-approved for acute and chronic pain in 
addition to opioid dependence. It is listed by the Drug Enforcement 
Administration (DEA) as a Schedule III controlled substance because of 
its moderate to low potential for physical and psychological 
dependence.\11\ \12\ The medication's partial agonist properties allow 
for its use in opioid replacement therapy, which is a process of 
treating OUD by using a substance, for example, buprenorphine or 
methadone, to substitute for a stronger full agonist opioid.\13\ 
Buprenorphine drug products that are currently FDA-approved and 
marketed for the treatment of opioid dependence include oral 
buprenorphine and naloxone \14\ films and tablets, an extended-release 
buprenorphine injection for subcutaneous use, and a buprenorphine 
implant for subdermal administration.\15\ In most patients with opioid 
dependence, the initial oral dose is 2 to 4 mg per day with a 
maintenance dose of 8-12 mg per day.\16\ Dosing for the extended-
release injection is 300 mg monthly for the first 2 months followed by 
a maintenance dose of 100 mg monthly.\17\ The extended-release 
injection is indicated for patients who have initiated treatment with 
an oral buprenorphine product for a minimum of 7 days.\18\ The 
buprenorphine implant consists of four rods containing 74.2 mg of 
buprenorphine each, and provides up to 6 months of treatment for 
patients who are clinically stable on low-to-moderate doses of an oral 
buprenorphine-containing product.\19\ Currently, federal regulations 
permit buprenorphine to be prescribed or dispensed by qualifying 
physicians and qualifying other practitioners at office-based practices 
and dispensed in OTPs.\20\ \21\
---------------------------------------------------------------------------

    \11\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \12\ https://www.dea.gov/drug-scheduling.
    \13\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
    \14\ Naloxone is added to buprenorphine in order to reduce its 
abuse potential and limit diversion.
    \15\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \16\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
    \17\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
    \18\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
    \19\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf.
    \20\ https://www.fda.gov/Drugs/NewsEvents/ucm611659.htm.
    \21\ 21 U.S.C. 823(g)(2).
---------------------------------------------------------------------------

    Methadone is FDA-approved for management of severe pain in addition 
to opioid dependence. It is listed by the DEA as a Schedule II 
controlled substance because of its high potential for abuse, with use 
potentially leading to severe psychological or physical dependence.\22\ 
\23\ Methadone drug products that are FDA-approved for the treatment of 
opioid dependence include oral methadone concentrate and tablets.\24\ 
In patients with opioid dependence, the total daily dose of methadone 
on the first day of treatment should not ordinarily exceed 40 mg, 
unless the program physician documents in the patient's record that 40 
milligrams did not suppress opioid abstinence, with clinical stability 
generally achieved at doses between 80 to 120 mg/day.\25\ By law, 
methadone can only be dispensed through an OTP certified by SAMHSA.\26\
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    \22\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \23\ https://www.dea.gov/drug-scheduling.
    \24\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \25\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf.
    \26\ https://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.
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    Naltrexone is FDA-approved to treat alcohol dependence in addition 
to opioid use disorder.\27\ Unlike buprenorphine and methadone, which 
activate opioid receptors, naltrexone binds and blocks opioid receptors 
and reduces opioid cravings.\28\ Therefore, naltrexone is not a 
scheduled substance; there is no abuse and diversion potential with 
naltrexone.29 30 The naltrexone drug product that is FDA-
approved for the treatment of opioid dependence is an extended-release, 
intramuscular injection.\31\ The recommended dose is 380 mg delivered 
intramuscularly every 4 weeks or once a month after the patient has 
achieved an opioid-free duration of a minimum of 7-10 days.\32\ 
Naltrexone can be prescribed by any health care provider who is 
licensed to prescribe medications.\33\
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    \27\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
    \28\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
    \29\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \30\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
    \31\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
    \33\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
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    We propose that the OUD treatment services that may be furnished by 
OTPs include the first five items and services listed in the statutory 
definition described above, specifically the medications approved by 
the FDA under section 505 of the FFDCA for use in the treatment of OUD; 
the dispensing and administration of such medication, if applicable; 
substance use counseling; individual and group therapy; and toxicology 
testing. We also propose to use our discretion under section 
1861(jjj)(1)(F) of the Act to include other items and services that the 
Secretary determines are appropriate to include the use of 
telecommunications for certain services, as discussed later in this 
section. We propose to codify this definition of OUD treatment services 
furnished by OTPs at Sec.  410.67(b). As part of this definition, we 
also propose to specify that an OUD treatment service is an item or 
service that is furnished by an OTP that meets the applicable 
requirements to participate in the Medicare Program and receive 
payment.
    We seek comment on any other items and services (not including 
meals or transportation as they are statutorily prohibited) currently 
covered and paid for under Medicare Part B when furnished by Medicare-
enrolled providers/suppliers that the Secretary should consider adding 
to this definition, including any evidence supporting the impact of the 
use of such items and services in the treatment of OUD and enumeration 
of their costs. We are particularly interested in public feedback on 
whether intake activities, which may include services such as an 
initial physical examination, initial assessments and preparation of a 
treatment plan, as well as periodic assessments, should be included in 
the definition of OUD treatment services. Additionally, we understand 
that while the current FDA-approved medications under section 505 of 
the FFDCA for the treatment of OUD are opioid agonists and antagonist 
medications, other

[[Page 40521]]

medications that are not opioid agonist and antagonist medications, 
including drugs and biologicals, could be developed for the treatment 
of OUD in the future. We would like public feedback on whether there 
are any drug development efforts in the pipeline that could result in 
medications intended for use in the treatment of OUD with a novel 
mechanism of action that does not involve opioid agonist and antagonist 
mechanisms (that is, outside of activating and/or blocking opioid 
receptors). We also welcome comment on how medications that may be 
approved by the FDA in the future for use in the treatment of OUD with 
a novel mechanism of action, such as medications approved under section 
505 of the FFDCA to treat OUD and biological products licensed under 
section 351 of the Public Health Service Act to treat OUD, should be 
considered in the context of OUD treatment services provided by OTPs, 
and whether CMS should use the discretion afforded under section 
1861(jjj)(1)(F) of the Act to include such medications in the 
definition of OUD treatment services given the possibility that such 
medications could be approved in the future.
b. Opioid Treatment Program
    Section 2005 of the SUPPORT Act also amended section 1861 of the 
Act by adding a new subsection (jjj)(2) to define an OTP as an entity 
meeting the definition of OTP in 42 CFR 8.2 or any successor regulation 
(that is, a program or practitioner engaged in opioid treatment of 
individuals with an opioid agonist treatment medication registered 
under 21 U.S.C. 823(g)(1)), that meets the additional requirements set 
forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the 
Act. Specifically that the OTP:
     Is enrolled under section 1866(j) of the Act;
     Has in effect a certification by SAMHSA for such a 
program;
     Is accredited by an accrediting body approved by SAMHSA; 
and
     Meets such additional conditions as the Secretary may find 
necessary to ensure the health and safety of individuals being 
furnished services under such program and the effective and efficient 
furnishing of such services.
    These requirements are discussed in more detail in this section.
(1) Enrollment
    As discussed previously, under section 1861(jjj)(2)(A) of the Act, 
an OTP must be enrolled in Medicare to receive Medicare payment for 
covered OUD treatment services under section 1861(jjj)(1) of the Act. 
We refer the reader to section III.H. of this proposed rule, Medicare 
Enrollment of Opioid Treatment Programs, for further details on our 
proposed policies related to enrollment of OTPs.
(2) Certification by SAMHSA
    As provided in section 1861(jjj)(2)(B) of the Act, OTPs must be 
certified by SAMHSA to furnish Medicare-covered OUD treatment services. 
SAMHSA has created a system to certify and accredit OTPs, which is 
governed by 42 CFR part 8, subparts B and C. This regulatory framework 
allows SAMHSA to focus its oversight efforts on improving treatment 
rather than solely ensuring that OTPs are meeting regulatory criteria, 
and preserves states' authority to regulate OTPs. To be certified by 
SAMHSA, OTPs must comply with the federal opioid treatment standards as 
outlined in Sec.  8.12, be accredited by a SAMHSA-approved 
accreditation body, and comply with any other conditions for 
certification established by SAMHSA. Specifically, SAMHSA requires OTPs 
to provide the following services:
     General--OTPs shall provide adequate medical, counseling, 
vocational, educational, and other assessment and treatment services.
     Initial medical examination services--OTPs shall require 
each patient to undergo a complete, fully documented physical 
evaluation by a program physician or a primary care physician, or an 
authorized healthcare professional under the supervision of a program 
physician, before admission to the OTP.
     Special services for pregnant patients--OTPs must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services for pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
     Initial and periodic assessment services--Each patient 
accepted for treatment at an OTP shall be assessed initially and 
periodically by qualified personnel to determine the most appropriate 
combination of services and treatment.
     Counseling services--OTPs must provide adequate substance 
abuse counseling to each patient as clinically necessary by a program 
counselor, qualified by education, training, or experience to assess 
the patient's psychological and sociological background.
     Drug abuse testing services--OTPs must provide adequate 
testing or analysis for drugs of abuse, including at least eight random 
drug abuse tests per year, per patient in maintenance treatment, in 
accordance with generally accepted clinical practice. For patients in 
short-term detoxification treatment, defined in 42 CFR 8.2 as 
detoxification treatment not in excess of 30 days, the OTP shall 
perform at least one initial drug abuse test. For patients receiving 
long-term detoxification treatment, the program shall perform initial 
and monthly random tests on each patient.
    The provisions governing recordkeeping and patient confidentiality 
at Sec.  8.12(g)(1) require that OTPs shall establish and maintain a 
recordkeeping system that is adequate to document and monitor patient 
care. All records are required to be kept confidential in accordance 
with all applicable federal and state requirements. The requirements at 
Sec.  8.12(g)(2) state that OTPs shall document in each patient's 
record that the OTP made a good faith effort to review whether or not 
the patient is enrolled in any other OTP. A patient enrolled in an OTP 
shall not be permitted to obtain treatment in any other OTP except in 
exceptional circumstances, which is determined by the medical director 
or program physician of the OTP in which the patient is enrolled (42 
CFR 8.12(g)(2)). Additionally, the requirements at Sec.  8.12(h) 
address medication administration, dispensing, and use.
    SAMHSA requires that OTPs shall ensure that opioid agonist 
treatment medications are administered or dispensed only by a 
practitioner licensed under the appropriate state law and registered 
under the appropriate state and federal laws to administer or dispense 
opioid drugs, or by an agent of such a practitioner, supervised by and 
under the order of the licensed practitioner. OTPs shall use only those 
opioid agonist treatment medications that are approved by the FDA for 
use in the treatment of OUD. They must maintain current procedures that 
are adequate to ensure that the dosing requirements are met, and each 
opioid agonist treatment medication used by the program is administered 
and dispensed in accordance with its approved product labeling.
    At Sec.  8.12(i), regarding unsupervised or ``take-home'' use of 
opioid agonist treatment medications, SAMHSA has specified that OTPs 
must follow requirements specified by SAMHSA to limit the potential for 
diversion of opioid agonist treatment medications to the illicit market 
when dispensed to patients as take-homes, including maintaining current 
procedures to identify the theft or diversion of take-

[[Page 40522]]

home medications. The requirements at Sec.  8.12(j) for interim 
maintenance treatment, state that the program sponsor of a public or 
nonprofit private OTP subject to the approval of SAMHSA and the state, 
may place an individual, who is eligible for admission to comprehensive 
maintenance treatment, in interim maintenance treatment if the 
individual cannot be placed in a public or nonprofit private 
comprehensive program within a reasonable geographic area and within 14 
days of the individual's application for admission to comprehensive 
maintenance treatment. Patients in interim maintenance treatment are 
permitted to receive daily dosing, but take-homes are not permitted. 
During interim maintenance treatment, initial treatment plans and 
periodic treatment plan evaluations are not required and a primary 
counselor is not required to be assigned to the patient. The OTP must 
be able to transfer these patients from interim maintenance into 
comprehensive maintenance treatment within 120 days. Interim 
maintenance treatment must be provided in a manner consistent with all 
applicable federal and state laws.
    The SAMHSA requirements at Sec.  8.12(b) address administrative and 
organizational structure, requiring that an OTP's organizational 
structure and facilities shall be adequate to ensure quality patient 
care and meet the requirements of all pertinent federal, state, and 
local laws and regulations. At a minimum, each OTP shall formally 
designate a program sponsor and medical director who is a physician who 
is licensed to practice medicine in the jurisdiction in which the OTP 
is located. The program sponsor shall agree on behalf of the OTP to 
adhere to all requirements set forth in 42 CFR part 8, subpart C and 
any regulations regarding the use of opioid agonist treatment 
medications in the treatment of OUD, which may be promulgated in the 
future. The medical director shall assume responsibility for 
administering all medical services performed by the OTP. In addition, 
the medical director shall be responsible for ensuring that the OTP is 
in compliance with all applicable federal, state, and local laws and 
regulations.
    The provision governing patient admission criteria at Sec.  8.12(e) 
requires that an OTP shall maintain current procedures designed to 
ensure that patients are admitted to maintenance treatment by qualified 
personnel who have determined, using accepted medical criteria such as 
those listed in the Diagnostic and Statistical Manual of Mental 
Disorders, including that the person has an OUD, and that the person 
has had an OUD at least 1 year before admission for treatment. If under 
18 years of age, the patient is required to have had two documented 
unsuccessful attempts at short-term detoxification or drug-free 
treatment within a 12-month period and have the written consent of a 
parent, legal guardian or responsible adult designated by the relevant 
state authority to be eligible for maintenance treatment.
    To ensure continuous quality improvement, the requirements at Sec.  
8.12(c) state that an OTP must maintain current quality assurance and 
quality control plans that include, among other things, annual reviews 
of program policies and procedures and ongoing assessment of patient 
outcomes and a current Diversion Control Plan as part of its quality 
assurance program.
    The requirements at Sec.  8.12(d) with respect to staff 
credentials, state that each person engaged in the treatment of OUD 
must have sufficient education, training, and experience, or any 
combination thereof, to enable that person to perform the assigned 
functions.
    In addition to meeting the criteria described above, OTPs must 
apply to SAMHSA for certification. As part of the conditions for 
certification, SAMHSA specifies that OTPs shall:
     Comply with all pertinent state laws and regulations.
     Allow inspections and surveys by duly authorized employees 
of SAMHSA, by accreditation bodies, by the DEA, and by authorized 
employees of any relevant State or federal governmental authority.
     Comply with the provisions of 42 CFR part 2 (regarding 
confidentiality of substance use disorder patient records).
     Notify SAMHSA within 3 weeks of any replacement or other 
change in the status of the program sponsor or medical director.
     Comply with all regulations enforced by the DEA under 21 
CFR chapter II, and be registered by the DEA before administering or 
dispensing opioid agonist treatment medications.
     Operate in accordance with federal opioid treatment 
standards and approved accreditation elements.
    Furthermore, SAMHSA has issued additional guidance for OTPs that 
describes how programs can achieve and maintain compliance with federal 
regulations.\34\
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    \34\ https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf.
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(3) Accreditation of OTPs by a SAMHSA-Approved Accrediting Body
    As provided in section 1861(jjj)(2)(C) of the Act, OTPs must be 
accredited by a SAMHSA-approved accrediting body in order to furnish 
Medicare-covered OUD treatment services. In 2001, the Department of 
Health and Human Services (HHS) and SAMHSA issued final regulations to 
establish a new oversight system for the treatment of substance use 
disorders with MAT (42 CFR part 8). SAMHSA-approved accrediting bodies 
evaluate OTPs and perform site visits to ensure SAMHSA's opioid 
dependency treatment standards are met. SAMHSA also requires OTPs to be 
accredited by a SAMHSA-approved accrediting body (42 CFR 8.11).
    The SAMHSA regulations establish procedures for an entity to apply 
to become a SAMHSA-approved accrediting body (42 CFR 8.3). When 
determining whether to approve an applicant as an accreditation body, 
SAMHSA examines the following:
     Evidence of the nonprofit status of the applicant (that 
is, of fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a state governmental entity or 
political subdivision;
     The applicant's accreditation elements or standards and a 
detailed discussion showing how the proposed accreditation elements or 
standards will ensure that each OTP surveyed by the applicant is 
qualified to meet or is meeting each of the federal opioid treatment 
standards set forth in Sec.  8.12;
     A detailed description of the applicant's decision-making 
process, including:
    ++ Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    ++ Procedures for assessing OTP personnel qualifications;
    ++ Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs 
during the accreditation process;
    ++ Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs; 
for suspending or revoking an OTP's accreditation; and to ensure 
processing of applications for accreditation and for renewal of 
accreditation within a timeframe approved by SAMHSA; and;
    ++ A description of the applicant's appeals process to allow OTPs 
to contest adverse accreditation decisions.
     Policies and procedures established by the accreditation 
body to avoid conflicts of interest, or the appearance of conflicts of 
interest;

[[Page 40523]]

     A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
     A description of the applicant's training policies;
     Fee schedules, with supporting cost data;
     Satisfactory assurances that the applicant will comply 
with the requirements of Sec.  8.4, including a contingency plan for 
investigating complaints under Sec.  8.4(e);
     Policies and procedures established to protect 
confidential information the applicant will collect or receive in its 
role as an accreditation body; and
     Any other information SAMHSA may require.
    SAMHSA periodically evaluates the performance of accreditation 
bodies primarily by inspecting a selected sample of the OTPs accredited 
by the accrediting body and by evaluating the accreditation body's 
reports of surveys conducted, to determine whether the OTPs surveyed 
and accredited by the accreditation body are in compliance with the 
federal opioid treatment standards. There are currently six SAMHSA-
approved accreditation bodies.\35\
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    \35\ https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-accrediting-bodies/approved.
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(4) Provider Agreement
    Section 2005(d) of the SUPPORT Act amends section 1866(e) of the 
Act by adding a new paragraph (3) which includes opioid treatment 
programs (but only with respect to the furnishing of opioid use 
disorder treatment services) as a ``provider of services'' for purposes 
of section 1866 of the Act. All providers of services under section 
1866 of the Act must enter into a provider agreement with the Secretary 
and comply with other requirements specified in that section. These 
requirements are implemented at 42 CFR part 489. Therefore, we are 
proposing to amend part 489 to include OTPs (but only with respect to 
the furnishing of opioid use disorder treatment services) as a 
provider. Specifically, we are proposing to add OTPs (but only with 
respect to the furnishing of opioid use disorder treatment services) to 
the list of providers in Sec.  489.2. This addition makes clear that 
the other requirements specified in Section 1866, and implemented in 
part 489, which include the limits on charges to beneficiaries, would 
apply to OTPs (with respect to the furnishing of opioid use disorder 
treatment services). We are also proposing additional changes to make 
clear that certain parts of part 489, which implement statutory 
requirements other than section 1866 of the Act, do not apply to OTPs. 
For example, since we are not proposing any conditions of participation 
for OTPs, we are proposing to amend Sec.  489.10(a), which states that 
providers specified in Sec.  489.2 must meet conditions of 
participation, to add that OTPs must meet the requirements set forth in 
part 489 and elsewhere in that chapter. In addition, we are proposing 
to specify that the effective date of the provider agreement is the 
date on which CMS accepts a signed agreement (proposed amendment to 
Sec.  489.13(a)(2)), and is not dependent on surveys or an accrediting 
organization's determination related to conditions of participation. 
Finally, as noted earlier in the preamble, OTPs are required to be 
certified by SAMHSA and accredited by an accrediting body approved by 
SAMHSA. In Sec.  489.53, we are proposing to create a basis for 
termination of the provider agreement if the OTP no longer meets the 
requirements set forth in part 489 or elsewhere in that chapter 
(including if it no longer has a SAMHSA certification or accreditation 
by a SAMHSA-approved accrediting body). Finally, we are also proposing 
to revise 42 CFR part 498 to ensure that OTPs have access to the appeal 
process in case of an adverse determination concerning continued 
participation in the Medicare program. Specifically, we are amending 
the definition of provider in Sec.  498.2 to include OTPs. We are 
continuing to review the application of the provider agreement 
requirements to OTPs and may make further amendments to parts 489 and 
498 as necessary to ensure that the existing provider agreement 
regulations are applied to OTPs consistent with our proposals and 
Section 2005 of the SUPPORT Act.
(5) Additional Conditions
    As provided in section 1861(jjj)(2)(D) of the Act, to furnish 
Medicare-covered OUD treatment services, OTPs must meet any additional 
conditions as the Secretary may find necessary to ensure the health and 
safety of individuals being furnished services under such program and 
the effective and efficient furnishing of such services. The 
comprehensive OTP standards for certification of OTPs address the same 
topics as would be addressed by CMS supplier standards, such as client 
assessment and the services required to be provided. Furthermore, the 
detailed process established by SAMHSA for selecting and overseeing its 
accreditation organizations is similar to the accrediting organization 
oversight process that would typically be established by CMS. Thus, we 
believe the existing SAMHSA certification and accreditation 
requirements are both appropriate and sufficient to ensure the health 
and safety of individuals being furnished services by OTPs, as well as 
the effective and efficient furnishing of such services. We also 
believe that creating additional conditions at this time for 
participation in Medicare by OTPs could create unnecessary regulatory 
duplication and could be potentially burdensome for OTPs. Therefore, 
CMS is not proposing any additional conditions for participation in 
Medicare by OTPs at this time. We welcome public comments on this 
proposed approach, including input on whether there are any additional 
conditions that should be required for OTPs furnishing Medicare-covered 
OUD treatment services.
(6) Proposed Definition of Opioid Treatment Program
    We propose to define ``opioid treatment program'' at Sec.  
410.67(b) as an entity that is an opioid treatment program as defined 
in 42 CFR 8.2 (or any successor regulation) and meets the applicable 
requirements for an OTP. We propose to codify this definition at Sec.  
410.67(b). In addition, we propose that for an OTP to participate and 
receive payment under the Medicare program, the OTP must be enrolled 
under section 1866(j) of the Act, have in effect a certification by 
SAMHSA for such a program, and be accredited by an accrediting body 
approved by SAMHSA. We are also proposing that an OTP must have a 
provider agreement as required by section 1866(a) of the Act. We 
propose to codify these requirements at Sec.  410.67(c). We welcome 
public comments on the proposed definition of OTP and the proposed 
Medicare requirements for OTPs.
3. Proposed Bundled Payments for OUD Treatment Services
    Section 1834(w) of the Act, added by section 2005 of the SUPPORT 
Act, directs the Secretary to pay to the OTP an amount that is equal to 
100 percent of a bundled payment for OUD treatment services that are 
furnished by the OTP to an individual during an episode of care. We are 
proposing to establish bundled payments for OUD treatment services 
which, as discussed above, would include the medications approved by 
the FDA under section 505

[[Page 40524]]

of the FFDCA for use in the treatment of OUD; the dispensing and 
administration of such medication, if applicable; substance use 
counseling; individual and group therapy; and toxicology testing. In 
calculating the proposed bundled payments, we propose to apply separate 
payment methodologies for the drug component (which includes the 
medications approved by the FDA under section 505 of the FFDCA for use 
in the treatment of OUD) and the non-drug component (which includes the 
dispensing and administration of such medications, if applicable; 
substance use counseling; individual and group therapy; and toxicology 
testing) of the bundled payments. We propose to calculate the full 
bundled payment rate by combining the drug component and the non-drug 
components. Below, we discuss our proposals for determining the bundled 
payments for OUD treatment services. As part of this discussion, we 
address payment rates for these services under the Medicaid and TRICARE 
programs, duration of the episode of care for which the bundled payment 
is made (including partial episodes), methodology for determining 
bundled payment rates for the drug and non-drug components, site of 
service, coding and beneficiary cost sharing. We propose to codify the 
methodology for determining the bundled payment rates for OUD treatment 
services at Sec.  410.67(d).
a. Review of Medicaid and TRICARE Programs
    Section 1834(w)(2) of the Act, added by section 2005(c) of the 
SUPPORT Act, provides that in developing the bundled payment rates for 
OUD treatment services furnished by OTPs, the Secretary may consider 
payment rates paid to the OTPs for comparable services under the state 
plans under title XIX of the Act (Medicaid) or under the TRICARE 
program under chapter 55 of title 10 of the United States Code 
(U.S.C.). The payments for comparable services under TRICARE and 
Medicaid programs are discussed below. We understand that many private 
payers cover services furnished by OTPs, and welcome comment on the 
scope of private payer OTP coverage and the payment rates private 
payers have established for OTPs furnishing comparable OUD treatment 
services. We may consider this information as part of the development 
of the final bundled payment rates for OUD treatment services furnished 
by OTPs in the final rule.
(1) TRICARE
    In the ``TRICARE: Mental Health and Substance Use Disorder 
Treatment'' final rule, which appeared in the September 2, 2016 Federal 
Register (81 FR 61068) (hereinafter referred to as the 2016 TRICARE 
final rule), the Department of Defense (DOD) finalized its methodology 
for determining payments for services furnished to TRICARE 
beneficiaries by an OTP in the regulations at 32 CFR 199.14(a)(2)(ix). 
The payments are also described in Chapter 7, Section 5 and Chapter 1, 
Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1, 
2015. As discussed in the 2016 TRICARE final rule, a number of 
commenters indicated that they believed the rates established by DOD 
are near market rates and acceptable (81 FR 61079).
    In the 2016 TRICARE final rule, DOD established separate payment 
methodologies for treatment in OTPs based on the particular medication 
being administered. DOD finalized a weekly all-inclusive per diem rate 
for OTPs when furnishing methadone for MAT. Under 32 CFR 
199.14(a)(2)(ix)(A)(3)(i), this weekly rate includes the cost of the 
drug and the cost of related non-drug services (that is, the costs 
related to the intake/assessment, drug dispensing and screening and 
integrated psychosocial and medical treatment and supportive services), 
hereafter referred as the non-drug services. We note that the services 
included in the TRICARE weekly bundle are generally comparable to the 
definition of OUD treatment services in Section 2005 of the SUPPORT 
Act. The weekly all-inclusive per diem rate for these services was 
determined based on preliminary review of industry billing practices 
(which included Medicaid and other third-party payers) for the 
dispensing of methadone, including an estimated daily drug cost of $3 
and a daily estimated cost of $15 for the non-drug services. These 
daily costs were converted to an estimated weekly per diem rate of $126 
($18 per day x 7 days) in the 2016 TRICARE final rule. Under 32 CFR 
199.14(a)(2)(iv)(C)(S), this rate is updated annually by the Medicare 
hospital inpatient prospective payment system (IPPS) update factor. The 
2019 TRICARE weekly per diem rate for methadone treatment in an OTP is 
$133.15.\36\ Beneficiary cost-sharing consists of a flat copayment that 
may be applied to this weekly rate.
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    \36\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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    DOD also established payment rates for other medications used for 
MAT (buprenorphine and extended-release injectable naltrexone) to allow 
OTPs to bill for the full range of medications available. Under 32 CFR 
199.14(a)(2)(ix)(A)(3)(ii), DOD established a fee-for-service payment 
methodology for buprenorphine and extended-release injectable 
naltrexone because they are more likely to be prescribed and 
administered in an office-based treatment setting but are still 
available for treatment furnished in an OTP. DOD stated in the 2016 
TRICARE final rule (81 FR 61080) that treatment with buprenorphine and 
naltrexone is more variable in dosage and frequency than with 
methadone. Therefore, TRICARE pays for these medications and the 
accompanying non-drug services separately on a fee-for-service basis. 
Buprenorphine is paid based on 95 percent of average wholesale price 
(AWP) and the non-drug component is paid on a per visit basis at an 
estimated cost of $22.50 per visit. Extended-release injectable 
naltrexone is paid at the average sales price (ASP) plus a drug 
administration fee while the non-drug services are also paid at an 
estimated per visit cost of $22.50. DOD also reserved discretion to 
establish the payment methodology for new drugs and biologicals that 
may become available for the treatment of SUDs in OTPs.
    DOD instructed that OTPs use the ``Alcohol and/or other drug use 
services, not otherwise specified'' H-code for billing the non-drug 
services when buprenorphine or naltrexone is used, and required OTPs to 
also include both the J-code and the National Drug Code (NDC) for the 
drug used, as well as the dosage and acquisition cost on the claim 
form.\37\ Drugs listed on Medicare's Part B ASP files are paid using 
the ASP.\38\ Drugs not appearing on the Medicare ASP file are paid at 
the lesser of billed charges or 95 percent of the AWP.\39\ Using this 
methodology, TRICARE estimated a daily drug cost of $10 for 
buprenorphine and a monthly drug cost of $1,129 for extended-release 
injectable naltrexone.\40\
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    \37\ 81 FR 61080.
    \38\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \39\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \40\ 81 FR 61080.

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[[Page 40525]]

(2) Medicaid (Title XIX)
    States have the flexibility to administer the Medicaid program to 
meet their own needs within the Medicaid program parameters set forth 
in federal statute and regulations. All states cover and pay for some 
form of medications for medication-assisted treatment of OUD under 
their Medicaid programs. However, as of 2018, only 42 states covered 
methadone for MAT for OUD under their Medicaid programs.\41\ We note 
that section 1006(b) of the SUPPORT Act amends sections 1902 and 1905 
of the Social Security Act to require that Medicaid State plans cover 
all drugs approved under section 505 of the FFDCA to treat OUD, 
including methadone, and all biological products licensed under section 
351 of the Public Health Service Act to treat OUD, beginning October 1, 
2020. This requirement sunsets on September 30, 2025.
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    \41\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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    In reviewing Medicaid payments for OUD treatment services furnished 
by OTPs in a few states, we found significant variation in the MAT 
coverage, OUD treatment services, and payment structure among the 
states. Thus, it is difficult to identify a standardized Medicaid 
payment amount for OTP services. A number of factors such as the unit 
of payment, types of services bundled within a payment code, and how 
MAT services are paid varied among the states. For example, for 
treatment of OUD using methadone for MAT, most OTPs bill under HCPCS 
code H0020 (Alcohol and/or drug services; methadone administration and/
or service (provision of the drug by a licensed program)) under the 
Medicaid program; however, the unit of payment varies by state from 
daily, weekly, or monthly. For example, the unit of payment in 
California is daily for methadone treatment,\42\ while the unit of 
payment in Maryland for methadone maintenance is weekly,\43\ and 
Vermont uses a monthly unit \44\ of payment of these OUD treatment 
items and services.
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    \42\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \43\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \44\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
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    For the other MAT drugs, all states cover buprenorphine and the 
buprenorphine-naloxone medications; \45\ however, fewer than 70 percent 
cover the implanted or extended-release injectable versions of 
buprenorphine.\46\ In addition, all states cover the extended-release 
injectable naltrexone.\47\ We also found that many states pay different 
rates based on the specific type of drug used for MAT.
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    \45\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \47\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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    Non-drug items and services may be included in a bundled payment 
with the drug or paid separately, depending on the state, and can 
include dosing, dispensing and administration of the drug, individual 
and group counseling, and toxicology testing. In some states, certain 
services such as assessments, individual and group counseling, and 
toxicology testing can be billed separately. For example, some states 
(such as Maryland,\48\ Texas,\49\ and California) \50\ separately 
reimburse for individual and group counseling services, while other 
states (such as Vermont \51\ and New Mexico) \52\ included these 
services in the OUD bundled payment.
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    \48\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \49\ http://www.tmhp.com/News_Items/2018/11-Nov/11-16-18%20Substance%20Use%20Disorder%20Benefits%20to%20Change%20for%20Texas%20Medicaid%20January%201,%202019.pdf.
    \50\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \51\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
    \52\ http://www.hsd.state.nm.us/uploads/FileLinks/e7cfb008157f422597cccdc11d2034f0/MAT_Proposed_reimb_MAD_website_pdf.pdf.
    https://stre.samhsa.gov/system/files/medicaidfinancingmatreport.pdfnm.us/uploads/FileLinks/c78b68d063e04ce5adffe29376ff402e/12_10_MAT_OTC_Clinics_Supp_09062012__2_.pdf.
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b. Aspects of the Bundle
(1) Duration of Bundle
    Section 1834(w)(1) of the Act requires the Secretary to pay an OTP 
an amount that is equal to 100 percent of the bundled payment for OUD 
treatment services that are furnished by the OTP to an individual 
during an episode of care (as defined by the Secretary) beginning on or 
after January 1, 2020. We are proposing that the duration of an episode 
of care for OUD treatment services would be a week (that is, a 
contiguous 7-day period that may start on any day of the week). This is 
similar to the structure of the TRICARE bundled payment to OTPs for 
methadone, which is based on a weekly bundled rate (81 FR 61079), as 
well as the payments by some state Medicaid programs. Given this 
similarity to existing coding structures, we believe a weekly duration 
for an episode of care would be most familiar to OTPs and therefore the 
least disruptive to adopt. We welcome comments on whether we should 
consider a daily or monthly bundled payment. We are proposing to define 
an episode of care at Sec.  410.67(b) as a 1 week (contiguous 7-day) 
period.
    We recognize that patients receiving MAT are often on this 
treatment regimen for an indefinite amount of time and therefore, we 
are not proposing any maximum number of weeks during an overall course 
of treatment for OUD.
(a) Requirements for an Episode
    We note that SAMHSA requires OTPs to have a treatment plan for each 
patient that identifies the frequency with which items and services are 
to be provided (Sec.  8.12(f)(4)). We recognize that there is a range 
of service intensity depending on the severity of a patient's OUD and 
stage of treatment and therefore, a ``full weekly bundle'' may consist 
of a very different frequency of services for a patient in the initial 
phase of treatment compared to a patient in the maintenance phase of 
treatment, but that we would still consider the requirements to bill 
for the full weekly bundle to be met if the patient is receiving the 
majority of the services identified in their treatment plan at that 
time. However, for the purposes of valuation, we assumed one substance 
use counseling session, one individual therapy session, and one group 
therapy session per week and one toxicology test per month. Given the 
anticipated changes in service intensity over time based on the 
individual patient's needs, we expect that treatment plans would be 
updated to reflect these changes or noted in the patient's medical 
record, for example, in a progress note. In cases where the OTP has 
furnished the majority (51 percent or more) of the services identified 
in the patient's current treatment plan (including any changes noted in 
the patient's medical record) over the course of a week, we propose 
that it could bill for a full weekly bundle. We are proposing to codify 
the payment methodology for full episodes of care (as well as partial 
episodes of care and non-drug episodes of care, as discussed below) in 
Sec.  410.67(d)(2).
(b) Partial Episode of Care
    We understand that there may be instances in which a beneficiary 
does not receive all of the services expected in a given week due to 
any number of issues, including, for example, an inpatient 
hospitalization during which a

[[Page 40526]]

beneficiary would not be able to go to the OTP or inclement weather 
that impedes access to transportation. To provide more accurate payment 
to OTPs in cases where a beneficiary is not able to or chooses not to 
receive all items and services described in their treatment plan or the 
OTP is unable to furnish services, for example, in the case of a 
natural disaster, we are proposing to establish separate payment rates 
for partial episodes that correspond with each of the full weekly 
bundles. In cases where the OTP has furnished at least one of the items 
or services (for example, dispensing one day of an oral MAT medication 
or one counseling session or one toxicology test) but less than 51 
percent of the items and services included in OUD treatment services 
identified in the patient's current treatment plan (including any 
changes noted in the patient's medical record) over the course of a 
week, we propose that it could bill for a partial weekly bundle. In 
cases in which the beneficiary does not receive a drug during the 
partial episode, we propose that the code describing a non-drug partial 
weekly bundle must be used. For example, the OTP could bill for a 
partial episode in instances where the OTP is transitioning the 
beneficiary from one OUD medication to another and therefore the 
beneficiary is receiving less than a week of one type of medication. In 
those cases, two partial episodes could be billed, one for each of the 
medications, or one partial episode and one full episode, if all 
requirements for billing are met. We intend to monitor this issue and 
will consider whether we would need to make changes to this policy in 
future rulemaking to ensure that the billing for partial episodes is 
not being abused. We are proposing to define a partial episode of care 
in Sec.  410.67(b) and to codify the payment methodology for partial 
episodes in Sec.  410.67(d). We seek comments on our proposed approach 
to full and partial episodes, including the threshold that should be 
applied to determine when an OTP may bill for the full weekly bundle 
versus a partial episode. We also seek comment on the minimum threshold 
that should be applied to determine when a partial episode could be 
billed (for example, at least one item or service, or an alternative 
threshold such as 10 or 25 percent of the items and services included 
in OUD treatment services identified in the patient's current treatment 
plan (including any changes noted in the patient's medical record) over 
the course of a week). We also welcome feedback regarding whether any 
other payers of OTP services allow for billing partial bundles and what 
thresholds they use.
(c) Non-Drug Episode of Care
    In addition to the bundled payments for full and partial episodes 
of care that are based on the medication administered for treatment 
(and include both a drug and non-drug component described in detail 
below), we are proposing to establish a non-drug episode of care to 
provide a mechanism for OTPs to bill for non-drug services, including 
substance use counseling, individual and group therapy, and toxicology 
testing that are rendered during weeks when a medication is not 
administered, for example, in cases where a patient is being treated 
with injectable buprenorphine or naltrexone on a monthly basis or has a 
buprenorphine implant. We are proposing to codify this non-drug episode 
of care at Sec.  410.67(d).
(2) Drug and Non-Drug Components
    As discussed above, in establishing the bundled payment rates, we 
propose to develop separate payment methodologies for the drug 
component and the non-drug (which includes the dispensing and 
administration of such medication, if applicable; substance use 
counseling; individual and group therapy; and toxicology testing) 
components of the bundled payment. Each of these components is 
discussed in this section.
(a) Drug Component
    As discussed previously, the cost of medications used by OTPs to 
treat OUD varies widely. Creating a single bundled payment rate that 
does not reflect the type of drug used could result in access issues 
for beneficiaries who might be best served by treatment using a more 
expensive medication. As a result, we believe that the significant 
variation in the cost of these drugs needs to be reflected adequately 
in the bundled payment rates for OTP services to avoid impairing access 
to appropriate care.
    Section 1834(w)(2) of the Act states that the Secretary may 
implement the bundled payment to OTPs though one or more bundles based 
on a number of factors, including the type of medication provided (such 
as buprenorphine, methadone, extended-release injectable naltrexone, or 
a new innovative drug). Accordingly, consistent with the discretion 
afforded under section 1834(w)(2) of the Act, and after consideration 
of payment rates paid to OTPs for comparable services by other payers 
as discussed above, we propose to base the OTP bundled payment rates, 
in part, on the type of medication used for treatment. Specifically, we 
propose the following categories of bundled payments to reflect those 
drugs currently approved by the FDA under section 505 of the FFDCA for 
use in treatment of OUD:
     Methadone (oral).
     Buprenorphine (oral).
     Buprenorphine (injection).
     Buprenorphine (implant).
     Naltrexone (injection).
    In addition, we propose to create a category of bundled payment 
describing a drug not otherwise specified to be used for new drugs (as 
discussed further below). We are also proposing a non-drug bundled 
payment to be used when medication is not administered (as discussed 
further below). We believe creating these categories of bundled 
payments based on the drug used for treatment would strike a reasonable 
balance between recognizing the variable costs of these medications and 
the statutory requirement to make a bundled payment for OTP services. 
We propose to codify this policy of establishing the categories of 
bundled payments based on the type of opioid agonist and antagonist 
treatment medication in Sec.  410.67(d)(1).
i. New Drugs
    We anticipate that there may be new FDA-approved opioid agonist and 
antagonist treatment medications to treat OUD in the future. In the 
scenario where an OTP furnishes MAT using a new FDA-approved opioid 
agonist or antagonist medication for OUD treatment that is not 
specified in one of our existing codes, we propose that OTPs would bill 
for the episode of care using the medication not otherwise specified 
(NOS) code, HCPCS code GXXX9 (or GXXX19 for a partial episode). In such 
cases, we propose to use the typical or average maintenance dose to 
determine the drug cost for the new bundle. Then, we propose that 
pricing would be determined based on the relevant pricing methodology 
as described later in this section (section II.G.) of the proposed rule 
or invoice pricing in the event the information necessary to apply the 
relevant pricing methodology is not available. For example, in the case 
of injectable and implantable drugs, which are generally covered and 
paid for under Medicare Part B, we propose to use the methodology in 
section 1847A of the Act (which bases most payments on ASP). For oral 
medications, which are generally covered and paid for under Medicare 
Part D, we propose to use ASP-based payment when we receive 
manufacturer-submitted ASP data for

[[Page 40527]]

these drugs. In the event that we do not receive manufacturer-submitted 
ASP pricing data, we are considering several potential pricing 
mechanisms (as discussed further below) to estimate the payment amounts 
for oral drugs typically paid for under Medicare Part D but that would 
become OTP drugs paid under Part B when used as part of MAT furnished 
in an OTP. We are not proposing a specific pricing mechanism at this 
time for the situation in which we do not receive manufacturer-
submitted ASP pricing data, but are requesting public comment on 
several potential approaches for estimating the acquisition cost and 
payment amounts for these drugs. We will consider the comments received 
in developing our final policy for determining these drug prices. If 
the information necessary to apply the alternative pricing methodology 
chosen for the oral drugs is also not available to price the new 
medication, we propose to use invoice pricing until either ASP pricing 
data or the information necessary to apply the chosen pricing 
methodology becomes available to price the medication. We are proposing 
to codify this approach for determining the amount of the bundled 
payment for new medications in Sec.  410.67(d)(2).The medication NOS 
code would be used until CMS has the opportunity to consider through 
rulemaking establishing a unique bundled payment for episodes of care 
during which the new drug is furnished. We welcome comments on this 
proposed approach to the treatment of new drugs used for MAT in OTPs.
    As discussed above, we also welcome comments on how new medications 
that may be approved by the FDA in the future for use in the treatment 
of OUD with a novel mechanism of action (for example, not an opioid 
agonist and/or antagonist), such as medications approved under section 
505 of the FFDCA to treat OUD and biological products licensed under 
section 351 of the Public Health Service Act to treat OUD, should be 
considered in the context of OUD treatment services provided by OTPs. 
We additionally welcome comments on how such new drugs with a novel 
mechanism of action should be priced, and specifically whether pricing 
for these new non-opioid agonist and/or antagonist medications should 
be determined using the same pricing methodology proposed for new 
opioid agonist and antagonist treatment medications, described above or 
whether an alternative pricing methodology should be used.
(b) Non-Drug Component
i. Counseling, Therapy, Toxicology Testing, and Drug Administration
    As discussed above, the bundled payment is for OUD treatment 
services furnished during the episode of care, which we are proposing 
to define as the FDA-approved opioid agonist and antagonist treatment 
medications, the dispensing and administration of such medications (if 
applicable), substance use disorder counseling by a professional to the 
extent authorized under state law to furnish such services, individual 
and group therapy with a physician or psychologist (or other mental 
health professional to the extent authorized under state law), and 
toxicology testing. The non-drug component of the OUD treatment 
services includes all items and services furnished during an episode of 
care except for the medication.
    Under the SAMSHA certification standards at Sec.  8.12(f)(5), OTPs 
must provide adequate substance abuse counseling to each patient as 
clinically necessary. We note that section 1861(jjj)(1)(C) of the Act, 
as added by section 2005(b) of the SUPPORT Act defines OUD treatment 
services as including ``substance use counseling by a professional to 
the extent authorized under state law to furnish such services.'' 
Therefore, professionals furnishing therapy or counseling services for 
OUD treatment must be operating within state law and scope of practice. 
These professionals could include licensed professional counselors, 
licensed clinical alcohol and drug counselors, and certified peer 
specialists that are permitted to furnish this type of therapy or 
counseling by state law and scope of practice. To the extent that the 
individuals furnishing therapy or counseling services are not 
authorized under state law to furnish such services, the therapy or 
counseling services would not be covered as OUD treatment services.
    Additionally, under SAMSHA certification standards at Sec.  
8.12(f)(6), OTPs are required to provide adequate testing or analysis 
for drugs of abuse, including at least eight random drug abuse tests 
per year, per patient in maintenance treatment, in accordance with 
generally accepted clinical practice. These drug abuse tests (which are 
identified as toxicology tests in the definition of OUD treatment 
services in section 1861(jjj)(1)(E) of the Act) are used for 
diagnosing, monitoring and evaluating progress in treatment. The 
testing typically includes tests for opioids and other controlled 
substances. Urinalysis is primarily used for this testing; however, 
there are other types of testing such as hair or fluid analysis that 
could be used. We note that any of these types of toxicology tests 
would be considered to be OUD treatment services and would be included 
in the bundled payment for services furnished by an OTP.
    The non-drug component of the bundle also includes the cost of drug 
dispensing and/or administration, as applicable. Additional details 
regarding our proposed approach for pricing this aspect of the non-drug 
component of the bundle are included in our discussion of payment rates 
later in this section.
ii. Other Services
    As discussed earlier, we are proposing to define OUD treatment 
services as those items and services that are specifically enumerated 
in section 1861(jjj)(1) of the Act, including services that are 
furnished via telecommunications technology, and are seeking comment on 
any other items and services we might consider including as OUD 
treatment services under the discretion given to the Secretary in 
subparagraph (F) of that section to determine other appropriate items 
and services. If we were to finalize a definition of OUD treatment 
services that includes any other items or services, such as intake 
activities or periodic assessments as discussed above, we would 
consider whether any changes to the payment rates for the bundled 
payments are necessary. See below for additional discussion related to 
how we could price these services.
(3) Adjustment to Bundled Payment Rate for Additional Counseling or 
Therapy Services
    In addition to the items and services already included in the 
proposed bundles, we recognize that counseling and therapy are 
important components of MAT and that patients may need to receive 
counseling and/or therapy more frequently at certain points in their 
treatment. We seek to ensure that patients have access to these needed 
services. Accordingly, we are proposing to adjust the bundled payment 
rates through the use of an add-on code in order to account for 
instances in which effective treatment requires additional counseling 
or group or individual therapy to be furnished for a particular patient 
that substantially exceeds the amount specified in the patient's 
individualized treatment plan. As noted previously, we understand that 
there is variability in the frequency of services a patient might 
receive in a given week depending on the patient's severity and stage 
of treatment; however, we assume

[[Page 40528]]

that a typical case might include one substance use counseling session, 
one individual therapy session, and one group therapy session per week. 
We further understand that the frequency of services will vary among 
patients and will change over time based on the individual patient's 
needs. We expect that the patient's treatment plan or the medical 
record will be updated to reflect when there are changes in the 
expected frequency of medically necessary services based on the 
patient's condition and following such an update, the add-on code 
should no longer be billed if the frequency of the patient's counseling 
and/or therapy services is consistent with the treatment plan or 
medical record. In the case of unexpected or unforeseen circumstances 
that are time-limited, resolve quickly, and do not lead to updates to 
the treatment plan, we expect that the medical necessity for billing 
the add-on code would be documented in the medical record. This add-on 
code (HCPCS code GXX19) would describe each additional 30 minutes of 
counseling or group or individual therapy furnished in a week of MAT, 
which could be billed in conjunction with the codes describing the full 
episode of care or the partial episodes. For example, there may be some 
weeks when a patient has a relapse or unexpected psychosocial stressors 
arise that warrant additional reasonable and necessary counseling 
services that were not foreseen at the time that the treatment plan was 
developed. Additionally, we note that there may be situations in which 
the add-on code could be billed in conjunction with the code for a 
partial episode; for example, if a patient requires prolonged 
counseling services on the initial day of treatment, but does not 
return for any of the other services specified in their treatment plan, 
such as daily medication dispensing, for the remainder of that week. We 
acknowledge that an unintended consequence of using the treatment plan 
is a potential incentive for OTPs to document minimal counseling and/or 
therapy needs for a beneficiary, thereby resulting in increased 
opportunity for billing the add-on code. We expect that OTPs will 
ensure that treatment plans reflect the full scope of services expected 
to be furnished during an episode of care and that they will update 
treatment plans regularly to reflect changes. We intend to monitor this 
issue and will consider whether we need to make changes to this policy 
through future rulemaking to ensure that this adjustment is not being 
abused. We welcome comments on the proposed add-on code and the 
threshold for billing. We propose to codify this adjustment to the 
bundled payment rate for additional counseling or therapy services in 
Sec.  410.67(d)(3)(i).
(4) Site of Service (Telecommunications)
    In recent years, we have sought to decrease barriers to access to 
care by furthering policies that expand the use of communication 
technologies. In the CY 2019 PFS final rule (83 FR 59482), we finalized 
new separate payments for communication technology-based services, 
including a virtual check-in and a remote evaluation of pre-recorded 
patient information. SAMHSA's federal guidelines (https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf) for OTPs refer to 
the CMS guidance on telemedicine and also state that OTPs are advised 
to proceed with full understanding of requirements established by state 
or health professional licensing boards. SAMHSA's federal guidelines 
for OTPs state that exceptional attention needs to be paid to data 
security and privacy in this evolving field. Telemedicine services 
should, under no circumstances, expand the scope of practice of a 
healthcare professional or permit practice in a jurisdiction (the 
location of the patient) where the provider is not licensed.
    We are proposing to allow OTPs to furnish the substance use 
counseling, individual therapy, and group therapy included in the 
bundle via two-way interactive audio-video communication technology, as 
clinically appropriate, in order to increase access to care for 
beneficiaries. We believe this is an appropriate approach because, as 
discussed previously, we expect the telehealth services that will be 
furnished by OTPs will be similar to the Medicare telehealth services 
furnished under section 1834(m) of the Act, and the use of two-way 
interactive audio-video communication technology is required for these 
Medicare telehealth services under Sec.  410.78(a)(3). By allowing use 
of communication technology in furnishing these services, OTPs in rural 
communities or other health professional shortage areas could 
facilitate treatment through virtual care coming from an urban or other 
external site; however, we note that the physicians and other 
practitioners furnishing these services would be required to comply 
with all applicable requirements related to professional licensing and 
scope of practice.
    We note that section 1834(m) of the Act applies only to Medicare 
telehealth services furnished by a physician or other practitioner. 
Because OUD treatment services furnished by an OTP are not considered 
to be services furnished by a physician or other practitioner, the 
restrictions of section 1834(m) of the Act would not apply. 
Additionally, we note that counseling or therapy furnished via 
communication technology as part of OUD treatment services furnished by 
an OTP must not be separately billed by the practitioner furnishing the 
counseling or therapy because these services would already be paid 
through the bundled payment made to the OTP.
    We are proposing to include language in Sec.  410.67(b) in the 
definition of opioid use disorder treatment services to allow OTPs to 
use two-way interactive audio-video communication technology, as 
clinically appropriate, in furnishing substance use counseling and 
individual and group therapy services, respectively. We invite comment 
as to whether this proposal, including whether furnishing these 
services through communication technology is clinically appropriate. We 
also invite public comment on other components of the bundle that may 
be clinically appropriate to be furnished via communication technology, 
while also considering SAMHSA's guidance that OTPs should pay 
exceptional attention to data security and privacy.
(5) Coding
    We are proposing to adopt a coding structure for OUD treatment 
services that varies by the medication administered. To operationalize 
this approach, we are proposing to establish G codes for weekly bundles 
describing treatment with methadone, buprenorphine oral, buprenorphine 
injectable, buprenorphine implants (insertion, removal, and insertion/
removal), extended-release injectable naltrexone, a non-drug bundle, 
and one for a medication not otherwise specified. We also propose to 
establish partial episode G codes to correspond with each of those 
bundles, respectively. Additionally, we propose to create an add-on 
code to describe additional counseling that is furnished beyond the 
amount specified in the patient's treatment plan. As discussed above, 
we are seeking comment on whether to include intake activities and 
periodic assessments in the definition of OUD treatment services. Were 
we to finalize including these activities in the definition of OUD 
treatment services, we welcome feedback on whether we should consider 
modifying the payment associated with the bundle or creating add-on 
codes for services such as the

[[Page 40529]]

initial physical examination, initial assessments and preparation of a 
treatment plan, periodic assessments or additional toxicology testing, 
and if so, what inputs we might consider in pricing such services, such 
as payment amounts for similar services under the PFS or Clinical Lab 
Fee Schedule (CLFS). For example, to price the initial assessment, 
medical examination, and development of a treatment plan, we could 
crosswalk to the Medicare payment rate for a level 3 Evaluation and 
Management (E/M) visit for a new patient and to price the periodic 
assessments, we could crosswalk to the Medicare payment rate for a 
level 3 E/M visit for an established patient. To price additional 
toxicology testing, we could crosswalk to the Medicare payment for 
presumptive drug testing, such as that described by CPT code 80305. 
Additionally, we welcome feedback on whether we should consider 
creating codes to describe bundled payments that include only the cost 
of the drug and drug administration as applicable in order to account 
for beneficiaries who are receiving interim maintenance treatment (as 
described previously in this section) or other situations in which the 
beneficiary is not receiving all of the services described in the full 
bundles.
    Regarding the non-drug bundle, we note that this code would be 
billed for services furnished during an episode of care or partial 
episode of care when a medication is not administered. For example, 
when a patient receives a buprenorphine injection on a monthly basis, 
the OTP will only require payment for the medication during the first 
week of the month when the injection is given, and therefore, would 
bill the code describing the bundle that includes injectable 
buprenorphine during the first week of the month and would bill the 
code describing the non-drug bundle for the remaining weeks in that 
month for services such as substance use counseling, individual and 
group therapy, and toxicology testing.
    As discussed previously, we propose that the codes describing the 
bundled payment for an episode of care with a medication not otherwise 
specified, HCPCS codes GXXX9 and GXX18, should be used when the OTP 
furnishes MAT with a new opioid agonist or antagonist treatment 
medication approved by the FDA under section 505 of the FFDCA for the 
treatment of OUD. OTPs would use these codes until we have the 
opportunity to propose and finalize a new G code to describe the 
bundled payment for treatment using that drug and price it accordingly 
in the next rulemaking cycle. We note that the code describing the 
weekly bundle for a medication not otherwise specified should not be 
used when the drug being administered is not a new opioid agonist or 
antagonist treatment medication approved by the FDA under section 505 
of the FFDCA for the treatment of OUD, and therefore, for which 
Medicare would not have the authority to make payment since section 
1861(jjj)(1)(A) of the Act requires that the medication must be an 
opioid agonist or antagonist treatment medication approved by the FDA 
under section 505 of the FFDCA for the treatment of OUD. Given the 
program integrity concerns regarding the potential for misuse of such a 
code, we also welcome comments as to whether this code is needed.
    The codes and long descriptors for the proposed OTP bundled 
services are:
     HCPCS code GXXX1: Medication assisted treatment, 
methadone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing, if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program).
     HCPCS code GXXX2: Medication assisted treatment, 
buprenorphine (oral); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXXX3: Medication assisted treatment, 
buprenorphine (injectable); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXXX4: Medication assisted treatment, 
buprenorphine (implant insertion); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXXX5: Medication assisted treatment, 
buprenorphine (implant removal); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXXX6: Medication assisted treatment, 
buprenorphine (implant insertion and removal); weekly bundle including 
dispensing and/or administration, substance use counseling, individual 
and group therapy, and toxicology testing if performed (provision of 
the services by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXXX7: Medication assisted treatment, 
naltrexone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program).
     HCPCS code GXXX8: Medication assisted treatment, weekly 
bundle not including the drug, including substance use counseling, 
individual and group therapy, and toxicology testing if performed 
(provision of the services by a Medicare-enrolled Opioid Treatment 
Program).
     HCPCS code GXXX9: Medication assisted treatment, 
medication not otherwise specified; weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing, if performed (provision of the 
services by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code GXX10: Medication assisted treatment, 
methadone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program); partial episode. Do not report with GXXX1.
     HCPCS code GXX11: Medication assisted treatment, 
buprenorphine (oral); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); partial episode. Do not 
report with GXXX2.
     HCPCS code GXX12: Medication assisted treatment, 
buprenorphine (injectable); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); partial episode. Do not 
report with GXXX3.

[[Page 40530]]

     HCPCS code GXX13: Medication assisted treatment, 
buprenorphine (implant insertion); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program); partial episode (only 
to be billed once every 6 months). Do not report with GXXX4.
     HCPCS code GXX14: Medication assisted treatment, 
buprenorphine (implant removal); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program); partial episode. Do 
not report with GXXX5.
     HCPCS code GXX15: Medication assisted treatment, 
buprenorphine (implant insertion and removal); weekly bundle including 
dispensing and/or administration, substance use counseling, individual 
and group therapy, and toxicology testing if performed (provision of 
the services by a Medicare-enrolled Opioid Treatment Program); partial 
episode. Do not report with GXXX6.
     HCPCS code GXX16: Medication assisted treatment, 
naltrexone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program); partial episode. Do not report with GXXX7.
     HCPCS code GXX17: Medication assisted treatment, weekly 
bundle not including the drug, including substance use counseling, 
individual and group therapy, and toxicology testing if performed 
(provision of the services by a Medicare-enrolled Opioid Treatment 
Program); partial episode. Do not report with GXXX8.
     HCPCS code GXX18: Medication assisted treatment, 
medication not otherwise specified; weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing, if performed (provision of the 
services by a Medicare-enrolled Opioid Treatment Program); partial 
episode. Do not report with GXXX9.
     HCPCS code GXX19: Each additional 30 minutes of counseling 
or group or individual therapy in a week of medication assisted 
treatment, (provision of the services by a Medicare-enrolled Opioid 
Treatment Program); List separately in addition to code for primary 
procedure.
    See Table 15 for proposed valuations for HCPCS codes GXXX1-GXX19. 
We propose that only an entity enrolled with Medicare as an OTP could 
bill these codes. Additionally, we propose that OTPs would be limited 
to billing only these codes describing bundled payments, and may not 
bill for other codes, such as those paid under the PFS.
(6) Payment Rates
    The codes describing the proposed OTP bundled services (HCPCS codes 
GXXX1-GXX19) would be assigned flat dollar payment amounts, which are 
listed in Table 15. As discussed previously, section 2005 of the 
SUPPORT Act amended the definition of ``medical and other health 
services'' in section 1861(s) of the Act to provide for coverage of OUD 
treatment services furnished by an OTP and also added a new section 
1834(w) to the Act and amended section 1833(a)(1) of the Act to 
establish a bundled payment to OTPs for OUD treatment services 
furnished during an episode of care beginning on or after January 1, 
2020. Therefore, OUD treatment services and the payments for such 
services are wholly separate from physicians' services, as defined 
under section 1848(j)(3) of the Act, and for which payment is made 
under the section 1848 of the Act. Because OUD treatment services are 
not considered physicians' services and are paid outside the PFS, they 
would not be priced using relative value units (RVUs).
    Consistent with section 1834(w) of the Act, which requires the 
Secretary to make a bundled payment for OUD treatment services 
furnished by OTPs, we are proposing to build the payment rates for OUD 
treatment services by combining the cost of the drug and the non-drug 
components (as applicable) into a single bundled payment as described 
in more detail below.
(a) Drug Component
    As part of determining a payment rate for these proposed bundles 
for OUD treatment services, a dosage of the applicable medication must 
be selected in order to calculate the costs of the drug component of 
the bundle. We propose to use the typical or average maintenance dose, 
as discussed earlier in this section, to determine the drug costs for 
each of the proposed bundles. As dosing for some, but not all, of these 
drugs varies considerably, this approach attempts to strike an 
appropriate balance between high- and low-dose drug regimens in the 
context of a bundled payment. Specifically, we propose to calculate 
payment rates using a 100 mg daily dose for methadone, a 10 mg daily 
dose for oral buprenorphine, a 100 mg monthly dose for the extended-
release buprenorphine injection, four rods each containing 74.2 mg of 
buprenorphine for the 6-month buprenorphine implant, and a 380 mg 
monthly dose for extended-release injectable naltrexone. We invite 
public comments on our proposal to use the typical maintenance dose in 
order to calculate the drug component of the bundled payment rate for 
each of the proposed codes. We also seek comment on the specific 
typical maintenance dosage level that we have identified for each drug, 
and a process for identifying the typical maintenance dose for new 
opioid agonist or antagonist treatment medication approved by the FDA 
under section 505 of the FFDCA when such medications are billed using 
the medication NOS code, such as using the FDA-approved prescribing 
information or a review of the published, preferably peer-reviewed, 
literature. We note that the bundled payment rates are intended to be 
comprehensive with respect to the drugs provided; therefore, we do not 
intend to include any other amounts related to drugs, other than for 
administration, as discussed below. This means, for example, that we 
would not pay for drug wastage, which we do not anticipate to be 
significant in the OTP setting.
i. Potential Drug Pricing Data Sources
    Payment structures that are closely tailored to the provider's 
actual acquisition cost reduce the likelihood that a drug will be 
chosen primarily for a reason that is unrelated to the clinical care of 
the patient, such as the drug's profit margin for a provider. We are 
proposing to estimate an OTP's costs for the drug component of the 
bundles based on available data regarding drug costs rather than a 
provider-specific cost-to-charge ratio or another more direct 
assessment of facility or industry-specific drug costs. OTPs do not 
currently report costs associated with their services to the Medicare 
program, and we do not believe that a cost-to-charge ratio based on 
such reported information could be available for a significant period 
of time. Furthermore, we are unaware of any industry-specific data that 
may be used to more accurately assess the prices at which OTPs acquire 
the medications used for OUD treatment. Therefore, at this time, we are 
proposing to estimate an OTP's costs for the drugs used in MAT based on 
other available data sources, rather than applying a cost-to-charge 
ratio or

[[Page 40531]]

another more direct assessment of drug acquisition cost, though we 
intend to continue to explore alternate ways to gather this 
information. As described in greater detail below, we propose that the 
payment amounts for the drug component of the bundles be based on CMS 
pricing mechanisms currently in place. We request comment on other 
potential data sources for pricing OUD treatment medications either 
generally or specifically with respect to acquisition by OTPs. In the 
case of oral drugs that we are proposing to include in the OTP bundled 
payments and for which we do not receive manufacturer-submitted ASP 
data, we are considering several potential approaches for determining 
the payment amounts for the drug component of the bundles. Although we 
are not proposing a specific pricing mechanism at this time, we are 
soliciting comments on several different approaches, and we intend to 
develop a final policy for determining the payment amount for the drug 
component of the relevant bundles after considering the comments 
received.
    In considering the payment amount for the drug component of each of 
the bundled payments that include a drug, we will begin by breaking the 
drugs into two categories based on their current coverage and payment 
by Medicare. First, we discuss the injectable and implantable drugs, 
which are generally covered and paid for under Medicare Part B, and 
then discuss the oral medications, which are generally covered and paid 
for under Medicare Part D.\53\ Buprenorphine (injection), buprenorphine 
(implant), and naltrexone (injection) would fall into the former 
category and methadone and buprenorphine (oral) would fall into the 
latter category.
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    \53\ Because, by law, methadone used in MAT cannot be dispensed 
by a pharmacy, it is not currently considered a Part D drug when 
used for MAT. Methadone used for this purpose can be dispensed only 
through an OTP certified by SAMHSA. However, methadone dispensed for 
pain may be considered a Part D drug and can be dispensed by a 
pharmacy.
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ii. Part B Drugs
    Part B includes a limited drug benefit that encompasses drugs and 
biologicals described in section 1861(t) of the Act. Currently, covered 
Part B drugs fall into three general categories: Drugs furnished 
incident to a physician's services, drugs administered via a covered 
item of durable medical equipment, and other drugs specified by statute 
(generally in section 1861(s)(2) of the Act). Types of providers and 
suppliers that are paid for all or some of the Medicare-covered Part B 
drugs that they furnish include physicians, pharmacies, durable medical 
equipment suppliers, hospital outpatient departments, and end-stage 
renal disease (ESRD) facilities.
    The majority of Part B drug expenditures are for drugs furnished 
incident to a physician's service. Drugs furnished incident to a 
physician's service are typically injectable drugs that are 
administered in a non-facility setting (covered under section 
1861(s)(2)(A) of the Act) or in a hospital outpatient setting (covered 
under section 1861(s)(2)(B) of the Act). The statute (sections 
1861(s)(2)(A) and 1861(s)(2)(B) of the Act) limits ``incident to'' 
services to drugs that are not usually self-administered; self-
administered drugs, such as orally administered tablets and capsules 
are not paid for under the ``incident to'' provision. Payment for drugs 
furnished incident to a physician's service falls under section 1842(o) 
of the Act. In accordance with section 1842(o)(1)(C) of the Act, 
``incident to'' drugs furnished in a non-facility setting are paid 
under the methodology in section 1847A of the Act. ``Incident to'' 
drugs furnished in a facility setting also are paid using the 
methodology in section 1847A of the Act when it has been incorporated 
under the relevant payment system (for example, the Hospital Outpatient 
Prospective Payment System (OPPS) \54\).
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    \54\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
---------------------------------------------------------------------------

    In most cases, determining payment using the methodology in section 
1847A of the Act means payment is based on the ASP plus a statutorily 
mandated 6 percent add-on. The payment for these drugs does not include 
costs for administering the drug to the patient (for example, by 
injection or infusion); payments for these physician and hospital 
services are made separately, and the payment amounts are determined 
under the PFS \55\ and the OPPS, respectively. The ASP payment amount 
determined under section 1847A of the Act reflects a volume-weighted 
ASP for all NDCs that are assigned to a HCPCS code. The ASP is 
calculated quarterly using manufacturer-submitted data on sales to all 
purchasers (with limited exceptions as articulated in section 
1847A(c)(2) of the Act such as sales at nominal charge and sales exempt 
from best price) with manufacturers' rebates, discounts, and price 
concessions reflected in the manufacturer's determination of ASP.
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    \55\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
---------------------------------------------------------------------------

    Although the Part B drug benefit is generally considered to be 
limited in scope, it includes many categories of drugs and encompasses 
a variety of care settings and payment methodologies. In addition to 
the ``incident to'' drugs described above, Part B also covers and pays 
for certain oral drugs with specific benefit categories defined under 
section 1861(s) of the Act including certain oral anti-cancer drugs and 
certain oral antiemetic drugs. In accordance with section 1842(o)(1) of 
the Act or through incorporation under the relevant payment system as 
discussed above, most of these oral Part B drugs are also paid based on 
the ASP methodology described in section 1847A of the Act.
    However, at times Part B drugs are paid based on wholesale 
acquisition cost (WAC) as authorized under section 1847A(c)(4) of the 
Act \56\ or average manufacturer price (AMP)-based price substitutions 
as authorized under section 1847A(d) of the Act.\57\ Also, in 
accordance with section 1842(o) of the Act, other payment methodologies 
may be applied to determine the payment amount for certain Part B 
drugs, for example, AWP-based payments (using current AWP) are made for 
influenza, pneumococcal pneumonia, and hepatitis B vaccines.\58\ We 
also use current AWP to make payment under the OPPS for very new drugs 
without an ASP.\59\ Contractors may also make independent payment 
amount determinations in situations where a national price is not 
available for physician and other supplier claims and for drugs that 
are specifically excluded from payment based on section 1847A of the 
Act (for example, radiopharmaceuticals as noted in section 303(h) of 
the Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003). In such cases, 
pricing may be determined based on compendia or invoices.\60\
---------------------------------------------------------------------------

    \56\ See 75 FR 73465-73466, the section titled Partial Quarter 
ASP data.
    \57\ See 77 FR 69140.
    \58\ Section 1842(o)(1)(A)(iv) of the Act.
    \59\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing 
Manual 100-04, Chapter 17, Section 20.1.3.
    \60\ Medicare Claims Processing Manual 100-04, Chapter 17, 
Section 20.1.3.
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    While most Part B drugs are paid based on the ASP methodology, 
MedPAC has noted that the ASP methodology may encourage the use of more 
expensive drugs because the 6 percent add-on generates more revenue

[[Page 40532]]

for more expensive drugs.\61\ The ASP payment amount also does not vary 
based on the price an individual provider or supplier pays to acquire 
the drug. The statute does not identify a reason for the additional 6 
percent add-on above ASP; however, as noted in the MedPAC report (and 
by sources cited in the report), the add-on is needed to account for 
handling and overhead costs and/or for additional mark-up in the 
distribution channels that are not captured in the manufacturer-
reported ASP.\62\
---------------------------------------------------------------------------

    \61\ See MedPAC Report to the Congress: Medicare and the Health 
Care Delivery System June 2015, pages 65-72.
    \62\ Ibid.
---------------------------------------------------------------------------

    We propose to use the methodology in section 1847A of the Act 
(which bases most payments on ASP) to set the payment rates for the 
``incident to'' drugs. However, we propose to limit the payment amounts 
for ``incident to'' drugs to 100 percent of the volume-weighted ASP for 
a HCPCS code instead of 106 percent of the volume-weighted ASP for a 
HCPCS code. We believe limiting the add-on will incentivize the use of 
the most clinically appropriate drug for a given patient. In addition, 
we understand that many OTPs purchase directly from drug manufacturers, 
thereby limiting the markup from distribution channels. We also propose 
to use the same version of the quarterly manufacturer-submitted data 
used for calculating the most recently posted ASP data files in 
preparing the CY 2020 payment rates for OTPs. Please note that the 
quarterly ASP Drug Pricing Files include ASP plus 6 percent payment 
amounts.\63\ Accordingly, we would adjust these amounts consistent with 
our proposal to limit the payment amounts for these drugs to 100 
percent of the volume-weighted ASP for a HCPCS code. Proposed payment 
rates are provided below in this section of this proposed rule. A 
discussion of the proposed annual payment update methodology is also 
provided below. We propose to codify the ASP payment methodology for 
the drug component at Sec.  410.67(d)(2). We solicit public comment on 
these proposals, as well as on using alternative ASP-based payments to 
price these drugs, such as a rolling average of the past year's ASP 
payment rates.
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    \63\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------

iii. Oral Drugs
    We propose to use ASP-based payment, which would be determined 
based on ASP data that have been calculated consistent with the 
provisions in 42 CFR part 414, subpart 800, to set the payment rates 
for the oral product categories when we receive manufacturer-submitted 
ASP data for these drugs. We believe that using the ASP pricing data 
for oral OTP drugs currently covered under Part D \64\ would facilitate 
the computation of the estimated costs of these drugs. However, we do 
not collect ASP pricing information under section 1927(b) of the Act 
for these drugs. We request public comment on whether manufacturers 
would be willing to submit ASP pricing data for OTP drugs currently 
covered under Part D on a voluntary basis.
---------------------------------------------------------------------------

    \64\ Please note that methadone is not currently considered a 
Part D drug when used for MAT. Methadone used for this purpose can 
be dispensed only through an OTP certified by SAMHSA. However, 
methadone dispensed for pain may be considered a Part D drug.
---------------------------------------------------------------------------

    We also propose to limit the payment amounts for oral drugs to 100 
percent of the volume-weighted ASP for a HCPCS code instead of 106 
percent of the volume-weighted ASP for a HCPCS code. We believe 
limiting the add-on will incentivize the use of the most clinically 
appropriate drug for a given patient. In addition, we understand that 
many OTPs purchase directly from drug manufacturers, thereby limiting 
the markup from distribution channels. We propose to use the same 
version of the quarterly manufacturer-submitted data used for 
calculating the most recently posted ASP data files in preparing the CY 
2020 payment rates for OTPs. Please note that the quarterly ASP Drug 
Pricing Files include ASP plus 6 percent payment amounts.\65\ 
Accordingly, we would adjust these amounts consistent with our proposal 
to limit the payment amounts for these drugs to 100 percent of the 
volume-weighted ASP for a HCPCS code. Proposed payment rates are 
provided below in this section of this proposed rule. A discussion of 
the proposed annual payment update methodology is also provided below. 
We propose to codify the ASP payment methodology for the drug component 
at Sec.  410.67(d)(2). We solicit public comment on these proposals, as 
well as on using alternative ASP-based payments to price these drugs, 
such as a rolling average of the past year's ASP payment rates.
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    \65\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------

    In the event that we do not receive manufacturer-submitted ASP 
pricing data, we are considering several potential pricing mechanisms 
to estimate the payment amounts for oral drugs typically paid for under 
Medicare Part D but that would become OTP drugs paid under Part B when 
used as part of MAT in an OTP. We are not proposing a specific pricing 
mechanism for these drugs at this time, but are requesting public 
comment on the following potential approaches for estimating the 
acquisition cost and payment amounts for these drugs and on alternative 
approaches. We will consider the comments received in developing our 
final policy for determining these drug prices.
Approach 1: The Methodology in Section 1847A of the Act
    One approach for estimating the cost of the drugs that are 
currently covered under Part D and for which ASP data are not available 
would be to use the methodology in section 1847A of the Act. Please see 
above for a discussion of the methodology in section 1847A of the Act. 
Under the methodology in section 1847A of the Act, when ASP data are 
not available, this option would price drugs using, for example, WAC or 
invoice pricing.
Approach 2: Medicare's Part D Prescription Drug Plan Finder Data
    On January 28, 2005, we issued the ``Medicare Program; Medicare 
Prescription Drug Benefit'' final rule (70 FR 4194) which implemented 
the Medicare voluntary prescription drug benefit, as enacted by section 
101 of the MMA. Beginning on January 1, 2006, a prescription drug 
benefit program was available to beneficiaries with much broader drug 
coverage than was previously provided under Part B to include: Brand-
name prescription drugs and biologicals, generic drugs, biosimilars, 
vaccines, and medical supplies associated with the injection of 
insulin.\66\ This prescription drug benefit is offered to Medicare 
beneficiaries through Medicare Advantage Drug Plans (MA-PDs) and stand-
alone Prescription Drug Plans (PDPs). The prescription drug benefit 
under Medicare Part D is administered based on the ``negotiated 
prices'' of covered Part D drugs. Under Sec.  423.100 of the Part D 
regulations, the negotiated price of a Part D drug equals the amount 
paid by the Part D sponsor (or its pharmacy benefit manager) to the 
pharmacy at the point-of-sale for that drug. Typically, these Part D 
``negotiated prices'' are based on AWP minus a percentage for brand 
drugs or either the maximum allowable cost, which is based on 
proprietary methodologies used to establish the same payment for 
therapeutically equivalent products marketed by multiple labelers with 
different AWPs,

[[Page 40533]]

or the Generic Effective Rate, which guarantees aggregate minimum 
reimbursement (for example, AWP-85 percent). The negotiated price under 
Part D also includes a dispensing fee (for example, $1-$2), which is 
added to the cost of the drug.
---------------------------------------------------------------------------

    \66\ See section 1860D-2(e) of the Act.
---------------------------------------------------------------------------

    Many of the beneficiaries who choose to enroll in Part D drug plans 
must pay premiums, deductibles, and copayments/co-insurance. The 
Medicare Prescription Drug Plan Finder is an online tool available at 
http://www.medicare.gov. This web tool allows beneficiaries to make 
informed choices about enrolling in Part D plans by comparing the 
plans' benefit packages, premiums, formularies, pharmacies, and pricing 
data. PDPs and MA-PDs are required to submit this information to CMS 
for posting on the Medicare Drug Plan Finder. The database structure 
provides the drug pricing and pharmacy network information necessary to 
accurately communicate plan information in a comparative format. The 
Medicare Prescription Drug Plan Finder displays information on 
pharmacies that are contracted to participate in the sponsors' network 
as either retail or mail order pharmacies.
    Another approach for estimating the cost of the drugs that are 
currently covered under Part D and for which ASP data are not available 
would be to use data retrieved from the online Medicare Prescription 
Drug Plan Finder. For example, the Part D drug prices for each drug 
used by an OTP as part of MAT could be estimated based on a national 
average price charged by all Part D plans and their network pharmacies. 
However, the prices listed in the Medicare Prescription Drug Plan 
Finder generally reflect the prices that are negotiated by larger 
buying groups, as larger pharmacies often have significant buying power 
and smaller pharmacies generally contract with a pharmacy services 
administrative organization (PSAO). As a result, our primary concern 
with this pricing approach is that such prices may fail to reflect the 
drug prices that smaller OTP facilities may pay in acquiring these 
drugs and could therefore disadvantage these facilities. If we were to 
select this pricing approach for oral drugs for which ASP data are not 
available, we would anticipate setting the pricing for these drugs 
using the most recent Medicare Drug Plan Finder data available at the 
drafting of the CY 2020 PFS final rule. We note that, for the Part B 
ESRD prospective payment system (PPS) outlier calculation, which 
provides ESRD facilities with additional payment in situations where 
the costs for treating patients exceed an established threshold under 
the ESRD PPS, we chose to adopt the ASP methodology in section 1847A of 
the Act, and the other pricing methodologies under section 1847A of the 
Act, as appropriate, when ASP data are not available, to price the 
renal dialysis drugs and biological products that were or would have 
been separately billable under Part B prior to implementation of the 
ESRD PPS,\67\ and the national average drug prices based on the 
Medicare Prescription Drug Plan Finder as the data source for pricing 
the renal dialysis drugs or biological products that were or would have 
been separately covered under Part D prior to implementation of the 
ESRD PPS.\68\
---------------------------------------------------------------------------

    \67\ 82 FR 50742 through 50745.
    \68\ 75 FR 49142.
---------------------------------------------------------------------------

    We believe that all of the MAT drugs proposed for inclusion in the 
OTP benefit that are currently covered under Part D have clinical 
treatment indications beyond MAT such as for the treatment of pain.\69\ 
These drugs will continue to be covered under Part D for these other 
indications. Buprenorphine will continue to be covered under Part D for 
MAT as well. Consequently, Part D pricing information should continue 
to be available for these drugs and could be used in the computation of 
payment under the approach discussed above.
---------------------------------------------------------------------------

    \69\ For example, while methadone is not covered by Medicare 
Part D for MAT, methadone dispensed for pain may be considered a 
Part D drug.
---------------------------------------------------------------------------

    Because, by law, methadone used in MAT cannot be dispensed by a 
pharmacy, it is not currently considered a Part D drug when used for 
MAT. Methadone used for this purpose can be dispensed only through an 
OTP certified by SAMHSA. However, methadone dispensed for pain may be 
considered a Part D drug and can be dispensed by a pharmacy. 
Accordingly, we also seek comment on the applicability of Part D 
payment rates for methadone dispensed by a pharmacy to methadone 
dispensed by an OTP for MAT.
Approach 3: Wholesale Acquisition Cost (WAC)
    Another approach for estimating the cost of the oral drugs that we 
propose to include as part of the bundled payments but for which ASP 
data are not available would be to use WAC. Section 1847A(c)(6)(B) of 
the Act defines WAC as the manufacturer's list price for the drug to 
wholesalers or direct purchasers in the U.S., not including prompt pay 
or other discounts, rebates, or reductions in price, for the most 
recent month for which the information is available, as reported in 
wholesale price guides or other publications of drug pricing data. As 
noted above in the discussion of Part B drugs, WAC is used as the basis 
for pricing some Part B drugs; for example, it is used when it is less 
than ASP in the case of single source drugs (section 1847A(b)(4) of the 
Act) and in cases where ASP is unavailable during the first quarter of 
sales (section 1847A(c)(4) of the Act).
    Because WAC is the manufacturer's list price to wholesalers, we 
believe that it is more reflective of the price paid by the end user 
than the AWP. As a result, we believe that this pricing mechanism would 
be consistent with pricing that currently occurs for drugs that are 
separately billable under Part B. However, we have concerns about the 
fact that WAC does not include prompt pay or other discounts, rebates, 
or reductions in price. If we select this option to estimate the cost 
of certain drugs, we would develop pricing using the most recent data 
files available at the drafting of the CY 2020 PFS final rule.
Approach 4: National Average Drug Acquisition Cost (NADAC)
    Another approach for estimating the cost of the oral drugs that we 
propose to include as part of the bundled payments but for which ASP 
data are not available would be to use Medicaid's NADAC survey. This 
survey provides another national drug pricing benchmark. CMS conducts 
surveys of retail community pharmacy prices, including drug ingredient 
costs, to develop the NADAC pricing benchmark. The NADAC was designed 
to create a national benchmark that is reflective of the prices paid by 
retail community pharmacies to acquire prescription and over-the-
counter covered outpatient drugs and is available for consideration by 
states to assist with their individual pharmacy payment policies.
    State Medicaid agencies reimburse pharmacy providers for prescribed 
covered outpatient drugs dispensed to Medicaid beneficiaries. The 
reimbursement formula consists of two parts: (1) Drug ingredient costs; 
and (2) a professional dispensing fee. In a final rule with comment 
period titled ``Medicaid Program; Covered Outpatient Drugs,'' which 
appeared in the February 1, 2016 Federal Register (81 FR 5169), we 
revised the methodology that state Medicaid programs use to determine 
drug ingredient costs, establishing an Actual Acquisition Cost (AAC) 
based determination, as opposed to a determination based on estimated 
acquisition costs (EAC). AAC is defined

[[Page 40534]]

at 42 CFR 447.502 as the agency's determination of the pharmacy 
providers' actual prices paid to acquire drugs marketed or sold by 
specific manufacturers. As explained in the Covered Outpatient Drugs 
final rule with comment period (81 FR 5175), CMS believes shifting from 
an EAC to an AAC based determination of ingredient costs is more 
consistent with the dictates of section 1902(a)(30)(A) of the Act. In 
2010, a working group within the National Association of State Medicaid 
Directors (NASMD) recommended the establishment of a single national 
pricing benchmark based on average drug acquisition costs. Pricing 
metrics based on actual drug purchase prices provide greater accuracy 
and transparency in how drug prices are established and are more 
resistant to manipulation. The NASMD requested that CMS coordinate, 
develop, and support this benchmark.
    Section 1927(f) of the Act provides, in part, that CMS may contract 
with a vendor to conduct monthly surveys with respect to prices for 
covered outpatient drugs dispensed by retail community pharmacies. We 
entered into a contract with Myers & Stauffer, LLC to perform a monthly 
nationwide retail price survey of retail community pharmacy covered 
outpatient drug prices (CMS-10241, OMB 0938-1041) and to provide states 
with weekly updates on pricing files, that is, the NADAC files. The 
NADAC survey process focuses on drug ingredient costs for retail 
community pharmacies. The survey collects acquisition costs for covered 
outpatient drugs purchased by retail pharmacies, which include invoice 
prices from independent and chain retail community pharmacies. The 
survey data provide information that CMS uses to assure compliance with 
federal requirements. We believe NADAC data could be used to set the 
prices for the oral drugs furnished by OTPs for which ASP data are not 
available. Survey data on invoice prices provide the closest pricing 
metric to ASP that we are aware of. However, similar to the other 
available pricing metrics, we have concerns about the applicability of 
retail pharmacy prices to the acquisition costs available to OTPs since 
we have no evidence to suggest that these entities would be able to 
acquire drugs at a similar price point. If we select this option, we 
would develop pricing using the most recent data files available at the 
drafting of the CY 2020 PFS final rule.
Alternative Methadone Pricing: TRICARE
    We are also considering an approach for estimating the cost of 
methadone using the amount calculated by TRICARE. As discussed above in 
this section of this proposed rule, the TRICARE rates for medications 
used in OTPs to treat opioid use disorder are spelled out in the 2016 
TRICARE final rule (81 FR 61068); in the regulations at Sec.  
199.14(a)(2)(ix); and in Chapter 7, Section 5 and Chapter 1, Section 15 
of the TRICARE Reimbursement Manual 6010.61-M, April 1, 2015.
    In the 2016 TRICARE final rule, DOD established separate payment 
methodologies for OTPs based on the particular medication being 
administered for treatment.\70\ Based on TRICARE's review of industry 
billing practices, the initial weekly bundled rate for administration 
of methadone included a daily drug cost of $3, which is subject to an 
update factor.\71\
---------------------------------------------------------------------------

    \70\ 81 FR 61079.
    \71\ 81 FR 61079.
---------------------------------------------------------------------------

    This option would only be applicable for methadone because TRICARE 
has developed a fee-for-service payment methodology for buprenorphine 
and naltrexone.\72\ In the 2016 TRICARE final rule, the DOD stated that 
the payments for buprenorphine and naltrexone are more variable in 
dosage and frequency for both the drug and non-drug services.\73\ 
Accordingly, TRICARE pays for drugs listed on Medicare's Part B ASP 
files, such as the injectable and implantable versions of buprenorphine 
using the ASP; drugs not appearing on the Medicare ASP file, such as 
oral buprenorphine, are priced at the lesser of billed charges or 95 
percent of the AWP.\74\
---------------------------------------------------------------------------

    \72\ 81 FR 61080.
    \73\ 81 FR 61080.
    \74\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
---------------------------------------------------------------------------

    We believe that pricing methadone consistent with the TRICARE 
payment rate may provide a reasonable payment amount for methadone when 
ASP data are not available. As DOD noted in the 2016 TRICARE final 
rule, ``a number of commenters indicated that they believed the rates 
DOD proposed for OTPs' services are near market rates and are 
acceptable.'' \75\
---------------------------------------------------------------------------

    \75\ 81 FR 61080.
---------------------------------------------------------------------------

    We are proposing to codify this proposal to apply an alternative 
approach for determining the payment rate for oral drugs only if ASP 
data are not available in Sec.  410.67(d)(2). We request public comment 
on the potential alternative approaches set forth above for estimating 
the cost of oral drugs that we propose to include as part of the 
bundled payments but for which ASP data are not available, including 
any other alternate sources of data to estimate the cost of these oral 
MAT drugs. Payment rates based on these different options are set forth 
in Table 14. We will consider the comments received on these different 
potential approaches when deciding on the approach that we will use to 
determine the payment rates for these drugs in the CY 2020 PFS final 
rule. We also invite public comment on any other potential data sources 
for estimating the provider acquisition costs of OTP drugs currently 
paid under either Part B or Part D. As noted previously, we welcome 
comments on how new drugs with a novel mechanism of action should be 
priced, and specifically whether pricing for non-opioid agonist and/or 
antagonist medications should be determined using the same pricing 
methodology, including the alternatives discussed above, as would be 
used for medications included in the proposed definition of OUD 
treatment services.

    TABLE 14--Estimated * Initial Drug Payment Rates for Each Pricing
                                Approach
------------------------------------------------------------------------
                                                      Estimated initial
    Pricing approach (or        Estimated initial    weekly drug payment
        alternative)           weekly drug payment        for oral
                                  for methadone         buprenorphine
------------------------------------------------------------------------
Proposal: ASP-Based Payment.  ASPs currently not    ASPs currently not
                               reported.             reported.
Approach 1: The Methodology   $29.61..............  $117.68.
 in Section 1847A of the Act.
Approach 2: Medicare's Part   22.47...............  97.65.
 D Prescription Drug Plan
 Finder Data.
Approach 3: WAC.............  27.93...............  111.02.
Approach 4: NADAC...........  11.76...............  97.02.

[[Page 40535]]

 
Alternative Methadone         22.19...............  N/A.
 Pricing: TRICARE.
------------------------------------------------------------------------
* The estimated payment amounts in this table are based on data files
  posted at the time of the drafting of this proposed rule. We would
  develop the final pricing for CY 2020 using the most recent data files
  available at the drafting of the CY 2020 PFS final rule.

(b) Non-Drug Component
    To price the non-drug component of the bundled payments, we are 
proposing to use a crosswalk to the non-drug component of the TRICARE 
weekly bundled rate for services furnished when a patient is prescribed 
methadone. As described above, in 2016, TRICARE finalized a weekly 
bundled rate for administration of methadone that included a daily drug 
cost of $3, along with a $15 per day cost for non-drug services (that 
is, the costs related to the intake/assessment, drug dispensing and 
screening and integrated psychosocial and medical treatment and 
supportive services). The daily projected per diem cost ($18/day) was 
converted to a weekly rate of $126 ($18/day x 7 days) (81 FR 61079). 
TRICARE updates the weekly bundled methadone rate for OTPs annually 
using the Medicare update factor used for other mental health care 
services rendered (that is, the Inpatient Prospective Payment System 
update factor) under TRICARE (81 FR 61079). The updated amount for CY 
2019 to $133.15 (of which $22.19 is the methadone cost and the 
remainder, $110.96, is for the non-drug services).\76\ We believe using 
the TRICARE weekly bundled rate is a reasonable approach to setting the 
payment rate for the non-drug component of the bundled payments to 
OTPs, particularly given the time constraints in developing a payment 
methodology prior to the January 1, 2020 effective date of this new 
Medicare benefit category. The TRICARE rate is an established national 
payment rate that was established through notice and comment 
rulemaking. As a result, OTPs and other interested parties had an 
opportunity to present information regarding the costs of these 
services. Furthermore the TRICARE rate describes a generally similar 
bundle of services to those services that are included in the 
definition of OUD treatment services in section 1861(jjj)(1) of the 
Act. We recognize that there are differences in the patient population 
for TRICARE compared with the Medicare beneficiary population. However, 
as OTP services have not previously been covered by Medicare, it is not 
clear what impact, if any, these differences would have on the cost of 
the services included in the non-drug component of the proposed bundled 
payments. We are proposing to codify the methodology for determining 
the payment rate for the non-drug component of the bundled payments 
using the TRICARE weekly rate for non-drug services at Sec.  
410.67(d)(2). As part of this proposal, we would plan to monitor 
utilization of non-drug services by Medicare beneficiaries and, if 
needed, would consider in future rulemaking ways we could tailor the 
TRICARE payment rate for these non-drug services to the Medicare 
population, including dually eligible beneficiaries.
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    \76\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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    Because the TRICARE payment rate for the non-drug services included 
in its weekly bundled rate for methadone includes daily administration 
of methadone, as part of our proposed approach we would adjust the 
TRICARE payment rate for non-drug services for most of the other 
bundled payments to more accurately reflect the cost of administering 
the other drugs used in MAT. For the oral buprenorphine bundled 
payment, we propose to retain the same amount as the rate for the 
methadone bundled payment based on an assumption that this drug is also 
being dispensed daily. We understand that patients who have stabilized 
may be given 7-14 day supplies of oral buprenorphine at a time, but for 
the purposes of developing the proposed rates, we valued this service 
to include daily drug dispensing to account for cases where daily drug 
dispensing is occurring. For the injectable drugs (buprenorphine and 
naltrexone), we propose to subtract from the non-drug component, an 
amount that is comparable to the dispensing fees paid by several state 
Medicaid programs ($10.50) for a week of daily dispensing of methadone. 
This adjustment accounts for the fact that these injectable drugs are 
not oral drugs that are dispensed daily; we would then instead add the 
fee that Medicare pays for the administration of an injection (which is 
currently $16.94 under the CY 2019 non-facility Medicare payment rate 
for CPT code 96372). We propose to update the amount of this adjustment 
annually using the same methodology that we are proposing to use to 
update the non-drug component of the bundled payments.
    Similarly, the payment rates for the non-drug component of the 
codes for the weekly bundled payments for buprenorphine implants would 
be adjusted to add an amount for insertion and/or removal based on a 
direct crosswalk to the non-facility payment rates under the Medicare 
PFS for the insertion, removal, or insertion and removal of these 
implants, which describe the physician work, practice expense (PE), and 
malpractice costs associated with these procedures, and to remove the 
costs of daily drug dispensing (determined based on the dispensing fees 
paid by several state Medicaid programs for a week of daily dispensing 
of methadone, currently $10.50). For HCPCS code GXXX5, we would use a 
crosswalk to the rate for HCPCS code G0516 (Insertion of non-
biodegradable drug delivery implants, 4 or more (services for subdermal 
rod implant)); for HCPCS code GXXX6, we would use a crosswalk to the 
rate for HCPCS code G0517 (Removal of non-biodegradable drug delivery 
implants, 4 or more (services for subdermal implants)); and for HCPCS 
code GXXX7, we would use a crosswalk to the rate for HCPCS code G0518 
(Removal with reinsertion, non-biodegradable drug delivery implants, 4 
or more (services for subdermal implants)). The amounts for HCPCS codes 
G0516, G0517 and G0518 under the CY 2019 non-facility Medicare payment 
rate are $111.00, $126.86, and $204.70, respectively.
    In order to determine the payment rates for the code describing a 
non-drug bundled payment, HCPCS code GXXX8, we propose to use a 
crosswalk to the reimbursement rate for the non-drug services included 
in the TRICARE weekly bundled rate for administration of methadone, 
adjusted to subtract the cost of methadone dispensing (using an amount 
that is comparable to the dispensing fees paid by several state 
Medicaid programs for a week of daily dispensing of methadone, which is 
currently $10.50).
    We propose that the payment rate for the add-on code, HCPCS code 
GXX19, would be based on 30 minutes of

[[Page 40536]]

substance use counseling and valued based on a crosswalk to the rates 
set by state Medicaid programs for similar services.
i. Medication Not Otherwise Specified
    We would expect the non-drug component for medication not otherwise 
specified bundled payments (HCPCS code GXXX9) to be consistent with the 
pricing methodology for the other bundled payments and therefore, be 
based on a crosswalk to the TRICARE rate, adjusted for any applicable 
administration and dispensing fees. For example, for oral medications, 
we would use the rate for the non-drug services included in the TRICARE 
methadone bundle, based on an assumption that the drug is also being 
dispensed daily. For the injectable medications, we would adjust the 
TRICARE payment rate for non-drug services using the same methodology 
we are proposing for injectable medications above (to subtract an 
amount for daily dispensing and add the non-facility Medicare payment 
rate for administration of the injection). For implantable medications, 
we would also use the same methodology we propose above, with the same 
crosswalked non-facility Medicare payment rates (for insertion, 
removal, and insertion and removal). We welcome comments on all of the 
proposed pricing methodologies described in this section. As noted 
above, we also welcome comments on how new drugs with a novel mechanism 
of action (that is, drugs that are not opioid agonists and/or 
antagonists) should be priced. We additionally welcome comments on how 
the price of the non-drug component of such bundled payments should be 
determined, in particular the dispensing and/or administration fees, 
including whether the methodology we propose above for determining the 
payment rate for the non-drug component of an episodes of are that 
includes a new opioid agonist and antagonist medication (which is based 
on whether the drug is oral, injectable, or implantable) would be 
appropriate to use for these new drugs.
(c) Partial Episode of Care
    For HCPCS codes GXX10 and GXX11 (codes describing partial episodes 
for methadone and oral buprenorphine), we propose that the payment 
rates for the non-drug component would be calculated by taking one half 
of the payment rate for the non-drug component for the corresponding 
weekly bundles. We chose one half as the best approximation of the 
median cost of the services furnished during a partial episode 
consistent with our proposal above to make a partial episode bundled 
payment when the majority of services described in a beneficiary's 
treatment plan are not furnished during a specific episode of care. 
However, we welcome comment on other methods that could be used to 
calculate these payment rates. We propose that the payment rates for 
the drug component of these partial episode bundles would be calculated 
by taking one half of the payment rate for the drug component of the 
corresponding weekly bundles.
    For HCPCS codes GXX12 and GXX16 (codes describing partial episodes 
for injectable buprenorphine and naltrexone), we propose that the 
payment rates for the drug component would be the same as the payment 
rate for the drug component of the full weekly bundle so that the OTP 
would be reimbursed for the cost of the drug that is given at the start 
of the episode. For the non-drug component, we propose that the payment 
rate would be calculated as follows: The TRICARE non-drug component 
payment rate ($110.96), adjusted to remove the cost of daily 
administration of an oral drug ($10.50), then divided by two; that 
amount would be added to the fee that Medicare pays for the 
administration of an injection (which is currently $16.94 under the CY 
2019 non-facility Medicare payment rate for CPT code 96372).
    For HCPCS codes GXX13, GXX14, GXX15 (codes describing partial 
episodes for the buprenorphine implant insertion, removal, and 
insertion and removal, respectively) we propose that the payment rates 
for drug component would be the same as the payment rate for the 
corresponding weekly bundle. For the non-drug component, we propose 
that the payment rate would be calculated as follows: The TRICARE non-
drug component payment rate ($110.96), adjusted to remove the cost of 
daily administration of an oral drug ($10.50), then divided by two; 
that amount would be added to the Medicare non-facility payment rate 
for the insertion, removal, or insertion and removal of the implants, 
respectively (based on the non-facility rates for HCPCS codes G0516, 
G0517, and G0518, which are currently $111.00, $126.86, and $204.70, 
respectively).
    For HCPCS code GXX17 (code describing a non-drug partial episode of 
care), we propose that the payment rate would be calculated by taking 
one half of the payment rate for the corresponding weekly bundle.
    We propose that the payment rate for the code describing partial 
episodes for a medication not otherwise specified (HCPCS code GXX18) 
would be calculated based on whether the medication is oral, injectable 
or implantable, following the methodology described above. For oral 
drugs, we would follow the methodology described for HCPCS codes GXX10 
and GXX11. For injectable drugs, we would follow the methodology 
described for HCPCS codes GXX12 and GXX16. For implantable drugs, we 
would follow the methodology described for HCPCS codes GXX13, GXX14, 
and GXX15. We welcome comments on how partial episodes of care using 
new drugs with a novel mechanism of action (that is, non-opioid agonist 
and/or antagonist treatment medications) should be priced. For example, 
we could use the same approach described previously for pricing new 
opioid agonist and antagonist medications not otherwise specified, 
which is to follow the methodology based on whether the drug is oral, 
injectable or implantable.
BILLING CODE 4120-01-P

[[Page 40537]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.007


[[Page 40538]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.008


[[Page 40539]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.009

BILLING CODE 4120-01-C
(8) Place of Service (POS) Code for Services Furnished at OTPs
    We are creating a new POS code specific to OTPs since there are no 
existing POS codes that specifically describe OTPs. Claims for OTP 
services would include this place of service code. We note that POS 
codes are available for use by all payers. We are not proposing to make 
any differential payment based on the use of this new POS code. Further 
guidance will be issued regarding the POS code that should be used by 
OTPs.
c. Duplicative Payments Under Parts B or D
    Section 1834(w)(1) of the Act, added by section 2005(c) of the 
SUPPORT Act, requires the Secretary to ensure, as determined 
appropriate by the Secretary, that no duplicative payments are made 
under Part B or Part D for items and services furnished by an OTP. We 
note that many of the individual items or services provided by OTPs 
that would be included in the bundled payment rates under our proposal 
may also be appropriately available to beneficiaries through other 
Medicare benefits. Although we recognize the potential for significant 
program integrity concerns when similar items or services are payable 
under separate Medicare benefits, we also believe that it is important 
that any efforts to prevent duplicative payments not inadvertently 
restrict Medicare beneficiaries' access to other Medicare benefits even 
for the time period they are being treated by an OTP. For example, we 
believe that a beneficiary receiving counseling or therapy as part of 
an OTP bundle of services may also be receiving medically reasonable 
and necessary counseling or therapy as part of a physician's service 
during the same time period. Similarly, we believe there could be 
circumstances where Medicare beneficiaries with OUD could receive 
treatment and/or medication from non-OTP entities that would not result 
in duplicative payments, presuming that both the OTP and the other 
entity appropriately furnished separate medically necessary services or 
items. Consequently, we do not believe that provision of the same kinds 
of services by both an OTP and a separate provider or supplier would 
itself constitute a duplicative payment.
    We believe that duplicative payments would result from the 
submission of claims to Medicare leading to payment for drugs furnished 
to a Medicare beneficiary and the associated dispensing fees on a 
certain date of service to both an OTP and another provider or supplier 
under a different benefit. In these circumstances, we would consider 
only one of the claims to be paid for appropriately. Accordingly, for 
purposes of implementing section 1834(w)(1) of the Act, we propose to 
consider payment for medications delivered, administered or dispensed 
to the beneficiary as part of the OTP bundled payment to be a 
duplicative payment if delivery, administration or dispensing of the 
same medications was also separately paid under Medicare Parts B or D. 
We propose to codify this policy at Sec.  410.67(d)(4). We understand 
that some OTPs negotiate arrangements whereby community pharmacies 
supply MAT-related medications to OTPs. If the OTP provides medically 
necessary MAT-related medications as part of an episode of care, we 
would expect the OTP to take measures to ensure that there is no claim 
for payment for these drugs other than as part of the OTP bundled 
payment. (For example, the MAT drugs billed by an OTP as part of a 
bundled payment should not be reported to or paid under a Part D plan.) 
We expect that OTPs will take reasonable steps to ensure that the items 
and services furnished under their care are not reported or billed 
under a different Medicare benefit. CMS intends to monitor for 
duplicative payments, and would take appropriate action as needed when 
such duplicative payments are identified. Therefore, we are proposing 
that in cases where a payment for drugs used as part of an OTP's 
treatment plan is identified as being a duplicative payment because the 
same costs were paid under a different Medicare benefit, CMS will 
generally recoup the duplicative payment made to the OTP as the OTP 
would be in the best position to know whether or not the drug that is 
included as part of the beneficiary's treatment plan is furnished by 
the OTP or by another provider or supplier given that the OTP is 
responsible for managing the beneficiary's overall OUD treatment. We 
propose to codify this policy at Sec.  410.67(d)(4). CMS notes that 
this general approach would not preclude CMS or other auditors from 
conducting appropriate oversight of duplicative payments made to the 
other provider or suppliers, particularly in cases of fraud and/or 
abuse.

[[Page 40540]]

d. Cost Sharing
    Section 2005(c) of the SUPPORT Act amends section 1833(a)(1) of the 
Act, relating to payment of Part B services, by adding a new 
subparagraph (CC), which specifies with respect to OUD treatment 
services furnished by an OTP during an episode of care that the amount 
paid shall be equal to the amount payable under section 1834(w) of the 
Act less any copayment required as specified by the Secretary. Section 
1834(w) of the Act, which was also added by section 2005(c) of the 
SUPPORT Act, requires that the Secretary pay an amount that is equal to 
100 percent of a bundled payment under this part for OUD treatment 
services. Given these two provisions, we believe that there is 
flexibility for CMS to set the copayment amount for OTP services either 
at zero or at an amount above zero. Therefore, we are proposing to set 
the copayment at zero for a time-limited duration (for example, for the 
duration of the national opioid crisis), as we believe this would 
minimize barriers to patient access to OUD treatment services. Setting 
the copayment at zero also ensures OTP providers receive the full 
Medicare payment amount for Medicare beneficiaries if secondary payers 
are not available or do not pay the copayment, especially for those 
dually eligible for Medicare and Medicaid.\77\ We intend to continue to 
monitor the opioid crisis in order to determine at what point in the 
future a copayment may be imposed. At such a time we deem appropriate, 
we would institute cost sharing through future notice and comment 
rulemaking. We welcome feedback from the public on our proposal to set 
the copayment at zero for a time-limited duration, such as for the 
duration of the national opioid crisis, and any other metrics CMS might 
consider using to determine when to start requiring a copayment. In 
developing our proposed approach, we also considered other 
alternatives, such as setting the copayment at a fixed fee calculated 
based on 20 percent of the payment rate for the bundle, consistent with 
the standard copayment requirement for other Part B services, or 
applying a flat dollar copayment amount similar to TRICARE's copayment; 
however, we recognize that setting the copayment for OUD services at a 
non-zero amount could create a barrier to access to treatment for many 
beneficiaries. We propose to codify the proposed copayment amount of 
zero at Sec.  410.67(e). We welcome feedback on our proposal to set the 
copayment amount for OTP services at zero, and on the alternatives 
considered, including whether we should consider any of these 
alternatives for CY 2020 or future years.
---------------------------------------------------------------------------

    \77\ For those dually eligible individuals in the Qualified 
Medicare Beneficiary program (7.7 million of the 12 million dually 
eligible individuals in 2017), state Medicaid programs cover the 
Medicare Part A and B deductible and coinsurance. However, section 
4714 of the Balanced Budget Act of 1997 (Pub. L. 105-33) provides 
discretion for states to pay Medicare cost-sharing only if the 
Medicaid payment rate for the service is above the Medicare paid 
amount for the service. Since most states opt for this discretion, 
and most Medicaid rates are lower than Medicare's, states often do 
not pay the provider for the Medicare cost-sharing amount. Providers 
are further prohibited from collecting the Medicare cost-sharing 
amount from the beneficiary, effectively having to take a discount 
compared to the amount received for other Medicare beneficiaries.
---------------------------------------------------------------------------

    Separately, we note that the Part B deductible would apply for OUD 
treatment services, as mandated for all Part B services by section 
1833(b) of the Act.
4. Adjustments to Bundled Payment Rates for OUD Treatment Services
    The costs of providing OUD treatment services will likely vary over 
time and depending on the geographic location where the services are 
furnished. Below we discuss our proposed adjustments to the bundled 
payment rates to account for these factors.
a. Locality Adjustment
    Section 1834(w)(2) of the Act, as added by section 2005(c) of the 
SUPPORT Act provides that the Secretary may implement the bundled 
payment for OUD treatment services furnished by OTPs through one or 
more bundles based on the type of medications, the frequency of 
services, the scope of services furnished, characteristics of the 
individuals furnished such services, or other factors as the Secretary 
determines appropriate. The cost for the provision of OTP treatment 
services, like many other healthcare services covered by Medicare, will 
likely vary across the country based upon the differing cost in a given 
geographic locality. To account for such geographic cost differences in 
the provision of services, in a number of payment systems, Medicare 
routinely applies geographic locality adjustments to the payment rates 
for particular services. As we believe OTP treatment services will also 
be subject to varying cost based upon the geographic locality where the 
services are furnished, we propose to apply a geographic locality 
adjustment to the bundled payment rate for OTP treatment services. 
Below, we discuss our proposed approach with respect to the drug 
component (which reflects payment for the drug) and the non-drug 
component (which reflects payment for all other services furnished to 
the beneficiary by the OTP, such as drug administration, counseling, 
toxicology testing, etc.) of the bundled payment.
(1) Drug Component
    Because our proposed approaches for pricing the MAT drugs included 
in the bundles all reflect national pricing, and because there is no 
geographic adjustment factor applied to the payment of Part B drugs 
under the ASP methodology, we do not believe that it is necessary to 
adjust the drug component of the bundled payment rates for OTP services 
based upon geographic locality. Therefore, we are proposing not to 
apply a geographic locality adjustment to the drug component of the 
bundled payment rate for OTP services.
(2) Non-Drug Component
    Unlike the national pricing of drugs, the costs for the services 
included in the non-drug component of the OTP bundled payment for OUD 
treatments are not constant across all geographic localities. For 
example, OTPs' costs for rent or employee wages could vary 
significantly across different localities and could potentially result 
in disparate costs for the services included in the non-drug component 
of OUD treatment services. Because the costs of furnishing the services 
included in the non-drug component of the OTP bundled payment for OUD 
treatment services will vary based upon the geographic locality in 
which the services are provided, we believe it would be appropriate to 
apply a geographic locality adjustment to the non-drug component of the 
bundled payments. We believe that the geographic variation in cost of 
the non-drug services provided by OTPs will be similar to the 
geographic variation in the cost of services furnished in physician 
offices. Therefore, to account for the differential costs of OUD 
treatment services across the country, we are proposing to adjust the 
non-drug component of the bundled payment rates for OUD treatment 
services using an approach similar to the established methodology used 
to geographically adjust payments under the PFS based upon the location 
where the service is furnished. The PFS currently provides for an 
adjustment to the payment for PFS services based upon the fee schedule 
area in which the service is provided through the use of Geographic 
Practice Cost Indices (GPCIs), which measure the relative cost 
differences among localities compared to the national average for each 
of the

[[Page 40541]]

three fee schedule components (work, PE, and malpractice).
    Although we are proposing to adjust the non-drug component of the 
OUD treatment services using an approach similar to the established 
methodology used to adjust PFS payment for geographic locality, because 
GPCIs provide for the application of geographic locality adjustments to 
the three distinct components of PFS services, and the OTP bundled 
payment is a flat rate payment for all OUD treatment services furnished 
during an episode of care, a single factor would be required to apply 
the geographic locality adjustment to the non-drug component of the OTP 
bundled payment rate. Therefore, to apply a geographic locality 
adjustment to the non-drug component of the OTP bundled payment for OUD 
treatment services through a single factor, we are proposing to use the 
Geographic Adjustment Factor (GAF) at Sec.  414.26. Specifically, we 
are proposing to use the GAF to adjust the payment for the non-drug 
component of the OTP bundled payment to reflect the costs of furnishing 
the non-drug component of OUD treatment services in each of the PFS fee 
schedule areas. The GAF is calculated using the GPCIs under the PFS, 
and is used to account for cost differences in furnishing physicians' 
services in differing geographic localities. The GAF is calculated for 
each fee schedule area as the weighted composite of all three GPCIs 
(work, PE, and malpractice) for that given locality using the national 
GPCI cost share weights. In developing this proposal, we also 
considered geographically adjusting the payment for the non-drug 
component of the OTP bundled payment using only the PE GPCI value for 
each fee schedule area. However, because the the non-drug component of 
OUD treatment services is comprised of work, PE, and malpractice 
expenses, we ultimately decided to propose using the GAF as we believe 
the weighted composite of all three GPCIs reflected in the GAF would be 
the more appropriate geographic adjustment factor to reflect geographic 
variations in the cost of furnishing these services.
    The GAF, which is determined under Sec.  414.26, is further 
discussed earlier in section II.D.1. of this proposed rule and the 
specific GAF values for each payment locality are posted in Addendum D 
to this proposed rule. In developing the proposed geographic locality 
adjustment for the non-drug component of the OUD treatment services 
payment rate, we also considered other potential locality adjustments, 
such as the Inpatient Prospective Payment System (IPPS) hospital wage 
index. However, we have opted to propose using the GAF as we believe 
the services provided in an OTP more closely resemble the services 
provided at a physician office than the services provided in other 
settings, such as inpatient hospitals. We propose to codify using the 
GAF to adjust the non-drug component of the OTP bundled payments to 
reflect the cost differences in furnishing these services in differing 
geographic localities at Sec.  410.67(d)(3)(ii). We invite public 
comment on our proposal to adjust the non-drug component of the OTP 
bundled payments for geographic variations in the costs of furnishing 
OUD treatment services using the GAF. We also welcome comments on any 
factors, other than the GAF, that could be used to make this payment 
adjustment.
    Additionally, we note that the majority of OTPs operate in urban 
localities. In light of this fact, we are interested in receiving 
information on whether rural areas have appropriate access to treatment 
for OUD. We are particularly interested in any potential limitations on 
access to care for OUD in rural areas and whether there are additional 
adjustments to the proposed bundled payments that should be made to 
account for the costs incurred by OTPs in furnishing OUD treatment 
services in rural areas. We invite public comment on this issue and 
potential solutions we could consider adopting to address this 
potential issue through future rulemaking.
b. Annual Update
    Section 1834(w)(3) of the Act, as added by section 2005(c) of the 
SUPPORT Act, requires that the Secretary provide an update each year to 
the OTP bundled payment rates. To fulfill this statutory requirement, 
we are proposing to apply a blended annual update, comprised of 
distinct updates for the drug and non-drug components of the bundled 
payment rates, to account for the differing rate of growth in the 
prices of drugs relative to other services. We propose that this 
blended annual update for the OTP bundled payment rates would first 
apply for determining the CY 2021 OTP bundled payment rates. The 
specific details of the proposed updates for the drug and non-drug 
components respectively are discussed in this section.
(1) Drug Component
    As stated above, we are proposing to establish the pricing of the 
drug component of the OTP bundled payment rates for OUD treatment 
services based on CMS pricing mechanisms currently in place. To 
recognize the potential change in costs of the drugs used in MAT from 
year to year and to fulfill the requirement to provide an annual update 
to the OTP bundled payment rates, we are proposing to update the 
payment for the drug component based upon the changes in drug costs 
reported under the pricing mechanism used to establish the pricing of 
the drug component of the applicable bundled payment rate, as discussed 
earlier. As an example, if we were to finalize our proposal to price 
the drug component of the bundled payment rate for episodes of care 
that include injectable and implantable drugs generally covered and 
paid under Medicare Part B using ASP data, the pricing of the drug 
component for these OTP bundled payments, would be updated using the 
most recently available ASP data at the time of ratesetting for the 
applicable calendar year. Similarly, if we finalize our proposal to 
price the drug component of the bundled payment rate for episodes of 
care that include oral drugs using ASP data, if such data are 
available, we would also update the pricing of the drug component using 
the most recently available ASP data at the time of ratesetting for the 
applicable calendar year. Previously, we also discussed a number of 
alternative data sources that could be used to price oral drugs in the 
drug component of OTP bundled payments in cases when we do not receive 
manufacturer-submitted ASP pricing data. As an example, if we were to 
use NADAC data as discussed as one of the alternatives, to determine 
the payment for the drug component of the bundled payment for oral 
drugs in cases when we do not have manufacturer-submitted ASP pricing 
data, this payment rate would also be updated using the most recently 
available NADAC data at the time of ratesetting for the applicable 
calendar year. We propose to codify this methodology for determining 
the annual update to the payment rate for the drug component at Sec.  
410.67(d)(3)(i).
    In developing the proposal to annually update the pricing of the 
drug component of the OUD treatment services payment rate, we also 
considered other methodologies, including applying a single uniform 
update factor to the drug and non-drug components of the proposed 
payment rates. We ultimately determined not to propose the use of a 
single uniform update factor, because we believe that it is important 
to apply an annual update to the payment rates that recognizes the 
differing rate of growth of drug costs

[[Page 40542]]

compared to the rate of growth in the cost of the other services. In 
addition, we also considered annually updating the pricing of the drug 
component of the OUD treatment services payment rate via an established 
update factor such as the Producer Price Index (PPI) for chemicals and 
allied products, analgesics (WPU06380202). The PPI for chemicals and 
allied products, analgesics is a subset of the PPI produced by the 
Bureau of Labor Statistics, which measures the average change over time 
in the selling prices received by domestic producers for their output. 
Ultimately we decided against updating the pricing of the drug 
component of the OUD treatment services payment rate via an established 
update factor such as the PPI in favor of our proposed approach because 
we believe the proposed approach updated the pricing of the drug 
component of the OUD treatment services payment rate in the manner most 
familiar to stakeholders. We invite public comment on our proposed 
approach to updating the drug component of the bundled payment rates. 
We also seek comment on possible alternate methodologies for updating 
the drug component of the payment rate for OUD treatment services, such 
as use of the PPI for chemicals and allied products, analgesics.
(2) Non-Drug Component
    To account for the potential changing costs of the services 
included in the non-drug component of the bundled payment rates for OUD 
treatment services, we are proposing to update the non-drug component 
of the bundled payment for OUD treatment services based upon the 
Medicare Economic Index (MEI). The MEI is defined in section 1842(i)(3) 
of the Act and the methodology for computing the MEI is described in 
Sec.  405.504(d). The MEI is used to update the payment rates for 
physician services under section 1842(b)(3) of the Act, which states 
that prevailing charge levels beginning after June 30, 1973, may not 
exceed the level from the previous year except to the extent that the 
Secretary finds, on the basis of appropriate economic index data, that 
such a higher level is justified by year-to-year economic changes. The 
MEI is a fixed-weight input price index that reflects the physicians' 
own time and the physicians' practice expenses, with an adjustment for 
the change in economy-wide, private nonfarm business multifactor 
productivity. The MEI was last revised in the CY 2014 PFS final rule 
with comment period (78 FR 74264). In developing the proposed update 
factor for the non-drug component of the OUD treatment services payment 
rate, we considered other potential update factors, such as the Bureau 
of Labor Statistics Consumer Price Index for All Items for Urban 
Consumers (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm) and the IPPS hospital market basket reduced 
by the multifactor productivity adjustment. The Consumer Price Index 
for All Items (CPI-U) is a measure of the average change over time in 
the prices paid by urban consumers for a market basket of consumer 
goods and services. However, we concluded that a healthcare-specific 
update factor, such as the MEI, would be more appropriate for OTPs than 
the CPI-U, which measures general inflation, as the MEI would more 
accurately reflect the change in the prices of goods and services 
included in the non-drug component of the OTP bundled payments.
    Similarly, we believe the MEI would be more appropriate than the 
IPPS market basket to update the non-drug component of the bundled 
payment rates as the services provided by an OTP more closely resemble 
the services provided at a physician office than the services provided 
by an inpatient hospital. Accordingly, we propose to update the payment 
amount for the non-drug component of each of the bundled payment rates 
for OUD treatment services furnished by OTPs based upon the most 
recently available historical annual growth in the MEI available at the 
time of rulemaking. We propose to codify this proposal at Sec.  
410.67(d)(3)(iii). We invite public comment on this proposal.

H. Bundled Payments Under the PFS for Substance Use Disorders

1. Background and Proposal
    In the CY 2019 PFS proposed rule (83 FR 35730), we solicited 
comment on creating a bundled episode of care payment for management 
and counseling treatment for substance use disorders. We received 
approximately 50 comments on this topic, most of which were supportive 
of creating a separate bundled payment for these services. Some 
commenters recommended focusing the bundle on services related to 
medication assisted treatment (MAT) used in treatment for opioid use 
disorder (OUD). Several commenters also recommended that we establish 
higher payment amounts for patients with more complex needs who require 
more intensive services and management, and also expressed concern that 
an episode of care that limited the duration of treatment would not be 
conducive to treating OUD, given the chronic nature of this disorder. 
Other commenters recommended that we establish separate bundled 
payments for treatment of substance use disorders that does, and does 
not, involve MAT.
    In response to the public comments, we are proposing to establish 
bundled payments for the overall treatment of OUD, including 
management, care coordination, psychotherapy, and counseling 
activities. We note that, if a patient's treatment involves MAT, this 
proposed bundled payment would not include payment for the medication 
itself. Billing and payment for medications under Medicare Part B or 
Part D would remain unchanged. Additionally, payment for medically 
necessary toxicology testing would not be included in the proposed OUD 
bundle, and would continue to be billed separately under the Clinical 
Lab Fee Schedule. We are also proposing in this proposed rule to 
implement the new Medicare Part B benefit added by section 2005 of the 
SUPPORT Act for coverage of certain services furnished by Opioid 
Treatment Programs (OTPs) beginning in CY 2020. We believe the proposed 
bundled payment under the PFS for OUD treatment described below will 
create an avenue for physicians and other health professionals to bill 
for a bundle of services that is similar to the new bundled OUD 
treatment services benefit, but not furnished by an OTP. By creating a 
separate bundled payment for these services under the PFS, we hope to 
incentivize increased provision of counseling and care coordination for 
patients with OUD in the office setting, thereby expanding access to 
OUD care.
    To implement this new bundled payment, we are proposing to create 
two HCPCS G-codes to describe monthly bundles of services that include 
overall management, care coordination, individual and group 
psychotherapy and counseling for office-based OUD treatment. Although 
we considered proposing weekly-reported codes to describe a bundle of 
services that would align with the proposed OTP bundle, we believe that 
monthly-reported codes will better align with the practice and billing 
of other types of care management services furnished in office settings 
and billed under the PFS (for example, behavioral health integration 
(BHI) services). We believe monthly-reported codes would be less 
administratively burdensome for practitioners, and more likely to be 
consistent with care management and prescribing patterns in the office 
setting (as compared with an OTP) given the increased use of long-
acting MAT drugs (such as injectable naltrexone or

[[Page 40543]]

implanted buprenorphine) in the office setting compared to the OTP 
setting. Based on feedback we received through the comment 
solicitation, we are proposing to create a code to describe the initial 
month of treatment, which would include intake activities and 
development of a treatment plan, as well as assessments to aid in 
development of the treatment plan in addition to care coordination, 
individual therapy, group therapy, and counseling; a code to describe 
subsequent months of treatment including care coordination, individual 
therapy, group therapy, and counseling; and an add-on code that could 
be billed in circumstances when effective treatment requires additional 
resources for a particular patient that substantially exceed the 
resources included in the base codes. In other words, the add-on code 
would address extraordinary circumstances that are not contemplated by 
the bundled code. We acknowledge that the course of treatment for OUD 
is variable, and in some instances, the first several months of 
treatment may be more resource intensive. We welcome comments on 
whether we should consider creating a separately billable code or codes 
to describe additional resources involved in furnishing OUD treatment-
related services after the first month, for example, when substantial 
revisions to the treatment plan are needed, and what resource inputs we 
might consider in setting values for such codes.
    We believe that, in general, bundled payments create incentives to 
provide efficient care by mitigating incentives tied to volume of 
services furnished, and that these incentives can be undermined by 
creating separate billing mechanisms to account for higher resource 
costs for particular patients. However, we share some of the concerns 
raised by commenters that an OUD bundle should not inadvertently limit 
the appropriate amount of OUD care furnished to patients with varying 
medical needs. In consideration of this concern, we are proposing to 
create an add-on code to make appropriate payment for additional 
resource costs in order to mitigate the risks that the bundled OUD 
payment might limit clinically-indicated patient care for patients that 
require significantly more care than is in the range of what is typical 
for the kinds of care described by the base codes. However, we are also 
interested in comments regarding ways we might better stratify the 
coding for OUD treatment to reflect the varying needs of patients 
(based on complexity or frequency of services, for example) while 
maintaining the full advantage of the bundled payment, including 
increased efficiency and flexibility in furnishing care.
    We anticipate that these services would often be billed by 
addiction specialty practitioners, but note that these codes are not 
limited to any particular physician or non-physician practitioner 
specialty. Additionally, unlike the codes that describe care furnished 
using the psychiatric collaborative care model (CPT codes 99492, 99493, 
and 99494), which require consultation with a psychiatric consultant, 
we are not proposing to require consultation with a specialist as a 
condition of payment for these codes.
    The codes and descriptors for the proposed services are:
     HCPCS code GYYY1: Office-based treatment for opioid use 
disorder, including development of the treatment plan, care 
coordination, individual therapy and group therapy and counseling; at 
least 70 minutes in the first calendar month.
     HCPCS code GYYY2: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; at least 60 minutes in a subsequent calendar 
month.
     HCPCS code GYYY3: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; each additional 30 minutes beyond the first 120 
minutes (List separately in addition to code for primary procedure).
    For the purposes of valuation for HCPCS codes GYYY1 and GYYY2, we 
are assuming two individual psychotherapy sessions per month and four 
group psychotherapy sessions per month; however, we understand that the 
number of therapy and counseling sessions furnished per month will vary 
among patients and also fluctuate over time based on the individual 
patient's needs. Consistent with the methodology for pricing other 
services under the PFS, HCPCS codes GYYY1, GYYY2, and GYYY3 are 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. In order to maintain the advantages inherent 
in developing a payment bundle, we are proposing that the add-on code 
(HCPCS code GYYY3) can only be billed when the total time spent by the 
billing professional and the clinical staff furnishing the OUD 
treatment services described by the base code exceeds double the 
minimum amount of service time required to bill the base code for the 
month. We believe it is appropriate to limit billing of the add-on code 
to situations where medically necessary OUD treatment services for a 
particular patient exceed twice the minimum service time for the base 
code because, as noted above, the add-on code is intended to address 
extraordinary situations where effective treatment requires additional 
resources that substantially exceed the resources included in the base 
codes. For example, the needs of a particular patient in a month may be 
unusually acute, well beyond the needs of the typical patient; or there 
may be some months when psychosocial stressors arise that were 
unforeseen at the time the treatment plan was developed, but warrant 
additional or more intensive therapy services for the patient. We are 
proposing that when the time requirement is met, HCPCS code GYYY3 could 
be billed as an add-on code during the initial month or subsequent 
months of OUD treatment. Practitioners should document the medical 
necessity for the use of the add-on code in the patient's medical 
record. We welcome comments on this proposal.
    We are proposing to value HCPCS codes GYYY1, GYYY2, and GYYY3 using 
a building block methodology that sums the work RVUs and direct PE 
inputs from codes that describe the component services we believe would 
be typical, consistent with the approach we have previously used in 
valuing monthly care management services that include face-to-face 
services within the payment. For HCPCS code GYYY1, we developed 
proposed inputs using a crosswalk to CPT code 99492 (Initial 
psychiatric collaborative care management, first 70 minutes in the 
first calendar month of behavioral health care manager activities, in 
consultation with a psychiatric consultant, and directed by the 
treating physician or other qualified health care professional, with 
the following required elements: Outreach to and engagement in 
treatment of a patient directed by the treating physician or other 
qualified health care professional; initial assessment of the patient, 
including administration of validated rating scales, with the 
development of an individualized treatment plan; review by the 
psychiatric consultant with modifications of the plan if recommended; 
entering patient in a registry and tracking patient follow-up and 
progress using the registry, with appropriate documentation, and 
participation in weekly caseload consultation with the psychiatric

[[Page 40544]]

consultant; and provision of brief interventions using evidence-based 
techniques such as behavioral activation, motivational interviewing, 
and other focused treatment strategies.), which is assigned a work RVU 
of 1.70, plus CPT code 90832 (Psychotherapy, 30 minutes with patient), 
which is assigned a work RVU of 1.50 (assuming two over the course of 
the month), and CPT code 90853 (Group psychotherapy (other than of a 
multiple-family group)), which is assigned a work RVU of 0.59 (assuming 
four over the course of a month), for a work RVU of 7.06. The required 
minimum number of minutes described in HCPCS code GYYY1 is also based 
on a crosswalk to CPT codes 99492. Additionally, for HCPCS code GYYY1, 
we are proposing to use a crosswalk to the direct PE inputs associated 
with CPT code 99492, CPT code 90832 (times two), and CPT code 90853 
(times four). We believe that the work and practice expense described 
by these crosswalk codes is analogous to the services described in 
HCPCS code GYYY1 because HCPCS code GYYY1 includes similar care 
coordination activities as described in CPT code 99492 and bundles in 
the psychotherapy services described in CPT codes 90832 and 90853.
    We are proposing to value HCPCS code GYYY2 using a crosswalk to CPT 
code 99493 (Subsequent psychiatric collaborative care management, first 
60 minutes in a subsequent month of behavioral health care manager 
activities, in consultation with a psychiatric consultant, and directed 
by the treating physician or other qualified health care professional, 
with the following required elements: Tracking patient follow-up and 
progress using the registry, with appropriate documentation; 
participation in weekly caseload consultation with the psychiatric 
consultant; ongoing collaboration with and coordination of the 
patient's mental health care with the treating physician or other 
qualified health care professional and any other treating mental health 
providers; additional review of progress and recommendations for 
changes in treatment, as indicated, including medications, based on 
recommendations provided by the psychiatric consultant; provision of 
brief interventions using evidence-based techniques such as behavioral 
activation, motivational interviewing, and other focused treatment 
strategies; monitoring of patient outcomes using validated rating 
scales; and relapse prevention planning with patients as they achieve 
remission of symptoms and/or other treatment goals and are prepared for 
discharge from active treatment), which is assigned a work RVU of 1.53, 
plus CPT code 90832, which is assigned a work RVU of 1.50 (assuming two 
over the course of the month), and CPT code 90853, which is assigned a 
work RVU of 0.59 (assuming four over the course of a month), for a work 
RVU of 6.89. The required minimum number of minutes described in HCPCS 
code GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS 
code GYYY2, we are proposing to use a crosswalk to the direct PE inputs 
associated with CPT code 99493, CPT code 90832 (times two), and CPT 
code 90853 (times four). We believe that the work and practice expense 
described by these crosswalk codes is analogous to the services 
described in HCPCS code GYYY2 because HCPCS code GYYY2 includes similar 
care coordination activities as described in CPT code 99493 and bundles 
in the psychotherapy services described in CPT codes 90832 and 90853.
    We are proposing to value HCPCS code GYYY3 using a crosswalk to CPT 
code 99494 (Initial or subsequent psychiatric collaborative care 
management, each additional 30 minutes in a calendar month of 
behavioral health care manager activities, in consultation with a 
psychiatric consultant, and directed by the treating physician or other 
qualified health care professional (List separately in addition to code 
for primary procedure)), which is assigned a work RVU of 0.82. The 
required minimum number of minutes described in HCPCS code GYYY2 is 
also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY3, we 
are proposing to use a crosswalk to the direct PE inputs associated 
with CPT code 99494. We believe that the work and practice expense 
described by this crosswalk code is analogous to the services described 
in HCPCS code GYYY3 because HCPCS code GYYY3 includes similar care 
coordination activities as described in CPT code 99494.
    For additional details on the proposed direct PE inputs for HCPCS 
codes GYYY1-GYYY3, see Table 22.
    We understand that many beneficiaries with OUD have comorbidities 
and may require medically-necessary psychotherapy services for other 
behavioral health conditions. In order to avoid duplicative billing, we 
are proposing that, when furnished to treat OUD, CPT codes 90832, 
90834, 90837, and 90853 may not be reported by the same practitioner 
for the same beneficiary in the same month as HCPCS codes GYYY1, GYYY2, 
and GYYY3. We welcome comments on this proposal.
    We are proposing that practitioners reporting the OUD bundle must 
furnish a separately reportable initiating visit in association with 
the onset of OUD treatment, since the bundle requires a level of care 
coordination that cannot be effective without appropriate evaluation of 
the patient's needs. This is similar to the requirements for chronic 
care management (CCM) services (CPT codes 99487, 99489, 99490, and 
99491) and BHI services (CPT codes 99484, 99492, 99493, and 99494) 
finalized in the CY 2017 PFS final rule (81 FR 80239) The initiating 
visit would establish the beneficiary's relationship with the billing 
practitioner, ensure the billing practitioner assesses the beneficiary 
to determine clinical appropriateness of MAT in cases where MAT is 
being furnished, and provide an opportunity to obtain beneficiary 
consent to receive care management services (as discussed further 
below). We propose that the same services that can serve as the 
initiating visit for CCM services and BHI services can serve as the 
initiating visit for the proposed services described by HCPCS codes 
GYYY1-GYYY3. For new patients or patients not seen by the practitioner 
within a year prior to the commencement of CCM services and BHI 
services, the billing practitioner must initiate the service during a 
``comprehensive'' E/M visit (levels 2 through 5 E/M visits), annual 
wellness visit (AWV) or initial preventive physical exam (IPPE). The 
face-to-face visit included in transitional care management (TCM) 
services (CPT codes 99495 and 99496) also qualifies as a 
``comprehensive'' visit for CCM and BHI initiation. We propose that 
these visits could similarly serve as the initiating visit for OUD 
services.
    We are proposing that the counseling, therapy, and care 
coordination described in the proposed OUD treatment codes could be 
provided by professionals who are qualified to provide the services 
under state law and within their scope of practice ``incident to'' the 
services of the billing physician or other practitioner. We are also 
proposing that the billing clinician would manage the patient's overall 
care, as well as supervise any other individuals participating in the 
treatment, similar to the structure of the BHI codes describing the 
psychiatric collaborative care model finalized in the CY 2017 PFS final 
rule (81 FR 80229), in which services are reported by a treating 
physician or other qualified health care professional and include the 
services of the treating physician or other qualified health care 
professional,

[[Page 40545]]

as well as the services of other professionals who furnish services 
incident to the services of the treating physician or other qualified 
health care professional. Additionally, we are proposing to add these 
codes to the list of designated care management services for which we 
allow general supervision of the non-face-to-face portion of the 
required services. Consistent with policies for other separately 
billable care management services under the PFS, because these proposed 
OUD treatment bundles include non-face-to-face care management 
components, we are proposing that the billing practitioner or clinical 
staff must document in the beneficiary's medical record that they 
obtained the beneficiary's consent to receive the services, and that, 
as part of the consent, they informed the beneficiary that there is 
cost sharing associated with these services, including potential 
deductible and coinsurance amounts, for both in-person and non-face-to-
face services that are provided.
    We are also proposing to allow any of the individual therapy, group 
therapy and counseling services included in HCPCS codes GYYY1, GYYY2, 
and GYYY3 to be furnished via telehealth, as clinically appropriate, in 
order to increase access to care for beneficiaries. As discussed in 
section II.F. of this proposed rule regarding Telehealth Services, like 
certain other non-face-to-face PFS services, the components of HCPCS 
codes GYYY1 through GYYY3 describing care coordination 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 services 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 GYYY1 
through GYYY3 are similar to other telehealth services. If the non-
face-to-face components of HCPCS codes GYYY1 through GYYY3 were 
separately billable, they would not need to be on the Medicare 
telehealth list to be covered and paid in the same way as services 
delivered without the use of telecommunications technology.
    Section 2001(a) of the SUPPORT Act amended section 1834(m) of the 
Act, adding a new paragraph (7) that removes the geographic limitations 
for telehealth services furnished on or after July 1, 2019, to an 
individual with a substance use disorder (SUD) diagnosis for purposes 
of treatment of such disorder or co-occurring mental health disorder. 
The new paragraph at section 1834(m)(7) of the Act also allows 
telehealth services for treatment of a diagnosed SUD or co-occurring 
mental health disorder to be furnished to individuals at any telehealth 
originating site (other than a renal dialysis facility), including in a 
patient's home. As discussed in section II.F. of this proposed rule, 
Telehealth Services, we are proposing to add HCPCS codes GYYY1, GYYY2, 
and GYYY3 to the list of Medicare Telehealth services. Because certain 
required services (such as individual psychotherapy or group 
psychotherapy services) that are included in the proposed OUD bundled 
payment codes would be furnished to treat a diagnosed SUD, and would 
ordinarily require a face-to-face encounter, they could be furnished 
more broadly as telehealth services as permitted under section 
1834(m)(7) of the Act.
    For these proposed services described above (HCPCS codes GYYY1, 
GYYY2, and GYYY3), we seek comment on how these potential codes, 
descriptors, and payment rates align with state Medicaid coding and 
payment rates for the purposes of state payment of cost sharing for 
Medicare-Medicaid dually eligible individuals. Additionally, we 
understand that treatment for OUD can vary, and that MAT alone has 
demonstrated efficacy. In cases where a medication such as 
buprenorphine or naltrexone is used to treat OUD alone, without therapy 
or counseling, we note that existing applicable codes can be used to 
furnishing and bill for that care (for example, using E/M visits, in 
lieu of billing the bundled OUD codes proposed here).
    As discussed in section II.G. of this proposed rule, Medicare 
Coverage for Certain Services Furnished by Opioid Treatment Programs, 
we are proposing to set the copayment at zero for OUD services 
furnished by an OTP, given the flexibility in section 1834(w)(1) of the 
Act for us to set the copayment amount for OTP services either at zero 
or at an amount above zero. We note that we do not have the statutory 
authority to eliminate the deductible and coinsurance requirements for 
the bundled OUD treatment services under the PFS. We acknowledge the 
potential impact of coinsurance on patient health care decisions and 
intend to monitor its impact if these proposals were to be finalized.
    Finally, we recognize that historically, the CPT Editorial Panel 
has frequently created CPT codes describing services that we originally 
established using G-codes and adopted them through the CPT Editorial 
Panel process. We note that we would consider new using any available 
CPT coding to describe services similar to those described here in 
future rulemaking, as early as CY 2021. We would consider and adopt any 
such CPT codes through subsequent rulemaking.
    Additionally, we understand that in some cases, OUD can first 
become apparent to practitioners in the emergency department setting. 
We recognize that there is not specific coding that describes diagnosis 
of OUD or the initiation of, or referral for, MAT in the emergency 
department setting. We are seeking comment on the use of MAT in the 
emergency department setting, including initiation of MAT and the 
potential for either referral or follow-up care, as well as the 
potential for administration of long-acting MAT agents in this setting, 
in order to better understand typical practice patterns to help inform 
whether we should consider making separate payment for such services in 
future rulemaking. We welcome feedback from stakeholders and the public 
on other potential bundles describing services for other substance use 
disorders for our consideration in future rulemaking.
2. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers 
(FQHCs)
    In the CY 2018 PFS final rule (82 FR 53169 through 53180), we 
established payment for General Care Management (CCM) services using 
HCPCS G0511 which is an RHC and FQHC-specific G code for at least 20 
minutes of CCM, complex CCM, or general behavioral health services. 
Payment for this code is currently set at the average of the non-
facility, non-geographically adjusted payment rates for CPT codes 
99490, 99487, 99491, and 99484. The types of chronic conditions that 
are eligible for care management services include mental health or 
behavioral health conditions, including substance use disorders.
    In the CY 2018 PFS final rule with comment period (82 FR 53169 
through 53180), we also established payment for psychiatric 
Collaborative Care Services (CoCM) using HCPCS code G0512, which is an 
RHC and FQHC specific G-code for at least 70 minutes in the first 
calendar month, and at least 60 minutes in subsequent calendar months 
of psychiatric CoCM services. Payment for this code is set at the 
average of the non-facility, non-geographically adjusted rates for CPT 
codes 99492 and 99493. The psychiatric CoCM model of care may be used 
to treat patients with any behavioral health condition that is being 
treated by the billing practitioner, including substance use disorders.

[[Page 40546]]

    RHCs and FQHCs can also bill for individual psychotherapy services 
using CPT codes 90791, 90792, 90832, 90834, 90837, 90839, or 90845, 
which are billable visits under the RHC all-inclusive rate (AIR) and 
FQHC Prospective Payment System (PPS) when furnished by an RHC or FQHC 
practitioner. If a qualified mental health service is furnished on the 
same day as a qualified primary care service, the RHC or FQHC can bill 
for 2 visits.
    RHCs and FQHCs are engaged primarily in providing services that are 
furnished typically in a physician's office or an outpatient clinic. As 
a result of the proposed bundled payment under the PFS for OUD 
treatment furnished by physicians, we reviewed the applicability of 
RHCs and FQHCs furnishing and billing for similar services. 
Specifically, we considered establishing a new RHC and FQHC specific G 
code for OUD treatment with the payment rate set at the average of the 
non-facility, non-geographically adjusted payment rates for GYYY1 and 
GYYY2, beginning on January 1, 2020. The requirements to bill the 
services would be similar to the requirements under the PFS for GYYY1 
and GYYY2, including that an initiating visit with a primary care 
practitioner must occur within one year before OUD services begin, and 
that consent be obtained before services are furnished.
    However, because RHCs and FQHCs that choose to furnish OUD services 
can continue to report these individual codes when treating OUD, and 
can also offer their patients comprehensive care coordination services 
using HCPCS codes G0511 and G0512, we do not believe that adding a new 
and separate code to report a bundle of OUD services is necessary. 
Therefore, we are not proposing to add a new G code for a bundle of OUD 
service.

I. Physician Supervision for Physician Assistant (PA) Services

1. Background
    Section 4072(e) of the Omnibus Budget Reconciliation Act of 1986 
(Pub. L. 99-509, October 21, 1986), added section 1861(s)(2)(K)(i) of 
the Act to establish a benefit for services furnished by a physician 
assistant (PA) under the supervision of a physician. We have 
interpreted this physician supervision requirement in the regulation at 
Sec.  410.74(a)(2)(iv) to require PA services to be furnished under the 
general supervision of a physician. This general supervision 
requirement was based upon another longstanding regulation at Sec.  
410.32(b)(3)(i) that defines three levels of supervision for diagnostic 
tests, which are general, direct and personal supervision. Of these 
three supervision levels, general supervision is the most lenient. 
Specifically, the general supervision requirement means that PA 
services must be furnished under a physician's overall direction and 
control, but the physician's presence is not required during the 
performance of PA services.
    In the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we 
published a request for information (RFI) on CMS flexibilities and 
efficiencies. In response to this RFI, commenters including PA 
stakeholders informed us about recent changes in the practice of 
medicine for PAs, particularly regarding physician supervision. These 
commenters also reached out separately to CMS with their concerns. They 
stated that PAs are now practicing more autonomously, like nurse 
practitioners (NPs) and clinical nurse specialists (CNSs), as members 
of medical teams that often consist of physicians, nonphysician 
practitioners and other allied health professionals. This changed 
approach to the delivery of health care services involving PAs has 
resulted in changes to scope of practice laws for PAs regarding 
physician supervision across some states. According to these 
commenters, some states have already relaxed their requirements for PAs 
related to physician supervision, some states have made changes and are 
now silent about their physician supervision requirements, while other 
states have not yet changed their PA scope of practice in terms of 
their physician supervision requirements. Overall, these commenters 
believe that as states continue to make changes to their physician 
supervision requirements for PAs, the Medicare requirement for general 
supervision of PA services may become increasingly out of step with 
current medical practice, imposing a more stringent standard than state 
laws governing physician supervision of PA services. Furthermore, as 
currently defined, stakeholders have suggested that the supervision 
requirement is often misinterpreted or misunderstood in a manner that 
restricts PAs' ability to practice to the full extent of their 
education and expertise. The stakeholders have suggested that the 
current regulatory definition of physician supervision as it applies to 
PAs could inappropriately restrict the practice of PAs in delivering 
their professional services to the Medicare population.
    We note that we have understood our current policy to require 
general physician supervision for PA services to fulfill the statutory 
physician supervision requirement; and we believe that general 
physician supervision gives PAs flexibility to furnish their 
professional services without the need for a physician's physical 
presence or availability. Nonetheless, we appreciate the concerns 
articulated by stakeholders. To more fully understand the current 
landscape for medical practice involving PA services and how the 
current regulatory definition may be problematic, we invite public 
comments on specific examples of changes in state law and state scope 
of practice rules that enable PAs to practice more broadly such that 
those rules are in tension with the Medicare requirement for general 
physician supervision of PA services that has been in place since the 
inception of the PA benefit category under Medicare law.
    Given the commenters' understanding of ongoing changes underway to 
the state scope of practice laws regarding physician supervision of PA 
services, commenters on our CY 2018 RFI have requested that CMS 
reconsider its interpretation of the statutory requirement that PA 
services must be furnished under the supervision of a physician to 
allow PAs to operate similarly to NPs and CNSs, who are required by 
section 1861(s)(2)(K)(ii) of the Act to furnish their services ``in 
collaboration'' with a physician. In general, we have interpreted 
collaboration for this purpose at Sec. Sec.  410.75(c)(3) and 
410.76(c)(3) of our regulations to mean a process in which an NP or CNS 
(respectively) works with one or more physicians to deliver health care 
services within the scope of the practitioner's expertise, with medical 
direction and appropriate supervision as provided by state law in which 
the services are performed. The commenters stated that allowing PA 
services to be furnished using such a collaborative process would offer 
PAs the flexibility necessary to deliver services more effectively 
under today's health care system in accordance with the scope of 
practice in the state(s) where they practice, rather than being limited 
by the system that was in place when PA services were first covered 
under Medicare Part B over 30 years ago.
2. Proposal
    After considering the comments we received on the RFI, as well as 
information we received regarding the scope of practice laws in some 
states regarding supervision requirements for PAs, we are proposing to 
revise the regulation at Sec.  410.74 that establishes physician 
supervision requirements for PAs. Specifically, we are proposing to

[[Page 40547]]

revise Sec.  410.74(a)(2) to provide that the statutory physician 
supervision requirement for PA services at section 1861(s)(2)(K)(i) of 
the Act would be met when a PA furnishes their services in accordance 
with state law and state scope of practice rules for PAs in the state 
in which the services are furnished, with medical direction and 
appropriate supervision as provided by state law in which the services 
are performed. In the absence of state law governing physician 
supervision of PA services, the physician supervision required by 
Medicare for PA services would be evidenced by documentation in the 
medical record of the PA's approach to working with physicians in 
furnishing their services. Consistent with current rules, such 
documentation would need to be available to CMS, upon request. This 
proposed change would substantially align the regulation on physician 
supervision for PA services at Sec.  410.74(a)(2) with our current 
regulations on physician collaboration for NP and CNS services at 
Sec. Sec.  410.75(c)(3) and 410.76(c)(3). We continue to engage with 
key stakeholders on this issue and receive information on the expanded 
role of nonphysician practitioners as members of the medical team. As 
we are informed about transitions in state law and state scope of 
practice governing physician supervision, as well as changes in the way 
that PAs practice, we acknowledge the state's role and autonomy to 
establish, uphold, and enforce their state laws and PA scope of 
practice requirements to ensure that an appropriate level of physician 
oversight occurs when PAs furnish their professional services to 
Medicare Part B patients. Our policy proposal on this issue largely 
defers to state law and state scope of practice and enables states the 
flexibility to develop requirements for PA services that are unique and 
appropriate for their respective state, allowing the states to be 
accountable for the safety and quality of health care services that PAs 
furnish.

J. Review and Verification of Medical Record Documentation

1. Background
    In an effort to reduce mandatory and duplicative medical record 
evaluation and management (E/M) documentation requirements, we 
finalized an amended regulatory provision at 42 CFR part 415, subpart 
D, in the CY 2019 PFS final rule (83 FR 59653 through 59654). 
Specifically, Sec.  415.172(a) requires as a condition of payment under 
the PFS that the teaching physician (as defined in Sec.  415.152) must 
be present during certain portions of services that are furnished with 
the involvement of residents (individuals who are training in a 
graduate medical education program). Section 415.174(a) provides for an 
exception to the teaching physician presence requirements in the case 
of certain E/M services under certain conditions, but requires that the 
teaching physician must direct and review the care provided by no more 
than four residents at a time. Sections 415.172(b) and 415.174(a)(6), 
respectively require that the teaching physician's presence and 
participation in services involving residents must be documented in the 
medical record. We amended these regulations to provide that a 
physician, resident, or nurse may document in the patient's medical 
record that the teaching physician presence and participation 
requirements were met. As a result, for E/M visits furnished beginning 
January 1, 2019, the extent of the teaching physician's participation 
in services involving residents may be demonstrated by notes in the 
medical records made by a physician, resident, or nurse.
    For the same burden reduction purposes, we issued CR 10412, 
Transmittal 3971 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3971CP.pdf on February 2, 2018, which 
revised a paragraph in our manual instructions on ``Teaching Physician 
Services'' at Pub. 100-04, Medicare Claims Processing Manual, Chapter 
12, Section 100.1.1B., to reduce duplicative documentation requirements 
by allowing a teaching physician to review and verify (sign/date) notes 
made by a student in a patient's medical record for E/M services, 
rather than having to re-document the information, largely duplicating 
the student's notes. We issued corrections to CR 10412 through 
Transmittal 4068 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4068CP.pdf and re-issued the CR on May 31, 
2018. Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 100 contains a list of definitions pertinent to teaching 
physician services. Following these amendments to our regulations and 
manual, certain stakeholders raised concerns about the definitions in 
this section, particularly those for teaching physician, student, and 
documentation; and when considered in conjunction with the 
interpretation of the manual provision at Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 100.1.1B., which addresses 
documentation of E/M services involving students. While there is no 
regulatory definition of student, the manual instruction defines a 
student as an individual who participates in an accredited educational 
program (for example, a medical school) that is not an approved 
graduate medical education (GME) program. The manual instructions also 
specify that a student is never considered to be an intern or a 
resident, and that Medicare does not pay for services furnished by a 
student (see Section 100.1.1B. for a discussion concerning E/M service 
documentation performed by students).
    We are aware that nonphysician practitioners who are authorized 
under Medicare Part B to furnish and be paid for all levels of E/M 
services are seeking similar relief from burdensome E/M documentation 
requirements that would allow them to review and verify medical record 
notes made by their students, rather than having to re-document the 
information. These nonphysician practitioners include nurse 
practitioners (NPs), clinical nurse specialists (CNSs), and certified 
nurse-midwives (CNMs), collectively referred to hereafter for purposes 
of this discussion as advanced practice registered nurses (APRNs), as 
well as physician assistants (PAs). Subsequent to the publication of 
the CY 2019 PFS final rule (83 FR 59653 through 59654), through 
feedback from listening sessions hosted by CMS' Documentation 
Requirements Simplification workgroup, we began to hear concerns from a 
variety of stakeholders about the requirements for teaching physician 
review and verification of documentation added to the medical record by 
other individuals. Physician and nonphysician practitioner stakeholders 
expressed concern about the scope of the changes to Sec. Sec.  
415.172(b) and 415.174(a)(6) which authorize only a physician, 
resident, or nurse to include notes in the medical record to document 
E/M services furnished by teaching physicians, because they believed 
that students and other members of the medical team should be similarly 
permitted to provide E/M medical record documentation. In addition to 
students, these stakeholders indicated that ``other members of the 
medical team'' could include individuals who the teaching physician, 
other physicians, PA and APRN preceptors designate as being appropriate 
to document services in the medical record, which the billing 
practitioner would then review and verify, and rely upon for billing 
purposes.
    Subsequent to the publication of the student documentation manual

[[Page 40548]]

instruction change at section 100.1.1B of the Medicare Claims 
Processing Manual, representatives of PAs and APRNs requested 
clarification about whether PA and APRN preceptors and their students 
were subject to the same E/M documentation requirements as teaching 
physicians and their medical students. These stakeholders suggested 
that the reference to ``student'' in the manual instruction on E/M 
documentation provided by students is ambiguous because it does not 
specify ``medical student''. These stakeholders also suggested that the 
definition of ``student'' in section 100 of this manual instruction is 
ambiguous because PA and APRN preceptors also educate students who are 
individuals who participate in an accredited educational program that 
is not an approved GME program. Accordingly, these stakeholders 
expressed concern that the uncertainty throughout the health care 
industry, including among our contractors, concerning the student E/M 
documentation review and verification policy under these manual 
guidelines results in unequal treatment as compared to teaching 
physicians. The stakeholders stated that depending on how the manual 
instruction is interpreted, PA and APRN preceptors may be required to 
re-document E/M services in full when their students include notes in 
the medical records, without having the same option that teaching 
physicians do to simply review and verify medical student 
documentation.
2. Proposal
    After considering the concerns expressed by these stakeholders, we 
believe it would be appropriate to provide broad flexibility to the 
physicians, PAs and APRNs (regardless of whether they are acting in a 
teaching capacity) who document and who are paid under the PFS for 
their professional services. Therefore, we propose to establish a 
general principle to allow the physician, the PA, or the APRN who 
furnishes and bills for their professional services to review and 
verify, rather than re-document, information included in the medical 
record by physicians, residents, nurses, students or other members of 
the medical team. This principle would apply across the spectrum of all 
Medicare-covered services paid under the PFS. Because this proposal is 
intended to apply broadly, we propose to amend regulations for teaching 
physicians, physicians, PAs, and APRNs to add this new flexibility for 
medical record documentation requirements for professional services 
furnished by physicians, PAs and APRNs in all settings. We invite 
comments on this proposal.
    Specifically, to reflect our simplified and standardized approach 
to medical record documentation for all professional services furnished 
by physicians, PAs and APRNs paid under the PFS, we are proposing to 
amend Sec. Sec.  410.20 (Physicians' services), 410.74 (PA services), 
410.75 (NP services), 410.76 (CNS services) and 410.77 (CNM services) 
to add a new paragraph entitled, ``Medical record documentation.'' This 
paragraph would specify that, when furnishing their professional 
services, the clinician may review and verify (sign/date) notes in a 
patient's medical record made by other physicians, residents, nurses, 
students, or other members of the medical team, including notes 
documenting the practitioner's presence and participation in the 
services, rather than fully re-documenting the information. We note 
that, while the proposed change addresses who may document services in 
the medical record, subject to review and verification by the 
furnishing and billing clinician, it does not modify the scope of, or 
standards for, the documentation that is needed in the medical record 
to demonstrate medical necessity of services, or otherwise for purposes 
of appropriate medical recordkeeping.
    We are also proposing to make conforming amendments to Sec. Sec.  
415.172(b) and 415.174(a)(6) to also allow physicians, residents, 
nurses, students, or other members of the medical team to enter 
information in the medical record that can then be reviewed and 
verified by a teaching physician without the need for re-documentation. 
We invite comments on these proposed amendments to our regulations.

K. Care Management Services

1. Background
    In recent years, we have updated PFS payment policies to improve 
payment for care management and care coordination. Working with the CPT 
Editorial Panel and other clinicians, we have expanded the suite of 
codes describing these services. New CPT codes were created that 
distinguish between services that are face-to-face; represent a single 
encounter, monthly service or both; are timed services; represent 
primary care versus specialty care; address specific conditions; and 
represent the work of the billing practitioner, their clinical staff, 
or both (see Table 16). Additional information regarding recent new 
codes and associated PFS payment rules is available on our website at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.

           Table 16--Summary of Special Care Management Codes
------------------------------------------------------------------------
                Service                              Summary
------------------------------------------------------------------------
Care Plan Oversight (CPO) (also          Supervision of home health,
 referred to as Home Health               hospice, per month.
 Supervision, Hospice Supervision)
 (HCPCS Codes G0181, G0182).
ESRD Monthly Services (CPT Codes 90951-  ESRD management, with and
 70).                                     without face-to-face visits,
                                          by age, per month.
Transitional Care Management (TCM)       Management of transition from
 (adopted in 2013) (CPT Codes 99495,      acute care or certain
 99496).                                  outpatient stays to a
                                          community setting, with face-
                                          to-face visit, once per
                                          patient within 30 days post-
                                          discharge.
Chronic Care Management (CCM) (adopted   Management of all care for
 in 2015, 2017, 2019) (CPT Codes 99487,   patients with two or more
 99489, 99490, 99491).                    serious chronic conditions,
                                          timed, per month.
Advance Care Planning (ACP) (adopted in  Counseling/discussing advance
 2016) (CPT Codes 99497, 99498).          directives, face-to-face,
                                          timed.
Behavioral Health Integration (BHI)      Management of behavioral health
 (adopted in 2017) (CPT Codes 99484,      conditions(s), timed, per
 99492, 99493, 99494).                    month.
Assessment/Care Planning for Cognitive   Assessment and care planning of
 Impairment (adopted in 2017) (CPT Code   cognitive impairment, face-to-
 99483).                                  face visit.
Prolonged Evaluation & Management (E/M)  Non-face-to-face E&M work
 Without Direct Patient Contact           related to a face-to-face
 (adopted in 2017) (CPT Codes 99358,      visit, timed.
 99359).

[[Page 40549]]

 
Remote Patient Monitoring (adopted in    Review and analysis of patient-
 2019) (CPT Code 99091).                  generated health data, timed,
                                          per 30 days.
Interprofessional Consultation (adopted  Inter-practitioner
 in 2019) (CPT Codes 99446, 99447,        consultation.
 99448, 99449, 99451, 99452).
------------------------------------------------------------------------

    Based on our review of the Medicare claims data we estimate that 
approximately 3 million unique beneficiaries (9 percent of the Medicare 
fee-for-service (FFS) population) receive these services annually, with 
higher use of chronic care management (CCM), transitional care 
management (TCM), and advance care planning (ACP) services. We believe 
gaps remain in coding and payment, such as for care management of 
patients having a single, serious, or complex chronic condition. In 
this proposed rule, we continue our ongoing work in this area through 
code set refinement related to TCM services and CCM services, in 
addition to proposing new coding for principal care management (PCM) 
services, and addressing chronic care remote physiologic monitoring 
(RPM) services.
2. Transitional Care Management (TCM) Services
    Utilization of TCM services has increased each year since CMS 
established coding and began paying separately for TCM services. 
Specifically, there were almost 300,000 TCM professional claims during 
2013, the first year of TCM services, and almost 1.3 million 
professional claims during 2018, the most recent year of complete 
claims data. However, based upon an analysis of claims data by Bindman 
and Cox,\78\ utilization of TCM services is low when compared to the 
number of Medicare beneficiaries with eligible discharges. 
Additionally, Bindman and Cox noted that the beneficiaries who received 
TCM services demonstrated reduced readmission rates, lower mortality, 
and decreased health care costs. Based upon these findings, we believe 
that increasing utilization of TCM services could positively affect 
patient outcomes.
---------------------------------------------------------------------------

    \78\ Bindman, AB, Cox DF. Changes in health care costs and 
mortality associated with transitional care management services 
after a discharge among Medicare beneficiaries [published online 
July 30, 2018]. JAMA Intern Med, doi:10.1001/
jamainternmed.2018.2572.
---------------------------------------------------------------------------

    In developing a proposal designed to increase utilization of TCM 
services, we considered possible factors contributing to low 
utilization. Bindman and Cox identified two likely contributing 
factors: The administrative burdens associated with billing TCM 
services and the payment amount to physicians for services.
    We focused initially on the requirements for billing TCM services. 
In reviewing the TCM billing requirements, we noted that we had 
established in the CY 2013 PFS final rule with comment period a list of 
57 HCPCS codes that cannot be billed during the 30-day period covered 
by TCM services by the same practitioner reporting TCM (77 FR 68990). 
This list mirrored reporting restrictions put in place by the CPT 
Editorial Panel for the TCM codes upon their creation. At the time we 
established separate payment for the TCM CPT codes, we agreed with the 
CPT Editorial Panel that the services described by the 57 codes could 
be overlapping and duplicative with TCM in their definition and scope; 
although, many of these codes were not separately payable or covered 
under the PFS so even if they were reported for PFS payment, they would 
not be have been separately paid (see, for example, 77 FR 68985). In 
response to those concerns, we adopted billing restrictions to avoid 
duplicative billing and payment for covered services. In our recent 
analysis of the services associated with the 57 codes, we found that 
the majority of codes on the list remain either bundled, noncovered by 
Medicare, or invalid for Medicare payment purposes. Table 17 provides 
detailed information regarding the subset of these codes that would be 
separately payable under the PFS (Status Indicator ``A'') and, as such, 
are the focus of this year's CY 2020 proposed policy for TCM. Fourteen 
(14) codes on the list represent active codes that are paid separately 
under the PFS and that upon reconsideration, we believe may not 
substantially overlap with TCM services and should be separately 
payable alongside TCM. For example, CPT code 99358 (Prolonged E/M 
service before and/or after direct patient care; first hour; non-face-
to-face time spent by a physician or other qualified health care 
professional on a given date providing prolonged service) would allow 
the physician or other qualified healthcare professional extra time to 
review records and manage patient support services after the face-to-
face visit required as part of TCM services. CPT code 99091 (Collection 
& interpretation of physiologic data, requiring a minimum of 30 minutes 
each 30 days) would permit the physician or other qualified healthcare 
professional to collect and analyze physiologic parameters associated 
with the patient's chronic disease.
    Thus, after review of the services described by these 14 HCPCS 
codes, we believe these codes, when medically necessary, may complement 
TCM services rather than substantially overlap or duplicate services. 
We also believe removing the billing restrictions associated with these 
codes may increase utilization of TCM services.

  Table 17--14 HCPCS Codes That Currently Cannot Be Billed Concurrently
    With TCM by the Same Practitioner and Are Active Codes Payable by
                              Medicare PFS
------------------------------------------------------------------------
           Code family              HCPCS code         Descriptor
------------------------------------------------------------------------
Prolonged Services without Direct        99358  Prolonged E/M service
 Patient Contact.                                before and/or after
                                                 direct patient care;
                                                 first hour; non-face-to-
                                                 face time spent by a
                                                 physician or other
                                                 qualified health care
                                                 professional on a given
                                                 date providing
                                                 prolonged service.
                                         99359  Prolonged E/M service
                                                 before and/or after
                                                 direct patient care;
                                                 each additional 30
                                                 minutes beyond the
                                                 first hour of prolonged
                                                 services.

[[Page 40550]]

 
Home and Outpatient International        93792  Patient/caregiver
 Normalized Ratio (INR)                  93793   training for initiation
 Monitoring Services.                            of home INR monitoring.
                                                Anticoagulant management
                                                 for a patient taking
                                                 warfarin; includes
                                                 review and
                                                 interpretation of a new
                                                 home, office, or lab
                                                 INR test result,
                                                 patient instructions,
                                                 dosage adjustment and
                                                 scheduling of
                                                 additional test(s).
End Stage Renal Disease Services         90960  ESRD related services
 (patients who are 20+ years).                   monthly with 4 or more
                                                 face-to-face visits per
                                                 month; for patients 20
                                                 years and older.
                                         90961  ESRD related services
                                                 monthly with 2-3 face-
                                                 to-face visits per
                                                 month; for patients 20
                                                 years and older.
                                         90962  ESRD related services
                                                 with 1 face-to-face
                                                 visit per month; for
                                                 patients 20 years and
                                                 older.
                                         90966  ESRD related services
                                                 for home dialysis per
                                                 full month; for
                                                 patients 20 years and
                                                 older.
                                         90970  ESRD related services
                                                 for dialysis less than
                                                 a full month of
                                                 service; per day; for
                                                 patient 20 years and
                                                 older.
Interpretation of Physiological          99091  Collection &
 Data.                                           interpretation of
                                                 physiologic data,
                                                 requiring a minimum of
                                                 30 minutes each 30
                                                 days.
Complex Chronic Care Management          99487  Complex Chronic Care
 Services.                               99489   with 60 minutes of
                                                 clinical staff time per
                                                 calendar month.
                                                Complex Chronic Care;
                                                 additional 30 minutes
                                                 of clinical staff time
                                                 per month.
Care Plan Oversight Services.....        G0181  Physician supervision of
                                                 a patient receiving
                                                 Medicare-covered
                                                 services provided by a
                                                 participating home
                                                 health agency (patient
                                                 not present) requiring
                                                 complex and
                                                 multidisciplinary care
                                                 modalities within a
                                                 calendar month; 30+
                                                 minutes.
                                         G0182  Physician supervision of
                                                 a patient receiving
                                                 Medicare-covered
                                                 hospice services (Pt
                                                 not present) requiring
                                                 complex and
                                                 multidisciplinary care
                                                 modalities; within a
                                                 calendar month; 30+
                                                 minutes.
------------------------------------------------------------------------

    Thus, with the goal of increasing medically appropriate use of TCM 
services, we are proposing to revise our billing requirements for TCM 
by allowing TCM codes to be billed concurrently with any of these 
codes. Before we finalize such a rule, however, we seek comment on 
whether overlap of services exists, and if so, which services should be 
restricted from being billed concurrently with TCM. We also seek 
comment on whether any overlap would depend upon whether the same or a 
different practitioner reports the services. We note that CPT reporting 
rules generally apply at the practitioner level, and we are seeking 
input from stakeholders as to whether our policy should differ based on 
whether it is the same or a different practitioner reporting the 
services. We are seeking comment on whether the newest CPT code in the 
chronic care management services family (CPT code 99491 for CCM by a 
physician or other qualified health professional, established in 2019) 
overlaps with TCM or should be reportable and separately payable in the 
same service period.
    As part of our analysis of the utilization data for TCM services, 
we also examined how current payment rates for TCM might negatively 
affect the appropriate utilization of TCM services, an idea proposed by 
Bindman and Cox. CPT code 99495 (Transitional Care Management services 
with the following required elements: Communication (direct contact, 
telephone, electronic) with the patient and/or caregiver within two 
business days of discharge; medical decision making of at least 
moderate complexity during the service period; face-to-face visit 
within 14 calendar days of discharge) and CPT code 99496 (Transitional 
Care Management services with the following required elements: 
Communication (direct contact, telephone, electronic) with the patient 
and/or caregiver within two business days of discharge; medical 
decision making of at least high complexity during the service period; 
face-to-face visit within 7 calendar days of discharge) were resurveyed 
during 2018 as part of a regular RUC review of new technologies or 
services. For this RUC resurvey, several years of claims data were 
available and clinicians had more experience to inform their views 
about the work required to furnish TCM services. Based upon the results 
of the 2018 RUC survey of the two TCM codes, the RUC recommended a 
slight increase in work RVUs for both codes. We believe the results 
from the new survey will better reflect the work involved in furnishing 
TCM services as care management services. Thus, also for CY 2020, we 
are proposing the RUC-recommended work RVU of 2.36 for CPT code 99495 
and the RUC-recommended work RVU of 3.10 for CPT code 99496. We are not 
proposing any direct PE refinements to the RUC's recommendations for 
this code family.
3. Chronic Care Management (CCM) Services
    CCM services are comprehensive care coordination services per 
calendar month, furnished by a physician or non-physician practitioner 
(NPP) managing overall care and their clinical staff, for patients with 
two or more serious chronic conditions. There are currently two subsets 
of codes: One for non-complex chronic care management (starting in 
2015, with a new code for 2019) and a set of codes for complex chronic 
care management (starting in 2017). Table 17 provides a high-level 
summary of the CCM service elements.
    Early data show that, in general, CCM services are increasing 
patient and practitioner satisfaction, saving costs and enabling solo 
practitioners to remain in independent practice.\79\ Utilization has 
reached approximately 75 percent of the level we initially assumed 
under the PFS when we began paying for CCM services separately under 
the PFS. While these are positive results, we believe that CCM services 
(especially complex CCM services) continue to be underutilized. In 
addition, we note that, at the February 2019 CPT Editorial Panel 
meeting, certain specialty associations requested refinements to the 
existing CCM codes, and consideration of their proposal was postponed. 
Also, we have heard from some stakeholders suggesting that the

[[Page 40551]]

time increments for non-complex CCM performed by clinical staff should 
be changed to recognize finer increments of time, and that certain 
requirements related to care planning are unclear. Based on our 
consideration of this ongoing feedback, we believe some of the 
refinements requested by specialty associations and other stakeholders 
may be necessary to improve payment accuracy, reduce unnecessary burden 
and help ensure that beneficiaries who need CCM services have access to 
them. Accordingly, we are proposing the following changes to the CCM 
code set for CY 2020.
---------------------------------------------------------------------------

    \79\ https://innovation.cms.gov/Files/reports/chronic-care-mngmt-finalevalrpt.pdf.
---------------------------------------------------------------------------

a. Non-Complex CCM Services by Clinical Staff (CPT Code 99490, HCPCS 
Codes GCCC1 and GCCC2)
    Currently, the clinical staff CPT code for non-complex CCM, CPT 
code 99490 (Chronic care management services, 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: 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.) describes 20 or more 
minutes of clinical staff time spent performing chronic care management 
activities under the direction of a physician/qualified health care 
professional. When we initially adopted this code for payment and, in 
feedback we have since received, a number of stakeholders suggested 
that CMS undervalued the PE RVU because we assumed that the minimum 
time for the code (20 minutes of clinical staff time) would be typical 
(see, for example, 79 FR 67717 through 67718). In the CY 2017 PFS final 
rule with comment period, we continued to consider whether the payment 
amount for CPT code 99490 is appropriate, given the amount of time 
typically spent furnishing CCM services (81 FR 80243 through 80244). We 
adopted the complex CCM codes for payment beginning in CY 2017, in 
part, to pay more appropriately for services furnished to beneficiaries 
requiring longer service times.
    There are two CPT codes for complex CCM:
     CPT code 99487 (Complex chronic care management 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; 
establishment or substantial revision of a comprehensive care plan; 
moderate or high complexity medical decision making; 60 minutes of 
clinical staff time directed by physician or other qualified health 
care professional, per calendar month. (Complex chronic care management 
services of less than 60 minutes duration, in a calendar month, are not 
reported separately); and
     CPT code 99489 (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).
    Complex CCM describes care management for patients who require not 
only more clinical staff time, but also complex medical decision-
making. Some stakeholders continue to recommend that, in addition to 
separate payment for the complex CCM codes, we should create an add-on 
code for non-complex CCM, such that non-complex CCM would be defined 
and valued in 20-minute increments of time with additional payment for 
each additional 20 minutes, or extra payment for 20 to 40 minutes of 
clinical staff time spent performing care management activities.
    We agree that coding changes that identify additional time 
increments would improve payment accuracy for non-complex CCM. 
Accordingly, we propose to adopt two new G codes with new increments of 
clinical staff time instead of the existing single CPT code (CPT code 
99490). The first G code would describe the initial 20 minutes of 
clinical staff time, and the second G code would describe each 
additional 20 minutes thereafter. We intend these would be temporary G 
codes, to be used for PFS payment instead of CPT code 99490 until the 
CPT Editorial Panel can consider revisions to the current CPT code set. 
We would consider adopting any CPT code(s) once the CPT Editorial Panel 
completes its work. We acknowledge that imposing a transitional period 
during which G codes would be used under the PFS in lieu of the CPT 
codes is potentially disruptive, and are seeking comment on whether the 
benefit of proceeding with the proposed G codes outweighs the burden of 
transitioning to their use in the intervening year(s) before a decision 
by the CPT Editorial Panel.
    We are proposing that the base code would be HCPCS code GCCC1 
(Chronic care management services, initial 20 minutes of clinical staff 
time directed by a physician or other qualified health care 
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; and comprehensive care plan 
established, implemented, revised, or monitored. (Chronic care 
management services of less than 20 minutes duration, in a calendar 
month, are not reported separately)). We propose a work RVU of 0.61 for 
HCPCS code GCCC1, which we crosswalked from CPT code 99490. We believe 
these codes have a similar amount of work since they would have the 
same intra-service time of 15 minutes.
    We propose an add-on HCPCS code GCCC2 (Chronic care management 
services, each additional 20 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). (Use 
GCCC2 in conjunction with GCCC1). (Do not report GCCC1, GCCC2 in the 
same calendar month as GCCC3, GCCC4, 99491)). We are proposing a work 
RVU of 0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107 
(Incisional biopsy of skin (eg, wedge) (including simple closure, when 
performed); each separate/additional lesion (List separately in 
addition to code for primary procedure)), which has a work RVU of 0.54, 
which we believe accurately reflects the work associated with each 
additional 20 minutes of CCM services. Both codes have the same 
intraservice time of 15 minutes. We note 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, 
codes need not share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk. In this case, 
CPT code 11107 shares a similar work intensity to proposed HCPCS code 
GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 share the same 
intraservice time, add-on codes often have lower intensity than the 
base codes because they describe the continuation of an already 
initiated service.
    We are soliciting public comment on whether we should limit the 
number of times this add-on code (HCPCS code GCCC2) can be reported in 
a given service period for a given beneficiary. It

[[Page 40552]]

is not clear how often more than 40 minutes of clinical staff time is 
currently spent or is medically necessary. In addition, once 60 minutes 
of clinical staff time is spent, many or most patients might also 
require complex medical decision-making, and such patients would be 
already described under existing coding for complex CCM. A limit (such 
as allowing the add-on code to be reported only once per service period 
per beneficiary) may be appropriate in order to maintain distinctions 
between complex and non-complex CCM, as well as appropriately limit 
beneficiary cost sharing and program spending to medically necessary 
services. We note that complex CCM already describes (in part) 60 or 
more minutes of clinical staff time in a service period. We are seeking 
comment on whether and how often beneficiaries who do not require 
complex CCM (for example, do not require the complex medical decision 
making that is part of complex CCM) would need 60 or more minutes of 
non-complex CCM clinical staff time and thereby warrant more than one 
use of HCPCS code GCCC2 within a service period.
b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes 
GCCC3 and GCCC4)
    Currently, the CPT codes for complex CCM include in the code 
descriptors a requirement for establishment or substantial revision of 
the comprehensive care plan (see above). The code descriptors for 
complex CCM also include moderate to high complexity medical decision-
making (moderate to high complexity medical decision-making is an 
explicit part of the services). We propose to adopt two new G codes 
that would be used for billing under the PFS instead of CPT codes 99487 
and 99489, and that would not include the service component of 
substantial care plan revision. We believe it is not necessary to 
explicitly include substantial care plan revision because patients 
requiring moderate to high complexity medical decision making 
implicitly need and receive substantial care plan revision. The service 
component of substantial care plan revision is potentially duplicative 
with the medical decision making service component and, therefore, we 
believe it is unnecessary as a means of distinguishing eligible 
patients. Instead of CPT code 99487, we propose to adopt HCPCS code 
GCCC3 (Complex chronic care management 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; 60 minutes of clinical staff time 
directed by physician or other qualified health care professional, per 
calendar month. (Complex chronic care management services of less than 
60 minutes duration, in a calendar month, are not reported 
separately)). We are proposing a work RVU of 1.00 for HCPCS code GCCC3, 
which is a crosswalk to CPT code 99487.
    Instead of CPT code 99489, we propose to adopt HCPCS code GCCC4 
(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). 
(Report GCCC4 in conjunction with GCCC3). (Do not report GCCC4 for care 
management services of less than 30 minutes additional to the first 60 
minutes of complex chronic care management services during a calendar 
month)). We are proposing a work RVU of 0.50 for HCPCS code GCCC4, 
which is a crosswalk to CPT code 99489.
    We intend these would be temporary G codes to remain in place until 
the CPT Editorial Panel can consider revising the current code 
descriptors for complex CCM services. We would consider adopting any 
new or revised complex CCM CPT code(s) once the CPT Editorial Panel 
completes its work. We acknowledge that imposing a transitional period 
during which G codes would be used under the PFS in lieu of the CPT 
codes is potentially disruptive. We are seeking comment on whether the 
benefit of proceeding with the proposed G codes outweighs the burden of 
transitioning to their use in the intervening year(s) before a decision 
by the CPT Editorial Panel.
c. Typical Care Plan
    In 2013, in working with the physician community to develop and 
propose the CCM codes for PFS payment, the medical community 
recommended and CMS agreed that adequate care planning is integral to 
managing patients with multiple chronic conditions. We stated our 
belief that furnishing care management to beneficiaries with multiple 
chronic conditions requires complex and multidisciplinary care 
modalities that involve, among other things, regular physician 
development and/or revision of care plans and integration of new 
information into the care plan (78 FR 43337). In the CY 2014 PFS final 
rule with comment period (78 FR 74416 through 74418), consistent with 
recommendations CMS received in 2013 from the AMA's Complex Chronic 
Care Coordination Workgroup, we finalized a CCM scope of service 
element for a patient-centered plan of care with the following 
characteristics: It is a comprehensive plan of care for all health 
problems and typically includes, but is not limited to, the following 
elements: Problem list; expected outcome and prognosis; measurable 
treatment goals; cognitive and functional assessment; symptom 
management; planned interventions; medical management; environmental 
evaluation; caregiver assessment; community/social services ordered; 
how the services of agencies and specialists unconnected to the 
practice will be directed/coordinated; identify the individuals 
responsible for each intervention, requirements for periodic review; 
and when applicable, revisions of the care plan.
    The CPT Editorial Panel also incorporated and adopted this language 
in the prefatory language for Care Management Services codes (page 49 
of the 2019 CPT Codebook) including CCM services.
    As we continue to consider the need for potential refinements to 
the CCM code set, we have heard that there is still some confusion in 
the medical community regarding what a care plan typically includes. We 
have re-reviewed this language for CCM, and we believe there may be 
aspects of the typical care plan language we adopted for CCM that are 
redundant or potentially unduly burdensome. We note that because these 
are ``typical'' care plan elements, these elements do not comprise a 
set of strict requirements that must be included in a care plan for 
purposes of billing for CCM services; the elements are intended to 
reflect those that are typically, but perhaps not always, included in a 
care plan as medically appropriate for a particular beneficiary. 
Nevertheless, we are proposing to eliminate the phrase ``community/
social services ordered, how the services of agencies and specialists 
unconnected to the practice will be directed/coordinated, identify the 
individuals responsible for each intervention'' and insert the phrase 
``interaction and coordination with outside resources and practitioners 
and providers.'' We believe simpler language would describe the 
important work of interacting and coordinating with resources external 
to the practice. While it is preferable, when feasible, to identify who 
is responsible for

[[Page 40553]]

interventions, it may be difficult to maintain an up-to-date listing of 
responsible individuals especially when they are outside of the 
practice, for example, when there is staff turnover or assignment 
changes.
    Our proposed new language would read: The comprehensive care plan 
for all health issues typically includes, but is not limited to, the 
following elements:
     Problem list.
     Expected outcome and prognosis.
     Measurable treatment goals.
     Cognitive and functional assessment.
     Symptom management.
     Planned interventions.
     Medical management.
     Environmental evaluation.
     Caregiver assessment.
     Interaction and coordination with outside resources and 
practitioners and providers.
     Requirements for periodic review.
     When applicable, revision of the care plan.
    We welcome feedback on our proposal, including language that would 
best guide practitioners as they decide what to include in their 
comprehensive care plan for CCM recipients.
    Additional information regarding the existing requirements for 
billing CCM, including links to prior rules, is available on our 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
4. Principal Care Management (PCM) Services
    A gap we identified in coding and payment for care management 
services is care management for patients with only one chronic 
condition. The current CCM codes require patients to have two or more 
chronic conditions. These codes are primarily billed by practitioners 
who are managing a patient's total care over a month, including primary 
care practitioners and some specialists such as cardiologists or 
nephrologists. We have heard from a number of stakeholders, especially 
those in specialties that use the office/outpatient E/M code set to 
report the majority of their services, that there can be significant 
resources involved in care management for a single high risk disease or 
complex chronic condition that is not well accounted for in existing 
coding (FR 78 74415). This issue has also been raised by the 
stakeholder community in proposal submissions to the Physician-Focused 
Payment Model Technical Advisory Committee (PTAC), which are available 
at https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee. Therefore, we are proposing separate coding and 
payment for Principal Care Management (PCM) services, which describe 
care management services for one serious chronic condition. A 
qualifying condition would typically be expected to last between three 
months and a year, or until the death of the patient, may have led to a 
recent hospitalization, and/or place the patient at significant risk of 
death, acute exacerbation/decompensation, or functional decline.
    While we are not proposing any restrictions on the specialties that 
could bill for PCM, we expect that most of these services would be 
billed by specialists who are focused on managing patients with a 
single complex chronic condition requiring substantial care management. 
We expect that, in most instances, initiation of PCM would be triggered 
by an exacerbation of the patient's complex chronic condition or recent 
hospitalization such that disease-specific care management is 
warranted. We anticipate that in the majority of instances, PCM 
services would be billed when a single condition is of such complexity 
that it could not be managed as effectively in the primary care 
setting, and instead requires management by another, more specialized, 
practitioner. For example, a typical patient may present to their 
primary care practitioner with an exacerbation of an existing chronic 
condition. While the primary care practitioner may be able to provide 
care management services for this one complex chronic condition, it is 
also possible that the primary care practitioner and/or the patient 
could instead decide that another clinician should provide relevant 
care management services. In this case, the primary care practitioner 
would still oversee the overall care for the patient while the 
practitioner billing for PCM services would provide care management 
services for the specific complex chronic condition. The treating 
clinician may need to provide a disease-specific care plan or may need 
to make frequent adjustments to the patient's medication regimen. The 
expected outcome of PCM is for the patient's condition to be stabilized 
by the treating clinician so that overall care management for the 
patient's condition can be returned to the patient's primary care 
practitioner. If the beneficiary only has one complex chronic condition 
that is overseen by the primary care practitioner, then the primary 
care practitioner would also be able to bill for PCM services. We are 
proposing that PCM services include coordination of medical and/or 
psychosocial care related to the single complex chronic condition, 
provided by a physician or clinical staff under the direction of a 
physician or other qualified health care professional.
    We anticipate that many patients will have more than one complex 
chronic condition. If a clinician is providing PCM services for one 
complex chronic condition, management of the patient's other conditions 
would continue to be managed by the primary care practitioner while the 
patient is receiving PCM services for a single complex condition. It is 
also possible that the patient could receive PCM services from more 
than one clinician if the patient experiences an exacerbation of more 
than one complex chronic condition simultaneously.
    For CY 2020, we are proposing to make separate payment for PCM 
services via two new G codes: HCPCS code GPPP1 (Comprehensive care 
management services for a single high-risk disease, e.g., Principal 
Care Management, at least 30 minutes of physician or other qualified 
health care professional time per calendar month with the following 
elements: One complex chronic condition lasting at least 3 months, 
which is the focus of the care plan, the condition is of sufficient 
severity to place patient at risk of hospitalization or have been the 
cause of a recent hospitalization, the condition requires development 
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) and HCPCS 
code GPPP2 (Comprehensive care management for a single high-risk 
disease services, e.g., Principal Care Management, at least 30 minutes 
of clinical staff time directed by a physician or other qualified 
health care professional, per calendar month with the following 
elements: One complex chronic condition lasting at least 3 months, 
which is the focus of the care plan, the condition is of sufficient 
severity to place patient at risk of hospitalization or have been cause 
of a recent hospitalization, the condition requires development 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). HCPCS code GPPP1 
would be reported when, during the calendar month, at least 30 minutes 
of physician or other qualified health care provider time is spent on 
comprehensive care management for a

[[Page 40554]]

single high risk disease or complex chronic condition. HCPCS code GPPP2 
would be reported when, during the calendar month, at least 30 minutes 
of clinical staff time is spent on comprehensive management for a 
single high risk disease or complex chronic condition.
    For HCPCS code GPPP1, we are proposing a crosswalk to the work 
value associated with CPT code 99217 (Observation care discharge day 
management (This code is to be utilized to report all services provided 
to a patient on discharge from outpatient hospital ``observation 
status'' if the discharge is on other than the initial date of 
``observation status.'' To report services to a patient designated as 
``observation status'' or ``inpatient status'' and discharged on the 
same date, use the codes for Observation or Inpatient Care Services 
[including Admission and Discharge Services, 99234-99236 as 
appropriate])) as we believe these values most accurately reflect the 
resource costs associated when the billing practitioner performs PCM 
services. CPT code 99217 has the same intraservice time as HCPCS code 
GPPP1 and the physician work is of similar intensity. Therefore, we are 
proposing a work RVU of 1.28 for HCPCS code GPPP1.
    For HCPCS code GPPP2 we are proposing a crosswalk to the work and 
PE inputs associated with CPT code 99490 (clinical staff non-complex 
CCM) as we believe these values reflect the resource costs associated 
with the clinician's direction of clinical staff who are performing the 
PCM services, and the intraservice times and intensity of the work for 
the two codes would be the same. Therefore, we are proposing a work RVU 
of 0.61 for HCPCS code GPPP2.
    While we are proposing separate coding and payment for PCM services 
performed by clinical staff with the oversight of the billing 
professional and services furnished directly by the billing 
professional, we are seeking comment on whether both codes are 
necessary to appropriately describe and bill for PCM services. We note 
that we are basing this coding structure on the codes for CCM services 
with CPT code 99491 reflecting care management by the billing 
professional and CPT code 99490 reflecting care management by clinical 
staff directed by a physician or other qualified health care 
professional.
    We acknowledge that we are concurrently proposing revisions for 
both complex and non-complex CCM services. Were we not to finalize the 
proposed changes for both complex and non-complex CCM services, we 
believe that the overall structure and description of the CCM services 
remain close enough to serve as a model for the coding structure and 
description of services for the proposed PCM services. We are seeking 
public comment on whether it would be appropriate to create an add-on 
code for additional time spent each month (similar to HCPCS code GCCC2 
discussed above) when PCM services are furnished by clinical staff 
under the direction of the billing practitioner.
    While we believe that PCM services describe a situation where a 
patient's condition is severe enough to require care management for a 
single complex chronic condition beyond what is described by CCM or 
performed in the primary care setting, we are concerned that a possible 
unintended consequence of making separate payment for care management 
for a single chronic condition is that a patient with multiple chronic 
conditions could have their care managed by multiple practitioners, 
each only billing for PCM, which could potentially result in fragmented 
patient care, overlaps in services, and duplicative services. While we 
are not proposing additional requirements for the proposed PCM 
services, we did consider alternatives such as requiring that the 
practitioner billing PCM must document ongoing communication with the 
patient's primary care practitioner to demonstrate that there is 
continuity of care between the specialist and primary care settings, or 
requiring that the patient have had a face-to-face visit with the 
practitioner billing PCM within the prior 30 days to demonstrate that 
they have an ongoing relationship. We are seeking comment on whether 
requirements such as these are necessary or appropriate, and whether 
there should be additional requirements to prevent potential care 
fragmentation or service duplication.
    Due to the similarity between the description of the PCM and CCM 
services, both of which involve non-face-to-face care management 
services, we are proposing that the full CCM scope of service 
requirements apply to PCM, including documenting the patient's verbal 
consent in the medical record. We are seeking comment on whether there 
are required elements of CCM services that the public and stakeholders 
believe should not be applicable to PCM, and should be removed or 
altered. A high level summary of these requirements is available in 
Table 18 and available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf. Both the initiating visit and the patient's 
verbal consent are necessary as not all patients who meet the criteria 
to receive separately billable PCM services may want to receive these 
services. The beneficiary should be educated as to what PCM services 
are and any cost sharing that may apply. Additionally, as practitioners 
have informed us that beneficiary cost sharing is a significant barrier 
to provision of other care management services, we are seeking comment 
on how best to educate practitioners and beneficiaries on the benefits 
of PCM services.
    Additionally, we are proposing to add GPPP2 to the list of 
designated care management services for which we allow general 
supervision as described in our regulation at Sec.  410.26(b)(5). Due 
to the potential for duplicative payment, we are proposing that PCM 
could not be billed by the same practitioner for the same patient 
concurrent with certain other care management services, such as CCM, 
behavioral health integration services, and monthly capitated ESRD 
payments. We are also proposing that PCM would not be billable by the 
same practitioner for the same patient during a surgical global period, 
as we believe those resource costs would already be included in the 
valuation of the global surgical code.

           Table 18--Chronic Care Management Services Summary
------------------------------------------------------------------------
                          CCM Service Summary *
-------------------------------------------------------------------------
Verbal Consent:
     Inform regarding availability of the service; that only one
     practitioner can bill per month; the right to stop services
     effective at the end of any service period; and that cost sharing
     applies (if no supplemental insurance).
     Document that consent was obtained.
Initiating Visit for New Patients (separately paid).
Certified Electronic Health Record (EHR) Use:
     Structured Recording of Core Patient Information Using
     Certified EHR (demographics, problem list, medications, allergies).

[[Page 40555]]

 
24/7 Access (``On Call'' Service).
Designated Care Team Member.
Comprehensive Care Management:
     Systematic needs assessment (medical and psychosocial).
     Ensure receipt of preventive services.
     Medication reconciliation, management and oversight of self-
     management.
Comprehensive Electronic Care Plan:
     Plan is available timely within and outside the practice
     (can include fax).
     Copy of care plan to patient/caregiver (format not
     prescribed).
     Establish, implement, revise or monitor the plan.
Management of Care Transitions/Referrals (e.g., discharges, ED visit
 follow up, referrals):
     Create/exchange continuity of care document(s) timely
     (format not prescribed).
Home- and Community-Based Care Coordination:
     Coordinate with any home- and community-based clinical
     service providers, and document communication with them regarding
     psychosocial needs and functional deficits.
Enhanced Communication Opportunities:
     Offer asynchronous non-face-to-face methods other than
     telephone, such as secure email.
------------------------------------------------------------------------
* All elements that are medically reasonable and necessary must be
  furnished during the month, but all elements do not necessarily apply
  every month. Consent need only be obtained once, and initiating visits
  are only for new patients or patients not seen within a year prior to
  initiation of CCM.

    We are also seeking comment on any potential for duplicative 
payment between the proposed PCM services and other services, such as 
interprofessional consultation services (CPT codes 99446-99449 
(Interprofessional telephone/internet/electronic health record 
assessment and management service provided by a consultative physician, 
including a verbal and written report to the patient's treating/
requesting physician or other qualified health care professional), CPT 
code 99451 (Interprofessional telephone/internet/electronic health 
record assessment and management service provided by a consultative 
physician, including a written report to the patient's treating/
requesting physician or other qualified health care professional, 5 
minutes or more of medical consultative time), and CPT code 99452 
(Interprofessional telephone/internet/electronic health record referral 
service(s) provided by a treating/requesting physician or other 
qualified health care professional, 30 minutes)) or remote patient 
monitoring (CPT code 99091 (Collection and interpretation of 
physiologic data (e.g., ECG, blood pressure, glucose monitoring) 
digitally stored and/or transmitted by the patient and/or caregiver to 
the physician or other qualified health care professional, qualified by 
education, training, licensure/regulation (when applicable) requiring a 
minimum of 30 minutes of time, each 30 days), CPT code 99453 (Remote 
monitoring of physiologic parameter(s) (e.g., weight, blood pressure, 
pulse oximetry, respiratory flow rate), initial; set-up and patient 
education on use of equipment), and CPT code 99457 (Remote physiologic 
monitoring treatment management services, 20 minutes or more of 
clinical staff/physician/other qualified health care professional time 
in a calendar month requiring interactive communication with the 
patient/caregiver during the month)).
5. Chronic Care Remote Physiologic Monitoring Services
    Chronic Care remote physiologic monitoring (RPM) services involve 
the collection, analysis, and interpretation of digitally collected 
physiologic data, followed by the development of a treatment plan, and 
the managing of a patient under the treatment plan. The current CPT 
code 99457 is a treatment management code, billable after 20 minutes or 
more of clinical staff/physician/other qualified professional time with 
a patient in a calendar month.
    In September 2018, the CPT Editorial Panel revised the CPT code 
structure for CPT code 99457 effective beginning in CY 2020. The new 
code structure retains CPT code 99457 as a base code that describes the 
first 20 minutes of the treatment management services, and uses a new 
add-on code to describe subsequent 20 minute intervals of the service. 
The new code descriptors for CY 2020 are: CPT code 99457 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; initial 20 minutes) and CPT code 994X0 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; additional 20 minutes).
    In considering the work RVUs for the new add-on CPT code 994X0, we 
first considered the value of its base code. We previously valued the 
base code at 0.61 work RVUs. Given the value of the base code, we do 
not agree with the RUC-recommended work RVU of 0.61 for the add-on 
code. Instead, we are proposing a work RVU of 0.50 for the add-on code. 
This value is supported by CPT code 88381 (Microdissection (i.e., 
sample preparation of microscopically identified target); manual), 
which has the same intraservice and total times of 20 minutes with an 
XXX global period and work RVU of 0.53, as well as the survey value at 
the 25th percentile. We are proposing the RUC-recommended direct PE 
inputs for CPT code 994X0.
    Finally, we are proposing that RPM services reported with CPT codes 
99457 and 994X0 may be furnished under general supervision rather than 
the currently required direct supervision. Because care management 
services include establishing, implementing, revising, or monitoring 
treatment plans, as well as providing support services, and because RPM 
services (that is, CPT codes 99457 and 994X0) include establishing, 
implementing, revising, and monitoring a specific treatment plan for a 
patient related to one or more chronic conditions that are monitored 
remotely, we believe that CPT codes 99457 and 994X0 should be included 
as designated care management services. Designated care management 
services can be furnished under general

[[Page 40556]]

supervision. Section 410.26(b)(5) of our regulations states that 
designated care management services can be furnished under the general 
supervision of the ``physician or other qualified health care 
professional (who is qualified by education, training, licensure/
regulation and facility privileging)'' (see also 2019 CPT Codebook, 
page xii) when these services or supplies are provided incident to the 
services of a physician or other qualified healthcare professional. The 
physician or other qualified healthcare professional supervising the 
auxiliary personnel need not be the same individual treating the 
patient more broadly. However, only the supervising physician or other 
qualified healthcare professional may bill Medicare for incident to 
services.
6. Comment Solicitation on Consent for Communication Technology-Based 
Services
    In the CY 2019 PFS Final Rule, CMS finalized separate payment for a 
number of services that could be furnished via telecommunications 
technology. Specifically, CMS finalized HCPCS code G2010 (Remote 
evaluation of recorded video and/or images submitted by an established 
patient (e.g., store and forward), including interpretation with 
follow-up with the patient within 24 business hours, 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)), HCPCS code 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)), CPT codes 99446-99449 (Interprofessional telephone/
internet/electronic health record assessment and management service 
provided by a consultative physician, including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional), CPT code 99451 (Interprofessional 
telephone/internet/electronic health record assessment and management 
service provided by a consultative physician, including a written 
report to the patient's treating/requesting physician or other 
qualified health care professional, 5 minutes or more of medical 
consultative time), and CPT code 99452 (Interprofessional telephone/
internet/electronic health record referral service(s) provided by a 
treating/requesting physician or other qualified health care 
professional, 30 minutes).
    As discussed in that rule, (83 FR 59490-59491), while a few 
commenters suggested that it would be less burdensome to obtain a 
general consent for multiple services at once, we stipulated that 
verbal consent must be documented in the medical record for each 
service furnished so that the beneficiary is aware of any applicable 
cost sharing. This is similar to the requirements for other non-face-
to-face care management services under the PFS.
    We have continued to hear from stakeholders that requiring advance 
beneficiary consent for each of these services is burdensome. For HCPCS 
codes G2010 and G2012, stakeholders have stated that it is difficult 
and burdensome to obtain consent at the outset of each of what are 
meant to be brief check-in services. For CPT codes 99446-99449, 99451 
and 99452, practitioners have informed us that it is particularly 
difficult for the consulting practitioner to obtain consent from a 
patient they have never seen. Given our longstanding goals to reduce 
burden and promote the use of communication technology-based services, 
we are seeking comment on whether a single advance beneficiary consent 
could be obtained for a number of communication technology-based 
services. During the consent process, the practitioner would make sure 
the beneficiary is aware that utilization of these services will result 
in a cost sharing obligation. We are seeking comment on the appropriate 
interval of time or number of services for which consent could be 
obtained, for example, for all these services furnished within a 6 
month or one year period, or for a set number of services, after which 
a new consent would need to be obtained. We are also seeking comment on 
the potential program integrity concerns associated with allowing 
advance consent and how best to minimize those concerns.
7. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers 
(FQHCs)
    RHCs and FQHCs are paid for general care management services using 
HCPCS code G0511, which is an RHC and FQHC-specific G-code for 20 
minutes or more of CCM services, complex CCM services, or general 
behavioral health services. Payment for this service is set at the 
average of the national, non-facility payment rates for CPT codes 
99490, 99487, and 99484. We are proposing to use the non-facility 
payment rates for HCPCS codes GCCC1 and GCCC3 instead of the non-
facility payment rates for CPT codes 99490 and 99487, respectively, if 
these changes are finalized for practitioners billing under the PFS. We 
note that we are not proposing any changes in the valuation of these 
codes. Upon finalization, the payment for HCPCS code G0511 would be set 
at the average of the national, non-facility payment rates for HCPCS 
codes GCCC1 and GCCC3 and CPT code 99484.

L. Coinsurance for Colorectal Cancer Screening Tests

    Section 1861(pp) of the Act defines ``colorectal cancer screening 
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act, 
``screening flexible sigmoidoscopy'' and ``screening colonoscopy'' are 
two of the recognized procedures. Among other things, section 
1861(pp)(1)(D) of the Act authorizes the Secretary to include other 
tests or procedures in the definition, and modifications to the tests 
and procedures described under this subsection, ``with such frequency 
and payment limits, as the Secretary determines appropriate, in 
consultation with appropriate organizations.'' Section 1861(s)(2)(R) of 
the Act includes these colorectal cancer screening tests in the 
definition of the medical and other health services that fall within 
the scope of Medicare Part B benefits described in section 1832(a)(1) 
of the Act. Section 1861(ddd)(3) of the Act includes these colorectal 
cancer screening services within the definition of ``preventive 
services.'' In addition, section 1833(a)(1)(Y) of the Act provides for 
payment for preventive services recommended by the United States 
Preventive Services Task Force (USPSTF) with a grade of A or B under 
the PFS at 100 percent of the lesser of the actual charge or the fee 
schedule amount for these colorectal cancer screening tests, and under 
the OPPS at 100 percent of the OPPS payment amount. As such, there is 
no beneficiary responsibility for coinsurance for recommended 
colorectal cancer screening tests as defined in section 1861(pp)(1) of 
the Act.
    Under these statutory provisions, we have issued regulations 
governing payment for colorectal cancer screening tests at 42 CFR 
410.152(l)(5). We pay 100 percent of the Medicare payment amount 
established under the applicable payment methodology for the setting 
for providers and suppliers, and beneficiaries are not required to pay 
Part B coinsurance.

[[Page 40557]]

    In addition to screening tests, which typically are furnished to 
patients in the absence of signs or symptoms of illness or injury, 
Medicare also covers various diagnostic tests (Sec.  410.32). In 
general, diagnostic tests must be ordered by the physician or 
practitioner who is treating the beneficiary, and who uses the results 
of the diagnostic test in the management of the patient's specific 
medical problem. Under Part B, Medicare may cover flexible 
sigmoidoscopies and colonoscopies as diagnostic tests when those tests 
are reasonable and necessary as specified in section 1862(a)(1)(A) of 
the Act. When these services are furnished as diagnostic tests rather 
than as screening tests, patients are responsible for the Part B 
coinsurance (normally 20 percent) associated with these services.
    We define ``colorectal cancer screening tests'' in our regulation 
at Sec.  410.37(a)(1) to include ``flexible screening sigmoidoscopies'' 
and ``screening colonoscopies, including anesthesia furnished in 
conjunction with the service.'' Under our current policies, we exclude 
from the definition of colorectal screening services colonoscopies and 
sigmoidoscopies that begin as a screening service, but where a polyp or 
other growth is found and removed as part of the procedure. The 
exclusion of these services from the definition of colorectal cancer 
screening services is based upon separate provisions of the statute 
dealing with the detection of lesions or growths during procedures (62 
FR 59048, 59082, October 31, 1997). Section 1834(d)(2)(D) of the Act 
provides that if, during the course of a screening flexible 
sigmoidoscopy, a lesion or growth is detected which results in a biopsy 
or removal of the lesion or growth, payment under Medicare Part B shall 
not be made for the screening flexible sigmoidoscopy but shall be made 
for the procedure classified as a flexible sigmoidoscopy with such 
biopsy or removal. Similarly, section 1834(d)(3)(D) of the Act that 
provides if, during the course of a screening colonoscopy, a lesion or 
growth is detected which results in a biopsy or removal of the lesion 
or growth, payment under Medicare Part B shall not be made for the 
screening colonoscopy but shall be made for the procedure classified as 
a colonoscopy with such biopsy or removal.
    Because we interpret sections 1834(d)(2)(C)(ii) and 
1834(d)(3)(C)(ii) of the Act to require us to pay for these tests as 
diagnostic tests, rather than as screening tests, the 100 percent 
payment rate for recommended preventive services under section 
1833(a)(1)(Y) of the Act, as codified in our regulation at Sec.  
410.152(l)(5), would not apply to those diagnostic procedures. As such, 
beneficiaries are responsible for the usual coinsurance that applies to 
the services (20 or 25 percent of the cost of the services depending on 
the setting).
    Under section 1833(b) of the Act, before making payment under 
Medicare Part B for expenses incurred by a beneficiary for covered Part 
B services, beneficiaries must first meet the applicable deductible for 
the year. Section 4104 of the Affordable Care Act (that is, the Patient 
Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23, 
2010), and the Health Care and Education Reconciliation Act of 2010 
(Pub. L. 111-152, enacted March 30, 2010), collectively referred to as 
the ``Affordable Care Act'') amended section 1833(b)(1) of the Act to 
make the deductible inapplicable to expenses incurred for certain 
preventive services that are recommended with a grade of A or B by the 
USPSTF, including colorectal cancer screening tests as defined in 
section 1861(pp) of the Act. Section 4104 of the Affordable Care Act 
also added a sentence at the end of section 1833(b)(1) of the Act 
specifying that the exception to the deductible shall apply with 
respect to a colorectal cancer screening test regardless of the code 
that is billed for the establishment of a diagnosis as a result of the 
test, or for the removal of tissue or other matter or other procedure 
that is furnished in connection with, as a result of, and in the same 
clinical encounter as the screening test. Although the Affordable Care 
Act addressed the applicability of the deductible in the case of a 
colorectal cancer screening test that involves biopsy or tissue 
removal, it did not alter the coinsurance provision in section 1833(a) 
of the Act for such procedures. Although public commenters encouraged 
the agency to also eliminate the coinsurance in these circumstances, 
the agency found that the statute did not provide for elimination of 
the coinsurance (75 FR 73170, 73431, November 29, 2010).
    Beneficiaries have continued to contact us noting their 
``surprise'' that a coinsurance (20 or 25 percent depending on the 
setting) applies when they expected to receive a colorectal screening 
procedure to which coinsurance does not apply, but instead received 
what Medicare considers to be a diagnostic procedure because polyps 
were discovered and removed. Similarly, physicians have also expressed 
concerns about the reactions of beneficiaries when they are informed 
that they will be responsible for coinsurance if polyps are discovered 
and removed during what they expected to be a screening procedure to 
which coinsurance does not apply. Other stakeholders and some members 
of Congress have regularly expressed to us that they consider the 
agency's policy on coinsurance for colorectal screening procedures 
during which tissue is removed to be a misinterpretation of the law.
    Over the years, we have released a wide variety of publicly 
available educational materials that explain the Medicare preventive 
services benefits as part of our overall outreach activities to 
Medicare beneficiaries. These materials contain a complete description 
of the Medicare preventive services benefits, including information on 
colorectal cancer screening, and also provide relevant details on the 
applicability of cost sharing. These materials can be found at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319.html. We believe that the 
information in these materials can be instrumental in continuing to 
educate physicians and beneficiaries about cost sharing obligations in 
order to mitigate instances of ``surprise'' billing. We invite comment 
on whether we should consider establishing a requirement that the 
physician who plans to furnish a colorectal cancer screening notify the 
patient in advance that a screening procedure could result in a 
diagnostic procedure if polyps are discovered and removed, and that 
coinsurance may apply. We specifically invite comment on whether we 
should require the physician, or their staff, to provide a verbal 
notice with a notation in the medical record, or whether we should 
consider a different approach to informing patients of the copay 
implications, such as a written notice with standard language that we 
would require the physician, or their staff, to provide to patients 
prior to a colorectal cancer screening. We note that we would consider 
adopting such a requirement in the final rule in accordance with public 
comments. We also invite comment on what mechanism, if any, we should 
consider using to monitor compliance with a notification requirement if 
we decide to finalize one for CY 2020 or through future rulemaking.

[[Page 40558]]

M. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate 
Therapy
a. Background
    In the CY 2019 PFS proposed and final rules (83 FR 34850; 83 FR 
59654 and 59661), we discussed the statutory requirements of section 
50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123, February 9, 2018). Beginning January 1, 2018, section 50202 of the 
BBA of 2018 repealed the Medicare outpatient therapy caps and the 
therapy cap exceptions process, while retaining the cap amounts as 
limitations and requiring medical review to ensure that therapy 
services are furnished when appropriate. Section 50202 of the BBA of 
2018 amended section 1833(g) of the Act by adding a new paragraph 
(7)(A) requiring that after expenses incurred for the beneficiary's 
outpatient therapy services for the year have exceeded one or both of 
the previous therapy cap amounts, all therapy suppliers and providers 
must continue to use an appropriate modifier on claims. We implemented 
this provision by continuing to require use of the existing KX 
modifier. By using the KX modifier on the claim, the therapy supplier 
or provider is attesting that the services are medically necessary and 
that supportive justification is documented in the medical record. As 
with the incurred expenses for the prior therapy cap amounts, there is 
one amount for physical therapy (PT) and speech language pathology 
(SLP) services combined, and a separate amount for occupational therapy 
(OT) services. These KX modifier threshold amounts are indexed annually 
by the Medicare Economic Index (MEI). After the beneficiary's incurred 
expenditures for outpatient therapy services exceed the KX modifier 
threshold amount for the year, claims for outpatient therapy services 
without the KX modifier are denied.
    Section 50202 of the BBA of 2018 also added a new paragraph 7(B) to 
section 1833(g) of the Act which retained the targeted medical review 
(MR) process for 2018 and subsequent years, but established a lower 
threshold amount of $3,000 rather than the $3,700 threshold amount that 
had applied for the original manual MR process established by section 
3005(g) of the Middle Class Tax Relief and Jobs Creation Act of 2012 
(MCTRJCA) (Pub. L. 112-96, February 22, 2012). The manual MR process 
with a threshold amount of $3,700 was replaced by the targeted MR 
process with the same threshold amount through amendments made by 
section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 
(MACRA) (Pub. L. 114-10, April 16, 2015).
    With the latest amendments made by the BBA of 2018, for CY 2018 
(and each successive calendar year until 2028, at which time it is 
indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP 
services and $3,000 for OT services. For purposes of applying the 
targeted MR process, we use a criteria-based process for selecting 
providers and suppliers that includes factors such as a high percentage 
of patients receiving therapy beyond the medical review threshold as 
compared to peers. For information on the targeted medical review 
process, please visit https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
    In the CY 2019 PFS final rule (83 FR 59661), when discussing our 
tracking and accrual process for outpatient therapy services in the 
section on the KX Threshold Amounts, we noted that we track each 
beneficiary's incurred expenses for therapy services annually by 
applying the PFS-based payment amount for each service less any 
applicable multiple procedure reduction for CMS-designated ``always 
therapy'' services. We also stated that we use the PFS rates to accrue 
expenses for therapy services provided in critical access hospitals 
(CAHs) as required by section 1833(g)(6)(B) of the Act, added by 
section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. 
L. 112-240, January 2, 2013). As discussed below, we mistakenly 
indicated that this statutory requirement was extended by subsequent 
legislation, including section 50202 of the BBA of 2018.
b. Proposed Regulatory Revisions
    While we explained and implemented the changes required by section 
50202 of the BBA of 2018 in CY 2019 PFS rulemaking (83 FR 34850; 83 FR 
59654 and 59661), we did not codify those changes in regulation text. 
We are now proposing to revise the regulations at Sec. Sec.  410.59 
(outpatient occupational therapy) and 410.60 (physical therapy and 
speech-language pathology) to incorporate the changes made by section 
50202 of the BBA of 2018. We propose to add a new paragraph (e)(1)(v) 
to Sec. Sec.  410.59 and 410.60 to clarify that the specified amounts 
of annual per-beneficiary incurred expenses are no longer applied as 
limitations but as threshold amounts above which services require, as a 
condition of payment, inclusion of the KX modifier; and that use of the 
KX modifier confirms that the services are medically necessary as 
justified by appropriate documentation in the patient's medical record. 
We propose to amend paragraph (e)(2) in Sec. Sec.  410.59 and 410.60 to 
specify the therapy services and amounts that are accrued for purposes 
of applying the KX modifier threshold, including the continued accrual 
of therapy services furnished by CAHs directly or under arrangements at 
the PFS-based payment rates. We are also proposing to amend paragraph 
(e)(3) in Sec. Sec.  410.59 and 410.60 for the purpose of applying the 
medical review threshold to clarify the threshold amounts and the 
applicable years for both the manual MR process originally established 
through section 3005(g) of MCTRJCA and the targeted MR process 
established by the MACRA, and including the changes made through 
section 50202 of the BBA of 2018 as discussed previously.
    In the CY 2019 PFS final rule (83 FR 59661), we incorrectly stated 
that section 1833(g)(6)(B) of the Act continues to require that we 
accrue expenses for therapy services furnished by CAHs at the PFS rate 
because the provision, originally added by section 603(b) of the ATRA, 
was extended by subsequent legislation, including section 50202 of the 
BBA of 2018. The requirement in section 1833(g)(6)(B) of the Act was 
actually time-limited to services furnished in CY 2013. To apply the 
therapy caps (and now the KX modifier thresholds) after the expiration 
of the requirement in 1833(g)(6)(B) of the Act, we needed a process to 
accrue the annual expenses for therapy services furnished by CAHs and, 
in the CY 2014 PFS final rule with comment period, we elected to 
continue the process prescribed in section 1833(g)(6)(B) of the Act (78 
FR 74405 through 74410).
2. Proposed Payment for Outpatient PT and OT Services Furnished by 
Therapy Assistants
a. Background
    Section 53107 of the BBA of 2018 added a new subsection 1834(v) to 
the Act to require in paragraph (1) that, for services furnished on or 
after January 1, 2022, payment for outpatient physical and occupational 
therapy services for which payment is made under sections 1848 or 
1834(k) of the Act which are furnished in whole or in part by a therapy 
assistant must be paid at 85 percent of the amount that is otherwise 
applicable. Section 1834(v)(2) of the Act further required that we 
establish a modifier to identify these services by January 1, 2019, and 
that claims for outpatient therapy services furnished in

[[Page 40559]]

whole or in part by a therapy assistant must include the modifier 
effective for dates of service beginning on January 1, 2020. Section 
1834(v)(3) of the Act required that we implement the subsection through 
notice and comment rulemaking.
    In the CY 2019 PFS proposed and final rules (83 FR 35850 through 
35852 and 83 FR 59654 through 50660, respectively), we established two 
modifiers--one to identify services furnished in whole or in part by a 
physical therapist assistant (PTA) and the other to identify services 
furnished in whole or in part by an occupational therapy assistant 
(OTA). The modifiers are defined as follows:
     CQ Modifier: Outpatient physical therapy services 
furnished in whole or in part by a physical therapist assistant.
     CO Modifier: Outpatient occupational therapy services 
furnished in whole or in part by an occupational therapy assistant.
    In the CY 2019 PFS final rule, we clarified that the CQ and CO 
modifiers are required to be used when applicable for services 
furnished on or after January 1, 2020, on the claim line of the service 
alongside the respective GP or GO therapy modifier to identify services 
furnished under a PT or OT plan of care. The GP and GO therapy 
modifiers, along with the GN modifier for speech-language pathology 
(SLP) services, have been used since 1998 to track and accrue the per-
beneficiary incurred expenses amounts to different therapy caps, now KX 
modifier thresholds, one amount for PT and SLP services combined and a 
separate amount for OT services. We also clarified in the CY 2019 PFS 
final rule that the CQ and CO modifiers will trigger application of the 
reduced payment rate for outpatient therapy services furnished in whole 
or in part by a PTA or OTA, beginning for services furnished in CY 
2022.
    In response to public comments on the CY 2019 PFS proposed rule, we 
did not finalize our proposed definition of ``furnished in whole or in 
part by a PTA or OTA'' as a service for which any minute of a 
therapeutic service is furnished by a PTA or OTA. Instead, we finalized 
a de minimis standard under which a service is considered to be 
furnished in whole or in part by a PTA or OTA when more than 10 percent 
of the service is furnished by the PTA or OTA.
    We also explained in the CY 2019 PFS proposed and final rules (83 
FR 35850 through 35852 and 83 FR 59654 through 59660, respectively) 
that the CQ and CO modifiers would not apply to claims for outpatient 
therapy services that are furnished by, or incident to the services of, 
physicians or nonphysician practitioners (NPPs) including nurse 
practitioners, physician assistants, and clinical nurse specialists. 
This is because our regulations for outpatient physical and 
occupational therapy services require that an individual furnishing 
outpatient therapy services incident to the services of a physician or 
NPP must meet the qualifications and standards for a therapist. As 
such, only therapists and not therapy assistants can furnish outpatient 
therapy services incident to the services of a physician or NPP (83 FR 
59655 through 59656); and, the new PTA and OTA modifiers cannot be used 
on the line of service of the professional claim when the rendering NPI 
identified on the claim is a physician or an NPP. We also intend to 
revise our manual provisions at Pub. 100-02, Medicare Benefit Policy 
Manual (MBPM), Chapter 15, section 230, as appropriate, to reflect 
requirements for the new CQ and CO modifiers that will be used to 
identify services furnished in whole or in part by a PTA or OTA 
starting in CY 2020. We anticipate amending these manual provisions for 
CY 2020 to reflect the policies we adopt through the CY 2020 PFS notice 
and comment rulemaking process.
    In PFS rulemaking for CY 2019, we identified certain situations 
when the therapy assistant modifiers do apply. The modifiers are 
applicable to:
     Therapeutic portions of outpatient therapy services 
furnished by PTAs/OTAs, as opposed to administrative or other non-
therapeutic services that can be performed by others without the 
education and training of OTAs and PTAs.
     Services wholly furnished by PTAs or OTAs without physical 
or occupational therapists.
     Evaluative services that are furnished in part by PTAs/
OTAs (keeping in mind that PTAs/OTAs are not recognized to wholly 
furnish PT and OT evaluation or re-evaluations).
    We also identified some situations when the therapy assistant 
modifiers do not apply. They do not apply when:
     PTAs/OTAs furnish services that can be done by a 
technician or aide who does not have the training and education of a 
PTA/OTA.
     Therapists exclusively furnish services without the 
involvement of PTAs/OTAs.
    Finally, we noted that we would be further addressing application 
of the modifiers for therapy assistant services and the 10 percent de 
minimis standard more specifically in PFS rulemaking for CY 2020, 
including how the modifiers are applied in different scenarios for 
different types of services.
b. Applying the CQ and CO Modifiers
    CMS interprets the references in section 1834(v)(1) and (2) of the 
Act to outpatient physical therapy ``service'' and outpatient 
occupational therapy ``service'' to mean a specific procedure code that 
describes a PT or OT service. This interpretation makes sense because 
section 1834(v)(2) of the Act requires the use of a modifier to 
identify on each request for payment, or bill submitted for an 
outpatient therapy service furnished in whole or in part by a PTA/OTA. 
For purposes of billing, each outpatient therapy service is identified 
by a procedure code.
    To apply the de minimis standard under which a service is 
considered to be furnished in whole or in part by a PTA or OTA when 
more than 10 percent of the service is furnished by the PTA or OTA, we 
propose to make the 10 percent calculation based on the respective 
therapeutic minutes of time spent by the therapist and the PTA/OTA, 
rounded to the nearest whole minute. The minutes of time spent by a 
PTA/OTA furnishing a therapeutic service can overlap partially or 
completely with the time spent by a physical or occupational therapist 
furnishing the service. We propose that the total time for a service 
would be the total time spent by the therapist (whether independent of, 
or concurrent with, a PTA/OTA) plus any additional time spent by the 
PTA/OTA independently furnishing the therapeutic service. When deciding 
whether the therapy assistant modifiers apply, we propose that if the 
PTA/OTA participates in the service concurrently with the therapist for 
only a portion of the total time that the therapist delivers a service, 
the CQ/CO modifiers apply when the minutes furnished by the therapy 
assistant are greater than 10 percent of the total minutes spent by the 
therapist furnishing the service. If the PTA/OTA and the therapist each 
separately furnish portions of the same service, we propose that the 
CQ/CO modifiers would apply when the minutes furnished by the therapy 
assistant are greater than 10 percent of the total minutes--the sum of 
the minutes spent by the therapist and therapy assistant--for that 
service. We propose to apply the CQ/CO modifier policies to all 
services that would be billed with the respective GP or GO therapy 
modifier. We believe this is appropriate because it is the same way 
that CMS currently identifies physical therapy or occupational therapy 
services for purposes of accruing incurred expenses for the thresholds 
and targeted review process.

[[Page 40560]]

    For purposes of deciding whether the 10 percent de minimis standard 
is exceeded, we offer two different ways to compute this. The first is 
to divide the PTA/OTA minutes by the total minutes for the service--
which is (a) the therapist's total time when PTA/OTA minutes are 
furnished concurrently with the therapist, or (b) the sum of the PTA/
OTA and therapist minutes when the PTA/OTA's services are furnished 
separately from the therapist; and then to multiply this number by 100 
to calculate the percentage of the service that involves the PTA/OTA. 
We propose to round to the nearest whole number so that when this 
percentage is 11 percent or greater, the 10 percent de minimis standard 
is exceeded and the CQ/CO modifier is applied. The other method is 
simply to divide the total time for the service (as described above) by 
10 to identify the 10 percent de minimis standard, and then to add one 
minute to identify the number of minutes of service by the PTA/OTA that 
would be needed to exceed the 10 percent standard. For example, where 
the total time of a service is 60 minutes, the 10 percent standard is 
six (6) minutes, and adding one minute yields seven (7) minutes. Once 
the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO 
modifier is required to be added to the claim for that service. As 
noted above, we propose to round the minutes and percentages of the 
service to the nearest whole integer. For example, when the total time 
for the service is 45 minutes, the 10 percent calculation would be 4.5 
which would be rounded up to 5, and the PTA/OTA's contribution would 
need to meet or exceed 6 minutes before the CQ/CO modifier is required 
to be reported on the claim. See Table 19 for minutes needed to meet or 
exceed using the ``simple'' method with typical times for the total 
time of a therapy service.

                       Table 19--Simple Method for Determining When CQ/CO Modifiers Apply
----------------------------------------------------------------------------------------------------------------
                        Method Two: simple method to apply 10 percent de minimis standard
-----------------------------------------------------------------------------------------------------------------
                               Determine the 10 percent
Total Time * examples using      standard by dividing      Round 10 percent standard   PTA/OTA Minutes needed to
typical service total times    service Total Time by 10      to next whole integer        exceed--apply CQ/CO
----------------------------------------------------------------------------------------------------------------
                       10                          1.0                         1.0                         2.0
                       15                          1.5                         2.0                         3.0
                       20                          2.0                         2.0                         3.0
                       30                          3.0                         3.0                         4.0
                       45                          4.5                         5.0                         6.0
                       60                          6.0                         6.0                         7.0
                       75                          7.5                         8.0                         9.0
----------------------------------------------------------------------------------------------------------------
Total Time equals total therapist minutes plus any PTA/OTA independent minutes. Concurrent minutes: When PTA/
  OTA's minutes are furnished concurrently with the therapist, total time equals the total minutes of the
  therapist's service. Separate minutes: When PTA/OTA's minutes are furnished separately from the minutes
  furnished by the therapist, total time equals the sum of the minutes of the service furnished by the PT/OT
  plus the minutes of the service furnished separately by the PTA/OTA.

    We want to clarify that the 10 percent de minimis standard, and 
therefore the CQ/CO modifiers, are not applicable to services in which 
the PTA/OTA did not participate. To the extent that the PTA/OTA and the 
physical therapist/occupational therapist (PT/OT) separately furnish 
different services that are described by procedure codes defined in 15-
minute increments, billing examples and proposed policies are included 
below in Scenario Two.
    As we indicated in the CY 2019 PFS final rule, we are addressing 
more specifically in this proposed rule the application of the 10 
percent de minimis standard in various clinical scenarios to decide 
when the CQ/CO modifiers apply. We acknowledge that application of the 
10 percent de minimis standard can work differently depending on the 
types of services and scenarios involving both the PTA/OTA and the PT/
OT. Therapy services are typically furnished in multiple units of the 
same or different services on a given treatment day, which can include 
untimed services (not billable in multiple units) and timed services 
that are defined by codes described in 15-minute intervals. The 
majority of the untimed services that therapists bill for fall into 
three categories: (1) Evaluative procedures, (2) group therapy, and (3) 
supervised modalities. We discuss each of these in greater detail 
below. Only one (1) unit can be reported in the claim field labeled 
``units'' for each procedure code representing an untimed service. The 
preponderance of therapy services, though, are billed using codes that 
are described in 15-minute increments. These services are typically 
furnished to a patient on a single day in multiple units of the same 
and/or different services. Under our current policy, the total number 
of units of one or more timed services that can be added to a claim 
depends on the total time for all the 15-minute timed codes that were 
delivered to a patient on a single date of service. We address our 
proposals for applying the CQ/CO modifiers using the 10 percent de 
minimis standard, along with applicable billing scenarios, by category 
below. In each of these scenarios, we assume that the PTA/OTA minutes 
are for therapeutic services.
     Evaluations and re-evaluations: CPT codes 97161 through 
97163 for physical therapy evaluations for low, moderate, and high 
complexity level, and CPT code 97164 for physical therapy re-
evaluation; and CPT codes 97165 through 97167 for occupational therapy 
evaluations for low, moderate, and high complexity level, and CPT 97168 
for occupational therapy re-evaluation. These PT and OT evaluative 
procedures are untimed codes and cannot be billed in multiple units--
one unit is billed on the claim. As discussed in CY 2019 PFS rulemaking 
(83 FR 35852 and 83 FR 59656) and noted above, PTAs/OTAs are not 
recognized to furnish evaluative or assessment services, but to the 
extent that they furnish a portion of an evaluation or re-evaluation 
(such as completing clinical labor tasks for each code) that exceeds 
the 10 percent de minimis standard, the appropriate therapy assistant 
modifier (CQ or CO) must be used on the claim. We note that it is 
possible for the PTA/OTA to furnish these minutes either concurrently 
or separately from the therapist. For example, when the PTA/OTA assists 
the PT/OT concurrently for a 5-minute portion of the 30 minutes that a 
PT or OT spent furnishing an evaluation (for example, CPT code 97162 
for moderate complexity PT evaluation or CPT code 97165 for a low 
complexity OT evaluation--each have a typical therapist face-to-face 
time of 30

[[Page 40561]]

minutes), the respective CQ or CO modifier is applied to the service 
because the 5 minutes surpasses the 10 percent de minimis standard. In 
other words, 10 percent of 30 minutes is 3 minutes, and the CQ or CO 
modifier applies if the PTA/OTA furnishes more than 3 minutes, meaning 
at least 4 minutes, of the service. If the PTA/OTA separately furnishes 
a portion of the service that takes 5 minutes (for example, performing 
clinical labor tasks such as obtaining vital signs, providing self-
assessment tool to the patient and verifying its completion), and then 
the PT/OT separately (without the PTA/OTA) furnishes a 30 minute face-
to-face evaluative procedure--bringing the total time of the service to 
35 minutes (the sum of the separate PTA/OTA minutes, that is, 5 
minutes, plus the 30-minute therapist service), the CQ or CO modifier 
would be applied to the service because the 5 minutes of OTA/PTA time 
exceeds 10 percent of the 35 total minutes for the service. In other 
words, 10 percent of 35 minutes is 3.5 minutes which is rounded up to 4 
minutes. The CQ or CO modifier would apply when the PTA/OTA furnishes 5 
or more minutes of the service, as discussed above and referenced in 
Table 19.
     Group Therapy: CPT code 97150 (requires constant 
attendance of therapist or assistant, or both). CPT code 97150 
describes a service furnished to a group of 2 or more patients. Like 
evaluative services, this code is an untimed service and cannot be 
billed in multiple units on the claim, so one unit of the service is 
billed for each patient in the group. For the group service, the CQ/CO 
modifier would apply when the PTA/OTA wholly furnishes the service 
without the therapist. The CQ/CO modifier would also apply when the 
total minutes of the service furnished by the PTA/OTA (whether 
concurrently with, or separately from, the therapist), exceed 10 
percent of the total time, in minutes, of the group therapy service 
(that is, the total minutes of service spent by the therapist (with or 
without the PTA/OTA) plus any minutes spent by the PTA/OTA separately 
from the therapist). For example, the modifiers would apply when the 
PTA/OTA participates concurrently with the therapist for 5 minutes of a 
total group therapy service time of 40-minutes (based on the time of 
the therapist); or when the PTA/OTA separately furnishes 5 minutes of a 
total group time of 40 minutes (based on the sum of minutes of the PTA/
OTA (5) and therapist (35)).
     Supervised Modalities: CPT codes 97010 through 97028, and 
HCPCS codes G0281, G0183, and G0329. Modalities, in general, are 
physical agents that are applied to body tissue in order to produce a 
therapeutic change through various forms of energy, including but not 
limited to thermal, acoustic, light, mechanical or electric. Supervised 
modalities, for example vasopneumatic devices, paraffin bath, and 
electrical stimulation (unattended), do not require the constant 
attendance of the therapist or supervised therapy assistant, unlike the 
modalities defined in 15-minute increments that are discussed in the 
below category. When a supervised modality, such as whirlpool (CPT code 
97022), is provided without the direct contact of a PT/OT and/or PTA/
OTA, that is, it is furnished entirely by a technician or aide, the 
service is not covered and cannot be billed to Medicare. Supervised 
modality services are untimed, so only one unit of the service can be 
billed regardless of the number of body areas that are treated. For 
example, when paraffin bath treatment is provided to both of the 
patient's hands, one unit of CPT code 97018 can be billed, not two. For 
supervised modalities, the CQ or CO modifier would apply to the service 
when the PTA/OTA fully furnishes all the minutes of the service, or 
when the minutes provided by the PTA or OTA exceed 10 percent of total 
minutes of the service. For example, the CQ/CO modifiers would apply 
when either (1) the PTA/OTA concurrently furnishes 2 minutes of a total 
8-minute service by the therapist furnishing paraffin bath treatment 
(HCPCS code 97018) because 2 minutes is greater than 10 percent of 8 
minutes (0.8 minute, or 1 minute after rounding); or (2) the PTA/OTA 
furnishes 3 minutes of the service separately from the therapist who 
furnishes 5 minutes of treatment for a total time of 8 minutes (total 
time equals the sum of the PT/OT minutes plus the separate PTA/OTA 
minutes) because 3 minutes is greater than 10 percent of 8 total 
minutes (0.8 minute rounded to 1 minute).
     Services defined by 15-minute increments/units: These 
timed codes are included in the following current CPT code ranges: CPT 
codes 97032 through 97542--including the subset of codes for modalities 
in the series CPT codes 97032 through 97036; and, codes for procedures 
in the series CPT codes 97110-97542; CPT codes 97750-97755 for tests 
and measurements; and CPT codes: 97760-97763 for orthotic management 
and training and prosthetic training. Based on CPT instructions for 
these codes, the therapist (or their supervised therapy assistant, as 
appropriate) is required to furnish the service directly in a one-on-
one encounter with the patient, meaning they are treating only one 
patient during that time. Examples of modalities requiring one-on-one 
patient contact include electrical stimulation (attended), CPT code 
97032, and ultrasound, CPT code 97035. Examples of procedures include 
therapeutic exercise, CPT code 97110, neuromuscular reeducation, CPT 
97112, and gait training, CPT code 97116.
    Our policy for reporting of service units with HCPCS codes for both 
untimed services and timed services (that is, only those therapy 
services defined in 15-minute increments) is explained in section 20.2 
of Chapter 5 of the Medicare Claims Processing Manual (MCPM). To bill 
for services described by the timed codes (hereafter, those codes 
described per each 15-minutes) furnished to a patient on a date of 
service, the therapist or therapy assistant needs to first identify all 
timed services furnished to a patient on that day, and then total all 
the minutes of all those timed codes. Next, the therapist or therapy 
assistant needs to identify the total number of units of timed codes 
that can be reported on the claim for the physical or occupational 
therapy services for a patient in one treatment day. Once the number of 
billable units is identified, the therapist or therapy assistant 
assigns the appropriate number of unit(s) to each timed service code 
according to the total time spent furnishing each service. For example, 
to bill for one 15-minute unit of a timed code, the qualified 
professional (the therapist or therapy assistant) must furnish at least 
8 minutes and up to 22 minutes of the service; to bill for 2 units, at 
least 23 minutes and up to 37 minutes, and to bill for 3 units, at 
least 38 minutes and up to 52 minutes. We note that these minute ranges 
are applicable when one service, or multiple services, defined by timed 
codes are furnished by the qualified professional on a treatment day. 
We understand that the therapy industry often refers to these billing 
conventions as the ``eight-minute rule.'' The idea is that when a 
therapist or therapy provider bills for one or more units of services 
that are described by timed codes, the therapist's direct, one-on-one 
patient contact time would average 15 minutes per unit. This idea is 
also the basis for the work values we have established for these timed 
codes. Our current policies for billing of timed codes and related 
documentation do not take into consideration whether a service is 
furnished ``in whole or in

[[Page 40562]]

part'' by a PTA/OTA, or otherwise address the application of the CQ/CO 
modifier when the 10 percent de minimis standard is exceeded, for those 
services in which both the PTA/OTA and the PT/OT work together to 
furnish a service or services.
    To support the number of 15-minute timed units billed on a claim 
for each treatment day, we require that the total timed-code treatment 
time be documented in the medical record, and that the treatment note 
must document each timed service, whether or not it is billed, because 
the unbilled timed service(s) can impact billing. The minutes that each 
service is furnished can be, but are not required to be, documented. We 
also require that each untimed service be documented in the treatment 
note in order to support these services billed on the claim; and, that 
the total treatment time for each treatment day be documented--
including minutes spent providing services represented by the timed 
codes (the total timed-code treatment time) and the untimed codes. To 
minimize burden, we are not proposing changes to these documentation 
requirements in this proposed rule.
    Beginning January 1, 2020, in order to provide support for 
application of the CQ/CO modifier(s) to the claim as required by 
section 1834(v)(2)(B) of the Act and our proposed regulations at 
Sec. Sec.  410.59(a)(4) and 410.60(a)(4), we propose to add a 
requirement that the treatment notes explain, via a short phrase or 
statement, the application or non-application of the CQ/CO modifier for 
each service furnished that day. We would include this documentation 
requirement in subsection in Chapter 15, MBPM, section 220.3.E on 
treatment notes. Because the CQ/CO modifiers also apply to untimed 
services, our proposal to revise our documentation requirement for the 
daily treatment note extends to those codes and services as well. For 
example, when PTAs/OTAs assist PTs/OTs to furnish services, the 
treatment note could state one of the following, as applicable: (a) 
``Code 97110: CQ/CO modifier applied--PTA/OTA wholly furnished''; or, 
(b) ``Code 97150: CQ/CO modifier applied--PTA/OTA minutes = 15%''; or 
``Code 97530: CQ/CP modifier not applied--PTA/OTA minutes less than 10% 
standard.'' For those therapy services furnished exclusively by 
therapists without the use of PTAs/OTA, the PT/OT could note one of the 
following: ``CQ/CO modifier NA'', or ``CQ/CO modifier NA--PT/OT fully 
furnished all services.'' Given that the minutes of service furnished 
by or with the PTA/OTA and the total time in minutes for each service 
(timed and untimed) are used to decide whether the CQ/CO modifier is 
applied to a service, we seek comment on whether it would be 
appropriate to require documentation of the minutes as part of the CQ/
CO modifier explanation as a means to avoid possible additional burden 
associated with a contractor's medical review process conducted for 
these services. We are also interested in hearing from therapists and 
therapy providers about current burden associated with the medical 
review process based on our current policy that does not require the 
times for individual services to be documented. Based on comments 
received, if we were to adopt a policy to include documentation of the 
PTA/OTA minutes and total time (TT) minutes, the CQ/CO modifier 
explanation could read similar to the following: ``Code 97162 (TT = 30 
minutes): CQ/CO modifier not applied--PTA/OTA minutes (3) did not 
exceed the 10 percent standard.''
    To recap, under our proposed policy, therapists or therapy 
assistants would apply the therapy assistant modifiers to the timed 
codes by first following the usual process to identify all procedure 
codes for the 15-minute timed services furnished to a beneficiary on 
the date of service, add up all the minutes of the timed codes 
furnished to the beneficiary on the date of service, decide how many 
total units of timed services are billable for the beneficiary on the 
date of service (based on time ranges in the chart in the manual), and 
assign billable units to each billable procedure code. The therapist or 
therapy assistant would then need to decide for each billed procedure 
code whether or not the therapy assistant modifiers apply.
    As previously explained, the CQ/CO modifier does not apply if all 
units of a procedure code were furnished entirely by the therapist; 
and, where all units of the procedure code were furnished entirely by 
the PTA/OTA, the appropriate CQ/CO modifier would apply. When some 
portion of the billed procedure code is furnished by the PTA/OTA, the 
therapist or therapy assistant would need to look at the total minutes 
for all the billed units of the service, and compare it to the minutes 
of the service furnished by the PTA/OTA as described above in order to 
decide whether the 10 percent de minimis standard is exceeded. If the 
minutes of the service furnished by the PTA/OTA are more than 10 
percent of the total minutes of the service, the therapist or therapy 
assistant would assign the appropriate CQ or CO modifier. We would make 
clarifying technical changes to chapter 5, section 20.2 of the MCPM to 
reflect the policies adopted through in this rulemaking related to the 
application or non-application of the therapy assistant modifiers. We 
anticipate that we will add examples to illustrate when the applicable 
therapy assistant modifiers must be applied, similar to the examples 
provided below.
    We are providing the following examples of clinical scenarios to 
illustrate how the 10 percent de minimis standard would be applied 
under our proposals when therapists and their assistants work together 
concurrently or separately to treat the same patient on the same day. 
These examples reflect how the therapist or therapy provider would 
decide whether the CQ or CO therapy assistant modifier should be 
included when billing for one or more service units of the 15-minute 
timed codes. In the following scenarios, ``PT'' is used to represent 
physical therapist and ``OT'' is used to refer to an occupational 
therapist for ease of reference; and, the services of the PTA/OTA are 
assumed to be therapeutic in nature, and not services that a technician 
or aide without the education and training of a PTA/OTA could provide.
     Scenario One: Where only one service, described by a 
single HCPCS code defined in 15-minute increments, is furnished in a 
treatment day:
    (1) The PT/OT and PTA/OTA each separately, that is individually and 
exclusively, furnish minutes of the same therapeutic exercise service 
(HCPCS code 97110) in different time frames: The PT/OT furnishes 7 
minutes and the PTA furnishes 7 minutes for a total of 14 minutes, one 
unit can be billed using the total time minute range of at least 8 
minutes and up to 22 minutes.
    Billing Example: One 15-minute unit of HCPCS code 97110 is reported 
on the claim with the CQ/CO modifier to signal that the time of the 
service furnished by the PTA/OTA (7 minutes) exceeded 10 percent of the 
14-minute total service time (1.4 minutes rounded to 1 minute, so the 
modifier would apply if the PTA/OTA had furnished 2 or more minutes of 
the service).
    (2) The PT/OT and PTA/OTA each separately, exclusive of the other, 
furnish minutes of the same therapeutic exercise service (HCPCS code 
97110) in different time frames: The PT/OT furnishes 20 minutes and the 
PTA/OTA furnishes 25 minutes for a total of 45 minutes, three units can 
be billed using the total time minute range of at least 38 minutes and 
up to 52 minutes.
    Billing Example: All three units of CPT code 97110 are reported on 
the claim with the corresponding CQ/CO modifier because the 25 minutes

[[Page 40563]]

furnished by the PTA/OTA exceeds 10 percent of the 45-minute total 
service time (4.5 minutes rounded to 5 minutes, so the modifier would 
apply if the PTA/OTA had furnished 6 or more minutes of the service).
    (3) The PTA/OTA works concurrently with the respective PT/OT as a 
team to furnish the same neuromuscular reeducation service (HCPCS code 
97112) for a 30-minute session, resulting in 2 billable units of the 
service (at least 23 minutes and up to 37 minutes).
    Billing Example: Both units of HCPCS code 97112 are reported with 
the appropriate CQ or CO modifier because the service time furnished by 
the PTA/OTA (30 minutes) exceeded 10 percent of the 30-minute total 
service time (3 minutes, so the modifier would apply if the PTA/OTA had 
furnished 4 or more minutes of the service).
     Scenario Two: When services that are represented by 
different procedure codes are furnished. Follow our current policy to 
identify the procedure codes to bill and the units to bill for the 
service(s) provided for the most time. We propose that when the PT/OT 
and the PTA/OTA each independently furnish a service defined by a 
different procedure code for the same number of minutes, for example 10 
minutes, for a total time of 20 minutes, qualifying for 1 unit to be 
billed (at least 8 minutes up to 23 minutes), the code for the service 
furnished by the PT/OT is selected to break the tie--one unit of that 
service would be billed without the CQ/CO modifier.
    (1) When only one unit of a service can be billed (requires a 
minimum of 8 minutes but less than 23 minutes):
    (a) The PT/OT independently furnishes 15 minutes of manual therapy 
(HCPCS code 97140) and the PTA/OTA independently furnishes 7 minutes of 
therapeutic exercise (HCPCS code 97110). One unit of HCPCS code 97140 
can be billed (at least 8 minutes and up to 22 minutes).
    Billing Example: One unit of HCPCS code 97140 is billed without the 
CQ/CO modifier because the PT/OT exclusively (without the PTA/OTA) 
furnished a full unit of a service defined by 15-minute time interval 
(current instructions require ``1'' unit to be reported). The 7 minutes 
of a different service delivered solely by the PTA/OTA do not result in 
a billable service. Both services, though, are documented in the 
medical record, noting which services were furnished by the PT/OT or 
PTA/OTA; and, the 7 minutes of HCPCS code 97110 would be included in 
the total minutes of timed codes that are considered when identifying 
the procedure codes and units of each that can be billed on the claim.
    (b) If instead, the PT/OT independently furnished 7 minutes of CPT 
code 97140 and the PTA/OTA independently furnished a full 15-minutes of 
CPT code 97110, one unit of CPT code 97110 is billed and the CQ/CO 
modifier is applied; the 7 minutes of the PT/OT service (CPT code 
97140) do not result in billable service, but all the minutes are 
documented and included in the total minutes of the timed codes that 
are considered when identifying the procedure codes and units of each 
that can be billed on the claim.
    (c) If the PT/OT and PTA/OTA each independently furnish an equal 
number of minutes of CPT codes 97140 and 97110, respectively, that is 
less than the full 15-minute mark, and the total minutes of the timed 
codes qualify for billing one unit of a service, the code furnished by 
the PT/OT would be selected to break the tie and billed without a CQ/CO 
modifier because the PT/OT furnished that service independently of the 
PTA/OTA.
    If instead the PT/OT furnishes an 8-minute service (CPT code 97140) 
and the PTA/OTA delivers a 13-minute service (CPT code 97110), one unit 
of the 13-minute PTA/OTA-delivered service (CPT code 97110) would be 
billed consistent with our current policy to bill the service with the 
greater time; and the service would be billed with a CQ/CO modifier 
because the PTA/OTA furnished the service independently.
    (2) When two or more units can be billed (requires a minimum of 23 
minutes), follow current instructions for billing procedure codes and 
units for each timed code.
    (a) The PT/OT furnishes 20 minutes of neuromuscular reeducation 
(CPT code 97112) and the PTA/OTA furnishes 8 minutes of therapeutic 
exercise (CPT code 97110) for a total of 28 minutes, which permits two 
units of the timed codes to be billed (at least 23 minutes and up to 37 
minutes).
    Billing Example: Following our usual process for billing for the 
procedure codes and units based on services furnished with the most 
minutes, one unit of each procedure code would be billed--one unit of 
CPT code 97112 is billed without a CQ/CO modifier and one unit of CPT 
code 97110 is billed with a CQ/CO modifier. This is because, under our 
current policy, the two billable units of timed codes are allocated 
among procedure codes by assigning the first 15 minutes of service to 
code 97112 (the code with the highest number of minutes), which leaves 
another 13 minutes of timed services: 5 minutes of code 97112 (20 minus 
15) and 8 minutes of code 97110. Since the 8 minutes of code 97110 is 
greater than the remaining 5 minutes of code 97112, the second billable 
unit of service would be assigned to 97110. The CQ/CO modifier would 
not apply to CPT code 97112 because the therapist furnished all minutes 
of that service independently. The CQ/CO modifier would apply to CPT 
code 97110 because the PTA/OTA furnished all minutes of that service 
independently.
    (b) The PT/OT furnishes 32 minutes of neuromuscular reeducation 
(CPT code 97112), the PT/OT and the PTA/OTA each separately furnish 12 
minutes and 14 minutes, respectively, of therapeutic exercise (CPT code 
97110) for a total of 26 minutes, and the PTA/OTA independently 
furnishes 12 minutes of self-care (CPT code 97535) for a total of 70 
minutes of timed code services, permitting five units to be billed (68-
82 minutes). Under our current policy, the five billable units would be 
assigned as follows: Two units to CPT code 97112, two units to CPT code 
97110, and one unit to CPT code 97535.
    Billing Example: The two units of CPT code 97112 would be billed 
without a CQ/CO modifier because all 32 minutes of that service were 
furnished independently by the PT/OT. The two units of CPT code 97110 
would be billed with the CQ/CO modifier because the PTA/OTA's 14 
minutes of the service are greater than 10 percent of the 26 total 
minutes of the service (2.6 minutes which is rounded to 3 minutes, so 
the modifiers would apply if the PTA/OTA furnished 4 or more minutes of 
the service), and the one unit of CPT code 97535 would be billed with a 
CQ/CO modifier because the PTA/OTA independently furnished all minutes 
of that service.
    (c) The PT/OT independently furnishes 12 minutes of neuromuscular 
reeducation activities (CPT code 97112) and the PTA/OTA independently 
furnishes 8 minutes of self-care activities (CPT code 97535) and 7 
minutes of therapeutic exercise (CPT code 97110)--the total treatment 
time of 27 minutes allows for two units of service to be billed (at 
least 23 minutes and up to 37 minutes). Under our current policy, the 
two billable units would be assigned as follows: One unit of CPT code 
97112 and one unit of CPT code 97535.
    Billing Example: The one unit of HCPCS code 97112 would be billed 
without the CQ/CO modifier because it was furnished independently by 
the PT/OT; and, the one unit of CPT code 97535 is billed with the CQ/CO 
modifier because it was independently furnished

[[Page 40564]]

by the PTA/OTA. In this example, CPT code 97110 is not billable; 
however, the minutes for all three codes are documented and counted 
toward the total time of the timed code services furnished to the 
patient on the date of service.
    (d) The PT/OT furnishes 15 minutes of each of two services 
described by CPT codes 97112 and 97535, and is assisted by the PTA/OTA 
who furnishes 3 minutes of each service concurrently with the PT/OT. 
The total time of 30 minutes allows two 15-minute units to be billed--
one unit each of CPT code 97112 and CPT code 97535.
    Billing Example: Both CPT codes 97112 and 97535 are billed with the 
applicable CQ/CO modifier because the time the PTA/OTA spent assisting 
the PT/OT for each service exceeds 10 percent of the 15-minute total 
time for each service (1.5 minutes which is rounded to 2 minutes, so 
that the modifiers apply if the PTA/OTA furnishes 3 or more minutes of 
the service).
c. Proposed Regulatory Provisions
    In accordance with section 1834(v)(2)(B) of the Act, we are 
proposing to amend Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for 
outpatient physical and occupational therapy services, respectively, 
and Sec.  410.105(d) for physical and occupational therapy services 
furnished by comprehensive outpatient rehabilitation facilities (CORFs) 
as authorized under section 1861(cc) of the Act, to establish as a 
condition of payment that claims for services furnished in whole or in 
part by an OTA or PTA must include a prescribed modifier; and that 
services will not be considered furnished in part by an OTA or PTA 
unless they exceed 10 percent of the total minutes for that service, 
beginning for services furnished on and after January 1, 2020. To 
implement section 1834(v)(1) of the Act, we are proposing to amend 
Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for outpatient physical and 
occupational therapy services, respectively, and at Sec.  410.105(d) 
for physical and occupational therapy services furnished by CORFs to 
specify that claims from physical and occupational therapists in 
private practice paid under section 1848 of the Act and from providers 
paid under section 1834(k) of the Act for physical therapy and 
occupational therapy services that contain a therapy assistant 
modifier, are paid at 85 percent of the otherwise applicable payment 
amount for the service for dates of service on and after January 1, 
2022. As specified in the CY 2019 PFS final rule, we also note that the 
CQ or CO modifier is to be applied alongside the corresponding GP or GO 
therapy modifier that is required on each claim line of service for 
physical therapy or occupational therapy services. Beginning for dates 
of service and after January 1, 2020, claims missing the corresponding 
GP or GO therapy modifier will be rejected/returned to the therapist or 
therapy provider so they can be corrected and resubmitted for 
processing.
    As discussed in the CY 2019 PFS proposed and final rules (see 83 FR 
35850 and 83 FR 59654), we established that the reduced payment rate 
under section 1834(v)(1) of the Act for the outpatient therapy services 
furnished in whole or in part by therapy assistants is not applicable 
to outpatient therapy services furnished by CAHs, for which payment is 
made under section 1834(g) of the Act. We would like to take this 
opportunity to clarify that we do not interpret section 1834(v) of the 
Act to apply to outpatient physical therapy or occupational therapy 
services furnished by CAHs, or by other providers for which payment for 
outpatient therapy services is not made under section 1834(k) of the 
Act based on the PFS rates.

N. 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 and CY 2015. 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.E. of this proposed 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 accepted 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 considered and responded to 
public comments received on the interim final values, and typically 
made any appropriate adjustments and finalized 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 reproposed 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

[[Page 40565]]

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 propose those values as 
recommended. Additionally, we continually engage with stakeholders, 
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 
included 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. The statute specifically 
defines the work component as the resources in time and intensity 
required 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 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 evaluation and management (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. When they exist we also include a summary of 
stakeholder reactions to our approach. We note that many commenters and 
stakeholders have expressed concerns over the years with our ongoing 
adjustment of work RVUs based on changes in the best information we had 
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 used to make the 
adjustments 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

[[Page 40566]]

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 stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC-recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277), we responded in detail to several comments 
that we received regarding this issue. 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. 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 
work RVUs did not appear to account for significant changes in time. In 
response to comments in the CY 2019 PFS final rule (83 FR 59515), we 
clarify 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 
stakeholder feedback, 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 look forward to continuing to engage with stakeholders 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 proposed 
valuation considered for specific codes. Table 20 contains a list of 
codes and descriptors for which we are proposing work RVUs; this 
includes all codes for which we received RUC recommendations by 
February 10, 2019. The proposed work RVUs, work time and other payment 
information for all CY 2020 payable codes are available on the CMS 
website under downloads for the CY 2020 PFS proposed 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 21 details 
our proposed refinements of the RUC's direct PE recommendations at the 
code-specific level. In section II.B. of this proposed rule, 
Determination of Practice Expense Relative Value Units (PE RVUs), we 
address certain proposed refinements that would be common across codes. 
Proposed refinements to particular codes are addressed in the portions 
of this section that are dedicated to particular codes. We note

[[Page 40567]]

that for each refinement, we indicate the impact on direct costs for 
that service. We 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 note 
that approximately half of the refinements listed in Table 21 result in 
changes under the $0.35 threshold and are unlikely to result in a 
change to the RVUs.
    We also note that the proposed direct PE inputs for CY 2020 are 
displayed in the CY 2020 direct PE input files, available on the CMS 
website under the downloads for the CY 2020 PFS proposed 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 proposed CY 2020 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 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 would 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 note that we believe these same assumptions would 
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 would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer 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 proposed rule, 
Determination of Practice Expense Relative Value Units (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 2020, we received invoices for several new supply and 
equipment items. Tables 22 and 23 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, Determination of Practice Expense Relative 
Value Units, we encouraged stakeholders 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 encouraged 
stakeholders 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.

[[Page 40568]]

    We remind stakeholders 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 22 and 23 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 stakeholders 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 stakeholders 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 stakeholders 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 included 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.
(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 proposed 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 public use files for the PFS proposed and final 
rules for each year display the services subject to the MPPR for 
diagnostic cardiovascular services, diagnostic imaging services, 
diagnostic ophthalmology services, and therapy services. We also 
include a 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 for the upcoming calendar year. The public use files for CY 
2020 are available on the CMS website under downloads for the CY 2020 
PFS proposed 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). For more information regarding the history of the OPPS 
cap, we refer readers to the CY 2007 PFS final rule with comment period 
(71 FR 69659 through 69662).
4. Proposed Valuation of Specific Codes for CY 2020
(1) Tissue Grafting Procedures (CPT Codes 15X00, 15X01, 15X02, 15X03, 
and 15X04)
    CPT code 20926 (Tissue grafts, other (e.g., paratenon, fat, 
dermis)), was identified through a review of services with anomalous 
sites of service when compared to Medicare utilization data. The CPT 
Editorial Panel subsequently replaced CPT code 20926 with five codes in 
the Integumentary section to better describe tissue grafting 
procedures.
    We are proposing the RUC-recommended work RVUs of 6.68 for CPT code 
15X00 (Grafting of autologous soft tissue, other, harvested by direct 
excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15X01 
(grafting of autologous fat harvested by liposuction technique to 
trunk, breasts, scalp, arms, and/or legs; 50cc or less injectate), 2.50 
for CPT code 15X02 (grafting of autologous fat harvested by liposuction 
technique to trunk, breasts, scalp, arms, and/or legs; each additional 
50cc injectate, or part thereof (list separately in addition to code 
for primary procedure)), 6.83 for CPT code 15X03 (grafting of 
autologous fat harvested by liposuction technique to face, eyelids, 
mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25cc or less 
injectate), and 2.41 for CPT code 15X04 (grafting of autologous fat 
harvested by liposuction technique to face, eyelids, mouth, neck, ears, 
orbits, genitalia, hands, and/or feet; each additional 25cc injectate, 
or part thereof (list separately in addition to code for primary 
procedure)).
    We are proposing the RUC-recommended direct PE inputs for this code 
family without refinement.
(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983, 
206X0, 206X1, 206X2, 206X3, 206X4, and 206X5)
    CPT codes 11980-11983 were identified as potentially misvalued 
since the majority specialty found in recent claims data differs from 
the two specialties that originally surveyed the codes. The current 
valuation of CPT code 11980 (Subcutaneous hormone pellet implantation 
(implantation of estradiol and/or testosterone pellets beneath the 
skin)) was reaffirmed by the RUC as the physician work had not changed 
since the last review. The CPT Editorial Panel revised the other three 
existing codes in the family and created six additional add-on codes to 
describe orthopaedic drug delivery. These codes were surveyed and 
reviewed for the October 2018 RUC meeting.
    CPT code 11980 (Subcutaneous hormone pellet implantation 
(implantation of estradiol and/or testosterone pellets beneath the 
skin)) with the current work value of 1.10 RVUs and 12 minutes of 
intraservice time, and 27 minutes of total time, was determined to be 
unchanged since last reviewed and was recommended by the RUC to be 
maintained. We concur. We also are not proposing any direct PE 
refinements to CPT code 11980. CPT code 11981 (Insertion, non-
biodegradable drug delivery implant) has a current work RVU of 1.48, 
with 39 minutes of total physician time. The specialty society survey 
recommended a work RVU of 1.30, with 31 minutes of total physician time 
and 5 minutes of intraservice time. The RUC recommended a work RVU of 
1.30 (25th percentile), with 30 minutes of total physician time and 5 
minutes of intraservice time. For comparable reference CPT codes to CPT 
code 11981, the RUC and the survey respondents had selected CPT code 
55876 (Placement of interstitial device(s) for radiation therapy 
guidance (e.g., fiducial markers, dosimeter), prostate (via needle, any 
approach), single or multiple (work RVU = 1.73, 20 minutes intraservice 
time and 59 total minutes)) and CPT code 57500 (Biopsy of cervix,

[[Page 40569]]

single or multiple, or local excision of lesion, with or without 
fulguration (separate procedure) (work RVU = 1.20, 15 minutes 
intraservice time and 29 total minutes)). The RUC further offers for 
comparison, CPT code 67515 (Injection of medication or other substance 
into Tenon's capsule (work RVU = 1.40 (from CY 2018), 5 minutes 
intraservice time and 21 minutes total time)), CPT code 12013 (Simple 
repair of superficial wounds of face, ears, eyelids, nose, lips and/or 
mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22 and 27 total 
minutes)) and CPT code 12004 (Simple repair of superficial wounds of 
scalp, neck, axillae, external genitalia, trunk and/or extremities 
(including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44 and 29 
total minutes)). In addition, we offer CPT code 67500 (Injection of 
medication into cavity behind eye) (work RVU = 1.18 and 5 minutes 
intraservice time and 33 total minutes) for reference. Given that the 
CPT code 11981 incurs a 23 percent reduction in the new total physician 
time and with reference to CPT code 67500, we are proposing a work RVU 
of 1.14, and accept the survey recommended 5 minutes for intraservice 
time and 30 minutes of total time. We are not proposing any direct PE 
refinements to CPT code 11981.
    CPT code 11982 (Removal, non-biodegradable drug delivery implant) 
has a current work RVU of 1.78, with 44 minutes of total physician 
time. The specialty society survey recommended a work RVU of 1.70 RVU, 
with 10 minutes of intraservice time and 34 minutes of total physician 
time. The RUC also recommended a work RVU of 1.70, with 10 minutes of 
intraservice time and 33 minutes of total physician time. The RUC 
confirmed that removal (CPT code 11982), requires more intraservice 
time to perform than the insertion (CPT code 11981). For comparable 
reference codes to CPT code 11982, the RUC and the survey respondents 
had selected CPT code 54150 (Circumcision, using clamp or other device 
with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes 
intraservice time and 45 total minutes)) and CPT code 12004 (Simple 
repair of superficial wounds of scalp, neck, axillae, external 
genitalia, trunk and/or extremities (including hands and feet); 7.6 cm 
to 12.5 cm) (work RVU = 1.44, with 17 minutes intraservice time and 29 
minutes total time)). We offer CPT code 64486 (Injections of local 
anesthetic for pain control and abdominal wall analgesia on one side) 
(work RVU = 1.27, 10 minutes intraservice time and 35 total minutes)) 
for reference. Given that the CPT code 11982 incurs a 25 percent 
reduction in the new total physician time and with reference to CPT 
code 64486, we are proposing a work RVU of 1.34, and accept the RUC-
recommended 10 minutes for intraservice time and 33 minutes of total 
time. We are not proposing any direct PE refinements to CPT code 11982.
    CPT code 11983 (Removal with reinsertion, non-biodegradable drug 
delivery implant) has a current work RVU of 3.30, with 69 minutes of 
total physician time. The specialty society survey recommended a work 
RVU of 2.50 RVU, with 15 minutes of intraservice time and 41 minutes of 
total physician time. The RUC also recommended a work RVU of 2.10, with 
15 minutes of intraservice time and 40 minutes of total physician time. 
The RUC confirmed that CPT code 11983 requires more intraservice time 
to perform than the insertion CPT code 11981. For comparable reference 
codes to CPT code 11983, the RUC and the survey respondents had 
selected CPT code 55700 (Biopsy, prostate; needle or punch, single or 
multiple, any approach) (work RVU = 2.50, 15 minutes intraservice time 
and 35 total minutes)), CPT code 54150 (Circumcision, using clamp or 
other device with regional dorsal penile or ring block) (work RVU = 
1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code 
52281 (Cystourethroscopy, with calibration and/or dilation of urethral 
stricture or stenosis, with or without meatotomy, with or without 
injection procedure for cystography, male or female) (work RVU = 2.75 
and 20 minutes intraservice time and 46 minutes total time)). We offer 
CPT code 62324 (Insertion of indwelling catheter and administration of 
substance into spinal canal of upper or middle back) (work RVU = 1.89, 
15 minutes intraservice time and 43 total minutes)) for reference. 
Given that the CPT code 11983 incurs a 42 percent reduction in new 
total physician time and with reference to CPT code 62324, we are 
proposing a work RVU of 1.91, and accept the RUC-recommended 15 minutes 
for intraservice time and 40 minutes of total time. We are not 
proposing any direct PE refinements to CPT code 11983.
    The new proposed add-on CPT codes 206X0-206X5 are intended to be 
typically reported with CPT codes 11981-11983, with debridement or 
arthrotomy procedures done primarily by orthopedic surgeons. The 
specialty society's survey for CPT code 206X0 (Manual preparation and 
insertion of drug delivery device(s), deep (e.g., subfascial)) found a 
2.00 work RVU value at the median and a 1.50 work RVU value at the 25th 
percentile, with 20 minutes of intraservice time and 30 minutes of 
total physician time, for the preparation of the antibiotic powder and 
cement, rolled into beads and threaded onto suture for insertion into 
the infected bone. The RUC recommended a work RVU of 1.50, with 20 
minutes of intraservice time and 27 minutes of total physician time. 
The RUC's reference CPT codes included CPT code 11047 (Debridement, 
bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or 
fascia, if performed); each additional 20 sq cm, or part thereof) (work 
RVU = 1.80, and 30 minutes intraservice time)), CPT codes 64484 
(Injection(s), anesthetic agent and/or steroid, transforaminal 
epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, 
each additional level) (work RVU = 1.00 and 10 minutes intraservice 
time)), and CPT code 36227 (Selective catheter placement, external 
carotid artery, unilateral, with angiography of the ipsilateral 
external carotid circulation and all associated radiological 
supervision and interpretation) (work RVU = 2.09 and 20 minutes 
intraservice time)). Our review of similar add-on CPT codes yielded CPT 
code 64634 (Destruction of upper or middle spinal facet joint nerves 
with imaging guidance) (work RVU = 1.32 and 20 minutes intraservice 
time)). We are proposing for CPT code 206X0, a work RVU of 1.32, and 
accept the RUC-recommended 20 minutes of intraservice time and 20 
minutes of total time.
    The specialty society's survey for CPT code 206X1 (Manual 
preparation and insertion of drug delivery device(s), intramedullary) 
found a 3.25 work RVU value at the median and a 2.50 work RVU value at 
the 25th percentile, with 25 minutes of intraservice time and 38 
minutes of total physician time, for the preparation of the 
``antibiotic nail'' ready for insertion into the intramedullary canal 
with fluoroscopic guidance. The RUC recommended a work RVU of 2.50, 
with 25 minutes of intraservice time and 32 minutes of total physician 
time. The RUC's reference CPT codes included CPT code 11047 
(Debridement, bone (includes epidermis, dermis, subcutaneous tissue, 
muscle and/or fascia, if performed); each additional 20 sq cm, or part 
thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 
57267 (Insertion of mesh or other prosthesis for repair of pelvic floor 
defect, each site (anterior, posterior compartment), vaginal approach 
(work

[[Page 40570]]

RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227 
(Selective catheter placement, external carotid artery, unilateral, 
with angiography of the ipsilateral external carotid circulation and 
all associated radiological supervision and interpretation (work RVU = 
2.09 and 15 minutes intraservice time)). We find that the reference CPT 
code 11047, with 30 minutes of intraservice time, is suitable, but we 
adjust our proposed work RVU of 1.70 to account for the 25 minutes, 
instead of our reference code's 30 minutes of intraservice time (and 
the 32 minutes of total time), for CPT code 206X1.
    The specialty society's survey for CPT code 206X2 (Manual 
preparation and insertion of drug delivery device(s), intra-articular) 
found a 4.00 work RVU value at the median and a 2.60 work RVU value at 
the 25th percentile, with 30 minutes of intraservice time and 45 
minutes of total physician time, for the preparation of the antibiotic 
cement inserted into a pre-fabricated silicone mold, when after setting 
up, will be cemented to the end of the bone (with the joint). The RUC 
recommended a work RVU of 2.60, with 30 minutes of intraservice time 
and 37 minutes of total physician time. The RUC's reference CPT codes 
included CPT code 11047 (Debridement, bone (includes epidermis, dermis, 
subcutaneous tissue, muscle and/or fascia, if performed); each 
additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes 
intraservice time)), CPT code 57267 (Insertion of mesh or other 
prosthesis for repair of pelvic floor defect, each site (anterior, 
posterior compartment), vaginal approach (work RVU = 4.88 and 45 
minutes intraservice time)), and CPT code 36227 (Selective catheter 
placement, external carotid artery, unilateral, with angiography of the 
ipsilateral external carotid circulation and all associated 
radiological supervision and interpretation (work RVU = 2.09 and 20 
minutes intraservice time)). We find that the reference CPT code 11047, 
with 30 minutes of intraservice time, is a suitable guide and we are 
proposing the work RVU of 1.80 with the RUC-recommended 30 minutes of 
intraservice time and 37 minutes of total time, for CPT code 206X2.
    The specialty society's survey for CPT code 206X3 (Removal of drug 
delivery device(s), deep (e.g., subfascial)) found a 1.75 work RVU 
value at the median and a 1.13 work RVU value at the 25th percentile, 
with 15 minutes of intraservice time and 18 minutes of total physician 
time. The work includes a marginal dissection to expose the drug 
delivery device and to remove it. The RUC recommended a work RVU of 
1.13, with 18 minutes of total physician time and 15 minutes of 
intraservice time. The RUC's reference CPT codes included CPT code 
11047 (Debridement, bone (includes epidermis, dermis, subcutaneous 
tissue, muscle and/or fascia, if performed); each additional 20 sq cm, 
or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), 
CPT code 64484 (Injection(s), anesthetic agent and/or steroid, 
transforaminal epidural, with imaging guidance (fluoroscopy or CT); 
lumbar or sacral, each additional level (work RVU = 1.00 and 10 minutes 
intraservice time)), and CPT code 64480 (Injection(s), anesthetic agent 
and/or steroid, transforaminal epidural, with imaging guidance 
(fluoroscopy or CT); cervical or thoracic, each additional level (work 
RVU = 1.20 and 15 minutes intraservice time)). We are proposing the 
RUC-recommended work RVU of 1.13 with 15 minutes of intraservice time 
and 18 minutes of total time for 206X3.
    The specialty society's survey for CPT code 206X4 (Removal of drug 
delivery device(s), intramedullary) found a 2.50 work RVU value at the 
median and a 1.80 work RVU value at the 25th percentile, with 20 
minutes of intraservice time and 28 minutes of total physician time. 
The work includes a marginal dissection, in addition to what was in the 
base procedure, to loosen and expose the drug delivery device and to 
remove it, any remaining drug delivery device shards that may have 
broken off. The RUC recommended a work RVU of 1.80, with 20 minutes of 
intraservice time and 23 minutes of total physician time. The RUC's 
reference CPT codes included CPT code 11047 (Debridement, bone 
(includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, 
if performed); each additional 20 sq cm, or part thereof (work RVU = 
1.80, and 30 minutes intraservice time)), CPT codes 37253 
(Intravascular ultrasound (noncoronary vessel) during diagnostic 
evaluation and/or therapeutic intervention, including radiological 
supervision and interpretation; each additional noncoronary vessel 
(work RVU = 1.44 and 20 minutes intraservice time)), and CPT code 36227 
(Selective catheter placement, external carotid artery, unilateral, 
with angiography of the ipsilateral external carotid circulation and 
all associated radiological supervision and interpretation (work RVU = 
2.09 and 15 minutes intraservice time)). We are proposing the RUC-
recommended work RVU of 1.80 with 20 minutes of intraservice time and 
23 minutes of total time for 206X4.
    The specialty society's survey for CPT code 206X5 (Removal of drug 
delivery device(s), intra-articular) found a 3.30 work RVU value at the 
median and a 2.15 work RVU value at the 25th percentile, with 25 
minutes of intraservice time and 28 minutes of total physician time. 
The work includes the removal of the intra-articular drug delivery 
device that is cemented to both sides of the joint without removing too 
much bone in the process. The RUC recommended a work RVU of 2.15, with 
25 minutes of intraservice time and 28 minutes of total physician time. 
The RUC's reference CPT codes included CPT code 11047 (Debridement, 
bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or 
fascia, if performed); each additional 20 sq cm, or part thereof (work 
RVU = 1.80, and 30 minutes intraservice time)), CPT code 36476 
(Endovenous ablation therapy of incompetent vein, extremity, inclusive 
of all imaging guidance and monitoring, percutaneous, radiofrequency; 
subsequent vein(s) treated in a single extremity, each through separate 
access sites (work RVU = 2.65 and 30 minutes intraservice time)), and 
CPT code 36227 (Selective catheter placement, external carotid artery, 
unilateral, with angiography of the ipsilateral external carotid 
circulation and all associated radiological supervision and 
interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We 
are proposing the RUC-recommended work RVU of 2.15 with 25 minutes of 
intraservice time and 28 minutes of total time for 206X5.
(3) Bone Biopsy Trocar-Needle (CPT Codes 20220 and 20225)
    In October 2017, CPT code 20225 (Biopsy, bone, trocar, or needle; 
deep (e.g., vertebral body, femur)) was identified as being performed 
by a different specialty than the one that originally surveyed this 
service. CPT code 20220 (Biopsy, bone, trocar, or needle; superficial 
(e.g., ilium, sternum, spinous process, ribs)) was added as part of the 
family, and both codes were surveyed and reviewed for the January 2019 
RUC meeting.
    We disagree with the RUC-recommended work RVU of 1.93 for CPT code 
20220 and we are proposing a work RVU of 1.65 based on a crosswalk to 
CPT code 47000 (Biopsy of liver, needle; percutaneous). CPT code 47000 
shares the same intraservice time of 20 minutes with CPT code 20220 and 
has slightly higher total time at 55 minutes as compared to 50 minutes. 
It

[[Page 40571]]

is also one of the top reference codes selected by the survey 
respondents. In our review of CPT code 20220, we noted that the 
recommended intraservice time is decreasing from 22 minutes to 20 
minutes (9 percent reduction), and that the recommended total time is 
increasing from 49 minutes to 50 minutes (2 percent increase). However, 
the RUC-recommended work RVU is increasing from 1.27 to 1.93, which is 
an increase of 52 percent. Although we do 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, changes in surveyed 
work time should be appropriately reflected in the proposed work RVUs.
    In the case of CPT code 20220, we believe that it would be more 
accurate to propose a work RVU of 1.65, based on a crosswalk to CPT 
code 47000, to account for the decrease in the surveyed intraservice 
work time. We believe that the work carried out by the practitioner in 
CPT code 47000 is potentially more intense than the work performed in 
CPT code 20220, as the reviewed code is a superficial bone biopsy as 
opposed to the non-superficial biopsy taking place on an internal organ 
(the liver) described by CPT code 47000. We also note that the survey 
respondents considered CPT code 47000 to have similar intensity to CPT 
code 20220: 50 percent or more of the survey respondents rated the two 
codes as ``identical'' under the categories of Mental Effort and 
Judgment, Physical Effort Required, and Psychological Stress, along 
with a plurality of survey respondents rating the two codes as 
identical in the category of Technical Skill Required. We believe that 
this provides further support for our belief that CPT code 20220 should 
be crosswalked to CPT code 47000 at the same work RVU of 1.65.
    We disagree with the RUC-recommended work RVU of 3.00 for CPT code 
20225 and we are proposing a work RVU of 2.45 based on a crosswalk to 
CPT code 30906 (Control nasal hemorrhage, posterior, with posterior 
nasal packs and/or cautery, any method; subsequent). CPT code 30906 
shares the same intraservice time of 30 minutes and has 1 fewer minute 
of total time as compared to CPT code 20225. When reviewing this code, 
we observed a pattern similar to what we had seen with CPT code 20220. 
We note that the recommended intraservice time for CPT code 20225 is 
decreasing from 60 minutes to 30 minutes (50 percent reduction), and 
the recommended total time is decreasing from 135 minutes to 64 minutes 
(53 percent reduction); however, the RUC-recommended work RVU is 
increasing from 1.87 to 3.00, which is an increase of about 60 percent. 
As we noted earlier, we do not believe 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, and we are not proposing a 
linear decrease in the work valuation based on these time ratios. 
Indeed, we agree with the RUC recommendation that the work RVU of CPT 
code 20225 should increase over the current valuation. However, we 
believe that since the two components of work are time and intensity, 
significant decreases in time should be appropriately reflected in 
changes to the work RVUs, and we do not believe that it would be 
accurate to propose the recommended work RVU of 3.00 given the 
significant decreases in surveyed work time.
    Instead, we believe that it would be more accurate to propose a 
work RVU of 2.45 for CPT code 20225 based on a crosswalk to CPT code 
30906. We note that this proposed work RVU is a very close match to the 
intraservice time ratio between the two codes in the family; we are 
proposing a work RVU of 1.65 for CPT code 20220 with 20 minutes of 
intraservice work time, and a work RVU of 2.45 for CPT code 20225 with 
30 minutes of intraservice work time. (The exact intraservice time 
ratio calculates to a work RVU of 2.47.) We believe that the proposed 
work RVUs maintain the relative intensity of the two codes in the 
family, and better preserve relativity with the rest of the codes on 
the PFS.
    For the direct PE inputs, we are proposing to replace the bone 
biopsy device (SF055) supply with the bone biopsy needle (SC077) in CPT 
code 20225. We note that this code currently makes use of the bone 
biopsy needle, and there was no rationale provided in the recommended 
materials to explain why it would now be typical for the bone biopsy 
needle to be replaced by the bone biopsy device. We are proposing to 
maintain the use of the current supply item. We are also proposing to 
adopt a 90 percent utilization rate for the use of the CT room (EL007) 
equipment in CPT code 20225. We previously finalized a policy in the CY 
2010 PFS final rule (74 FR 61754 through 61755) to increase the 
equipment utilization rate to 90 percent for expensive diagnostic 
equipment priced at more than $1 million, and specifically cited the 
use of CT and MRI equipment which would be subject to this utilization 
rate.
(4) Trigger Point Dry Needling (CPT Codes 205X1 and 205X2)
    For CY 2020, the CPT Editorial Panel approved two new codes to 
report dry needling of musculature trigger points. These codes were 
surveyed and reviewed by the HCPAC for the January 2019 RUC meeting.
    We disagree with the HCPAC-recommended work RVU of 0.45 for CPT 
code 205X1 (Needle insertion(s) without injection(s), 1 or 2 muscle(s)) 
and we are proposing a work RVU of 0.32 based on a crosswalk to CPT 
code 36600 (Arterial puncture, withdrawal of blood for diagnosis). CPT 
code 36600 shares the identical intraservice time, total time, and 
intensity with CPT code 205X1, which makes it an appropriate choice for 
a crosswalk. In our review of CPT code 205X1, we compared the procedure 
to the top reference code chosen by the survey participants, CPT code 
97140 (Manual therapy techniques (e.g., mobilization/manipulation, 
manual lymphatic drainage, manual traction), 1 or more regions, each 15 
minutes). This therapy procedure has 50 percent more intraservice time 
than CPT code 205X1, as well as higher total time; however, the 
recommended work RVU of 0.45 was higher than the work RVU of 0.43 for 
the top reference code from the survey. We did not agree that CPT code 
205X1 should be valued at a higher rate, and therefore, we are 
proposing a work RVU of 0.32 based on the aforementioned crosswalk to 
CPT code 36600.
    We disagree with the HCPAC-recommended work RVU of 0.60 for CPT 
code 205X2 (Needle insertion(s) without injection(s), 3 or more 
muscle(s)) and we are proposing a work RVU of 0.48 based on a crosswalk 
to CPT codes 97113 (Therapeutic procedure, 1 or more areas, each 15 
minutes; aquatic therapy with therapeutic exercises) and 97542 
(Wheelchair management (e.g., assessment, fitting, training), each 15 
minutes). Both of these codes share the same work RVU of 0.48 and the 
same intraservice time of 15 minutes as CPT code 205X2, with CPT code 
97113 having two fewer minutes of total time and CPT code 97542 having 
two additional minutes of total time. We note that this proposed work 
RVU is an exact match of the intraservice time ratio between the two 
codes in the family; we are proposing a work RVU of 0.32 for CPT code 
205X1 with 10 minutes of intraservice work time, and a work RVU of 0.48 
for CPT code 205X2 with 15 minutes of intraservice work time. We also 
considered crosswalking the work RVU of CPT code 205X2 to the

[[Page 40572]]

top reference code from the survey, CPT code 97140, at a work RVU of 
0.43. However, we chose to employ the crosswalk to CPT codes 97113 and 
97542 at a work RVU of 0.48 instead, due to the fact that the survey 
respondents indicated that CPT code 205X2 was more intense than CPT 
code 97140.
    We are also proposing to designate CPT codes 205X1 and 205X2 as 
``always therapy'' procedures, and we are soliciting comments on this 
designation. We are proposing the RUC-recommended direct PE inputs for 
all codes in the family.
(5) Closed Treatment Vertebral Fracture (CPT Code 22310)
    This service was identified through a screen of services with a 
negative IWPUT and Medicare utilization over 10,000 for all services or 
over 1,000 for Harvard valued and CMS/Other source codes.
    For CPT code 22310 (Closed treatment of vertebral body fracture(s), 
without manipulation, requiring and including casting or bracing), we 
disagree with the recommended work RVU of 3.75 because we do not 
believe that this reduction in work RVU from the current value of 3.89 
is commensurate with the RUC-recommended a 33-minute reduction in 
intraservice time and a 105-minute reduction in total time. While we 
understand that the RUC considers the current Harvard study time values 
for this service to be invalid estimations, we believe that a further 
reduction in work RVUs is warranted given the significance of the RUC-
recommended reduction in physician time. We believe that it would be 
more accurate to propose a work RVU of 3.45 with a crosswalk to CPT 
code 21073 (Manipulation of temporomandibular joint(s) (TMJ), 
therapeutic, requiring an anesthesia service (i.e., general or 
monitored anesthesia care)), which has an identical intraservice time 
and similar total time as those proposed by the RUC for CPT code 22310, 
as we believe that this better accounts for the decrease in the 
surveyed work time.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the power table (EF031) to conform to our established standard 
for non-highly technical equipment.
(6) Tendon Sheath Procedures (CPT Codes 26020, 26055, and 26160)
    The RUC identified these services through a screen of services with 
a negative IWPUT and Medicare utilization over 10,000 for all services 
or over 1,000 for Harvard valued and CMS/Other source codes. For CPT 
code 26020 (Drainage of tendon sheath, digit and/or palm, each), we do 
not agree with the RUC-recommended work RVU of 7.79 based on the survey 
median. While we agree that the survey data validate an increase in 
work RVU, we see no compelling reason that this service would be 
significantly more intense to furnish than services of similar time 
values. Therefore, we are proposing a work RVU of 6.84 which is the 
survey 25th percentile. As further support for this value, we note that 
it falls between the work RVUs of CPT code 28122 (Partial excision 
(craterization, saucerization, sequestrectomy, or diaphysectomy) bone 
(e.g., osteomyelitis or bossing); tarsal or metatarsal bone, except 
talus or calcaneus), with a work RVU of 6.76, and CPT code 28289 
(Hallux rigidus correction with cheilectomy, debridement and capsular 
release of the first metatarsophalangeal joint; without implant), with 
a work RVU of 6.90; both codes have intraservice time values that are 
identical to, and total time values that are similar to, the RUC-
recommended time values for CPT code 26020.
    For CPT code 26055 (Tendon sheath incision (e.g., for trigger 
finger)), we do not agree with the RUC recommendation to increase the 
work RVU to 3.75 despite a reduction in physician time. Instead, we are 
proposing to maintain the current work RVU of 3.11; we are supporting 
this based on a total time increment methodology between the CPT code 
26020 and CPT code 26055. The total time ratio between the recommended 
time of 119 minutes and the recommended 262 minutes for code 26020 
equals 45 percent, and 45 percent of our proposed RVU of 6.84 for CPT 
code 26020 equals a work RVU of 3.10, which we believe validates the 
current work RVU of 3.11. We are proposing the RUC-recommended work RVU 
of 3.57 for CPT code 26160 (Excision of lesion of tendon sheath or 
joint capsule (e.g., cyst, mucous cyst, or ganglion), hand or finger). 
We note that our proposed work RVUs validate the RUC's contention that 
CPT code 26160 is slightly more intense to perform than CPT code 26055.
    For the direct PE inputs, we are proposing to refine the quantity 
of the impervious staff gown (SB027) supply from 2 to 1 for CPT codes 
26055 and 26160. We believe that the second impervious staff gown 
supply is duplicative due to the inclusion of this same supply in the 
surgical cleaning pack (SA043). The recommended materials state that a 
gown is worn by the practitioner and one assistant, which are provided 
by one standalone gown and a second gown in the surgical cleaning pack.
(7) Closed Treatment Fracture--Hip (CPT Code 27220)
    This service was identified through a screen of services with a 
negative IWPUT and Medicare utilization over 10,000 for all services or 
over 1,000 for Harvard valued and CMS/Other source codes. For CPT code 
27220 (Closed treatment of acetabulum (hip socket) fracture(s); without 
manipulation), we disagree with the RUC-recommended work RVU of 6.00 
based on the survey median value, because we do not believe that this 
reduction in work RVU from the current value of 6.83 is commensurate 
with the RUC-recommended a 19-minute reduction in intraservice time and 
an 80-minute reduction in total time. While we understand that the RUC 
considers the current Harvard study time values for this service to be 
invalid estimations, we believe that a further reduction in work RVUs 
is warranted given the significance of the RUC-recommended reduction in 
physician time. We believe that it would be more accurate to propose 
the survey 25th percentile work RVU of 5.50, and we are supporting this 
value with a crosswalk to CPT code 27267 (Closed treatment of femoral 
fracture, proximal end, head; without manipulation) to account for the 
decrease in the surveyed work time.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the power table (EF031) to conform to our established standard 
for non-highly technical equipment.
(8) Arthrodesis--Sacroliliac Joint (CPT Code 27279)
    In the CY 2018 PFS final rule (82 FR 53017), CPT code 27279 
(Arthrodesis, sacroiliac joint, percutaneous or minimally invasive 
(indirect visualization), with image guidance, includes obtaining bone 
graft when performed, and placement of transfixing device) was 
nominated for review by stakeholders as a potentially misvalued 
service. We stated that CPT code 27279 is potentially misvalued, and 
that a comprehensive review of the code values was warranted. This code 
was subsequently reviewed by the RUC. According to the specialty 
societies, the previous 2014 survey of CPT code 27279, was based on 
flawed methodology that resulted in an underestimation of 
intraoperative intensity. When CPT code 27279 was surveyed in 2014, 
there was a low rate of response. Due to the dearth of survey data and 
the RUC's agreement with the specialty society at the time that the

[[Page 40573]]

survey respondents had somewhat overvalued the work involved in 
performing this service, the RUC used a crosswalk to CPT code 62287 
(Decompression procedure, percutaneous, of nucleus pulposus of 
intervertebral disc, any method utilizing needle based technique to 
remove disc material under fluoroscopic imaging or other form of 
indirect visualization, with discography and/or epidural injection(s) 
at the treated level(s), when performed, single or multiple levels, 
lumbar) to recommend a work RVU of 9.03. The specialty societies 
indicated that with increased and broader utilization of this 
technique, the 2018 survey is a more robust assessment of physician 
work and intensity and provides more data with which to make a 
crosswalk recommendation. According to the RUC, there is no compelling 
evidence that the physician work, intensity or complexity has changed 
for this service.
    We are proposing to maintain the current work RVU of 9.03 as 
recommended by the RUC. A stakeholder stated that maintaining this RVU 
would constitute the continued undervaluation of this service, and that 
this would incentivize use of a more intensive and invasive procedure, 
CPT code 27280 (Arthrodesis, open, sacroiliac joint, including 
obtaining bone graft, including instrumentation, when performed), as 
well as incentivize this service to be inappropriately furnished on an 
inpatient basis. This stakeholder has requested that, in the interest 
of protecting patient access, we implement payment parity between the 
two services by proposing to crosswalk the work RVU of CPT code 27279 
to that of CPT code 27280, which has a work RVU of 20.00. While we are 
proposing the RUC-recommended work RVU, we are soliciting public 
comment on whether an alternative valuation of 20.00 would be more 
appropriate. This alternative valuation would recognize relative parity 
between these two services in terms of the work inherent in furnishing 
them.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
27279.
(9) Pericardiocentesis and Pericardial Drainage (CPT Code 3X000, 3X001, 
3X002, and 3X003)
    CPT code 33015 (Tube pericardiostomy) was identified as potentially 
misvalued on a Relativity Assessment Workgroup (RAW) screen of codes 
with a negative IWPUT and Medicare utilization over 10,000 for all 
services or over 1,000 for Harvard valued and CMS or other source 
codes. In September 2018, the CPT Editorial Panel deleted four existing 
codes and created four new codes to describe periodcardiocentesis 
drainage procedures to differentiate by age and to include imaging 
guidance.
    We are proposing to refine the work RVU for all four codes in the 
family. We disagree with the RUC-recommended work RVU of 5.00 for CPT 
code 3X000 (Pericardiocentesis, including imaging guidance, when 
performed) and are proposing a work RVU of 4.40 based on a crosswalk to 
CPT code 43244 (Esophagogastroduodenoscopy, flexible, transoral; with 
band ligation of esophageal/gastric varices). CPT code 43244 shares the 
same intraservice time of 30 minutes with CPT code 3X000 and has a 
slightly longer total time of 81 minutes as compared to 75 minutes for 
the reviewed code. In our review of CPT code 3X000, we noted that the 
recommended intraservice time as compared to the current initial 
pericardiocentesis procedure (CPT code 33010) is increasing from 24 
minutes to 30 minutes (25 percent), and the recommended total time is 
remaining the same at 75 minutes; however, the RUC-recommended work RVU 
is increasing from 1.99 to 5.00, which is an increase of 151 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 increase in the 
valuation of work RVUs, we believe that since the two components of 
work are time and intensity, modest increases in time should be 
appropriately reflected with a commensurate increase the work RVUs. We 
also conducted a search in the RUC database among 0-day global codes 
with 30 minutes of intraservice time and comparable total time of 65-85 
minutes. Our search identified 49 codes and all 49 of these codes had a 
work RVU lower than 5.00. We do not believe that it would serve the 
interests of relativity to establish a new maximum work RVU for this 
range of time values.
    As a result, we believe that it is more accurate to propose a work 
RVU of 4.40 for CPT code 3X000 based on a crosswalk to CPT code 43244 
to account for these modest increases in the surveyed work time as 
compared to the predecessor pericardiocentesis codes. We are aware that 
CPT code 3X000 is bundling imaging guidance into the new procedure, 
which was not included in the previous pericardiocentesis codes. 
However, we do not believe that the recoding of the services in this 
family has resulted in an increase in their intensity, only a change in 
the way in which they will be reported, and therefore, we do not 
believe that it would serve the interests of relativity to propose the 
RUC-recommended work values for all of the codes in this family. We 
also note that, through the bundling of some of these frequently 
reported services, it is reasonable to expect that the new coding 
system will achieve savings via elimination of duplicative assumptions 
of the resources involved in furnishing particular servicers. For 
example, a practitioner would not be carrying out the full preservice 
work twice for CPT codes 33010 and 76930, but preservice times were 
assigned to both codes under the old coding. 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 were largely unchanged from the predecessor codes.
    We disagree with the RUC-recommended work RVU of 5.50 for CPT code 
3X001 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including fluoroscopy and/or ultrasound guidance, when 
performed; 6 years and older without congenital cardiac anomaly) and 
are proposing a work RVU of 4.62 based on a crosswalk to CPT code 52234 
(Cystourethroscopy, with fulguration (including cryosurgery or laser 
surgery) and/or resection of; SMALL bladder tumor(s) (0.5 up to 2.0 
cm)). CPT code 52234 shares the same intraservice time of 30 minutes 
with CPT code 3X001 and has 2 additional minutes of total time at 79 
minutes as compared to 77 minutes for the reviewed code. In our review 
of CPT code 3X001, we noted many of the same issues that we had raised 
with CPT code 3X000, in particular with the increase in the work RVU 
greatly exceeding the increase in the surveyed work times as compared 
to the predecessor pericardiocentesis codes. We searched the RUC 
database again for 0-day global codes with 30 minutes of intraservice 
time and comparable total time of 67-87 minutes. Our search identified 
43 codes and again all 43 of these codes had a work RVU lower than 
5.50. As we stated with regard to CPT code 3X000, we do not believe 
that it would serve the interests of relativity to establish a new 
maximum work RVU for this range of time values. We believe that it is 
more accurate to propose a work RVU of 4.62 for CPT code 3X001 based on 
a crosswalk to CPT code 52234 based on the same rationale that we

[[Page 40574]]

detailed with regards to CPT code 3X000.
    We disagree with the RUC-recommended work RVU of 6.00 for CPT code 
3X002 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including fluoroscopy and/or ultrasound guidance, when 
performed; birth through 5 years of age, or any age with congenital 
cardiac anomaly) and are proposing a work RVU of 5.00 based on the 
survey 25th percentile value. In our review of CPT code 3X002, we noted 
many of the same issues that we had raised with CPT codes 3X000 and 
3X001, in particular with the increase in the work RVU greatly 
exceeding the increase in the surveyed work times as compared to the 
predecessor pericardiocentesis codes. The recommended work RVU of 6.00 
was based on a crosswalk to CPT code 31603 (Tracheostomy, emergency 
procedure; transtracheal), which shares the same intraservice time of 
30 minutes with CPT code 3X002 and very similar total time. While we 
agree that CPT code 31603 is a close match to the surveyed work times 
for CPT code 3X002, we do not believe that it is the most accurate 
choice for a crosswalk due to the fact that CPT code 31603 is a clear 
outlier in work valuation. We searched for 0-day global codes in the 
RUC database with 30 minutes of intraservice time and a comparable 90-
120 minutes of total time. There were 21 codes that met this criteria, 
and the recommended crosswalk to CPT code 31603 had the highest work 
RVU of any of these codes at the recommended 6.00. Furthermore, there 
was only one other code with a work RVU above 5.00, another 
tracheostomy procedure described by CPT code 31600 (Tracheostomy, 
planned (separate procedure)) at a work RVU of 5.56. None of the other 
codes had a work RVU higher than 4.69, and the median work RVU of the 
group comes out to only 4.00. The two tracheostomy procedures have work 
RVUs more than a full standard deviation above any of the other codes 
in this group of 0-day global procedures.
    We do not mean to suggest that the work RVU for a given service 
must always fall in the middle of a range of codes with similar time 
values. 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. 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. However, we also do 
not believe that it would serve the interests of relativity by 
crosswalking the work RVU of CPT code 3X002 to tracheostomy procedures 
that are higher than anything else in this group of codes, procedures 
that we believe to be outliers due to the serious risk of patient 
mortality associated with their performance. We believe that it is this 
patient risk which is responsible for the otherwise anomalously high 
intensity in CPT codes 31600 and 31603. Therefore, we are proposing a 
work RVU of 5.00 for CPT code 3X002 based on the survey 25th 
percentile, which we believe more accurately captures both the time and 
intensity associated with the procedure.
    We disagree with the RUC-recommended work RVU of 5.00 for CPT code 
3X003 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including CT guidance) and are proposing a work RVU of 
4.29 based on the survey 25th percentile value. In our review of CPT 
code 3X003, we noted many of the same issues that we had raised with 
CPT codes 3X000-3X002, in particular with the increase in the work RVU 
greatly exceeding the increase in the surveyed work times as compared 
to the predecessor pericardiocentesis codes. We searched for 0-day 
global codes in the RUC database with 30 minutes of intraservice time 
(slightly higher than the 28 minutes of intraservice time in CPT code 
3X003) and a comparable 70-100 minutes of total time. Our search 
identified 45 codes and again all 45 of these codes had a work RVU 
lower than 5.00, which led us to believe that the recommended work RVU 
for CPT code 3X003 was overvalued. We also compared CPT code 3X003 to 
the most similar code in the family, CPT code 3X001, and noted that the 
survey respondents indicated that CPT code 3X003 should have a lower 
work RVU at both the survey 25th percentile and survey median values. 
Therefore, we are proposing a work RVU of 4.29 for CPT code 3X003 based 
on the survey 25th percentile value. We are supporting this proposal 
with a reference to CPT code 31254 (Nasal/sinus endoscopy, surgical 
with ethmoidectomy; partial (anterior)), a recently-reviewed code with 
an intraservice work time of 30 minutes, a total time of 84 minutes, 
and a work RVU of 4.27.
    The RUC did not recommend and we are not proposing any direct PE 
inputs for the codes in this family.
(10) Pericardiotomy (CPT Codes 33020 and 33025)
    CPT code 33020 (Pericardiotomy for removal of clot or foreign body 
(primary procedure)) was identified as potentially misvalued on a 
Relativity Assessment Workgroup (RAW) screen of codes with a negative 
IWPUT and Medicare utilization over 10,000 for all services or over 
1,000 for Harvard valued and CMS or other source codes. The RAW 
determined that CPT code 33020 should be surveyed for April 2018; CPT 
code 33025 (Creation of pericardial window or partial resection for 
drainage) was included for review as part of this code family.
    We disagree with the RUC-recommended work RVU of 14.31 (25th 
percentile survey value) for CPT code 33020 and are proposing a work 
RVU of 12.95. Our proposed work RVU is based on a crosswalk to CPT code 
58700 (Salpingectomy, complete or partial, unilateral or bilateral 
(separate procedure)), which has an identical work RVU of 12.95, 
identical 60 minutes intraservice time, and near identical total time 
values as CPT code 33020.
    In our review of CPT code 33020, we note that the RUC-recommended 
intraservice time is decreasing from 85 minutes to 60 minutes (29 
percent reduction), and that the RUC- recommended total time is 
decreasing from 565 minutes to 321 minutes (43 percent reduction). 
However, the RUC-recommended work RVU is only decreasing from 14.95 to 
14.31, which is a reduction of less than 5 percent. Although we do 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 33020, we 
believe that it would be more accurate to propose a work RVU of 12.95, 
based on a crosswalk to CPT code 58700 to account for these decreases 
in surveyed work times.
    For CPT code 33025, the RUC recommended a work RVU of 13.20 (survey 
25th percentile value). Although we disagree with the RUC-recommended 
work RVU of 13.20, based on RUC survey results and the time resources 
involved in furnishing these two procedures we agree that the relative 
difference in work RVUs between CPT codes 33020 and 33025 is equivalent 
to the RUC-recommended incremental difference of 1.11 less work RVUs. 
Therefore, we are proposing a work RVU of 11.84 based on a reference to 
CPT code 34712 (Transcatheter delivery of enhanced fixation devices(s) 
to the endograft (e.g., anchor, screw,

[[Page 40575]]

tack) and all associated radiological supervision and interpretation), 
which has a work RVU of 12.00, identical intraservice time of 60 
minutes, and similar total time as CPT code 33025.
    In reviewing CPT code 33025, we note that the RUC-recommended 
intraservice time is decreasing from 66 minutes to 60 minutes (9 
percent reduction), and that the RUC-recommended total time is 
decreasing from 410 minutes to 301 minutes (27 percent reduction). 
However, the RUC-recommended work RVU is only decreasing from 13.70 to 
13.20, which is a reduction of less than 5 percent. Although we do 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 33025, we 
believe that it would be more accurate to propose a work RVU of 11.84, 
based on less the incremental difference of 1.11 work RVUs between CPT 
codes 33020 and 33025 and a crosswalk to CPT code 34712 to account for 
these decreases in surveyed work times.
    We are proposing the RUC-recommended direct PE inputs for all the 
codes in this family.
(11) Transcatheter Aortic Valve Replacement (TAVR) (CPT Codes 33361, 
33362, 33363, 33364, 33365, and 33366)
    In October 2016, the RUC's RAW reviewed codes that had been flagged 
in the period from October 2011 to April 2012, using 3 years of 
available Medicare claims data (2013, 2014 and preliminary 2015 data). 
The RUC workgroup determined that the technology for these 
transcatheter aortic valve replacement (TAVR) services was evolving, as 
the typical site of service had shifted from being provided in academic 
centers to private centers, and the RUC recommended that CPT codes 
33361-33366 be resurveyed for physician work and practice expense. 
These six codes were surveyed and reviewed at the April 2018 RUC 
meeting using a survey methodology that reflected the unique nature of 
these codes. CPT codes 33361-33366 are currently the only codes on the 
PFS where the -62 co-surgeon modifier is required 100 percent of the 
time.
    We are proposing the RUC-recommended work RVU for all six of the 
codes in this family. We are proposing a work RVU of 22.47 for CPT code 
33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with 
prosthetic valve; percutaneous femoral artery approach), a work RVU of 
24.54 for CPT code 33362 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; open femoral artery approach), a work RVU 
of 25.47 for CPT code 33363 (Transcatheter aortic valve replacement 
(TAVR/TAVI) with prosthetic valve; open axillary artery approach), a 
work RVU of 25.97 for CPT code 33364 (Transcatheter aortic valve 
replacement (TAVR/TAVI) with prosthetic valve; open iliac artery 
approach), a work RVU of 26.59 for CPT code 33365 (Transcatheter aortic 
valve replacement (TAVR/TAVI) with prosthetic valve; transaortic 
approach (e.g., median sternotomy, mediastinotomy)), and a work RVU of 
29.35 for CPT code 33366 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; transapical exposure (e.g., left 
thoracotomy)).
    Although we have some concerns that the RUC-recommended work RVUs 
for these six codes do not match the decreases in surveyed work time, 
we recognize that the technology described by the TAVR procedures is in 
the process of being adopted by a much wider audience, and that there 
will be greater intensity on the part of the practitioner when this 
particular new technology is first being adopted. However, we intend to 
continue examining whether these services are appropriately valued, in 
light of the proposed national coverage determination proposing to use 
TAVR for the treatment of symptomatic aortic valve stenosis that we 
posted on March 26, 2019. We will also consider any further 
improvements to the valuation of these services, as their use becomes 
more commonplace, through future notice and comment rulemaking. The 
text of the proposed national coverage determination is available on 
the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(12) Aortic Graft Procedures (CPT Codes 338XX, 338X1, 33863, 33864, 
338X2, and 33866)
    In 2017, CPT created a new add-on code, CPT code 33866 (Aortic 
hemiarch graft including isolation and control of the arch vessels, 
beveled open distal aortic anastomosis extending under one or more of 
the arch vessels, and total circulatory arrest or isolated cerebral 
perfusion (List separately in addition to code for primary procedure)). 
For CY 2019, we finalized the RUC's recommended work RVU for this code 
on an interim basis (83 FR 59528). CPT revised the code set to develop 
distinct codes for ascending aortic repair for dissection and ascending 
aortic repair for other ascending aortic disease such as aneurysms and 
congenital anomalies, creating two new codes, as well as revaluating 
the two other codes in the family.
    For CPT code 338XX (Ascending aorta graft, with cardiopulmonary 
bypass, includes valve suspension, when performed; for aortic 
dissection), we disagree with the RUC-recommended work RVU of 65.00, 
because the RUC is recommending an increase in work RVU that is not 
commensurate with a reduction in physician time, and because we do not 
believe that the RUC's recommendation that this service be increased to 
a value that would place it among the highest valued of all services of 
similar physician time is appropriate; we think a comparison to other 
services of similar time indicates that the RUC's recommended increase 
overstates the work. Instead, we are proposing to increase the work RVU 
to 63.40 based on a crosswalk to CPT code 61697 (Surgery of complex 
intracranial aneurysm, intracranial approach; carotid circulation). For 
CPT code 338X1 (Ascending aorta graft, with cardiopulmonary bypass, 
includes valve suspension, when performed; for aortic disease other 
than dissection (e.g., aneurysm)), we disagree with the RUC-recommended 
work RVU of 50.00, because we do not believe it adequately reflects the 
recommended decrease in physician time, and because we do not believe 
this service should be assigned a value that is among the highest of 
all 90-day global services with similar physician time values. Instead, 
we are proposing a work RVU of 45.13 based on a crosswalk to CPT code 
33468 (Tricuspid valve repositioning and plication for Ebstein 
anomaly), which is a code with an identical intraservice time and 
similar total time value.
    For CPT code 33863 (Ascending aorta graft, with cardiopulmonary 
bypass, with aortic root replacement using valved conduit and coronary 
reconstruction (e.g., Bentall)), according to the RUC, the survey 
respondents underestimated the intraservice time of the procedure and 
the RUC recommended a work RVU of 59.00 based on the 75th percentile of 
survey responses for intraservice time. We believe the use of the 
survey 75th percentile value to be problematic, as the intraservice 
time values should generally reflect the survey median. We are 
requesting that this code be

[[Page 40576]]

resurveyed to determine more accurate physician time values, and we are 
proposing to maintain the current RVU of 58.79 for CY 2020. For CPT 
code 33864 (Ascending aorta graft, with cardiopulmonary bypass with 
valve suspension, with coronary reconstruction and valve-sparing aortic 
root remodeling (e.g., David Procedure, Yacoub procedure)), we do not 
agree with the RUC-recommended work RVU of 63.00, because we believe 
this increase is not justified given that the intraservice time is not 
changing from its current value, and the physician total time value is 
decreasing. Therefore, we are proposing to maintain the current work 
RVU of 60.08 for this service.
    For CPT code 338X2 (Transverse aortic arch graft, with 
cardiopulmonary bypass, with profound hypothermia, total circulatory 
arrest and isolated cerebral perfusion with reimplantation of arch 
vessel(s) (e.g., island pedicle or individual arch vessel 
reimplantation)), we disagree with the RUC's recommended work RVU of 
65.75. While we agree that an increase in work RVU is justified, as 
discussed above, we believe that the use of the 75th percentile of 
physician intraservice work time is problematic, and believe such a 
significant increase in work RVU is not validated. Therefore, we are 
proposing a less significant increase to 60.88 using the RUC-
recommended difference in work value between CPT code 338X1 and the 
code in question, CPT code 338X2 (a difference of 15.75). As further 
support for this value, we note that it falls between CPT codes 33782 
(Aortic root translocation with ventricular septal defect and pulmonary 
stenosis repair (i.e., Nikaidoh procedure); without coronary ostium 
reimplantation), which has a work RVU of 60.08, and CPT code 43112 
(Total or near total esophagectomy, with thoracotomy; with 
pharyngogastrostomy or cervical esophagogastrostomy, with or without 
pyloroplasty (i.e., McKeown esophagectomy or tri-incisional 
esophagectomy)), which has a work RVU of 62.00. Both of these 
bracketing reference codes have similar intraservice and total time 
values. For CPT code 33X01 (Aortic hemiarch graft including isolation 
and control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion (List separately in addition to 
code for primary procedure)), we are proposing the RUC-recommended work 
RVU of 17.75.
    For the direct PE inputs, we are proposing to refine the clinical 
labor to align with the number of post-operative visits. Thus, we are 
proposing to add 12 minutes of clinical labor time for ``Discharge day 
management'' for CPT codes 338X1, 33863, 33864, and 338X2, as each of 
these codes include a 99238 discharge visit within their global periods 
that should be reflected in the clinical labor inputs.
(13) Iliac Branched Endograft Placement (CPT Codes 34X00 and 34X01)
    For CY 2018, the CPT Editorial Panel created a family of 20 new and 
revised codes that redefined coding for endovascular repair of the 
aorta and iliac arteries. The iliac branched endograft technology has 
become more mainstream over time, and two new CPT codes were created to 
capture the work of iliac artery endovascular repair with an iliac 
branched endograft. These two new codes were surveyed and reviewed for 
the January 2019 RUC meeting.
    We are proposing the RUC-recommended work RVU of 9.00 for CPT code 
34X00 (Endovascular repair of iliac artery at the time of aorto-iliac 
artery endograft placement by deployment of an iliac branched endograft 
including pre-procedure sizing and device selection, all ipsilateral 
selective iliac artery catheterization(s), all associated radiological 
supervision and interpretation, and all endograft extension(s) 
proximally to the aortic bifurcation and distally in the internal 
iliac, external iliac, and common femoral artery(ies), and treatment 
zone angioplasty/stenting, when performed, for rupture or other than 
rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous 
malformation, penetrating ulcer, traumatic disruption), unilateral) and 
the RUC-recommended work RVU of 24.00 for CPT code 34X01 (Endovascular 
repair of iliac artery, not associated with placement of an aorto-iliac 
artery endograft at the same session, by deployment of an iliac 
branched endograft, including pre-procedure sizing and device 
selection, all ipsilateral selective iliac artery catheterization(s), 
all associated radiological supervision and interpretation, and all 
endograft extension(s) proximally to the aortic bifurcation and 
distally in the internal iliac, external iliac, and common femoral 
artery(ies), and treatment zone angioplasty/stenting, when performed, 
for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, 
arteriovenous malformation, penetrating ulcer), unilateral).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(14) Exploration of Artery (CPT Codes 35701, 35X01, and 35X01)
    CPT code 35701 (Exploration not followed by surgical repair, 
artery; neck (e.g., carotid, subclavian)) was identified via a screen 
for services with a ne.g.ative IWPUT and Medicare utilization over 
10,000 for all services or over 1,000 for Harvard valued and CMS/Other 
source codes. In September 2018, the CPT Editorial Panel revised one 
code, added two new codes, and deleted three existing codes in the 
family to report major artery exploration procedures and to condense 
the code set due to low frequency.
    We are proposing the RUC-recommended work RVU for all three codes 
in the family. We are proposing a work RVU of 7.50 for CPT code 35701, 
a work RVU of 7.12 for CPT code 35X00 (Exploration not followed by 
surgical repair, artery; upper extremity (e.g., axillary, brachial, 
radial, ulnar)), and a work RVU of 7.50 for CPT code 35X01 (Exploration 
not followed by surgical repair, artery; lower extremity (e.g., common 
femoral, deep femoral, superficial femoral, popliteal, tibial, 
peroneal)).
    For the direct PE inputs, we are proposing to refine the clinical 
labor, supplies, and equipment to match the number of office visits 
contained in the global periods of the codes under review. We are 
proposing to refine the clinical labor time for the ``Post-operative 
visits (total time)'' (CA039) activity from 36 minutes to 27 minutes 
for CPT codes 35701 and 35X00, and from 63 minutes to 27 minutes for 
CPT code 35X01. Each of these CPT codes contains a single postoperative 
level 2 office visit (CPT code 99212) in its global period, and 27 
minutes of clinical labor is the time associated with this office 
visit. We are proposing to refine the equipment time for the exam table 
(EF023) to the same time of 27 minutes for each code to match the 
clinical labor time. Finally, we are also proposing to refine the 
quantity of the minimum multi-specialty visit pack (SA048) from 2 to 1 
for CPT code 35X01 to match the single postoperative visit in the 
code's global period. We believe that the additional direct PE inputs 
in the recommended materials were an accidental oversight due to 
revisions that took place at the RUC meeting following the approval of 
the PE inputs for these codes.
(15) Intravascular Ultrasound (CPT Codes 37252 and 37253)
    In CY 2014, the CPT Editorial Panel deleted CPT codes 37250 
(Ultrasound evaluation of blood vessel during

[[Page 40577]]

diagnosis or treatment )and 37251 (Ultrasound evaluation of blood 
vessel during diagnosis or treatment) and created new bundled codes 
37252 (Intravascular ultrasound (noncoronary vessel) during diagnostic 
evaluation and/or therapeutic intervention, including radiological 
supervision and interpretation; initial noncoronary vessel) and 37253 
(Intravascular ultrasound (noncoronary vessel) during diagnostic 
evaluation and/or therapeutic intervention, including radiological 
supervision and interpretation; each additional noncoronary vessel) to 
describe intravascular ultrasound (IVUS). CPT codes 37252 and 37253 
were reviewed at the January 2015 RUC meeting. The RUC's recommendation 
for these codes were to result in an overall work savings that should 
have been redistributed back to the Medicare conversion factor. The 
codes have had a 44 percent increase in work RVUs over the old codes, 
CPT codes 37250 and 37251, from 2015 to 2016 and the utilization has 
doubled from that of the previous coding structure, not considering the 
radiological activities. In April 2018, the RUC reviewed this code 
family and determined the utilization of the bundling of these services 
was underestimated. Consequently, the RUC recommended that these 
services be surveyed for October 2018. The RUC indicated that the 
specialty societies should research why there was such an increase in 
the utilization. Accordingly, the specialty society surveyed these ZZZ-
day global codes, and the survey results indicated the intraservice and 
total work times, along with the work RVU should remain the same 
despite the underestimation in utilization.
    We disagreed with the RUC-recommended work RVU of 1.80 for CPT code 
37252 and are proposing a work RVU of 1.55 based on a crosswalk to CPT 
code 19084. CPT code 19084 is a recently reviewed code with 20 minutes 
of intraservice time and 25 minutes of total time. In reviewing CPT 
code 37252, we note, as mentioned above, that in CY 2015 the specialty 
society stated that bundling this service would achieve savings. 
However, since 2015 observed utilization for CPT code 37252 has greatly 
exceeded proposed estimates, thus we are proposing to restore work 
neutrality to the intravascular ultrasound code family to achieve the 
initial estimated savings.
    For CPT code 37253, we disagreed with the RUC-recommended work RVU 
of 1.44 and we are proposing a work RVU of 1.19. Although we disagreed 
with the RUC-recommended work RVU, we note the relative difference in 
work between CPT codes 37252 and 37253 is an interval of 0.36 RVUs. 
Therefore, we are proposing a work RVU of 1.19 for CPT code 37253, 
based on the recommended interval of 0.36 fewer RVUs than our proposed 
work RVU of 1.55 for CPT code 37252.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(16) Stab Phlebectomy of Varicose Veins (CPT Codes 37765 and 37766)
    These services were identified in February 2008 via the High Volume 
Growth screen, for services with a total Medicare utilization of 1,000 
or more that have increased by at least 100 percent from 2004 through 
2006. The RUC subsequently recommended monitoring and reviewing changes 
in utilization over multiple years. In October 2017, the RUC 
recommended that this service be surveyed for April 2018. We are 
proposing the RUC-recommended work RVUs of 4.80 for CPT code 37765 
(Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions) 
and 6.00 for CPT code 37766 (Stab phlebectomy of varicose veins, 1 
extremity; more than 20 incisions). We are proposing the RUC-
recommended direct PE inputs for all codes in the family.
(17) Biopsy of Mouth Lesion (CPT Code 40808)
    CPT code 40808 (Biopsy, vestibule of mouth) was identified via a 
screen for services with a negative IWPUT and Medicare utilization over 
10,000 for all services or over 1,000 for Harvard valued and CMS/Other 
source codes.
    We disagree with the RUC's recommended work RVU of 1.05 with a 
crosswalk to CPT code 11440 (Excision, other benign lesion including 
margins, except skin tag (unless listed elsewhere), face, ears, 
eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less), 
as we believe this increase in work RVU is not commensurate with the 
RUC-recommended 5-minute reduction in intraservice time and a 10-minute 
reduction in total time. While we understand that the RUC considers the 
current time values for this service to be invalid estimations, we do 
not see compelling evidence that would indicate that an increase in 
work RVU that would be concurrent with a reduction in physician time is 
appropriate. Therefore, we are proposing to maintain the current work 
RVU of 1.01, and note that implementing the current work RVU with the 
RUC-recommended revised physician time values would correct the 
negative IWPUT anomaly.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. As we 
detailed when discussing this issue in the CY 2019 PFS final rule (83 
FR 59463 through 59464), CPT code 40808 does not include the old 
clinical labor task ``Patient clinical information and questionnaire 
reviewed by technologist, order from physician confirmed and exam 
protocoled by radiologist'' on a prior version of the PE worksheet, nor 
does the code contain any clinical labor for the CA007 activity 
(``Review patient clinical extant information and questionnaire''). CPT 
code 40808 does not appear to be an instance where an old clinical 
labor task was split into two new clinical labor activities, and 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. We also note that there 
is no effect on the total clinical labor direct costs in these 
situations, since the same 3 minutes of clinical labor time is still 
being furnished.
    We are also proposing to refine the equipment time for the 
electrocautery-hyfrecator (EQ110) to conform to our established 
standard for non-highly technical equipment.
(18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946, 
and 46X48)
    We are proposing the RUC-recommended work RVU for all three codes 
in the family. We are proposing a work RVU of 3.69 for CPT code 46945 
(Hemorrhoidectomy, internal, by ligation other than rubber band; single 
hemorrhoid column/group, without imaging guidance), a work RVU of 4.50 
for CPT code 46946 (2 or more hemorrhoid columns/groups, without 
imaging guidance), and a work RVU of 5.57 for CPT code 46X48 
(Hemorrhoidectomy, internal, by transanal hemorrhoidal 
dearterialization, 2 or more hemorrhoid columns/groups, including 
ultrasound guidance, with mucopexy when performed).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(19) Preperitoneal Pelvic Packing (CPT Codes 490X1 and 490X2)
    In May 2018, the CPT Editorial Panel approved the addition of two 
codes for preperitoneal pelvic packing, removal

[[Page 40578]]

and/or repacking for hemorrhage associated with pelvic trauma. These 
new codes were surveyed and reviewed for the October 2018 RUC meeting.
    We disagree with the RUC-recommended work RVU of 8.35 for CPT code 
490X1 (Preperitoneal pelvic packing for hemorrhage associated with 
pelvic trauma, including local exploration) and are proposing a work 
RVU of 7.55 based on a crosswalk to CPT code 52345 (Cystourethroscopy 
with ureteroscopy; with treatment of ureteropelvic junction stricture 
(e.g., balloon dilation, laser, electrocautery, and incision)). We are 
also proposing to reduce the immediate postservice work time from 60 
minutes to 45 minutes, which results in a total work time of 140 
minutes for this procedure. We believe that the survey respondents 
overstated the immediate postservice work time that would typically be 
required to perform CPT code 490X1, which we investigated by comparing 
this new service against the existing 0-day global codes on the PFS. We 
found that among the roughly 1,100 codes with 0-day global periods, 
only 21 codes had an immediate postservice work time of 60 minutes or 
longer. The 21 codes that fell into this category had significantly 
higher intraservice work times than CPT code 490X1, with an average 
intraservice work time of 111 minutes as compared to the 45 minutes of 
intraservice work time in CPT code 490X1. Generally speaking, it is 
extremely rare for a service to have more immediate postservice work 
time than intraservice work time, and in fact only 28 out of the 
roughly 1,100 codes with 0-day global periods had more immediate 
postservice work time than intraservice work time. While we agree that 
each service on the PFS is its own unique entity, these comparisons to 
other 0-day global codes suggest that the survey respondents 
overestimated the amount of immediate postservice work time that would 
typically be associated with CPT code 490X1.
    As a result, we believe that it would be more accurate to reduce 
the immediate postservice work time to 45 minutes and to propose a work 
RVU of 7.55 based on a crosswalk to CPT code 52345. This crosswalk code 
shares an intraservice work time of 45 minutes and a similar total time 
of 135 minutes after taking into account the reduced immediate 
postservice work time that we are proposing for CPT code 490X1. We 
searched the RUC database for 0-day global procedures with 45 minutes 
of intraservice work time, and at the recommended work RVU of 8.35, CPT 
code 490X1 would establish a new maximum value, higher than all of the 
79 other codes that fall into this category. We recognize that CPT code 
490X1 describes a preperitoneal pelvic packing service associated with 
pelvic trauma, and that this is a difficult and intensive procedure 
that rightly has a higher work RVU than many of these other 0-day 
global codes. However, we believe that it better maintains relativity 
to propose a crosswalk to CPT code 52345 at a work RVU of 7.55, which 
would still assign this code the second-highest work RVU among all 0 
day global codes with 45 minutes of intraservice work time, as opposed 
to proposing the survey median work RVU of 8.35 at a rate higher than 
anything in the current RUC database.
    We disagree with the RUC-recommended work RVU of 6.73 for CPT code 
490X2 (Re-exploration of pelvic wound with removal of preperitoneal 
pelvic packing including repacking, when performed) and are proposing a 
work RVU of 5.70 based on the 25th percentile survey value. We believe 
that the survey 25th percentile work RVU more accurately describes the 
work of re-exploring this type of pelvic wound, and by proposing the 
survey 25th percentile we are maintaining the general increment in RVUs 
between the two codes in the family (a difference of 1.62 RVUs as 
recommended by the RUC as compared to 1.85 RVUs as proposed here). We 
are supporting this valuation with a reference to CPT code 39401 
(Mediastinoscopy; includes biopsy(ies) of mediastinal mass (e.g., 
lymphoma), when performed), a recently reviewed code from CY 2015 which 
shares the same intraservice time of 45 minutes, a slightly higher 
total time of 142 minutes and a lower work RVU of 5.44.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(20) Cystourethroscopy Insertion Transprostatic Implant (CPT Codes 
52441 and 52442)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
AMA/Specialty Society RVS Update Committee. This service was reviewed 
at the October 2018 RAW meeting, and the RAW indicated that the 
utilization is increasing and questioned the time required to perform 
these services. These two codes were surveyed and reviewed for the 
January 2019 RUC meeting.
    We disagree with the RUC-recommended work RVU of 4.50 (current 
value) for CPT code 52441 (Cystourethroscopy, with insertion of 
permanent adjustable transprostatic implant; single implant) and are 
proposing a work RVU of 4.00. This proposed work RVU is based on a 
crosswalk from recently reviewed CPT code 58562 (Hysterscopy, surgical; 
with removal of impacted foreign body), which has a work RVU of 4.00, 
and an identical 25 minutes of intraservice time as CPT code 52441.
    We disagree with the RUC-recommended work RVU of 1.20 (current 
value) for CPT code 52442 (Cystourethroscopy, with insertion of 
permanent adjustable transprostatic implant; each additional permanent 
adjustable transprostatic implant (List separately in addition to code 
for primary procedure)) and are proposing a work RVU of 1.01. This 
proposed work RVU is based on a crosswalk from CPT code 36218 
(Selective catheter placement, arterial system; additional second 
order, third order, and beyond, thoracic or brachiocephalic branch, 
within a vascular family (List in addition to code for initial second 
or third order vessel as appropriate)), which has a work RVU of 1.01, 
and an identical 15 minutes of intraservice time as CPT code 52442. The 
RUC survey showed a reduction in time, and the work should reflect 
these changes.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family without refinement.
(21) Orchiopexy (CPT Code 54640)
    The CPT Editorial Panel revised existing CPT code 54640 to describe 
an additional approach for orchiopexy (scrotal) and to clearly indicate 
that hernia repair is separately reportable. This code was surveyed and 
reviewed for the January 2019 RUC meeting.
    We are proposing to maintain the current work RVU of 7.73 as 
recommended by the RUC. We are proposing the RUC-recommended direct PE 
inputs for CPT code 54640 without refinement.
(22) Radiofrequency Neurootomy Sacroiliac Joint (CPT Codes 6XX00, 
6XX01)
    In September 2018, the CPT Editorial Panel created two new codes to 
describe injection and radiofrequency ablation of the sacroiliac joint 
with image guidance for somatic nerve procedures. We are proposing the 
RUC-recommended work RVU of 1.52 for CPT code 6XX00 (Injection(s), 
anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac 
joint, with image guidance (i.e., fluoroscopy or computed tomography)) 
and the RUC-recommended work RVU of 3.39 for CPT code 6XX01 
(Radiofrequency ablation, nerves innervating the sacroiliac joint, with

[[Page 40579]]

image guidance (i.e., fluoroscopy or computed tomography)).
    For the direct PE inputs, we are proposing to refine the quantity 
of the ``needle, 18-26g 1.5-3.5in, spinal'' (SC028) supply from 3 to 1 
for CPT code 6XX00. There are no spinal needles in use in the reference 
code associated with CPT code 6XX00, and there was no explanation in 
the recommended materials explaining why three such needles would be 
typical for this procedure. We agree that the service being performed 
in CPT code 6XX00 would require a spinal needle, but we do not believe 
that the use of three such needles would be typical.
    We are proposing to refine the quantity of the ``cannula 
(radiofrequency denervation) (SMK-C10)'' (SD011) supply from 4 to 2 for 
CPT code 6XX01. We do not believe that the use of 4 of these cannula 
would be typical for the procedure, as the reference code currently 
used for destruction by neurolytic agent contains only a single 
cannula. We believe that the nerves would typically be ablated one at a 
time using this cannula, as opposed to ablating four of them 
simultaneously as suggested in the recommended direct PE inputs. We 
also searched in the RUC database for other CPT codes that made use of 
the SD011 supply, and out of the seven codes that currently use this 
item, none of them include more than 2 cannula. As a result, we are 
proposing to refine the supply quantity to 2 cannula to match the 
highest amount contained in an existing code on the PFS. We are also 
refining the equipment time for the ``radiofrequency kit for 
destruction by neurolytic agent'' (EQ354) equipment from 164 minutes to 
82 minutes. The RUC's equipment time recommendation was predicated on 
the use of 4 of the SD011 supplies for 41 minutes apiece, and we are 
refining the equipment time to reflect our supply refinement to 2 
cannula. It was unclear in the recommended materials as to whether the 
radiofrequency kit equipment was in use simultaneously or sequentially 
along with the cannula supplies, and therefore, we are soliciting 
comments on the typical use of this equipment.
    Finally, we are proposing to refine the equipment time for the 
technologist PACS workstation (ED050) equipment to match our standard 
equipment time formulas, which results in an increase of 5 minutes of 
equipment time for both codes.
(23) Lumbar Puncture (CPT Codes 62270, 622X0, 62272, and 622X1)
    In October 2017, these services were identified as being performed 
by a different specialty than the specialty that originally surveyed 
this service. In January 2018, the RUC recommended that these services 
be referred to CPT to bundle image guidance. At the September 2018 CPT 
Editorial Panel meeting, the Panel created two new codes to bundle 
diagnostic and therapeutic lumbar puncture with fluoroscopic or CT 
image guidance and revised the existing diagnostic and therapeutic 
lumbar puncture codes so they would only be reported without 
fluoroscopic or CT guidance.
    For CPT code 62270 (Spinal puncture, lumbar, diagnostic), we 
disagree with the RUC-recommended work RVU of 1.44 and we are proposing 
a work RVU of 1.22 based on a crosswalk to CPT code 40490 (Biopsy of 
lip). CPT code 40490 has the same intraservice time of 15 minutes and 2 
additional minutes of total time. In reviewing CPT code 62270, we noted 
that the recommended intraservice time is decreasing from 20 minutes to 
15 minutes (25 percent reduction), and the recommended total time is 
decreasing from 40 minutes to 32 minutes (20 percent reduction); 
however, the RUC-recommended work RVU is increasing from 1.37 to 1.44, 
which is an increase of just over 5 percent. Although we do 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 62270, we believed that 
it was more accurate to propose a work RVU of 1.22 based on a crosswalk 
to CPT code 40490 to account for these decreases in the surveyed work 
time.
    For CPT code 622X0 (Spinal puncture, lumbar, diagnostic; with 
fluoroscopic or CT guidance), we disagree with the RUC-recommended work 
RVU of 1.95 and we are proposing a work RVU of 1.73. Although we 
disagree with the RUC-recommended work RVU, we note that the relative 
difference in work between CPT codes 62270 and 622X0 is equivalent to 
an interval of 0.51 RVUs. Therefore, we are proposing a work RVU of 
1.73 for CPT code 622X0, based on the recommended interval of 0.51 
additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
    For CPT code 62272 (Spinal puncture, therapeutic, for drainage of 
cerebrospinal fluid (by needle or catheter), we disagree with the RUC-
recommended work RVU of 1.80 and we are proposing a work RVU of 1.58. 
Although we disagree with the RUC-recommended work RVU, we note that 
the relative difference in work between CPT codes 62270 and 622X0 is 
equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we 
are proposing a work RVU of 1.58 for CPT code 62272, based on the 
recommended interval of 0.36 additional RVUs above our proposed work 
RVU of 1.22 for CPT code 62270.
    For CPT code 622X1 (Spinal puncture, therapeutic, for drainage of 
cerebrospinal fluid (by needle or catheter); with fluoroscopic or CT 
guidance), we disagree with the RUC-recommended work RVU of 2.25 and we 
are proposing a work RVU of 2.03. Although we disagree with the RUC-
recommended work RVU, we note that the relative difference in work 
between CPT codes 62270 and 622X1 is equivalent to the recommended 
interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 2.03 
for CPT code 622X1, based on the recommended interval of 0.81 
additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
(24) Electronic Analysis of Implanted Pump (CPT Codes 62367, 62368, 
62369, and 62370)
    CPT code 62368 (Electronic analysis of programmable, implanted pump 
for intrathecal or epidural drug infusion (includes evaluation of 
reservoir status, alarm status, drug prescription status); with 
reprogramming) was identified by the RUC on a list of services which 
were originally surveyed by one specialty but are now typically 
performed by a different specialty. It was reviewed along with three 
other codes in the family for PE only at the April 2018 RUC meeting. 
The RUC did not recommend work RVUs for these codes and we are not 
proposing to change the current work RVUs.
    For the direct PE inputs, we are proposing to remove the minimum 
multi-specialty visit pack (SA048) from CPT code 62370 as a duplicative 
supply due to the fact that this code is typically billed with an E/M 
or other evaluation service.
(25) Somatic Nerve Injection (CPT Codes 64400, 64408, 64415, 64416, 
64417, 64420, 64421, 64425, 64430, 64435, 64445, 64446, 64447, 64448, 
64449, and 64450)
    In May 2018, the CPT Editorial Panel approved the revision of 
descriptors and guidelines for the codes in this family and the 
deletion of three CPT codes to clarify reporting (i.e., separate 
reporting of imaging guidance, number of units and a change from a 0-
day global to ZZZ for one of the CPT codes in this

[[Page 40580]]

family). This family of services describe the injection of an 
anesthetic agent(s) and/or steroid into a nerve plexus, nerve, or 
branch; reported once per nerve plexus, nerve, or branch as described 
in the descriptor regardless of the number of injections performed 
along the nerve plexus, nerve, or branch described by the code.
    CPT codes 64400 (Injection(s), anesthetic agent(s); trigeminal 
nerve, each branch (ie ophthalmic, maxillary, mandibular)), 64408 
(Injection(s), anesthetic agent(s), and/or steroid; vagus nerve), 64415 
(Injection(s), anesthetic agent(s) and/or steroid; brachial plexus), 
64416 (Injection(s), anesthetic agent(s) and/or steroid; brachial 
plexus, continuous infusion by catheter (including catheter 
placement)), 64417 (Injection(s), anesthetic agent(s) and/or steroid; 
axillary 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), 64445 (Injection(s), 
anesthetic agent(s) and/or steroid; sciatic nerve), 64446 
(Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve, 
continuous infusion by catheter (including catheter placement)), 64447 
(Injection(s), anesthetic agent(s); femoral nerve), 64448 
(Injection(s), anesthetic agent(s) and/or steroid; femoral nerve, 
continuous infusion by catheter (including catheter placement)), 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) were reviewed for work and PE at the 
October 2018 RUC meeting. The PE for CPT code 64450 was re-reviewed 
during the RUC January 2019 meeting.
    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 CPT code 76942 
(Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, 
injection, localization device), imaging supervision and 
interpretation) more than 50 percent of the time. Specifically, 76 
percent with CPT code 64415, 85 percent with CPT code 64416, 68 percent 
with CPT code 64417, 77 percent with CPT code 64446, 77 percent with 
CPT code 66447, and 79 percent with CPT code 64448. It was also noted 
in the RUC recommendations that this overlap was accounted for in the 
RUC recommendations submitted for these services. Furthermore, the RUC 
recommendations sated that the RUC referred CPT codes 64415, 64416, 
64417, 64446, 64447 and 64448 to be bundled with ultrasound guidance, 
CPT code 76942 to the CPT Editorial Panel for CPT 2021.
    In reviewing this family of services, our proposed work and PE 
values for CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 do not 
consider the overlap of imaging as noted in the RUC recommendations. We 
note that the RUC recommendations did not include values to support the 
valuation for the bundling of imaging in their work or PE 
recommendations and that the CPT code descriptors do not state that 
imaging is included.
    For CY 2020, we are proposing the RUC-recommended work RVUs for CPT 
codes 64417 (work RVU of 1.27), 64435 (work RVU of 0.75), 64447 (work 
RVU of 1.10), and 64450 (work RVU of 0.75), the RUC reaffirmed work RVU 
of 0.94 for CPT code 64405 (Injection, anesthetic agent; greater 
occipital nerve), which is the current work RVU finalized in the CY 
2019 final rule (83 FR 59542), and the RUC reaffirmed work RVU of 1.10 
for CPT code 64418 (Injection, anesthetic agent; suprascapular nerve), 
which is the current work RVU value finalized in the CY 2018 final rule 
(82 FR 53054). Although we are proposing the RUC reaffirmed work RVUs 
for these two codes, as submitted in the RUC recommendations, we note 
that comparable codes in this family of services have lower work RVUs. 
Thus, these two codes may have become misvalued since their last 
valuation, as they were not resurveyed under this code family during 
the October 2018 RUC meeting.
    In continuing our review of this code family, we disagree with the 
RUC-recommended work RVU of 1.00 for CPT code 64400 and are proposing a 
work RVU of 0.75, to maintain rank order in this code family. Our 
proposed work RVU is based on a crosswalk to another code in this 
family, CPT code 64450, which has an identical work RVU of 0.75 and 
near identical intraservice and total time values to CPT code 64400.
    We note that the RUC-recommended intraservice time decreased from 
37 to 6 minutes (84 percent reduction) and the RUC-recommended total 
time decreased from 69 to 20 minutes (71 percent reduction) for CPT 
code 64400. However, the RUC-recommended work RVU only decreased by 
0.11, a 10 percent reduction. We do not believe the RUC-recommended 
work RVU appropriately accounts for the substantial reductions in the 
surveyed work times for the procedure. 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 and time are 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. In the case of CPT 
code 64400, we believe that it would be more accurate to propose a work 
RVU of .075 based on a crosswalk to CPT code 64450, which has an 
identical work RVU of 0.75 and near identical intraservice and total 
times to CPT code 64400. We further note that our proposed work RVU 
maintains rank order in this code family among comparable codes.
    For CPT code 64408, we disagree with the RUC-recommended work RVU 
of 0.90 and are proposing a work RVU of 0.75, to maintain rank order in 
this code family. Our proposed work RVU is based on a crosswalk to 
another code in this family, CPT code 64450, which has an identical 
work RVU of 0.75, and near identical intraservice and total time values 
to CPT code 64408.
    We note that the RUC-recommended intraservice time decreased from 
16 to 5 minutes (69 percent reduction) and RUC-recommended total time 
decreased from 36 to 20 minutes (44 percent reduction) for CPT code 
64408. Although the RUC-recommended work RVU decreased by 0.51, a 36 
percent reduction, we do not believe the RUC-recommended work RVU 
appropriately accounts for the substantial reductions in the surveyed 
work times for the procedure. 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 and time are 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. In the case of CPT code 
64408, we believe that it would be more accurate to propose a work RVU 
of .075, based on a crosswalk CPT code 64450,

[[Page 40581]]

to account for these decrease in the surveyed work times. We further 
note that our proposed work RVU maintains rank order in this code 
family among comparable codes.
    For CPT code 64415, we disagree with the RUC-recommended work RVU 
of 1.42 and are proposing a work RVU of 1.35, based on our time ratio 
methodology and further supported by a reference to CPT code 49450 
(Replacement of gastrostomy or cecostomy (or other colonic) tube, 
percutaneous, under fluoroscopic guidance including contrast 
injections(s), image documentation and report), which has a work RVU of 
1.36 and similar intraservice and total time values to CPT code 64415.
    We note that the RUC-recommended intraservice time decreased from 
15 to 12 minutes (20 percent reduction) and RUC-recommended total time 
decreased from 44 to 40 minutes (9 percent reduction). However, the 
RUC-recommended work RVU only decreased by 0.06, which is a 4 percent 
reduction. We do not believe the RUC-recommended work RVU appropriately 
accounts for the substantial reductions in the surveyed work times for 
the procedure. 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 and time are 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. In the case of CPT code 64415, we 
believe that it would be more accurate to propose a work RVU of 1.35, 
based on our time ratio methodology and a reference to CPT code 49450, 
to account for these decrease in the surveyed work times.
    For CPT code 64416, we disagree with the RUC-recommended work RVU 
of 1.81 and are proposing a work RVU of 1.48, based on our time ratio 
methodology and further supported by a bracket of CPT code 62270 
(Spinal puncture, lumbar, diagnostic), which has a work RVU of 1.37, 
identical intraservice, and similar total time to CPT code 64416 and 
CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal 
attached telemetry pH electrode placement, recording, analysis and 
interpretation), which has a work RVU of 1.59, identical intraservice, 
and near identical total time values to CPT code 64416.
    We note that while the RUC-recommended intraservice time remained 
unchanged, the RUC-recommended total time decreased from 60 to 49 
minutes (18 percent reduction). However, the RUC recommended 
maintaining the current work RVU of 1.81. We do not believe the RUC-
recommended work RVU appropriately accounts for the substantial 
reductions in the surveyed total time for the procedure. 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 and time 
are 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. In the 
case of CPT code 64416, we believe that it would be more accurate to 
propose a work RVU of 1.48, based on our time ratios methodology and a 
bracket of CPT code 62270 and CPT code 91035, to account for these 
decreases in the surveyed work times.
    For CPT code 64420, we disagree with the RUC-recommended work RVU 
of 1.18 and are proposing a work RVU of 1.08, based on our time ratio 
methodology and further supported by a reference to CPT code 12011 
(Simple repair of superficial wounds of face, ears, eyelids, nose, lips 
and/or mucous membranes; 2.5 cm or less), which has a work RVU of 1.07 
and similar intraservice and total time values to CPT code 64420.
    We note that the RUC-recommended intraservice time decreased from 
17 to 10 minutes (41 percent reduction) and the RUC-recommended total 
time decreased from 37 to 34 minutes (8 percent reduction). However, 
the RUC recommended to maintaining the current work RVU of 1.18. We do 
not believe the RUC-recommended work RVU appropriately accounts for the 
substantial reductions in the surveyed work times for the procedure. 
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 and time are 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. In the case of CPT code 64420, we believe that 
it would be more accurate to propose a work RVU of 1.08 based on our 
times ratio methodology and a crosswalk to CPT code 12011, to account 
for these decreases in the surveyed work times.
    For CPT code 64421, we disagree with the RUC-recommended work RVU 
of 0.60 and are proposing a work RVU of 0.50, based on our time ratio 
methodology and to maintain rank order among comparable codes in the 
family. Our proposed work RVU is further supported by a crosswalk to 
CPT code 15276 (Application of skin substitute graft to face, scalp, 
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or 
multiple digits, total wound surface area up to 100 sq cm; each 
additional 25 sq cm wound surface area, or part thereof (List 
separately in addition to code for primary procedure)), which has a 
work RVU of 0.50 and identical intraservice and total times to CPT code 
64421.
    We note that our time ratio methodology suggests the code is better 
valued at 0.50. Furthermore, the RUC-recommended work RVU of 0.60 
creates a rank order anomaly in the code family. In the case of CPT 
code 64421, we believe that it would be more accurate to propose a work 
RVU of 0.50, based on our time ratio methodology and a crosswalk to CPT 
code 15276, to maintain rank order among comparable codes in the 
family.
    For CPT code 64425, we disagree with the RUC-recommended work RVU 
of 1.19 and are proposing a work RVU of 1.00, to maintain rank order 
among comparable codes in the family, based on a bracket of CPT code 
12001 (Simple repair of superficial wounds of scalp, neck, axillae, 
external genitalia, trunk and/or extremities (including hands and 
feet); 2.5 cm or less) which has a work RVU of 0.84 and near identical 
intraservice and total time values to CPT code 64425 and CPT code 30901 
(Control nasal hemorrhage, anterior, simple (limited cautery and/or 
packing) any method), which has a work RVU of 1.10 and near identical 
intraservice and total times to CPT code 64425.
    We note that the RUC-recommended work RVU of 1.19 creates a rank 
order anomaly in the code family. In the case of CPT code 64425, we 
believe that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 12001 and 30901 to maintain rank order 
among comparable codes in the family.
    For CPT code 64430, we disagree with the RUC-recommended work RVU 
of 1.15 and are proposing a work RVU of 1.00, to maintain rank order 
among comparable codes in the family, based on a bracket of CPT code 
45330 (Sigmoidoscopy, flexible; diagnostic, including collection of 
specimen(s) by brushing or washing, when performed (separate 
procedure)), which has a work RVU of 0.84 and near identical

[[Page 40582]]

intraservice and total time values to CPT code 64430 and CPT code 31576 
(Laryngoscopy, flexible; with biopsy(ies)), which has a work RVU of 
1.89 and near identical intraservice and total time values to CPT code 
64430.
    We note that the RUC-recommended intraservice time decreased from 
17 to 10 minutes (41 percent reduction) and the RUC-recommended total 
time increased from 39 to 43 minutes (10 percent increase). While the 
RUC-recommended work RVU is decreasing by 0.31, a 21 percent reduction, 
we do not believe the RUC-recommended work RVU appropriately accounts 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. 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 and time are 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. In the case of CPT code 64430, we 
believe that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 45300 and 31576 to account for these 
decreases in surveyed work times and to maintain rank order among 
comparable codes in this family.
    For CPT code 64445, we disagree with the RUC-recommended work RVU 
of 1.18 and are proposing a work RVU of 1.00, based on our time ratio 
methodology and to maintain rank order among comparable codes in the 
family. Our proposed work RVU is based on a bracket of CPT code 12001 
(Simple repair of superficial wounds of scalp, neck, axillae, external 
genitalia, trunk and/or extremities (including hands and feet); 2.5 cm 
or less), which has a work RVU of 0.84 and near identical intraservice 
and total times to CPT code 64445 and CPT code 30901 (Control nasal 
hemorrhage, anterior, simple (limited cautery and/or packing) any 
method), which has a work RVU of 1.10 and near identical intraservice 
and total time values to CPT code 64445.
    We note that the RUC-recommended intraservice time decreased from 
15 to 10 minutes (33 percent reduction) and the RUC-recommended total 
time decreased from 48 to 24 minutes (50 percent reduction). While the 
RUC-recommended work RVU is decreasing by 0.30, a 21 percent reduction, 
we do not believe the RUC-recommended work RVU appropriately accounts 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. 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 and time are 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. In the case of CPT code 64445, we 
believe that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 12001 and 30901 to account for these 
decreases in surveyed work times and to maintain rank order among 
comparable codes in the family.
    For CPT code 64446, we disagree with the RUC-recommended work RVU 
of 1.54 and are proposing a work RVU of 1.36 based on our time ratios 
methodology and further supported by a reference to CPT code 51710 
(Change of cystostomy tube; complicated), which has a near identical 
work RVU of 1.35 and near identical intraservice and total time values 
to CPT code 64446.
    We note that RUC-recommended intraservice time decreased from 20 to 
15 minutes (25 percent reduction) and the RUC-recommended total time 
decreased from 64 to 40 minutes (38 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.27, a 15 percent reduction, we 
do not believe the RUC-recommended work RVU appropriately accounts for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. 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 and time are 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. In the case of CPT code 64446, we 
believe that it would be more accurate to propose a work RVU of 1.36, 
based on our time ratios methodology and a reference to CPT code 51710 
to account for these decreases in surveyed times and to maintain rank 
order among comparable codes in the family.
    For CPT code 64448, we disagree with the RUC-recommended work RVU 
of 1.55 and are proposing a work RVU of 1.41, based our time ratio 
methodology and a reference to CPT code 27096 (Injection procedure for 
sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy 
or CT) including arthrography when performed), which has a work RVU of 
1.48 and near identical intraservice time and identical total time 
values to CPT code 64448.
    We note that RUC-recommended intraservice time decreased from 15 to 
13 minutes (13 percent reduction) and the RUC-recommended total time 
decreased from 55 to 38 minutes (62 percent reduction). While the RUC-
recommended work RVU is only decreasing by 0.08, which is only a 5 
percent reduction. We do not believe the RUC-recommended work RVU 
appropriately accounts for the substantial reductions in the surveyed 
intraservice work time for the procedure. 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 and time are 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. In the case of CPT 
code 64448, we believe that it would be more accurate to propose a work 
RVU of 1.41, based on our time ratios methodology and a crosswalk to 
CPT code 27096 to account for these decreases in surveyed times and to 
maintain rank order among comparable codes in the family.
    For CPT code 64449, we disagree with the RUC-recommended work RVU 
of 1.55 and are proposing a work RVU of 1.27, based our time ratio 
methodology and a reference to CPT code 11755 (Biopsy of nail unit (eg, 
plate, bed, matrix, hyponychium, proximal and lateral nail folds) 
(separate procedure)), which has a work RVU of 1.25 and near identical 
intraservice and total times to CPT code 64449.
    We note that RUC-recommended intraservice time decreased from 20 to 
14 minutes (30 percent reduction) and the RUC-recommended total time 
decreased from 60 to 38 minutes (37 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.26, a 14 percent reduction, we 
do not believe the RUC-recommended work RVU appropriately accounts for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. 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 and time are 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

[[Page 40583]]

work RVUs. In the case of CPT code 64449, we believe that it would be 
more accurate to propose a work RVU of 1.27, based on our time ratios 
methodology and a reference to CPT code 11755 to account for these 
decreases in surveyed times and to maintain rank order among comparable 
codes in the family.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Confirm availability of prior images/studies'' 
(CA006) activity for CPT code 64450. This code does not currently 
include this clinical labor time, and unlike the new code, CPT code 
64XX1, in the Genicular Injection and RFA code family, in which the PE 
for CPT code 64450 was resurveyed at the January 2019 RUC for PE, CPT 
code 64450 does not include imaging guidance in its code descriptor. 
When CPT code 64450 is performed with imaging guidance, it would be 
billed together with a separate imaging code that already includes 
clinical labor time for confirming the availability of prior images. As 
a result, it would be duplicative to include this clinical labor time 
in CPT code 64450. We are also proposing to refine the clinical labor 
time for the ``Assist physician or other qualified healthcare 
professional--directly related to physician work time (100 percent)'' 
(CA018) activity from 10 to 5 minutes for CPT code 64450, to match the 
intraservice work time and proposing to refine the equipment times in 
accordance with our standard equipment time formulas for CPT code 
64450.
    Additionally, we are proposing to refine the clinical labor time 
for the ``provide education/obtain consent'' (CA011) from 3 minutes to 
2 minutes, for CPT codes 64400, 64408, 64415, 64417, 64420, 64425, 
64430, 64435, 64445, 64447 and 64450, to conform to the standard for 
this clinical labor task. We are also proposing to refine the equipment 
time in accordance with our standard equipment time formula for these 
codes. We note that there were no RUC-recommended direct PE inputs 
provided for CPT codes 64416, 64446, and 64448.
(26) Genicular Injection and RFA (CPT Codes 64640, 64XX0, and 64XX1)
    In May 2018, the CPT Editorial Panel approved the addition of two 
codes to report injection of anesthetic and destruction of genicular 
nerves by neurolytic agent. In October 2018, the RUC discussed the 
issues surrounding the survey of this family of services and supported 
the specialty societies' request for CPT codes 64640 (Destruction by 
neurolytic agent; other peripheral nerve or branch), 64XX0 
(Injection(s), anesthetic agent(s) and/or steroid; genicular nerve 
branches including imaging guidance, when performed), and 64XX1 
(Destruction by neurolytic agent genicular nerve branches including 
imaging guidance, when performed) to be resurveyed and presented at the 
January 2019 RUC meeting, based on their concern that many survey 
respondents appeared to be confused about the number of nerve branch 
injections involved with these three codes. The RUC resurveyed these 
services at the January 2019 RUC meeting.
    For CY 2020, we are proposing the RUC-recommended work RVUs for two 
of the three codes in this family. We are proposing the RUC-recommended 
work RVU of 1.98 (25th percentile survey value) for CPT code 64640 and 
the RUC-recommended work RVU of 1.52 (25th percentile survey value) for 
CPT code of 64XX0.
    For CPT code 64XX1, we disagree with the RUC-recommended work RVU 
of 2.62, which is higher than the 25th percentile survey value, a work 
RVU 2.50, and are proposing a work RVU of 2.50 (25th percentile survey 
value) based on a reference to CPT code 11622 (Excision, malignant 
lesion including margins, trunk, arms, or legs; excised diameter 1.1 to 
2.0 cm), which has a work RVU of 2.41 and near identical intraservice 
and total times to CPT code 64XX1.
    In our review of CPT code 64XX1, we examined the intraservice time 
ratio for the new code, CPT code 64XX1, in relation to an existing code 
in this family of services, CPT code 64640. CPT code 64XX1 has a RUC-
recommended work RVU of 2.62, 25 minutes of intraservice time, and 74 
minutes of total time. CPT code 64640 has a RUC-recommended work RVU of 
1.98, 20 minutes of intraservice time, and 64 minutes of total time. To 
derive our proposed work RVU of 2.50, we calculated the intraservice 
time ratio between these two codes, which is a calculated value of 
1.25, and applied this ratio times the RUC-recommended work RVU of 1.98 
for CPT code 64650, which resulted in a calculated value of 2.48. This 
value is nearly identical to the January 2018 RUC 25th percentile 
survey value for CPT code 64XX1, a work RVU of 2.50. Our proposed work 
RVU of 2.50 is further supported by a reference to CPT code 11622.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Confirm availability of prior images/studies'' 
(CA006) activity for CPT code 64640. This code does not currently 
include this clinical labor time, and unlike the new code in the family 
(CPT code 64XX1), CPT code 64640 does not include imaging guidance in 
its code descriptor. When CPT code 64640 is performed with imaging 
guidance, it would be billed together with a separate imaging code that 
already includes clinical labor time for confirming the availability of 
prior images. As a result, it would be duplicative to include this 
clinical labor time in CPT code 64640. We are proposing to refine the 
clinical labor time for the ``Assist physician or other qualified 
healthcare professional--directly related to physician work time (100 
percent)'' (CA018) activity from 25 to 20 minutes for CPT code 64640, 
to match the intraservice work time. We are also proposing to refine 
the equipment times in accordance with our standard equipment time 
formulas for CPT code 64640.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
64XX0 without refinement.
    For CPT code 64XX1, we are proposing to refine the quantity of the 
``cannula (radiofrequency denervation) (SMK-C10)'' (SD011) supply from 
3 to 1. We do not believe that the use of 3 of this supply item would 
be typical for the procedure. We note that the RUC recommendations for 
another code in this family, CPT code 64640 only contains 1 of this 
supply item. We believe that the nerves would typically be ablated one 
at a time using this cannula, as opposed to ablating three of them 
simultaneously as suggested in the recommended direct PE inputs. We 
also searched in the RUC database for other CPT codes that made use of 
the SD011 supply, and out of the seven codes that currently use this 
item, none of them include more than 2 cannula. As a result, we are 
proposing to refine the supply quantity to 2 cannula to match the 
highest amount contained in an existing code on the PFS. We are also 
refining the equipment time for the ``radiofrequency kit for 
destruction by neurolytic agent'' (EQ354) equipment from 141 minutes to 
47 minutes. The equipment time recommendation was predicated on the use 
of 3 of the SD011 supplies for 47 minutes apiece, and we are refining 
the equipment time to reflect our supply refinement to 1 cannula. It 
was unclear in the RUC recommendation materials as to whether the 
radiofrequency kit equipment was in use simultaneously or sequentially 
along with the cannula supplies, and therefore, we are soliciting 
comments on the typical use of this equipment.

[[Page 40584]]

(27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984, 
66X01, and 66X02)
    In October 2017, CPT codes 66711 (Ciliary body destruction; 
cyclophotocoagulation, endoscopic) and 66984 (Extracapsular cataract 
removal with insertion of intraocular lens prosthesis (1 stage 
procedure), manual or mechanical technique (e.g., irrigation and 
aspiration or phacoemulsification) were identified as codes reported 
together 75 percent of the time or more. The RUC reviewed action plans 
to determine whether a code bundle solution should be developed for 
these services. In January 2018, the RUC recommended to refer to CPT to 
bundle 66711 with 66984 for CPT 2020. In May 2018, the CPT Editorial 
Panel revised three codes and created two new codes, CPT codes 66X01 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; with endoscopic cyclophotocoagulation) 
and 66X02 (Extracapsular cataract removal with insertion of intraocular 
lens prosthesis (1 stage procedure), manual or mechanical technique 
(e.g., irrigation and aspiration or phacoemulsification); with 
endoscopic cyclophotocoagulation) to differentiate cataract procedures 
performed with and without endoscopic cyclophotocoagulation.
    The codes discussed above and CPT codes 66982 (Extracapsular 
cataract removal with insertion of intraocular lens prosthesis (1-stage 
procedure), manual or mechanical technique (e.g., irrigation and 
aspiration or phacoemulsification), complex, requiring devices or 
techniques not generally used in routine cataract surgery (e.g., iris 
expansion device, suture support for intraocular lens, or primary 
posterior capsulorrhexis) or performed on patients in the amblyogenic 
developmental stage) and 66983 (Intracapsular cataract extraction with 
insertion of intraocular lens prosthesis (1 stage procedure)) were 
reviewed at the January 2019 RUC meeting.
    For CY 2020, we are proposing the RUC-recommended work RVU of 10.25 
for CPT code 66982, the RUC recommendation to contractor-price CPT code 
66983, and the RUC-recommended work RVU of 7.35 for CPT code 66984. We 
disagree with the RUC recommendations for CPT codes 66711, 66X01, and 
66X02.
    For CPT code 66711, we disagree with the RUC-recommended work RVU 
of 6.36 and are proposing a work RVU of 5.62, based on crosswalk to CPT 
code 28285 (Correction, hammertoe (e.g., interphalangeal fusion, 
partial or total phalangectomy), which has an identical work RVU of 
5.62, and similar intraservice and total times.
    In our review of CPT code 66711, we note that the recommended 
intraservice time is decreasing from 20 minutes to 10 minutes (33 
percent reduction), and that the recommended total time is decreasing 
from 192 minutes to 191 minutes (0.5 percent reduction). While the RUC-
recommended work RVU is decreasing from 7.93 to 6.36, which is a 20 
percent reduction, we do not believe it appropriately accounts for the 
decreases in survey time. Time ratio methodology suggest that CPT code 
66711 is better valued at a work RVU of 5.29, thus it is overvalued 
with consideration to the decreases in survey times. Although we do 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 66711, we 
believe that it would be more accurate to propose a work RVU of 5.62, 
based on our time ratio methodology and a crosswalk to CPT code 28285 
to account for these decreases in surveyed work times.
    For CPT code 66X01, the RUC recommended a work RVU of 13.15, we 
disagree with the RUC-recommended work RVU and are proposing 
contractor-pricing for this code. In reviewing this code, we note that 
the RUC recommendation survey values do not support the RUC-recommended 
work RVU of 13.15 and furthermore, the RUC recommendations do not 
include a crosswalk to support the RUC-recommended work RVU. The RUC 
recommendations noted a lack of potential crosswalk codes due to the 
complete lack of similarly intense major surgical procedures comparable 
in the amount of skin-to-skin time, operating room time and amount of 
post-operative care. We note that the RUC-recommended work RVU of 13.15 
is higher than similarly timed codes on the PFS. Given that lack of 
both survey data and a crosswalk to support the RUC-recommended work 
RVU for this new code, and that the RUC-recommended work RVU of 13.15 
is higher than similarly timed codes on the PFS, we believe it is more 
appropriate to propose contractor-pricing for CPT code 66X01. We also 
note that the RUC recommended contractor-pricing for another code in 
this family, CPT code 66983, which we are proposing for CY 2020.
    For CPT code 66X02, the RUC recommended a work RVU of 10.25, we 
disagree with the RUC-recommended work RVU and are proposing 
contractor-pricing for this code. In reviewing this code, we note that 
the RUC recommendation survey values do not support the RUC-recommended 
work RVU of 10.25. Furthermore, we are concerned with the RUC 
recommended crosswalk, CPT code 67110 (Repair of retinal detachment; by 
injection of air or other gas (e.g., pneumatic retinopexy), which is 
the same crosswalk used to support the RUC-recommended work RVU of 
10.25 for another code in this family, CPT code 66982. CPT code 67110 
has 30 minutes of intraservice time and 196 minutes of total time. 
Although CPT code 67110 has the identical intraservice time to CPT 
codes 66982 and 66X02, we note that CPT code 67110 has 196 minutes of 
total time, which is 21 minutes less than the 175 minutes of total time 
of CPT code 66982, and 6 minutes less than the 202 minutes of total 
time of CPT Code 66X02. However, the RUC is recommending the same work 
RVU of 10.25 for CPT codes 66982 and 66X02, supported by the same 
crosswalk to CPT code 67110.
    Given that lack of survey data and our concern for the RUC-
recommended crosswalk to support the RUC-recommended work RVU of 10.25 
for CPT code 66X02, we believe it is appropriate to propose contractor-
pricing for CPT code 66X02. We also note that the RUC recommended 
contractor-pricing for another code in this family, CPT code 66983, 
which we are prosing for CY 2020.
    We are proposing to remove all the direct PE inputs for CPT codes 
66X01 and 66X02, given our proposal for contractor-pricing for these 
codes. We are proposing the RUC-recommended direct PE inputs for the 
other codes in this family.
(28) X-Ray Exam--Sinuses (CPT Codes 70210 and 70220)
    CPT code 70210 (Radiologic examination, sinuses, paranasal, less 
than 3 views) and CPT code 70220 (Radiologic examination, sinuses, 
paranasal, complete, minimum of 3 views) were identified as potentially 
misvalued through a screen for

[[Page 40585]]

Medicare services with utilization of 30,000 or more annually. These 
two codes were first reviewed by the RUC in April 2018, but were 
subsequently surveyed by the specialty societies and reviewed again by 
the RUC in January 2019.
    The RUC recommended a work RVU for CPT code 70210 of 0.20, which is 
a slight increase over the current work RVU for this code (0.17). The 
RUC's recommendation is consistent with 25th percentile of survey 
results and is based on a comparison of the survey code with the two 
key reference services. The first key reference service, CPT code 71046 
(Radiologic examination, chest; 2 views), has a work RVU of 0.22, 4 
minutes of intraservice time, and 6 minutes of total time. The RUC 
noted that the survey code has one minute less intraservice and total 
time compared with the first key reference service (CPT code 71046), 
which accounts for the slightly lower work RVU for the survey code. The 
RUC also compared CPT code 70210 to CPT code 70355 (Orthopantogram 
(e.g., panoramic X-ray)), with a work RVU of 0.20, 5 minutes of 
intraservice time, and 6 minutes of total time. Although the 
intraservice and total times are lower for CPT code 70210 than for CPT 
code 70355, the work is slightly more intense for the survey code, 
according to the RUC, justifying an identical work RVU of 0.20 for CPT 
code 70210. We disagree with the RUC's recommendation to increase the 
work RVU for CPT code 70210 from the current value (0.17) to 0.20 for 
two main reasons. First, the total time (5 minutes) for this code has 
not changed from the current total time and without a corresponding 
explanation for an increase in valuation despite maintaining the same 
total time, we do are not convinced that the work RVU for this code 
should increase. In addition, we note that based on a general 
comparison of CPT codes with identical intraservice time and total time 
(approximately 23 comparison codes, excluding those currently under 
review), a work RVU of 0.20 would establish a new upper threshold among 
this cohort. We are proposing to maintain the work RVU for CPT code 
70210 of 0.17 work RVUs, bracketed by two services. On the upper side, 
we identified CPT code 73501 (Radiologic examination, hip, unilateral, 
with pelvis when performed; 1 view) with a work RVU of 0.18, and on the 
lower side, we identified CPT code 73560 (Radiologic examination, knee; 
1 or 2 views) with a work RVU of 0.16. For CPT code 70220, we are 
proposing the RUC-recommended work RVU of 0.22.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(29) X-Ray Exam--Skull (CPT Codes 70250 and 70260)
    CPT code 70250 (Radiologic examination, skull, less than 4 views) 
was identified as potentially misvalued through a screen of Medicare 
services with utilization of 30,000 or more annually. CPT code 70260 
(Radiologic examination, skull; complete, minimum of 4 views) was 
included as part of the same family. These two codes were first 
reviewed by the RUC in April 2018, but were subsequently surveyed by 
the specialty societies and reviewed by the RUC again in January 2019.
    The RUC-recommended work RVU for CPT code 70250 is 0.20, which is a 
slight decrease from the current work RVU for this code (0.24). The 
decrease, according to the RUC, reflects a slightly lower total time 
required to furnish the service (from 7 minutes to 5 minutes) and is 
consistent with the 25th percentile work RVU from the survey results. 
The RUC-recommended work RVU is bracketed by two CPT codes: Top key 
reference service, CPT code 71046 (Radiologic examination, chest; 2 
views) with 4 minutes of intraservice time, 6 minutes total time, and a 
work RVU of 0.22; and key reference service, CPT code 73562 (Radiologic 
examination, knee; 3 views), with intraservice time of 4 minutes, total 
time of 6 minutes, and a work RVU of 0.18. The RUC noted that while the 
survey code has less time than CPT code 71046, the work is slightly 
more intense due to anatomical and contextual complexity. The survey 
code is also more intense compared with the second key reference 
service, CPT code 73562, according to the RUC, because of the higher 
level of technical skill involved in an X-ray of the skull (axial 
skeleton) compared with an X-ray of the knee (appendicular skeleton). 
The RUC further indicated that a comparison between the survey code and 
CPT codes with a work RVU of 0.18 would not be appropriate given the 
higher level of complexity associated with an X-ray of the skull than 
with other CPT codes that have similar times. We disagree with the 
recommended work RVU of 0.20 for CPT code 70250. The total time for 
furnishing the service has decreased by 2 minutes while the description 
of the work involved in furnishing the service has not changed. This 
suggests that a value closer to the total time ratio (TTR) calculation 
(0.17 work RVU) might be more appropriate. In addition, a search of CPT 
codes with 3 minutes of intraservice time and 5 minutes of total time 
indicates that the maximum work RVU for codes with these times is 0.18, 
meaning that a work RVU of 0.20 would establish a new relative high 
work RVU for codes with these times. We believe that a crosswalk to CPT 
code 73501 (Radiologic examination, hip, unilateral, with pelvis when 
performed; 1 view) with a work RVU of 0.18, 3 minutes of intraservice 
time, and 5 minutes of total time, accurately reflects both the time 
and intensity of furnishing the service described by CPT code 70250. 
Therefore, we are proposing a work RVU of 0.18 for CPT code 70250.
    The RUC recommended a work RVU of 0.29 for CPT code 70260, which is 
lower than the current work RVU of 0.34. The survey times for 
furnishing the service are 4 minutes of intraservice time and 7 minutes 
total time, compared with the current intraservice time and total time 
of 7 minutes. However, in developing their recommendation, the RUC 
reduced the total time for this code from 7 minutes to 6 minutes. 
Although the RUC's recommended work RVU reflects the 25th percentile of 
survey results, the survey 25th percentile is based on an additional 
minute of total time compared with the RUC's total time for this CPT 
code. Moreover, since we are proposing a lower work RVU for the base 
code for this family (work RVU of 0.18 for CPT code 70250), we believe 
a lower work RVU for CPT code 70260 is warranted. To identify an 
alternative value, we calculated the increment between the current work 
RVU for CPT code 72050 (work RVU of 0.24) and the current work RVU for 
CPT code 72060 (work RVU of 0.34) and applied it to the CMS proposed 
work RVU for CPT code 70250 (0.18 + 0.10) to calculate a work RVU of 
0.28. We believe that applying this increment is a better reflection of 
the work time and intensity involved in furnishing CPT code 70260. We 
are proposing a work RVU for CPT code 70260 of 0.28.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(30) X-Ray Exam--Neck (CPT Code 70360)
    CPT code 70360 (Radiologic examination; neck, soft tissue) was 
identified as potentially misvalued through a screen of CPT codes with 
annual Medicare utilization of 30,000 or more. CPT code 70360 was first 
reviewed by the RUC in April 2018 but was subsequently surveyed by the 
specialty societies and reviewed by the RUC again in January 2019.
    The RUC recommended a work RVU of 0.20 for CPT code 70360, which is 
an increase over the current work RVU

[[Page 40586]]

(0.17). To support their recommendation, the RUC cited the survey key 
reference service, CPT code 71046 (Radiologic examination, chest; 2 
views), with a work RVU of 0.22, 4 minutes of intraservice time, and 6 
minutes of total time. They noted that the key reference code has one 
minute higher intraservice and total time, accounting for the slightly 
higher work RVU compared with the survey code, CPT code 70360. The RUC 
also cited the second highest key reference service, CPT code 73562 
(Radiologic examination, knee; 3 views) with a work RVU of 0.18, 
intraservice time of 4 minutes, and total time of 6 minutes. They noted 
that, while the survey code has lower intraservice time (3 minutes) and 
total time (5 minutes) compared with CPT code 73562, the survey code is 
more complex than the key reference service, thereby supporting a 
higher work RVU for the survey code (CPT code 70360) of 0.20. We do not 
agree with the RUC that the work RVU for CPT code 70360 should increase 
from 0.17 to 0.20. The total time for the CPT code, as recommended by 
the RUC (5 minutes), is unchanged from the existing total time. Without 
a corresponding discussion of why the current work RVU is insufficient, 
we do not agree that there should be an increase in the work RVU. 
Furthermore, although the RUC's recommendation is consistent with the 
25th percentile of survey results for the work RVU, the total time from 
the survey results was 6 minutes, not the RUC-recommended time of 5 
minutes. When we looked at CPT codes with identical times to the survey 
code for a crosswalk, we identified CPT code 73552 (Radiologic 
examination, femur; minimum 2 views), with a work RVU of 0.18. We 
believe this is a more appropriate valuation for CPT code 70360 and we 
are proposing a work RVU for this CPT code of 0.18.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
70360.
(31) X-Ray Exam--Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 
72072, 72074, 72080, 72100, 72110, 72114, and 72120)
    CPT codes 72020 (Radiologic examination spine, single view, specify 
level) and 72072 (Radiologic examination, spine; thoracic, 3 views) 
were identified through a screen of CMS/Other Source codes with 
Medicare utilization greater than 100,000 services annually. The code 
family was expanded to include 10 additional CPT codes to be reviewed 
together as a group: CPT code 72040 (Radiologic examination, spine, 
cervical; 2 or 3 views), CPT code 72050 (Radiologic examination, spine, 
cervical; 4 or 5 views), CPT code 72052 (Radiologic examination, spine 
cervical; 6 or more views), CPT code 72070 (Radiologic examination 
spine; thoracic, 2 views), CPT code 72074 (Radiologic examination, 
spine; thoracic, minimum of 4 views), CPT code 72080 (Radiologic 
examination, spine; thoracolumbar junction, minimum of 2 views), CPT 
code 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views), 
CPT code 72110 (Radiologic examination, spine, lumbosacral; minimum of 
4 views), CPT code 72114 (Radiologic examination, spine, lumbosacral; 
complete, including bending views, minimum of 6 views), and CPT code 
72120 (Radiologic examination, spine, lumbosacral; bending views only, 
2 or 3 views). This family of CPT codes was originally valued by the 
specialty societies using a crosswalk methodology approved by the RUC 
Research Subcommittee. However, after we expressed concern about the 
use of this approach for valuing work and PE, the specialty society 
agreed to survey these codes and the RUC reviewed them again in January 
2019.
    For the majority of CPT codes in this family, the RUC recommended a 
work RVU that is slightly different (higher or lower) than the current 
work RVU. Three CPT codes in this family are maintaining the current 
work RVU. We are proposing the RUC-recommended work RVU for all 12 CPT 
codes in this family as follows: CPT code 72020 (work RVU = 0.16); CPT 
code 72040 (work RVU = 0.22); CPT code 72050 (work RVU = 0.27); CPT 
code 72052 (work RVU = 0.30); CPT code 72070 (work RVU = 0.20); CPT 
code 72072 (work RVU = 0.23); CPT code 72074 (work RVU = 0.25); 72080 
(work RVU = 0.21); CPT code 72100 (work RVU = 0.22); CPT code 72110 
(work RVU =0.26); CPT code 72114 (work RVU = 0.30); and CPT code 72120 
(work RVU = 0.22).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(32) CT-Orbit-Ear-Fossa (CPT Codes 70480, 70481, and 70482)
    In October 2017, the RAW requested that AMA staff develop a list of 
CMS/Other codes with Medicare utilization of 30,000 or more. CPT code 
70480 (Computed tomography (CT), orbit, sella, or posterior fossa or 
outer, middle, or inner ear; without contrast material) was identified. 
In addition, the code family was expanded to include two related CT 
codes, CPT code 70481 (Computed tomography, orbit, sella, or posterior 
fossa or outer, middle, or inner ear; with contrast material) and CPT 
code 70482 (Computed tomography, orbit, sella, or posterior fossa or 
outer, middle, or inner ear; without contrast material followed by 
contrast material(s) and further sections). In 2018, the RUC 
recommended this code family be surveyed.
    For CPT code 70840, we disagree with the RUC-recommended work RVU 
of 1.28 and propose instead a work RVU of 1.13. We are proposing a 
lower work RVU because 1.13 represents the commensurate 12 percent 
decrease in work time reflected in survey values. We reference the work 
RVUs of CPT codes 72128 (Computed tomography, chest, spine; without 
dye) and 71250 (Computed tomography, thorax without dye) both of which 
have the same intraservice time (that is, 15 minutes) as CPT code 70840 
but longer total times (that is, 25 minutes versus 22 minutes). We 
believe that CPT code 72128 with a work RVU of 1.0 and CPT code 71250 
with a work RVU of 1.16 more accurately reflect the relative work 
values of CPT code 70840.
    We also disagree with the RUC-recommended work RVU of 1.13 for CPT 
code 70481. Instead, we are proposing a work RVU of 1.06 for CPT code 
70481. As with CPT code 70840, we are proposing a lower work RVU for 
CPT code 70481 because a work RVU of 1.06 is commensurate with the 23 
percent decrease in surveyed total time from 26 to 20 minutes. We 
believe CPT code 76641 (Ultrasound, breast, unilateral) with a work RVU 
of 0.73 and CPT code 70460 (Computed Tomography, head or brain, without 
contrast) with a work RVU of 1.13 serve as appropriate references for 
our proposed work RVU for CPT code 70841. Although CPT codes 76641 and 
70460 have longer total times at 22 minutes and lower intraservice 
times at 12 minutes, we believe they better reflect the relative work 
value of CPT code 70481 with a proposed work RVU of 1.06, total time of 
20 minutes, and intraservice time of 13 minutes.
    For the third code in the family, CPT code 70482, we are proposing 
the RUC-recommended work RVU of 1.27.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(33) CT Spine (CPT Codes 72125, 72126, 72127, 72128, 72129, 72130, 
72131, 72132, and 72133)
    CPT code 72132 (Computed tomography, lumbar spine; with contrast 
material) was identified as potentially misvalued on a screen of CMS/
Other codes with Medicare

[[Page 40587]]

utilization of 30,000 or more. Eight other spine CT codes were 
identified as part of the family, and they were surveyed and reviewed 
together at the April 2018 RUC meeting.
    We are proposing the RUC-recommended work RVU for eight of the nine 
codes in the family. We are proposing a work RVU of 1.22 for CPT code 
72126 (Computed tomography, cervical spine; with contrast material), a 
work RVU of 1.27 for CPT code 72127 (Computed tomography, cervical 
spine; without contrast material, followed by contrast material(s) and 
further sections), a work RVU of 1.00 for CPT code 72128 (Computed 
tomography, thoracic spine; without contrast material), a work RVU of 
1.22 for CPT code 72129 (Computed tomography, thoracic spine; with 
contrast material), a work RVU of 1.27 for CPT code 72130 (Computed 
tomography, thoracic spine; without contrast material, followed by 
contrast material(s) and further sections), a work RVU of 1.00 for CPT 
code 72131 (Computed tomography, lumbar spine; without contrast 
material), a work RVU of 1.22 for CPT code 72132 (Computed tomography, 
lumbar spine; with contrast material), and a work RVU of 1.27 for CPT 
code 72133 (Computed tomography, lumbar spine; without contrast 
material, followed by contrast material(s) and further sections).
    We disagree with the RUC-recommended work RVU of 1.07 for CPT code 
72125 (Computed tomography, cervical spine; without contrast material) 
and we are proposing a work RVU of 1.00 to match the other without 
contrast codes in the family. The cervical spine CT procedure described 
by CPT code 72125 shares the identical surveyed work time as the 
thoracic spine CT procedure described by CPT code 72128 and the lumbar 
spine CT procedure described by CPT code 72131, and we believe that 
this indicates that these three CPT codes should share the same work 
RVU of 1.00. Our proposed work RVU would also match the pattern 
established by the rest of the codes in this family, in which the 
contrast procedures (CPT codes 72126, 72129, and 72132) share a 
proposed work RVU of 1.22 and the without/with contrast procedures (CPT 
codes 72127, 72130, and 72133) share a proposed work RVU of 1.27.
    We recognize that the RUC has stated that they believe CPT code 
72125 to be a more complex study than CPT codes 72128 and 72131 because 
the cervical spine is subject to an increased number of injuries and 
there are a larger number of articulations to evaluate. This was the 
basis for their recommendation that this code should be valued slightly 
higher than the other without contrast codes. However, if CPT code 
72125 has a more difficult patient population and requires a larger 
number of articulations to evaluate as compared to CPT codes 72128 and 
72131, we do not understand why this was not reflected in the surveyed 
work times, which were identical for the three procedures. We believe 
that if the intensity of the procedure were higher due to these 
additional difficulties, it would be reflected in a longer surveyed 
work time. In addition, the survey respondents selected a higher work 
RVU for CPT code 72131 than CPT code 72125 at both the survey 25th 
percentile (1.20 to 1.18) and survey median values (1.39 to 1.28), 
which does not suggest that CPT code 72125 should be valued at a higher 
rate.
    We also note that the surveyed intraservice work time for CPT code 
72125 is decreasing from 15 minutes to 12 minutes, and we believe that 
this provides additional support for a slight reduction in the work RVU 
to match the other without contrast codes in the family. 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 want to 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 prior work time values 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(34) X-Ray Exam--Pelvis (CPT Codes 72170 and 72190)
    CPT code 72190 (Radiologic examination, pelvis; complete, minimum 
of 3 views) was identified as potentially misvalued through a screen of 
CMS/Other codes with Medicare utilization of 30,000 or more annually. 
CPT code 72170 (Radiologic examination, pelvis; 1 or 2 views) was added 
as part of the family. The RUC originally reviewed these two codes 
after specialty societies employed a crosswalk methodology to value 
work and PE. However, after we expressed concern about the use of this 
approach, the specialty society agreed to survey the codes and the RUC 
reviewed them again at the meeting in January 2019.
    The RUC recommended a work RVU of 0.17 for CPT code 72170, which 
maintains the current value. For CPT code 72190, the RUC recommended a 
work RVU of 0.25, which is slightly higher than the current value 
(0.21). We are proposing the RUC-recommended values for these two CPT 
codes.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(35) X-Ray Exam--Sacrum (CPT Codes 72200, 72202, and 72220)
    CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum 
of 2 views) was identified on a screen of CMS/Other source codes with 
Medicare utilization greater than 100,000 annually. CPT codes 72200 
(Radiologic examination, sacroiliac joints; less than 3 views) and 
72202 (Radiologic examination, sacroiliac joints; 3 or more views) were 
also included for review as part of the same family of codes. These 
three codes were originally valued by the specialty societies using a 
crosswalk methodology approved by the RUC Research Subcommittee. 
However, after we expressed concern about the use of this approach for 
valuing work and PE, the specialty society agreed to survey these codes 
and the RUC reviewed them again in January 2019.
    For CPT code 72200, the RUC is recommending a work RVU of 0.20, 
which is higher than the current work RVU (0.17). To support their 
recommendation, the RUC compared the survey code to the key reference 
service, CPT code 73522 (Radiologic examination, hips, bilateral, with 
pelvis when performed; 3-4 views), with a work RVU of 0.29, 5 minutes 
of intraservice time and 7 minutes of total time. The intraservice and 
total times for the key reference service are one minute higher than 
the survey code (4 minutes intraservice time, 6 minutes total time for 
CPT code 72200) and the survey code is less intense, according to the 
RUC, thereby supporting a slightly lower work RVU of 0.20 for CPT code 
72200. The second key reference service is CPT code 73562 (Radiologic 
examination, knee; 3 views), with 4 minutes of intraservice time, 6 
minutes of total time, and a work RVU of 0.18. The RUC noted that this 
second key reference service is less intense to furnish than the survey 
code, which justifies a slightly lower work RVU despite identical 
intraservice time (4 minutes) and total time (6 minutes). The

[[Page 40588]]

RUC supported their recommendation of a work RVU for CPT code 72200 of 
0.20 with two bracketing codes: CPT code 93042 (Rhythm ECG, 1-3 leads; 
interpretation and report only) with work RVU of 0.15, and CPT code 
70355 (Orthopantogram (e.g. panoramic x-ray)) with a work RVU of 0.20 
(which is identical to the RUC-recommended work RVU for CPT code 72200 
but has one additional minute of intraservice time). A work RVU of 0.20 
is consistent with the work RVU estimated by the TTR and reflects the 
25th percentile of survey results. Nevertheless, we do not agree that 
there is sufficient justification for an increase in work RVU for CPT 
code 72200. We are concerned that the large variation in specialty 
societies' survey times is indicative of differences in patient 
population, practice workflow, or even possibly some ambiguity 
associated with the survey vignette. We also note that the 25th 
percentile of survey results are based on the overall survey total 
time, which is 8 minutes, rather than the RUC's recommended 6 minutes. 
The time parameters for furnishing the service affect all other points 
of comparison for purpose of valuing the code, including TTR, 
identification of potential crosswalks, and increment calculations. We 
found no corresponding explanation for the variability in survey times, 
leading us to question why there should be an increase in work RVU from 
the current value. Therefore, we are proposing to maintain the current 
work RVU for CPT code 72200 at 0.17.
    For CPT code 72202, the RUC recommended a work RVU of 0.26, which 
is considerably higher than the current work RUV for this code of 0.19. 
The RUC supported their recommendation with two key reference services. 
The first is CPT code 73522 (Radiologic examination, hips, bilateral, 
with pelvis when performed; 3-4 views) with 5 minutes intraservice 
time, 7 minutes total time, and a work RVU of 0.29. They note that this 
code has an additional minute for intraservice and total time compared 
with the survey code, reflecting the additional views associated with 
evaluating bilateral hip joints. The second key reference service is 
CPT code 73562 (Radiologic examination, knee; 3 views) with 4 minutes 
intraservice time, 6 minutes total time, and a work RVU of 0.18. The 
RUC notes that the survey code has the same times but requires more 
intensity and includes an additional view compared with the reference 
service, which justifies a higher work RVU for the survey code. We 
disagree with the RUC's recommended work RVU for CPT code 72202. Given 
that there is no change in the total time required to furnish the 
service and there is no corresponding description of an increase in the 
intensity of the work relative to the existing value, we do not believe 
an increase of 0.07 work RVUs is warranted. The TTR calculation yields 
a work RVU of .019, suggesting that a value closer to the current work 
RVU would be more appropriate. In addition, since we consider the RUC-
recommended work RVU for this code as an incremental change from the 
prior code in this family, we believe that an increase of 0.06 over the 
proposed work RVU of 0.18 for CPT code 72200, which yields a work RVU 
of 0.23, is a better reflection of the time and intensity required to 
furnish CPT code 72202. Our proposed value work RVU of 0.23 is 
bracketed by CPT code 73521 (Radiologic examination, hips, bilateral, 
with pelvis when performed; 2 views) on the lower end (work RVU = .22), 
and CPT code 74021 (Radiologic examination, abdomen; 3 or more views), 
on the higher end (work RVU = 0.27). CPT code 73521 has the same times 
as the survey code but describes a bilateral service with 2 views, 
which is slightly less intense. CPT code 74021 also has identical times 
but involves X-ray of the abdomen with 3 views, a slightly higher 
intensity than the survey code.
    The RUC-recommended work RVU for CPT code 72220 is 0.20, which 
reflects an increase over the current work RVU for this code (0.17). 
The key reference service from the survey results is CPT code 73522 
(Radiologic examination, hips, bilateral, with pelvis when performed, 
2-4 views), with a work RVU of 0.29, 5 minutes intraservice time, and 7 
minutes total time. The RUC noted that the recommended work RVU for CPT 
code 72220 has a lower value than the top key reference code (CPT code 
73522) because of the shorter time and lower intensity involved in 
furnishing the survey code. The second highest key reference service, 
CPT code 73562 (Radiologic examination, knee; 3 views) has a work RVU 
of 0.18 with 4 minutes of intraservice time and 6 minutes of total 
time. The RUC notes that this second key reference service has a lower 
work RVU than the survey code despite having a slightly higher 
intraservice time and total time because it involves an X-ray of just 
one knee. We disagree with the RUC's recommended increase in the work 
RVU for CPT code 72220 from 0.17 to 0.20. We note that there is no 
change in the total time required to furnish the service. We also note 
that a work RVU of 0.20 for CPT code 72220 would place it near the 
maximum work RVU for CPT codes with identical intraservice time (3 
minutes) and total time (5 minutes). Instead, we are proposing to 
maintain the work RVU for this service at 0.17, which is consistent 
with our proposal to maintain the current work RVU for CPT code 72200 
at 0.17 as well.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(36) X-Ray Exam--Clavicle-Shoulder (CPT Codes 73000, 73010, 73020, 
73030, and 73050)
    CPT code 73030 (Radiologic examination, shoulder; complete, minimum 
of 2 views) was identified as potentially misvalued through a screen of 
services with more than 100,000 utilization annually. CPT codes 73000 
(Radiologic examination; clavicle, complete), 73010 (Radiologic 
examination; scapula, complete), 73020 (Radiologic examination, 
shoulder; 1 view), and 73050 (Radiologic examination, acromioclavicular 
joints, bilateral, with or without weighted distraction) were included 
for review as part of the same family. We are proposing the RUC-
recommended work RVUs for all five codes in this family as follows: CPT 
code 73000 (work RVU = 0.16); CPT code 73010 (work RVU = 0.17); CPT 
code 73020 (work RVU = 0.15); CPT code 73030 (work RVU = 0.18); and CPT 
code 73050 (work RVU = 0.18).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(37) CT Lower Extremity (CPT Codes 73700, 73701, and 73702)
    CPT code 73701 (Computed tomography, lower extremity; with contrast 
material(s)) was identified as potentially misvalued on a screen of 
CMS/Other codes with Medicare utilization of 30,000 or more. Two other 
lower extremity CT codes were identified as part of the family, and 
they were surveyed and reviewed together at the April 2018 RUC meeting.
    We are proposing the RUC-recommended work RVU for all three codes 
in this family. We are proposing a work RVU of 1.00 for CPT code 73700 
(Computed tomography, lower extremity; without contrast material), a 
work RVU of 1.16 for CPT code 73701 (Computed tomography, lower 
extremity; with contrast material(s)), and a work RVU of 1.22 for CPT 
code 73702 (Computed tomography, lower extremity; without contrast 
material, followed by contrast material(s) and further sections).

[[Page 40589]]

    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(38) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
    CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090 
(Radiologic examination; forearm, 2 views) were identified on a screen 
of CMS/Other source codes with Medicare utilization greater than 
100,000 services annually. CPT code 73080 (Radiologic examination, 
elbow; complete, minimum of 3 views) was included for review as part of 
the same code family. All three CPT codes in this family were 
originally valued by the specialty societies using a crosswalk 
methodology approved by the RUC research committee. However, after we 
expressed concern about the use of this approach for valuing work and 
PE, the specialty society agreed to survey the codes and the RUC 
reviewed them again at the meeting in January 2019. We are proposing 
the RUC-recommended work RVU for all three codes in this family as 
follows: CPT code 73070 (work RVU = 0. 16); CPT code 73080 (work RVU = 
0.17); and CPT code 73090 (work RVU = 0.16).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(39) X-Ray Heel (CPT Code 73650)
    CPT code 73650 (Radiologic examination; calcaneous, minimum of 2 
views) was identified on a screen of CMS/Other source codes with 
Medicare utilization greater than 100,000 services annually. CPT code 
73650 was originally valued by the specialty societies using a 
crosswalk methodology approved by the RUC Research Subcommittee. 
However, after we expressed concern about the use of this approach for 
valuing work and PE, the specialty society agreed to survey the code 
and the RUC reviewed it again in January 2019. For CPT code 73650, we 
are proposing the RUC-recommended work RVU of 0.16. We are also 
proposing the RUC-recommended direct PE inputs for CPT code 73650.
(40) X-Ray Toe (CPT Code 73660)
    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) 
was identified on a screen of CMS/Other source codes with Medicare 
utilization greater than 100,000 services annually. CPT code 73660 was 
originally valued by the specialty societies using a crosswalk 
methodology approved by the RUC Research Subcommittee. However, after 
we expressed concern about the use of this approach for valuing work 
and PE, the specialty society agreed to survey the code and the RUC 
reviewed it again in January 2019. We are proposing the RUC-recommended 
work RVU for this code of 0.13 for CPT code 73660. We are also 
proposing the RUC-recommended direct PE inputs for CPT code 73660.
(41) Upper Gastrointestinal Tract Imaging (CPT Codes 74210, 74220, 
74230, 74X00, 74240, 74246, and 74X01)
    These services were identified through a list of list of CMS/Other 
codes with Medicare utilization of 30,000 or more. The CPT Editorial 
Panel subsequently revised this code set in order to conform to other 
families of radiologic examinations.
    We are proposing the RUC-recommended work RVUs of 0.59 for CPT code 
74210 (Radiologic examination, pharynx and/or cervical esophagus, 
including scout neck radiograph(s) and delayed image(s), when 
performed, contrast (e.g., barium) study), 0.60 for CPT code 74220 
(Radiologic examination, esophagus, including scout chest radiograph(s) 
and delayed image(s), when performed; single-contrast (e.g., barium) 
study), 0.70 for CPT code 74X00 (Radiologic examination, esophagus, 
including scout chest radiograph(s) and delayed image(s), when 
performed; double-contrast (e.g., high-density barium and effervescent 
agent) study), 0.53 for CPT code 74230 (Radiologic examination, 
swallowing function, with cineradiography/videoradiography, including 
scout neck radiograph(s) and delayed image(s), when performed, contrast 
(e.g., barium) study), 0.80 for CPT code 74240 (Radiologic examination, 
upper gastrointestinal tract, including scout abdominal radiograph(s) 
and delayed image(s), when performed; single-contrast (e.g., barium) 
study) 0.90 for CPT code 74246 (Radiologic examination, upper 
gastrointestinal tract, including scout abdominal radiograph(s) and 
delayed image(s), when performed; double-contrast (e.g., high-density 
barium and effervescent agent) study, including glucagon, when 
administered), and 0.70 for CPT code 74X01 (Radiologic examination, 
upper gastrointestinal tract, including scout abdominal radiograph(s) 
and delayed image(s), when performed; with small intestine follow-
through study, including multiple serial images (List separately in 
addition to code for primary procedure)). We are also proposing the 
reaffirmed work RVU of 0.59 for CPT code 74210 (Radiologic examination, 
pharynx and/or cervical esophagus, including scout neck radiograph(s) 
and delayed image(s), when performed, contrast (e.g., barium) study) 
and the reaffirmed work RVU of 0.53 for CPT code 74230 (Radiologic 
examination, swallowing function, with cineradiography/
videoradiography, including scout neck radiograph(s) and delayed 
image(s), when performed, contrast (e.g., barium) study).
    For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we note that no 
rationale was given for the RUC-recommended times for these codes, and 
we are requesting comment on the appropriateness of the RUC-recommended 
clinical labor times for this activity of 13 minutes, 13 minutes, 15 
minutes, 15 minutes, 19 minutes, 22 minutes, and 15 minutes for CPT 
codes 74210, 74220, 74X00, 74230, 74240, and 74246, respectively. In 
addition, for CPT code 74230, we are proposing to refine the clinical 
labor times for the ``Prepare room, equipment and supplies'' (CA013) 
and ``Prepare, set-up and start IV, initial positioning and monitoring 
of patient'' (CA016) activity codes to the standard values of 2 minutes 
each, as well as to refine the equipment times to reflect these changes 
in clinical labor.
(42) Lower Gastrointestinal Tract Imaging (CPT Codes 74250, 74251, 
74270, and 74280)
    These services were identified through a list CMS/Other codes with 
Medicare utilization of 30,000 or more. We are proposing the RUC-
recommended work RVUs of 0.81 for CPT code 74250 (Radiologic 
examination, small intestine, including multiple serial images and 
scout abdominal radiograph(s), when performed; single-contrast (e.g., 
barium) study), 1.17 for CPT code 74251 (Radiologic examination, small 
intestine, including multiple serial images and scout abdominal 
radiograph(s), when performed; double-contrast (e.g., high-density 
barium and air via enteroclysis tube) study, including glucagon, when 
administered), 1.04 for 74270 (Radiologic examination, colon, including 
scout abdominal radiograph(s) and delayed image(s), when performed; 
single-contrast (e.g., barium) study), and 1.26 for CPT code 74280 
(Radiologic examination, colon, including scout abdominal radiograph(s) 
and delayed image(s), when performed; double-contrast (e.g., high 
density barium and air) study, including glucagon, when administered).

[[Page 40590]]

    For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we note that no 
rationale was given for the recommended times for these codes, and we 
are requesting comment on the appropriateness of the RUC-recommended 
clinical labor times for this activity of 19 minutes, 30 minutes, 25 
minutes, and 36 minutes for CPT codes 74250, 74251, 74270, and 74280, 
respectively. In addition, we are proposing to refine the equipment 
time for the room, radiographic-fluoroscopic (EL014) for CPT code 74250 
to conform to our established standard for highly technical equipment 
and to match the rest of the codes in the family.
(43) Urography (CPT Code 74425)
    The physician time and work described by CPT code 74425 (Urography, 
antegrade (pyelostogram, nephrostogram, loopogram), radiological 
supervision and interpretation) was combined with services describing 
genitourinary catheter procedures in CY 2016, resulting in CPT codes 
50431 (Injection procedure for antegrade nephrostogram and/or 
ureterogram, complete diagnostic procedure including imaging guidance 
(e.g., ultrasound and fluoroscopy) and all associated radiological 
supervision and interpretation; existing access) and 50432 (Placement 
of nephrostomy catheter, percutaneous, including diagnostic 
nephrostogram and/or ureterogram when performed, imaging guidance 
(e.g., ultrasound and/or fluoroscopy) and all associated radiological 
supervision and interpretation). CPT code 74425 was not deleted at the 
time, but the RUC agreed with the specialty societies that 2 years of 
Medicare claims data should be available for analysis before the code 
was resurveyed for valuation to allow for any changes in the 
characteristics and process involved in furnishing the service 
separately from the genitourinary catheter procedures. The specialty 
society surveyed CPT code 74425 and reviewed the results with the RUC 
in October 2018.
    The results of the specialty society surveys indicated a large 
increase in the amount of time required to furnish the service and, 
correspondingly, to the work RVU. The total time for CPT code 74425 
based on the survey results was 34 minutes, an increase of 25 minutes 
over the current total time of 9 minutes. In reviewing the survey 
results, the RUC revised the total time for this CPT code to 24 
minutes, with a recommended work RVU of 0.51. The reason for the large 
increase in time according to the RUC, is a change in the typical 
patient profile in which the typical patient is one with an ileal 
conduit through which nephrostomy tubes have been placed for post-
operative obstruction. Based on the described change in patient 
population and increased time required to furnish the service, we are 
proposing the RUC-recommended work RVU of 0.51 for CPT code 74425.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
74425.
(44) Abdominal Aortography (CPT Codes 75625 and 75630)
    In October 2017, the RAW requested that AMA staff compile a list of 
CMS/Other codes with Medicare utilization of 30,000 or more. In January 
2018, the RUC recommended to survey these services for the October 2018 
RUC meeting. Subsequently, the specialty society surveyed these codes.
    We disagree with the RUC-recommended work RVU of 1.75 for CPT code 
75625 (Aortography, abdominal, by serialography, radiological 
supervision and interpretation). In reviewing CPT code 75625, we note 
that the key reference service, CPT Code 75710 (Angiography, extremity, 
unilateral, radiological supervision and interpretation), has 10 
additional minutes of intraservice time, 10 additional minutes of total 
time and the same work RVU, which would indicate the RUC-recommended 
work RVU of 1.75 appears to be overvalued. When we compared the 
intraservice time ratio between the RUC-recommended time of 30 minutes 
and the reference code intraservice time of 40 minutes we found a ratio 
of 25 percent. 25 percent of the reference code work RVU of 1.75 equals 
a work RVU of 1.31. When we compared the total service time ratio 
between the RUC-recommended time of 60 minutes and the reference code 
total service time of 70 minutes we found a ratio of 14 percent. 14 
percent of the reference code work RVU of 1.75 equals a work RVU of 
1.51. Therefore, we believe an accurate value would lie between 1.31 
and 1.52 RVUs. In looking for a comparative code, we have identified 
CPT code 38222. CPT Code 38222 is a recently reviewed CPT code with the 
identical intraservice and total times. As a result, we believe that it 
is more accurate to propose a work RVU of 1.44 based on a crosswalk to 
CPT code 38222.
    In case of CPT code 75630 (Aortography, abdominal plus bilateral 
iliofemoral lower extremity, catheter, by serialography, radiological 
supervision and interpretation), we are proposing the RUC-recommended 
value of 2.00 RVUs.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(45) Angiography (CPT Codes 75726 and 75774)
    We are proposing the RUC-recommend work RVU for both codes in this 
family. We are proposing a work RVU of 2.05 for CPT code 75726 
(Angiography, visceral, selective or supraselective (with or without 
flush aortogram), radiological supervision and interpretation), a work 
RVU of 1.01 for CPT code 75774 (Angiography, selective, each additional 
vessel studied after basic examination, radiological supervision and 
interpretation (List separately in addition to code for primary 
procedure).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(46) X-Ray Exam Specimen (CPT Code 76098)
    CPT code 70098 was reviewed by the RUC based on a request from the 
American College of Radiology (ACR) to determine whether CPT code 76098 
was undervalued because of the assumption that the service is typically 
furnished concurrently with a placement of localization device service 
(CPT codes 19281 through 19288 each representing a different imaging 
modality). In a letter to the RUC, ACR expressed concern about the 
appropriateness of a codes valuation process in which physician time 
and intensity for a code are reduced to account for overlap with codes 
that are furnished to a patient on the same day. During the April 2018 
RUC meeting, the specialty societies requested a work RVU of 0.40 for 
CPT code 76098, with intraservice time of 5 minutes and total time of 
15 minutes. Currently, this service has a work RVU of 0.16, with 5 
minutes of total time and no available intraservice time. In April 
2018, the RUC and the specialty society agreed that additional analysis 
of the data was warranted in consideration of the relatively large 
change in survey time and work RVU for this service. The RUC agreed to 
review the CPT code (CPT code 76098) again in October 2018.
    The RUC recommended a work RVU, based on the October 2018 meeting, 
of 0.31 for CPT code 76098, which represents an increase over the 
current value (0.16) but a decrease relative to the specialty society's 
original request of 0.40. The intraservice time for this CPT code is 5 
minutes, and the total time is 11 minutes. Based on the parameters we

[[Page 40591]]

typically use to review and evaluate RUC recommendations, which rely 
heavily on survey data, we agree that a work RVU of 0.31 for a CPT code 
with 5 minutes intraservice and 11 minutes total time is consistent 
with other CPT codes with similar times and levels of intensity. We are 
proposing the RUC-recommended work RVU for CPT code 76098 of 0.31.
    We share the ACR's interest in establishing or clarifying 
parameters that indicate when CPT codes that are furnished concurrently 
by the same provider should be valued to account for the overlap in 
physician work time and intensity, and even PE. We are broadly 
interested in stakeholder feedback and suggestions about what those 
parameters might be and whether or how they should affect code 
valuation.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
76098.
(47) 3D Rendering (CPT Code 76376)
    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) was identified as potentially misvalued on a screen of 
codes with a negative intraservice work per unit of time (IWPUT), with 
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes 
and over 1,000 for Harvard valued and CMS/Other source codes. It was 
surveyed and reviewed at the April 2018 RUC meeting.
    We are proposing the RUC-recommended work RVU of 0.20 for CPT code 
76376. We are also proposing the RUC-recommended direct PE inputs for 
CPT code 76376.
(48) Ultrasound Exam--Chest (CPT Code 76604)
    CPT code 76604 (Ultrasound, chest (includes mediastinum), real time 
with image documentation) was identified as potentially misvalued on a 
screen of CMS/Other codes with Medicare utilization of 30,000 or more. 
It was surveyed and reviewed for the April 2018 RUC meeting.
    We are proposing the RUC-recommended work RVU of 0.59 for CPT code 
76604. We are also proposing the RUC-recommended direct PE inputs for 
CPT code 76604.
(49) X-Ray Exam--Bone (CPT Codes 77073, 77074, 77075, 77076, and 77077)
    CPT codes 77073 (Bone length studies (orthoroentgenogram, 
scanogram)), 77075 (Radiologic examination, osseous survey; complete 
(axial and appendicular skeleton)), and 77077 (Joint survey, single 
view, 2 or more joints) were identified as potentially misvalued on a 
screen of CMS/Other codes with Medicare utilization of 30,000 or more. 
CPT codes 77074 (Radiologic examination, osseous survey; limited (e.g., 
for metastases)) and 77076 (Radiologic examination, osseous survey, 
infant) were reviewed as part of the same family.
    We are proposing the RUC-recommended work RVUs for all five CPT 
codes in this family as follows: CPT code 77073 (work RVU = 0.26); CPT 
code 77074 (work RVU = 0.44); CPT code 77075 (work RVU = 0.55); CPT 
code 77076 (work RVU = 0.70); and CPT code 77077 (work RVU = 0.33).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(50) SPECT-CT Procedures (CPT Codes 78800, 78801, 78802, 78803, 78804, 
788X0, 788X1, 788X2, and 788X3)
    The CPT Editorial Panel revised five codes, created four new codes 
and deleted nine codes to better differentiate between planar 
radiopharmaceutical localization procedures and SPECT, SPECT-CT and 
multiple area or multiple day radiopharmaceutical localization/
distribution procedures.
    For CPT code 78800 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar 
limited single area (e.g., head, neck, chest pelvis), single day of 
imaging), we disagree with the RUC recommendation to assign a work RVU 
of 0.70 based on the survey 25th percentile to this code, because we 
believe that it is inconsistent with the RUC-recommended reduction in 
physician time. We are proposing a work RVU of 0.64 based on the 
following total time ratio: The RUC-recommended 27 minutes divided by 
the current 28 minutes multiplied by the current work RVU of 0.66, 
which results in a work RVU of 0.64. We note that this value is 
bracketed by the work RVUs of CPT code 93287 (Peri-procedural device 
evaluation (in person) and programming of device system parameters 
before or after a surgery, procedure, or test with analysis, review and 
report by a physician or other qualified health care professional; 
single, dual, or multiple lead implantable defibrillator system), with 
a work RVU of 0.45, and CPT code 94617 (Exercise test for bronchospasm, 
including pre- and post-spirometry, electrocardiographic recording(s), 
and pulse oximetry), with a work RVU of 0.70. Both of these supporting 
crosswalks have intraservice time values of 10 minutes, and they have 
similar total time values.
    For CPT code 78801 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
2 or more areas (e.g., abdomen and pelvis, head and chest), 1 or more 
days of imaging or single area imaging over 2 or more days), we 
disagree with the RUC recommendation to maintain the current work RVU 
of 0.79 despite a 22-minute reduction in intraservice time. We believe 
a reduction from the current value is warranted given the recommended 
reduction in physician time, and also to be consistent with other 
services of similar time values. We are proposing a work RVU of 0.73 
based on the RUC-recommended incremental relationship between this code 
and CPT code 78800 (a difference of 0.09 RVU), which we apply to our 
proposed value for the latter code. As support for our proposed work 
RVU of 0.73, we note that it falls between the work RVUs of CPT code 
94617 (Exercise test for bronchospasm, including pre- and post-
spirometry, electrocardiographic recording(s), and pulse oximetry) with 
a work RVU of 0.70, and CPT code 93280 (Programming device evaluation 
(in person) with iterative adjustment of the implantable device to test 
the function of the device and select optimal permanent programmed 
values with analysis, review and report by a physician or other 
qualified health care professional; dual lead pacemaker system) with a 
work RVU of 0.77.
    For CPT code 78802 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
whole body, single day of imaging), we disagree with the RUC 
recommendation to maintain the current work RVU of 0.86, as we believe 
that it is inconsistent with a reduction in time values, and because we 
do not agree that a work RVU that is among the highest of other 
services of similar intraservice time values is appropriate. We are 
proposing a work RVU of 0.80 based on the RUC-recommended incremental

[[Page 40592]]

relationship between this code and CPT code 78800 (a difference of 0.16 
RVU), which we apply to our proposed value for the latter code. As 
support for our proposed work RVU of 0.80, we note that it falls 
between the work RVUs of CPT code 92520 (Laryngeal function studies 
(i.e., aerodynamic testing and acoustic testing)) with a work RVU of 
0.75, and CPT code 93282 (Programming device evaluation (in person) 
with iterative adjustment of the implantable device to test the 
function of the device and select optimal permanent programmed values 
with analysis, review and report by a physician or other qualified 
health care professional; single lead transvenous implantable 
defibrillator system) with a work RVU of 0.85.
    For CPT code 78804 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
whole body, requiring 2 or more days of imaging), we disagree with the 
RUC recommendation to maintain the current work RVU of 1.07, as we 
believe that it is inconsistent with a reduction in time values, and 
because this work RVU appears to be valued highly relative to other 
services of similar time values. We are proposing a work RVU of 1.01 
based on the RUC-recommended incremental relationship between this code 
and CPT code 78800 (a difference of 0.37 RVU), which we apply to our 
proposed value for the latter code. As support for our proposed work 
RVU of 1.01, we reference CPT code 91111 (Gastrointestinal tract 
imaging, intraluminal (e.g., capsule endoscopy), esophagus with 
interpretation and report), which has a work RVU of 1.00 and similar 
physician time values.
    For CPT code 78803 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT), single area (e.g., head, neck, chest pelvis), 
single day of imaging), we disagree with the RUC recommendation to 
increase the work RVU to 1.20 based on the survey 25th percentile to 
this code, because we believe that it is inconsistent with the RUC-
recommended reduction in physician time. We are proposing to maintain 
the current work RVU of 1.09. We support this value with a reference to 
CPT code 78266 (Gastric emptying imaging study (e.g., solid, liquid, or 
both); with small bowel and colon transit, multiple days), which has a 
work RVU of 1.08, and similar time values.
    For CPT code 788X0 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT) with concurrently acquired computed tomography (CT) 
transmission scan for anatomical review, localization and 
determination/detection of pathology, single area (e.g., head, neck, 
chest or pelvis), single day of imaging), we disagree with the RUC 
recommendation to assign a work RVU of 1.60 based on the survey 25th 
percentile to this code, as this would value this code more highly than 
services of similar time values. To maintain relativity among services 
in this family, we are proposing a work RVU of 1.49 for CPT code 788X0 
based on the RUC-recommended incremental relationship between CPT code 
788X0 and CPT code 78803 (a difference of 1.09 RVU), which we apply to 
our proposed value for the latter code. As support for our proposed 
work RVU of 1.49, we note that it is bracketed by the work RVUs of CPT 
codes 72195 (Magnetic resonance (e.g., proton) imaging, pelvis; without 
contrast material(s)) with a work RVU of 1.46, and 95861 (Needle 
electromyography; 2 extremities with or without related paraspinal 
areas) with a work RVU of 1.54. The physician time values of these 
services bracket those recommended for CPT code 778X0.
    For CPT code 788X1 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT), minimum 2 areas (e.g., pelvis and knees, abdomen 
and pelvis), single day of imaging, or single area of imaging over 2 or 
more days), we disagree with the RUC recommendation to assign a work 
RVU of 1.93 based on the survey 50th percentile to this code, as this 
would value this code more highly than services of similar time values. 
To maintain relativity among services in this family, we are proposing 
a work RVU of 1.82 based on the RUC-recommended incremental 
relationship between this code and CPT code 78803 (a difference of 0.73 
RVU), which we apply to our proposed value for the latter code. As 
support for our proposed work RVU of 1.82, we note that it is bracketed 
by the work RVUs of the CPT codes which are members of the same code 
families referenced for the previous CPT code, 788X0: CPT codes 72191 
(Computed tomographic angiography, pelvis, with contrast material(s), 
including noncontrast images, if performed, and image postprocessing) 
with a work RVU of 1.81, and 95863 (Needle electromyography; 3 
extremities with or without related paraspinal areas) with a work RVU 
of 1.87. The physician time values of these services bracket those 
recommended for CPT code 778X1.
    For CPT code 788X2 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT) with concurrently acquired computed tomography (CT) 
transmission scan for anatomical review, localization and 
determination/detection of pathology, minimum 2 areas (e.g., pelvis and 
knees, abdomen and pelvis), single day of imaging, or single area of 
imaging over 2 or more days imaging), we disagree with the RUC 
recommendation to assign a work RVU of 2.23 based on the survey 50th 
percentile to this code, as this would value this code more highly than 
services of similar time values. To maintain relativity among services 
in this family, we are proposing a work RVU of 2.12 based on the RUC-
recommended incremental relationship between this code and CPT code 
78803 (a difference of 1.03 RVU), which we apply to our proposed value 
for the latter code. As support for our proposed work RVU of 2.12, we 
reference CPT code 70554 (Magnetic resonance imaging, brain, functional 
MRI; including test selection and administration of repetitive body 
part movement and/or visual stimulation, not requiring physician or 
psychologist administration), which has a work RVU of 2.11 and 
physician intraservice and total time values that are identical to 
those recommended for this service.
    For CPT code 788X3 (Radiopharmaceutical quantification 
measurement(s) single area), we disagree with the RUC recommendation to 
assign a work RVU of 0.51 based on the survey 25th percentile to this 
code, because we wish to maintain relativity and proportionality among 
codes of this family. We based our values for the other codes in this 
family on their relative relationship to either CPT code 78800 or 
788X2, depending on the type of service described by the code. For CPT 
code 788X0, which describes a single day of imaging and is thus 
analagous to CPT code 788X3 in terms of units of service, our analysis 
indicates a reduction from the RUC value of approximately 7 percent is 
appropriate. Therefore, we apply a

[[Page 40593]]

similar reduction of 7 percent to the RUC-recommended work RVU of 0.51 
to arrive at an RVU of 0.47. We support this value by noting that it is 
bracketed by add-on CPT codes 77001 (Fluoroscopic guidance for central 
venous access device placement, replacement (catheter only or 
complete), or removal (includes fluoroscopic guidance for vascular 
access and catheter manipulation, any necessary contrast injections 
through access site or catheter with related venography radiologic 
supervision and interpretation, and radiographic documentation of final 
catheter position) (List separately in addition to code for primary 
procedure)) with a work RVU of 0.38, and 77002 (Fluoroscopic guidance 
for needle placement (e.g., biopsy, aspiration, injection, localization 
device) (List separately in addition to code for primary procedure)), 
with a work RVU of 0.54. Both of these reference CPT codes have 
intraservice time values that are similar to, and total time values 
that are identical to, those recommended for CPT code 788X3.
    For the direct PE inputs, we are refining the number of minutes of 
clinical labor allocated to the activity ``Prepare, set-up and start 
IV, initial positioning and monitoring of patient'' to the 2-minute 
standard for CPT codes 78800, 78801, 78802, 78804, 78803, 788X0, 788X1, 
and 788X2, as no rationale was provided for these codes to have times 
above the standard for this activity. We are also refining the 
equipment time formulas to reflect this clinical labor refinement for 
these codes. For CPT codes 78800, 78801, 78802, 78804, 78803, 788X0, 
788X1, and 788X2, we are proposing to refine the equipment times to 
match our standard equipment time formula for the professional PACS 
workstation. For the supply item SM022 ``sanitizing cloth-wipe 
(surface, instruments, equipment),'' we are refining these supplies to 
quantities of 5 each for CPT codes 78801, 78804, and 788X2 to conform 
with other codes in the family.
(51) Myocardial PET (CPT Codes 78459, 78X29, 78491, 78X31, 78492, 
78X32, 78X33, 78X34, and 78X35)
    CPT code 78492 was identified via the High Volume Growth screen 
with total Medicare utilization over 10,000 that increased by at least 
100 percent from 2009 through 2014. The CPT Editorial Panel revised 
this code set to reflect newer technology aspects such as wall motion, 
ejection fraction, flow reserve, and technology updates for hardware 
and software. The CPT Editorial Panel deleted a Category III code, 
added six Category I codes, and revised the three existing codes to 
separately identify component services included for myocardial imaging 
using positron emission tomography.
    For CPT code 78491 (Myocardial imaging, positron emission 
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or 
stress (exercise or pharmacologic)), we disagree with the RUC-
recommended work RVU of 1.56, which is the survey 25th percentile 
value, as we believe that the 30-minute reduction in intraservice time 
and 15-minute reduction in physician total time does not validate an 
increase in work RVU, and we believe that the significance of the 
reductions in recommended physician time values warrants a reduction in 
work RVU. We are proposing a work RVU of 1.00 based on the following 
total time ratio: The recommended 30 minutes divided by the current 45 
minutes multiplied by the current work RVU of 1.50, which results in a 
work RVU of 1.00. As further support for this value, we note that it 
falls between CPT code 78278 (Acute gastrointestinal blood loss 
imaging), with a work RVU of 0.99, and CPT code 10021 (Fine needle 
aspiration biopsy, without imaging guidance; first lesion), with a work 
RVU of 1.03.
    For CPT code 78X31 (Myocardial imaging, positron emission 
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or 
stress (exercise or pharmacologic), with concurrently acquired computed 
tomography transmission scan), we disagree with the RUC recommendation 
of 1.67 based on the survey 25th percentile, as we do not agree this 
service would be appropriately valued with an RVU that is among the 
highest of all services of similar times with this global period. We 
are proposing a work RVU of 1.11 by applying the RUC-recommended 
increment between CPT code 78491 and this code, an increment of 0.11, 
to our proposed value of 1.00 for CPT code 78491, thus maintaining the 
RUC's recommended incremental relationship between these codes. As 
further support for this value, we note that it falls between CPT codes 
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)), with a work 
RVU of 0.97, and CPT code 93284 (Programming device evaluation (in 
person) with iterative adjustment of the implantable device to test the 
function of the device and select optimal permanent programmed values 
with analysis, review and report by a physician or other qualified 
health care professional; multiple lead transvenous implantable 
defibrillator system), with a work RVU of 1.25; both of these codes 
have similar physician time values.
    For CPT code 78459 (Myocardial imaging, positron emission 
tomography (PET), metabolic evaluation study (including ventricular 
wall motion(s), and/or ejection fraction(s), when performed) single 
study), we disagree with the RUC recommendation to increase the work 
RVU to 1.61 based on the survey 25th percentile. We believe that the 
magnitude of the recommended reductions in physician time (a 50-minute 
reduction in intraservice time and a 32-minute reduction in total time) 
suggests that this value is overestimated; furthermore, we note that 
the RUC's recommendation is among the highest for all XXX-global period 
codes with similar time values. We are proposing a work RVU of 1.05 by 
applying the RUC-recommended increment between this code and CPT code 
78491, a difference of 0.05, which we apply to our proposed value for 
the latter code. We support our RVU of 1.05 by referencing two CPT 
codes: 10021 (Fine needle aspiration biopsy, without imaging guidance; 
first lesion), and 36440 (Push transfusion, blood, 2 years or younger), 
both of which have work RVUs of 1.03, as well as identical intraservice 
and similar total time values.
    We disagree with the RUC's recommended valuation of 1.76 for CPT 
code 78X29 (Myocardial imaging, positron emission tomography (PET), 
metabolic evaluation study (including ventricular wall motion(s), and/
or ejection fraction(s), when performed) single study; with 
concurrently acquired computed tomography transmission scan), which is 
based on the survey 25th percentile, because we believe a work RVU that 
is greater than those of all other services of similar intraservice 
time values is not appropriate. We are proposing a work RVU of 1.20 for 
CPT code 78X29. We are proposing to value CPT code 78X29 with an 
incremental methodology, which preserves the RUC-recommended 
relationship among the codes in this family; the RUC

[[Page 40594]]

recommends an increment of 0.20 between CPT code 78X29 and CPT code 
78491. We are proposing to apply this increment to our proposed value 
of 1.00 for CPT code 78491 to arrive at our value of 1.20.
    We disagree with the RUC's recommendation of 1.80 for CPT code 
78492 (Myocardial imaging, positron emission tomography, perfusion 
study (including ventricular wall motion(s), and/or ejection 
fractions(s), when performed); multiple studies at rest and stress 
(exercise or pharmacologic)) given the magnitude of the recommended 
reduction in physician time values (a 35-minute reduction in 
intraservice time and a 17-minute reduction in total time), and also 
given the fact that the RUC's recommended value would be the highest of 
all codes of this intraservice time and global period. We are proposing 
a work RVU of 1.24 based on the RUC-recommended incremental difference 
between 78491 and 78492 of 0.24, which we add to our proposed value for 
78491 for a work RVU of 1.24. As further support for this value, we 
reference CPT code 95908 (Nerve conduction studies; 3-4 studies), with 
a work RVU of 1.25, similar physician time values.
    We disagree with the RUC's recommendation of 1.90 for CPT code 
78X32 (Myocardial imaging, positron emission tomography, perfusion 
study (including ventricular wall motion(s), and/or ejection 
fractions(s), when performed); multiple studies at rest and stress 
(exercise or pharmacologic), with concurrently acquired computed 
tomography transmission scan) which is based on a crosswalk to CPT code 
64617 (Chemodenervation of muscle(s); larynx, unilateral, percutaneous 
(e.g., for spasmodic dysphonia), includes guidance by needle 
electromyography, when performed), because the fact that this work RVU 
that is greater than those of all other services of similar 
intraservice time values suggests that it is an overestimate. Instead 
we are proposing a work RVU of 1.34 for CPT code 78X32, based on an 
incremental methodology. We apply the RUC-recommended increment between 
78491 and CPT code 78X32, a difference of 0.34, to our proposed value 
of 1.00 for CPT code 78491, for a value of 1.34. We support this value 
by referencing CPT code 77261 (Therapeutic radiology treatment 
planning; simple), with a work RVU of 1.30, and CPT code 94003 
(Ventilation assist and management, initiation of pressure or volume 
preset ventilators for assisted or controlled breathing; hospital 
inpatient/observation, each subsequent day), with a work RVU of 1.37. 
These codes have similar physician time values.
    We disagree with the RUC's recommendation of 2.07 for CPT code 
78X33 (Myocardial imaging, positron emission tomography, combined 
perfusion with metabolic evaluation study (including ventricular wall 
motion(s), and/or ejection fraction(s), when performed), dual 
radiotracer (e.g., myocardial viability)), because we believe the fact 
that this work RVU is greater than those of all other services of 
similar intraservice time values suggests that it is an overestimate. 
We are proposing a work RVU of 1.51 for CPT code 78X33, based on an 
incremental methodology. We apply the RUC-recommended increment between 
78491 and CPT code 78X33, a difference of 0.51, to our proposed value 
of 1.00 for CPT code 78491, for a value of 1.51. We support this value 
by referencing CPT code 10005 (Fine needle aspiration biopsy, including 
ultrasound guidance; first lesion), with a work RVU of 1.46, and 
similar physician time values.
    Similarly for CPT code 78X34 (Myocardial imaging, positron emission 
tomography, combined perfusion with metabolic evaluation study 
(including ventricular wall motion(s), and/or ejection fraction(s), 
when performed), dual radiotracer (e.g., myocardial viability); with 
concurrently acquired computed tomography transmission scan), we 
disagree with the RUC's recommendation of 2.26 based on a crosswalk to 
CPT code 71552 (Magnetic resonance (e.g., proton) imaging, chest (e.g., 
for evaluation of hilar and mediastinal lymphadenopathy); without 
contrast material(s), followed by contrast material(s) and further 
sequences), because we believe the fact that this work RVU is among the 
highest among services of similar intraservice time values suggests 
that it is an overestimate. We are proposing a work RVU of 1.70 by 
applying the RUC-recommended increment between CPT code 78X34 and CPT 
code 78491, which is a difference of 0.70, to our proposed value for 
CPT code 78491 for a value of 1.70. We support this value by 
referencing CPT codes 95924 (Testing of autonomic nervous system 
function; combined parasympathetic and sympathetic adrenergic function 
testing with at least 5 minutes of passive tilt) and 74182 (Magnetic 
resonance (e.g., proton) imaging, abdomen; with contrast material(s)), 
both of which have work RVUs of 1.73.
    For CPT code 78X35 (Absolute quantitation of myocardial blood flow 
(AQMBF), positron emission tomography, rest and pharmacologic stress 
(List separately in addition to code for primary procedure)), we 
disagree with the RUC recommendation to assign a work RVU of 0.63 to 
this code based on the survey 25th percentile, because we believe a 
comparison to other codes with a global period of ZZZ suggests that 
this is somewhat overvalued, and because we wish to maintain relativity 
and proportionality to other codes in this series. We based our values 
for the other codes in this family on their relative relationships to 
CPT code 78491; for that code our analysis indicates that a reduction 
from the RUC value of roughly \1/3\ is appropriate, based on a ratio of 
the decrease in total time to the current work RVU. Therefore, we apply 
a similar reduction of \1/3\ to the RUC-recommended work RVU of 0.63 to 
arrive at an RVU of approximately 0.42. Applying a reduction that is 
similar to the reduction we think is warranted from the RUC value for 
CPT code 78491 to CPT code 78X35 will maintain consistency in value 
among these services. We believe this work RVU is validated by noting 
that it is bracketed by CPT codes 15272 (Application of skin substitute 
graft to trunk, arms, legs, total wound surface area up to 100 sq cm; 
each additional 25 sq cm wound surface area, or part thereof (List 
separately in addition to code for primary procedure)), with a work RVU 
of 0.33, and 11105 (Punch biopsy of skin (including simple closure, 
when performed); each separate/additional lesion (List separately in 
addition to code for primary procedure)), with a work RVU of 0.45. A 
work RVU of 0.42 is thus consistent with ZZZ global period codes of 
similar physician times.
    For the direct PE inputs, for several of the equipment items, we 
are proposing to refine the equipment times to conform to our 
established policies for non-highly, as well as for highly technical 
equipment. In addition, we are proposing to refine the equipment times 
to conform to our established policies for PACS Workstation. For the 
new equipment items ER110: ``PET Refurbished Imaging Cardiac 
Configuration'' and ER111: ``PET/CT Imaging Camera Cardiac 
Configuration,'' we are proposing to assume that a 90 percent equipment 
utilization rate is typical, as this would be consistent with our 
equipment utilization assumptions for expensive diagnostic imaging 
equipment. For the supply item SM022 ``sanitizing cloth-wipe (surface, 
instruments, equipment),'' we are refining these supplies to quantities 
of 5 each for CPT codes 78X33 and 78X34 to conform with other codes in 
the family. We are proposing that we will

[[Page 40595]]

not price the ``Software and hardware package for Absolute 
Quantitation'' as a new equipment item, due to the fact that the 
submitted invoices included a service contract and a combined software/
hardware bundle with no breakdown on individual pricing. Based on our 
lack of specific pricing data, we believe that this software is more 
accurately characterized as an indirect PE input that is not 
individually allocable to a particular patient for a particular 
service.
(52) Cytopathology, Cervical-Vaginal (CPT Code 88141, HCPCS Codes 
G0124, G0141, and P3001)
    CPT code 88141 (Cytopathology, cervical or vaginal (any reporting 
system), requiring interpretation by physician), HCPCS code G0124 
(Screening cytopathology, cervical or vaginal (any reporting system), 
collected in preservative fluid, automated thin layer preparation, 
requiring interpretation by physician), HCPCS code G0141 (Screening 
cytopathology smears, cervical or vaginal, performed by automated 
system, with manual rescreening, requiring interpretation by 
physician), and HCPCS code P3001 (Screening Papanicolaou smear, 
cervical or vaginal, up to three smears, requiring interpretation by 
physician) were identified as potentially misvalued on a list of CMS or 
other source codes with Medicare utilization of 30,000 or more.
    In the CY 2000 PFS final rule (64 FR 59408), we finalized a policy 
that it was more appropriate to evaluate the work, PE, and MP RVUs for 
HCPCS codes P3001, G0124, and G0141 identical or comparable to the 
values of CPT code 88141.
    For CY 2020, the RUC recommended a work RVU of 0.42 for CPT code 
88141 and HCPCS codes G0124, G0141, and P3001, based on the current 
value. We disagree with the RUC-recommended work RVU and are proposing 
a work RVU of 0.26 for all four codes in this family, based on our time 
ratio methodology and a crosswalk to CPT code 93313 (Echocardiography, 
transesophageal, real-time with image documentation (2D) (with or 
without M-mode recording); placement of transesophageal probe only), 
which has an identical work RVU of 0.26, identical intraservice and 
total work times values to CPT code 88141 and HCPCS codes G0124, and 
G0141, and similar intraservice and total time values to HCPCS code 
P3001.
    In reviewing this family of codes, we note that the intraservice 
and total work times for CPT code 88141 and HCPCS codes G0124, and 
G0141 are decreasing from 16 minutes to 10 minutes (38 percent 
reduction) and the intraservice and total work times for HCPCS code 
P3001 are decreasing from 16 minutes to 12 minutes (25 percent 
reduction). However, the RUC recommended a work RVU of 0.42 for all 
four codes in this family, based on the maintaining the current work 
RVU. Although we do 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 88141 and HCPCS codes G0124, G0141, and P3001, we believe that it 
would be more accurate to propose a work RVU of 0.26, based on our time 
ratio methodology and a crosswalk to CPT code 93313 to account for 
these decreases in the surveyed work times.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Perform regulatory mandated quality assurance 
activity'' (CA033) activity from 7 minutes to 5 minutes for all four 
codes in the family. We believe that these quality assurance activities 
would not typically take 7 minutes to perform, given that similar 
federally mandated MQSA activities were recommended and finalized at a 
time of 4 minutes for CPT codes 77065-77067 in CY 2017 (81 FR 80314-
80316), and other related regulatory compliance activities were 
recommended and finalized at a time of 5 minutes for CPT codes 78012-
78014 in CY 2013 (77 FR 69037). To preserve relativity between 
services, we are proposing a clinical labor time of 5 minutes for the 
codes in this family based on this prior allocation of clinical labor 
time.
    We are also proposing to remove the 1-minute of clinical labor time 
for the ``File specimen, supplies, and other materials'' (PA008) 
activity from all four codes under the rationale that this task is a 
form of indirect PE. As we stated in the CY 2017 PFS final rule (81 FR 
80324), we agree that filing specimens is an important task, and we 
agree that these would take more than zero minutes to perform. However, 
we continue to believe that these activities are correctly categorized 
under indirect PE as administrative functions, and therefore, we do not 
recognize the filing of specimens as a direct PE input, and we do not 
consider this task as typically performed by clinical labor on a per-
service basis.
    We are proposing to refine the equipment time for the compound 
microscope (EP024) equipment to 10 minutes for all four codes in the 
family to match the work time of the procedures. The recommended 
materials for this code family state that the compound microscope is 
utilized by the pathologist, and therefore, we believe that the 10-
minute work time of the procedures would be the most accurate equipment 
time to propose.
(53) Biofeedback Training (CPT Codes 908XX and 909XX)
    CPT code 90911 (Biofeedback training, perineal muscles, anorectal 
or urethral sphincter, including EMG and/or manometry) was identified 
as potentially misvalued on a RAW screen of codes with a negative IWPUT 
and Medicare utilization over 10,000 for all services or over 1,000 for 
Harvard valued and CMS or other source codes. In September 2018, the 
CPT Editorial Panel replaced this code with two new codes to describe 
biofeedback training initial 15 minutes of one-on-one patient contact 
and each additional 15 minutes of biofeedback training.
    We are proposing the RUC-recommended work RVU of 0.90 for CPT code 
908XX (Biofeedback training, perineal muscles, anorectal or urethral 
sphincter, including EMG and/or manometry when performed; initial 15 
minutes of one-on-one patient contact), as well as the RUC-recommended 
work RVU of 0.50 for CPT code 909XX (Biofeedback training, perineal 
muscles, anorectal or urethral sphincter, including EMG and/or 
manometry when performed; each additional 15 minutes of one-on-one 
patient contact). For the direct PE inputs, we are proposing to refine 
the equipment time for the power table (EF031) equipment in CPT code 
908XX to conform to our established standard for non-highly technical 
equipment.
    We are also proposing to designate CPT codes 908XX and 909XX as 
``sometimes therapy'' procedures which means that an appropriate 
therapy modifier is always required when this service is furnished by 
therapists. For more information we direct readers to the Therapy Code 
List section of the CMS website at https://www.cms.gov/Medicare/Billing/TherapyServices/AnnualTherapyUpdate.html.
(54) Corneal Hysteresis Determination (CPT Code 92145)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
AMA/Specialty Society RVS Update Committee. The AMA RUC reviewed this 
service at the October 2018 RAW meeting, and indicated that the

[[Page 40596]]

utilization is continuing to increase for this service. This code was 
surveyed and reviewed for the January 2019 RUC meeting.
    We are proposing the work RVU of 0.10 as recommended by the RUC. We 
are also proposing the RUC-recommended direct PE inputs for CPT code 
92145 without refinement.
(55) Computerized Dynamic Posturography (CPT Codes 92548 and 92XX0)
    CPT code 92548 (Computerized dynamic posturography) was identified 
via the negative IWPUT screen. CPT revised one code and added another 
code to more accurately describe the current clinical work and 
equipment necessary to provide this service.
    We do not agree with the RUC's recommended work RVUs of 0.76 for 
CPT code 92548 (Computerized dynamic posturography sensory organization 
test (CDP-SOT), 6 conditions (i.e., eyes open, eyes closed, visual 
sway, platform sway, eyes closed platform sway, platform and visual 
sway), including interpretation and report), or 0.96 for CPT code 92XX0 
(Computerized dynamic posturography sensory organization test (CDP-
SOT), 6 conditions (i.e., eyes open, eyes closed, visual sway, platform 
sway, eyes closed platform sway, platform and visual sway), including 
interpretation and report; with motor control test (MCT) and adaptation 
test (ADT)). For CPT code 92548, we agree that an increase in work RVU 
is warranted; however, we believe the surveyed time values suggest an 
increase of a less significant magnitude than that recommended. We are 
proposing a work RVU of 0.67 based on the intraservice time ratio: we 
divide the RUC-recommended intraservice time value of 20 by the current 
value of 15 and multiply the product by the current work RVU of 0.50 
for a ratio of 0.67. As a supporting crosswalk, we note that our value 
is greater than the work RVU of 0.60 for CPT code 93316 
(Transesophageal echocardiography for congenital cardiac anomalies; 
placement of transesophageal probe only), which has identical 
intraservice and total times.
    We are proposing to maintain relativity between these two codes by 
valuing CPT code 92XX0 by applying the RUC-recommended incremental 
difference between the two codes, a difference of 0.20, to our proposed 
value of 0.66 for CPT code 93316; therefore, we are proposing a work 
RVU of 0.87 for CPT code 92XX0. As further support for this value, we 
note that it falls between the work RVUs of CPT codes 95972 (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 
spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator 
pulse generator/transmitter programming by physician or other qualified 
health care professional), with a work RVU of 0.80, and CPT code 38207 
(Transplant preparation of hematopoietic progenitor cells; 
cryopreservation and storage), with a work RVU of 0.89.
    We are proposing the RUC-recommended direct PE inputs for these 
codes without refinement.
(56) Auditory Function Evaluation (CPT Codes 92626 and 92627)
    CPT code 92626 (Evaluation of auditory function for surgically 
implanted device(s), candidacy or post-operative status of a surgically 
implanted device(s); first hour) appeared on the RAW 2016 high volume 
growth screen. In 2017, it was identified through a CMS request. CPT 
code 92627 (Evaluation of auditory function for surgically implanted 
device(s), candidacy or post-operative status of a surgically implanted 
device(s); each additional 15 minutes) the add-on code for CPT code for 
92626, also was included in the CMS request to review audiology 
services.
    For CY 2020, we are proposing the HCPAC-recommended work RVU of 
1.40 for CPT code 92626, which is identical to its current RVU. We are 
also proposing the HCPAC-recommended work RVU of 0.33 for the add-on 
code, CPT code 92627. We are proposing the RUC-recommended direct PE 
inputs for all codes in the family.
(57) Septostomy (CPT Codes 92992 and 92993)
    CPT codes 92992 (Atrial septectomy or septostomy; transvenous 
method, balloon (e.g., Rashkind type) (includes cardiac 
catheterization)) and 92993 (Atrial septectomy or septostomy; blade 
method (Park septostomy) (includes cardiac catheterization)) were 
nominated as potentially misvalued services. These services are 
typically performed on children, a non-Medicare population, and are 
currently contractor-priced. These codes were surveyed and reviewed for 
the January 2019 RUC meeting.
    We are proposing to maintain contractor pricing for CPT codes 92992 
and 92993, as recommended by the RUC. These codes will be referred to 
the CPT Editorial Panel for revision and potential deletion. We are 
also proposing a change from 90-day to 0-day global period status for 
these two procedures, also as recommended by the RUC.
(58) Opthalmoscopy (CPT Codes 92X18 and 92X19)
    CPT code 92225 was identified as potentially misvalued on a screen 
of codes with a negative IWPUT, with 2016 estimated Medicare 
utilization over 10,000 for RUC reviewed codes and over 1,000 for 
Harvard valued and CMS/Other source codes. In February 2018, the CPT 
Editorial Panel deleted CPT codes 92225 and 92226 and created two new 
codes to specify what portion of the eye is examined for a service 
beyond the normal comprehensive eye exam.
    We are proposing the RUC-recommended work RVUs of 0.40 for CPT code 
92X18 (Ophthalmoscopy, extended, with retinal drawing and scleral 
depression of peripheral retinal disease (e.g., for retinal tear, 
retinal detachment, retinal tumor) with interpretation and report, 
unilateral or bilateral) and 0.26 for CPT code 92X19 (Ophthalmoscopy, 
extended, with drawing of optic nerve or macula (e.g., for glaucoma, 
macular pathology, tumor) with interpretation and report, unilateral or 
bilateral).
    We are proposing the RUC-recommended direct PE inputs for this code 
family without refinement.
(59) Remote Interrogation Device Evaluation (CPT Codes 93297, 93298, 
93299, and HCPCS Code GTTT1)
    When the RUC previously reviewed the CPT code 93299 at the January 
2017 RUC meeting, the specialty society submitted PE inputs for CPT 
code 93299 (Interrogation device evaluation(s), (remote) up to 30 days; 
implantable cardiovascular physiologic monitor system or subcutaneous 
cardiac rhythm monitor system, remote data acquisitions(s), receipt of 
transmissions and technician review, technical support and distribution 
of results); the PE Subcommittee and RUC accepted the society 
recommendations. In the CY 2018 PFS final rule (82 FR 53064), we did 
not finalize our proposal to establish national pricing for CPT code 
93299 and the code remained contractor-priced.
    At the October 2018 RUC meeting, the RUC re-examined CPT code 
93299. CPT codes 93297 (Interrogation device evaluation(s), (remote) up 
to 30 days; implantable cardiovascular physiologic

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monitor system, including analysis of 1 or more recorded physiologic 
cardiovascular data elements from all internal and external sensors, 
analysis, review(s) and report(s) by a physician or other qualified 
health care professional) and 93298 (Interrogation device 
evaluation(s), remote up to 30 days; subcutaneous cardiac rhythm 
monitor system, including analysis or recorded heart rhythm data, 
analysis, review(s) and report(s) by a physician or other qualified 
health care professional) were added to this family of services. These 
three codes were reviewed for practice expense only.
    CPT codes 93297 and 93298 are work-only codes and CPT code 93299 is 
meant to serve as the catch-all for both 30-day remote monitoring 
services. The RUC is unclear why the code family was designed this way, 
noting it may have been a way to allow for the possibility that the 
technical work would be provided by vendors, but they noted that this 
is not how the service is currently provided. Stating that in the 
decade since these codes were created, it has become clear that 
implantable cardiovascular monitor (ICM) and implantable loop recorder 
(ILR) services are very different and the PE cannot be appropriately 
captured for both services in a single technical code. They noted that 
CPT codes 93297-93299 will be placed on the new technology/new services 
list and be re-reviewed by the RUC in 3 years to ensure correct 
calculation and utilization assumptions. It was noted in the RUC 
recommendations that the specialty society intended to submit a coding 
proposal to the CPT Editorial Panel to delete CPT code 93299, as it 
will no longer be necessary to have a separate code for PE if CPT codes 
93297 and 93298 are allocated direct PE in CY 2020.
    In our review of these services, we note that the RUC 
recommendations did not provide a detailed description of the clinical 
labor tasks being performed or detailed information on the typical use 
of the supply and equipment used when furnishing these services. These 
details are important in order for us to review if the RUC-recommended 
PE inputs are appropriate to furnish these services. The RUC submitted 
PE inputs (which were not previously included) for the work-only CPT 
codes 93297 and 93298, but did not include details to substantiate 
these recommended PE inputs for any of the three codes in this family.
    Additionally, we are concerned with the appropriateness of the 
RUC's reference code, CPT code 93296 (Interrogation device 
evaluation(s) (remote), up to 90 days; single, dual, or multiple lead 
pacemaker system, leadless pacemaker system, or implantable 
defibrillator system, remote data acquisition(s), receipt of 
transmissions and technician review, technical support and distribution 
of results). CPT code 93296 is for remote monitoring over a 90-day 
period, but was used as a reference to derive the RUC-recommended 
direct PE inputs for CPT codes 93297-93299, which are for remote 
monitoring over a 30-day period.
    For the CY 2020 direct PE inputs, we are proposing to remove the 
clinical labor time for ``Perform procedure/service--not directly 
related to physician work time'' (CA021); to remove the requested 
quantity for the supply ``Paper, laser printing (each sheet)'' (SK057); 
and to refine the equipment times in accordance with our standard 
equipment time formulas for CPT codes 93297 and 93298.
    Although we are not proposing to allocate direct PE inputs for CPT 
codes 93297 and 93298, we are seeking additional comment on the 
appropriateness of CPT code 93296 as the reference code, details on the 
clinical labor tasks, and more information on the typical use of the 
supply and equipment used to furnish these services. For example, it 
was unclear in the RUC recommendations how many patients are monitored 
concurrently. As an additional example, it was unclear in the RUC 
recommendations as to what tasks are involved when clinical staff 
engage with the patient throughout the month to perform education about 
the device and re-education protocols after the initial enrollment.
    The CPT Editorial Panel is deleting CPT code 93299 for CY 2020. We 
note this differs from the RUC recommendations for this code from the 
October 2018 meeting, which stated that the specialty society intended 
to submit a coding proposal to the CPT Editorial Panel to delete CPT 
code 93299, as it would no longer be necessary to have a separate code 
for PE, if CPT codes 93297 and 93298 are allocated direct PE for CY 
2020. Given that we are proposing to not allocate direct PE inputs for 
CPT code 93297 and 93298 for CY 2020 and CPT code 93299 is being 
deleted for CY 2020, we are proposing to create a G-code to describe 
the services previously furnished under CPT code 93299. We are 
proposing to create HCPCS code GTTT1 (Interrogation device 
evaluation(s), (remote) up to 30 days; implantable cardiovascular 
physiologic monitor system, implantable loop recorder system, or 
subcutaneous cardiac rhythm monitor system, remote data acquisition(s), 
receipt of transmissions and technician review, technical support and 
distribution of results), to describe the services previously furnished 
under CPT code 93299, effective for CY 2020.
(60) Duplex Scan Arterial Inflow-Venous Outflow (CPT Codes 93X00 and 
93X01)
    In September 2018, the CPT Editorial Panel recommended replacing 
one HCPCS code (G0365) with two new codes to describe the duplex scan 
of arterial inflow and venous outflow for preoperative vessel 
assessment prior to creation of hemodialysis access for complete 
bilateral and unilateral study. We are proposing the RUC-recommended 
work RVU of 0.80 for CPT code 93X00 (Duplex scan of arterial inflow and 
venous outflow for preoperative vessel assessment prior to creation of 
hemodialysis access; complete bilateral study), as well as the RUC-
recommended work RVU of 0.50 for CPT code 93X01 (Duplex scan of 
arterial inflow and venous outflow for preoperative vessel assessment 
prior to creation of hemodialysis access; complete unilateral study).
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity from 4 minutes to 2 minutes for both codes in the family. Two 
minutes is the standard time for this clinical labor activity, and 2 
minutes is also the time assigned for this activity in the reference 
code, CPT code 93990 (Duplex scan of hemodialysis access (including 
arterial inflow, body of access and venous outflow)). There was no 
rationale provided in the recommended materials indicating why this 
additional clinical labor time would be typical for the procedures, and 
therefore, we are proposing to refine to the standard time of 2 
minutes. We are also proposing to adjust the equipment times to conform 
to this change in the clinical labor time.
(61) Myocardial Strain Imaging (CPT Code 933X0)
    The CPT Editorial Panel deleted one Category III code and created 
one new Category I add-on code CPT code 933X0 to describe the work of 
myocardial strain imaging performed in supplement to transthoracic 
echocardiography services. We are proposing the RUC-recommended work 
RVU of 0.24.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
933X0. However, we note that no rationale was given for the RUC-
recommended 12 minutes of clinical labor time for the activity CA021

[[Page 40598]]

``Perform procedure/service,'' and we are requesting comment on the 
appropriateness of this allocated time value.
(62) Lung Function Test (CPT Code 94200)
    The RUC recommended this service for survey because it appeared on 
a list of CMS/Other codes with Medicare utilization of 30,000 or more. 
According to the RUC, this service is typically reported with an E/M 
service and another pulmonary function test, and the RUC-recommended 
times would appropriately account for any overlap with other services. 
The RUC stated that the intraservice time involves reading and 
interpreting the test to determine if a significant interval change has 
occurred and then generating a report, which supports the 5 minutes of 
physician work indicated in the survey. The RUC did not agree with the 
specialty society that communication of the report required an 
additional 2 minutes of physician time over the postservice time 
included in the other services reported on the same day. The RUC 
reduced the postservice time from 2 minutes to 1 minute because the 
service requires minimal time to enter the results into the medical 
record and communicate the results to the patient and the referring 
physician. Based in part on these reductions in physician time, the RUC 
recommended a reduction in work RVU from the current value with a 
crosswalk to CPT code 95905 (Motor and/or sensory nerve conduction, 
using preconfigured electrode array(s), amplitude and latency/velocity 
study, each limb, includes F-wave study when performed, with 
interpretation and report).
    For CPT code 94200 (Maximum breathing capacity, maximal voluntary 
ventilation), we are proposing the RUC-recommended work RVU of 0.05. A 
stakeholder stated that the RUC's recommended work RVU understates the 
costs inherent in performing this service, and that the survey 25th 
percentile value of 0.10 is more accurate for this service. While we 
are proposing the RUC-recommended 0.05, we are soliciting public 
comment on this stakeholder-recommended potential alternative value.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
94200 without refinement.
(63) Long-Term EEG Monitoring (CPT Codes 95X01, 95X02, 95X03, 95X04, 
95X05, 95X06, 95X07, 95X08, 95X09, 95X10, 95X11, 95X12, 95X13, 95X14, 
95X15, 95X16, 95X17, 95X18, 95X19, 95X20, 95X21, 95X22, and 95X23)
    In January 2017, the RUC identified CPT code 95951 via the high 
volume growth screen, which considers if the service has total Medicare 
utilization of 10,000 or more and if utilization has increased by at 
least 100 percent from 2009 through 2014. The RUC recommended that this 
service be referred to the CPT Editorial Panel for needed changes, 
including code deletions, revision of code descriptors, and the 
addition of new codes to this family. In May 2018, the CPT Editorial 
Panel approved the revision of one code, deletion of five codes, and 
addition of 23 new codes for reporting long-term EEG professional and 
technical services.
    We are proposing the RUC-recommended work RVU for six of the 
professional component codes in this family. We are proposing a work 
RVU of 3.86 for CPT code 95X18 (Electroencephalogram, continuous 
recording, physician or other qualified health care professional review 
of recorded events, complete study; greater than 36 hours, up to 60 
hours of EEG recording, without video), a work RVU of 4.70 for CPT code 
95X19 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, complete 
study; greater than 36 hours, up to 60 hours of EEG recording, with 
video), a work RVU of 4.75 for CPT code 95X20 (Electroencephalogram, 
continuous recording, physician or other qualified health care 
professional review of recorded events, complete study; greater than 60 
hours, up to 84 hours of EEG recording, without video), a work RVU of 
6.00 for CPT code 95X21 (Electroencephalogram, continuous recording, 
physician or other qualified health care professional review of 
recorded events, complete study; greater than 60 hours, up to 84 hours 
of EEG recording, with video), a work RVU of 5.40 for CPT code 95X22 
(Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, complete 
study; greater than 84 hours of EEG recording, without video) and a 
work RVU of 7.58 for CPT code 95X23 (Electroencephalogram, continuous 
recording, physician or other qualified health care professional review 
of recorded events, complete study; greater than 84 hours of EEG 
recording, with video).
    We are also proposing the RUC-recommended work RVU of 0.00 for the 
13 technical component codes in the family: CPT code 95X01 
(Electroencephalogram (EEG) continuous recording, with video when 
performed, set-up, patient education, and take down when performed, 
administered in-person by EEG technologist, minimum of 8 channels), CPT 
code 95X02 (Electroencephalogram (EEG) without video, review of data, 
technical description by EEG technologist, 2-12 hours; unmonitored), 
CPT code 95X03 (Electroencephalogram (EEG) without video, review of 
data, technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95X04 
(Electroencephalogram (EEG) without video, review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95X05 (Electroencephalogram (EEG) 
without video, review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95X06 (Electroencephalogram (EEG) without video, review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with intermittent monitoring and maintenance), CPT code 95X07 
(Electroencephalogram (EEG) without video, review of data, technical 
description by EEG technologist, each increment of 12-26 hours; with 
continuous, real-time monitoring and maintenance), CPT code 95X08 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; unmonitored), CPT code 
95X09 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95X10 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95X11 (Electroencephalogram with 
video (VEEG), review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95X12 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with intermittent monitoring and

[[Page 40599]]

maintenance), and CPT code 95X13 (Electroencephalogram with video 
(VEEG), review of data, technical description by EEG technologist, each 
increment of 12-26 hours; with continuous, real-time monitoring and 
maintenance).
    We disagree with the RUC-recommended work RVU of 2.00 for CPT code 
95X14 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, 2-12 
hours of EEG recording; without video) and we are proposing a work RVU 
of 1.85 based on a crosswalk to CPT code 93314 (Echocardiography, 
transesophageal, real-time with image documentation (2D) (with or 
without M-mode recording); image acquisition, interpretation and report 
only). CPT code 93314 is a recently-reviewed code with 2 additional 
minutes of intraservice time and 4 additional minutes of total time as 
compared to CPT code 95X14. When considering the work RVU for CPT code 
95X14, we looked to the second reference code chosen by the survey 
participants, CPT code 95957 (Digital analysis of electroencephalogram 
(EEG) (e.g., for epileptic spike analysis)). This code has 2 additional 
minutes of intraservice time and 9 additional minutes of total time as 
compared to CPT code 95X14, yet has a work RVU of 1.98, lower than the 
recommended work RVU of 2.00. These time values suggested that CPT code 
95X14 would be more accurately valued at a work RVU slightly below the 
1.98 of CPT code 95957. We also looked at the intraservice time ratio 
between CPT code 95X14 and some of its predecessor codes. The 
intraservice time ratio with CPT code 95953 (Monitoring for 
localization of cerebral seizure focus by computerized portable 16 or 
more channel EEG, electroencephalographic (EEG) recording and 
interpretation, each 24 hours, unattended) suggests a similar potential 
work RVU of 1.91 (28 minutes divided by 45 minutes times a work RVU of 
3.08). Based on this information, we are proposing a work RVU of 1.85 
for CPT code 95X14 based on the aforementioned crosswalk to CPT code 
93314.
    We disagree with the RUC-recommended work RVU of 2.50 for CPT code 
95X15 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, interpretation, and report, 2-12 hours 
of EEG recording; with video (VEEG)) and we are proposing a work RVU of 
2.35. Although we disagree with the RUC-recommended work RVU, we concur 
that the relative difference in work between CPT codes 95X14 and 95X15 
is equivalent to the recommended interval of 0.50 RVUs. Therefore, we 
are proposing a work RVU of 2.35 for CPT code 95X15, based on the 
recommended interval of 0.50 additional RVUs above our proposed work 
RVU of 1.85 for CPT code 95X14. We are supporting this work RVU with a 
reference to CPT code 99310 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of the 3 key components), which shares the same intraservice time of 
35 minutes and the identical work RVU of 2.35. CPT code 99310 is a 
lower intensity procedure but has increased total work time as compared 
to CPT code 95X15.
    We disagree with the RUC-recommended work RVU of 3.00 for CPT code 
95X16 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, each increment of greater than 12 
hours, up to 26 hours of EEG recording, interpretation and report after 
each 24-hour period; without video) and we are proposing a work RVU of 
2.60 based on a crosswalk to CPT code 99219 (Initial observation care, 
per day, for the evaluation and management of a patient, which requires 
3 key components). CPT code 99219 shares the same intraservice time of 
40 minutes and has a slightly higher total time as compared to CPT code 
95X16. We also note that the observation care described by CPT code 
99219 shares some clinical similarities to the long term EEG monitoring 
described by CPT code 95X16, although we note as always that the nature 
of the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another, and that codes do 
not need to share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk.
    In addition, we believe that the proposed crosswalk to CPT code 
99219 at a work RVU of 2.60 more accurately captures the intensity of 
CPT code 95X16. At the recommended work RVU of 3.00, the intensity of 
CPT code 95X16 is anomalously high in comparison to the rest of the 
family, higher than any of the other professional component codes. We 
have no reason to believe that the 24-hour EEG monitoring done without 
video as described in CPT code 95X16 would be notably more intense than 
the other codes in the same family. Furthermore, the recommendations 
for this code family specifically state that the codes that describe 
video EEG monitoring are more intense than the codes that describe non-
video EEG monitoring. However, at the recommended work RVU for CPT code 
95X16, this non-video form of EEG monitoring had the highest intensity 
in the family. At our proposed work RVU of 2.60, the intensity of CPT 
code 95X16 is no longer anomalously high in comparison to the rest of 
the family, and also remains lower than the intensity of the 24 hour 
EEG monitoring with video procedure described by CPT code 95X17.
    We disagree with the RUC-recommended work RVU of 3.86 for CPT code 
95X17 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, each increment of greater than 12 
hours, up to 26 hours of EEG recording, interpretation and report after 
each 24-hour period; with video (VEEG)) and we are proposing a work RVU 
of 3.50 based on the survey 25th percentile value. The RUC-recommended 
work RVU of 3.86 was based on a crosswalk to CPT code 99223 (Initial 
hospital care, per day, for the evaluation and management of a patient, 
which requires 3 key components), a code that shares the same 
intraservice time of 55 minutes but has 15 additional minutes of total 
time as compared to CPT code 95X17, at 90 minutes as compared to 75 
minutes. We disagree with the use of this crosswalk, as the 15 minutes 
of additional total time in CPT code 99223 result in a higher work 
valuation that overstates the work RVU of CPT code 95X17. These 15 
additional minutes of preservice and postservice work time in the 
recommended crosswalk code have a calculated work RVU of 0.34 under the 
building block methodology; subtracting out this work RVU of 0.34 from 
the crosswalk code's work RVU of 3.86 results in an estimated work RVU 
of 3.52, which is nearly identical to the survey 25th percentile work 
RVU of 3.50. Similarly, if we were to calculate a total time ratio 
between CPT code 95X17 and the recommended crosswalk code 99223, it 
would produce a noticeably lower work RVU of 3.22 (75 minutes divided 
by 90 minutes times a work RVU of 3.86). Based on this rationale, we do 
not believe that it would serve the interests of relativity to propose 
a work RVU of 3.86 based on the recommended crosswalk.
    Instead, we are proposing a work RVU of 3.50 for CPT code 95X17 
based on the

[[Page 40600]]

survey 25th percentile value. We note that among the predecessor codes 
for this family, CPT code 95956 (Monitoring for localization of 
cerebral seizure focus by cable or radio, 16 or more channel telemetry, 
electroencephalographic (EEG) recording and interpretation, each 24 
hours, attended by a technologist or nurse) has a higher intraservice 
time of 60 minutes and a higher total time of 105 minutes at a work RVU 
of 3.61. This prior valuation of CPT code 95956 does not support the 
RUC-recommended work RVU of 3.86 for CPT code 95X17, but does support 
the proposed work RVU of 3.50 at the slightly lower newly surveyed work 
times. We also note that at the recommended work RVU of 3.86, the 
intensity of CPT code 95X17 was anomalously high in comparison to the 
rest of the family, the second-highest intensity as compared to the 
other professional component codes. We have no reason to believe that 
the 24 hour EEG monitoring done with video as described in CPT code 
95X17 would be notably more intense than the other codes in the same 
family. At our proposed work RVU of 3.50, the intensity of CPT code 
95X17 is no longer anomalously high in comparison to the rest of the 
family, while still remaining slightly higher than the intensity of the 
24 hour EEG monitoring performed without video procedure described by 
CPT code 95X16.
    For the direct PE inputs, we are proposing to make a series of 
refinements to the clinical labor times of CPT code 95X01. Many of the 
clinical labor times for this CPT code were derived using a survey 
process and were recommended to CMS at the survey median values. This 
was in contrast to the typical process for recommended direct PE 
inputs, where the inputs are usually based on either standard times or 
carried over from reference codes. We believe that when surveys are 
used to recommended direct PE inputs, we must apply a similar process 
of scrutiny to that used in assessing the work RVUs that are 
recommended based on a survey methodology. We have long expressed our 
concerns over the validity of the survey results used to produce work 
RVU recommendations, such as in the CY 2011 PFS final rule (75 FR 
73328), and we have noted that over the past decade the AMA RUC has 
increasingly chosen to recommend the survey 25th percentile work RVU 
over the survey median value, potentially responding to the same 
concerns that we have identified.
    As a result, we believe that when assessing the survey of direct PE 
inputs used to produce many of the recommendations for CPT code 95X01, 
it would be more accurate to propose the survey 25th percentile direct 
PE inputs as opposed to the recommended survey median direct PE inputs. 
Therefore, we are proposing to refine the clinical labor time for the 
``Provide education/obtain consent'' (CA011) activity from 13 minutes 
to 7 minutes and to refine the clinical labor time for the ``Review 
home care instructions, coordinate visits/prescriptions'' (CA035) 
activity from 10 minutes to 7 minutes. In both of these cases, the 
recommended clinical labor times based on the survey median values are 
more than double the standard time for these activities. Although we 
agree that additional clinical labor time would be required to carry 
out these activities for CPT code 95X01, we do not believe that the 
survey median times would be typical. We are proposing the survey 25th 
percentile times of 7 minutes for each activity as we believe that this 
time would be more typical for obtaining consent and reviewing home 
care instructions.
    We are also proposing to refine the clinical labor time for the 
``Complete pre-procedure phone calls and prescription'' (CA005) 
activity from 10 minutes to 3 minutes for CPT code 95X01. This is 
another situation where we are proposing the survey 25th percentile 
clinical labor time of 3 minutes instead of the survey median clinical 
labor time of 10 minutes. However, we also note that many of the tasks 
that fell under the CA005 activity code as described in the PE 
recommendations appear to constitute forms of indirect PE, such as 
collecting supplies for setup and loading equipment and supplies into 
vehicles. Collecting supplies and loading equipment are administrative 
tasks that are not individually allocable to a particular patient for a 
particular service, and therefore, constitute indirect PE under our 
methodology. Due to the fact that many of the tasks described under the 
CA005 activity code are forms of indirect PE, we believe that the RUC-
recommended survey median clinical labor time of 10 minutes overstates 
the amount of direct clinical labor taking place. We believe that it is 
more accurate to propose the survey 25th percentile clinical labor time 
of 3 minutes for this activity code to reflect the non-administrative 
tasks performed by the clinical staff.
    We are also proposing to refine the quantity of the non-sterile 
gloves (SB022) supply from 3 to 2 for CPT code 95X01. We note that the 
current reference code, CPT code 95953, uses 2 of these pairs of gloves 
and the survey also stated that 2 pairs of gloves were typical for the 
procedure. Although the recommended materials state that a pair of 
gloves is needed to set up the equipment, to take down the equipment, 
and a third is required for electrode changes, we do not agree that the 
use of a third pair of gloves would be typical given their usage in the 
reference code and in the responses from the survey.
    We note that we are not proposing to refine many of the other 
clinical labor times for CPT code 95X01, which remain at the survey 
median clinical labor times. Due to the nature of the continuous 
recording EEG service taking place, we agree that the survey median 
clinical labor times of 12 minutes for the ``Prepare room, equipment 
and supplies'' (CA013) activity, 45 minutes for the ``Prepare, set-up 
and start IV, initial positioning and monitoring of patient'' (CA016) 
activity, and 22 minutes for the ``Clean room/equipment by clinical 
staff'' (CA024) activity would be typical for this procedure. We 
reiterate that we assess the direct PE inputs for each procedure 
individually based on our methodology of what would be reasonable and 
medically necessary for the typical patient.
    For CPT codes 95X02-95X13, we are proposing to refine the clinical 
labor time for the ``Coordinate post-procedure services'' (CA038) 
activity from either 11 minutes to 5 minutes or from 22 minutes to 10 
minutes as appropriate for the CPT code in question. The recommended 
materials for these procedures state that the tasks taking place 
constitute ``Merge EEG and Video files (partially automated program), 
confirm transfer of data, delete from laptop/computer if necessary''. 
We believe that many of the tasks detailed here are administrative in 
nature, consisting of forms of data entry, and therefore, would be 
considered types of indirect PE. We note that when CPT code 95812 
(Electroencephalogram (EEG) extended monitoring; 41-60 minutes) was 
recently reviewed for CY 2017, we finalized the recommended clinical 
labor time of 2 minutes for ``Transfer data to reading station & 
archive data'', a task which we believe to be highly similar. Due to 
the longer duration of the procedures in CPT codes 95X02-95X13, we are 
proposing clinical labor times of 5 minutes and 10 minutes for the 
CA038 activity for these CPT codes. We are also refining the equipment 
time for the Technologist PACS workstation (ED050) to match the 
clinical labor time proposed for the CA038 activity.
    For the four continuous monitoring procedures, CPT codes 95X04, 
95X07, 95X10, and 95X13, we are proposing to refine the equipment time 
for the

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ambulatory EEG review station (EQ016) equipment. The recommended 
equipment time for the ambulatory EEG review station was equal to four 
times the ``Perform procedure/service'' (CA021) clinical labor time 
plus a small amount of extra prep time. We do not agree that it would 
be typical to assign this much equipment time, as it is our 
understanding that one ambulatory EEG review station can be hooked up 
to as many as four monitors at a time for continuous monitoring. 
Therefore, we do not believe that each monitor would require its own 
review station, and that the equipment time should not be equal to four 
times the clinical labor of the ``Perform procedure/service'' (CA021) 
activity. As a result, we are proposing to refine the ambulatory EEG 
review station equipment time from 510 minutes to 150 minutes for CPT 
code 95X04, from 1,480 minutes to 400 minutes for CPT code 95X07, from 
514 minutes to 154 minutes for CPT code 95X10, and from 1,495 minutes 
to 415 minutes for CPT code 95X13.
    For the 10 professional component procedures, CPT codes 95X14-
95X23, we are again proposing to refine the equipment time for the 
ambulatory EEG review station (EQ016) equipment. We believe that the 
use of the ambulatory EEG review station is analogous in these 
procedures to the use of the professional PACS workstation (ED053) in 
other procedures, and we are proposing to refine the equipment times 
for these 10 procedures to match our standard equipment time formula 
for the professional PACS workstation. Therefore, we are proposing an 
equipment time for the ambulatory EEG review station equal to half the 
preservice work time (rounded up) plus the intraservice work time for 
CPT codes 95X14 through 95X23. We believe that this equipment time is 
more accurate than the recommended equipment time, which was equal to 
the total work time of the procedures, as the work descriptors for CPT 
codes 95X14-95X23 make no mention of the ambulatory EEG review station 
in the postservice work period.
    Finally, we are proposing to price the new ``EEG, digital, 
prolonged testing system with remote video, for patient home use'' 
(EQ394) equipment at $26,410.95 based on an invoice submission. We did 
not use a second invoice submitted for the new equipment for pricing, 
as it contained a disaggregated list of equipment components and it was 
not clear if they represented the same equipment item as the first 
invoice.
(64) Health and Behavioral Assessment and Intervention (CPT Codes 
961X0, 961X1, 961X2, 961X3, 961X4, 961X5, 961X6, 961X7, and 961X8)
    The 2001 Health and Behavior Assessment and Intervention (HBAI) RUC 
valuations were based on the old CPT code 90801 (Psychiatric diagnostic 
interview evaluation), a 60-minute service. The RUC originally 
recommended the Health and Behavior Assessment and Intervention 
procedures to be 15-minute services, approximately equal to one-quarter 
of the value of CPT code 90801, which we finalized without refinements. 
While the RUC may have assumed that these services would typically be 
reported in four, 15-minute services per single patient encounter, in 
actual claims data, there is wide variation in the number of services 
provided and submitted. The RUC reconsidered their rationale for the 
original RUC-recommended valuation of this family of codes in September 
2018. The CPT Editorial Panel deleted the six existing Health and 
Behavior Assessment and Intervention procedure CPT codes and replaced 
them with nine new CPT codes.
    The six deleted CPT codes include CPT code 96150 (Health and 
behavior assessment (e.g., health-focused clinical interview, 
behavioral observations, psychophysiological monitoring, health-
oriented questionnaires), each 15 minutes face-to-face with the 
patient; initial assessment), CPT code 96151 (Health and behavior 
assessment (e.g., health-focused clinical interview, behavioral 
observations, psychophysiological monitoring, health-oriented 
questionnaires), each 15 minutes face-to-face with the patient; re-
assessment), CPT code 96152 (Health and behavior intervention, each 15 
minutes, face-to-face; individual), CPT code 96153 (Health and behavior 
intervention, each 15 minutes, face-to-face; group (2 or more 
patients)), CPT code 96154 (Health and behavior intervention, each 15 
minutes, face-to-face; family (with the patient present)), and CPT code 
96155 (Health and behavior intervention, each 15 minutes, face-to-face; 
family (without the patient present)).
    The nine replacement HBAI CPT codes include CPT code 961X0 (Health 
behavior assessment, including re-assessment (i.e., health-focused 
clinical interview, behavioral observations, clinical decision 
making)), CPT code 961X1 (Health behavior intervention, individual, 
face-to-face; initial 30 minutes), CPT code 961X2 (Health behavior 
intervention, individual, face-to-face; each additional 15 minutes 
(list separately in addition to code for primary service)), CPT code 
961X3 (Health behavior intervention, group (2 or more patients), face-
to-face; initial 30 minutes), CPT code 961X4 (Health behavior 
intervention, group (2 or more patients), face-to-face; each additional 
15 minutes (list separately in addition to code for primary service)), 
CPT code 961X5 (Health behavior intervention, family (with the patient 
present), face-to-face; initial 30 minutes), CPT code 961X6 (Health 
behavior intervention, family (with the patient present), face-to-face 
each additional 15 minutes (list separately in addition to code for 
primary service)), CPT code 961X7 (Health behavior intervention, family 
(without the patient present), face-to-face; initial 30 minutes), CPT 
code 961X8 (Health behavior intervention, family (without the patient 
present), face-to-face; each additional 15 minutes (list separately in 
addition to code for primary service)).
    We are proposing the RUC-recommended work RVUs for each of the 
codes in this family as follows.
     For CPT code 961X0, we are proposing a work RVU of 2.10.
     For CPT code 961X1, we are proposing a work RVU of 1.45.
     For CPT code 961X2, we are proposing a work RVU of 0.50.
     For CPT code 961X3, we are proposing a work RVU of 0.21.
     For CPT code 961X4, we are proposing a work RVU of 0.10.
     For CPT code 961X5, we are proposing a work RVU of 1.55.
     For CPT code 961X6, we are proposing a work RVU of 0.55.
     For CPT code 961X7, we are proposing a work RVU of 1.50 
(but this code will be non-covered by Medicare).
     For CPT code 961X8, we are proposing a work RVU of 0.54 
(but this code will be non-covered by Medicare).
    We are proposing the RUC-recommended direct PE inputs for all of 
the CPT codes in this family without refinement.
(66) Cognitive Function Intervention (CPT Codes 971XX and 9XXX0)
    In 2017, we received HCPAC recommendations for new CPT code 97127 
(Development of cognitive skills to improve attention, memory, problem 
solving, direct patient contact, 1) that described the services under 
CPT code 97532 (Development of cognitive skills to improve attention, 
memory, problem solving, direct patient contact, each 15 minutes). CPT 
code 97532 was scheduled to be deleted and replaced by the new untimed 
code CPT code 97127. In the CY 2018 PFS final rule (82 FR 53074 through 
53076); however, we

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suggested that CPT code 97127 as an untimed/per day code did not 
appropriately account for the variable amounts of time spent with a 
patient depending upon the discipline and/or setting and assigned the 
code a procedure status of ``I'' (Invalid). In place of CPT code 97127, 
we established a new HCPCS G-code, G0515 (Development of cognitive 
skills to improve attention, memory, problem solving, direct patient 
contact, each 15 minutes), with a work RVU of 0.44. HCPCS code G0515 
maintained the descriptor and values from the former CPT code 97532.
    In September 2018, the CPT Editorial Panel revised CPT code 971XX 
(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-to-one) 
patient contact; initial 15 minutes) and created an add-on code, CPT 
code 9XXX0 (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-
to-one) patient contact; each additional 15 minutes (list separately in 
addition to code for primary procedure)).
    We are proposing the RUC-recommended work RVUs of 0.50 for CPT code 
971XX and 0.48 for CPT code 9XXX0. We are proposing the RUC-recommended 
direct PE inputs for all codes in the family. We are also proposing to 
designate CPT codes 971XX and 9XXX0 as sometime therapy codes because 
the services might be appropriately furnished by therapists under the 
outpatient therapy services benefit (includes physical therapy, 
occupational therapy, or speech-language pathology) or outside the 
therapy benefit by physicians, NPPs, and psychologists.
(67) Open Wound Debridement (CPT Codes 97597 and 97598)
    CPT code 97598 (Debridement (e.g., high pressure waterjet with/
without suction, sharp selective debridement with scissors, scalpel and 
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or 
dermis, exudate, debris, biofilm), including topical application(s), 
wound assessment, use of a whirlpool, when performed and instruction(s) 
for ongoing care, per session, total wound(s) surface area; each 
additional 20 sq cm, or part thereof) was identified by the RUC on a 
list of services that were originally surveyed by one specialty but are 
now typically performed by a different specialty. It was reviewed along 
CPT code 97597 (Debridement (e.g., high pressure waterjet with/without 
suction, sharp selective debridement with scissors, scalpel and 
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or 
dermis, exudate, debris, biofilm), including topical application(s), 
wound assessment, use of a whirlpool, when performed and instruction(s) 
for ongoing care, per session, total wound(s) surface area; first 20 sq 
cm or less) at the October 2018 RUC meeting.
    We disagree with the RUC-recommended work RVU of 0.88 for CPT code 
97597 and we are proposing a work RVU of 0.77 based on a crosswalk to 
CPT code 27369 (Injection procedure for contrast knee arthrography or 
contrast enhanced CT/MRI knee arthrography). CPT code 27369 is a 
recently-reviewed code with the same intraservice time of 15 minutes 
and a total time of 28 minutes, one minute fewer than CPT code 97597. 
In reviewing this code, we noted that the recommended intraservice time 
is increasing from 14 minutes to 15 minutes (7 percent), and the 
recommended total time is increasing from 24 minutes to 29 minutes (21 
percent); however, the RUC-recommended work RVU is increasing from 0.51 
to 0.88, which is an increase of 73 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 increase in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
modest increases in time should be appropriately reflected with a 
commensurate increase the work RVUs. In the case of CPT code 97597, we 
believed that it is more accurate to propose a work RVU of 0.77 based 
on a crosswalk to CPT code 27369 to account for these modest increases 
in the surveyed work time. We also note that even at the proposed work 
RVU of 0.77 the intensity of this procedure as measured by IWPUT is 
increasing by more than 50 percent over the current value.
    We are proposing the RUC-recommended work RVU of 0.50 for CPT code 
97598. We are also proposing the RUC-recommended direct PE inputs for 
all codes in the family.
(68) Negative Pressure Wound Therapy (CPT Codes 97607 and 97608)
    In the CY 2013 final rule with comment period, we created two HCPCS 
codes to provide a payment mechanism for negative pressure wound 
therapy services furnished to beneficiaries using equipment that is not 
paid for as durable medical equipment: G0456 (Negative pressure wound 
therapy, (for example, vacuum assisted drainage collection) using a 
mechanically powered device, not durable medical equipment, including 
provision of cartridge and dressing(s), topical application(s), wound 
assessment, and instructions for ongoing care, per session; total 
wound(s) surface area less than or equal to 50 square centimeters) and 
G0457 (Negative pressure wound therapy, (for example, vacuum assisted 
drainage collection) using a mechanically-powered device, not durable 
medical equipment, including provision of cartridge and dressing(s), 
topical application(s), wound assessment, and instructions for ongoing 
care, per session; total wound(s) surface area greater than 50 sq. cm). 
For CY 2015, the CPT Editorial Panel created CPT codes 97607 (Negative 
pressure wound therapy, (e.g., vacuum assisted drainage collection), 
utilizing disposable, non-durable medical equipment including provision 
of exudate) and 97608 (Negative pressure wound therapy, (e.g., vacuum 
assisted drainage collection), utilizing disposable, non-durable 
medical equipment including provision of exudate) to describe negative 
pressure wound therapy with the use of a disposable system. In 
addition, CPT codes 97605 (Negative pressure wound therapy (e.g., 
vacuum assisted drainage collection), utilizing durable medical 
equipment (DME), including topical application(s), wound assessment, 
and instruction(s) for ongoing care, per session; total wound(s) 
surface area less than or equal to 50 square centimeters) and 97606 
(Negative pressure wound therapy (e.g., vacuum assisted drainage 
collection), utilizing durable medical equipment (DME), including 
topical application(s), wound assessment, and instruction(s) for 
ongoing care, per session; total wound(s) surface area greater than 50 
square centimeters) were revised to specify the use of durable medical 
equipment. Based upon the revised coding scheme for negative pressure 
wound therapy, we deleted the G-codes. Due to concerns that we had with 
these services, we contractor priced CPT codes 97607 and 97608 
beginning in CY 2015 (79 FR 67670). In the CY 2016 Final Rule (80 FR 
71005),

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in response to comment expressing disappointment with CMS' decision to 
contractor price these codes, we noted that there were obstacles to 
developing accurate payment rates for these services within the PE RVU 
methodology, including the indirect PE allocation for the typical 
practitioners who furnish these services and the diversity of the 
products used in furnishing these services.
    We have received repeated requests from stakeholders, including in 
comment received in response to the CY 2019 PFS final rule, to assign 
an active status to these codes, meaning we would assign rates to the 
codes rather than allowing them to be contractor priced. In that rule, 
(83 FR 59473), we noted that we received a request that CMS should 
assign direct cost inputs and PE RVUs to CPT codes 97607 and 97608, and 
we indicated that we would take this feedback from commenters under 
consideration for future rulemaking.
    In response to stakeholder feedback, we evaluated the codes and 
determined there was adequate volume to assign an active status. We are 
proposing to assign an active status to CPT codes 97607 and 97608 and 
we are proposing the work RVUs as recommended by the RUC that we 
received for CY 2015 when the CPT Editorial Panel created these codes. 
Thus, we are proposing a work RVU of 0.41 for CPT code 97607 and a work 
RVU of 0.46 for CPT code 97608. Similarly, we are proposing the RUC-
recommended direct PE inputs originally for CY 2015 with the following 
refinement: For the clinical labor activity ``check dressings & wound/
home care instructions/coordinate office visits/prescriptions,'' we are 
refining the clinical labor time to the standard 2 minutes for this 
task. In addition, the direct inputs for these codes include the new 
supply item, ``kit, negative pressure wound therapy, disposable.'' A 
search of publicly available commercial pricing data indicates that a 
unit price of approximately $100 is appropriate, and therefore, we are 
proposing this price for this supply item. If more accurate invoices 
are available, we are soliciting such invoices to more accurately price 
it.
(69) Ultrasonic Wound Assessment (CPT Code 97610)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
Committee. CPT code 97610 (Low frequency, non-contact, non-thermal 
ultrasound, including topical application(s), when performed, wound 
assessment, and instruction(s) for ongoing care, per day) was flagged 
for CPT 2015 and reviewed at the October 2018 RAW meeting. The 
Workgroup indicated that the utilization is continuing to increase for 
this service, and recommended that it be resurveyed for physician work 
and practice expense for the January 2019 RUC meeting.
    We are proposing the RUC-recommend work 0.40 for CPT code 97610. We 
are also proposing the RUC-recommended direct PE inputs for CPT code 
97610.
(70) Online Digital Evaluation Service (e-Visit) (CPT Codes 98X00, 
98X01, and 98X02)
    In September 2018, the CPT Editorial Panel deleted two codes and 
replaced them with six new non-face-to-face codes to describe patient-
initiated digital communications that require a clinical decision that 
otherwise typically would have been provided in the office. The HCPAC 
reviewed and made recommendations for CPT code 98X00 (Qualified 
nonphysician healthcare professional online digital evaluation and 
management service, for an established patient, for up to seven days, 
cumulative time during the 7 days; 5-10 minutes), CPT code 98X01 
(Qualified nonphysician healthcare professional online digital 
evaluation and management service, for an established patient, for up 
to seven days, cumulative time during the 7 days; 11-20 minutes), and 
CPT code 98X02 (Qualified nonphysician qualified healthcare 
professional online digital evaluation and management service, for an 
established patient, for up to seven days, cumulative time during the 7 
days; 21 or more minutes). CPT codes 9X0X1-9X0X3 are for practitioners 
who can independently bill E/M services while CPT codes 98X00-98X02 are 
for practitioners who cannot independently bill E/M services.
    The statutory requirements that govern the Medicare benefit are 
specific regarding which practitioners may bill for E/M services. As 
such, when codes are established that describe E/M services that fall 
outside the Medicare benefit category of the practitioners who may bill 
for that service, we have typically created parallel HCPCS G-codes with 
descriptors that refer to the performance of an ``assessment'' rather 
than an ``evaluation''. We acknowledge that there are qualified non-
physician health care professionals who will likely perform these 
services. Therefore, for CY 2020, we are proposing separate payment for 
online digital assessments via three HCPCS G-codes that mirror the RUC 
recommendations for CPT codes 98X00-98X02. The proposed HCPCS G codes 
and descriptors are as follows:
     HCPCS code GNPP1 (Qualified nonphysician healthcare 
professional online assessment, for an established patient, for up to 
seven days, cumulative time during the 7 days; 5-10 minutes);
     HCPCS code GNPP2 (Qualified nonphysician healthcare 
professional online assessment service, for an established patient, for 
up to seven days, cumulative time during the 7 days; 11-20 minutes); 
and
     HCPCS code GNPP3 (Qualified nonphysician qualified 
healthcare professional assessment service, for an established patient, 
for up to seven days, cumulative time during the 7 days; 21 or more 
minutes).
    For CY 2020, we are proposing a work RVU of 0.25 for CPT code 
GNPP1, which reflects the RUC-recommended work RVU for CPT code 98X00. 
For HCPCS codes GNPP2 and GNPP3, we believe that the 25th percentile 
work RVU associated with CPT codes 98X01 and 98X02 respectively, better 
reflects the intensity of performing these services, as well as the 
methodology used to value the other codes in the family, all of which 
use the 25th percentile work RVU. Therefore, we are proposing a work 
RVU of 0.44 for HCPCS code GNPP1 and a work RVU of 0.69 for HCPCS code 
GNPP2.
    We are proposing the direct PE inputs associated with CPT codes 
98X00, 98X01, and 98X02 for GNPP1, GNPP2, and GNPP3 respectively.
(71) Emergency Department Visits (CPT Codes 99281, 99282, 99283, 99284, 
and 99285)
    In the CY 2018 PFS final rule, we finalized a proposal to nominate 
CPT codes 99281-99285 as potentially misvalued based on information 
suggesting that the work RVUs for emergency department visits may not 
appropriately reflect the full resources involved in furnishing these 
services (FR 82 53018.) These five codes were surveyed and reviewed for 
the April 2018 RUC meeting. For CY 2020 we are proposing the RUC-
recommended work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93 
for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60 
for 99284, and a work RVU of 3.80 for CPT code 99285.
    The RUC did not recommend and we are not proposing any direct PE 
inputs for the codes in this family.

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(72) Self-Measured Blood Pressure Monitoring (CPT Codes 99X01, 99X02, 
93784, 93786, 93788, and 93790)
    In September 2018, the CPT Editorial Panel created two new codes 
and revised four other codes to describe self-measured blood pressure 
monitoring services and to differentiate self-measured blood pressuring 
monitoring services from ambulatory blood pressure monitoring services. 
The first of the two new codes that describe self-measured blood 
pressure monitoring is CPT code 99X01 (Self-measured blood pressure 
using a device validated for clinical accuracy; patient education/
training and device calibration) and is a PE only code. The second code 
is 99X02 (Self-measured blood pressure using a device validated for 
clinical accuracy; separate self-measurements of two readings, one 
minute apart, twice daily over a 30-day period (minimum of 12 
readings), collection of data reported by the patient and/or caregiver 
to the physician or other qualified health care professional, with 
report of average systolic and diastolic pressures and subsequent 
communication of a treatment plan to the patient).
    The remaining four codes, which monitor ambulatory blood pressure, 
include CPT code 93784 (Ambulatory blood pressure monitoring, utilizing 
report-generating software, automated, worn continuously for 24 hours 
or longer; including recording, scanning analysis, interpretation and 
report), CPT code 93786 (Ambulatory blood pressure monitoring, 
recording only), CPT code 93788 (Ambulatory blood pressure monitoring, 
scanning analysis with report), and CPT code 93790 (Ambulatory blood 
pressure monitoring, review with interpretation and report). CPT code 
93784 is a composite code that is the sum of CPT codes 93786, 93788, 
and 93790. CPT codes 93786 and 93788 are PE only codes.
    We are proposing the RUC-recommended work RVU of 0.18 for CPT code 
99X02, the RUC-recommended work RVU of 0.38 for CPT code 93784, and the 
RUC-recommended work RVU of 0.38 for CPT code 93790. We are proposing 
the RUC-recommended work RVU of 0.00 for CPT codes 93786, 93788, and 
99X01. We are also proposing the RUC-recommended direct PE inputs for 
all codes in the family.
(73) Online Digital Evaluation Service (e-Visit) (CPT Codes 9X0X1, 
9X0X2, and 9X0X3)
    In September 2018, the CPT Editorial Panel deleted two codes and 
replaced them with six new non-face-to face codes to describe patient-
initiated digital communications that require a clinical decision that 
otherwise typically would have been provided in the office. The RUC 
reviewed and made recommendations for CPT code 9X0X1 (Online digital 
evaluation and management service, for an established patient, for up 
to 7 days, cumulative time during the 7 days; 5-10 minutes), CPT code 
9X0X2 (Online digital evaluation and management service, for an 
established patient, for up to 7 days, cumulative time during the 7 
days; 11-20 minutes), and CPT code 9X0X3 (Online digital evaluation and 
management service, for an established patient, for up to 7 days, 
cumulative time during the 7 days; 21 or more minutes).
    For CY 2020, we are proposing the RUC-recommended work RVUs of 0.25 
for CPT code 9X0X1, 0.50 for CPT code 9X0X2, and 0.80 for CPT code 
9X0X3. We are proposing the RUC-recommended direct PE inputs for all 
codes in the family.
(74) Radiation Therapy Codes (HCPCS Codes G6001, G6002, G6003, G6004, 
G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014, 
G6015, G6016 and G6017)
    For CY 2015, CPT revised the radiation therapy code set for 
following identification of some of the codes as potentially misvalued 
and the affected specialty society's contention that the provision of 
radiation therapy could not be accurately reported under the existing 
code set. In the CY 2015 PFS final rule, we finalized that we were 
delaying implementation of this revised code set, citing concerns with 
our potentially having finalized a substantial coding revision on an 
interim final basis. In addition, we stated that substantial work 
needed to be done to assure the new valuations for these codes 
accurately reflect the coding changes. We finalized that we would 
maintain inputs at CY 2014 levels by creating G-codes as necessary to 
allow practitioners to continue to report services to CMS in CY 2015 as 
they did in CY 2014 and for payments to be made in the same way. 
Following the publication of the CY 2015 PFS final rule, the Patient 
Access and Medicare Protection Act (Pub. L. 114-115, December 28, 2015) 
was enacted, which included the provision that the code definitions, 
the work relative value units and the direct inputs for the PE RVUs for 
radiation treatment delivery and related imaging services (identified 
in 2016 by HCPCS G-codes G6001 through G6015) for the fee schedule 
established under this subsection for services furnished in 2017 and 
2018 shall be the same as such definitions, units, and inputs for such 
services for the fee schedule established for services furnished in 
2016. In CY 2018, Congress extended this ``freeze'' in coding 
descriptions and inputs through CY 2019 as a provision of the 
Bipartisan Budget Act of 2018. For CY 2020, in the interest of payment 
stability, we are proposing to continue using these G-codes, as well as 
their current work RVUs and direct PE inputs. We are also proposing 
that, for CY 2020, our PE methodology will continue to include a 
utilization rate assumption of 60 percent for the equipment item: 
ER089, ``IMRT Accelerator.''
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

O. Comment Solicitation on Opportunities for Bundled Payments Under the 
PFS

    Under the PFS, Medicare typically makes a separate payment for each 
individual service furnished to a beneficiary consistent with section 
1848 of the Act, which requires CMS to establish payment for 
physicians' services based on the relative resources involved in 
furnishing the service. The statute defines ``services'' broadly, with 
reference to the uniform procedure coding system established by CMS for 
the purpose of Medicare FFS payments, called the Healthcare Common 
Procedure Coding System (HCPCS). There are sets of HCPCS codes that 
represent health care procedures, supplies, medical equipment, 
products, and services. The majority of physicians' services for which 
payment is made under the PFS are described using HCPCS Level I codes 
and descriptors that are the AMA's Current Procedural Terminology (CPT) 
code set. CPT codes generally describe an individual item or service, 
while some codes describe a combination of services (a procedure and 
imaging guidance, for example) bundled together. Some HCPCS codes 
explicitly encompass multiple services (global surgery codes, for 
example), and the PFS payment for some services is reduced when a 
combination of services is furnished to the same patient on the same 
day (through multiple procedure payment reduction policies). However, 
payment for most services under the PFS is made based on rates 
established for individual services, each described by a CPT code. 
Identifying and developing appropriate payment policies that aim to 
achieve better care and improved health for Medicare beneficiaries is a 
priority for CMS. Consistent with that goal, we are interested in 
exploring new options for establishing PFS payment rates or adjustments 
for services that are furnished together. For purposes of this 
discussion, we will refer to the circumstances where a set of services 
is grouped together for purposes of ratesetting and payment as 
``bundled payment.''
    One of the mechanisms through which we support innovative payment 
and service delivery models, for Medicare and other beneficiaries, is 
through CMS' Center for Medicare and Medicaid Innovation (the 
Innovation Center). The Innovation Center is currently testing models 
in which payment for physicians' services is bundled on a per-
beneficiary population basis, or is based on episodes of care that 
usually begin with a triggering event and extend for a specified period 
of time thereafter. An example of a model in which payment is made on a 
per-beneficiary population basis is Comprehensive Primary Care Plus 
(CPC+), in which participating practices receive prospective per-
beneficiary care management fees and Comprehensive Primary Care 
Payments for certain primary care services such as chronic care 
management and evaluation and management services. An example of an 
episode payment model is the Oncology Care Model (OCM), in which 
participating physician practices receive a per-beneficiary Monthly 
Enhanced Oncology Services payment for care management and care 
coordination surrounding chemotherapy administration to cancer 
patients. We are actively exploring the extent to which these basic 
principles of bundled payment, such as establishing per-beneficiary 
payments for multiple services or condition-specific episodes of care, 
can be applied within the statutory framework of the PFS.
    We are seeking public comments on opportunities to expand the 
concept of bundling to recognize efficiencies among physicians' 
services paid under the PFS and better align Medicare payment policies 
with CMS's broader goal of achieving better care for patients, better 
health for our communities, and lower costs through improvement in our 
health care system. We believe that the statute, while requiring CMS to 
pay for physicians' services based on the relative resources involved 
in furnishing the service, allows considerable flexibility for 
developing payments under the PFS.

P. Payment for Evaluation and Management (E/M) Visits

1. Background
a. E/M Visits Coding Structure
    Physicians and other practitioners who are paid under the PFS bill 
for common office visits for evaluation and management (E/M) services 
under a relatively generic set of CPT codes (Level I HCPCS codes) that 
distinguish visits based on the level of complexity, site of service, 
and whether the patient is new or established. These CPT codes are 
broadly referred to as E/M visit codes and have three key components 
within their code descriptors: History of present illness (History), 
physical examination (Exam), and medical decision-making (MDM).\80\
---------------------------------------------------------------------------

    \80\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
---------------------------------------------------------------------------

    The CPT code descriptors recognize counseling, care coordination, 
and the nature of the presenting problem as additional service 
components, but these are contributory factors in determining which 
code to report.\81\ Per the CPT code descriptors, counseling and/or 
care coordination are provided consistent with the nature of the 
problem and the patient's and/or family's needs. Counseling and care 
coordination are not required at every patient encounter and can be 
accounted for in separate coding.\82\
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    \81\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
    \82\ 2019 CPT Codebook, Evaluation and Management, pp. 4-56.
---------------------------------------------------------------------------

    As finalized in the CY 2019 PFS final rule, the amount of time 
spent by the billing practitioner is not a determining factor in code 
level selection unless (1) counseling and care coordination dominate 
the visit, in which case time becomes the key factor in determining 
visit level; and/or (2) the service is a prolonged (or beginning in 
2021, ``extended'') (83 FR 59630) E/M visit. Typical times for each 
level of E/M visit are included in each of the CPT code descriptors, 
are used for PFS rate setting purposes, and provide a reference point 
for the reporting of prolonged visits. Separate add-on codes describe, 
and can be reported for, visits that take prolonged (or beginning in 
2021, ``extended'') (83 FR 59630) amounts of time.
    There are 3 to 5 E/M visit code levels, depending upon site of 
service and the extent of the three components of history, exam, and 
MDM. For example, there are 3 to 4 levels of E/M visit codes in the 
inpatient hospital and nursing facility settings based on a relatively 
narrow range of complexity in those settings. In contrast, there are 5 
levels of E/M visit codes in the office or other outpatient setting 
based on a broader range of complexity in those settings.
    PFS payment rates for E/M visit codes generally increase with the 
level of visit billed, although in the CY 2019 PFS final rule (83 FR 
59638), for reasons discussed below, we finalized the assignment of a 
single payment rate for levels 2 through 4 office/outpatient E/M visits 
beginning in CY 2021. As for all services under the PFS, the payment 
rates for E/M visits are based on the work (time and intensity), 
practice expense, and malpractice expense resources required to furnish 
the typical case of the service.
    In total, E/M visits comprise approximately 40 percent of allowed 
charges for PFS services, and office/outpatient E/M visits comprise

[[Page 40671]]

approximately 20 percent of allowed charges for PFS services. Within 
the E/M services represented in these percentages, there is wide 
variation in the volume and level of E/M visits billed by different 
specialties. According to Medicare claims data, E/M visits are 
furnished by nearly all specialties, but represent a greater share of 
total allowed services for physicians and other practitioners who do 
not routinely furnish procedural interventions or diagnostic tests. 
Generally, these practitioners include both primary care practitioners 
and certain specialists such as neurologists, endocrinologists and 
rheumatologists. Certain specialties, such as podiatry, tend to furnish 
lower level E/M visits more often than higher level E/M visits. Some 
specialties, such as dermatology and otolaryngology, tend to bill more 
E/M visits on the same day as they bill minor procedures.
b. E/M Documentation Guidelines
    For CY 2019 and 2020, when coding and billing E/M visits to 
Medicare, practitioners may use one of two versions of the E/M 
Documentation Guidelines for a patient encounter, commonly referenced 
based on the year of their release: the ``1995'' or ``1997'' E/M 
Documentation Guidelines (hereafter, the 1995 and 1997 Guidelines).\83\ 
These Guidelines specify the medical record information within each of 
the three key components (such as number of body systems reviewed) that 
serves as support for billing a given level of E/M visit. The 1995 and 
1997 Guidelines are very similar to the guidelines for E/M visits that 
currently reside within the AMA's CPT codebook for E/M visits. For 
example, the core structure of what comprises or defines the different 
levels of history, exam, and medical decision-making in the 1995 and 
1997 Guidelines are the same as those in the CPT codebook. However, the 
1995 and 1997 Guidelines include extensive examples of clinical work 
that comprise different levels of medical decision-making that do not 
appear in the AMA's CPT codebook. Also, the 1995 and 1997 Guidelines do 
not contain references to preventive care that appear in the AMA's CPT 
codebook. We provide an example of how the 1995 and 1997 Guidelines 
distinguish between level 2 and level 3 E/M visits in Table 25.
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    \83\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the 
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.

                 Table 25--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit
----------------------------------------------------------------------------------------------------------------
         Key component *            Level 2 (1995)      Level 3 (1995)      Level 2 (1997)      Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present       Review of Systems   Problem Pertinent   No change from      No change from
 Illness or HPI).                  (ROS) n/a.          ROS: Inquires       1995.               1995.
                                                       about the system
                                                       directly related
                                                       to the problem(s)
                                                       identified in the
                                                       HPI.
Physical Examination (Exam).....  A limited           A limited           General multi-      General multi-
                                   examination of      examination of      system exam:        system exam:
                                   the affected body   the affected body   Performance and     Performance and
                                   area or organ       area or organ       documentation of    documentation of
                                   system.             system and other    one to five         at least six
                                                       symptomatic or      elements in one     elements in one
                                                       related organ       or more organ       or more organ
                                                       system(s).          system(s) or body   system(s) or body
                                                                           area(s).            area(s).
                                                                          Single organ        Single organ
                                                                           system exam:        system exam:
                                                                           Performance and     Performance and
                                                                           documentation of    documentation of
                                                                           one to five         at least six
                                                                           elements.           elements.
 
Medical Decision Making (MDM).    Straightforward:    Low complexity:              No change from 1995.
 Measured by: **
    1. Problem--Number of            1. Minimal.....  1. Limited.
     diagnoses/treatment options.
    2. Data--Amount and/or           2. Minimal or    2. Limited data
     complexity of data to be         no data review.  review.
     reviewed.
    3. Risk--Risk of                 3. Minimal risk  3. Low risk.
     complications and/or
     morbidity or mortality.
----------------------------------------------------------------------------------------------------------------
 * For certain settings and patient types, each of these three key components must be met or exceeded (for
  example, new patients; initial hospital visits). For others, only two of the three key components must be met
  or exceeded (for example, established patients, subsequent hospital or other visits).
** Two of three met or exceeded.

    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2019 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to 
select the code for the service based

[[Page 40672]]

upon the content of the service. The duration of the visit is an 
ancillary factor and does not control the level of the service to be 
billed unless more than 50 percent of the face-to-face time (for non-
inpatient services) or more than 50 percent of the floor time (for 
inpatient services) is spent providing counseling or coordination of 
care as described in subsection C.'' Subsection C states that ``the 
physician may document time spent with the patient in conjunction with 
the medical decision-making involved and a description of the 
coordination of care or counseling provided. Documentation must be in 
sufficient detail to support the claim.'' The example included in 
subsection C further states, ``The code selection is based on the total 
time of the face-to-face encounter or floor time, not just the 
counseling time. The medical record must be documented in sufficient 
detail to justify the selection of the specific code if time is the 
basis for selection of the code.''
    Both the 1995 and 1997 Guidelines address time, stating that, ``In 
the case where counseling and/or coordination of care dominates (more 
than 50 percent of) the physician/patient and/or family encounter 
(face-to-face time in the office or other outpatient setting or floor/
unit time in the hospital or nursing facility), time is considered the 
key or controlling factor to qualify for a particular level of E/M 
services.'' The Guidelines go on to state that, ``If the physician 
elects to report the level of service based on counseling and/or 
coordination of care, the total length of time of the encounter (face-
to-face or floor time, as appropriate) should be documented and the 
record should describe the counseling and/or activities to coordinate 
care.'' \84\ Additional manual provisions regarding E/M visits are 
housed separately within Medicare's internet-Only Manuals, and are not 
contained within the 1995 or 1997 Guidelines.
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    \84\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997 
guidelines.
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    In accordance with section 1862(a)(1)(A) of the Act, which requires 
services paid under Medicare Part B to be reasonable and necessary for 
the diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member, medical necessity is a 
prerequisite to Medicare payment for E/M visits. Pub. 100-04, Medicare 
Claims Processing Manual, Chapter 12, Section 30.6.1.B states, 
``Medical necessity of a service is the overarching criterion for 
payment in addition to the individual requirements of a CPT code. It 
would not be medically necessary or appropriate to bill a higher level 
of evaluation and management service when a lower level of service is 
warranted. The volume of documentation should not be the primary 
influence upon which a specific level of service is billed. 
Documentation should support the level of service reported.''
c. Summary of Changes to Coding, Payment and Documentation of Office/
Outpatient E/M Visits Finalized for CY 2021 in the CY 2019 PFS Final 
Rule
    In the CY 2019 PFS final rule (83 FR 59452 through 60303), we 
finalized a number of coding, payment, and documentation changes under 
the PFS for office/outpatient E/M visits (CPT codes 99201-99215) to 
reduce administrative burden, improve payment accuracy, and update this 
code set to better reflect the current practice of medicine. In 
summary, we finalized the following policy changes for office/
outpatient E/M visits under the PFS effective January 1, 2021:
     Reduction in the payment variation for office/outpatient 
E/M visit levels by paying a single rate (also referred to as a blended 
rate) for office/outpatient E/M visit levels 2 through 4 (one rate for 
established patients and another rate for new patients), while 
maintaining the payment rate for office/outpatient E/M visit level 5 in 
order to better account for the care and needs of complex patients. 
Practitioners will still report the appropriate code for the level of 
service they furnished, since we did not replace these CPT codes with 
HCPCS G codes and will continue to use typical times associated with 
each individual CPT code when time is used to document the office/
outpatient E/M visit.
     Permitting practitioners to choose to document office/
outpatient E/M level 2 through 5 visits using MDM or time, or the 
current framework based on the 1995 or 1997 Guidelines.
     As a corollary to the uniform payment rate for level 2-4 
E/M visits, when using MDM or the current framework to document the 
office/outpatient E/M visit, a minimum supporting documentation 
standard associated with level 2 office/outpatient E/M visits will 
apply. For these cases, Medicare will require information to support a 
level 2 office/outpatient E/M visit code for history, exam, and/or MDM.
     When time is used to document, practitioners will document 
the medical necessity of the office/outpatient E/M visit and that the 
billing practitioner personally spent the required amount of time face-
to-face with the beneficiary. The required face-to-face time will be 
the typical time for the reported code, except for extended or 
prolonged visits where extended or prolonged times will apply.
     Implementation of HCPCS add-on G codes that describe the 
additional resources inherent in visits for primary care and particular 
kinds of non-procedural specialized medical care (HCPCS codes GPC1X and 
GCG0X, respectively). These codes were finalized in order to reflect 
the differential resource costs associated with performing certain 
types of office/outpatient E/M visits. These codes will only be 
reportable with office/outpatient E/M level 2 through 4 visits.
     Adoption of a new ``extended visit'' add-on G code (HCPCS 
code GPRO1) for use only with office/outpatient E/M level 2 through 4 
visits, to account for the additional resources required when 
practitioners need to spend extended time with the patient for these 
visits. The existing prolonged E/M codes can continue to be used with 
levels 1 and 5 office/outpatient E/M visits.
    We stated that we believed these policies would allow practitioners 
greater flexibility to exercise clinical judgment in documentation so 
they can focus on what is clinically relevant and medically necessary 
for the beneficiary. We believed these policies will reduce a 
substantial amount of administrative burden (83 FR 60068 through 60070) 
and result in limited specialty-level redistributive impacts (83 FR 
60060). We stated our intent to continue engaging in further 
discussions with the public over the next several years to potentially 
further refine our policies for 2021. We finalized the coding, payment, 
and documentation changes to reduce administrative burden, improve 
payment accuracy, and update the code set to better reflect the current 
practice of medicine.
2. Continued Stakeholder Feedback
    In January and February 2019, we hosted a series of structured 
listening sessions on the forthcoming changes that CMS finalized for 
office/outpatient E/M visit coding, documentation and payment for CY 
2021. These sessions provided an opportunity for CMS to gain further 
input and information from the wide range of affected stakeholders on 
these important policy changes. Our goal was to continue to listen and 
consider perspectives from individual practicing clinicians, specialty 
associations, beneficiaries and their advocates, and other interested 
stakeholders to prepare for implementation of the office/outpatient

[[Page 40673]]

E/M visit policies that we finalized for CY 2021.
    In these listening sessions, although stakeholders supported our 
intention to reduce burdensome, clinically outdated documentation 
requirements, they noted that in response to the office/outpatient E/M 
visit policies CMS finalized for CY 2021, the AMA/CPT established the 
Joint AMA CPT Workgroup on E/M to develop an alternative solution. This 
workgroup developed an alternative approach, similar to the one we 
finalized, for office/outpatient E/M coding and documentation. That 
approach was approved by the CPT Editorial Panel in February 2019, with 
an effective date of January 1, 2021 and is available on the AMA's 
website at https://www.ama-assn.org/cpt-evaluation-and-management.
    Effective January 1, 2021, the CPT Editorial Panel adopted 
revisions to the office/outpatient E/M code descriptors, and 
substantially revised both the CPT prefatory language and the CPT 
interpretive guidelines that instruct practitioners on how to bill 
these codes. The AMA has approved an accompanying set of interpretive 
guidelines governing and updating what determines different levels of 
MDM for office/outpatient E/M visits. Some of the changes made by the 
CPT Editorial Panel parallel our finalized policies for CY 2021, such 
as the choice of time or MDM in determination of code level. Other 
aspects differ, such as the number of code levels retained, presumably 
for purposes of differential payment; the times, and inclusion of all 
time spent on the day of the visit; and elimination of options such as 
the use of history and exam or time in combination with MDM, to select 
code level.
    Many stakeholders have continued to express objections to our 
assignment of a single payment rate to level 2-4 office/outpatient E/M 
visits stating that this inappropriately incentivizes multiple, shorter 
visits and seeing less complex patients. Many stakeholders also stated 
that the purpose and use of the HCPCS add-on G codes that we 
established for primary care and non-procedural specialized medical 
care remain ambiguous, expressed concern that the codes are potentially 
contrary to current law prohibiting specialty-specific payment, and 
asserted that Medicare's coding approach is unlikely to be adopted by 
other payers.
    In meetings with stakeholders since we issued the CY 2019 PFS final 
rule, some stakeholders suggested that only time should be used to 
select the service level because time is easy to audit, simple to 
document, and better accounts for patient complexity, in comparison to 
the CPT Editorial Panel revised MDM interpretive guidance. These 
stakeholders stated that the implementation of the CPT Editorial Panel 
revised MDM interpretive guidance will result in the likely increase in 
the selection of levels 4 and 5, relative to current typical coding 
patterns. They suggested that to more accurately distinguish varying 
levels of patient complexity, either the visit levels should be 
recalibrated so that levels 4 and 5 no longer represent the most often 
billed visit, or a sixth level should be added. In these meetings, some 
stakeholders also stated that the office/outpatient E/M codes fail to 
capture the full range of services provided by certain specialties, 
particularly primary care and other specialties that rely heavily on 
office/outpatient E/M services rather than procedures, systematically 
undervaluing primary care visits and visits furnished in the context of 
non-procedural specialty care, thereby creating payment disparities 
that have contributed to workforce shortages and beneficiary access 
challenges across a range of specialties. They reiterated that office/
outpatient E/M visit codes have not been extensively examined since the 
creation of the PFS and recommended that CMS conduct an extensive 
research effort to revise and revalue office/outpatient E/M services 
through a major research initiative akin to that undertaken when the 
PFS was first established.
    The AMA believes its approach will accomplish greater burden 
reduction, is more clinically intuitive and reflects the current 
practice of medicine, and is more likely to be adopted by all payers 
than the policies CMS finalized for CY 2021. The AMA has posted an 
estimate of the burden reduction associated with the policies approved 
at CPT on the AMA's website, available at https://www.ama-assn.org/cpt-evaluation-and-management.
    Given the CPT coding changes that will take effect in 2021, the AMA 
RUC has conducted a resurvey and revaluation of the office/outpatient 
E/M visit codes, and provided us with its recommendations. We discuss 
our proposal to adopt the CPT coding for office/outpatient E/M visits 
below, noting that the CPT coding changes will also necessitate some 
changes to CMS' policies for CY 2021, due to forthcoming changes in 
code descriptors. In addition, we address revaluation of the codes, 
proposing new values for the codes as revised by CPT. We propose to 
assign separate payment rather than a blended rate, to each of the 
office/outpatient E/M visit codes (except CPT code 99201, which CPT is 
deleting) and the new prolonged visit add-on CPT code (CPT code 99XXX). 
We propose to delete the HCPCS add-on code we finalized last year for 
CY 2021 for extended visits (GPRO1). We propose to simplify, 
consolidate and revalue the HCPCS add-on codes we finalized last year 
for CY 2021 for primary care (GPC1X) and non-procedural specialized 
medical care (GCG0X), and to allow the new code to be reported with all 
office/outpatient E/M visit levels (not just levels 2 through 4). All 
of these changes would be effective January 1, 2021. We believe our 
proposed policies will further our ongoing effort to reduce 
administrative burden, improve payment accuracy, and update the office/
outpatient EM visit code set to better reflect the current practice of 
medicine.
3. Proposed Policies for CY 2021 for Office/Outpatient E/M Visits
a. Office/Outpatient E/M Visit Coding and Documentation
    For CY 2021, for office/outpatient E/M visits (CPT codes 99201-
99215) we are proposing to adopt the new coding, prefatory language, 
and interpretive guidance framework that has been issued by the AMA/CPT 
(see https://www.ama-assn.org/cpt-evaluation-and-management) because we 
believe it would accomplish greater burden reduction than the policies 
we finalized for CY 2021 and would be more intuitive and consistent 
with the current practice of medicine. We note that this includes 
deletion of CPT code 99201 (Level 1 office/outpatient visit, new 
patient), which the CPT Editorial Panel decided to eliminate as CPT 
codes 99201 and 99202 are both straightforward MDM and only 
differentiated by history and exam elements.
    Under this new framework, history and exam would no longer select 
the level of code selection for office/outpatient E/M visits. Instead, 
an office/outpatient E/M visit would include a medically appropriate 
history and exam, when performed. The clinically outdated system for 
number of body systems/areas reviewed and examined under history and 
exam would no longer apply, and these components would only be 
performed when, and to the extent medically necessary and clinically 
appropriate. Level 1 visits would only describe or include visits 
performed by clinical staff for established patients.
    For levels 2 through 5 office/outpatient E/M visits, the code level 
reported would be decided based on

[[Page 40674]]

either the level of MDM (as redefined in the new AMA/CPT guidance 
framework) or the total time personally spent by the reporting 
practitioner on the day of the visit (including face-to-face and non-
face-to-face time). Because we would no longer assign a blended payment 
rate (discussed below), we would no longer adopt the minimum supporting 
documentation associated with level 2 office/outpatient E/M visits, 
which we finalized as a corollary to the uniform payment rate for level 
2-4 office/outpatient E/M visits when using MDM or the current 
framework to document the office/outpatient E/M visit.
    We would adopt the new time ranges within the CPT codes as revised 
by the CPT Editorial Panel. We interpret the revised CPT prefatory 
language and reporting instructions to mean that there would be a 
single add-on CPT code for prolonged office/outpatient E/M visits (CPT 
code 99XXX) that would only be reported when time is used for code 
level selection and the time for a level 5 office/outpatient visit (the 
floor of the level 5 time range) is exceeded by 15 minutes or more on 
the date of service. The long descriptor for CPT code 99XXX is 
Prolonged office or other outpatient evaluation and management 
service(s) (beyond the total time of the primary procedure which has 
been selected using total time), requiring total time with or without 
direct patient contact beyond the usual service, on the date of the 
primary service; each 15 minutes (List separately in addition to codes 
99205, 99215 for office or other outpatient Evaluation and Management 
services). We demonstrate below how prolonged office/outpatient E/M 
visit time would be reported:

  Table 26--Total Proposed Practitioner Times for Office/Outpatient E/M
             Visits When Time Is Used To Select Visit Level
------------------------------------------------------------------------
Established patient office/outpatient E/
 M visit (total practitioner time, when
   time is used to select code level)                CPT code
               (minutes)
------------------------------------------------------------------------
40-54..................................  99215.
55-69..................................  99215x1 and 99XXXx1.
70-84..................................  99215x1 and 99XXXx2.
85 or more.............................  99215x1 and 99XXXx3 or more for
                                          each additional 15 mintues.
------------------------------------------------------------------------


 
New patient office/outpatient E/M visit
 (total practitioner time, when time is              CPT code
  used to select code level) (minutes)
------------------------------------------------------------------------
60-74..................................  99205.
75-89..................................  99205x1 and 99XXXx1.
90-104.................................  99205x1 and 99XXXx2.
105 or more............................  99205x1 and 99XXXx3 or more for
                                          each additional 15 minutes.
------------------------------------------------------------------------

    We are proposing to adopt our interpretation of the revised CPT 
prefatory language and reporting instructions, that CPT codes 99358-9 
(Prolonged E/M without Direct Patient Contact) would no longer be 
reportable in association or ``conjunction'' with office/outpatient E/M 
visits. In other words, when using time to select office/outpatient E/M 
visit level, any additional time spent by the reporting practitioner on 
a prior or subsequent date of service (such as reviewing medical 
records or test results) could not count towards the required times for 
reporting CPT codes 99202-99215 or 99XXX, or be reportable using CPT 
codes 99358-9. This interpretation would be consistent with the way the 
office/outpatient E/M visit codes were resurveyed, where the AMA/RUC 
instructed practitioners to consider all time spent 3 days prior to, or 
7 days after, the office/outpatient E/M visit (see below for a 
discussion of revaluation proposals). Moreover we note that CPT codes 
99358-9 describe time spent beyond the ``usual'' time (CPT prefatory 
language), and it is not clear what would comprise ``usual'' time given 
the new time ranges for the office/outpatient E/M visit codes and new 
CPT code 99XXX (prolonged office/outpatient E/M visit). New CPT 
prefatory language specifies, ``For prolonged services on a date other 
than the date of a face-to-face encounter, including office or other 
outpatient services (99202, 99203, 99204, 99205, 99211, 99212, 99213, 
99214, 99215), see 99358, 99359 . . . Do not report 99XXX in 
conjunction with . . . 99358, 99359''. We do not believe CPT code 99211 
should be included in this list of base codes since it will only 
include clinical staff time. Also given that CPT codes 99358, 99359 can 
be used to report practitioner time spent on any date (the date of the 
visit or any other day), the CPT reporting instruction ``see 99358, 
99359'' seems circular. The new prefatory language seems unclear 
regarding whether CPT codes 99358, 99359 could be reported instead of, 
or in addition to, CPT code 99XXX, and whether the prolonged time would 
have to be spent on the visit date, within 3 days prior or 7 days after 
the visit date, or outside of this new 10-day window relevant for the 
base code. We are seeking public input on this proposal and whether it 
would be appropriate to interpret the CPT reporting instructions for 
CPT codes 99358-9 as proposed, as well as how this interpretation may 
impact valuation. We believe CPT codes 99358 and 99359 may need to be 
redefined, resurveyed and revalued. After internal review, we believe 
that when time is used to select visit level, having one add-on code 
(CPT code 99XXX) instead of multiple add-on codes for additional time 
may be administratively simpler and most consistent with our goal of 
documentation burden reduction.
    HCPCS code GPRO1 (extended office/outpatient E/M time) would no 
longer be needed because the time described by this code would instead 
be described by a level 3, 4 or 5 office/outpatient E/M visit base code 
and, if applicable, the single new add-on CPT code for prolonged 
office/outpatient E/M visits (CPT code 99XXX). Therefore, we propose to 
delete HCPCS code GPRO1 for CY 2021. We propose to adopt the AMA/CPT 
prefatory language that lists qualifying activities that could be 
included when time is used to select the visit level. Alternatively, if 
MDM is used to choose the visit level, time would not be relevant to 
code selection.

[[Page 40675]]

b. Office/Outpatient E/M Visit Revaluation (CPT Codes 99201 Through 
99215)
    We have received valuation recommendations from the AMA RUC for the 
revised office/outpatient E/M codes (CPT codes 99201 through 99215) 
following completion of its survey and revaluation process for these 
codes. Although these codes do not take effect until CY 2021, we 
believe that it is appropriate to follow our usual process of 
addressing the valuation of the revised office/outpatient E/M codes 
through rulemaking after we receive the RUC recommendations. 
Additionally, establishing values for the new codes through rulemaking 
this year will allow more time for clinicians to make any necessary 
process and systems adjustments before they begin using the codes. In 
recent years, we have considered how best to update and revalue the 
office/outpatient E/M codes as they represent a significant proportion 
of PFS expenditures.
    MedPAC has had longstanding concerns that office/outpatient E/M 
services are undervalued in the PFS, and in its March 2019 Report to 
Congress, further asserted that the office/outpatient E/M code set has 
become passively devalued as values of these codes have remained 
unchanged, while the coding and valuation for other types of services 
under the fee schedule have been updated to reflect changes in medical 
practice (see pages 120 through 121 at http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch4_sec.pdf?sfvrsn=0).
    In April 2019, the RUC provided us the results of its review, and 
recommendations for work RVUs, practice expense inputs and physician 
time (number of minutes) for the revised office/outpatient E/M code 
set. Please note that these proposed changes in coding and values are 
for the revised office/outpatient E/M code set and a new 15-minute 
prolonged services code. That code set is effective beginning in CY 
2021, and the proposed values would go into effect with those codes as 
of January 1, 2021.
    We are proposing to adopt the RUC-recommended work RVUs for all of 
the office/outpatient E/M codes and the new prolonged services add-on 
code. Specifically, we are proposing a work RVU of 0.93 for CPT code 
99202 (Office or other outpatient visit for the evaluation and 
management of a new patient, which requires a medically appropriate 
history and/or examination and straightforward medical decision making. 
When using time for code selection, 15-29 minutes of total time is 
spent on the date of the encounter), a work RVU of 1.6 for CPT code 
99203 (Office or other outpatient visit for the evaluation and 
management of a new patient, which requires a medically appropriate 
history and/or examination and low level of medical decision making. 
When using time for code selection, 30-44 minutes of total time is 
spent on the date of the encounter), a work RVU of 2.6 for CPT code 
99204 (Office or other outpatient visit for the evaluation and 
management of a new patient, which requires a medically appropriate 
history and/or examination and moderate level of medical decision 
making. When using time for code selection, 45-59 minutes of total time 
is spent on the date of the encounter), a work RVU of 3.5 for CPT code 
99205 (Office or other outpatient visit for the evaluation and 
management of a new patient, which requires a medically appropriate 
history and/or examination and high level of medical decision making. 
When using time for code selection, 60-74 minutes of total time is 
spent on the date of the encounter. (For services 75 minutes or longer, 
see Prolonged Services 99XXX)), a work RVU of 0.18 for CPT code 99211 
(Office or other outpatient visit for the evaluation and management of 
an established patient, that may not require the presence of a 
physician or other qualified health care professional. Usually, the 
presenting problem(s) are minimal)), a work RVU of 0.7 for CPT code 
99212 (Office or other outpatient visit for the evaluation and 
management of an established patient, which requires a medically 
appropriate history and/or examination and straightforward medical 
decision making. When using time for code selection, 10-19 minutes of 
total time is spent on the date of the encounter), a work RVU of 1.3 
for 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), a work RVU of 1.92 
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), a work RVU of 2.8 
for CPT code 99215 (Office or other outpatient visit for the evaluation 
and management of an established patient, which requires a medically 
appropriate history and/or examination and high level of medical 
decision making. When using time for code selection, 40-54 minutes of 
total time is spent on the date of the encounter. (For services 55 
minutes or longer, see Prolonged Services 99XXX)) and a work RVU of 
0.61 for CPT code 99XXX (Prolonged office or other outpatient 
evaluation and management service(s) (beyond the total time of the 
primary procedure which has been selected using total time), requiring 
total time with or without direct patient contact beyond the usual 
service, on the date of the primary service; each 15 minutes (List 
separately in addition to codes 99205, 99215 for office or other 
outpatient Evaluation and Management services)).
    Regarding the RUC recommendations for practice expense inputs for 
these codes, we are proposing to remove equipment item ED021 (computer, 
desktop, with monitor), as we do not believe that this item would be 
allocated to the use of an individual patient for an individual 
service; rather, we believe this item is better characterized as part 
of indirect costs similar to office rent or administrative expenses.
    The information we reviewed on the RUC valuation exercise was based 
on an extensive survey the RUC conducted of over 50 specialty 
societies. For purposes of valuation, survey respondents were asked to 
consider the total time spent on the day of the visit, as well as any 
pre- and post-service time occurring within a time frame of 3 days 
prior to the visit and 7 days after, respectively. This is different 
from the way codes are usually surveyed by the RUC for purposes of 
valuation, where pre-, intra-, and post-service time were surveyed, but 
not within a specific time frame. The RUC then separately averaged the 
survey results for pre-service, day of service, and post-service times, 
and the survey results for total time, with the result that, for some 
of the codes, the sum of the times associated with the three service 
periods does not match the RUC-recommended total time. The RUC's 
approach sometimes results in two conflicting sets of times: The 
component times as surveyed and the total time as surveyed. Although we 
are proposing to adopt the RUC-recommended times as explained below, we 
are seeking comment on how CMS should address the discrepancies in 
times, which have implications both for for valuation of individual 
codes and for PFS ratesetting in general, as the intra-service times 
and total times are used as references for valuing many other services 
under the PFS and that the programming used for PFS ratesetting 
requires that the

[[Page 40676]]

component times sum to the total time. Specifically, we request comment 
on which times should CMS use, and how we should resolve differences 
between the component and total times when they conflict. Table 27A 
illustrates the surveyed times for each service period and the surveyed 
total time. It also shows the actual total time if summed from the 
component times.

  Table 27A--RUC-Recommended Pre-, Intra-, Post-Service Times, RUC-Recommended Total Times for CPT Codes 99202-
                                           99215 and Actual Total Time
----------------------------------------------------------------------------------------------------------------
                                                                                                       RUC-
              HCPCS                 Pre-service    Intra-service  Immediate post-  Actual total     recommended
                                       time            time        service time        time         total time
----------------------------------------------------------------------------------------------------------------
99202...........................               2              15               3              20              22
99203...........................               5              25               5              35              40
99204...........................              10              40              10              60              60
99205...........................              14              59              15              88              85
99211...........................  ..............               5               2               7               7
99212...........................               2              11               3              16              18
99213...........................               5              20               5              30              30
99214...........................               7              30              10              47              49
99215...........................              10              45              15              70              70
----------------------------------------------------------------------------------------------------------------

    Table 27B summarizes the current office/outpatient E/M services 
code set, and the new prolonged services code physician work RVUs and 
total time compared to what CMS finalized in CY 2019 for CY 2021, and 
the RUC-recommended work RVU and total time.

 Table 27B--Side by Side Comparison of Work RVUs and Physician Time for the Office/Outpatient E/M Services Code Set, and the New Prolonged Services Code
                                                                [Current versus revised]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Current total   Current work    CY 2021 total   CY 2021 work    RUC rec total   RUC rec work
                       HCPCS code                           time (mins)         RVU         time (mins)         RVU         time (mins)         RVU
--------------------------------------------------------------------------------------------------------------------------------------------------------
99201...................................................              17            0.48              17            0.48             N/A             N/A
99202...................................................              22            0.93              22            1.76              22            0.93
99203...................................................              29            1.42              29            1.76              40             1.6
99204...................................................              45            2.43              45            1.76              60             2.6
99205...................................................              67            3.17              67            3.17              85             3.5
99211...................................................               7            0.18               7            0.18               7            0.18
99212...................................................              16            0.48              16            1.18              18             0.7
99213...................................................              23            0.97              23            1.18              30             1.3
99214...................................................              40             1.5              40            1.18              49            1.92
99215...................................................              55            2.11              55            2.11              70             2.8
99XXX...................................................             N/A             N/A             N/A             N/A              15            0.61
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The RUC recommendations reflect a rigorous robust survey approach, 
including surveying over 50 specialty societies, demonstrate that 
office/outpatient E/M visits are generally more complex, for most 
clinicians. In the CY 2019 PFS final rule, we finalized for CY 2021 a 
significant reduction in the payment variation in office/outpatient E/M 
visit levels by paying a single blended rate for E/M office/outpatient 
visit levels 2 through 4 (one for established and another for new 
patients). We also maintained the separate payment rates for E/M 
office/outpatient level 5 visits in order to better account for the 
care and needs of particularly complex patients. We believed that the 
single blended payment rate for E/M office/outpatient visit levels 2-4 
better accounted for the resources associated with the typical visit. 
After reviewing the RUC recommendations, in conjunction with the 
revised code descriptors and documentation guidelines for CPT codes 
99202 through 99215, we believe codes and recommended values would more 
accurately account for the time and intensity of office/outpatient E/M 
visits than either the current codes and values or the values we 
finalized in the CY 2019 PFS final rule for CY 2021. Therefore, we are 
proposing to establish separate values for Levels 2-4 office/outpatient 
E/M visits for both new and established patients rather than continue 
with the blended rate. We are proposing to accept the RUC-recommended 
work and time values for the revised office/outpatient E/M codes 
without refinement for CY 2021. With regard to the RUC's 
recommendations for practice expense inputs, we are proposing to remove 
equipment item ED021 (computer, desktop, with monitor), as this item is 
included in the overhead costs. Note that these changes to codes and 
values would go into effect January 1, 2021.
c. Simplification, Consolidation and Revaluation of HCPCS Codes GCG0X 
and GPC1X
    Although we believe that the RUC-recommended values for the revised 
office/outpatient E/M visit codes would more accurately reflect the 
resources involved in furnishing a typical office/outpatient E/M visit, 
we believe that the revalued office/outpatient E/M code set itself 
still does not appropriately reflect differences in resource costs 
between certain types of office/outpatient E/M visits. In the CY 2019 
PFS proposed rule we articulated that, based on stakeholder comments, 
clinical examples, and our review of the literature on office/
outpatient E/M

[[Page 40677]]

services, there are three types of office/outpatient E/M visits that 
differ from the typical office/outpatient E/M visit and are not 
appropriately reflected in the current office/outpatient E/M code set 
and valuation. These three types of office/outpatient E/M visits can be 
distinguished by the mode of care provided and, as a result, have 
different resource costs. The three types of office/outpatient E/M 
visits that differ from the typical office/outpatient E/M service are 
(1) separately identifiable office/outpatient E/M visits furnished in 
conjunction with a global procedure, (2) primary care office/outpatient 
E/M visits for continuous patient care, and (3) certain types of 
specialist office/outpatient E/M visits. We proposed, but did not 
finalize, the application of an MPPR to the first category of visits, 
to account for overlapping resource costs when office/outpatient E/M 
visits were furnished on the same day as a 0-day global procedure. To 
address the shortcomings in the E/M code set in appropriately 
describing and reflecting resource costs for the other two types of 
office/outpatient E/M visits, we proposed and finalized the two HCPCS G 
codes: HCPCS code GCG0X (Visit complexity inherent to evaluation and 
management associated with non-procedural specialty care including 
endocrinology, rheumatology, hematology/oncology, urology, neurology, 
obstetrics/gynecology, allergy/immunology, otolaryngology, 
interventional pain management, cardiology, nephrology, infectious 
disease, psychiatry, and pulmonology (Add-on code, list separately in 
addition to level 2 through 4 office/outpatient evaluation and 
management visit, new or established) which describes the inherent 
complexity associated with certain types of specialist visits and GPC1X 
(Visit complexity inherent to evaluation and management associated with 
primary medical care services that serve as the continuing focal point 
for all needed health care services (Add-on code, list separately in 
addition to level 2 through 4 office/outpatient evaluation and 
management visit, new or established), which describes additional 
resources associated with primary care visits.
    Although we finalized two separate codes, we valued both HCPCS 
codes GCG0X and GPC1X via a crosswalk to 75 percent of the work and 
time value of CPT code 90785 (Interactive complexity (List separately 
in addition to the code for primary procedure)). Interactive complexity 
is an add-on code that may be billed when a psychotherapy or 
psychiatric service requires more work due to the complexity of the 
patient, and we believed that 75 percent of its work and time values 
accurately captured the additional resource costs of primary care 
office/outpatient visits and certain types of specialty office/
outpatient visits when billed with the single, blended payment rate for 
office/outpatient E/M visit levels 2-4.
    In the CY 2019 PFS final rule, we stated that, due to the variation 
among the types of visits performed by certain specialties, we did not 
believe that the broad office/outpatient E/M code set captured the 
resource costs associated with furnishing primary care and certain 
types of specialist visits (FR 83 59638). As we stated above, we 
believe that the revised office/outpatient E/M code set and RUC-
recommended values more accurately reflect the resources associated 
with a typical visit. However, we believe the typical visit described 
by the revised code set still does not adequately describe or reflect 
the resources associated with primary care and certain types of 
specialty visits.
    As such, we believe that there is still a need for add-on coding 
because the revised office/outpatient E/M code set does not recognize 
that there are additional resource costs inherent in furnishing some 
kinds of office/outpatient E/M visits. However, based on previous 
public comments and ongoing engagement with stakeholders, we understand 
the need for the add-on code(s) and descriptor(s) to be easy to 
understand and report when appropriate, including in terms of medical 
record documentation and billing. We also want to make it clear that 
the add-on coding is not intended to reflect any difference in payment 
based on the billing practitioner's specialty, but rather the 
recognition of different per-visit resource costs based on the kinds of 
care the practitioner provides, regardless of their specialty. 
Therefore, we are proposing to simplify the coding by consolidating the 
two add-on codes into a single add-on code and revising the single code 
descriptor to better describe the work associated with visits that are 
part of ongoing, comprehensive primary care and/or visits that are part 
of ongoing care related to a patient's single, serious, or complex 
chronic condition.
    We are proposing to revise the descriptor for HCPCS code GPC1X and 
delete HCPCS code GCG0X. The proposed descriptor for GPC1X appears in 
Table 28. We are seeking comment from the public and stakeholders 
regarding these proposed changes, particularly the proposed new code 
descriptor for GPC1X and whether or not more than one code, similar to 
the policy finalized last year, would be necessary or beneficial.
    We have also reconsidered the appropriate valuation for this HCPCS 
add-on G-code in the context of the revised office/outpatient E/M 
service code set and proposed values. Upon further review and in light 
of the other proposed changes to the office/outpatient E/M service code 
set, we believe that valuing the add-on code at 75 percent of CPT code 
90785 would understate the additional inherent intensity associated 
with furnishing primary care and certain types of specialty visits. As 
CPT code 90785 also describes additional work associated with certain 
psychotherapy or psychiatric services, we believe its work and time 
values are the most appropriate crosswalk for the revised HCPCS code 
GPC1X. Therefore, we are proposing to value HCPCS code GPC1X at 100 
percent of the work and time values for CPT code 90785, and proposing a 
work RVU of 0.33 and a physician time of 11 minutes. We are also 
proposing that this HCPCS add-on G code could be billed as applicable 
with every level of office and outpatient E/M visit, and that we would 
revise the code descriptor to reflect that change. See Table 28 for the 
proposed changes to the code descriptor. We note that if the CPT 
Editorial Panel makes any further changes to the office and outpatient 
E/M codes and descriptors, or creates one or more CPT codes that 
duplicate this add-on code, or if the RUC and/or stakeholders or other 
public commenters recommend values for these or other related codes, we 
would consider them through subsequent rulemaking.

[[Page 40678]]



                   Table 28--Proposed Revaluation of HCPCS Add-On G Code Finalized for CY 2021
----------------------------------------------------------------------------------------------------------------
                          Proposed code        FR 2019 total     FR 2019 work    Proposed total   Proposed work
     HCPCS code        descriptor revisions     time (mins)          RVU          time (mins)          RVU
----------------------------------------------------------------------------------------------------------------
GPC1X..............  Visit complexity                   8.25             0.25               11             0.33
                      inherent to evaluation
                      and management
                      associated with
                      medical care services
                      that serve as the
                      continuing focal point
                      for all needed health
                      care services and/or
                      with medical care
                      services that are part
                      of ongoing care
                      related to a patient's
                      single, serious, or
                      complex chronic
                      condition. (Add-on
                      code, list separately
                      in addition to office/
                      outpatient evaluation
                      and management visit,
                      new or established).
----------------------------------------------------------------------------------------------------------------

d. Valuation of CPT Code 99xxx (Prolonged Office/Outpatient E/M)
    The RUC also provided a recommendation for new CPT code 99XXX 
(Prolonged office or other outpatient evaluation and management 
service(s) (beyond the total time of the primary procedure which has 
been selected using total time), requiring total time with or without 
direct patient contact beyond the usual service, on the date of the 
primary service; each 15 minutes (List separately in addition to codes 
99205, 99215 for office or other outpatient Evaluation and Management 
services). The RUC recommended 15 minutes of physician time and a work 
RVU of 0.61. We are proposing to delete to the HCPCS add-on code we 
finalized last year for CY 2021 for extended visits (GPRO1) and adopt 
the new CPT code 99XXX. Further, as discussed above we are proposing to 
accept the RUC recommended values for CPT code 99XXX without 
refinement.
    We are seeking comment on these proposals, as well as any 
additional information stakeholders can provide on the appropriate 
valuation for these services.
e. Implementation Timeframe
    We propose that these policy changes for office/outpatient E/M 
visits would be effective for services furnished starting January 1, 
2021. We believe this would allow sufficient time for practitioner and 
provider education and further feedback; changes in clinical workflows, 
EHRs and any other impacted systems; and corresponding changes that may 
be made by other payers. In summary, we propose to adopt the following 
policies for office/outpatient E/M visits effective January 1, 2021:
     Separate payment for the five levels of office/outpatient 
E/M visit CPT codes, as revised by the CPT Editorial Panel effective 
January 1, 2021 and resurveyed by the AMA RUC, with minor refinement. 
This would include deletion of CPT code 99201 (Level 1 new patient 
office/outpatient E/M visit) and adoption of the revised CPT code 
descriptors for CPT codes 99202-99215;
     Elimination of the use of history and/or physical exam to 
select among code levels;
     Choice of time or medical decision making to decide the 
level of office/outpatient E/M visit (using the revised CPT 
interpretive guidelines for medical decision making);
     Payment for prolonged office/outpatient E/M visits using 
the revised CPT code for such services, including separate payment for 
new CPT code 99xxx and deletion of HCPCS code GPRO1 (extended office/
outpatient E/M visit) that we previously finalized for 2021;
     Revise the descriptor for HCPCS code GPC1X and delete 
HCPCS code GCG0X; and
     Increase in value for HCPCS code GCG1X and allowing it to 
be reported with all office/outpatient E/M visit levels.
f. Global Surgical Packages
    In addition to their recommendations regarding physician work, 
time, and practice expense for office/outpatient E/M visits, the AMA 
RUC also recommended adjusting the office/outpatient E/M visits for 
codes with a global period to reflect the changes made to the values 
for office/outpatient E/M visits. Procedures with a 10- and 90-day 
global period have post-operative visits included in their valuation. 
These post-operative visits are valued with reference to values for the 
E/M visits and each procedure has at least a half of an E/M visit 
included the global period. However, these visits are not directly 
included in the valuation. Rather, work RVUs for procedures with a 
global period are generally valued using magnitude estimation.
    In the CY 2015 PFS final rule, we discussed the challenges of 
accurately accounting for the number of visits included in the 
valuation of 10- and 90-day global packages. (79 FR 67548, 67582.) We 
finalized a policy to change all global periods to 0-day global 
periods, and to allow separate payment for post-operative follow-up E/M 
visits. Our concerns were based on a number of key points including: 
The lack of sufficient data on the number of visits typically furnished 
during the global periods, questions about whether we will be able to 
adjust values on a regular basis to reflect changes in the practice of 
medicine and health care delivery, and concerns about how our global 
payment policies could affect the services that are actually furnished. 
In finalizing a policy to transform all 10- and 90-day global codes to 
0-day global codes in CY 2017 and CY 2018, respectively, to improve the 
accuracy of valuation and payment for the various components of global 
packages, including pre- and post-operative visits and the procedure 
itself, we stated that we were adopting this policy because it is 
critical that PFS payment rates be based upon RVUs that reflect the 
relative resources involved in furnishing the services. We also stated 
our belief that transforming all 10- and 90-day global codes to 0-day 
global packages would:
     Increase the accuracy of PFS payment by setting payment 
rates for individual services that more closely reflect the typical 
resources used in furnishing the procedures;
     Avoid potentially duplicative or unwarranted payments when 
a beneficiary receives post-operative care from a different 
practitioner during the global period;
     Eliminate disparities between the payment for E/M services 
in global periods and those furnished individually;
     Maintain the same-day packaging of pre- and post-operative 
physicians' services in the 0-day global packages; and
     Facilitate the availability of more accurate data for new 
payment models and quality research.
    Section 523(a) of MACRA added section 1848(c)(8)(A) of the Act, 
which

[[Page 40679]]

prohibited the Secretary from implementing the policy described above, 
which would have transformed all 10-day and 90-day global surgery 
packages to 0-day global packages. Section 1848(c)(8)(B) of the Act, 
which was also added by section 523(a) of the MACRA, required us to 
collect data to value surgical services. Section 1848(c)(8)(B)(i) of 
the Act requires us to develop a process to gather information needed 
to value surgical services from a representative sample of physicians, 
and requires that the data collection begin no later than January 1, 
2017. The collected information must include the number and level of 
medical visits furnished during the global period and other items and 
services related to the surgery and furnished during the global period, 
as appropriate. Section 1848(c)(8)(B)(iii) of the Act specifies that 
the Inspector General shall audit a sample of the collected information 
to verify its accuracy. Section 1848(c)(8)(C) of the Act, which was 
also added by section 523(a) of the MACRA, requires that, beginning in 
CY 2019, we must use the information collected as appropriate, along 
with other available data, to improve the accuracy of valuation of 
surgical services under the PFS.
    Resource-based valuation of individual physicians' services is a 
critical foundation for Medicare payment to physicians. It is essential 
that the RVUs under the PFS be based as closely and accurately as 
possible on the actual resources used in furnishing specific services 
to make appropriate payment and preserve relativity among services. For 
global surgical packages, this requires using objective data on all of 
the resources used to furnish the services that are included in the 
package. Not having such data for some components may significantly 
skew relativity and create unwarranted payment disparities within the 
PFS. The current valuations for many services valued as global packages 
are based upon the total package as a unit rather than by determining 
the resources used in furnishing the procedure and each additional 
service/visit and summing the results. As a result, we do not have the 
same level of information about the components of global packages as we 
do for other services. To value global packages accurately and relative 
to other procedures, we need accurate information about the resources--
work, PEs and malpractice--used in furnishing the procedure, similar to 
what is used to determine RVUs for all services. In addition, we need 
the same information on the postoperative services furnished in the 
global period (and pre-operative services the day before for 90-day 
global packages).
    In response to the MACRA amendments to section 1848(c)(8 of the 
Act), CMS required practitioners who work in practices that include 10 
or more practitioners in Florida, Kentucky, Louisiana, Nevada, New 
Jersey, North Dakota, Ohio, Oregon, and Rhode Island to report using 
CPT 99024 on post-operative visits furnished during the global period 
for select procedures furnished on or after July 1, 2017. The specified 
procedures are those that are furnished by more than 100 practitioners 
and either are nationally furnished more than 10,000 times annually or 
have more than $10 million in annual allowed charges.
    RAND analyzed the data collected from the post-operative visits 
through this claim-based reporting for the first year of reporting, 
July 1, 2017-June 30, 2018. They found that only 4 percent of 
procedures with 10-day global periods had any post-operative visits 
reported. While 71 percent of procedures with 90-day global periods had 
at least one associated post-operative visit, only 39 percent of the 
total post-operative visits expected for procedures with 90-day global 
periods were reported. (A complete report on this is available at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html).
    In addition to the claims-based data collection, RAND collected 
data on the level of visits. They began with an attempt to collect data 
via a survey from all specialties as described in the 2017 final rule. 
Given the low rate of response from practitioners, we shifted the study 
and focused on three high-volume procedures with global periods that 
were common enough to likely result in a robust sample size: (1) 
Cataract surgery; (2) hip arthroplasty; and (3) complex wound repair. A 
total of 725 physicians billing frequently for cataract surgery, hip 
arthroplasty, and complex wound repair reported on the time, 
activities, and staff involved in 3,469 visits. Our findings on 
physician time and work from the survey were broadly similar to what we 
expected based on the Time File for cataract surgery and hip 
replacement and somewhat different for complex wound repair. (For the 
complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html).
    The third report in the series looks at ways we could consider 
revaluing procedures using the collected data. To provide us with 
estimates to frame a discussion, RAND modeled how valuation for 
procedures would change by adjusting work RVUs, physician time, and 
direct PE inputs based on the difference between the number of post-
operative visits observed via claims-based reporting and the expected 
number of post-operative visits used during valuation. RAND looked at 
three types of changes: (1) Updated work RVUs based on the observed 
number of post-operative visits measured four ways (median, 75th 
percentile, mean, and modal observed visits); (2) Allocated PE RVUs 
reflecting direct PE inputs updated to reflect the median number of 
reported post-operative visits; and (3) Modeled total RVUs reflecting 
(a) updated work RVUs, (b) updated physician time, and (c) updated 
direct PE inputs, and including allocated PE and malpractice RVUs. This 
report is designed to inform further conversations about how to revalue 
global procedures. (For the complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.) We will give the public and 
stakeholders time to study the reports we are making available along 
with this rule and consider an appropriate approach to revaluing global 
surgical procedures. We also note that the Office of the Inspector 
General (OIG) has published a number of reports on this topic. We will 
continue to study and consider alternative ways to address the values 
for these services.
g. Comment Solicitation on Revaluing the Office/Outpatient E/M Visit 
Within TCM, Cognitive Impairment Assessment/Care Planning and Similar 
Services
    We recognize there are services other than the global surgical 
codes for which the values are closely tied to the values of the 
office/outpatient E/M visit codes, such as transitional care management 
services (CPT codes 99495, 99496); cognitive impairment assessment and 
care planning (CPT code 99483); certain ESRD monthly services (CPT 
codes 90951 through 90961); the Initial Preventive Physical Exam 
(G0438) and the Annual Wellness Visit (G0439). In future rulemaking, we 
may consider adjusting the RVUs for these services and are seeking 
public input on such a policy. We note that unlike the global surgical 
codes, these services always include an office/outpatient E/M visit(s) 
furnished by the reporting practitioner as part of the service, and it 
may therefore be appropriate to adjust their valuation commensurate 
with any

[[Page 40680]]

changes to the values for the revised codes for office/outpatient E/M 
visits. While some of these services do not involve an E/M visit, we 
valued them using a direct crosswalk to the RVUs assigned to an office/
outpatient E/M visit(s) and for this reason they are closely tied to 
values for office/outpatient E/M visits.
    We are also seeking comment on whether or not the public believes 
it would be necessary or beneficial to make systematic adjustments to 
other related PFS services to maintain relativity between these 
services and office/outpatient E/M visits. We are particularly 
interested in whether it would be beneficial or necessary to make 
corresponding adjustments to E/M codes describing visits in other 
settings, such as home visits, or to codes describing more specific 
kinds of visits, like counseling visits. For example, CPT code 99348 
(Home visit for the evaluation and management of an established 
patient, which requires at least 2 of these 3 key components: An 
expanded problem focused interval history; An expanded problem focused 
examination; Medical decision making of low complexity. Counseling and/
or coordination of care with other physicians, other qualified health 
care professionals, or agencies are provided consistent with the nature 
of the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are of low to moderate severity. Typically, 25 
minutes are spent face-to-face with the patient and/or family) is 
commonly used to report home visits, and like CPT code 99214, the code 
describes approximately 45 minutes of time with the patient and has a 
work RVU of 1.56. Under the proposal to increase the work RVU of CPT 
code 99214 from 1.5 to 1.92, the proportional value of CPT code 99348 
would decrease relative to the work RVU for CPT code 99214. To maintain 
the same proportional value to CPT code 99214, the work RVU for CPT 
code 99348 would need to increase from 1.56 to 2.00. We understand that 
certain other services, such as those that describe ophthalmological 
examination and evaluation, as well as psychotherapy visit codes, are 
used either in place of or in association with office/outpatient visit 
codes. For example, CPT code 92012 (Ophthalmological services: Medical 
examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; intermediate, established patient) 
currently has a work RVU of 0.92. Under the proposal to increase the 
work RVU of CPT code 99213 from 0.97 to 1.30, the proportional value of 
CPT code 92012 would decrease relative to the work RVU for CPT code 
99213, as both codes describe around 30 minutes of work. To maintain 
the same proportional value to CPT code 99213, the work RVU for CPT 
code 92012 would need to increase from 0.92 to 1.23. Similarly, 
behavioral health professionals report several codes to describe 
psychiatric diagnostic evaluations and visits they furnish. When 
furnished with an evaluation and management service, practitioners 
report psychotherapy add-on codes instead of stand-alone psychotherapy 
codes that would otherwise be reported. Because the overall work RVUs 
for the combined service, including the value for the office/outpatient 
visit code, would increase under the proposal, we are interested in 
comments regarding whether or not it would be appropriate to reconsider 
the value of the psychotherapy codes, as well as the psychiatric 
diagnostic evaluations relative to the proposed values for the office/
outpatient visit codes. Under the proposed revaluation of the office/
outpatient E/M visits, the proportional value of CPT code 90834 
(Psychotherapy, 45 minutes with patient) would decrease relative to 
work RVUs for CPT code 99214 plus CPT code 90836. The current work RVU 
for CPT code 99214 when reported with CPT code 90836 is 3.40 (1.90 + 
1.50) and the current work RVU for CPT code 90834 is 2.0. Under the 
proposed revaluation of the office/outpatient E/M visits, the combined 
work RVU for CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92). In 
order to maintain the proportionate difference between these services, 
the work RVU for CPT code 90834 would increase from 2.00 to 2.25. Based 
on these three examples, we are seeking public comment on whether we 
should make similar adjustments to E/M codes in different settings, and 
other types of visits, such as counseling services.

III. Other Provisions of the Proposed Regulations

A. Changes to the Ambulance Physician Certification Statement 
Requirement

    Under our ongoing initiative to identify Medicare regulations that 
are unnecessary, obsolete, or excessively burdensome on health care 
providers and suppliers, we are proposing to revise Sec. Sec.  410.40 
and 410.41. Importantly, we first clarify that these requirements apply 
to ambulance providers, as well as suppliers. The proposed revisions 
would give certain clarity to ambulance providers and suppliers 
regarding the physician or non-physician certification statement and 
add staff who may sign certification statements when the ambulance 
provider or supplier is unable to obtain a signed statement from the 
attending physician.
1. Exceptions to Certification Statement Requirement
    Under section 1861(s)(7) of the Act, ambulance services are covered 
where the use of other methods of transportation is contraindicated by 
the individual's condition, but only to the extent provided in 
regulations. Currently, Sec.  410.40(d) specifies the medical necessity 
requirements for both nonemergency, scheduled, repetitive ambulance 
services and nonemergency ambulance services that are either 
unscheduled or that are scheduled on a nonrepetitive basis. In the 
final rule with comment period that appeared in the January 25, 1999 
Federal Register (64 FR 3637) (hereinafter referred to as the ``January 
25, 1999 final rule with comment period''), we stated that a physician 
certification statement (PCS) must be obtained as evidence that the 
attending physician has determined that other means of transportation 
are contraindicated and that the transport is medically necessary (64 
FR 3639). In the final rule with comment period that appeared in the 
February 27, 2002 Federal Register (67 FR 9100) (hereinafter referred 
to as the ``February 27, 2002 final rule with comment period'') we 
added that a certification statement (hereinafter referred to as non-
physician certification statement) could be obtained from other 
authorized staff should the attending physician be unavailable. (67 FR 
9111)
    Currently there are no circumstances, other than those specified at 
Sec.  410.40(d)(3)(ii) and (iv), granting exceptions to the need for a 
PCS or non-physician certification statement, and we have received 
feedback from ambulance providers, suppliers, and their industry 
representatives (``stakeholders'') that various situations exist where 
the need for a PCS or non-physician certification is excessive, or at 
least redundant to similar existing documentation requirements. Two of 
the most prominent circumstances identified by the stakeholders include 
interfacility transports (IFTs), commonly referred to as hospital to 
hospital transports and specialty care transports (SCTs), and it has 
been requested that we incorporate additional exceptions into the 
regulatory framework.
    Upon reviewing the need for a PCS and non-physician certification

[[Page 40681]]

statement, stakeholders' concerns, and our commitment to reducing the 
burden placed on providers and suppliers, we have determined that 
instead of incorporating additional exceptions, our efforts would be 
better served by minorly altering the structure of the existing 
regulatory framework. These changes are intended to maximize 
flexibility for ambulance providers and suppliers to obtain the 
requisite certification statements and maintain the focus on the 
determination that other means of transportation are contraindicated 
and that the transport is medically necessary.
    To accomplish this, we are proposing to add a new paragraph (a) in 
Sec.  410.40 in which we would define both PSCs, as well as non-
physician certification statements. Therefore, we are proposing to 
redesignate existing paragraph (a) ``Basic rules'' as paragraph (b) and 
redesignate the remaining paragraphs, respectively. Most significantly, 
paragraph (d) ``Medical necessity requirements'' will be redesignated 
as paragraph (e).
    For new proposed paragraph (a), the two definitions, PCSs and non-
physician certification statements, would clarify that: (1) The focus 
is on the certification of the medical necessity provisions contained 
in proposed newly redesignated paragraph (e)(1); and (2) the form of 
the certification statement is not prescribed, thus affording maximum 
flexibility to ambulance providers and suppliers. Since the two 
definitions incorporate the requirement to obtain a certification of 
medical necessity, we are proposing a conforming change to newly 
redesignated paragraph (e)(2) to remove the language requiring that an 
order certifying medical necessity be obtained.
    We have repeatedly been told by stakeholders that there are ample 
opportunities for ambulance providers and suppliers to convey the 
information required in the certification statement. Stakeholders have 
mentioned, for example, that for transports such as IFTs and SCTs other 
requirements of federal, state, or local law require them to obtain 
other documentation, such as Emergency Medical Treatment & Labor Act 
(EMTALA) forms and medical transport forms, that can serve the same 
purpose as the PCS or non-physician certification statement. There is 
every likelihood that other ambulance transports require similarly 
styled documentation that likewise could serve the same purpose.
    To be clear, our regulations have never prescribed the precise form 
or format of this required documentation. To satisfy the requirements 
of section 1861(s)(7) of the Act, ambulance providers' and suppliers' 
focus should be on clearly documenting the threshold determination that 
other means of transportation are contraindicated and that the 
transport is medically necessary. The precise form or format by which 
that information is conveyed has never been prescribed. We aim here to 
ensure that ambulance providers and suppliers understand they have 
flexibility in the form by which they convey the requirements of 
proposed Sec.  410.40(e), so long as that threshold determination is 
clearly expressed.
    The definition of non-physician certification statement in proposed 
Sec.  410.40(a) would incorporate the existing requirements that apply 
when an ambulance provider or supplier is unable to obtain a signed PCS 
from the attending physician and, instead, obtains a non-physician 
certification statement, including: (1) That the staff have personal 
knowledge of the beneficiary's condition at the time the ambulance 
transport is ordered or the service is furnished; (2) the employment 
requirements; and (3) the specific staff that can sign in lieu of the 
attending physician. Included within the proposed definition of non-
physician certification statement, and as further discussed below, is 
an expansion of the list of staff who may sign when the attending 
physician is unavailable. In light of the staff being listed as part of 
the definition of non-physician certification statement proposed at 
Sec.  410.40(a), we are proposing a corresponding change to proposed 
and newly redesignated paragraph (e)(3)(iii) to remove the reference to 
the staff currently listed within the paragraph. Moreover, in 
paragraphs (e)(3)(i) and (iv) we have proposed changes to refer to the 
newly redesignated paragraph (e) and in paragraph (e)(3)(v) we have 
proposed changes to refer to the newly defined terms in paragraph (a), 
specifically the physician or non-physician certification statement. 
Lastly, we are also proposing a corresponding change to Sec.  
410.41(c)(1) to add that ambulance providers or suppliers must indicate 
on the claims form that, ``when applicable, a physician certification 
statement or non-physician certification statement is on file.''
    In the CY 2013 PFS final rule with comment period (77 FR 69161), we 
stated that the Secretary is the final arbiter of whether a service is 
medically necessary for Medicare coverage. We believe that the proposed 
changes would better enable contractors to establish the medical 
necessity of these transports by focusing more on the threshold medical 
necessity determination as opposed to the form or format of the 
documentation used. We do not anticipate that this clarification will 
alter the frequency of claim denials.
2. Addition of Staff Authorized To Sign Non-Physician Certification 
Statements
    In the January 25, 1999 final rule with comment period (64 FR 
3637), we finalized language at Sec.  410.40 to require ambulance 
providers or suppliers, in the case of nonemergency unscheduled 
ambulance services (Sec.  410.40(d)(3)) to obtain a PCS. In that rule, 
we explained that: (1) Nonemergency ambulance service is a Medicare 
service furnished to a beneficiary for whom a physician is responsible, 
therefore, the physician is responsible for the medical necessity 
determination; and (2) the PCS will help to ensure that the claims 
submitted for ambulance services are reasonable and necessary, because 
other methods of transportation are contraindicated (64 FR 3641). We 
further stated that we believed the requirement would help to avoid 
Medicare payment for unnecessary ambulance services that are not 
medically necessary even though they may be desirable to beneficiaries.
    In that final rule with comment period, however, we also addressed 
the ability of ambulance providers or suppliers to obtain a written 
order from the beneficiary's attending physician within 48 hours after 
the transport to avoid unnecessary delays. We agreed with stakeholders 
that while it is reasonable to expect that an ambulance supplier could 
obtain a pretransport PCS for routine, scheduled trips, it is less 
reasonable to impose such a requirement on unscheduled transports, and 
that it was not necessary that the ambulance suppliers have the PCS in 
hand prior to furnishing the service. To avoid unnecessary delays for 
unscheduled transports, we therefore finalized the requirement that 
required documentation can be obtained within 48 hours after the 
ambulance transportation service has been furnished.
    In the February 27, 2002 final rule with comment period (67 FR 
9111), we noted that we had been made aware of instances in which 
ambulance suppliers, despite having provided ambulance transports, 
were, through no fault of their own, experiencing difficulty in 
obtaining the necessary PCS within the required 48-hour timeframe. We 
stated that the 48-hour period remained the appropriate period of time, 
but created alternatives for ambulance providers and suppliers unable 
to obtain a PCS. We finalized an alternative at Sec.  410.40(d)(3)(iii) 
where ambulance providers and suppliers

[[Page 40682]]

unable to obtain a PCS from the attending physician could obtain a 
signed certification (not a physician certification statement) from 
certain other staff. At that time, we identified several staff members, 
including a physician assistant (PA), nurse practitioner (NP), clinical 
nurse specialist (CNS), registered nurse (RN), and a discharge planner 
as staff members able to sign such a non-physician certification 
statement. The only additional constraints are: (1) That the staff be 
employed by the beneficiary's attending physician or by the hospital or 
facility where the beneficiary is being treated and from which the 
beneficiary is transported; and (2) that the staff have personal 
knowledge of the beneficiary's condition at the time the ambulance 
transport is ordered or the service is furnished.
    In the intervening years, we have received feedback from 
stakeholders that other staff, such as licensed practical nurses 
(LPNs), social workers, and case managers, should be included in the 
list of staff that can sign a certification statement. Similar to the 
currently designated staff, we now believe that LPNs, social workers, 
and case managers who have personal knowledge of a beneficiary's 
condition at the time ambulance transport is ordered and the service is 
furnished have a skill set largely equal or similar to the other staff 
members. Thus, we are proposing as part of the new proposed definition 
of non-physician certification statement at Sec.  410.40(a)(2)(iii) to 
add LPNs, social workers, and case managers to the list of staff who 
may sign a certification statement when the ambulance provider or 
supplier is unable to obtain a signed PCS from the attending physician. 
As with the staff currently listed in Sec.  410.40(d)(3)(iii), LPNs, 
social workers, and case managers would need to be employed by the 
beneficiary's attending physician or the hospital or facility where the 
beneficiary is being treated and from which the beneficiary is 
transported, and have personal knowledge of the beneficiary's condition 
at the time the ambulance transport is ordered or the service is 
furnished. We also request comments on whether other staff should be 
included in this regulation, and request that commenters identify such 
staff's licensure and position and the reason it would be appropriate 
for such staff to sign a certification statement.

B. Proposal To Establish a Medicare Ground Ambulance Services Data 
Collection System

1. Background
    Section 1861(s)(7) of the Act establishes an ambulance service as a 
Medicare Part B service where the use of other methods of 
transportation is contraindicated by the individual's condition, but 
only to the extent provided in regulations. Since April 1, 2002, 
payment for ambulance services has been made under the ambulance fee 
schedule (AFS), which the Secretary established under section 1834(l) 
of the Act. Payment for an ambulance service is made at the lesser of 
the actual billed amount or the AFS amount, which consists of a base 
rate for the level of service, a separate payment for mileage to the 
nearest appropriate facility, a geographic adjustment factor, and other 
applicable adjustment factors as set forth at section 1834(l) of the 
Act and 42 CFR 414.610 of the regulations. In accordance with section 
1834(l)(3) of the Act and Sec.  414.610(f), the AFS rates are adjusted 
annually based on an inflation factor. The AFS also incorporates two 
permanent add-on payments and three temporary add-on payments to the 
base rate and/or mileage rate. The two permanent add-on payments are: 
(1) A 50 percent increase in the standard mileage rate for ground 
ambulance transports that originate in rural areas where the travel 
distance is between 1 and 17 miles; and (2) a 50 percent increase to 
both the base and mileage rate for rural air ambulance transports. The 
three temporary add-on payments are: (1) A 3 percent increase to the 
base and mileage rate for ground ambulance transports that originate in 
rural areas; (2) a 2 percent increase to the base and mileage rate for 
ground ambulance transports that originate in urban areas; and (3) a 
22.6 percent increase in the base rate for ground ambulance transports 
that originate in ``super rural'' areas. Our regulations relating to 
coverage of and payment for ambulance services are set forth at 42 CFR 
part 410, subpart B, and 42 CFR part 414, subpart H.
2. Statutory Requirement for Ground Ambulance Providers and Suppliers 
To Submit Cost and Other Information
    Section 50203(b) of the BBA of 2018 added a new paragraph (17) to 
section 1834(l) of the Act, which requires ground ambulance providers 
of services and suppliers to submit cost and other information. 
Specifically, section 1834(l)(17)(A) of the Act requires the Secretary 
to develop a data collection system (which may include use of a cost 
survey) to collect cost, revenue, utilization, and other information 
determined appropriate by the Secretary for providers and suppliers of 
ground ambulance services. Such system must be designed to collect 
information: (1) Needed to evaluate the extent to which reported costs 
relate to payment rates under the AFS; (2) on the utilization of 
capital equipment and ambulance capacity, including information 
consistent with the type of information described in section 1121(a) of 
the Act; and (3) on different types of ground ambulance services 
furnished in different geographic locations, including rural areas and 
low population density areas described in section 1834(l)(12) of the 
Act (super rural areas).
    Section 1834(l)(17)(B)(i) of the Act requires the Secretary to 
specify the data collection system by December 31, 2019, and to 
identify the ground ambulance providers and suppliers that would be 
required to submit information under the data collection system, 
including the representative sample defined at clause (ii).
    Under section 1834(l)(17)(B)(ii) of the Act, not later than 
December 31, 2019, for the data collection for the first year and for 
each subsequent year through 2024, the Secretary must determine a 
representative sample to submit information under the data collection 
system. The sample must be representative of different types of ground 
ambulance providers and suppliers (such as those providers and 
suppliers that are part of an emergency service or part of a government 
organization) and the geographic locations in which ground ambulance 
services are furnished (such as urban, rural, and low population 
density areas), and not include an individual ground ambulance provider 
or supplier in the sample for 2 consecutive years, to the extent 
practicable.
    Section 1834(l)(17)(C) of the Act requires that for each year, a 
ground ambulance provider or supplier identified by the Secretary in 
the representative sample as being required to submit information under 
the data collection system for a period for the year must submit to the 
Secretary the information specified under the system in a form and 
manner, and at a time specified by the Secretary.
    Section 1834(l)(17)(D) of the Act requires that beginning January 
1, 2022, the Secretary apply a 10 percent payment reduction to payments 
made under section 1834(l) of the Act for the applicable period to a 
ground ambulance provider or supplier that is required to submit 
information under the data collection system and does not

[[Page 40683]]

sufficiently submit such information. The term ``applicable period'' is 
defined under section 1834(l)(17)(D)(ii) of the Act to mean, for a 
ground ambulance provider or supplier, a year specified by the 
Secretary not more than 2 years after the end of the period for which 
the Secretary has made a determination that the ground ambulance 
provider or supplier has failed to sufficiently submit information 
under the data collection system. A hardship exemption to the payment 
reduction is authorized under section 1834(l)(17)(D)(iii) of the Act, 
which provides that the Secretary may exempt a ground ambulance 
provider or supplier from the payment reduction for an applicable 
period in the event of significant hardship, such as a natural 
disaster, bankruptcy, or other similar situation that the Secretary 
determines interfered with the ability of the ground ambulance provider 
or supplier to submit such information in a timely manner for the 
specified period. Lastly, section 1834(l)(17)(D)(iv) of the Act 
requires the Secretary to establish an informal review process under 
which a ground ambulance provider or supplier may seek an informal 
review of a determination that the provider or supplier is subject to 
the payment reduction.
    Section 1834(l)(17)(E)(i) allows the Secretary to revise the data 
collection system as appropriate and, if available, taking into 
consideration the report (or reports) that the Medicare Payment 
Advisory Commission (MedPAC) will submit to Congress. Section 
1834(l)(17)(E)(ii) of the Act specifies that, to continue to evaluate 
the extent to which reported costs relate to payment rates under 
section 1834(l) of the Act and other purposes as the Secretary deems 
appropriate, the Secretary shall require ground ambulance providers and 
suppliers to submit information for years after 2024, but in no case 
less often than once every 3 years, as determined appropriate by the 
Secretary.
    As required by section 1834(l)(17)(F) of the Act, not later than 
March 15, 2023, and as determined necessary by MedPAC, MedPAC must 
assess, and submit to Congress a report on, information submitted by 
providers and suppliers of ground ambulance services through the data 
collection system, the adequacy of payments for ground ambulance 
services and geographic variations in the cost of furnishing such 
services. The report must contain the following:
     An analysis of information submitted through the data 
collection system;
     An analysis of any burden on ground ambulance providers 
and suppliers associated with the data collection system;
     A recommendation as to whether information should continue 
to be submitted through such data collection system or if such system 
should be revised by the Secretary, as provided under section 
1834(l)(17)(E)(i) of the Act; and
     Other information determined appropriate by MedPAC.
    Section 1834(l)(17)(G) of the Act requires the Secretary to post 
information on the results of the data collection on the CMS website, 
as determined appropriate by the Secretary.
    Section 1834(l)(17)(H) of the Act requires the Secretary to 
implement the provisions of section 1834(l)(17) of the Act through 
notice and comment rulemaking.
    Section 1834(l)(17)(I) of the Act provides that the Paperwork 
Reduction Act (Title 44, Chapter 35 of the U.S. Code) does not apply to 
collection of information required under section 1834(l)(17) of the 
Act.
    Section 1834(l)(17)(J) of the Act provides that there shall be no 
administrative or judicial review under sections 1869 or 1878 of the 
Act, or otherwise, of the data collection system or identification of 
respondents.
    We note that while the requirements of section 1834(l)(17) of the 
Act are specific to ground ambulance organizations, many stakeholders 
have expressed interest to us in making this type of information 
available for other providers and suppliers of ambulance services. For 
example, air ambulance organizations have suggested they are interested 
in making this information available. We recognize that the regulation 
of air ambulances spans multiple federal agencies, and note that 
section 418 of the FAA Reauthorization Act of 2018 (Pub. L. 115-254, 
enacted October 5, 2018) requires the Secretary of HHS, in consultation 
with the Secretary of Transportation, to establish an advisory 
committee that includes HHS, DOT, and others to review options to 
improve the disclosure of charges and fees for air medical services, 
better inform consumers of insurance options for those services, and 
better inform and protect consumers of these services. We welcome 
comments on the state of the air ambulance industry and how CMS can 
work within its statutory authority to ensure that appropriate payments 
are made to air ambulance organizations serving the Medicare 
population.
3. Research To Inform the Development of a Ground Ambulance Data 
Collection System
    To inform the development of a ground ambulance data collection 
system, including a representative sampling plan, our contractor 
developed recommendations regarding the methodology for collecting 
cost, revenue, utilization and other information from ground ambulance 
providers and suppliers (collectively referred to in this proposed rule 
as ``ground ambulance organizations'') and a sampling plan consistent 
with sections 1834(l)(17)(A) and (B) of the Act. Our contractor also 
developed recommendations for the collection and reporting of data with 
the least amount of burden possible to ground ambulance organizations. 
The recommendations took into consideration the following:
     An environmental scan consisting of a review of existing 
peer-reviewed literature, government and association reports, and 
targeted web searches. The purpose of the environmental scan was to 
collect information on costs and revenues of ground ambulance 
transportation services, identify background information regarding the 
differences among ground ambulance organizations including state and 
local requirements that may impact the costs of providing ambulance 
services, and describe financial challenges facing the ambulance 
industry. Five previously fielded ambulance cost collection tools were 
also identified and analyzed and are described below.
     Interviews with ambulance providers and suppliers, billing 
companies, and other stakeholders to determine all major cost, revenue, 
and utilization components, and differences in these components across 
ground ambulance organizations. These discussions provided valuable 
information on the process for developing a data collection system, 
including how to best elicit valid responses and limit burden on 
respondents, as well as the timing of the data collection.
     Analyses of Medicare claims and enrollment data, including 
all fee-for-service (FFS) Medicare claims with dates of service in 
2016, the most recent complete year of claims data for ground ambulance 
services.
    Our contractor also analyzed the following five data collection 
tools that currently collect or have collected data from ground 
ambulance organizations:
     The Moran Company Statistical and Financial Data Survey 
(the ``Moran

[[Page 40684]]

survey'').\85\ In 2012, American Ambulance Association (AAA) 
commissioned a study with the goal of developing a data collection 
instrument and making recommendations for collecting data to determine 
the costs of delivering ground ambulance services to Medicare 
beneficiaries. The result was the Moran survey, which is a two-step 
data collection method in which all ambulance providers and suppliers 
first complete a short survey with basic descriptive information on 
their characteristics, and second, a representative sample of ambulance 
providers and suppliers report more specific cost information.
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    \85\ The Moran Company (2014). Detailing ``Hybrid Data 
Collection Method'' for the Ambulance Industry: Beta Test Results of 
the Statistical & Financial Data Survey & Recommendations, [Online]. 
Available at https://s3.amazonaws.com/americanambulance-advocacy/AAA+Final+Report+Detailing+Hybrid+Data+Collection+Method.pdf.
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     Ground Emergency Medical Transportation (GEMT) Cost Report 
form and instructions from California's Medicaid program.\86\ The GEMT 
Cost Report form and instructions is used by some states to determine 
whether ambulance providers and suppliers should receive supplemental 
payments from state Medicaid programs to cover shortfalls between 
revenue and costs. This data collection instrument is geared toward 
government entities, as private ambulance providers and suppliers do 
not qualify for the supplemental payments.
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    \86\ State of California--Health and Human Services Agency 
Department of Health Care Services Ground Emergency Medical 
Transportation (2013). Ground Emergency Medical Transportation 
Services Cost Report General Instructions for Completing Cost Report 
Forms, [Online]. Available at http://www.dhcs.ca.gov/provgovpart/documents/gemt/gemt_cstrptinstr.pdf.
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     The Emergency Medical Services Cost Analysis Project 
(EMSCAP) framework.\87\ The National Highway Traffic Safety 
Administration funded EMSCAP in 2007 to develop a framework for 
determining the cost for an EMS system at the community level. 
Subsequently, EMSCAP researchers used this framework to develop a cost 
workbook and pilot test the instrument on three communities 
representing rural, urban, and suburban areas. EMS services within the 
three communities included volunteer, paid, and combination EMS 
agencies, both fire department and third service-based. Third service-
based refers to services provided by a local government that include a 
fire department, police department and a separate EMS, forming an 
emergency trio.
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    \87\ Lerner, E.B., Nichol, G., Spaite, D.W., Garrison, H.G., & 
Maio, R.F. (2007). A comprehensive framework for determining the 
cost of an emergency medical services system. Available at https://www.mcw.edu/departments/emergency-medicine/research/emergency-medical-services-cost-analysis-project.
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     A 2012 Government Accountability Office (GAO) ambulance 
survey.\88\ To examine ground ambulance suppliers' costs for 
transports, in 2012 GAO administered a web-based survey to a random 
sample of 294 eligible ambulance suppliers. GAO collected data on their 
2010 costs, revenues, transports, and organizational characteristics. 
Although the GAO survey collected data for each domain at the summary 
level, it also prompted respondents to take into account multiple 
factors when calculating their summary costs.
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    \88\ U.S. Government Accountability Office (2012). Survey of 
Ambulance Services. Available at https://www.gao.gov/assets/650/649018.pdf.
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     The Rural Ambulance Service Budget Model.\89\ This tool 
was developed by a task force of the Rural EMS and Trauma Technical 
Assistance Center with funds from the Health Resources and Services 
Administration (HRSA) in the early 2000s. The purpose was to provide 
assistance to rural ambulance entities in establishing an annual budget 
and to calculate the value of services donated by other entities, as 
well as services donated by the ambulance entity's staff to the 
community. The tool was last updated in 2010 and has been cited as a 
resource for rural ground ambulance organizations by state and national 
government agencies. However, use of the tool is not required by any of 
these agencies.
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    \89\ Health Resources and Services Administration. The Rural 
Ambulance Service Budget Model, [Online]. Available at https://www.ruralcenter.org/resource-library/rural-ambulance-service-budget-model.
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    Our contractor's analysis of these tools revealed that while there 
was overlap of the broad cost categories collected (for example, labor, 
vehicles, and facilities costs) via these tools, there were significant 
differences in the more specific data collected within these broad 
categories. Overall, there was a large amount of variability regarding 
whether the tools allowed for detailed accounting of costs and whether 
the tools used respondent-defined or survey-defined categories for 
reporting. The five tools also differed in terms of their instructions, 
format, and design in terms of how a portion of organizations' total 
costs were allocated to ground ambulance costs, the time frame for 
reporting, and the flexibility of reporting.
    Based on these activities, our contractor prepared a report 
entitled, ``Medicare Ground Ambulance Data Collection System--Sampling 
and Data Collection Instrument Considerations and Recommendations'' 
(referred to as ``the CAMH \90\ report'') which is referenced 
throughout this proposed rule. It is available at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html and provides more 
detail on the research, findings and recommendations concerning the 
data collection instrument and sampling. This report, in addition to 
other considerations we describe below, informed our proposals for the 
data collection instrument.
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    \90\ CMS Alliance to Modernize Healthcare.
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4. Proposals for the Data Collection Instrument
a. Proposed Format
    We considered several options for collecting the data including a 
survey, a cost report spreadsheet like the GEMT, and the Medicare Cost 
Report (MCR). During interviews with ambulance providers and suppliers, 
some participants stated that they would prefer that data collection be 
done through a cost report spreadsheet, rather than a survey, such as 
the GEMT and other similar data collection tools utilized by state 
Medicaid programs. They noted that data cost collection spreadsheets 
such as the GEMT are used in some states where supplemental payments 
are made to ground ambulance organizations based on costs and revenue 
reported via a cost reporting template. Although these tools are 
valuable to the ambulance suppliers that utilize them for Medicaid 
payment purposes, we note that only a small number of states make use 
of these tools for the purpose of providing supplemental payments and 
that they are generally geared toward government run entities that 
provide a broad range of emergency medical services and not just ground 
ambulance services. For these reasons, we do not believe that these 
tools could be used by all ground ambulance organizations for Medicare 
payment purposes without significant revision.
    Other ambulance providers and suppliers stated their preference for 
survey-based reporting, such as the Moran survey, because they believe 
survey reporting is less burdensome and allows more flexibility for 
reporting. We agree that survey reporting can be designed to provide 
greater flexibility of reporting with reduced reporting burden. 
However, the Moran survey recommended excluding small ground ambulance 
organizations with limited capacity or those which relied heavily

[[Page 40685]]

on volunteer services, which would exclude a large percentage of ground 
ambulance organizations from our sample. It would also not take into 
account the unique differences of government run ground ambulance 
entities, and specifically ground ambulance entities that provide other 
emergency services such as fire services, and could not be used by all 
ground ambulance organizations without significant revisions. Some 
ambulance organizations that favored using the Moran survey also 
recommended using cost reporting guidelines that are similar to the CMS 
requirements for the MCR. Although we agree that standardization is 
important for data analysis, many smaller ground ambulance 
organizations have said they would have difficulty complying with 
complex cost reporting guidelines. We believe that requiring ground 
ambulance organizations to complete and submit an MCR for the purpose 
of the data collection required in section 1834(l)(17) of the Act would 
be unnecessarily resource intensive and burdensome.
    We also considered using multiple instruments or staged data 
collection as recommended in the Moran Report, where we would first 
collect organizational characteristic data from all ground ambulance 
organizations, use that information for sampling purposes, and then 
collect cost and revenue information from a sample of ambulance 
providers and suppliers. Using this approach, we would need 100 percent 
participation from all ground ambulance organizations in reporting the 
organizational characteristic data in order for the data to be used for 
sampling purposes. We are not proposing this approach because we 
believe multiple data collections would increase respondent burden and 
may not align with sections 1834(l)(17)(A) and (B) of the Act which 
requires CMS to collect data from a random sample and prohibits data 
collection from the same ground ambulance organizations in 2 
consecutive years to the extent practicable. We will discuss this more 
in the options we considered for sampling section of this proposed 
rule.
    Based on our analysis of the existing or previously used data 
collection instruments described above, we do not believe that any of 
them would be sufficient to adequately capture the data required by 
section 1834(l) of the Act. Therefore, we are proposing to collect 
ground ambulance organization data using a survey that we developed 
specifically for this purpose, which we will refer to from this point 
forward in this proposed rule as the data collection instrument, and 
which we would make available via a secure web-based system. We believe 
that the data collection instrument should be usable by all ground 
ambulance organizations, regardless of their size, scope of operations 
and services offered, and structure. The proposed data collection 
instrument includes screening questions and skip patterns that direct 
ground ambulance organizations to only view and respond to questions 
that apply to their specific type of organization. We also believe that 
the proposed data collection instrument is easier to navigate and less 
time consuming to complete than a cost report spreadsheet. The proposed 
secure web-based survey would be available before the start of the 
first data reporting period to allow time for users to register, 
receive their secure login information, and receive training from CMS 
on how to use the system. We are also proposing to codify these 
policies at Sec.  414.626.
b. Proposed Scope of Cost, Revenue, and Utilization Data
    Section 1834(l)(17)(A) of the Act requires CMS to develop a data 
collection system to collect data related to cost, revenue, 
utilization, and other information determined appropriate by the 
Secretary for ground ambulance organizations. Section 1834(1)(17)(A)(i) 
of the Act further specifies that the information collected through the 
system should be sufficient to evaluate the extent to which reported 
costs relate to payment rates.
    We considered several options regarding the scope of collecting 
data on ground ambulance cost, revenue, and utilization. One option 
would be to require ground ambulance organizations to report on their: 
(1) Total costs related to ground ambulance services; (2) total revenue 
from ground ambulance services; and (3) total ground ambulance service 
utilization. This approach would consider all ground ambulance costs, 
revenue, and utilization, regardless of whether the service was 
billable to Medicare or related to a Medicare beneficiary. The 
advantage of this approach is that ground ambulance organizations 
already track information at their organizational level on total costs, 
revenue, and utilization for their own internal budgeting and planning. 
This method was also used to calculate an organization-level average 
cost per transport in two previous studies described below:
    In a 2012 study entitled, ``Ambulance Providers: Costs and Medicare 
Margins Varied Widely; Transports of Beneficiaries has Increased'',\91\ 
the GAO performed an analysis to assess how Medicare payments, 
including the temporary add-on payments, compared to costs reported 
using a survey. The GAO collected information via a survey on 
organizations' total costs, including operating and capital costs, 
without restriction to costs associated with Medicare transports or 
costs incurred in responding to calls for service from Medicare 
beneficiaries. GAO then divided reported total costs by the reported 
number of transports (regardless of whether Medicare paid for the 
transport) to calculate an average cost per transport for each 
organization, and reported summary statistics across these averages, 
including a median cost per transport of $429. However, to simplify 
data collection and analysis, the analysis was limited to ambulance 
suppliers that did not share operational costs with a fire department, 
hospital, or other entity. GAO stated that its calculations assumed 
that this average cost per transport was constant for all of an 
organization's transports regardless of whether or not the patient 
transported was a Medicare beneficiary. This approach implicitly loads 
the costs associated with activities that did not result in a 
transport, such as responses by a ground ambulance where the patient 
could not be located, refused transport, or was treated on the scene, 
into the estimated cost per transport.
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    \91\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
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    The second study, ``Report to Congress Evaluation of Hospitals' 
Ambulance Data on Medicare Cost Reports and Feasibility of Obtaining 
Cost Data from All Ambulance Providers and Suppliers,'' \92\ was 
conducted by HHS as required under the American Taxpayer Relief Act of 
2012 (ATRA) (Pub. L. 112-240, enacted January 2, 2013). This report 
used data from Medicare cost reports as its data source, rather than a 
survey, and included only ambulance providers, rather than ambulance 
providers and suppliers. It described substantially higher costs per 
transports for ambulance providers compared to the estimate from GAO, 
with a median of approximately $1,750 per transport. It did not compare 
reported total costs to Medicare revenue tallied in claims data with 
and without the temporary add-on payments. Neither the GAO nor the HHS 
report compared costs and AFS payment rates for specific Healthcare 
Common Procedure Coding System

[[Page 40686]]

(HCPCS) codes because the available cost data in both studies did not 
support that level of analysis.
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    \92\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
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    Another option would be to consider only those costs that are 
relevant to ground ambulance services furnished to Medicare 
beneficiaries. Collecting costs associated with specific services (such 
as Medicare transports) and excluding other services (such as Medicaid 
transports or responses that did not result in transport) would require 
either a much more intensive and costly data collection approach (such 
as time and motion studies) or assumptions on which portions of total 
costs were related to the specific activity. We believe this approach 
would be overly burdensome and complex for ground ambulance 
organizations, especially those who provide other services in addition 
to ground ambulance services.
    A third option would be to consider only those costs that are 
related to the specific ground ambulance transport services that are 
paid under the AFS. This would require ground ambulance organizations 
to report costs, revenue, and utilization related to specific levels of 
services reported with HCPCS codes, but not costs, revenue, and 
utilization for other services such as responses that did not result in 
a transport (which is not covered under the AFS). We believe this 
option would also be overly burdensome and complex.
    In discussions with ambulance providers and suppliers, we were 
informed that ground ambulance organizations most often track 
organization-level total costs, revenue, and utilization across all 
activities and services furnished to all patients, and that most would 
find it difficult to report costs, revenue, and utilization associated 
with services furnished exclusively to Medicare beneficiaries or 
associated with Medicare services covered under the AFS.
    Therefore, we propose the first option as discussed above, which 
would require ground ambulance organizations to report on their: (1) 
Total costs related to ground ambulance services; (2) total revenue 
from ground ambulance services; and (3) total ground ambulance service 
utilization. This approach would consider all ground ambulance costs, 
revenue, and utilization, regardless of whether the service was 
billable to Medicare or related to a Medicare beneficiary to collect 
total cost, total revenue, and total utilization data.
    Although we are proposing to collect a ground ambulance 
organization's total costs and total revenues, we are aware that many 
ground ambulance organizations share operational costs with fire 
departments, other public service organizations, air ambulance 
services, hospitals, and other entities. For these organizations, only 
a portion of certain capital and operational costs contribute to total 
ground ambulance costs, and only a portion of revenue is from ground 
ambulance services. We are also aware that some ground ambulance 
suppliers deploy emergency medical technicians (EMTs) in fire trucks, 
which would make it difficult to determine whether the fire truck costs 
should be factored into the total ground ambulance costs, and if so, 
how that would be calculated.
    One option to address these challenges is to limit data collection 
to ground ambulance organizations that do not share operational costs 
with fire departments, hospitals, or other entities, as GAO did for 
their 2012 report. However, we do not believe this approach meets the 
requirement in section 1834(l)(17)(B)(ii) of the Act for a 
representative sample because many ambulance suppliers and all 
ambulance providers share operational costs with fire, police, health 
care delivery or other activities. We also considered including 
providers' and suppliers' total costs and revenues across all 
activities. While this would simplify cost and revenue data reporting, 
the resulting data would not be limited to ground ambulance activities, 
and therefore, would result in biased estimates of ground ambulance 
costs or require significant assumptions to estimate ground ambulance 
costs alone.
    To more accurately define total costs and total revenues related to 
ground ambulance services for those ground ambulance organizations that 
provide other services in addition to ground ambulance services, we are 
proposing an approach where the data collection instrument instructions 
would separately address three further refined proposed categories of 
total ground ambulance costs and revenues:
     Cost and revenue components completely unrelated to ground 
ambulance services. These costs and revenues would be unrelated to this 
data collection and not reported. Examples include administrative staff 
without ground ambulance responsibilities, health care delivery outside 
of ground ambulance, community paramedicine, community education and 
outreach, and fire and police public safety response.
     Cost and revenue components partially related to ground 
ambulance services. These costs and revenue would be reported in full, 
but respondents would report additional information that can be used to 
allocate a portion of the costs to ground ambulance services. Depending 
on how the data would be utilized, certain costs could be included or 
excluded from an analysis after data are collected. Examples include 
EMTs who are also firefighters and facilities with both ground 
ambulance and fire department functions. (We considered an alternative 
where respondents would allocate costs and report only costs associated 
with ground ambulance services but believe that would pose an 
additional burden on the respondent to calculate allocated amounts, and 
would result in an allocation process that is less transparent and 
standardized).
     Cost and revenue components entirely related to ground 
ambulance services. These costs are reported in full. Examples include 
EMTs with only ground ambulance responsibilities and ground ambulance 
vehicles.
    We believe that this approach would enable us to collect the data 
necessary to evaluate the adequacy of payments for ground ambulance 
services, the utilization of capital equipment and ambulance capacity, 
and the geographic variation in the cost of furnishing such services. 
The data could be analyzed in the same manner as the data in the GAO 
report, for example, calculating an average per-transport cost for each 
organization and calculating Medicare margins with and without add-on 
payments, or could provide the basis for other analyses to link 
reported costs to AFS rates. For example, an analysis could use 
reported total costs and information on the volume of transports by 
levels of services to estimate a cost for each HCPCS code reported for 
the AFS, or regression-based approaches to estimate the marginal cost 
of furnishing each HCPCS code on the AFS. We believe that under our 
proposed approach, the collected data would be available to estimate 
total costs and revenue relevant to ground ambulance services.
c. Proposed Data Collection Elements
    The draft data collection instrument is available on the CMS 
website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. An overview of the elements of the data 
collection instrument we are proposing is in Table 29, including 
information on costs, revenues, utilization (which we define for the 
purposes of the instrument as service volume and service mix), as well 
as the characteristics of ground ambulance organizations.
    To help structure the data collection instrument, we organized 
costs by category (for example, labor, vehicles, and facilities), which 
is the approach

[[Page 40687]]

used in the GEMT and the AAA/Moran survey.

    Table 29--Proposed Components for the Data Collection Instrument
------------------------------------------------------------------------
  Component (data collection
     instrument section)                   Broad description
------------------------------------------------------------------------
Ground ambulance organization  Information regarding the identity of the
 characteristics (2-4).         organization and respondent(s), service
                                area, ownership, response time, and
                                other characteristics; broad questions
                                about offered services to serve as
                                screening questions.
Utilization: Ground ambulance  Number of responses and transports, level
 service volume and service     of services reported by HCPCS code.
 mix (5 and 6).
Costs (7-12).................  Information on all costs partially or
                                entirely related to ground ambulance
                                services.
     Staffing and      Number and costs associated with EMTs
     Labor Costs (7).           administrative staff, and facilities
                                staff; separate reporting of volunteer
                                staff and associated costs.
     Facilities Costs  Number of facilities; rent and mortgage
     (8).                       payments, insurance, maintenance, and
                                utility costs.
     Vehicle Costs     Number of ground ambulances; number of
     (9).                       other vehicles used in ground ambulance
                                responses; annual depreciation; total
                                fuel, maintenance, and insurance costs.
     Equipment &       Capital medical and non-medical
     Supply Costs (10).         equipment; medical and non-medical
                                supplies and other equipment.
     Other Costs (11)  All other costs not reported elsewhere.
     Total Cost (12).  Total costs for the ground ambulance
                                organization included as a way to cross-
                                check costs reported in the instrument.
Revenue (13).................  Revenue from health insurers (including
                                Medicare); revenue from all other
                                sources including communities served.
------------------------------------------------------------------------

    The following sections describe our proposed approach for data 
collection in each of these categories.
(1) Collecting Data on Ground Ambulance Provider and Supplier 
Characteristics
    CMS is required to collect information regarding the geographic 
location of ground ambulance organizations to meet the requirement at 
section 1834(l)(17)(A)(iii) of the Act that the collected data include 
information on services furnished in different geographic locations, 
including rural areas and low population density areas. We also 
recognize that there are differences between and among ground ambulance 
organizations on several key characteristics, including geographic 
location; ownership (for-profit or non-profit, government or non-
government, etc.); service volume, organization type (including whether 
costs are shared with fire or police response or health care delivery 
operations); EMS responsibilities; and staffing models. Research 
conducted for this proposal indicates that:
     There are differences in costs per transport by ground 
ambulance organizations with a different ownership status;
     EMS level of service and staffing models often have an 
important impact on costs, with higher EMS levels of service (for 
example, quicker response times) and static staffing models (that is, 
mainatining a constant response capability 24 hours a day, 7 days a 
week, 365 days a year) involving higher fixed costs; and
     Utilization varies significantly across ambulance 
providers and suppliers of different characteristics.
    Due to this variation in characteristics and the effect it has on 
costs and revenues, we believe it is important for ground ambulance 
organizations to report additional characterictics, as described below, 
to adequately analyze the differences in costs and revenue among 
different types of ambulance providers and suppliers. We also believe 
collecting this information directly through the proposed data 
collection instrument will improve data quality with minimal burden on 
the respondents because the proposed data collection instrument is 
designed to tailor later sections and questions based on respondents' 
characteristics through programmed ``skip patterns''. We considered 
relying exclusively on the Medicare enrollment form CMS 855A for ground 
ambulance providers or CMS 855B for ground ambulance suppliers to 
capture this information, but believe that data accuracy would be more 
robust if reported directly by respondents for the specific purpose of 
this data collection.
    The proposed data collection questions related to organizational 
characteristics and service area are in sections 2, 3, and 4 of the 
data collection instrument. We are proposing to collect information on 
ownership and organization type through a sequence of questions in 
section 2 of the data collection instrument. Some of the questions in 
this section are adapted in part from prior surveys (such as the GAO 
and Moran surveys) with changes as necessary to fit scenarios reported 
during interviews with ground ambulance organizations. The first 
question related to organizational characteristics, question 6, asks 
about the organizations' ownership status. This item aligns closely 
with a similar question on the Medicare enrollment form CMS 855B for 
ambulance suppliers. Question 7 asks whether the respondent's 
organization uses any volunteer labor. While this question could have 
been asked later in the data collection instrument around the 
collection of labor data, we opted to include it here because many 
ground ambulance organizations informed CMS that they view the use of 
volunteer labor as a defining organizational characteristic, on par 
with ownership status, and that a volunteer labor question was expected 
by respondents at this early point in the data collection instrument. 
Question 8 asks respondents to select a category that best describes 
their ambulance organization. The response options for this item are 
mutually exclusive and align with the ambulance provider and supplier 
taxonomy described in the CAMH report. The next two questions, 9 and 
10, more directly ask whether the respondent has shared operational 
costs with an entity of another type, including a fire department, 
hospital, or other entity. We are proposing these questions in addition 
to the organization type question to account for situations where a 
respondent might primarily identify as an organization of one type 
(with implications for shared operational costs) but then might have 
shared

[[Page 40688]]

operational costs with another entity type. Responses to questions 9 
and 10 play an important role in skip logic later in the data 
collection instrument regarding questions and response options relevant 
only to ground ambulance organizations with shared operational costs 
with an entity of another type.
    Other proposed questions regarding organizational characteristics 
are necessary to tailor later parts of the data collection instrument 
to the respondent. These include proposed questions in section 2 of the 
data collection instrument on whether the respondent's ambulance 
organization:
     Is part of a broader corporation or other entity billing 
under multiple National Provider Identifiers (NPIs) (question 2).
     Routinely responds to emergency calls for service 
(question 11).
     Operates land, water, and air ambulances (questions 12-
14).
     Has a staffing model that is static (that is, consistent 
staffing over the course of a day/week) or dynamic (that is, staffing 
varies over the course of a day/week) or combined deployment (certain 
times of the day have a fixed number of units, and other times are 
dynamic depending on need) (question 15).
     Provides continuous (also known as ``24/7/365'') emergency 
services) (question 16).
     Provides paramedic or other emergency response staff to 
meet ambulances from other organizations in the course of a response 
(questions 17 and 18).
    In our interviews with ambulance providers and suppliers, some 
participants indicated that their staffing model is an organizational 
characteristic that would likely be associated with costs per 
transport. Organizations that need to maintain fixed staffing levels 
over time (for example, to maintain an emergency response capability to 
serve a community) would likely have higher costs than those that do 
not.
    Section 1834(l)(17)(A)(iii) of the Act requires collecting data 
from ambulance providers and suppliers in different geographic 
locations, including rural areas and low population density areas. The 
area served by ambulance providers and suppliers is an important 
characteristic and we are proposing to collect information on the 
geographic area served by each ambulance provider and supplier in 
section 3 of the data collection instrument.
    Many ground ambulance organizations have a primary service area in 
which they are responsible for a certain type of service (for example, 
ALS-1 emergency response within the borders of a county, town, or other 
municipality) and may have secondary services areas for a variety 
reasons, such as providing mutual or auto aid, or providing a different 
service in a secondary area (for example, non-emergency transports 
state-wide). We considered several alternatives to collect information 
on service area. One option would be to utilize Medicare claims data, 
but this would limit the information to Medicare billed transports only 
and would also not differentiate between primary and other service 
areas. Another option would be to allow respondents to write in a 
description of their primary and other service areas, but this would 
require converting written responses to a format that can be used for 
analysis. A third option would be for respondents to report the ZIP 
codes that constitute their primary and other service area. This 
approach aligns with the Medicare enrollment process requirement to 
submit ZIP codes where the ground ambulance organization operates. It 
would also collect ZIP code-based information on service area that can 
be easily linked to the ZIP Code to Carrier Locality file \93\ that 
lists each ZIP code and its designation as urban; rural; or super-
rural. This file is used by the MACs to determine if the temporary add-
on payments should apply to a transport under the AFS. The main 
limitation of this approach is that ZIP codes would not always align to 
service areas, because ZIP codes routinely cross town, county, and 
other boundaries that are likely relevant for defining ground ambulance 
organizations' service areas.
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    \93\ Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html.
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    We are proposing to require ground ambulance organizations that are 
selected during sampling to identify their primary service area by 
either: (1) Providing a list of ZIP codes that constitute their primary 
service area; or (2) selecting a primary service area using pre-
populated drop-down menus at the county and municipality level in 
question 1, section 3 of the data collection instrument. We are also 
proposing to require respondents to specify whether they have a 
``secondary'' service area, which are areas where services are 
regularly provided under mutual aid, auto-aid, or other agreements in 
section 3, question 4 of the data collection instrument and if so, to 
identify the secondary service area using ZIP codes or other regions as 
described above for the primary service area (section 3, question 5). 
Mutual aid agreements are joint agreements with neighboring areas in 
which they can ask each other for assistance. Auto-aid arrangements 
allow a central dispatch to send the closest ambulance to the scene. We 
are not proposing to collect information on areas served only in 
exceptional circumstances, such as areas rarely served under mutual or 
auto-aid agreements or deployments in response to natural disasters or 
mass casualty events because we believe reporting on rarely-served 
areas would involve significant additional burden and would add to 
instrument complexity without generating data that would be useful for 
analysis.
    The proposed approach distinguishes between primary and secondary 
service areas. This would allow subsequent questions on the balance of 
transports in a respondent's primary versus secondary service area and 
whether average trip time and response times are substantively longer 
in the secondary versus primary service area. We believe this approach 
results in data that can be easily analyzed and eliminates the need to 
ask certain other questions (such as the population and square mileage 
of the respondent's service area) because this information can be 
inferred using the reported geographic service area boundaries.
    We are proposing to ask the following questions in sections 3 and 4 
of the of the data collection instrument, service area and subsequent 
emergency response time, because the responses to these questions are 
closely related to the area served by the organization:
     Whether the respondent is the primary emergency ambulance 
organization for at least one type of service in their primary service 
area (section 3, question 2).
     Average trip time in primary and secondary service areas 
(section 3, questions 3 and 6).
     Average response time (for organizations responding to 
emergency calls for service) for primary and secondary service areas 
(section 4, questions 1-2).
     Whether the organization is required or incentivized to 
meet response time targets by contract or other arrangement (for 
organizations responding to emergency calls for service) (section 4, 
question 3).
    Average trip and response time are necessary to understand how 
geographic distance between the ground ambulance organization's 
facilities and patients affects costs. In interviews, ground ambulance 
organizations recommended the collection of average trip time in 
addition to mileage because some rural and remote areas may have 
relatively

[[Page 40689]]

long average trip times even though mileage may be more modest due to 
terrain, the quality of roads, and other factors. We believe that 
collecting information on average response time would allow the 
analysis of whether communities with different response time 
expectations and targets have systematically different costs.
(2) Collecting Data on Ground Ambulance Utilization
    CMS is required to collect information on the utilization of ground 
ambulance services. While we could collect information on the volume of 
ground ambulance services that can be billed to Medicare, this approach 
would not provide information needed to determine total utilization of 
ground ambulance organizations. Another option would be to utilize 
Medicare claims data for estimates of ground ambulance transport volume 
and separately collect information on services not payable by Medicare 
(such as responses that did not result in a transport). This approach 
would also not provide complete information on total transport volume, 
since other services, such as responses that do not result in a 
transport, would not be included.
    Based on information provided during interviews with ground 
ambulance organizations, we identified several distinct utilization 
categories, such as total responses and ground ambulance responses. 
This is particularly important for fire-based and police-based 
organizations that may have a significant volume of fire and police 
responses that do not involve a ground ambulance. The number of 
responses that did not result in a transport can be separately tallied. 
Other important utilization categories are ground ambulance transports 
(that is, responses during which a patient is loaded in a ground 
ambulance), which can be measured in terms of total transports (that 
is, all ground ambulance transports regardless of payor) or paid 
transports (that is, transports for which the ambulance provider or 
supplier was paid in part or in full). Another utilization category 
would include information on ambulance providers and suppliers that 
furnish paramedic intercept services or provide paramedic-level staff 
in the course of a BLS response where another organization provides the 
ground ambulance transport.
    We believe it is important to collect utilization data related to 
all services, not just transports, because other services that 
contribute to the total volume of responses have direct implications 
for costs. Collecting utilization information related to transports but 
not other services could omit important cost information. Some 
utilization measures, such as the ratio of ground ambulance to total 
responses, may be one basis for allocating certain costs reported 
elsewhere in the data collection instrument. Another example would be 
the difference between total and paid transport, as this would provide 
information on services that were provided to patients but for which no 
payment is received.
    To best capture the full range of utilization data, we are 
proposing a two-pronged approach to collect data on the volume and the 
mix of services. First, we are proposing to collect total volume of 
services for each of the categories listed below in section 5 of the 
proposed data collection instrument:
     Total responses, including those where a ground ambulance 
was not deployed (question 1).
     Ground ambulance responses, that is, responses where a 
ground ambulance was deployed (question 2).
     Ground ambulance responses that did not result in a 
transport (question 4).
     Ground ambulance transports (question 5).
     Paid ground ambulance transports, that is, ground 
ambulance transports where the ambulance provider or supplier was paid 
for a billed amount in part or in full (question 6).
     Standby events (question 7).
     Paramedic intercept services as defined by Medicare 
(question 8).
     Other situations where paramedic staff contributes to a 
response where another organization provides the ground ambulance 
transport (question 9).
    The CAMH report describes several cases where an ambulance provider 
or suppliers' mix of services within one of the utilization categories 
described above could affect costs or revenue. Most importantly, within 
billed transports, variation in the mix of specific ground ambulance 
services (for example, ALS versus BLS services) will affect both costs 
(because ALS transports require more and more costly inputs) and 
revenue (because ALS services are generally paid at a higher rate). 
Ground ambulance organizations with a higher share of responses that 
are emergency responses may also face higher fixed costs, and that the 
costs for organizations furnishing larger shares of water ambulance 
transports are likely different than costs from organizations that do 
not furnish water ambulance transports. There is a subset of ground 
ambulance organizations that specialize in non-emergency transports or 
inter-facility transports, which suggests that this business model may 
result in different per-transport costs compared to EMS-focused 
ambulance providers and suppliers.
    Second, to account for this significant variation, we are proposing 
to collect the following information related to service mix:
     The share of responses that were emergency versus non-
emergency (section 6 question 1).
     The share of transports that were land versus water (asked 
only of organizations reporting that they operate water ambulances; 
section 6 question 2).
     The share of transports by service level (section 6 
question 3).
     The share of transports that were inter-facility 
transports (section 6 question 4).
    We are not proposing that respondents report on their mix of 
services in primary and secondary service areas (as defined above) 
separately because this would double the length of this section of the 
data collection instrument and require complex calculations or use of 
assumptions by respondents that do not separately track services by 
area. Instead, we are proposing that respondents report the share of 
total ground ambulance responses that were in a secondary rather than 
primary service area in a single item (section 5 question 3). We also 
are not proposing to collect detailed information regarding the mix of 
services for total transports (versus paid transports) and paid 
transports (versus total transports) because collecting information on 
the mix of services for total and paid transports separately would 
double the reporting burden in this section and because we believe, 
based on discussions with stakeholders, that it is reasonable to assume 
that the distribution of transports across categories would be the 
same.
(3) Collecting Data on Costs
    Section 1834(l)(17)(A) of the Act requires CMS to collect cost 
information from ground ambulance organizations, and we previously 
discussed our proposal to collect data on a ground ambulance 
organization's total costs. This part of the proposed rule describes 
the data in each cost category that we are proposing to collect, as 
well as alternatives that we considered.
    The costs reported separately in the categories of costs we are 
proposing to collect would sum to an organization's total ground 
ambulance costs. In addition to ground ambulance costs, we are 
proposing to ask all respondents in the proposed data collection 
instrument

[[Page 40690]]

to report their total annual costs (that is, operating and capital 
expenses), inclusive of costs unrelated to ground ambulance services, 
in a single survey item (section 12, question 1). For ground ambulance 
organizations that do not have costs from other activities (such as 
from operating a fire or police department), the reported total costs 
are a way to cross-check costs reported in individual cost categories 
throughout the instrument, and we can compare the reported total to the 
sum of costs across categories. Such a cross-check may also be 
appropriate for ground ambulance organizations with costs from other 
activities, as the sum of costs across ground ambulance cost categories 
should always be less than the ground ambulance organization's reported 
total costs. We believe that this cross-check will improve data quality 
and is consistent with existing survey-based data collection tools. 
This approach will also provide a better understanding of the overall 
size and scope of ground ambulance organizations, including activities 
other than providing ground ambulance services. Relatively larger 
organizations may have lower ground ambulance costs due to due to 
economies of scale and scope.
    To avoid reporting the same costs multiple times, there are 
instructions and reminders throughout the proposed data collection 
instrument to avoid double-counting of costs. From a design 
perspective, we believe it is less important where a particular cost is 
reported on the survey data collection instrument and more important 
that the cost is reported only once.
    We are making two proposals that have important implications for 
reporting in all cost sections in the proposed data collection 
instrument. First, in the case where a sampled organization is part of 
a broader organization (such as when a single parent company operates 
different ground ambulance suppliers), we propose to ask the 
respondents to report an allocated portion of the relevant ground 
ambulance labor, facilities, vehicle, supply/equipment, and other costs 
from the broader parent organization level in separate questions in 
several places in the cost sections of the data collection instrument 
(section 7.2 question 3, section 8.2 question 2, section 8.3 question 
2, section 9.2 question 5, section 9.3 question 6, section 10.2 
question 4, and section 11 questions 2 and 5). This scenario is 
discussed in more detail in the sampling section below. In exploratory 
analyses, we found that a small share of NPIs were part of broader 
parent organizations. Due to the rarity of this scenario and the 
complexity of calculations required, we are proposing to allow the 
respondent to report an allocated amount directly for these questions 
using an allocation approach they regularly use for this purpose. We 
believe that while proposing a specific allocation approach would yield 
more uniform and transparent data, we believe that these benefits are 
not worth the additional respondent burden.
    Second, we are proposing to include a general instruction stating 
that in cases where costs are paid by another entity with which the 
respondent has an ongoing business relationship, the respondent must 
collect and report these costs to ensure that the data reported 
reflects all costs relevant to ground ambulance services. Examples 
include when a municipality pays rent, utilities, or benefits directly 
for a government or non-profit ambulance organization, or when 
hospitals provide supplies and/or medications to ground ambulance 
operations at no cost. During interviews with ground ambulance 
organizations, we were told that there are many nuanced arrangements 
that fit this broad scenario. Although we recognize this would be an 
additional step for some ground ambulance organizations, we are 
concerned that the lack of reported cost data in one of these major 
categories could significantly affect calculated total cost.
    Because some ambulances, other vehicles, and buildings are donated 
to ground ambulance organizations, we considered asking respondents to 
report fair market values for these vehicles and buildings. However, we 
are aware that while the lack of reported cost data in one of these 
major categories could affect calculated total cost, it is not always 
clear what cost is appropriate to report. To avoid the subjectivity and 
burden involved in asking respondents to report fair market value, we 
propose instead that respondents report which ambulances, other 
vehicles, and buildings have been donated, but not an estimate of the 
fair market value of those donations. We believe fair market values 
could be imputed using publicly available sources of data to facilitate 
comparison of data between organizations that have donations and those 
that do not. For the same reasons, we are also proposing not to collect 
an estimate of fair market value for donated equipment, supplies, and 
costs collected in the ``other costs'' section of the instrument. As 
noted above, for those organizations with costs that were paid by 
another entity with which the respondent has an ongoing business 
relationship, such as a ground ambulance organization that is part of 
or owned by a government entity, respondents would obtain the cost 
information directly from that entity since we would not consider these 
to be donated items.
    The following sections describe each cost category, alternative for 
data collection, and our proposals related to each category of costs 
separately.
(i.) Collecting Data on Staffing and Labor Costs
    In interviews with ambulance providers and suppliers, they stated 
that labor is one the largest contributors to total ground ambulance 
costs (especially medical staff such as EMTs, paramedics, and medical 
directors) and that they use a broad mix of labor types and hiring 
arrangements. There is also significant variation in tracking staffing 
and labor cost inputs that are needed to calculate costs. We were also 
informed by ambulance providers and suppliers that data on the number 
of ground ambulance staff and associated labor costs were often 
available at one of three levels: The individual employee level; 
aggregated by category such as EMT-Basic or Medical Director; or 
aggregated across all staff. Additionally, we were told by ambulance 
providers and suppliers that ground ambulance organizations typically 
face challenges in tracking ground ambulance staff and costs by 
category when staff had multiple ground ambulance responsibilities (for 
example, EMTs with supervisory responsibilities, EMTs who are also 
firefighters, etc.).
    We agree that labor costs are an important component of total costs 
and believe that it is necessary to collect information on both 
staffing levels, that is, the quantity of labor used, and the labor 
costs resulting from these labor inputs. Without information on 
staffing levels, we would not be able to gauge whether differences in 
labor costs are due to compensation or different levels of staffing. 
Collecting information on staffing levels also allows the use of 
imputed labor rates from other sources (such as the Bureau of Labor 
Statistics). We also acknowledge the practical need to balance the 
burden involved in reporting extremely detailed staffing and labor 
costs information against the usefulness of detailed data for 
explaining variation in ground ambulance costs. Therefore, we are 
proposing to collect information in the proposed data collection 
instrument on the number of staff and labor costs for several detailed 
categories of response staff (for example, EMT-basic, EMT-intermediate, 
and EMT-paramedic) (section 7.1), and for a single category for paid 
administrative and facilities

[[Page 40691]]

staff (for example, executives, billing staff, and maintenance staff) 
(section 7.2), and (c) separately for medical directors (section 7.2). 
We believe this approach involves less respondent burden compared to 
reporting on each individual staff member. If more detailed categories 
were used for reporting staffing levels and costs, we believe the 
burden involved in assigning paid administrative and facilities staff 
with multiple roles to individual categories or apportioning their 
labor and costs to separate categories would increase.
    The main limitation of the proposed approach is that we would not 
collect detailed information on specific paid administration and 
facilities labor categories. Therefore, we are also proposing to 
collect some information that would help explain variation in labor 
costs by asking whether the ground ambulance organization has some 
staff in more specific paid administration and facilities categories 
such as billing, dispatch, and maintenance staff (section 7, question 
1). This question also serves as a screening question to determine 
which response options appear to the respondent in several other 
questions in this section of the proposed data collection instrument. 
We also propose to ask for information on why individual labor 
categories are not used (section 7, question 1) and if there is at 
least one individual with 20 hours a week or more of effort devoted to 
specific activities such as training and quality assurance (section 
7.2, question 2).
Reporting Staffing Levels
    In reporting staffing levels in the proposed data collection 
instrument, we considered several approaches. One approach we 
considered was asking the respondent to report only the number of staff 
(that is, counts of people). Under this approach, a part-time employee 
would count as ``1'' to the number of staff even if they worked a small 
number of hours per week. We believe this approach would result in less 
accurate reporting of labor inputs, especially from organizations 
relying heavily on part-time staff or staff with responsibilities 
unrelated to ground ambulance services. We also considered allowing 
respondents to report full-time-equivalent (FTE) staff on a 40-hour per 
week basis, but ground ambulance organizations informed us that 
reporting FTEs would be burdensome. As a third approach, we considered 
asking respondents to report ground ambulance staffing levels in terms 
of hours over a reporting year. Reporting labor hours over the entire 
reporting year allows for more accurate reporting of staff working 
part-time and may involve less burden for respondents that already 
tally annual labor hours (for example, via payroll records), but would 
likely be difficult for those who do not already track labor hours in 
this manner. As a fourth approach, we considered asking respondents to 
report ground ambulance staffing levels in terms of hours worked during 
a typical week. Reporting staffing levels in terms of hours worked 
either over a reporting year or during a typical week allows detailed 
accounting of part-time staff and staff with ground ambulance and other 
responsibilities and involves fewer calculations and adjustments than 
reporting FTEs. Reporting in terms of hours over a typical week has the 
additional advantage of simplifying reporting for staff that start or 
stop work during the 12-month reporting period. The main limitation of 
reporting staffing levels in terms of hours over a typical week is that 
the week that the respondent selects for reporting may not be 
generalizable to other weeks in the reporting period.
    In the interest of minimizing reporting burden, we are proposing to 
collect information on the number of staff in terms of hours worked 
over a typical week (sections 7.1 and 7.2). The instructions in the 
proposed data collection instrument ask respondents to ``select a week 
for reporting that is typical, in terms of seasonality, in the volume 
of services that you offer (if any) and staffing levels during the 
reporting year.''
Scope of Reported Labor Costs
    For the purposes of collecting information on labor costs, we are 
proposing to define labor costs to include compensation, benefits (for 
example, healthcare, paid time off, retirement contributions, etc.), 
stipends, overtime pay, and all other compensation to staff. We refer 
to these costs as fully-burdened costs. Some ambulance providers and 
suppliers track compensation but not benefits because another entity, 
such as a municipality, pays for benefits, and that the ability of 
these ambulance providers and suppliers to report fully burdened costs 
may be limited. Despite this limitation, due to the importance of labor 
costs as a component of total ground ambulance costs, we believe that 
information on fully burdened costs (sections 7.1 and 7.2) must be 
reported so that all relevant ground ambulance transport costs are 
collected. Ambulance providers and suppliers selected to report data 
may need to implement new tracking systems or request information from 
other entities (such as municipalities) to be able to report fully-
burdened labor costs.
Volunteer Labor
    Ground ambulance organizations have also informed CMS that a 
significant share of ambulance providers and suppliers rely in part or 
entirely on volunteer labor and that the systems and data available to 
track the number of volunteers and the time that they devote to ground 
ambulance services varies. We are proposing to collect information on 
the total number of volunteers and the total volunteer hours in a 
typical week using the same EMT/response staff and administrative and 
facilities staff categories used elsewhere in the proposed data 
collection instrument (section 7.3, questions 1-5). Although some 
suggested that assigning a value to volunteer labor hours may be 
important, the proposed data collection instrument collects information 
only on the amount of volunteer labor (measured in hours in a typical 
week) and not a market value for that labor. We believe reported hours 
can be converted, if necessary, to market rates using data from other 
sources. We are also proposing to collect the total realized costs 
associated with volunteer labor such as stipends, honorariums, and 
other benefits to ensure all costs associated with ground ambulance 
transport are collected (section 7.3, question 6).
Allocation and Reporting Staff With Other Non-Ground Ambulance 
Responsibilities
    Since firefighter/EMTs are common in many ambulance suppliers, we 
are proposing to ask respondents that share costs with a fire or police 
department to report total hours in a typical week for paid EMT/
response staff with fire/police duties only (section 7.1). We believe 
this information can be used to subtract a portion of associated labor 
costs when calculating ground ambulance labor costs. We believe our 
proposed approach is more consistent and involves less burden than 
asking respondents to perform their own allocation calculations 
necessary to report only the hours or full-time equivalents related to 
ground ambulance services.
    As already noted, many ground ambulance organizations have staff 
with responsibilities beyond ground ambulance and fire/police response. 
To account for these scenarios, we are proposing to ask respondents to 
report the total hours in a typical week unrelated to ground ambulance 
or fire/police response duties (which are

[[Page 40692]]

addressed separately as described in section 7.1), as the costs 
associated with this labor can be subtracted by those analyzing the 
data when calculating ground ambulance labor costs. We believe this 
proposed approach provides both transparency and consistency in the 
data with minimal burden, and may avoid scenarios where all of the 
costs associated with staff with limited ground ambulance 
responsibilities contribute to total ground ambulance costs.
(ii.) Collecting Data on Facility Costs
    Facility costs may include rent, mortgage payments, depreciation, 
property taxes, utilities, insurance, and maintenance, and the 
associated costs vary widely across ambulance providers and suppliers. 
Some ground ambulance organizations own facilities while for others, 
rent, mortgage, or leasing is an important component of total 
operational costs. Some ground ambulance organizations share facilities 
with other operations (such as fire and rescue services), and 
individual ground ambulance organizations often operate out of several 
facilities of different types, sizes, and share of space related to 
ground ambulance operations.
    We considered proposing to require respondents to report facilities 
costs aggregated across all facilities. We believe this approach would 
minimize burden on the respondent by eliminating the need to break 
costs down by facility; however, it may also increase the risk for 
inconsistencies in how respondents report total facilities costs. Under 
this approach, respondents whose ground ambulance organizations share 
operational costs with a fire department or other entity would need to 
calculate and report an estimate of facilities costs that was relevant 
only to ground ambulance services.
    We also considered proposing to require respondents to report all 
costs on a per-facility basis. We believe this approach would allow the 
most flexibility in reporting complex facility arrangements from ground 
ambulance organizations operating out of multiple facilities. However, 
this approach may also involve more burden, particularly for larger 
organizations, to report costs on a facility-by-facility basis, and 
many organizations do not track costs such as maintenance or utilities 
on a per-facility basis.
    We are proposing a hybrid approach involving both per-facility and 
aggregate reporting of different information. First, respondents report 
the total number of facilities (section 8., questions 1-2) and then 
indicate for each facility whether they paid rent, mortgage, or neither 
during the reporting period, total square footage, and share of square 
footage related to ground ambulance services (section 8.1, question 3). 
Second, respondents report their per-facility rent, mortgage, or annual 
depreciation (section 8.2). Third, respondents report facilities-
related insurance, maintenance, utilities, and property taxes 
aggregated across all facilities (section 8.3).
    We believe this proposed approach allows for the collection of the 
information needed to calculate a total facilities cost related to 
ground ambulance services while avoiding a burden on respondents to 
calculate allocated facility costs. Total insurance, maintenance, 
utility, and property tax costs can be allocated using reported square 
footage and shares of square footage related to ground ambulance 
services. The proposed approach requires respondents to provide both 
the square footage of each facility, and the share of square footage 
for the facility that is related to ground ambulance operations. We 
expect that some ground ambulance organizations would have this 
information available and others would need to collect this square 
footage information to report along with facilities costs, but do not 
believe this information would be difficult to collect.
(iii.) Collecting Data on Vehicle Costs
    Section 1834(l)(17)(A)(ii) of the Act requires CMS to collect 
information on ``the utilization of capital equipment and ambulance 
capacity.'' We are proposing to collect information on the number of 
ground ambulances and other vehicles related to providing ground 
ambulance services, as well as the costs associated with these vehicles 
to meet these requirements.
    Ambulance providers and suppliers operate ground ambulances, as 
well as other vehicles to support their ground ambulance operation, and 
some may have a variety of other vehicles that are associated with 
ground ambulance responses. For example, a fire truck staffed with fire 
personnel cross-trained as EMTs may respond with a ground ambulance to 
an emergency call. Other vehicles might be used in responses and may be 
referred to as a non-transporting EMS vehicle, a quick response 
vehicle, a fly-car, or an SUV that carries a paramedic to meet a BLS 
ambulance from another organization during the course of a response.
    We considered two alternatives for collecting vehicle costs. One 
alternative would be to only include the costs for ambulances and 
exclude other certain non-ambulance response vehicles from reported 
costs. We believe that excluding other certain non-ambulance response 
vehicles from reported costs could potentially result in underreporting 
of total ground ambulance costs, particularly among those providers or 
suppliers that rely heavily on these vehicles to support their ground 
ambulance services. Another alternative would be to include the costs 
of all vehicles that are used as part of ambulance services, such as 
quick response vehicles that are used to supplement ambulances.
    For all vehicles, vehicle costs can be reported either in aggregate 
or on a per-vehicle basis. We believe that while reporting vehicle 
costs in aggregate may involve less burden for some respondents, those 
respondents that do not track aggregated costs would still require a 
tool to enter information on per-vehicle basis. Furthermore, we believe 
that aggregated costs for vehicles other than ground ambulances offer 
analysts with fewer alternatives to allocate a share of vehicle costs 
to ground ambulance services.
    We are proposing to collect data on vehicle costs in the proposed 
data collection instrument in two parts: Ground ambulance vehicles 
(section 9.1); and all other vehicles related to ground ambulance 
operations (section 9.2). For ground ambulance vehicles, we are 
proposing to collect information on the number of vehicles, total miles 
traveled, and per-vehicle information on annual depreciated value (and 
remounting costs if applicable) for owned vehicles, and annual lease 
payments for rented vehicles (section 9.1, questions 1-4). We 
considered proposing to collect the necessary information to calculate 
annual depreciated value using a standardized approach. However, we are 
proposing to allow respondents with owned vehicles to use their own 
accounting approach to calculate annual depreciated value per vehicle. 
We believe that allowing flexibility for respondents to use their 
standard approach for this calculation would result in more accurate 
data and less reporting burden.
    We are also proposing to use a similar approach to collect per-
vehicle information for owned and leased vehicles of any other type 
that contribute to ground ambulance operations, including fire trucks, 
quick response vehicles, all-terrain vehicles, etc. (section 9.2, 
questions 1-5). The proposed instructions in section 9.2 of the data 
collection instrument specify that reported vehicles must support 
ground ambulance services. We are proposing to collect the type of each 
vehicle in broad categories in addition

[[Page 40693]]

to the annual depreciated value or lease payment amount for each 
vehicle.
    In addition to the above costs, we also are proposing to collect 
aggregate costs associated with licensing, registration, maintenance, 
fuel, insurance costs for all vehicles combined (ambulance and non-
ambulance) (section 9.3, questions 1-5). We believe that these costs 
are often aggregated within providers' and suppliers' records and that 
reporting in aggregate form may reduce respondent burden with minimum 
risk for reporting error.
    When estimating total ground ambulance vehicle costs for ground 
ambulance organizations that share operational costs with fire and 
police response or other non-ground ambulance activities, a share of 
vehicle costs reported via the instrument will need to be allocated as 
vehicle costs related to ground ambulance services. One alternative we 
considered to do this was simply to ask respondents about the share of 
costs associated with ground ambulance services as we thought this 
would be the least burdensome approach; however, we believe data 
collected in this manner would not allow for estimation of costs 
associated with non-ground ambulance vehicles that support ambulance 
services. We considered another alternative where (1) the ratio of 
ground ambulance to total responses would be used to allocate costs 
associated with non-ambulance vehicles, (2) the total number of 
vehicles would be used to allocate aggregate costs associated with 
licensing, registration, maintenance, and fuel costs, and (3) 
depreciated annual costs and/or lease payment amounts would be used to 
allocate insurance costs. The main limitation of this approach is that 
maintenance and fuel costs could vary significantly across vehicle 
categories. For example, maintenance and fuel costs may be 
significantly different for ground ambulance than for other types of 
vehicles. As a result, we are proposing a modification of this 
alternative where we also ask respondents to list percent of total 
maintenance and fuel costs attributable to each type of vehicle (that 
is, ground ambulances, fire trucks, land rescue vehicles, water rescue 
vehicle, other vehicles that respond to emergencies such as quick 
response vehicles, and other vehicles; section 9.3, questions 4 and 5). 
We propose to also ask respondents to report total mileage for ground 
ambulance (land and water separately) and total mileage for other 
vehicles related to ground ambulance responses (land and water 
separately) as a potential alternative means to allocate fuel and 
maintenance costs.
(iv.) Collecting Data on Equipment and Supply Costs
    In our interviews with ground ambulance organizations, we were told 
that not all ground ambulance organizations would be able to report 
detailed item-by-item equipment and supply information, and that some 
organizations have far more sophisticated inventory tracking systems 
than others that would allow them to report detailed information within 
a category.
    We considered alternative approaches related to reporting equipment 
and supply costs that varied primarily on the level of detail for 
reporting. We considered extremely detailed data reporting as it would 
be potentially useful to identify variability in costs across 
organizations. However, as noted above, many ground ambulance 
organizations may not keep detailed records of all their individual 
equipment and supply costs. Taking those factors into account, we are 
proposing to request total costs in a small number of equipment and 
supply categories rather than itemized information for all equipment 
and supply categories (section 10). These would include:
     Capital medical equipment.
     Medications.
     All other medical equipment, supplies, and consumables.
     Capital non-medical equipment.
     Uniforms.
     All other non-medical equipment and supplies.
    We also considered whether to have respondents report both medical 
and non-medical equipment and supplies together. We believe that the 
majority of medical supplies are more likely to be related to ground 
ambulance services than non-medical supplies for organizations with 
shared services, and therefore, we are proposing to collect this 
information separately.
Reporting of Capital Versus Non-Capital Equipment
    To meet the requirement in section 1834(l)(17)(A)(ii) of the Act to 
collect information to facilitate the analysis of ``the utilization of 
capital equipment,'' we are proposing to separately collect information 
on capital equipment expenses (rather than equipment-related operating 
expenses). Capital equipment (both medical and non-medical) yield 
utility over time, which can vary depending on the expected service 
life of the specific good. In addition to the cost of purchasing or 
leasing durable goods equipment, depreciation and maintenance costs 
must be considered in the total cost calculations. Since ground 
ambulance organizations often track capital equipment on an itemized 
level, separating items of significantly different age and cost is 
necessary to calculate depreciation. Therefore, to minimize burden by 
aligning reporting with the accounting approaches used by respondents, 
we are proposing to ask for capital (section 10.1, question 1; section 
10.2, question 1) and non-capital costs (section 10.1, questions 2-3; 
section 10.2, questions 2-3) separately so that respondents can report 
annual depreciated costs for capital equipment and total annual costs 
otherwise. We also are proposing to allow respondents to report annual 
maintenance and service costs for capital equipment because ground 
ambulance organizations have stated during interviews that these costs 
can be significant compared to purchase costs or annual depreciated 
costs. Finally, we are proposing to allow respondents to use their own 
standard accounting practice to categorize equipment as capital or non-
capital. While we believe it would be possible to ask respondents to 
use a standard approach, we believe this would require respondents with 
another practice to recalculate annual depreciated cost and potentially 
increase respondent burden and reporting errors.
Allocation of Shared Costs
    During interviews with ground ambulance organizations, it was noted 
that although the vast majority of equipment and supplies are for 
ground ambulance services, some costs are shared with hospitals or 
clinics. We believe separate reporting on medical and non-medical 
equipment and supplies would facilitate allocation (section 10.1, 
versus section 10.2). For organizations that indicate the use of shared 
services, we are proposing to ask separately what share of medical and 
non-medical equipment and supply costs are related to ground ambulance 
services (section 10.1, questions 1c, 2a; section 10.2, questions 1c, 
2a, 3a). The share of non-medical equipment and supplies used for 
ambulance services may vary for respondents with operations beyond 
ambulance services. While other allocation methods (such as the share 
of responses that are ground ambulance responses) may be appropriate to 
allocate equipment and supply costs, asking respondents to provide 
their estimate of the share of equipment and supply costs related to 
ambulance services reduces assumptions made about how best to apply 
allocation across the various equipment and supplies reported.

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(v.) Collecting Data on Other Costs
    In addition to core costs for ambulance providers and suppliers 
that are associated with labor, vehicles, facilities, and equipment or 
supplies, ground ambulance organizations have indicated that these 
entities incur costs associated with contracted services (for example, 
for billing, vehicle maintenance, accounting, dispatch or call center 
services, facilities maintenance, and IT support), as well as other 
miscellaneous costs (for example, administrative expenses, fees and 
taxes) to support ground ambulance services.
    We considered including contracted services as part of the labor 
section, since many of the contracted services related to costs that 
would otherwise be labor-related if the tasks were performed by 
employed staff. However, we were concerned that ground ambulance 
organizations might report this information in multiple instrument 
sections (for example, both labor and miscellaneous costs). As a 
result, we separated contracted services into their own categories. 
While we considered allowing respondents to report in the aggregate any 
other miscellaneous costs associated with ground ambulance services 
because we believed this approach may be less burdensome for 
organizations that track miscellaneous costs in aggregate, we believe 
this would introduce a large amount of reporting bias and inconsistency 
in reporting across organizations. Our proposals related to reporting 
contracted services and miscellaneous costs are described below.
Reporting Contracted Services
    For contracted services, we are proposing that respondents indicate 
whether their organization utilizes contracted services to support a 
variety of tasks (section 11, question 1), the associated total annual 
cost for these services, and the percentage of costs attributable to 
ground ambulance services. The proposed data collection instrument 
would provide instructions to ensure that respondents do not report on 
contracted costs multiple times.
Reporting of Miscellaneous Costs
    For other miscellaneous costs not otherwise captured in prior 
sections of the data collection instrument, we are proposing that 
respondents be able to report additional costs first using an extensive 
list of other potential cost categories (section 11, question 2) and 
then use write-in fields if necessary. Providing a pre-populated check 
list would help ensure the consistency and completeness of reporting 
across respondents.
Allocation of Miscellaneous Shared Costs
    Information from ground ambulance organizations indicates that 
there are a number of miscellaneous costs associated with the overall 
operation of organizations that are shared across services. To account 
for these shared costs, we are proposing that respondents report an 
allocation factor for each contracted service, (section 11, question 
1), as well as for each reported miscellaneous expense (section 11, 
questions 3-4) as described in the data collection instrument. We 
considered the alternative of asking for an overall share of 
miscellaneous costs associated with ground ambulance services or 
utilizing information gathered about the share of ground ambulance 
responses versus total responses to determine an overall allocation 
factor. While this would present less burden on respondents, the share 
of miscellaneous costs and share of contracted services varies widely 
across organizations with shared services.
d. Proposed Data Collection on Revenue
    Section 1834(l)(17)(A) of the Act requires the development of a 
data collection system to collect revenue information for ground 
ambulance provider and suppliers. Payments from Medicare and other 
health care payers are important components of total revenue for some 
ambulance providers and suppliers. Most ambulance providers and 
suppliers also have other sources of revenue in addition to payments 
for billed services. Based on review of existing literature and 
discussions with ground ambulance organizations, these primary sources 
of revenue include, but are not limited to: Patient out-of-pocket 
payments; direct public financing of fire, EMS, or other agencies; 
subsidies, grants, and other revenue from local, state, or federal 
government sources; revenue from providing services under contract; and 
fundraising and donations. We view total revenue as the sum of payments 
from health care payers and all other sources of revenue, including 
those listed above.
    While collecting information on total revenue is essential to 
understanding variations in how EMS services are financed across the 
country, this information is not collected by Medicare or by any other 
entity of which we are aware. Similar to other sections of the data 
collection instrument, we also considered what level of data to request 
in this section. We are proposing to ask for total revenue in aggregate 
(section 13, question 1) and total revenue from paid ground ambulance 
transports for Medicare and, if possible, broken down by payer category 
for other payers (section 13, questions 2-5). We are proposing this 
level of detail because we believe understanding payer mix would be 
helpful to assess Medicare's contributions to total revenue. Based on 
information provided by ambulance providers and suppliers, there is 
variation in how patient-paid amounts were recorded in ambulance 
billing systems. We are proposing to ask respondents whether revenue by 
payer includes corresponding patient cost sharing or whether cost-
sharing amounts are included in a self-pay category. For other revenue 
(for example, contracts from facilities and membership fees (such as 
those associated with community members that enroll in ambulance 
clubs), we are proposing to request information on additional revenue 
in predetermined categories and using write-in fields if necessary 
(section 13, question 5).
    Allocation of Shared Revenues. Ground ambulance organizations vary 
widely in the types of other revenue sources (as noted in section 13, 
question 6) they receive and their share of allocated costs. For this 
reason, we are proposing to have respondents report the share of 
revenue for each category that is attributable to ground ambulance 
services (section 13). Similar to miscellaneous costs, we considered 
the alternative of asking for an overall share of other revenue sources 
associated with ground ambulance services or utilizing information 
gathered about the share of ground ambulance responses versus total 
responses to determine an overall allocation factor. While this would 
present less burden on respondents, we do not believe it would not 
adequately capture the revenue only associated with ground ambulance 
services, especially for organization with shared services.
    To collect information on uncompensated care, including charity 
care and bad debt, we are proposing to collect information on both 
total and paid transports. These two measures of volume can be used to 
provide insight into the share of transports that are not paid. The 
proposed data collection instrument broadly collects information on 
total costs (including costs incurred in furnishing services that are 
ultimately paid and not paid) and total transports (again including 
transports that are both paid and not paid). The collected data could 
be used to estimate per-transport costs that can be estimated by 
dividing total costs by total transports, so we do

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not believe it is necessary to directly collect information on 
uncompensated care in the revenue section of the data collection 
instrument.
    We invite comments regarding all the proposals for data collection 
described in this section, including our proposals on the format, 
scope, elements (characteristics, utilization, and costs), collection 
of equipment and supply costs, and other costs.
5. Proposals for Sampling
    Section 1834(l)(17)(B)(i) of the Act requires that CMS identify the 
ground ambulance providers and suppliers organizations that would be 
required to submit information under the data collection system, 
including the representative sample. Section 1834(l)(17)(B)(ii)(II) of 
the Act requires the representative sample must be representative of 
the different types of providers and suppliers of ground ambulance 
services (such as those providers and suppliers that are part of an 
emergency service or part of a government organization) and the 
geographic locations in which ground ambulance services are furnished 
(such as urban, rural, and low population density areas). Under section 
1834(l)(17)(B)(ii)(III) of the Act, the Secretary cannot include an 
individual ambulance provider and supplier in 2 consecutive years, to 
the extent practicable. In addition to meeting the requirements set 
forth in the statute, including developing a representative sample, our 
proposals around sampling aim to balance our need for statistical 
precision with reporting burden. Our proposals to meet these statutory 
requirements are described below, and were developed with the intention 
of obtaining statistical precision with the least amount of reporting 
burden.
    Eligible Organizations. A sampling frame drawing on all ground 
ambulance organizations in the United States and its territories that 
provide ground ambulance services (that is, not just those enrolled in 
Medicare or billing Medicare in a given year) may be of interest 
conceptually, but we have not identified a data source listing all 
ambulance providers and suppliers that could be used as the source for 
a broader sampling frame. Since sections 1834(l)(17)(A) of the Act 
requires the Secretary to collect cost, revenue, and utilization 
information from providers of services and suppliers of ground 
ambulance services (which are Medicare specific terms with specific 
meaning) with the purpose of determining the adequacy of payment rates 
and section 1834(l)(17)(D) of the Act requires the Secretary to reduce 
payments to ground ambulance organizations that do not sufficiently 
report, we believe that the intent of the statute is to collect 
information under the data collection system from ground ambulance 
organizations that bill Medicare. Therefore, we are proposing to sample 
ground ambulance organizations that are enrolled in Medicare and that 
billed for at least one Medicare