[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Rules and Regulations]
[Pages 59452-60303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24170]



[[Page 59451]]

Vol. 83

Friday,

No. 226

November 23, 2018

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 411, et al.





 Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared 
Savings Program Requirements; Quality Payment Program; Medicaid 
Promoting Interoperability Program; Quality Payment Program--Extreme 
and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; 
Provisions From the Medicare Shared Savings Program--Accountable Care 
Organizations--Pathways to Success; and Expanding the Use of Telehealth 
Services for the Treatment of Opioid Use Disorder Under the Substance 
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act; Final Rules and Interim 
Final Rule

Federal Register / Vol. 83 , No. 226 / Friday, November 23, 2018 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, 425, and 495

[CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F]
RIN 0938-AT31, 0938-AT13, & 0938-AT45


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act

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

ACTION: Final rules and interim final rule.

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SUMMARY: This major final rule addresses changes to the Medicare 
physician fee schedule (PFS) and other Medicare Part B payment policies 
to ensure that our payment systems are updated to reflect changes in 
medical practice and the relative value of services, as well as changes 
in the statute. This final rule also finalizes policies included in the 
interim final rule with comment period in ``Medicare Program; CY 2018 
Updates to the Quality Payment Program; and Quality Payment Program: 
Extreme and Uncontrollable Circumstance Policy for the Transition 
Year'' that address the extreme and uncontrollable circumstances MIPS 
eligible clinicians faced as a result of widespread catastrophic events 
affecting a region or locale in CY 2017, such as Hurricanes Irma, 
Harvey and Maria. In addition, this final rule addresses a subset of 
the changes to the Medicare Shared Savings Program for Accountable Care 
Organizations (ACOs) proposed in the August 2018 proposed rule 
``Medicare Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success''. This final rule also addresses 
certain other revisions designed to update program policies under the 
Shared Savings Program.
    The interim final rule implements amendments made by the SUPPORT 
for Patients and Communities Act to the Medicare telehealth provisions 
in the Social Security Act and regarding permissible telehealth 
originating sites for purposes of treatment of a substance use disorder 
or a co-occurring mental health disorder for telehealth services 
furnished on or after July 1, 2019 to an individual with a substance 
use disorder diagnosis.

DATES: Effective Dates: These regulations are effective on January 1, 
2019, except for the following:
     Revisions to Sec. Sec.  414.1415(b)(2) and (3), and 
414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
     Amendments to Part 425, which are effective on December 
31, 2018.
    Applicability Date: The following provisions related to Section 
II.I. of this final rule, Evaluation and Management Services, are 
applicable beginning January 1, 2021: Implementation of a blended 
payment rate for E/M visits levels 2-4; Payment to adjust the base E/M 
visit rate(s) upward to account for visit complexity associated with 
non-procedural specialty care and primary care; Payment to adjust the 
base visit rate(s) upward to account for the additional resource costs 
when practitioners need to spend significantly more time with 
particular patients; and Flexible documentation requirements related to 
Medical Decision Making, Time or Current E/M visit documentation 
framework. The amendment to the definition of ``low-volume criteria'' 
at Sec.  414.1305 is applicable at the start of the first Merit-based 
Incentive Payment System (MIPS) determination period for CY 2018 MIPS 
performance period.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on December 31, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-IFC. 
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-1693-IFC, P.O. Box 8010, 
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-1693-IFC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Jamie Hermansen, (410) 786-2064, for any physician payment issues 
not identified below.
    Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, 
for issues related to evaluation and management (E/M) payment, 
communication technology-based services and telehealth services.
    Lindsey Baldwin, (410) 786-1694, for issues related to sections 
2001(a) and 2005 of the SUPPORT for Patients and Communities Act.
    Kathy Bryant, (410) 786-3448, for issues related to global surgery 
data collection.
    Isadora Gil, (410) 786-4532, for issues related to payment rates 
for nonexcepted items and services furnished by nonexcepted off-campus 
provider-based departments of a hospital, and work relative value units 
(RVUs).
    Ann Marshall, (410) 786-3059, for issues related to E/M 
documentation guidelines.
    Geri Mondowney, (410) 786-1172, for issues related to potentially 
misvalued services, geographic price cost indices (GPCIs), and 
malpractice RVUs.
    Donta Henson, (410) 786-1947, for issues related to geographic 
price cost indices (GPCIs).
    Tourette Jackson, (410) 786-4735, for issues related to malpractice 
RVUs.
    Patrick Sartini, (410) 786-9252, for issues related to radiologist 
assistants.
    Michael Soracoe, (410) 786-6312, for issues related to practice 
expense, work RVUs, impacts, and conversion factor.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Edmund Kasaitis, (410) 786-0477, for issues related to reduction of 
wholesale acquisition cost (WAC)-based payment.
    Marcie O'Reilly, (410) 786-9764, for issues related to the 
Potential Model for Radiation Therapy.

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    Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584, 
for issues related to aggregate reporting of applicable information for 
clinical laboratory fee schedule.
    Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for 
issues related to the ambulance fee schedule.
    Corinne Axelrod, (410) 786-5620, for issues related to care 
management services and communication technology-based services in 
Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs).
    JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, 
for issues related to appropriate use criteria for advanced diagnostic 
imaging services.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) Quality Measures.
    Matthew Edgar, (410) 786-0698, for issues related to the physician 
self-referral law.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Benjamin Chin, (410) 786-0679, for inquiries related to Alternative 
Payment Models (APMs).
    David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 
for issues related to the Medicaid Promoting Interoperability Program.
    Elizabeth November, (410) 786-8084, for inquiries related to the 
Medicare Shared Savings Program [Pathways to Success].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Provisions of the Final Rule for PFS
    A. Background
    B. Determination of Practice Expense (PE) Relative Value Units 
(RVUs)
    C. Determination of Malpractice Relative Value Units (RVUs)
    D. Modernizing Medicare Physician Payment by Recognizing 
Communication Technology-Based Services and Interim Final Rule 
Expanding the Use of Telehealth Services for the Treatment of Opioid 
Use Disorder and Other Substance Use Disorders Under the Substance 
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act
    E. Potentially Misvalued Services Under the PFS
    F. Radiologist Assistants
    G. Payment Rates Under the Medicare PFS for Nonexcepted Items 
and Services Furnished by Nonexcepted Off-Campus Provider-Based 
Departments of a Hospital
    H. Valuation of Specific Codes
    I. Evaluation & Management (E/M) Visits
    J. Teaching Physician Documentation Requirements for Evaluation 
and Management Services
    K. GPCI Comment Solicitation
    L. Therapy Services
    M. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
    N. Potential Model for Radiation Therapy
III. Other Provisions of the Final Rule
    A. Clinical Laboratory Fee Schedule
    B. Changes to the Regulations Associated With the Ambulance Fee 
Schedule
    C. Payment for Care Management Services and Communication 
Technology-Based Services in Rural Health Clinics (RHCs) and 
Federally Qualified Health Centers (FQHCs)
    D. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    E. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals
    F. Medicare Shared Savings Program Quality Measures
    G. Physician Self-Referral Law
    H. Physician Self-Referral Law: Annual Update to the List of 
CPT/HCPCS Codes
    I. CY 2019 Updates to the Quality Payment Program (Includes the 
Extreme and Uncontrollable Circumstances MIPS Eligible Clinicians 
Faced as a Result of Widespread Catastrophic Events Affecting a 
Region or Locale in CY 2017 IFC Policies)
IV. Requests for Information
V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Finalized MIPS Quality Measures
Appendix 2: Improvement Activities

Addenda Available Only Through the Internet on the CMS Website

    The PFS Addenda along with other supporting documents and tables 
referenced in this final rule are available on the CMS website at 
http://www.cms.gov/Medicare/Medicare-Fee-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 2019 PFS final rule, refer to item CMS-
1693-F. Readers with questions related to accessing any of the Addenda 
or other supporting documents referenced in this final rule and posted 
on the CMS website identified above should contact Jamie Hermansen at 
(410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this final rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2018 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major final rule makes payment and policy changes under the 
Medicare PFS and implements certain provisions of the Bipartisan Budget 
Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for 
Patients and Communities Act (Pub. L. 115-271, October 24, 2018) 
related to Medicare Part B payment, and except as specified otherwise, 
applicable to services furnished in CY 2019. This final rule also 
revises certain policies under the Medicare Shared Savings Program.
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 final 
rule, we establish RVUs for CY 2019 for the PFS, and other Medicare 
Part B payment policies, to ensure that our payment systems are updated 
to reflect changes in medical practice and the relative value of 
services, as well as changes in the statute. This final rule includes 
discussions regarding:
     Potentially Misvalued Codes.
     Communication Technology-Based Services.
     Provisions Expanding Telehealth Services for the Treatment 
of Opioid Use Disorder and Other Substance Use Disorders under the 
SUPPORT Act.
     Valuation of New, Revised, and Misvalued Codes.
     Payment Rates under the PFS for Nonexcepted Items and 
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments 
of a Hospital.
     Evaluation & Management (E/M) Visits.

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     Therapy Services.
     Part B Drugs: Application of an Add-on Percentage for 
Certain Wholesale Acquisition Cost (WAC)-based Payments.
     Potential Model for Radiation Therapy.
     Clinical Laboratory Fee Schedule.
     Ambulance Fee Schedule--Provisions in the Bipartisan 
Budget Act of 2018.
     Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs).
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     Medicaid Promoting Interoperability Program Requirements 
for Eligible Professionals.
     Medicare Shared Savings Program Quality Measures.
     Physician Self-Referral Law.
     Physician Self-Referral Law: Annual Update to the List of 
CPT/HCPCS Codes.
     CY 2019 Updates to the Quality Payment Program (including 
the extreme and uncontrollable circumstances MIPS eligible clinicians 
faced as a result of widespread catastrophic events affecting a region 
or locale in CY 2017).
     Comments in response to the Request for Information on 
Promoting Interoperability and Electronic Healthcare Information 
Exchange through Possible Revisions to the CMS Patient Health and 
Safety Requirements for Hospitals and Other Medicare- and Medicaid-
Participating Providers and Suppliers.
     Comments in response to the Request for Information on 
Price Transparency: Improving Beneficiary Access to Provider and 
Supplier Charge Information.
    This rule also finalizes certain provisions from the ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success'' proposed rule that appeared in the 
August 17, 2018 Federal Register (83 FR 41786). Under the Medicare 
Shared Savings Program, providers of services and suppliers that 
participate in an ACO continue to receive traditional Medicare fee-for-
service (FFS) payments under Parts A and B, but the ACO may be eligible 
to receive a shared savings payment if it meets specified quality and 
savings requirements. ACOs participating under a two-sided shared 
savings and shared losses model of the program may also be responsible 
for repaying shared losses if the Parts A and B FFS expenditures for 
their assigned beneficiaries exceed the ACO's historical benchmark. The 
revised policies for ACOs participating in the Medicare Shared Savings 
Program will ensure continuity of program participation for ACOs whose 
agreement periods expire on December 31, 2018 by allowing these ACOs 
the opportunity to elect a voluntary 6-month extension of their current 
agreement periods; supporting coordination of care across settings and 
strengthening beneficiary engagement; providing relief for ACOs 
impacted by extreme and uncontrollable circumstance in performance year 
2018 and subsequent years; and promoting interoperable electronic 
health record technology among ACO providers/suppliers. We plan to 
address the remaining proposals from the August 2018 proposed rule (83 
FR 41786) in a forthcoming second final rule.
2. Summary of Costs and Benefits
    We have determined that this major final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII. of this final rule.

B. Determination of Practice Expense (PE) Relative Value Units (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 Five-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).
    Comment: Several commenters requested that CMS include pharmacists 
as active qualified health care providers for purposes of calculating 
physician PE direct costs. The commenters stated that pharmacists need 
to be included in the calculation of direct PE expenses as an element 
of the clinical labor variable relating to physicians' services. The 
commenter stated that pharmacists are key members of the healthcare 
team supporting the advent of digital medicine and telehealth services 
and suggested that pharmacists should be recognized as staff included 
in practice expense inputs.
    Response: The direct PE input database contains the service-level 
costs in clinical labor based on the typical service furnished to 
Medicare beneficiaries. When these resource costs are typically 
incurred in furnishing services, we do not have any standing policies 
that would prohibit the inclusion of the costs in the direct PE input 
database used to develop PE RVUs for individual services, to the extent 
that inclusion of such costs would not lead to duplicative payments. 
Therefore, we welcome more detailed information regarding the typical 
clinical labor costs involving pharmacists for particular PFS services. 
We note, however, that in the case of many PFS services, especially 
care management services, certain elements of the services could be 
provided by clinicians other than the billing professionals, which 
could include services provided by pharmacists. As such, we encourage 
interested stakeholders to provide information through the RUC process 
or directly to us by February 10th prior to annual rulemaking about the 
inclusion of additional clinical labor costs for specific services 
described by HCPCS codes for which payment is made under the PFS, as 
opposed to clinical labor costs that may be typical only under certain 
circumstances.

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b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine 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 2019 PFS Final Rule PE/HR'' 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.
    Comment: Several commenters recommended that it was time to 
consider a new nationwide all specialty PE/HR survey, given the amount 
of time that has passed since the last survey was conducted. The 
commenters stated that the practice of medicine has significantly and 
substantially evolved in the past decade and that many specialties have 
had extensive changes in physician employment models during that time. 
The commenters stated that continued use of the outdated PPIS survey 
leads to an inappropriate and inaccurate distortion of the PE RVUs for 
current practice.
    Response: We have previously identified several concerns regarding 
the underlying data used in determining PE RVUs in the CY 2014 PFS 
final rule with comment period (78 FR 74246 through 74247). While we 
continue to believe that the PPIS survey data are the best data 
currently available, we continue to seek the best broad based, 
auditable, routinely updated source of information regarding PE costs. 
To that end, we have engaged a contractor, the RAND Corporation, to 
explore the feasibility of updating the data used in the development of 
PE RVUs.
    Comment: One commenter requested that CMS consider studying 
indirect PE associated with emergency departments including Emergency 
Medical Treatment & Labor Act (EMTALA)-mandated uncompensated care. The 
commenter stated that emergency physicians are not able to schedule 
their patients and therefore cannot maximize the use of staff and 
resources, and that there are costs associated with being open and 
having to pay shift differentials over nights, weekends, and holidays.
    Response: We will take the information under consideration for 
future rulemaking.
    For CY 2019, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2017. These specialties are Hospitalists and Advanced 
Heart Failure and Transplant Cardiology. We proposed 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:
     Hospitalists from Emergency Medicine, and
     Advanced Heart Failure and Transplant Cardiology from 
Cardiology.
    These updates are reflected in the ``CY 2019 PFS Final Rule PE/HR'' 
file available on the CMS website under the supporting data files 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 following is a summary of the public comments we received on 
our proposal to use proxy PE/HR values for these two new specialties.
    Comment: One commenter stated that they supported the CMS proposal 
to crosswalk the Advanced Heart Failure and Transplant specialty to the 
cardiology PPIS data.
    Response: We appreciate the support from the commenter for our 
proposal.
    Comment: A few commenters wrote to detail their concerns with the 
current PE/HR assigned to home PT/INR monitoring services. Commenters 
stated that these services are provided by entities that are enrolled 
in Medicare as independent testing facilities because there is no other 
specialty category that currently describes these suppliers; however, 
home PT/INR monitoring services are fundamentally different in nature. 
Commenters stated that home PT/INR monitoring services tend to be

[[Page 59456]]

more therapeutic than diagnostic in nature, typically utilize different 
staffing types, and have a different ratio of direct to indirect costs. 
The commenters encouraged CMS to consider home PT/INR monitoring as a 
distinct specialty from independent testing facilities and to survey 
suppliers to determine accurate indirect cost factors for these 
services, while using either the Pathology or All Physicians specialty 
as a proxy for PE/HR in the meantime. One commenter suggested that CMS 
should consider holding payments harmless for home PT/INR monitoring 
services while additional analysis is completed.
    Response: We welcome suggestions from interested parties regarding 
new indirect PE surveys and the use of PE/HR proxies that could be 
considered for future rulemaking. Interested parties may wish to submit 
a physician specialty designation request per the instructions found in 
Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section 
10.8 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf). This section of 
the Medicare Claims Processing Manual includes the criteria that CMS 
uses to evaluate physician specialty designation requests.
    After consideration of the public comments, we are finalizing our 
proposal to use proxy PE/HR values for Hospitalists and Advanced Heart 
Failure and Transplant Cardiology as described above.
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 (see section 
II.B.2.b of this final rule). 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 incorporated 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.
    Comment: One commenter stated that it was not clear why the PE 
change would differ so greatly between the office and facility settings 
for CPT code 37227 (Revascularization, endovascular, open or 
percutaneous, femoral, popliteal artery(s), unilateral; with 
transluminal stent placement(s) and atherectomy, includes angioplasty 
within the same vessel, when performed). The commenter stated that the 
facility PE RVU for this CPT code was proposed to decrease by 4.8 
percent while the non-facility PE RVU was proposed to decrease by 10.6 
percent, and the commenter could not understand how these payment rates 
were determined.
    Response: As detailed above, 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. It is not unusual 
for facility and nonfacility RVUs for a CPT code to change at different 
rates from year to year, as the direct costs associated with the 
facility and nonfacility settings are typically distinct from one 
another. For a more detailed description of the PE RVU methodology, we 
refer readers to the CY 2007 PFS final rule with comment period (71 FR 
69630 through 69643) and the CY 2010 PFS final rule with comment period 
(74 FR 61745 through 61746).
(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 59457]]

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 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to 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 2019, we proposed to add 28 additional codes that we 
identified as low volume services to the list of codes for which we 
assign the expected specialty. Based on our own medical review and 
input from the RUC and from specialty societies, we proposed to assign 
the expected specialty for each code as indicated in Table 1. For each 
of these codes, only the professional component (reported with the -26 
modifier) is nationally priced. The global and technical components are 
priced by the Medicare Administrative Contractors (MACs) which 
establish RVUs and payment amounts for these services. The list of 
codes that we proposed to add is displayed in Table 1.

                    Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
                                                                                                       2017
      CPT code             Modifier            Short descriptor           Expected specialty        utilization
----------------------------------------------------------------------------------------------------------------
70557..............  26.................  Mri brain w/o dye.........  Diagnostic Radiology......             126
70558..............  26.................  Mri brain w/dye...........  Diagnostic Radiology......              32
74235..............  26.................  Remove esophagus            Gastroenterology..........              10
                                           obstruction.
74301..............  26.................  X-rays at surgery add-on..  Diagnostic Radiology......              73
74355..............  26.................  X-ray guide intestinal      Diagnostic Radiology......              11
                                           tube.
74445..............  26.................  X-ray exam of penis.......  Urology...................              26
74742..............  26.................  X-ray fallopian tube......  Diagnostic Radiology......               5
74775..............  26.................  X-ray exam of perineum....  Diagnostic Radiology......              80
75801..............  26.................  Lymph vessel x-ray arm/leg  Diagnostic Radiology......             114
75803..............  26.................  Lymph vessel x-ray arms/    Diagnostic Radiology......              41
                                           leg.
75805..............  26.................  Lymph vessel x-ray trunk..  Diagnostic Radiology......              50
75810..............  26.................  Vein x-ray spleen/liver...  Diagnostic Radiology......              46

[[Page 59458]]

 
76941..............  26.................  Echo guide for transfusion  Obstetrics/Gynecology.....              15
76945..............  26.................  Echo guide villus sampling  Obstetrics/Gynecology.....              31
76975..............  26.................  Gi endoscopic ultrasound..  Gastroenterology..........              49
78282..............  26.................  Gi protein loss exam......  Diagnostic Radiology......               8
79300..............  26.................  Nuclr rx interstit colloid  Diagnostic Radiology......               2
86327..............  26.................  Immunoelectrophoresis       Pathology.................              24
                                           assay.
87164..............  26.................  Dark field examination....  Pathology.................              30
88371..............  26.................  Protein western blot        Pathology.................               2
                                           tissue.
93532..............  26.................  R & l heart cath            Cardiology................              28
                                           congenital.
93533..............  26.................  R & l heart cath            Cardiology................              36
                                           congenital.
93561..............  26.................  Cardiac output measurement  Cardiology................              28
93562..............  26.................  Card output measure subsq.  Cardiology................              38
93616..............  26.................  Esophageal recording......  Cardiology................              38
93624..............  26.................  Electrophysiologic study..  Cardiology................              51
95966..............  26.................  Meg evoked single.........  Neurology.................              72
95967..............  26.................  Meg evoked each addl......  Neurology.................              61
----------------------------------------------------------------------------------------------------------------

    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 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the public comments we received on 
our proposal to update the list of expected specialty assignments for 
low volume services.
    Comment: Several commenters supported the continued use of service-
level overrides for low volume codes, and stated that they agreed with 
the addition of the proposed 28 codes to the list of expected 
specialties.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters stated that CPT code 22857 (Total disc 
arthroplasty (artificial disc), anterior approach, including discectomy 
to prepare interspace (other than for decompression), single 
interspace, lumbar) was missing from the proposed list. These 
commenters requested that CMS include CPT code 22857 in the low 
utilization category and permanently assign it to the orthopaedic 
surgery specialty to maintain payment stability and minimize annual 
fluctuations.
    Response: We agree with the commenters that CPT code 22857 
qualifies as a low volume code, with an annual Medicare utilization of 
roughly 20 services. We agree with the commenters that assigning this 
code to the orthopaedic surgery specialty will help to maintain payment 
stability, and we are finalizing the addition of CPT code 22857 to the 
low volume services list.
    Comment: One commenter stated that several of the proposed low 
volume services would be more accurately assigned to different expected 
specialties based on their practice patterns. The commenter stated that 
CPT codes 70557 and 70558 are intraoperative exams and are most often 
performed by neurosurgeons and that CPT code 74235 is a diagnostic 
radiology code rather than a gastroenterology code. The commenter 
stated that CPT code 75810 should be assigned to interventional 
radiology rather than diagnostic radiology, and that CPT codes 78282 
and 79300 should be assigned to nuclear medicine rather than diagnostic 
radiology.
    Response: We agree that these codes would be more accurately 
assigned to the expected specialties described by the commenter based 
on an examination of the claims data. We are finalizing changes in 
expected specialty to these six codes as described by the commenter.
    Comment: One commenter stated that there are four codes that are 
still not included in the proposed CY 2019 low volume override list and 
recommended that the following low volume procedures be added to the 
override list with the indicated specialty assignment:
     Cardiac Surgery: CPT code 35812, and
     Thoracic Surgery: CPT codes 32654, 33025 and 33251
    Response: We agree with the inclusion of CPT codes 32654 and 33251. 
These are services with very low annual utilization, and we are 
finalizing their addition to the low volume services list with the 
expected specialty as described by the commenter. We note that CPT code 
33251 is already on the low volume services list with an expected 
specialty of Cardiac Surgery; we are finalizing a change to the 
Thoracic Surgery specialty as requested by the commenter. We are not 
finalizing the addition of CPT code 35812 to the list, as it does not 
appear to be a current CPT code. We are also not finalizing the 
addition of CPT code 33025 to the list, as the code had a utilization 
of more than 5,000 services in the most recent year of claims data, and 
this would not qualify as a low volume service under the criteria that 
we have previously finalized through rulemaking.
    Comment: One commenter stated that the appropriate low volume 
overrides were not applied to a series of congenital/pediatric cardiac 
surgery codes. The commenter stated that each of these operations can 
only be performed by congenital heart surgeons classified as either 
cardiac or thoracic surgeons, and that they believe the malpractice 
RVUs had been improperly decreased as a result of the low volume 
service overrides not being applied.
    Response: Each of the CPT codes identified by the commenter was 
already present on the low volume services list with an expected 
specialty assignment of either Cardiac Surgery or Thoracic Surgery. The 
shifts in malpractice RVUs identified by the commenter were a result of 
proposed policies associated with E/M visits. We refer readers to 
section II.I. of this final rule for additional details on these 
policies.
    After consideration of the public comments, we are finalizing the 
addition of the proposed 28 codes to the low volume services list, with 
the expected specialty as proposed except where modified in response to 
comments. We are also finalizing the addition of CPT codes 32654 and 
33251 to the list with an expected specialty of Thoracic Surgery as 
detailed previously.

[[Page 59459]]

    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.
    The following is a summary of the public comments we received on 
the indirect practice cost indices.
    Comment: Many commenters stated that they were opposed to the 
proposed significant shifts in the indirect practice cost indices at 
the specialty level. Commenters stated that the creation of a separate 
PE/HR rate for the E/M visits resulted in large unintended effects on 
specialties given the way that indirect PE is allocated, and that this 
was inconsistent with CMS' intent to maintain stability in payment. One 
commenter stated that the proposal to create a separate PE/HR rate for 
the E/M visits was based on statistically unsound methodology, had 
opaque analytics, and was not resource-based. Many commenters stated 
that the effects of the proposed changes to the indirect practice cost 
indices had not been sufficiently detailed in the proposed rule to 
allow for proper feedback from commenters. Commenters expressed concern 
that a reduction in payment due to shifts in the indirect PE allocation 
could affect patient access to critical services, such as but not 
limited to CPT codes 96360 (intravenous infusion, hydration; initial, 
31 minutes to 1 hour), 96372 (therapeutic, prophylactic, or diagnostic 
injection (specify substance or drug); subcutaneous or intramuscular), 
96374 (therapeutic, prophylactic or diagnostic injection IV push, 
single or initial substance/drug), 96375 (therapeutic, prophylactic or 
diagnostic injection; each additional sequential IV push of a new 
substance/drug), and HCPCS code G0416 (Surgical pathology, gross and 
microscopic examinations, for prostate needle biopsy, any method). A 
few commenters stated that the proposed indirect practice cost indices 
ignored statutory requirements that payments under the PFS must be 
resource based and failed to meet the transparency requirements of the 
Protecting Access to Medicare Act of 2014 (PAMA). Commenters urged CMS 
not to finalize the proposed changes to the indirect practice cost 
indices.
    Response: The proposed changes in the indirect practice cost 
indices identified by the commenters were a result of proposed policies 
associated with E/M visits, and specifically the proposal to establish 
a separate specialty for E/M visits. We refer readers to section II.I. 
of this final rule for additional discussion of these policies.
    Comment: One commenter stated that the level of detail in the CY 
2019 PFS proposed rule was insufficient to comment on several aspects 
of the proposed changes in coding and payment related to office/
outpatient E/M visits, which was a departure from past rules. The 
commenter specifically stated that there was insufficient information 
to model how the proposed changes in the office/outpatient E/M visit 
codes affected the indirect practice cost indices for all other 
services. Similarly, the commenter suggested that not enough 
information was provided to simulate the PFS ratesetting in a way that 
would isolate the impact of the proposed multiple procedure payment 
reduction (MPPR), in the proposed rates and associated estimates of 
specialty-level impact. The commenter requested that CMS provide 
additional technical information and files going forward to enable the 
commenter to better model proposed and future policies.
    Response: We agree with commenters regarding the importance of 
transparency and the need for detailed

[[Page 59460]]

information about proposed policies so that public commenters can 
provide a full and informed response. We also understand that there is 
merit to providing as much information as possible that would allow for 
complete reproduction of our proposed and final ratesetting 
methodologies. We also understand that the proposals related to office/
outpatient E/M visits are of great importance to the medical community 
and represent a significant portion of spending under the PFS. We do 
not agree with the commenter that the level of detail provided in the 
proposed rule, including the data provided as publicly available 
download files, was insufficient for public comment due to the 
extensive documentation associated with the E/M policy proposals, or 
that it represented a departure from past practice. Over several years, 
we have invested significant resources in improving the transparency of 
the data we use in developing proposed and final PFS rates. We intend 
to maintain a focus on increasing transparency, and believe the 
commenters' concerns will help us understand the kind of information 
that can be most helpful to stakeholders interested in the underlying 
data sets. While we are not finalizing the MPPR element of the E/M 
proposal, we appreciate the commenter's interest in the use of code-
level assumptions regarding proposed payment adjustments that are 
reflected in the discounts in the setup file, as discussed in section 
II.B.2.(5)(e) of this final rule.
(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 final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
    Comment: We received many comments regarding the ongoing decrease 
in the technical component of CPT code 76881 (Ultrasound, complete 
joint (i.e., joint space and peri-articular soft tissue structures) 
real-time with image documentation). Commenters stated that this 
procedure is essential for making appropriate diagnosis and managing 
patients with various rheumatologic conditions and musculoskeletal 
disorders. Commenters stated that cutting the reimbursement for the 
code would not only result in poor patient care but also increase total 
costs through the use of more expensive MRI procedures. Commenters also 
disagreed with the RUC's recommended direct PE inputs for CPT code 
76881 from the CY 2018 rule cycle, citing concerns with the RUC's use 
of workforce data, and urged CMS not to make further reductions in 
payment.
    Response: The comments regarding CPT code 76881 are out of scope, 
as we did not make any proposals involving this code for CY 2019. The 
reductions in payment described by the commenters for CPT code 76881 
were finalized as part of the CY 2018 PFS final rule (82 FR 53058-
53059), and are continuing to be phased in over time as part of the 
transition policy described above. 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 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.

[[Page 59461]]

 
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.
B2.................................  Pedorthic personnel.
B3.................................  Medical supply company with pedorthic personnel.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 3 details the manner in which the 
modifiers are applied.

                         Table 3--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
            Modifier                    Description              Volume adjustment           Time adjustment
----------------------------------------------------------------------------------------------------------------
80, 81, 82......................  Assistant at Surgery...  16%.........................  Intraoperative portion.
AS..............................  Assistant at Surgery--   14% (85% * 16%).............  Intraoperative portion.
                                   Physician Assistant.
50 or LT and RT.................  Bilateral Surgery......  150%........................  150% of work time.
51..............................  Multiple Procedure.....  50%.........................  Intraoperative portion.
52..............................  Reduced Services.......  50%.........................  50%.
53..............................  Discontinued Procedure.  50%.........................  50%.
54..............................  Intraoperative Care      Preoperative +                Preoperative +
                                   only.                    Intraoperative Percentages    Intraoperative
                                                            on the payment files used     portion.
                                                            by Medicare contractors to
                                                            process Medicare claims.
55..............................  Postoperative Care only  Postoperative Percentage on   Postoperative 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 
final rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:


[[Page 59462]]


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

Where:

minutes per year = maximum minutes per year if usage were continuous 
(that is, usage = 1); generally 150,000 minutes.

usage = variable, see discussion in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this final rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    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.
    Comment: A few commenters stated that equipment time associated 
with payment for diagnostic imaging services is not aligned with 
practice. The commenters disagreed with the CMS statement that certain 
highly technical equipment is less likely to be used during all of the 
preservice or postservice tasks performed by clinical labor staff, and 
stated that the CMS analysis of equipment time is not accurate based on 
their experience with imaging centers. Commenters stated that there are 
non-imaging functions that are required by CMS for payment, such as 
documentation requirements and the need for enrollment in Medicare by 
professionals, which add to their administrative burden and increase 
costs yet are underrepresented in the PE methodology. Commenters stated 
that they disagreed with how CMS defined room time as inconsistent with 
how imaging centers actually function, and indicated a preference for 
assigning equipment time based on the total technologist time.
    Response: We disagree with the commenters regarding the equipment 
time assigned to highly technical equipment. We continue to 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 and 
are typically available for other patients even when one member of 
clinical staff may be occupied with a preservice or postservice task 
related to the procedure. For a more detailed description of this 
topic, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67639 through 67640).
    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 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.
    Comment: A commenter stated that they continue to believe that 
maintenance costs for imaging equipment are much higher than the 
current 5 percent assumption. The commenter stated that they were 
hopeful that the market-based research into equipment and supply 
pricing would result in a broad range, systematic data collection 
methodology that could be applied to collecting information on 
equipment maintenance costs.
    Response: As detailed above, we continue to believe that the 
current 5 percent maintenance factor likely understates the true cost 
of maintaining some equipment and overstates the maintenance costs for 
other equipment. We continue at this time to lack publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining maintenance factor. With 
regards to the market-based study, the StrategyGen contractors were 
tasked with updating the commercial pricing of supplies and equipment, 
and did not include an investigation of equipment maintenance rates as 
part of their research.
    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 
did not propose any changes to these interest rates for CY 2019. The 
interest rates are listed in Table 4.

                   Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                      Useful
                       Price                           life     Interest
                                                     (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 2019 direct PE input database, which is 
available 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.
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

[[Page 59463]]

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.
    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.
    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 for CY 2018, to facilitate rulemaking for 
CY 2019, we are continuing to display two versions of the Labor Task 
Detail public use file: one version with the old listing of clinical 
labor tasks, and one with the same tasks cross-walked to the new 
listing of clinical labor activity codes. These lists are available on 
the CMS website under downloads for the CY 2019 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    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. These RUC-reviewed codes do 
not currently have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we do not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets.
    As a result, 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. If we had received RUC recommendations 
for codes that currently include clinical labor time for the ``Confirm 
order, protocol exam'' clinical labor task, we would have left the RUC-
recommended clinical labor times unchanged, but there were no such 
codes reviewed for CY 2019. We 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 used in the calculation 
of PE RVUs.
    The following is a summary of the public comments we received on 
our proposal 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 the aforementioned pattern in the RUC-recommended 
direct PE inputs.
    Comment: Several commenters supported CMS' proposal and requested 
that these clinical labor refinements should be finalized wherever the 
refinement had been proposed. These commenters noted that there was no 
change in the total clinical labor direct costs in these situations and 
urged CMS to finalize the proposal.

[[Page 59464]]

    Response: We appreciate the support for the proposal from the 
commenters.
    Comment: Other commenters disagreed with the proposal. Commenters 
stated that the standard clinical labor time for the CA013 ``Prepare 
room, equipment and supplies'' activity has always been 2 minutes, and 
that the occasional assignment of additional clinical labor time in 
individual procedures has not changed this standard.
    Response: We agree with the commenters that the standard clinical 
labor time for the CA013 activity code is 2 minutes. We noted in the 
proposed rule that 3 minutes has often traditionally been assigned for 
this clinical labor activity, and our proposal was intended to reflect 
this common practice pattern. In our table of direct PE refinements, we 
listed many of these clinical labor refinements using the refinement 
code ``L1: Refined time to standard for this clinical labor task.'' 
This was the incorrect refinement code to use in these situations, and 
we acknowledge that this was a technical error. The direct PE 
refinements would have more accurately employed the general refinement 
code ``G1: See preamble text'' instead. We wish to clarify that 
although we agree that the standard clinical labor time for the CA013 
activity is 2 minutes, we continue to believe that 2 minutes would not 
be typical for many of the codes currently under discussion.
    Comment: Commenters explained 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. 
In the old version of the PE worksheet, there was a clinical labor task 
named ``Patient clinical information and questionnaire reviewed by 
technologist, order from physician confirmed and exam protocoled by 
radiologist.'' Commenters stated that this 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 is now divided into the CA007 and CA014 activity 
codes, with a standard of 1 minute for each activity. The commenters 
stated that they recognized that the proposal had no effect on the 
total clinical labor direct costs, but urged CMS not to finalize anyway 
due to concerns over inaccuracy and long term effects on the direct 
practice expense inputs across the PFS.
    Response: We agree with the commenters that in situations where a 
CPT code under review had 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, and where that old clinical labor 
task was divided into the new CA007 and CA014 activity codes as 
described by the commenters, we will not finalize our proposed 
refinements to maintain 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, 
as we agree that the old clinical labor task is adequately accounted 
for by being divided into the new activity codes. In these cases, we 
will finalize the RUC-recommended 2 minutes of clinical labor time for 
the CA007 activity code and 1 minute for the CA014 activity code.
    However, when reviewing the clinical labor for the reviewed codes 
affected by this issue, we found that several of the codes did 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. We also noted that several of the reviewed codes that 
contained the CA014 clinical labor activity code for ``Confirm order, 
protocol exam'' did not contain any clinical labor for the CA007 
activity (``Review patient clinical extant information and 
questionnaire''). In these situations, we believe that it is more 
accurate to finalize our direct PE refinements 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 as proposed, since the 
rationale provided by the commenters does not appear to be the case. 
These codes do not appear to be an instance where the old clinical 
labor task was split into two new clinical labor activities. We do not 
understand how time assigned to an old clinical labor task could be 
divided between the CA007 and CA014 activity codes, as the commenters 
suggested, in situations where the code under review does not contain 
any clinical labor for the CA007 activity. 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, as these codes do not currently have clinical 
labor time assigned for the CA014 ``Confirm order, protocol exam'' 
clinical labor activity.
    After consideration of the public comments, we are finalizing our 
proposal for the reviewed codes that did not include the old clinical 
labor task described above and do not contain any clinical labor for 
the CA007 clinical labor activity. We are therefore finalizing our 
proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and 
92274. We are not finalizing our proposal for the reviewed codes where 
we were able to determine that the old clinical labor task had been 
divided into the CA007 and CA014 activity codes as described by the 
commenters. We are therefore finalizing the RUC-recommended CA013 and 
CA014 clinical labor for CPT codes 76978, 76981, and 76982.
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 proposed rule (81 FR 46176 through 46177), 
we proposed standardizing refinements to the way scopes have been 
defined in the direct PE input database. We believe that there are four 
general types of scopes: Non-video scopes; flexible

[[Page 59465]]

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 CY 2018 (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 is to create an 
administratively simple scheme that will be easier to maintain and help 
to reduce administrative burden. We look forward to receiving detailed 
recommendations from expert stakeholders regarding the scope equipment 
items that would be typically required for each scope category, as well 
as the proper pricing for each scope.
(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, and indicated our intention to address these changes 
in CY 2019 to incorporate feedback from expert stakeholders.
(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 2019
    We understand that the RUC has convened a Scope Equipment 
Reorganization Workgroup that will be incorporating 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 proposed to delay proposals for any further 
changes to scope equipment until CY 2020 so that we can incorporate the 
feedback from the aforementioned workgroup. However, we proposed to 
update the price of the scope video system (ES031) from its current 
price of $33,391 to a price of $36,306 to reflect the addition of the 
LED light and miscellaneous small equipment associated with the system 
that falls below the threshold of individual equipment pricing as scope 
accessories, as we explained in detail in the CY 2018 PFS final rule 
(82 FR 52992 through 52993). We also proposed to update the name of the 
ES031

[[Page 59466]]

equipment item from ``video system, endoscopy (processor, digital 
capture, monitor, printer, cart)'' 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.
    The following is a summary of the public comments we received on 
our proposals involving scopes and scope systems.
    Comment: Several commenters supported the decision to delay 
proposals for any further changes to scope equipment until CY 2020 in 
order to incorporate the feedback from the RUC's Scope Equipment 
Reorganization Workgroup. One commenter thanked CMS for adding a scope 
category for multi-channeled flexible video scopes. A different 
commenter supported the proposal to increase the price of the scope 
video system (ES03l) from its current price of $33,391 to a price of 
$36,306 and also supported the proposed update to the name of the ES03l 
equipment item since the use of the scope video system is not limited 
to endoscopy procedures.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter stated that they were concerned that the 
proposed pricing for both the scope video system (ES03l) and the 
stroboscopy system (ES065) are less than the true cost of the equipment 
items, and therefore do not accurately reimburse physicians for their 
direct overhead costs. The commenter stated that they had supplied more 
recent invoices for these equipment items, which should be taken into 
consideration for pricing, and reiterated their disagreement with the 
CMS proposal from the previous calendar year to create single scope 
equipment categories for all specialties, as scope equipment is not 
always comparable across specialties. A different commenter supplied 
invoices for several other scope equipment items and requested that CMS 
update the prices for these equipment codes and that the new pricing 
take effect for CY 2019.
    Response: We continue to believe that any further changes to scope 
equipment, including invoice submissions to update scope pricing, 
should be delayed until CY 2020 so that we can incorporate the feedback 
from the RUC's Scope Equipment Reorganization Workgroup.
    After consideration of the public comments, we are finalizing our 
scope proposals for CY 2019 without refinement.
c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation
    Several stakeholders contacted CMS with regard to the use of the 
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106) 
supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with 
dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal 
or via canine fossa), 31296 (Nasal/sinus endoscopy, surgical; with 
dilation of frontal sinus ostium (e.g., balloon dilation)), and 31297 
(Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus 
ostium (e.g., balloon dilation)). The stakeholders stated that the 
price of the SA106 supply (currently $2,599.86) had decreased 
significantly since it was priced through rulemaking for CY 2011 (75 FR 
73351 through 75532), and that the Medicare payment for these three CPT 
codes using the supply no longer seemed to be in proportion to what the 
kits cost. They also indicated that the same catheter could be used to 
treat multiple sinuses rather than being a disposable one-time use 
supply. The stakeholders stated that marketing firms and sales 
representatives are advertising these CPT codes as a method for 
generating additional profits due to the payment for the procedures 
exceeding the resources typically needed to furnish the services, and 
requested that CMS investigate the use of the SA106 supply in these 
codes.
    When CPT codes 31295 through 31297 were initially reviewed during 
the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR 
73184 through 73186, respectively), we expressed our reservations about 
the pricing and the typical quantity of this supply item used in 
furnishing these services. The RUC recommended for the CY 2012 
rulemaking cycle that CMS remove the balloon sinus surgery kit from 
each of these codes and implement separately billable alpha-numeric 
HCPCS codes to allow practitioners to be paid the cost of the 
disposable kits per patient encounter instead of per CPT code. We 
stated at the time, and we continue to believe, that this option 
presents a series of potential problems that we have addressed 
previously in the context of the broader challenges regarding our 
ability to price high cost disposable supply items. (For a discussion 
of this issue, we direct the reader to our discussion in the CY 2011 
PFS final rule with comment period (75 FR 73251)). We stated at the 
time that since the balloon sinus surgery kits can be used when 
furnishing more than one service to the same beneficiary on the same 
day, we believed that it would be appropriate to include 0.5 balloon 
sinus surgery kits for each of the three codes, and we have maintained 
this 0.5 supply quantity when CPT codes 31295-31297 were recently 
reviewed again in CY 2018.
    In light of the additional information supplied by the 
stakeholders, we solicited comments on two aspects of the use of the 
balloon sinus surgery kit (SA106) supply. First, we solicited comments 
on whether the 0.5 supply quantity of the balloon sinus surgery kit in 
CPT codes 31295-31297 would be typical for these procedures. We are 
concerned that the same kit can be used when furnishing more than one 
service to the same beneficiary on the same day, and that even the 0.5 
supply quantity may be overstating the resources typically needed to 
furnish each service. Second, we solicited comments on the pricing of 
the balloon sinus surgery kit, given that we have received letters 
stating that the price has decreased since the initial pricing in the 
CY 2011 final rule. See Table 5 for the current component pricing of 
the balloon sinus surgery kit.

                                Table 5--Balloon Sinus Surgery Kit (SA106) Price
----------------------------------------------------------------------------------------------------------------
                 Supply components                     Quantity                 Unit                   Price
----------------------------------------------------------------------------------------------------------------
kit, sinus surgery, balloon (maxillary, frontal,    ..............  kit.........................       $2,599.86
 or sphenoid).
Sinus Guide Catheter..............................               1  item........................          444.00
Sinus Balloon Catheter............................               1  item........................          820.80
Sinus Illumination System (100 cm lighted                        1  item........................          454.80
 guidewire).
Light Guide Cable (8 ft)..........................               1  item........................          514.80
ACMI/Stryker Adaptor..............................               1  item........................           42.00
Sinus Guide Catheter Handle.......................               1  item........................           66.00
Sinus Irrigation Catheter (22 cm).................               1  item........................          150.00
Sinus Balloon Catheter Inflation Device...........               1  item........................           89.46
Extension Tubing (High Pressure) (20 in)..........               1  item........................           18.00
----------------------------------------------------------------------------------------------------------------


[[Page 59467]]

    We are interested in any information regarding possible changes in 
the pricing for this kit or its individual components since the initial 
pricing we adopted in CY 2011. The following is a summary of the public 
comments we received on our comment solicitation regarding the balloon 
sinus surgery kit supply.
    Comment: Several commenters stated that the variability inherent in 
the underlying patient anatomy makes it extremely difficult to reliably 
assign a fixed number of sinuses that can be dilated per balloon or 
establish a supply quantity that would constitute the typical case. 
These commenters urged CMS to create a separate HCPCS code for the 
balloon sinus surgery kit that would be billable based on the number of 
balloons used per patient.
    Response: As we stated in the proposed rule, we continue to believe 
that this option presents a series of potential problems that we have 
addressed previously in the context of the broader challenges regarding 
our ability to maintain appropriate relativity while pricing high cost 
disposable supply items. For a discussion of this issue, we direct the 
reader to our discussion in the CY 2011 PFS final rule with comment 
period (75 FR 73251).
    Comment: One commenter provided extensive information regarding the 
pricing and composition of the balloon sinus surgery kit. This 
commenter stated that the components of the supply kit have changed 
from those listed in Table 5, and that there are multiple different 
types of this kit available for purchase. The commenter stated that the 
total cost of the balloon sinus surgery kit varies by sinus dilated, 
whether navigation is used, and by manufacturer, with the average price 
of a basic kit costing $2,204 and the average price of the kit used for 
navigation costing $2,850, not including the navigation device itself. 
The commenter stated that the kit components should not be individually 
priced and that invoices could be made available upon request.
    With regards to the number of sinus dilation procedures that 
typically can be performed per balloon, the commenter repeated that the 
variability inherent in the underlying patient anatomy makes it 
extremely difficult to assign a fixed number of sinuses that can be 
dilated per balloon. The commenter also urged CMS to consider a shift 
away from the current supply methodology and instead create a separate 
HCPCS code for the balloon sinus surgery kit which would be billable 
based on the number of balloons used per patient. The commenter stated 
that should CMS elect to preserve the current policy of assigning a 
fixed number of sinus dilations per kit, they recommended maintaining 
the current supply quantity that allows one kit for every two sinuses, 
as they were unable to find compelling evidence to support a more 
appropriate supply amount.
    Response: We are particularly interested in the feedback suggesting 
that there may be multiple types of balloon sinus surgery kits that 
have different prices, and we would be interested in further 
information, including invoice submissions, on this subject for future 
rulemaking.
    After consideration of the public comments, we are not finalizing 
any changes to the balloon sinus surgery kit (SA106) supply for CY 
2019, outside of the market-based supply and equipment pricing update 
to the supply cost. We do not believe that we have sufficient 
information to finalize any other changes to the supply cost or supply 
quantity in the associated CPT codes at this point in time.
d. Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2018 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We proposed to correct these inconsistencies as 
described below and reflected in the CY 2019 final direct PE input 
database 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.
    For CY 2019, we proposed to address the following inconsistencies:
     The RUC alerted us that there are 165 CPT codes billed 
with an office E/M code more than 50 percent of the time in the 
nonfacility setting that have more minimum multi-specialty visit supply 
packs (SA048) than post-operative visits included in the code's global 
period. This indicates that either the inclusion of office E/M services 
was not accounted for in the code's global period when these codes were 
initially reviewed by the PE Subcommittee, or that the PE Subcommittee 
initially approved a minimum multi-specialty visit supply pack for 
these codes without considering the resulting overlap of supplies 
between SA048 and the E/M supply pack (SA047). The RUC regarded these 
overlapping supply packs as a duplication, due to the fact that the 
quantity of the SA048 supply exceeded the number of postoperative 
visits, and requested that CMS remove the appropriate number of supply 
item SA048 from 165 codes. After reviewing the quantity of the SA048 
supply pack included for the codes in question, we proposed to refine 
the quantity of minimum multi-specialty visit packs as displayed in 
Table 6.

                    Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Proposed CY
                                                                                      CY 2018          2019
                                                                  Number of post-   nonfacility     nonfacility
                            CPT code                                 op office      quantity of     quantity of
                                                                      visits       minimum visit   minimum visit
                                                                                   pack (SA048)    pack (SA048)
----------------------------------------------------------------------------------------------------------------
10040...........................................................               1               2               1
10060...........................................................               1               2               1
10061...........................................................               2               3               2
10080...........................................................               1               2               1
10120...........................................................               1               2               1
10121...........................................................               1               2               1
10180...........................................................               1               2               1
11200...........................................................               1               2               1
11300...........................................................               0               1               0
11301...........................................................               0               1               0
11302...........................................................               0               1               0

[[Page 59468]]

 
11303...........................................................               0               1               0
11306...........................................................               0               1               0
11307...........................................................               0               1               0
11310...........................................................               0               1               0
11311...........................................................               0               1               0
11312...........................................................               0               1               0
11400...........................................................               1               2               1
11750...........................................................               1               2               1
11900...........................................................               0               1               0
11901...........................................................               0               1               0
12001...........................................................               0               1               0
12002...........................................................               0               1               0
12004...........................................................               0               1               0
12011...........................................................               0               1               0
12013...........................................................               0               1               0
16020...........................................................               0               1               0
17000...........................................................               1               2               1
17004...........................................................               1               2               1
17110...........................................................               1               2               1
17111...........................................................               1               2               1
17260...........................................................               1               2               1
17270...........................................................               1               2               1
17280...........................................................               1               2               1
19100...........................................................               0               1               0
20005...........................................................               1               2               1
20520...........................................................               1               2               1
21215...........................................................               6               7               6
21550...........................................................               1               2               1
21920...........................................................               1               2               1
22310...........................................................             1.5             2.5             1.5
23500...........................................................             2.5             3.5             2.5
23570...........................................................             2.5             3.5             2.5
23620...........................................................               3               4               3
24500...........................................................               4               5               4
24530...........................................................               4               5               4
24650...........................................................               3               4               3
24670...........................................................               3               4               3
25530...........................................................               3               4               3
25600...........................................................               5               6               5
25605...........................................................               5               6               5
25622...........................................................             3.5             4.5             3.5
25630...........................................................               3               4               3
26600...........................................................               4               5               4
26720...........................................................               2               3               2
26740...........................................................             2.5             3.5             2.5
26750...........................................................               2               3               2
27508...........................................................               4               5               4
27520...........................................................             3.5             4.5             3.5
27530...........................................................               4               5               4
27613...........................................................               1               2               1
27750...........................................................             3.5             4.5             3.5
27760...........................................................               4               5               4
27780...........................................................             3.5             4.5             3.5
27786...........................................................             3.5             4.5             3.5
27808...........................................................               4               5               4
28190...........................................................               1               2               1
28400...........................................................               3               4               3
28450...........................................................             2.5             3.5             2.5
28490...........................................................             1.5             2.5             1.5
28510...........................................................             1.5             2.5             1.5
30901...........................................................               0               1               0
30903...........................................................               0               1               0
30905...........................................................               0               1               0
31000...........................................................               1               2               1
31231...........................................................               0               1               0
31233...........................................................               0               1               0
31235...........................................................               0               1               0

[[Page 59469]]

 
31238...........................................................               0               1               0
31525...........................................................               0               1               0
31622...........................................................               0               1               0
32554...........................................................               0               1               0
36600...........................................................               0               1               0
38220...........................................................               0               1               0
40490...........................................................               0               1               0
42800...........................................................               1               2               1
43200...........................................................               0               1               0
45330...........................................................               0               1               0
46040...........................................................               3               4               3
46050...........................................................               1               2               1
46083...........................................................               1               2               1
46320...........................................................             0.5             1.5             0.5
46600...........................................................               0               1               0
46604...........................................................               0               1               0
46900...........................................................               1               2               1
51102...........................................................               0               2               0
51701...........................................................               0               1               0
51702...........................................................               0               1               0
51703...........................................................               0               1               0
51710...........................................................               0               1               0
51725...........................................................               0               1               0
51736...........................................................               0               1               0
51741...........................................................               0               1               0
51792...........................................................               0               1               0
51798...........................................................               0               1               0
52000...........................................................               0               1               0
52001...........................................................               0               1               0
52214...........................................................               0               1               0
52265...........................................................               0               1               0
52281...........................................................               0               1               0
52285...........................................................               0               1               0
53601...........................................................               0               1               0
53621...........................................................               0               1               0
53660...........................................................               0               1               0
53661...........................................................               0               1               0
54050...........................................................               1               2               1
54056...........................................................               1               2               1
54100...........................................................               0               1               0
54235...........................................................               0               1               0
54450...........................................................               0               1               0
55000...........................................................               0               1               0
56405...........................................................               1               2               1
56605...........................................................               0               1               0
56820...........................................................               0               1               0
57061...........................................................               1               2               1
57100...........................................................               0               1               0
57420...........................................................               0               1               0
57500...........................................................               0               1               0
57505...........................................................               1               2               1
62252...........................................................               0               1               0
62367...........................................................               0               1               0
62368...........................................................               0               1               0
62370...........................................................               0               1               0
64413...........................................................               0               1               0
64420...........................................................               0               1               0
64450...........................................................               0               1               0
64611...........................................................               1               2               1
69000...........................................................               1               2               1
69100...........................................................               0               1               0
69145...........................................................             1.5             2.5             1.5
69210...........................................................               0               1               0
69420...........................................................               1               2               1
69433...........................................................               1               2               1
69610...........................................................               1               2               1
93292...........................................................               0               1               0

[[Page 59470]]

 
93303...........................................................               0               1               0
94667...........................................................               0               1               0
95044...........................................................               0           0.028               0
95870...........................................................               0               1               0
95921...........................................................               0               1               0
95922...........................................................               0               1               0
95924...........................................................               0               1               0
95972...........................................................               0               1               1
96904...........................................................               0               1               1
----------------------------------------------------------------------------------------------------------------

    In general, we proposed to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits 
included in these codes. We did not propose any supply pack quantity 
refinements for CPT codes 11100, 95974, or 95978 since they are being 
deleted for CY 2019. We also did not propose any supply pack quantity 
refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405, 
95970, or HCPCS code G0268 since these codes were reviewed by the RUC 
this year and their previous direct PE inputs will be superseded by the 
new direct PE inputs we establish through this rulemaking process for 
CY 2019.
    Comment: One commenter stated that they supported this effort as it 
serves to remedy any discrepancies/errors that may be in the PFS 
related to postoperative visits and the required multi-specialty packs 
needed to render those visits.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: One commenter stated that removal of the SA048 supply pack 
was inappropriate for CPT code 43200 (Esophagoscopy, flexible, 
transoral; diagnostic, including collection of specimen(s) by brushing 
or washing, when performed (separate procedure)) as it is required for 
the esophagoscopy procedure and the supply is included in the other 
codes in the family (CPT codes 43201-43233) as well as for the other GI 
endoscopy code families. The commenter requested that CMS not remove 
the SA048 supply from CPT code 43200.
    Response: After reviewing the supply inputs for the group of codes 
identified by the commenter, we agree that it would not be consistent 
to remove the SA048 multi-specialty pack from CPT code 43200 while 
retaining the supply pack in CPT codes 43201-43233. As a result, we are 
not finalizing the removal of the SA048 multi-specialty pack from CPT 
code 43200. However, we note that many of the CPT codes in this range 
also contain SA048 supply packs without having any postoperative office 
visits included in their global periods. We believe that it may be more 
accurate to achieve consistency within this range of CPT codes by 
removing the SA048 supply pack from all of these codes, as opposed to 
adding the SA048 supply pack to CPT code 43200. In regard to this 
topic, stakeholders can always provide data to us if they believe the 
code is not bundled/valued/etc. correctly.
    After consideration of the public comments, we are finalizing our 
proposal to align the number of minimum multi-specialty visit packs 
with the number of post-operative office visits included in these CPT 
codes listed in Table 6, with the exception of CPT code 43200 as 
detailed above.
    A stakeholder notified us regarding a potential rank order anomaly 
in the direct PE inputs established for the Shaving of Epidermal or 
Dermal Lesions code family through PFS rulemaking for CY 2013. Three of 
these CPT codes describe benign shave removal of increasing lesion 
sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single 
lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion 
diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or 
dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous 
membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving 
of epidermal or dermal lesion, single lesion, face, ears, eyelids, 
nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of 
these codes has a progressively higher work RVU corresponding to the 
increasing lesion diameter, and the recommended direct PE inputs also 
increase progressively from CPT codes 11310 to 11311 to 11312. However, 
the nonfacility PE RVU we established for CPT code 11311 is lower than 
the nonfacility PE RVU for CPT code 11310, which the stakeholder 
suggested may represent a rank order anomaly.
    We reviewed the direct PE inputs for CPT code 11311 and found that 
there were clerical inconsistencies in the data entry that resulted in 
the assignment of the lower nonfacility PE RVU for CPT code 11311. We 
proposed to revise the direct PE inputs to reflect the ones previously 
finalized through rulemaking for CPT code 11311.
    Comment: One commenter agreed that a significant clerical error 
occurred after the RUC recommended its valuation of CPT code 11311 and 
its final acceptance by CMS. The commenter recommended that the direct 
PE inputs of CPT code 11310 be replicated for CPT code 11311 and 
submitted a table with recommended values.
    Response: After reviewing this information, we found that the 
direct PE inputs requested by the commenter mostly, but do not 
entirely, match the direct PE inputs that CMS finalized through 
rulemaking for CY 2013. The commenter requested the inclusion of an 
additional SB007 (drape, sterile barrier 16in x 29in) supply and a 
SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving 
out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022 
(sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and 
4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise 
the direct PE inputs to match the ones previously finalized through 
rulemaking for CPT code 11311, we are not finalizing these five changes 
to the direct PE inputs requested by the commenter. In all other 
respects, the direct PE inputs recommended by the commenter matched the 
direct PE inputs previously finalized through

[[Page 59471]]

rulemaking. We are therefore finalizing our proposal to revise the 
direct PE inputs to reflect the ones previously finalized in CY 2013 
for CPT code 11311.
     In CY 2018, we inadvertently assigned too many minutes of 
clinical labor time for the ``Obtain vital signs'' task to three 
therapy codes, given that these codes are typically billed in multiple 
units and in conjunction with other therapy codes for the same patient 
on the same day, and we do not believe that it would be typical for 
clinical staff to obtain vital signs for each time a code is reported. 
The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; massage, including effleurage, petrissage and/or 
tapotement (stroking, compression, percussion)); CPT code 97750 
(Physical performance test or measurement (e.g., musculoskeletal, 
functional capacity), with written report, each 15 minutes); and CPT 
code 97755 (Assistive technology assessment (e.g., to restore, augment 
or compensate for existing function, optimize functional tasks and/or 
maximize environmental accessibility), direct one-on-one contact, with 
written report, each 15 minutes).
    Therefore, we proposed to refine the ``Obtain vital signs'' 
clinical labor task for these three codes back to their previous times 
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 
97755. We also proposed to refine the equipment time for the table, 
mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the 
change in the clinical labor time.
    Comment: Several commenters agreed with the CMS rationale for 
refining the clinical labor task times for each of these codes.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: One commenter opposed the CMS proposal to refine the 
equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for 
CPT code 97124 to reflect the change in the clinical labor time.
    Response: We continue to believe that changes in clinical labor 
time should be matched with corresponding changes in equipment time. 
Since the commenter did not supply a rationale as to why the EF028 
equipment time should not match the change in clinical labor time, we 
are finalizing our proposal to refine the ``Obtain vital signs'' 
clinical labor task for these three codes back to their previous times 
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 
97755.
    We received a letter from a commenter alerting us to an anomaly in 
the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate 
procedure)). The commenter stated that the inclusion of an endoscope 
disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was 
inadvertently overlooked in the recommendations for CPT code 52000 when 
it was reviewed during PFS rulemaking for CY 2017, and that the 
equipment would be necessary for endoscope sterilization. The commenter 
requested that this piece of equipment should be added to the direct PE 
inputs for CPT code 52000.
    After reviewing the direct PE inputs for this code, we agreed with 
the commenter and we proposed to add the endoscope disinfector (ES005) 
to CPT code 52000, and to add 22 minutes of equipment time for that 
item to match the equipment time of the other non-scope items included 
in this code.
    Comment: One commenter supported the CMS proposal to add an 
endoscope disinfector to CPT code 52000 and to add 22 minutes of 
equipment time to match the equipment time of the other non-scope items 
included in the code. This commenter requested that this addition apply 
to all endoscopic urologic procedures that do not already include the 
endoscope disinfector.
    Response: We do not agree that the endoscope disinfector should be 
added to all endoscopic urologic procedures that lacked the equipment, 
as the addition of this equipment to CPT code 52000 is a technical 
correction to address a specific anomaly with the recommendations for 
CPT code 52000 and not the implementation of a new policy. After 
consideration of the public comments, we are finalizing the addition of 
22 minutes of equipment time for the endoscope disinfector (ES005) to 
CPT code 52000 as proposed.
    The following is a summary of the public comments we received on 
additional technical corrections to the direct PE input database and 
supporting files.
    Comment: A commenter stated that they had reviewed the CY 2019 
Proposed Rule physician work time file and discovered an issue with 13 
CPT codes that had incorrect work times. The commenter stated that 
these were technical errors in which the current work time values did 
not match what CMS had finalized through rulemaking, and the commenter 
requested that these services be corrected in the CY 2019 CMS work time 
file for the CY 2019 Final Rule.
    Response: We agree with the commenter that some of these CPT codes 
are subject to technical corrections, while disagreeing with the 
commenter with regards to other CPT codes, as described in more detail 
below.
    Listed in order, the commenter identified these issues:
    Comment: For CPT code 15220 (Full thickness graft, free, including 
direct closure of donor site, scalp, arms, and/or legs; 20 sq cm or 
less), the commenter stated that their records showed CMS missing 15 
min of positioning time from the Harvard study.
    Response: We are not finalizing a change in the work time of this 
code at this time, as we were unable to verify the positioning time of 
CPT code 15220 as originally measured by the Harvard study.
    Comment: For CPT code 22558 (Arthrodesis, anterior interbody 
technique, including minimal discectomy to prepare interspace (other 
than for decompression); lumbar), the commenter stated that the CMS 
work time file accidentally double counted postoperative visit time in 
the immediate postoperative time field.
    Response: We agree with the commenter that this is subject to a 
technical correction, and we are finalizing an immediate postservice 
work time of 25 minutes for CPT code 22558.
    Comment: For CPT code 43760 (Change of gastrostomy tube, 
percutaneous, without imaging or endoscopic guidance), the commenter 
stated that the code is being deleted for CY 2019 and should not appear 
in the work time file.
    Response: We agree with the commenter, and we are finalizing the 
removal of this code from the work time file.
    Comment: For CPT codes 61645 (Percutaneous arterial transluminal 
mechanical thrombectomy and/or infusion for thrombolysis, intracranial, 
any method, including diagnostic angiography, fluoroscopic guidance, 
catheter placement, and intraprocedural pharmacological thrombolytic 
injection(s)) and 61650 (Endovascular intracranial prolonged 
administration of pharmacologic agent(s) other than for thrombolysis, 
arterial, including catheter placement, diagnostic angiography, and 
imaging guidance; initial vascular territory), the commenter stated 
that CMS incorrectly applied 23 hour stay rule for these codes even 
though the RUC recommended these services as typically inpatient. The 
commenter stated that there are now available data to see that these 
CPT codes are done on an inpatient basis 98 percent and 86 percent of 
the time respectively.
    Response: We do not believe that the work times of these codes are 
subject to

[[Page 59472]]

a technical correction, as the work times finalized for these codes in 
the CY 2017 PFS final rule (81 FR 80307-08) were based on a 
disagreement in policy with the commenter and not a technical error.
    Comment: For CPT code 91200 (Liver elastography, mechanically 
induced shear wave (e.g., vibration), without imaging, with 
interpretation and report), the commenter stated that the RUC 
recommended 5 minutes of immediate postservice work time, not 3 
minutes, and that CMS had finalized the code without a time refinement. 
The commenter stated that the immediate postservice work time for CPT 
code 91200 should be 5 minutes in accordance with the RUC 
recommendations.
    Response: We investigated the RUC recommendations from the April 
2015 RUC meeting when CPT code 91200 was reviewed, and we found that 
the RUC recommended an immediate postservice work time of 3 minutes on 
the code family's cover sheet and the accompanying summary spreadsheet. 
Although the RUC may have intended to recommend an immediate 
postservice work time of 5 minutes for this code, we proposed and 
finalized an immediate postservice work time of 3 minutes for CPT code 
91200 without receiving any comments on the issue. Therefore we are not 
finalizing any changes to the work time of CPT code 91200 at this time, 
which will remain 3 minutes.
    Comment: For CPT codes 93281 (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 pacemaker system), 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), and 93286 (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 pacemaker system), 
the commenter stated that CMS has the wrong intraservice work times, 
despite the CY 2018 final rule indicating no time refinement for these 
codes.
    Response: After reviewing the work times for these codes, we agree 
with the commenter and we are finalizing a technical correction to the 
intraservice work times as recommended.
    Comment: For CPT code 97166 (Occupational therapy evaluation, 
moderate complexity), the commenter stated that the HCPAC recommended 
15 min of immediate postservice work time, not 10 minutes, and that CMS 
had finalized the code without a time refinement.
    Response: We investigated the RUC recommendations from the October 
2015 RUC meeting when CPT code 97166 was reviewed, and we found that 
the HCPAC recommendations contained two different values for the 
immediately postservice work time. The written recommendations stated 
that the immediate postservice work time was recommended at 15 minutes, 
while the data on the summary spreadsheet stated that the immediate 
postservice work time was recommended at 10 minutes. Although there 
were two conflicting HCPAC recommendations for this code, we finalized 
in the CY 2017 PFS final rule (81 FR 80331) an immediate postservice 
work time of 10 minutes for CPT code 97166 without receiving any 
comments on the issue. Therefore we are not finalizing any changes to 
the work time of CPT code 97166 at this time.
    Comment: For 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)), the commenter stated that the 
RUC recommendation was rescinded and that the code should be removed 
from the work time file.
    Response: We disagree with the commenter, and we are not finalizing 
the removal of CPT code 33866 from the work time file; we refer readers 
to the code valuation section of this final rule for additional details 
regarding CPT code 33866.
    Comment: For CPT code 96X11 (Psychological or neuropsychological 
test administration using single instrument, with interpretation and 
report by physician or other qualified health care professional and 
interactive feedback to the patient, family member(s), or 
caregivers(s), when performed), the commenter stated that the code is 
not being created for CY 2019 by the CPT Editorial Panel and should be 
removed from the work time file.
    Response: We agree with the commenter and we are finalizing the 
removal of this code from the work time file.
    Comment: For HCPCS code G0281 (Electrical stimulation, 
(unattended), to one or more areas, for chronic stage iii and stage iv 
pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis 
ulcers not demonstrating measurable signs of healing after 30 days of 
conventional care, as part of a therapy plan of care), the commenter 
stated that their records show an intraservice time for this code of 11 
minutes and not 7 minutes as currently listed in the work time file.
    Response: We disagree with the commenter. As we stated in the CY 
2003 PFS final rule with comment period (67 FR 80014), the work, 
practice expense, and malpractice values G0281 are based on a crosswalk 
to CPT code 97014 (Application of a modality to 1 or more areas; 
electrical stimulation (unattended)), and the intraservice work time of 
CPT code 97014 remains 7 minutes.
    Comment: Many commenters raised concerns about the use of the 
portable X-ray machine (EF041) equipment in CPT code 71045 (Radiologic 
examination, chest; single view). Commenters stated that the use of the 
portable X-ray machine in CPT code 71045 understated the price of the 
equipment typically used in the service, and that the default equipment 
utilization rate of 50 percent did not reflect the experience of 
portable X-ray suppliers. Commenters supplied an invoice for a Digital 
Radiography portable X-ray machine, which they stated would be typical 
for use in this procedure, along with data on the equipment utilization 
rate that suggested a utilization rate significantly lower than 50 
percent would be typical. Commenters requested modifying the direct PE 
inputs for CPT code 71045 to include the use of the Digital Radiography 
portable X-ray machine at a distinctive utilization rate of 
approximately 22 percent, or alternatively, to use the same equipment 
as the other three codes in the Chest X-Ray code family (CPT codes 
71046-71048) as direct PE inputs for CPT code 71045.
    Response: We agree with the commenters and we are finalizing the 
replacement of the 9 minutes of equipment time for the portable X-ray 
machine (EF041) with 9 minutes of equipment time for a basic radiology 
room (EL012) for CPT code 71045. The equipment cost per minute of the 
basic radiology room (48.4 cents) is nearly identical to the equipment 
cost per

[[Page 59473]]

minute of the proposed Digital Radiography portable X-ray machine (46.0 
cents), and we believe that it would better serve the interests of 
relativity for CPT code 71045 to match the same equipment inputs as the 
rest of the Chest X-Ray code family. We previously updated the PE RVU 
of this code in the July 2018 Quarterly Update (CMS Change Request 
10644) based on the same information previously supplied by the 
commenters, and due to a technical error, this update to the direct PE 
inputs of CPT code 71045 was not included in the CY 2019 PFS proposed 
rule. We are finalizing this technical correction to the direct PE 
inputs of CPT code 71045 for CY 2019.
    Comment: One commenter stated that there was a typographical error 
in Attachment B of the proposed rule, which resulted in the 
misstatement of the total RVUs for CPT code 48554 (Transplantation of 
pancreatic allograft). The commenter recommended that we include 74.81 
total RVUs for CPT code 48554 to correct the error of 73.70 total RVUs.
    Response: We do not agree with the commenter that there was a 
typographical error in Addendum B for CPT code 48554, which appears to 
sum its component parts of the work RVU (37.80), PE RVU (27.72), and 
malpractice RVU (9.29) to the correct total RVU of 74.81.
    We also received comments regarding a variety of subjects about 
which we did not make proposals for CY 2019. These included comments 
regarding: The level of physician supervision for CPT code 99091, the 7 
percent reduction to the technical component of computed radiography 
services not performed using digital radiography, a request to migrate 
the RUC recommended RVU assignment of CPT code 77387 to HCPCS code 
G6017, a request that CMS not finalize the proposed changes in payment 
for the revascularization codes (CPT codes 37225-37231) that were a 
byproduct of the E/M proposals and the supply/equipment pricing update, 
a request that CMS should assign direct cost inputs and PE RVUs to 
several disposable negative pressure wound therapy codes (CPT codes 
97607-97608), a disagreement with previous reductions in the payment 
rate for HCPCS code G0416 from past calendar years, a request for 
clarification regarding the facility PE RVUs for CPT code 99153, a 
request for CMS to provide additional reimbursement stability for 
vascular access services by increasing the work RVUs and direct PE 
inputs for these codes (CPT codes 36901-36909), and a request for CMS 
to study the possible effect of tariffs on the cost of imaging 
equipment manufactured overseas. These comments are considered out of 
scope for the CY 2019 PFS final rule, as we did not make any proposals 
on these issues in the CY 2019 PFS Proposed Rule. We will take the 
feedback from the commenters under consideration for future rulemaking.
    After consideration of the public comments, we are finalizing 
technical corrections to the direct PE input database and supporting 
files as described above.
e. Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019, 
we proposed the following price updates for existing direct PE inputs.
    We proposed to update the price of four supplies 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 
proposed that the new pricing take effect for CY 2019 for these items 
instead of being phased in over 4 years. For the details of these 
proposed price updates, please refer to section II.H. of this final 
rule, Table 15: Invoices Received for Existing Direct PE Inputs.
(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, as 
added by PAMA, 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 has 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 FY 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

[[Page 59474]]

equipment and a more precise reference for the RP.
    2. If StrategyGen did not have market share for commercial 
products, then they used a weighted average (weighted by sample size) 
of the commercial price and GSA price for the RP. The impact of the GSA 
price may be nominal in some of these cases since it is proportionate 
to the commercial samples sizes.
    3. Otherwise, if single price points existed from alternate 
supplier sites, the RP was the weighted average of the commercial price 
and the GSA price.
    4. Finally, if no data were available for commercial products, the 
GSA average price was used as the RP; and when StrategyGen could find 
no market research for a particular piece of equipment or supply item, 
the current CMS prices were used as the RP.
    After reviewing the StrategyGen report, we proposed to adopt the 
updated direct PE input prices for supplies and equipment as 
recommended by StrategyGen. For the reasons subsequently discussed, the 
GSA price was not incorporated into the calculation for the StrategyGen 
recommended prices printed in the proposed rule. The proposed 
recommended price was developed as follows:
    Recommended CMS Price: The StrategyGen proposed recommended price 
was the researched-commercial price, when available. If not, the 
StrategyGen proposed recommended price was the current CMS price.
    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 indicate 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 will 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, 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-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 proposed transition from the 
current to the fully-implemented new pricing is provided in Table 7.

                                Table 7--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

[[Page 59475]]

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 were particularly interested in comments regarding 
the supply and equipment pricing for CPT codes 95165 and 95004 that are 
frequently used by the Allergy/Immunology specialty. The Allergy/
Immunology specialty was disproportionately affected by the updated 
pricing, even with a 4-year phase-in. The direct PE costs for CPT code 
95165 would go down from $8.43 to $8.17 as a result of the updated 
supply and equipment pricing information. This would result in the PE 
RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking 
feedback on the supply and equipment pricing for the affected codes 
typically performed by this specialty and whether the direct PE inputs 
should be reviewed along with the pricing. The full report from the 
contractor, including the updated supply and equipment pricing that we 
proposed to be implemented over the proposed 4-year transition period, 
will be made 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 following is a summary of the public comments we received on 
our proposals associated with the market research study to update the 
PFS direct PE inputs for supply and equipment pricing.
    Comment: Many commenters were concerned with the transparency of 
the data used to calculate medical equipment and supply prices. The 
commenters were particularly concerned about the use of a subscription-
based benchmark database as a source for pricing data. The commenters 
stated that without identification of the database and access to the 
precise data used in determining the pricing update, they would have no 
systematic way to evaluate pricing accuracy. In addition, these 
commenters were concerned that small physician practices are not well 
represented in benchmark databases, with the consequence that the 
proposed repricing did not reflect the typical price paid by smaller 
stakeholders. Commenters stated a general concern that any methodology 
that more heavily weighs larger physician groups, group purchasing 
organizations (GPOs), or even hospital contract pricing would result in 
pricing that is significantly depressed compared to the pricing that 
can be obtained by an individual practitioner. The commenters asserted 
that this has the potential to pressure the financial viability of 
smaller physician practices and to force lower cost non-facility 
procedures into hospital outpatient or inpatient sites of service.
    Response: As to whether there is sufficient transparency to enable 
others to replicate and validate the proposed pricing, the StrategyGen 
contractors carried out a market research plan designed to estimate the 
typical discounted prices that physicians and other providers normally 
pay. The proprietary database of buyer reported pricing is one of the 
few sources of typical discounted price data available. Other potential 
sources of typical discounted pricing were other proprietary databases 
and the publicly available GSA pricing. For each item priced, the 
analysis from the contractors included research on as many as five 
current sources of prices: (1) A proprietary database of buyer reported 
pricing, (2) Prices reported by GSA, (3) Amazon Business, (4) Cardinal 
Healthcare, and (5) Vendors' and manufacturers' catalogs.
    The proprietary database of buyer reported pricing offers three 
advantages: (1) It represents discounted prices as opposed to retail 
pricing, (2) It has the largest sample sizes to represent a wider range 
of pricing as opposed to single invoices, and (3) The database provides 
variety with respect to the purchaser's geographic location, purchasing 
method, procedure volume and other purchasing arrangements. We 
initially assumed that GSA also represents typical discounted pricing 
across regions with smaller sample sizes, but subsequently rejected GSA 
data because we did not believe that its prices were typically 
representative of commercially available pricing. As a result, GSA data 
were not used to calculate the StrategyGen recommended prices included 
in the proposed rule. Amazon Business and Cardinal Healthcare represent 
typical retail pricing, with smaller sample sizes. In addition, the 
StrategyGen contractors utilized vendors' and manufacturers' catalogs 
to identify publicly available pricing. Table 8 summarizes sources of 
online pricing and characteristics of each source:

                     Table 8--Market-Based Supply and Equipment Pricing Update Data Sources
----------------------------------------------------------------------------------------------------------------
                                                                                             Variety (that is,
       Source of pricing data            Discounted pricing           Sample size          geography, purchasing
                                                                                            arrangement, etc.)
----------------------------------------------------------------------------------------------------------------
Buyers database.....................  Actual discounts.......  Largest..................  National footprint.
GSA.................................  Wholesale price........  3-5......................  Government purchasers
                                                                                           only.
Amazon Business (on-line)...........  Retail price...........  3-5......................  National footprint.
Cardinal Healthcare (on-line).......  Retail price...........  3-5......................  National footprint.
Catalogs (on-line)..................  Retail price...........  3-5......................  National footprint.
----------------------------------------------------------------------------------------------------------------


[[Page 59476]]

    The Buyers database provides the most accurate market pricing 
estimates that include market discounts for a range of buyer 
organizations. Its larger sample sizes provide more confidence that the 
proposed pricing is not skewed toward higher or lower pricing but 
toward the actual market price paid by purchasers.
    The StrategyGen contractors chose not to include invoice research 
in the market research plan as there is already an existing process to 
modify Direct Practice Expense Input (DPEI) prices based on invoices. 
Additionally, the contractors determined that providing specific models 
and other identifying data with the researched prices would offer a 
broader and more consistent source of pricing data. We do not agree 
with the commenters that the updated supply and equipment prices will 
pressure the financial viability of smaller physician practices, as we 
believe that the larger sample sizes obtained by StrategyGen's research 
provide more accurate and more consistent pricing of actual market 
conditions than the single invoices that we have traditionally been 
reliant upon for pricing.
    As to whether the proposed pricing is representative of prices 
available to small physician practices and non-facility practitioners 
generally, one of the objectives of the primary market research was to 
understand what kind of discounts are available to small physician 
practices similar to discounted pricing available to large health 
systems under GPOs. The market research plan included a series of 
questions to vendors designed to illuminate typical discounts they 
offer to large and small providers other than GPOs. This market 
research indicates that there are a variety of discount purchasing 
options available. Vendors indicated that both volume and timing can 
influence pricing discounts. Approximately 80 percent of respondents 
indicated that timing has some impact on the price of equipment, and 
about half of respondents indicated that timing had some impact on the 
price of supplies. Discussions with other subject matter experts also 
indicated that timing of purchase is an important factor in pricing. 
For example, the end of the sales cycle can drive discounts. Less than 
10 percent of vendors indicated that these timing discounts may not be 
available to smaller practices outside of a GPO. The vendor research 
also indicated that other factors beyond ``size and timing'' influence 
discounted pricing, such as service agreements and bundled purchases.
    Research indicates that service agreements often include discounts 
for equipment and supplies. For example, longer term service agreements 
generally result in larger discounts. However, some vendors indicated 
that the effect of service agreements was to reduce the size of the 
discounts, negatively impacting providers. This may be a difference in 
service agreement strategies across different vendors. Regardless, only 
3 percent of respondents indicated that the availability of service 
agreement discounts was dependent on a GPO.
    The vendors identified other factors that impact pricing decisions 
including:
     Market demand and competitive pricing;
     Contract renewal;
     Customer history and contract history; and
     Vendor considerations independent of the purchaser such as 
manufacturer and sales incentives, revenue goals, and new product 
releases.
    In conclusion, while volume purchasing and GPOs can drive down 
prices for many large providers, these are not the only drivers of 
discounts for providers. A number of additional factors applicable to 
large, small, and non-facility practices may result in discounts for 
the buying organizations. We believe that the pricing update required 
looking at a broad range of data that was collected from different 
sources, which included pricing data from both large and small 
organizations. We note that not all private practices are small in 
nature, and we do not agree that it would be more accurate to obtain 
prices only from small practices as opposed to the broader data 
collection undertaken by the StrategyGen contractor.
    Comment: Some commenters were concerned that the researched GSA 
price was incorporated into the recommended commercial price. These 
commenters expressed concern as to how the GSA price fit into the 
calculation of new recommended prices.
    Response: We want to clarify how the GSA price was used in 
developing the new recommended DPEI prices for equipment and supplies. 
We regret the confusion on this issue, which was due to a technical 
error in the drafting of the language in the proposed rule. We wish to 
clarify that the GSA price was not used to calculate the StrategyGen 
recommended prices printed in the proposed rule. Our use of the GSA 
website to research supply and equipment pricing was found to have a 
number of limitations. Only suppliers that meet stringent 
qualifications and that complete a lengthy and detailed application 
process are eligible to participate in GSA Advantage, GSA's online 
shopping and ordering system. These requirements sharply curtail the 
number and type of suppliers whose products may be accessed on the GSA 
Advantage website. In addition, only products that are purchased by 
federal agencies or other qualified government entities are listed on 
the GSA Advantage website, which has the effect of eliminating a number 
of medical supplies and equipment that are reflected in the CMS DPEI 
codes. This limitation was especially acute when researching bundled 
codes for equipment rooms and lanes, and supply packs, kits, and trays. 
The GSA website does not record comparable bundled purchasing of 
medical equipment or supplies, so no GSA pricing could be recovered for 
products included in the bundled codes organized as rooms, lanes, 
packs, kits or trays. Finally, the prices listed on the GSA Advantage 
website are required to be the supplier's best offer, which may often 
be lower than prices that are available to non-governmental purchasers.
    For these reasons, the GSA price was not incorporated into the 
calculation for the StrategyGen recommended prices printed in the 
proposed rule. The final recommended price for CY 2019 was the 
commercially researched price, if available. Otherwise the current CY 
2018 CMS price remained in place as the CY 2019 CMS price.
    Comment: Several commenters were concerned with the methodology 
used by StrategyGen to conduct market research to determine an updated 
price for medical equipment and supplies. There were significant 
concerns with the use of market research to supplement the current AMA/
Specialty Society RVS Update Committee (RUC) process. A number of 
commenters stated that CMS should only use invoices supplied by the 
specialty society via the RUC process, and should not finalize the 
updated prices researched by the StrategyGen contractor.
    Response: We determined that the most effective way to update the 
DPEI for CY 2019 was through comprehensive market research. The current 
RUC process has resulted in updates to many of the equipment and supply 
codes, but many of the prices in the CY 2018 DPEI are over a decade 
old, and a significant number date back to research conducted 15 years 
ago. Therefore, we requested a market research plan from the 
StrategyGen contractor designed to research current pricing to estimate 
the typical discounted prices that physicians and other providers 
normally pay.

[[Page 59477]]

    The comprehensive market research plan to update DPEI equipment and 
supplies was designed to supplement the AMA RUC process, not replace 
it. The current RUC process, while indispensable, does not provide for 
comprehensive pricing updates. Under the current process, physicians 
and other providers voluntarily submit invoices for items to RUC for 
consideration, and after review, the RUC submits these invoices to us. 
This process results in inherent biases due to the limited number of 
items represented by submitted invoices and due to the voluntary 
selection of reported invoices.
    The StrategyGen market research plan examined up to five online 
sources of current prices for each item of equipment or supply 
researched, including: (1) A proprietary database of buyer reported 
pricing, (2) Prices offered on GSA (Note: This data was subsequently 
excluded from the recommended 2019 CMS prices), (3) Amazon Business, 
(4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs. 
Each of these sources contains nationally reported vendor and buyer 
pricing data. The research plan also included vendor interviews to 
clarify the variety of discount programs available to physicians and 
other providers.
    The comprehensive research plan for the 2019 DPEI required 
researching approximately 2,000 supply and equipment codes. Qualitative 
and potentially quantitative research to include all the specialty 
societies impacted by the DPEI updates was beyond the resources and 
time allocated to this update. The market research plan did include a 
physician panel with specialists and a general practitioner to review 
the reasonableness of the researched data. In addition, the regulatory 
process remains available to all specialty societies to comment on the 
recommended prices. We encouraged interested stakeholders to continue 
to provide feedback on supply and equipment pricing, including the 
submission of invoices, throughout the 4-year pricing transition.
    Comment: Several commenters stated that there is an inherent bias 
to prioritizing the medical equipment and supplies based on spending 
and code utilization. These commenters stated that any attempt to 
accurately price items in the supply and equipment list should devote 
equal effort to each item of equipment or supply and should not devote 
additional attention to the most utilized codes. These commenters 
stated that using utilization data as the primary driver for 
identifying supply and equipment items to review suggests that there 
may have been specific intent to lower the cost of high utilization 
items, perhaps to the detriment of pricing accuracy. In addition, there 
was concern that some underutilized codes were not researched.
    Response: To control for potential research bias, the StrategyGen 
market research team used an identical online methodology to research 
commercial pricing data for each of the supply and equipment codes, 
regardless of the code's prioritization. The prioritization of high-
utilization supply and equipment codes was not designed to reduce 
prices for these codes.
    The prioritization of supply and equipment codes was designed to 
facilitate understanding and validation of the researched commercial 
prices for these items. Surveying other market entities, including 
vendors, as opposed to buyers, was used to more precisely identify the 
range of commercial pricing and factors impacting those prices. For 
example, additional priority research included a physician panel that 
reviewed the researched commercial prices for reasonableness. The 
prioritization of research for certain codes did not change the 
recommended commercial prices.
    In addition, limited time and resources required prioritizing the 
codes based on use. We recognize that a few medical supply and 
equipment codes do not have updated recommended prices, and we continue 
to welcome the submission of updated pricing information from 
stakeholders for these and other codes.
    Comment: Many commenters were supportive of the proposal to use a 
4-year pricing transition. Commenters agreed with using the transition 
period as an opportunity for specialty societies and other stakeholders 
to continue to evaluate the new pricing and submit invoices and other 
pricing data as needed. Commenters who disagreed with the use of the 4-
year pricing transition also requested that CMS not finalize the 
proposal. One commenter stated that CMS should phase in the new prices 
for equipment and supplies during a shorter transition period than the 
proposed 4-year transition, and suggested a 2-year transition instead.
    Response: Our proposal was intended to minimize any potential 
disruptive effects during the proposed transition period, and we 
continue to believe that implementing the proposed updated prices with 
a 4-year phase-in will 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.
    Comment: Several commenters stated that CMS should consider 
delaying implementation of this proposal until there could be a more 
thorough and adequate review of the inputs and give medical societies 
and/or practices more time to gather invoices in order to determine if 
the proposed pricing is accurate. Some commenters similarly requested 
that the 4-year pricing transition should begin in CY 2020 to provide 
stakeholders with additional time to evaluate the approach used by 
StrategyGen. A few commenters stated that they would prefer a delay of 
more than 1 year before implementation began.
    Response: We disagree with the commenters that delaying the 
implementation of the pricing updates for a year or longer would lead 
to more accurate pricing. We believe that our proposal to update the 
pricing of direct PE inputs for supplies and equipment over a 4 year-
transition already allows many opportunities for public comment and the 
submission of additional, applicable data. We welcomed feedback from 
commenters on the proposed updated supply and equipment pricing, 
including the submission of additional invoices for consideration, and 
many commenters provided detailed feedback regarding the pricing of 
individual supply and equipment items. We note that we received 
feedback from commenters on approximately 65 individual supply and 
equipment codes, which is roughly 3 percent of the total number of 
items we proposed to update. We also note that commenters did not 
identify an alternative source for pricing information outside of the 
sources employed by the StrategyGen contractors, with commenters 
largely suggesting that we should continue to rely on invoice 
submissions included along with the review of individual codes via the 
RUC process.
    We continue to believe that a delay in implementation would be 
unlikely to result in more accurate pricing information. Therefore, we 
are finalizing the 4-year pricing transition, beginning in CY 2019. We 
look forward to working with commenters over the 4-year transition for 
assistance in identifying individual supply and equipment codes that 
may require additional research into their pricing. As a reminder, to 
be included in a given year's proposed rule, we generally need to 
receive invoices by the same February 10th

[[Page 59478]]

deadline used 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 for the following year.
    Comment: Many commenters addressed the proper pricing of some 
multi-component items, including supply kits, packs, and trays as well 
as some items of equipment. Several commenters noted some of the 
proposed prices for supply and equipment items that contain multiple 
components may not accurately reflect all the components, while other 
commenters noted that some of the components could be improperly 
priced. Commenters expressed concerns that some equipment may not 
possess precise components that are necessary for a specific procedure.
    Response: Using the information provided by these commenters, the 
StrategyGen contractors re-examined the pricing of the multi-component 
supply and equipment items that had been identified. In some instances, 
the additional research confirmed some commenters' concerns, as the 
contractors found that a limited set of these multi-item supply and 
equipment kits required further clarification of components. For 
example, an item within a kit, pack, or tray may have had an updated 
component, resulting in a mispriced item within that kit. To further 
clarify the prices of these kits, the kits were broken into their most 
basic components and priced individually. The total price of the kit 
was determined by adding the specific item prices together. If one of 
the items within a kit was misidentified, it resulted in an incorrect 
price of the entire kit.
    For example, a review of the recommended price for the ``Antigens, 
multi'' (SH007) supply code identified the need to add pricing data for 
additional antigens and to refine the unit of measurement used in 
calculating the price. For SH007, additional antigens were added and 
data analyzed for 1 milliliter vials of two allergy antigens. The first 
antigen is an allergy antigen for pollen and mites and contains 
antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the 
mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The 
second antigen is an allergy antigen for mold and cats and contains 
antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1. 
To determine the price of the allergy antigen, the StrategyGen 
contractor researched each component of the antigen separately and 
averaged the price of the separate vials as the recommended price to 
arrive at an updated recommended price of $8.96.
    In instances related to equipment, an item may have been improperly 
priced because a specific component was omitted but the items priced 
could perform the requisite task. An example of this occurred in the 
pricing of the ``SRS System, SBRT'' (ER083) equipment item where the 
equipment priced would retrofit a system to perform SBRT procedures, 
but pricing did not include the linear accelerator. When re-examining 
this specific medical equipment, we ensured it was a linear accelerator 
with SBRT capabilities and arrived at an updated recommended price of 
$2,973,721.83.
    We reexamined the recommended price of each multi-component item 
cited by a commenter. Table 9 at the conclusion of this section lists 
the supply and equipment codes with price changes based on feedback 
from the commenters and the resulting additional research into pricing.
    Comment: Several commenters questioned the prices of certain supply 
codes based on their conclusion that the quantity of the items priced 
was inaccurate. Depending on the type of supply, a number of different 
units of measurement are used to set prices for DPEI supply codes. 
Commenters stated that StrategyGen had used the incorrect unit of 
measurement in their recommended prices, and identified specific supply 
codes where they believed these errors had taken place.
    Response: In each instance in which a commenter questioned the 
accuracy of a DPEI code's recommended price based on a concern about 
the unit quantity of the item priced, the StrategyGen contractor 
conducted further research of the item and its price with special 
attention to ensuring that the recommended price was based on the 
clarified unit of measure. The price assigned to a given code may be 
for a single item, a kit, a tray, or it may be based on a per test or 
per ml basis. For example, the price for the SG055 supply is for a 
single sterile 4in x 4in gauze sponge; whereas the price for SG056 is 
for a tray/pack of 10 sterile 4in x 4in gauze sponges. In other 
situations, such as the ``Embedding Mold'' (SL060) supply, the price 
for a package of multiple molds was reported instead of the price of a 
single embedding mold. After consideration of comments received and 
additional price research, we have updated the recommended prices for a 
number of relevant supply codes identified by the commenters. Table 9 
at the conclusion of this section lists the supply and equipment codes 
with price changes based on feedback from the commenters and the 
resulting additional research into pricing.
    Comment: Several commenters addressed the subject of the proper 
pricing for certain items of medical supply and equipment. These 
commenters requested these specific CMS codes be reviewed again to 
ensure the correct items were being researched and priced accordingly.
    Response: 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. An example of such 
clarification occurred with the ``Covered Stent (Viabahn, Gore)'' 
(SD254) supply, which encompasses a wide range of stents, with varying 
sizes and other qualities. In other cases, such as the ``Patient Worn 
Telemetry System'' (EQ340) equipment, an inpatient unit was originally 
priced as opposed to an outpatient unit. After an extensive review and 
validation process, we updated our recommended prices for a number of 
supply and equipment codes. Table 9 at the conclusion of this section 
lists the supply and equipment codes with price changes based on 
feedback from the commenters and the resulting additional research into 
pricing.
    Comment: Several commenters expressed concerns with the proposed 
prices for individual supply and equipment codes, and recommended that 
the price of these codes remain unchanged until additional research can 
be conducted.
    Response: The StrategyGen contractor investigated the accuracy of 
components or features included in an item by researching the identity 
of the item based on the description contained in the item's supply or 
equipment code, as well as the identity of any item's prices

[[Page 59479]]

in submitted invoices. Additional research into approximately half a 
dozen supply/equipment codes failed to produce reliable product data 
sufficient to calculate a recommended price. To price these equipment 
and supply items accurately, we believe additional information is 
required. Therefore, we will continue to use the current CMS price for 
these supply and equipment items pending additional research and 
analysis. We welcome the submission of updated pricing information 
regarding these supply and equipment items through submission of valid 
invoices from commenters and other stakeholders. These supply and 
equipment codes are also listed in Table 9 at the conclusion of this 
section.
    Comment: A few commenters stated that CMS should ensure that the 
direct practice expenses for HCPCS codes G6001-G6015 are applied 
consistent with the directives of the Patient Access and Medicare 
Protection Act (PAMPA) (Pub. L. 114-115) and the Bipartisan Budget Act 
(BBA) of 2018 (Pub. L. 115-123). Commenters stated that Congress 
established via statute that the direct PE inputs for these radiation 
treatment delivery services furnished in CY 2017, CY 2018, and CY 2019 
shall be the same as such inputs as established for these services in 
CY 2016. These commenters stated that the proposed changes to the PE 
RVUs for HCPCS codes G6001-G6015 were directly opposed to current law, 
and that CMS should revisit its analysis to ensure that the direct PE 
inputs are consistent with those used in 2016 as required by Congress.
    Response: We disagree with the commenters that the proposed direct 
PE inputs for HCPCS codes G6001-G6015 were not applied consistent with 
the directives established in the PAMPA and the BBA. The statute at 
section 1848(b)(11) of the Act (as added by the PAMPA and amended) 
specifies that the code definitions, work RVUs, and direct inputs for 
the practice expense RVUs for these services shall be the same as such 
definitions, units, and inputs for such services for the fee schedule 
established for services furnished in CY 2016. We did not propose to 
change the code definitions, work relative value units, or direct 
practice expense inputs from those established for CY 2016. We proposed 
to update the pricing of those same supply and equipment inputs as part 
of the market-based study of commercial pricing undertaken by the 
contractor, which was not a subject addressed by the statutory 
provisions concerning HCPCS codes G6001-G6015. We did not propose 
changes to the direct practice expense inputs for these services. We 
simply proposed to update pricing for these inputs; and to adopt the 
same prices for these supplies and equipment across the PFS for all 
codes that include them. We note that we estimate that the overall 
effect of incorporating the new prices in calculating the payment rates 
for these services results in higher overall RVUs for these services, 
on the whole, than the potential alternative of relying exclusively on 
pricing from prior years.
    After consideration of the public comments, we are finalizing 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 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. However, while we are adopting most of the prices for 
supplies and equipment as recommended by StrategyGen and included in 
the proposed rule, in response to the initial feedback provided by the 
commenters, we are finalizing changes to the proposed pricing of 
approximately 60 supply and equipment codes as detailed in Table 9:

                      Table 9--Supply and Equipment Prices Updated in Response to Comments
----------------------------------------------------------------------------------------------------------------
                                                                                    Proposed CY    Final CY 2019
     Supply/ equipment code                Description             CY 2018 price    2019 price         price
----------------------------------------------------------------------------------------------------------------
ED033..........................  treatment planning system, IMRT    $350,545.000    $157,392.835    $197,247.000
                                  (Corvus w-Peregrine 3D Monte
                                  Carlo).
EF031..........................  table, power...................       6,153.630       5,438.120       5,906.760
EL015..........................  room, ultrasound, general......     369,945.000     130,252.571     369,945.000
EL016..........................  Room--Ultrasound, vascular/         466,492.000     199,449.308     466,492.000
                                  Original submission.
EP014..........................  flow cytometer.................     119,850.000     147,210.980     192,000.000
EP088..........................  ThermoBrite....................       6,120.000       3,467.000       4,795.000
EP116..........................  VP-2000 Processor..............      30,800.000      81,775.462      37,993.000
EQ031..........................  INR monitor, home..............       2,000.000       6,014.819         635.000
EQ125..........................  glucose continuous monitoring         1,170.540         835.527         850.000
                                  system.
EQ288..........................  ultrasonic cleaning unit.......         895.000      76,725.556         895.000
EQ312..........................  INR analysis and reporting           21,085.000       6,014.819      19,325.000
                                  system w-software.
EQ340..........................  Patient Worn Telemetry System..      23,537.000      18,565.719      23,494.000
EQ343..........................  Radioaerosol Administration           2,560.250          30.000         623.000
                                  System.
ER003..........................  HDR Afterload System,               375,000.000     111,425.876     132,574.780
                                  Nucletron--Oldelft.
ER083..........................  SRS system, SBRT, six systems,    4,000,000.000     931,965.479   2,973,721.836
                                  average.
ES052..........................  brachytherapy treatment vault..     175,000.000     134,998.000     193,114.250
SA026..........................  kit, radiofrequency introducer.          50.000         658.700          24.160
SA074..........................  kit, endovascular laser                 519.000         313.460         323.330
                                  treatment.
SA081..........................  pack, drapes, ortho, small.....           1.128           1.000           2.250
SA099..........................  Kit, probe, cryoablation,             4,700.000       1,539.560       1,539.560
                                  prostate (Galil-Endocare).
SA100..........................  kit, probe, radiofrequency, XIi-      2,695.000         753.420       1,966.670
                                  enhanced RF probe.
SA105..........................  UroVysion test kit.............         176.800         132.130         129.280
SA106..........................  Balloon Sinus Surgery Kit......       2,599.860       2,876.220       2,374.330
SA117..........................  Universal Detection Kit........           4.000           6.510           4.000
SA122..........................  Claravein Kit..................         890.000         575.000         883.330
SB019..........................  drape-towel, sterile 18in x               0.282           0.920           0.470
                                  26in.
SB026..........................  gown, patient..................           0.533           3.540           0.590
SD109..........................  probe, radiofrequency, 3 array        2,233.000         871.660       2,289.000
                                  (StarBurstSDE).
SD114..........................  sensor, glucose monitoring               53.080          43.950          59.310
                                  (interstitial).

[[Page 59480]]

 
SD134..........................  tubing, suction, non-latex                2.961           0.290           2.670
                                  (6ft) with Yankauer tip (1).
SD155..........................  catheter, RF endovenous                 725.000       1,010.550         550.000
                                  occlusion.
SD250..........................  introducer sheath, Ansel [45 cm          90.000          64.450          72.640
                                  6 Fr Ansel].
SD251..........................  Sheath Shuttle (Cook)..........           0.000           0.000         109.690
SD253..........................  atherectomy device                    4,979.670       2,293.100       3,048.330
                                  (Spectronetics laser or Fox
                                  Hollow).
SD254..........................  covered stent (VIABAHN, Gore)..       3,768.000       2,573.000       3,129.000
SD255..........................  Reentry device (Frontier,                 0.000           0.000       2,343.120
                                  Outback, Pioneer).
SD304..........................  IVUS catheter..................       1,025.000         727.750         858.330
SF040..........................  suture, vicryl, 3-0 to 6-0, p,            7.852           4.310           8.520
                                  ps.
SG055..........................  gauze, sterile 4in x 4in.......           0.159           0.030           0.190
SG056..........................  gauze, sterile 4in x 4in (10              0.798           0.030           1.200
                                  pack uou).
SH007..........................  antigen, multi (pollen, mite,             6.700           4.780           8.960
                                  mold, cat).
SH009..........................  antigen, venom.................          20.140          27.360          30.930
SH010..........................  antigen, venom, tri-vespid.....          44.050          51.320          60.240
SH033..........................  fluorescein inj (5ml uou)......           5.442          10.310          24.390
SJ055..........................  test strip, INR................           5.660           3.750           4.710
SL012..........................  antibody IgA FITC..............          41.180         274.090          30.025
SL060..........................  embedding mold.................           0.149           5.140           0.123
SL182..........................  mounting media (DAPI II                  67.000          14.420          54.000
                                  counterstain).
SL184..........................  slide, negative control, Her-2.          29.400          21.240          29.400
SL185..........................  slide, positive control, Her-2.          29.400          25.000          26.200
SL191..........................  ethanol, 85%...................           0.003           0.170           0.021
SL195..........................  kit, FISH paraffin pretreatment          20.850          23.290          20.850
SL196..........................  kit, HER-2/neu DNA Probe.......         105.000          80.450          79.050
SL258..........................  Control slides.................         228.000         279.000         203.730
SL261..........................  FISH pre-treatment kit.........         549.000         454.480         579.210
SL474..........................  Confirm anti-CD15 Mouse                   3.610           3.880           3.820
                                  Monoclonal Antibody (Ventana
                                  760-2504).
SL483..........................  Hematoxylin II (Ventana 790-              0.023           0.023           0.780
                                  2208).
SL484..........................  Bluing reagent (Ventana 760-              4.522           0.290           0.450
                                  2037).
SL488..........................  UltraView Universal DAB                  10.485          15.390           9.700
                                  Detection Kit.
SL493..........................  Antibody Estrogen Receptor               14.470         322.400          16.117
                                  monoclonal.
SL497..........................  (EBER) DNA Probe Cocktail......           8.570         420.060           8.189
SL498..........................  Kappa Probe Cocktail...........           0.095           0.070           0.910
----------------------------------------------------------------------------------------------------------------

    The 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 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    To maintain relativity between the clinical labor, supplies, and 
equipment portions of the PE methodology, we believe that the rates for 
the clinical labor staff should also be updated along with the updated 
pricing for supplies and equipment. We solicited public comment 
regarding whether to update the clinical labor wages used in developing 
PE RVUs in future calendar years during the 4-year pricing transition 
for supplies and equipment, or whether it would be more appropriate to 
update the clinical labor wages at a later date following the 
conclusion of the transition for supplies and equipment, for example, 
to avoid other potentially large shifts in PE RVUs during the 4-year 
pricing transition period.
    The following is a summary of the public comments we received on 
our comment solicitation regarding whether to update of the rates for 
the clinical labor staff types during the 4-year pricing transition for 
supplies and equipment.
    Comment: Most commenters were supportive of the idea of updating 
the clinical labor wages during the 4-year pricing transition for 
supplies and equipment. Several commenters requested that the updated 
pricing for clinical labor should continue to be based on Bureau of 
Labor Statistics wage data and remain open for public comment from 
interested commenters through the rulemaking process. One commenter 
supported updating the prices for the clinical labor staff types and 
stated that they had convened an expert physician panel that suggested 
that the clinical labor costs for radiation therapists and nurses are 
up to 33 percent higher than what is currently included in the CMS 
database. A few commenters did not support updating clinical labor 
wages during the 4-year pricing transition for supplies and equipment, 
in one case stating that the clinical labor pricing should be updated 
after the pricing transition for supplies and equipment was complete, 
and in another case stating that CMS should not make any changes to 
clinical labor costs for the foreseeable future.
    Response: We will take this information into account for future 
rulemaking on the subject of whether or not to update the clinical 
labor wages used in future calendar years alongside the 4-year pricing 
transition for supplies and equipment.
(2) Breast Biopsy Software (EQ370)
    Following the publication of the CY 2018 PFS final rule, a 
stakeholder contacted us and requested that we update the price for the 
Breast Biopsy software (EQ370) equipment. This equipment item currently 
lacks a price in the direct PE database, and when an invoice for the 
Breast Biopsy software was first submitted during CY 2014 PFS 
rulemaking, we stated that this item served clinical functions similar 
to other items already included in the Magnetic Resonance (MR) room 
equipment package (EL008) included in the same CPT codes under review. 
Therefore, we did not create new direct PE inputs for this equipment 
item (78 FR 74344

[[Page 59481]]

through 74345). The stakeholder suggested that this software is used to 
subtract the imaging raw data series from the MRI Scanner, reformat the 
images in multiple planes to allow accurate targeting of the lesion to 
be biopsied, identify the location of a fiducial marker on the 
patient's skin, and then target the location of the enhancing lesion to 
be biopsied. The stakeholder requested that EQ370 be renamed as 
``Breast MRI computer aided detection and biopsy guidance software'' 
and added to existing CPT codes 19085 (Biopsy, breast, with placement 
of breast localization device(s) (e.g., clip, metallic pellet), when 
performed, and imaging of the biopsy specimen, when performed, 
percutaneous; first lesion, including magnetic resonance guidance), 
19086 (Biopsy, breast, with placement of breast localization device(s) 
(e.g., clip, metallic pellet), when performed, and imaging of the 
biopsy specimen, when performed, percutaneous; each additional lesion, 
including magnetic resonance guidance), 19287 (Placement of breast 
localization device(s) (e.g., clip, metallic pellet, wire/needle, 
radioactive seeds), percutaneous; first lesion, including magnetic 
resonance guidance), and 19288 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds), percutaneous; each additional lesion, including magnetic 
resonance guidance), as well as adding the equipment to two newly 
created MR breast codes with CAD, CPT codes 77048 (Magnetic resonance 
imaging, breast, without and with contrast material(s), including 
computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral) and 77049 (Magnetic resonance imaging, breast, without and 
with contrast material(s), including computer-aided detection (CAD-real 
time lesion detection, characterization and pharmacokinetic analysis) 
when performed; bilateral). The stakeholder supplied an invoice with a 
purchase price of $52,275 for the equipment.
    After reviewing the use of the Breast Biopsy software (EQ370) 
equipment in these six codes, we did not propose to update the price or 
add the software to these procedures. As we stated in the CY 2014 PFS 
final rule with comment period (78 FR 74345), we continue to believe 
that equipment item EQ370 serves clinical functions similar to other 
items already included in the MR room equipment package (EL008), and 
that it would be duplicative to include this Breast Biopsy software as 
a separate direct PE input. We also note that the RUC recommendations 
for the new CPT codes 77048 and 77049 do not include EQ370 in the 
recommended equipment for these procedures, and we do not have any 
reason to believe that the inclusion of additional Breast Biopsy 
software beyond what is already contained in the MR room equipment 
package would be typical. However, we will update the name of the EQ370 
equipment item from ``Breast Biopsy software'' to the requested 
``Breast MRI computer aided detection and biopsy guidance software'' to 
help better describe the equipment in question.
    The following is a summary of the public comments we received on 
our proposal not to update the price of the Breast Biopsy software or 
add the software to the listed procedures.
    Comment: Several commenters stated that CAD or biopsy software is 
not part of any standard MRI room package available for purchase, and 
that these are different equipment items sold by different vendors. One 
commenter requested that CMS clarify the equipment items that make up 
the MR room (EL008) in order to verify whether or not legitimate 
duplication exists with the Breast Biopsy software. Another commenter 
stated that the new CAD Software equipment (ED058) in CPT codes 77048 
and 77049 is actually synonymous with the ``breast biopsy software'' 
(EQ370). This commenter stated that there had been a lack of 
consistency in identifying the equipment item between the breast biopsy 
codes and the MR breast codes, and requested updating the price of the 
equipment item consistent with the submitted invoices.
    Response: In response to the comment requesting that CMS clarify 
the equipment items that make up the MR room (EL008), we can state that 
the MR room contains a 1.5T MR Scanner as well as coils, NV array, 
torso array, shoulder, wrist, extremity, dual array, power injector, 
and a computer workstation.
    After consideration of the public comments, we are finalizing our 
proposal not to update the price of the Breast Biopsy software (EQ370). 
However, we note that in light of the information supplied by the 
commenter that the new CAD Software equipment (ED058) is actually 
synonymous with the Breast Biopsy software (EQ370), we had already 
proposed to include this equipment in CPT codes 77048 and 77049. We are 
finalizing the inclusion of the new CAD Software equipment (ED058) in 
these procedures, and we are finalizing an update in the price of the 
CAD Software to $43,308.12. This is based on a submitted invoice from 
the commenters which contained a price of $52,725 as averaged together 
with additional invoices for the same CAD Software equipment researched 
by the StrategyGen contractor. We are also finalizing the replacement 
of the time assigned to the EQ370 Breast Biopsy software in CPT codes 
19085, 19086, 19287, and 19288 with an equal amount of time assigned to 
the new ED058 CAD Software equipment. Finally, due to the continued 
confusion and lack of price for the EQ370 equipment item, and due to 
its redundancy with the new ED058 equipment code, we are deleting 
EQ370.
(3) 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 2019, 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.
(4) 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

[[Page 59482]]

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 2019, we proposed to 
continue with the second year of the transition of this adjustment to 
the standard process for allocating indirect PE.
    We received no comments specific to our proposal to continue with 
the 2nd year of the transition to the standard process for allocating 
indirect PE. Therefore, we are finalizing our proposal to proceed with 
the second year of implementing an alternative methodology for the 
allocation of indirect PE for some office-based services.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that the payment amount for 
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 
PFS proposed rule (79 FR 40349 through 40355) and final rule with 
comment period (79 FR 67591 through 67596).
    To determine MP RVUs for individual PFS services, our MP 
methodology is composed of three factors: (1) Specialty-level risk 
factors derived from data on specialty-specific MP premiums paid 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 RVU. Prior to CY 2016, MP RVUs were 
only updated once every 5 years, except in the case of new and revised 
codes.
    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, 
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 3 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 risk factor to individual codes based on the same utilization 
assumptions we make regarding the 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-specific 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.
    In CY 2017, we finalized the 8th GPCI update, which reflected 
updated MP premium data. We did not propose to use the updated MP 
premium data to propose updates for CY 2017 to the specialty risk 
factors used in the calculation of MP RVUs because it was inconsistent 
with the policy we previously finalized in the CY 2016 PFS final rule 
with comment period. That is, we indicated that the specialty-specific 
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. However, we solicited comment on 
whether we should consider doing so, perhaps as early as for CY 2018, 
prior to the fourth review and update of MP RVUs that must occur no 
later than CY 2020. After consideration of the comments received, we 
stated in the CY 2017 PFS final rule that we would consider the 
possibility of using the updated MP data to update the specialty risk 
factors used in the calculation of the MP RVUs prior to the next 5-year 
update in future rulemaking (81 FR 80191 through 80192).
    In the CY 2018 PFS proposed rule, we proposed to use the updated MP 
data to update the specialty risk factors used in calculation of the MP 
RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018 
PFS final rule (82 FR 53000 through 53006), after consideration of the 
comments received and some differences we observed in the descriptions 
on the raw rate filings as compared to how those data were categorized 
to conform with the CMS specialties, we did not finalize our proposal 
to use the updated MP data. We are required to review, and if 
necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback 
provided by commenters in response to the CY 2018 PFS proposed rule.
    In the CY 2019 PFS proposed rule, we solicited additional comment 
regarding the next MP RVU update which must occur by CY 2020. 
Specifically, we solicited comment on how we might improve the way that 
specialties in the state-level raw rate filings data are crosswalked 
for categorization into CMS specialty codes, which are used to develop 
the specialty-level risk factors and the MP RVUs.
    We received a few comments in response to the comment solicitation, 
and we appreciate the commenters' feedback and input. We will consider 
the suggestions and information received for future rulemaking, and in 
particular for the CY 2020 statutorily required update to MP RVUs.

D. Modernizing Medicare Physician Payment by Recognizing Communication 
Technology-Based Services

    The health care community uses the term ``telehealth'' broadly to 
refer to medical services furnished via communication technology. Under 
current PFS payment rules, Medicare routinely pays for many of these 
kinds of services. This includes some kinds of remote patient 
monitoring (either as separate services or as parts of bundled 
services), interpretations of diagnostic tests when furnished remotely 
and, under conditions specified in section 1834(m) of the Act, services 
that would otherwise be furnished in person but are instead furnished 
via real-time, interactive communication technology. Over the past 
several years, we have also established several PFS policies to 
explicitly pay for non-face-to-face services included as part of 
ongoing care management.
    Although all of the kinds of services stated above might be called 
``telehealth'' by patients, other payers and health care providers, we 
have generally used the term ``Medicare telehealth services'' to refer 
to the subset of services defined in section 1834(m) of the Act. 
Section 1834(m) of the Act defines Medicare telehealth services and 
specifies the payment amounts and circumstances under which Medicare 
makes payment for a discrete set of services, all of which must 
ordinarily be furnished in-person, when they are instead furnished 
using interactive, real-time telecommunication technology. Section 
1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth 
services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary 
to specify

[[Page 59483]]

additional Medicare telehealth services using an annual process to add 
or delete services from the Medicare telehealth list. Section 
1834(m)(4)(C) of the Act limits the scope of Medicare telehealth 
services for which payment may be made to those furnished to a 
beneficiary who is located in certain types of originating sites in 
certain, mostly rural, areas. Section 1834(m)(1) of the Act permits 
only physicians and certain other types of practitioners to furnish and 
be paid for Medicare telehealth services. Although section 
1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add 
services to, and delete services from, the list of telehealth services 
based on the established annual process, it does not provide any 
authority to change the limitations relating to geography, patient 
setting, or type of furnishing practitioner because these requirements 
are specified in statute. However, we note that sections 50302, 50324, 
and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) (Pub. L. 115-
123) have modified or removed the limitations relating to geography and 
patient setting for certain telehealth services, including for certain 
home dialysis end-stage renal disease-related services, services 
furnished by practitioners in certain Accountable Care Organizations, 
and acute stroke-related services, respectively.
    In the CY 2018 PFS proposed rule (82 FR 53012), we solicited 
information from the public regarding ways that we might further expand 
access to telehealth services within the current statutory authority 
and pay appropriately for services that take full advantage of 
communication technologies. Commenters were very supportive of CMS 
expanding access to these kinds of services. Many commenters noted that 
Medicare payment for telehealth services is restricted by statute, but 
encouraged CMS to recognize and support technological developments in 
healthcare.
    We believe that the provisions in section 1834(m) of the Act apply 
particularly to the kinds of professional services explicitly 
enumerated in the statutory provisions, like professional 
consultations, office visits, and office psychiatry services. 
Generally, the services we have added to the telehealth list are 
similar to these kinds of services. As has long been the case, certain 
other kinds of services that are furnished remotely using 
communications technology are not considered ``Medicare telehealth 
services'' and are not subject to the restrictions articulated in 
section 1834(m) of the Act. This is true for services that were 
routinely paid separately prior to the enactment of the provisions in 
section 1834(m) of the Act and do not usually include patient 
interaction (such as remote interpretation of diagnostic imaging 
tests), and for services that were not discretely defined or separately 
paid for at the time of enactment and that do include patient 
interaction (such as chronic care management services).
    As we considered the concerns expressed by commenters about the 
statutory restrictions on Medicare telehealth services, we recognized 
that the concerns were not limited to the barriers to payment for 
remotely furnished services like those described by the office visit 
codes. The commenters also expressed concerns pertaining to the 
limitations on appropriate payment for evolving physicians' services 
that are inherently furnished via communication technology, especially 
as technology and its uses have evolved in the decades since the 
Medicare telehealth services statutory provision was enacted.
    In recent years, we have sought to recognize significant changes in 
health care practice, especially innovations in the active management 
and ongoing care of chronically ill patients, and have relied on the 
medical community to identify and define discrete physicians' services 
through the CPT Editorial Panel (82 FR 53163). In response to our 
comment solicitation on Medicare telehealth services in the CY 2018 PFS 
proposed rule (82 FR 53012), commenters provided many suggestions for 
how CMS could expand access to telehealth services within the current 
statutory authority and pay appropriately for services that take full 
advantage of communication technologies, such as waiving portions of 
the statutory restrictions using demonstration authority. After 
considering those comments we recognized that concerns regarding the 
provisions in section 1834(m) of the Act may have been limiting the 
degree to which the medical community developed coding for new kinds of 
services that inherently utilize communication technology. We have come 
to believe that section 1834(m) of the Act does not apply to all kinds 
of physicians' services whereby a medical professional interacts with a 
patient via remote communication technology. Instead, we believe that 
section 1834(m) of the Act applies to a discrete set of physicians' 
services that ordinarily involve, and are defined, coded, and paid for 
as if they were furnished during an in-person encounter between a 
patient and a health care professional.
    For CY 2019, we aimed to increase access for Medicare beneficiaries 
to physicians' services that are routinely furnished via communication 
technology by clearly recognizing a discrete set of services that are 
defined by and inherently involve the use of communication technology. 
Accordingly, we made several proposals for modernizing Medicare 
physician payment for communication technology-based services, 
described below. These services will not be subject to the limitations 
on Medicare telehealth services in section 1834(m) of the Act because, 
as we have explained, we do not consider them to be Medicare telehealth 
services; instead, they will be paid under the PFS like other 
physicians' services. Additionally, we note that in furnishing these 
services, practitioners need to comply with any applicable privacy and 
security laws, including the HIPAA Privacy Rule.
1. Brief Communication Technology-Based Service, e.g. Virtual Check-In 
(HCPCS Code G2012)
    The traditional office visit codes describe a broad range of 
physicians' services. Historically, we have considered any routine non-
face-to-face communication that takes place before or after an in-
person visit to be bundled into the payment for the visit itself. In 
recent years, we have recognized payment disparities that arise when 
the amount of non-face-to-face work for certain kinds of patients is 
disproportionately higher than for others, and created coding and 
separate payment to recognize care management services such as chronic 
care management and behavioral health integration services (81 FR 
80226). We now recognize that advances in communication technology have 
changed patients' and practitioners' expectations regarding the 
quantity and quality of information that can be conveyed via 
communication technology. From the ubiquity of synchronous, audio/video 
applications to the increased use of patient-facing health portals, a 
broader range of services can be furnished by health care professionals 
via communication technology as compared to 20 years ago.
    Among these services are the kinds of brief check-in services 
furnished using communication technology that are used to evaluate 
whether or not an office visit or other service is warranted. When 
these kinds of check-in services are furnished prior to an office 
visit, then we would currently consider them to be bundled into the 
payment for the resulting visit, such as through an evaluation and 
management (E/M) visit

[[Page 59484]]

code. However, in cases where the check-in service does not lead to an 
office visit, then there is no office visit with which the check-in 
service can be bundled. To the extent that these kinds of check-ins 
become more effective at addressing patient concerns and needs using 
evolving technology, we believe that the overall payment implications 
of considering the services to be broadly bundled becomes more 
problematic. This is especially true in a resource-based relative value 
payment system. Effectively, the better practitioners are in leveraging 
technology to furnish effective check-ins that mitigate the need for 
potentially unnecessary office visits, the fewer billable services they 
furnish. Given the evolving technological landscape, we believe this 
creates incentives that are inconsistent with current trends in medical 
practice and potentially undermines payment accuracy.
    Therefore, we proposed to pay separately, beginning January 1, 
2019, for a newly defined type of physicians' service furnished using 
communication technology. We stated this service would be billable when 
a physician or other qualified health care professional has a brief 
non-face-to-face check-in with a patient via communication technology, 
to assess whether the patient's condition necessitates an office visit. 
We understand that the kind of communication technology used to furnish 
these kinds of services has broadened over time and has enhanced the 
capacity for medical professionals to care for patients. We solicited 
comment on what types of communication technology are utilized by 
physicians or other qualified health care professionals in furnishing 
these services, including whether audio-only telephone interactions are 
sufficient compared to interactions that are enhanced with video or 
other kinds of data transmission.
    The following discussion summarizes particular definitions and 
billing rules for these services, as proposed, and more detailed 
comments we received regarding these aspects of the proposal. Our 
responses below include information regarding the service definitions 
and billing requirements applicable for CY 2019.
    Comment: Many commenters supported the proposal to pay for these 
kinds of services. Many commenters offered specific suggestions 
regarding the service definitions and associated billing rules, which 
we describe in detail below. Several commenters urged CMS to take a 
cautious approach in paying for these services, given concerns these 
commenters stated regarding potential overutilization, while some noted 
that potential overutilization would be mitigated by Medicare's 
requirements for the visit to be reasonable and medically necessary/
appropriate. Specific aspects of these comments are detailed below.
    Response: Based on the broad support for the proposal, we are 
creating coding and finalizing our proposal to make separate payment 
for this service. We note that in the proposed rule we referred to this 
service as HCPCS code GVCI1, which was a placeholder code. The code 
will be described as 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).
    We appreciate commenters' concerns regarding the potential for 
overutilization of these services. We plan to monitor utilization with 
the intention of determining whether changes, such as a frequency 
limitation on the use of this code, are warranted. We would consider 
proposing such changes in future rulemaking. We note that, like all 
other physicians' services billed under the PFS, each of these services 
must be medically reasonable and necessary to be paid by Medicare.
    Comment: Many commenters suggested that we not be overly 
prescriptive regarding the types of communication technology that are 
utilized by physicians or other qualified health care professionals in 
furnishing these services. The commenters noted that technology is 
evolving at a rapid pace and would require us to have to update our 
policies frequently. Several commenters suggested that we permit the 
use of email and Electronic Health Record (EHR) patient portals to 
qualify. A few commenters stated that audio-visual communication is 
ideal. Others acknowledged that not all patients have the same level of 
connectivity and therefore recommended allowing audio-only 
communication.
    Response: We are persuaded by the comments advising us not to be 
overly prescriptive about the technology that is used, and are 
finalizing allowing audio-only real-time telephone interactions in 
addition to synchronous, two-way audio interactions that are enhanced 
with video or other kinds of data transmission. We note that telephone 
calls that involve only clinical staff could not be billed using HCPCS 
code G2012 since the code explicitly describes (and requires) direct 
interaction between the patient and the billing practitioner.
    We further proposed that in instances when the brief communication 
technology-based service originates from a related E/M service provided 
within the previous 7 days by the same physician or other qualified 
health care professional, that this service would be considered bundled 
into that previous E/M service and would not be separately billable, 
which is consistent with code descriptor language for CPT code 99441 
(Telephone evaluation and management service by a physician or other 
qualified health care professional who may report evaluation and 
management services provided to an established patient, parent, or 
guardian 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), on which this service is partially modeled. We proposed 
that in instances when the brief communication technology-based service 
leads to an E/M service with the same physician or other qualified 
health care professional, this service would be considered bundled into 
the pre- or post-visit time of the associated E/M service, and 
therefore, would not be separately billable. We also noted that this 
service could be used as part of a treatment regimen for opioid use 
disorders and other substance use disorders to assess whether the 
patient's condition requires an office visit.
    We proposed pricing this distinct service at a rate lower than 
current E/M in-person visits to reflect the low work time and intensity 
and to account for the resource costs and efficiencies associated with 
the use of communication technology. We expect that these services will 
be initiated by the patient, especially since many beneficiaries would 
be financially liable for sharing in the cost of these services. For 
the same reason, we believe it is important for patients to consent to 
receiving these services. Therefore, we specifically solicited comment 
on whether we should require, for example, verbal consent that will be 
noted in the medical record for each service.
    Comment: Many commenters stated that it would be burdensome to 
obtain consent from the patient prior to each occurrence of this 
service. Some commenters suggested that the patient be informed through 
the use of a service agreement which could be signed once and kept on 
file. Several commenters

[[Page 59485]]

expressed concern about the cost to beneficiaries, especially since 
they may have previously received this service without financial 
liability, and therefore recommended requiring verbal consent that is 
documented in the medical record.
    Response: We understand the potential burden regarding obtaining 
consent for each occurrence of this service. However, we are persuaded 
by those commenters who suggest that unexpected cost to beneficiaries 
would be particularly problematic. We note that under our current 
policy for several types of care management services, verbal consent is 
required to be obtained and documented in the medical record. The 
consent policy was implemented, in part, based on feedback we received 
from practitioners reporting the care management services, to alleviate 
burdens of alternative approaches, such as requirements for written 
consent or completion of particular forms. Consequently, we believe the 
same requirement could be applied here, without imposition of 
significant burden. We are finalizing requiring verbal consent that is 
noted in the medical record for each billed service.
    We also proposed that this service can only be furnished for 
established patients because we believe that the practitioner needs to 
have an existing relationship with the patient, and therefore, basic 
knowledge of the patient's medical condition and needs, in order to 
perform this service.
    Comment: Many commenters were supportive of our proposal to limit 
this service to established patients, while several commenters noted 
that there would be instances when it would be appropriate to bill this 
service for new patients. MedPAC noted particular concern regarding 
potential increases in volume that are not related to ongoing, informed 
patient care. A few commenters requested that CMS clarify that 
established patients include those patients who have been seen by a 
practitioner within the same group practice.
    Response: After considering the comments, we are finalizing our 
proposal to limit this service to established patients, given the 
concern expressed by commenters regarding the degree to which these 
services can be furnished without familiarity and experience with 
individual patients, and in light of MedPAC's concerns regarding 
increases in utilization that are not related to ongoing, informed 
patient care. In response to the request for clarification about what 
constitutes an established patient, we defer to CPT's definition of 
this term. CPT defines an established patient as one who has received 
professional services from the physician or qualified health care 
professional or another physician or qualified health care professional 
of the exact same specialty and subspecialty who belongs to the same 
group practice, within the past 3 years. We also emphasize that payment 
for this service would not preclude a physician or other qualified 
health care professional from having communication via phone or other 
modalities with any patient, new or existing, for a variety of reasons. 
We believe that much of the pre- and post- work associated with, and 
included in the valuation of existing in-person services that are paid 
under the PFS can include some types of interactions with patients that 
are not in-person.
    We did not propose to apply a frequency limit on the use of this 
code by the same practitioner with the same patient, but we want to 
ensure that this code is appropriately utilized for circumstances when 
a patient needs a brief non-face-to-face check-in to assess whether an 
office visit is necessary. We solicited comment on whether it would be 
clinically appropriate to apply a frequency limitation on the use of 
this code by the same practitioner with the same patient, and on what 
would be a reasonable frequency limitation.
    Comment: Many commenters were opposed to creating a frequency 
limitation, suggesting we wait and monitor utilization. Others noted 
that it could be clinically appropriate to utilize this service 
multiple times in a week. A few commenters stated that this service 
could be utilized in behavioral health treatment, and cited an example 
of assessing suicidal risk, in which case they suggested the frequency 
should not be limited since routine virtual check-ins would be 
clinically warranted in some cases. Some commenters suggested a 
frequency limit of three times per week whereas others suggested a 
limit of once per week.
    Response: After considering these comments, we are not implementing 
a frequency limitation for CY 2019. However, we plan to monitor 
utilization with the intention of determining whether such a limitation 
is warranted. In that case, we would consider proposing a limitation in 
future rulemaking. We note that, like all other physicians' services 
billed under the PFS, each of these services must be medically 
reasonable and necessary to be paid by Medicare.
    We also solicited comment on the timeframes under which this 
service would be separately billable compared to when it would be 
bundled. We believe the general construct of bundling the services that 
lead directly to a billable visit is important, but we are concerned 
that establishing strict timeframes may create unintended consequences 
regarding scheduling of care. For example, we do not want to bundle 
only the services that occur within 24 hours of a visit only to see a 
significant number of visits occurring at 25 hours after the initial 
service. In order to mitigate these incentives, we solicited comment on 
whether we should consider broadening the window of time and/or 
circumstances in which this service should be bundled into the 
subsequent related visit. We noted that these services, like any other 
physicians' service, must be medically reasonable and necessary in 
order to be paid by Medicare.
    Comment: Several commenters suggested that we remove the language 
in the code descriptor that states ``or soonest available 
appointment.'' A few commenters suggested we extend the timeframe to 48 
hours following the virtual check-in, while others suggested it would 
be reasonable to expand the limit to 14 days before and 72 hours after 
the service. Several commenters stated concerns that it might be 
difficult to document that a subsequent visit was not the ``soonest 
available appointment.'' Several commenters expressed concern about the 
potential for overutilization of this code.
    Response: We agree with commenters that urged caution regarding 
overutilization of this service and believe that the language stating, 
`or soonest available appointment' in the code description may serve to 
reduce potential perverse payment incentives to delay seeing patients 
to ensure payment for this code. We appreciate the concerns regarding 
potential difficulty in proving that a particular visit was not the 
``soonest available.'' We agree that in each individual case, it might 
be challenging to prove whether or not other appointments were 
available prior to the visit, especially since beneficiary convenience 
is also presumably a factor for when appointments are scheduled. 
However, we believe that, as written, the code description could help 
to guard against the potential for abuse that would be present if we 
instead adopted a purely time-based window for bundling of this 
service. We also believe that ``soonest available appointment'' might 
allow for clinically appropriate flexibility. Therefore, after 
consideration of the public comments, we are finalizing the code 
descriptor for HCPCS code G2012 as proposed. However, we plan to 
monitor this service with the intention of determining whether changes 
are

[[Page 59486]]

necessary to the timeframes under which this service would be 
separately billable compared to when it would be bundled. We would 
consider any such changes in future rulemaking.
    We solicited comment on how clinicians could best document the 
medical necessity of this service, consistent with documentation 
requirements necessary to demonstrate the medical necessity of any 
service under the PFS.
    Comment: A few commenters stated that documentation for this 
service should be consistent with the requirements for an in-person 
encounter and requested appropriate documentation requirements to 
ensure that the check-in is fully incorporated into the individual's 
medical history. Other commenters urged us not to be overly 
prescriptive.
    Response: We appreciate the commenters' input. We do not want to 
impose undue administrative burden likely to discourage appropriate 
provision of these services, and are therefore not requiring any 
service-specific documentation requirements for this service. We note 
again that these services, like any other physicians' service, must be 
medically reasonable and necessary in order to be paid by Medicare.
    Comment: Several commenters stated that the proposed payment rate 
would be inadequate for modalities that are both audio- and visual-
capable, whereas others stated that the proposed valuation was 
appropriate. One commenter suggested we create a second code for a 
virtual check-in that only utilizes synchronous audio/video technology, 
with a higher reimbursement rate associated with the increased 
complexity of technology.
    Response: As discussed in section II.H of this final rule, we are 
finalizing the valuation for HCPCS code G2012 as proposed. We believe 
this valuation reflects the work time and intensity of the service 
relative to other PFS services and accounts for the resource costs and 
efficiencies associated with the use of communication technology. We 
recognize that the valuation of this service is relatively modest, 
especially compared to in-person services, however, we believe that the 
proposed valuation accurately reflects the resources involved in 
furnishing this service. We plan to monitor the utilization of this 
code and note that we routinely address recommended changes in values 
for codes paid under the PFS.
    Comment: A few commenters requested that CMS allow licensed 
physical therapists to furnish these services. Additionally, a few 
commenters requested that we allow other clinical staff, such as 
registered nurses, to furnish this service.
    Response: We are finalizing maintaining this code as part of the 
set of codes that is only reportable by those that can furnish E/M 
services. We believe this is appropriate since the service describes a 
check-in directly with the billing practitioner to assess whether an 
office visit is needed. We agree that similar check-ins provided by 
nurses and other clinical staff can be important aspects of coordinated 
patient care. We note that these kinds of non-face-to-face services by 
other medical professionals and clinical staff continue to be included 
in the RVUs for other codes, including those that describe E/M visits, 
and for procedures with global periods. We also note that non-face-to-
face services provided by clinical staff can be explicitly and 
separately paid for as part of several care management services, many 
of which we have introduced over the past several years. However, this 
service is meant to describe, and account for the resources involved, 
when the billing practitioner directly furnishes the virtual check-in.
    Comment: Several commenters requested that CMS waive the 
beneficiary co-payment for this service.
    Response: We appreciate the commenters' request; however, we do not 
have the statutory authority to make specific changes to the 
requirements regarding beneficiary cost sharing for this service.
    In summary, we are creating coding and finalizing our proposal to 
make separate payment for brief communication technology-based 
services. The code will be described as 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). We are finalizing allowing real-time audio-only telephone 
interactions in addition to synchronous, two-way audio interactions 
that are enhanced with video or other kinds of data transmission. We 
are finalizing our proposal to limit this service to established 
patients.
    We are finalizing that if the service originates from a related E/M 
service provided within the previous 7 days by the same physician or 
other qualified health care professional, that this service would be 
considered bundled into that previous E/M service and would not be 
separately billable. In instances when the service leads to an E/M 
service with the same physician or other qualified health care 
professional, we are finalizing that this service would be considered 
bundled into the pre- or post-visit time of the associated E/M service, 
and therefore, would not be separately billable. We plan to monitor 
this service with the intention of determining whether changes are 
necessary to the timeframes under which this service would be 
separately billable compared to when it would be bundled. We would 
consider any such changes in future rulemaking.
    We are finalizing requiring verbal consent from beneficiaries that 
is noted in the medical record for each service. We are not 
implementing a frequency limitation for CY 2019, however, we plan to 
monitor utilization with the intention of determining whether such a 
limitation is warranted. In that case, we would consider that for 
future rulemaking.
    We are finalizing the valuation for HCPCS code G2012 as proposed. 
We will monitor the utilization of this code and consider any potential 
adjustments to billing rules or valuation for this service through 
future rulemaking. We note that cost sharing for these services will 
apply.
    For details related to developing utilization estimates for this 
service, see section VII. of this final rule, Regulatory Impact 
Analysis. For additional details related to valuation of this service, 
see section II.H. of this final rule, Valuation of Specific Codes.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code 
G2010)
    Stakeholders have requested that CMS make separate Medicare payment 
when a physician uses recorded video and/or images captured by a 
patient in order to evaluate a patient's condition. These services 
involve what is referred to under section 1834(m) of the Act as 
``store-and-forward'' communication technology that provides for the 
``asynchronous transmission of health care information.'' We noted in 
the proposed rule that we believe these services involve pre-recorded 
patient-generated still or video images. Other types of patient-
generated information, such as information from heart rate monitors or 
other devices that collect patient health marker data, could 
potentially be reported with CPT codes that describe remote patient 
monitoring (83 FR 35724). Under section 1834(m) of

[[Page 59487]]

the Act, payment for telehealth services furnished using such store-
and-forward technology is permitted only under federal telemedicine 
demonstration programs conducted in Alaska or Hawaii, and these 
telehealth services remain subject to the other statutory restrictions 
governing Medicare telehealth services. However, much like the brief 
communication technology-based service (``virtual check-in service'') 
that we are finalizing in this rule as described previously, this 
remote evaluation service would not be a substitute for an in-person 
service currently separately payable under the PFS. As such, this 
remote evaluation service is distinct from the telehealth services 
described under section 1834(m) of the Act. Effective January 1, 2019, 
we proposed to create specific coding that describes the remote 
professional evaluation of patient-transmitted information conducted 
via pre-recorded ``store and forward'' video or image technology. 
Because this service would not be considered a Medicare telehealth 
service, it would not be subject to the geographic and other 
restrictions on telehealth services under section 1834(m) of the Act; 
and the proposed valuation reflects the resource costs associated with 
furnishing services utilizing communication technology.
    Also like the virtual check-in service we are finalizing as 
described previously, this service would be used to determine whether 
or not an office visit or other service is warranted. When the remote 
evaluation of pre-recorded patient-submitted images and/or video 
results in an in-person E/M office visit with the same physician or 
qualified health care professional, we proposed that this remote 
service will be considered bundled into that office visit and therefore 
not be separately billable. We further proposed that in instances when 
the remote service originates from a related E/M service provided 
within the previous 7 days by the same physician or qualified health 
care professional that this service will be considered bundled into 
that previous E/M service and not be separately billable. In summary, 
we proposed this service to be a stand-alone service that could be 
separately billed to the extent that there is no resulting E/M office 
visit and there is no related E/M office visit within the previous 7 
days of the remote service being furnished. We believe the coding and 
separate payment for this service is consistent with the progression of 
technology and its impact on the practice of medicine in recent years, 
and would result in increased access to services for Medicare 
beneficiaries. We note that in the proposed rule we referred to this 
service as HCPCS code GRAS1, which was a placeholder code. The code for 
this service is 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). We 
solicited comment as to whether these services should be limited to 
established patients; or whether there are certain cases, like 
dermatological or ophthalmological services, where it might be 
appropriate for a new patient to receive these services. For example, 
when a patient seeks care for a specific skin condition from a 
dermatologist with whom she does not have a prior relationship, and 
part of the inquiry is an assessment of whether the patient needs an 
in-person visit, the patient could share, and the dermatologist could 
remotely evaluate, pre-recorded information. We also noted that this 
service is distinct from the virtual check-in service described 
previously in that this service involves the practitioner's evaluation 
of a patient-generated still or video image transmitted by the patient, 
and the subsequent communication of the practitioner's response to the 
patient; while the virtual check-in service describes a service that 
occurs in real time and does not involve the asynchronous transmission 
of any recorded image.
    The following discussion summarizes particular definitions and 
billing rules we proposed for this service and the more detailed 
comments we received regarding these aspects of the proposal. Our 
responses below include information regarding the service definitions 
and billing requirements applicable for 2019. We additionally address 
comments we received regarding whether these services should be limited 
to established patients; or whether there are certain cases, like 
dermatological or ophthalmological services, where it might be 
appropriate for a new patient to receive these services.
    Comment: Several commenters were supportive of the proposal to pay 
for these kinds of services. Several commenters urged CMS to take a 
cautious approach in paying for these services, given concerns these 
commenters expressed regarding potential overutilization.
    Response: We appreciate the many thoughtful comments regarding this 
proposal. Based on our review of the comments received, especially the 
broad support for the proposal, we are creating coding and finalizing 
our proposal to make separate payment for this service. The code will 
be described as 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).
    We appreciate commenters' concerns regarding the potential for 
overutilization of these services. We plan to monitor utilization. We 
note that, like all other physicians' services billed under the PFS, 
each of these services must be medically reasonable and necessary to be 
paid by Medicare.
    Comment: Many commenters supported allowing this service to be 
furnished to new patients, noting that an established relationship is 
not required for the practitioner to remotely evaluate an image or 
video to consider whether an office visit or other service is 
warranted, particularly in dermatology and ophthalmology. One commenter 
stated that allowing new patients to receive this service would also be 
of value in urology, as it would provide a way to assess patients with 
conditions such as hematuria (that is, blood in the urine) in a timely 
manner. The AMA and other commenters urged CMS to limit these services 
to established patients. The AMA also suggested that, at some point 
before a physician or practitioner furnishes a virtual service, the 
clinician (or another clinician with whom the furnishing clinician has 
a cross-coverage agreement in place) should conduct a face-to-face 
examination (either in-person or via telehealth) with the patient, 
noting that the existence of a valid patient-physician relationship 
ensures that the treating physician or qualified health professional 
meets a threshold standard of care, enhances care coordination/
continuity of care, and ensures that patients are afforded advance 
notice of when the relationship is being established and that such a 
patient-initiated service may result in out-of-pocket expenses 
including deductibles and co-insurance, and additionally serves to 
minimize the potential for program integrity concerns.
    Response: We are persuaded by comments urging us to permit separate

[[Page 59488]]

payment for these services only for established patients. Since this 
service is furnished directly by the billing practitioner, we believe 
it should be furnished in the context of an existing patient-clinician 
relationship. Therefore, we are finalizing the reporting and billing of 
HCPCS code G2010 only for established patients.
    Comment: Many commenters stated that it would be burdensome to 
obtain consent from the patient prior to each occurrence of this 
service. Some commenters suggested that the patient could be informed 
through the use of a service agreement which could be signed once and 
kept on file. Several commenters expressed concern about the cost to 
beneficiaries and therefore recommended requiring verbal consent that 
is documented in the medical record.
    Response: As noted previously regarding HCPCS code G2012, we 
believe it is important for patients to consent to receive these 
services, especially since many beneficiaries would be financially 
liable for sharing in the cost of these services. We understand the 
potential burden regarding obtaining consent for each occurrence of 
this service. However, we are persuaded by those commenters who suggest 
that unexpected cost to beneficiaries would be particularly 
problematic. We are finalizing requiring beneficiary consent that could 
be verbal or written, including electronic confirmation that is noted 
in the medical record for each billed service for HCPCS code G2010.
    We acknowledge that verbal consent could be obtained using more 
than one communication modality, especially since this service is 
initiated by the patient and involves submission of an image or video. 
Therefore, we do not intend to include the word ``verbal'' in the 
descriptor for the code that describes this services, since ``verbal'' 
could imply written or electronic consent.
    Comment: Several commenters stated that the proposed payment rate 
is too low, citing that it is below market compared to the rate many 
asynchronous telemedicine companies pay their contracted/employed 
physician staff, and noted that new patients in particular require more 
resources, whereas others stated that the proposed valuation was 
appropriate. One commenter suggested that CMS should encourage 
clinicians to recommend that patients have virtual or in-person visits 
if the clinician has concerns about the quality of the pre-recorded 
patient information, such as still or video images.
    Response: As discussed in section II.H. of this final rule, we are 
finalizing the valuation for HCPCS code G2010 as proposed. As stated 
previously regarding the valuation of the brief communication 
technology-based service code, HCPCS code G2012, we believe that the 
proposed valuation accurately reflects the resources involved in 
furnishing this service. We will monitor the utilization of this code 
and consider any potential adjustments to billing rules or valuation 
for this service through future rulemaking.
    Comment: A few commenters requested that CMS clarify that the 
``verbal follow-up'' that occurs after the billing practitioner 
evaluates the images or video submitted by the patient may take place 
via any mode of communication, including secure text messaging, phone 
call, or live/asynchronous video chat, so as not to restrict a 
clinician's interaction with patients. One commenter suggested that CMS 
should encourage clinicians to recommend that patients have a face-to-
face visit (in-person or via telehealth) if the clinician has concerns 
about the quality of the pre-recorded patient information, such as 
still or video images.
    Response: We are finalizing that the follow-up could take place via 
phone call, audio/video communication, secure text messaging, email, or 
patient portal communication and note that accordingly, we do not 
intend to include the word ``verbal'' in the code descriptor. We note 
that any such communications must be compliant with HIPAA and other 
relevant laws. Additionally, we agree that in instances in which the 
quality of the pre-recorded information submitted by a patient is 
insufficient for the clinician to assess whether an office visit or 
other medical service is warranted, the clinician could not fully 
furnish a remote evaluation service and, therefore, could not bill for 
the service. We anticipate that in such a circumstance, the clinician 
would attempt other methods of communication with the patient to either 
obtain sufficient images to enable a remote evaluation service or 
suggest other appropriate alternatives.
    Comment: Several commenters suggested that we remove the language 
in the code descriptor for this service that states ``or soonest 
available appointment,'' and stated that it might be difficult to 
document that a subsequent visit was not the ``soonest available 
appointment.''
    Response: As noted previously regarding similar comments on HCPCS 
code G2012, we appreciate the concerns regarding potential difficulty 
in proving that a particular visit was not the ``soonest available.'' 
We agree that in each individual case, it might be challenging to prove 
whether or not other appointments were available prior to the visit, 
especially since beneficiary convenience is also presumably a factor in 
when appointments are scheduled. However, we believe that, as written, 
the code description would guard against the potential for abuse that 
would be present if we instead adopted a purely time-based window for 
bundling of this service. Therefore, in response to the comments, we 
are finalizing retaining this language in the code descriptor for HCPCS 
code G2010 as proposed. However, we plan to monitor this service with 
the intention of determining if changes are necessary to the timeframes 
under which this service would be separately billable compared to when 
it would be bundled. We would consider any such changes in future 
rulemaking.
    Comment: A few commenters suggested that CMS consider inclusion of 
email/messaging or questionnaires/assessments that do not include an 
image or other visual item in the scope of this code.
    Response: The scope of this service is limited to the evaluation of 
pre-recorded video and/or images. We note that there is separate coding 
under the PFS for several types of formal assessments, such as CPT code 
96160 (Administration of patient-focused health risk assessment 
instrument (e.g., health hazard appraisal) with scoring and 
documentation, per standardized instrument), many of which can be 
reported when the form is completed by the patient and submitted using 
remote communication technology for subsequent evaluation by the 
clinician. Additionally, behavioral health assessments are included in 
coding and payment for the behavioral health integration services that 
were finalized for separate payment beginning in CY 2017.
    In summary, we are creating coding and finalizing our proposal to 
make separate payment for remote evaluation of recorded video and/or 
images submitted by the patient. The code will be described as 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). We are finalizing that

[[Page 59489]]

HCPCS code G2010 may be billed only for established patients. We are 
finalizing that the follow-up with the patient could take place via 
phone call, audio/video communication, secure text messaging, email, or 
patient portal communication.
    When the review of the patient-submitted image and/or video results 
in an in-person E/M office visit with the same physician or qualified 
health care professional, we are finalizing that this remote service 
will be considered bundled into that office visit and therefore will 
not be separately billable. We are further finalizing that in instances 
when the remote service originates from a related E/M service provided 
within the previous 7 days by the same physician or qualified health 
care professional that this service will be considered bundled into 
that previous E/M service and also will not be separately billable.
    We are finalizing requiring beneficiary consent that could be 
verbal or written, including electronic confirmation that is noted in 
the medical record for each billed service for HCPCS code G2010.
    We are finalizing the valuation for HCPCS code G2010 as proposed. 
We will monitor utilization of this code and consider any potential 
adjustments to billing rules or valuation of this service through 
future rulemaking. We note that cost sharing for these services will 
apply.
    For details related to our utilization estimates for this service, 
see section VII. of this final rule, Regulatory Impact Analysis. For 
further discussion related to valuation of this service, please see the 
section II.H. of this final rule, Valuation of Specific Codes.
3. Interprofessional Internet Consultation (CPT Codes 99451, 99452, 
99446, 99447, 99448, and 99449)
    As part of our standard rulemaking process, we received 
recommendations from the RUC to assist in establishing values for six 
CPT codes that describe interprofessional consultations. In 2013, CMS 
received recommendations from the RUC for CPT codes 99446 
(Interprofessional telephone/internet 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; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet 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; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet 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; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet 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; 31 minutes or more of medical 
consultative discussion and review). CMS declined to adopt these codes 
for separate payment, stating in the CY 2014 PFS final rule with 
comment period that these kinds of services are considered bundled (78 
FR 74343). For CY 2019, the CPT Editorial Panel created two new codes 
to describe additional consultative services, including a code 
describing the work of the treating physician when initiating a 
consult, and the RUC recommended valuation for new codes, CPT codes 
99452 (Interprofessional telephone/internet/electronic health record 
referral service(s) provided by a treating/requesting physician or 
qualified health care professional, 30 minutes) and 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 or more 
minutes of medical consultative time). The RUC also reaffirmed their 
prior recommendations for the existing CPT codes. The six codes 
describe assessment and management services conducted through 
telephone, internet, or electronic health record consultations 
furnished when a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a consulting physician or qualified healthcare professional with 
specific specialty expertise to assist with the diagnosis and/or 
management of the patient's problem without the need for the patient's 
face-to-face contact with the consulting physician or qualified 
healthcare professional. Currently, the resource costs associated with 
seeking or providing such a consultation are considered bundled, which 
in practical terms means that specialist input is often sought through 
scheduling a separate visit for the patient when a phone or internet-
based interaction between the treating practitioner and the consulting 
practitioner would have been sufficient. We believe that proposing 
payment for these interprofessional consultations performed via 
communications technology such as telephone or internet is consistent 
with our ongoing efforts to recognize and reflect medical practice 
trends in primary care and patient-centered care management within the 
PFS.
    Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have 
recognized the changing focus in medical practice toward managing 
patients' chronic conditions, many of which particularly challenge the 
Medicare population, including heart disease, diabetes, respiratory 
disease, breast cancer, allergies, Alzheimer's disease, and factors 
associated with obesity. We have expressed concerns that the current E/
M coding does not adequately reflect the changes that have occurred in 
medical practice, and the activities and resource costs associated with 
the treatment of these complex patients in the primary care setting. In 
the years since 2012, we have acknowledged the shift in medical 
practice away from an episodic treatment-based approach to one that 
involves comprehensive patient-centered care management, and have taken 
steps through rulemaking to better reflect that approach in payment 
under the PFS. In CY 2013, we established new codes to pay separately 
for transitional care management (TCM) services. Next, we finalized new 
coding and separate payment beginning in CY 2015 for chronic care 
management (CCM) services provided by clinical staff (81 FR 80226). In 
the CY 2017 PFS final rule, we established separate payment for complex 
CCM services, an add-on code to the visit during which CCM is initiated 
to reflect the work of the billing practitioner in assessing the 
beneficiary and establishing the CCM care plan, and established 
separate payment for Behavioral Health Integration (BHI) services (81 
FR 80226 through 80227).
    As part of this shift in medical practice, and with the 
proliferation of team-based approaches to care that are often 
facilitated by electronic medical record technology, we believe that 
making separate payment for interprofessional consultations undertaken 
for the benefit of treating a patient will contribute to payment 
accuracy for primary care and care management services. We proposed

[[Page 59490]]

separate payment for these services, discussed in section II.H. of this 
final rule, Valuation of Specific Codes.
    Although we proposed to make separate payment for these services 
because we believe they describe resource costs directly associated 
with seeking a consultation for the benefit of the beneficiary, we do 
have concerns about how these services can be distinguished from 
activities undertaken for the benefit of the practitioner, such as 
information shared as a professional courtesy or as continuing 
education. We do not believe that those examples will constitute a 
service directly attributable to a single Medicare beneficiary, and 
therefore neither the Medicare program nor the beneficiary should be 
responsible for those costs. We therefore solicited comment on our 
assumption that these are separately identifiable services, and the 
extent to which they can be distinguished from similar services that 
are nonetheless primarily for the benefit of the practitioner. We noted 
that there are program integrity concerns around making separate 
payment for these interprofessional consultation services, including 
around CMS's or its contractors' ability to evaluate whether an 
interprofessional consultation is reasonable and necessary under the 
particular circumstances. As the beneficiary would be liable for any 
cost sharing associated with these services, we also sought comment on 
the necessity of requiring patient consent for these, and whether than 
consent should be written or verbal. We solicited comment on how best 
to minimize potential program integrity issues, and noted we were 
particularly interested in information on whether these types of 
services are paid separately by private payers and if so, what controls 
or limitations private payers have put in place to ensure these 
services are billed appropriately.
    The following is a summary of the comments we received regarding 
how best to minimize potential program integrity issues.
    Comment: Almost all commenters were very supportive of CMS 
proposing separate payment for these services. Commenters pointed out 
that these are discrete physician services undertaken for the benefit 
of the patient, and easily distinguished from consultations undertaken 
for the edification of the practitioner. One commenter stated as 
medical care moves toward more comprehensive patient-centered care 
management, frequent consultation with multiple specialists is 
necessary. Under the current model this means separate visits for the 
patients that are costly and inconvenient. Internet-based consultations 
between the treating practitioner and the consulting specialists 
provide appropriate, convenient and cost effective alternatives. 
Commenters were clear that, by not making separate payment for these 
services, CMS would not be accurately paying for the work of both the 
treating and consulting physicians in a consultative scenario.
    Many commenters provided helpful responses to CMS' request for 
information on how to minimize program integrity concerns for these 
services. A few commenters provided suggestions as to how CMS could 
verify the medical necessity of the consultation, including verifying 
that the treating and consulting physician were of different medical 
specialties, requiring patient identifiers and documentation of how the 
interaction improved patient care, defining a time period under which 
an E/M visit and an Interprofessional Consultation cannot both be 
billed for the same diagnosis, and creating frequency limitations on 
billing. Others suggested that the treating physician must document 
that they acted on the recommendation of the consulting physician prior 
to billing for CPT code 99452. Commenters had a number of suggestions 
for items that CMS should require, including that Interprofessional 
Consultations should consist of focused questions that are answerable 
solely from information in the EMR; that they be answered in 3 business 
days; and that the consulting physician should restate the question in 
their response, provide recommendations for evaluation, management, 
and/or ongoing monitoring, provide a rationale for recommendations, and 
provide recommendations for contingencies. Other commenters suggested 
that CMS could make separate payment contingent upon whether the 
underlying condition was urgent or related to critical care and that 
the consultation helped avoid transfer or interruption of care or that 
internal expertise was sought and was not available. Many commenters 
also encouraged CMS to avoid imposing overly restrictive documentation 
requirements. One commenter stated that, due to potential program 
integrity concerns, these services should be subject to the Medicare 
telehealth restrictions on beneficiary location and site of service. 
Another commenter recommended that CMS delay implementation until the 
program integrity concerns have been addressed. Other commenters 
encouraged CMS to monitor utilization for abuse.
    Response: We thank commenters for their support and additional 
information on the ways in which these services are distinct physician 
services. We note that because these services are inherently non face-
to-face (the patient need not be present in order for the service to be 
furnished in its entirety), they would not be considered as potential 
Medicare telehealth services under section 1834(m) of the Act. We 
appreciate the wealth of information and suggestions from commenters; 
however, we also agree with the many commenters who pointed out that 
adding many additional billing requirements may inhibit uptake for 
these services. As we note below, we are requiring documentation of 
verbal patient consent to receive these services, and are adopting 
existing CPT prefatory language. We plan to monitor utilization of 
these services and will consider making refinements to billing rules, 
documentation requirements or claims edits, including those suggested 
by commenters, through future rulemaking as necessary.
    Comment: Many commenters suggested that CMS limit or eliminate 
beneficiary cost sharing for these services to obviate the question of 
patient consent entirely.
    Response: Under current statute, we do not have the authority to 
change the requirements for the beneficiary cost sharing for these 
services.
    Additionally, since these codes describe services that are 
furnished without the beneficiary being present, we proposed to require 
the treating practitioner to obtain verbal beneficiary consent in 
advance of these services, which would be documented by the treating 
practitioner in the patient's medical record, similar to the conditions 
of payment associated with separately billable care management services 
under the PFS. Obtaining advance beneficiary consent includes ensuring 
that the patient is aware of applicable cost sharing.
    The following is a summary of the comments we received regarding 
whether to require the treating practitioner to obtain verbal 
beneficiary consent in advance of these services, which would be 
documented by the treating practitioner in the medical record similar 
to the conditions of payment associated with the care management 
services under the PFS, as well as comments on other aspects of this 
proposal.
    Comment: Many commenters stated that verbal patient consent was an 
appropriate safeguard against unnecessary utilization, while others 
disagreed, stating that the requirement

[[Page 59491]]

to obtain consent may cause unnecessary burden in cases where the 
patient is unresponsive or the need for the interprofessional 
consultation is urgent such as in a critical care or emergency setting. 
Other commenters stated that a single blanket patient consent to 
receive interprofessional consultation services would be preferable to 
minimize the need to obtain consent for each of what may be multiple 
consultations. One commenter questioned whether the consulting 
physician would need to verify that the beneficiary had consented, 
given that only the treating physician is in contact with the 
beneficiary.
    Response: We understand the potential burden regarding obtaining 
consent. However, we believe that it is important for beneficiaries to 
consent to the service and thus be notified of their cost-sharing 
obligations. We note that under our current policy for several care 
management services, consent is required to be documented in the 
medical record. That policy was implemented, in part, based on feedback 
we received from practitioners reporting the care management services, 
to alleviate burdens of alternative approaches. Consequently, we 
believe the same requirement could be applied here, without imposition 
of significant burden.
    We are finalizing that the patient's verbal consent is required, 
and that consent must be noted in the medical record for each service, 
consistent with the policy we are finalizing for the brief 
communication technology-based services (HCPCS code G2012) as noted 
above, as well as with the patient consent policies in place for care 
management services, under the PFS.
    Comment: Commenters requested that CMS clarify whether billing for 
these services is limited to physicians or if other healthcare 
practitioners, such as nurses or physical therapists, may bill for 
these services as well.
    Response: We appreciate commenters' request for clarification. We 
believe that billing of these services should be limited to those 
practitioners that can independently bill Medicare for E/M visits, as 
interprofessional consultations are primarily for the ongoing 
evaluation and management of the patient, including collaborative 
medical decision making among practitioners. We are therefore not 
finalizing any expansion of these services beyond their current scope.
    Comment: A few commenters requested that CMS adopt CPT prefatory 
language for these services as is CMS' longstanding practice when 
adopting most new CPT coding.
    Response: We agree with the commenters and confirm that we will be 
adopting existing CPT prefatory language regarding these services.
    In summary, we are finalizing separate payment for CPT codes 99451, 
99452, 99446, 99447, 99448, and 99449 describing Interprofessional 
consultations. We are finalizing a policy to require the patient's 
verbal consent that is noted in the medical record for each 
interprofessional consultation service. We note that cost sharing will 
apply for these services. These interprofessional services may be 
billed only by practitioners that can bill Medicare independently for 
E/M services.
    For further discussion related to the valuation of these services, 
please see section II.H. of this final rule, Valuation of Specific 
Codes.
4. Medicare Telehealth Services Under Section 1834(m) of the Act
a. Billing and 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).
b. 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, is included in the Downloads section 
to this proposed rule 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, 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. To be

[[Page 59492]]

considered during PFS rulemaking for CY 2020, requests to add services 
to the list of Medicare telehealth services must be submitted and 
received by February 10, 2019. 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.
c. Submitted Requests To Add Services to the List of Telehealth 
Services for CY 2019
    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, 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 received several requests in CY 2017 to add various services as 
Medicare telehealth services effective for CY 2019. The following 
presents a discussion of these requests, and our proposals for 
additions to the CY 2019 telehealth list. Of the requests received, we 
found that two services were sufficiently similar to services currently 
on the telehealth list to be added on a Category 1 basis. Therefore, we 
proposed to add the following services to the telehealth list on a 
Category 1 basis for CY 2019:
     HCPCS codes G0513 and G0514 (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; first 30 minutes (list separately in 
addition to code for preventive service) and (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; each additional 30 minutes (list 
separately in addition to code G0513 for additional 30 minutes of 
preventive service).
    We found that the services described by HCPCS codes G0513 and G0514 
are sufficiently similar to office visits currently on the telehealth 
list. We believe that all the components of this service can be 
furnished via interactive telecommunications technology. Additionally, 
we believe that adding these services to the telehealth list will make 
it administratively easier for practitioners who report these services 
in connection with a preventive service that is furnished via 
telehealth, as both the base code and the add-on code would be reported 
with the telehealth place of service.
    We also received requests to add services to the telehealth list 
that do not meet our criteria for Medicare telehealth services. We did 
not propose to add to the Medicare telehealth services list the 
following procedures for chronic care remote physiologic monitoring, 
interprofessional internet consultation, and initial hospital care; or 
to change the requirements for subsequent hospital care or subsequent 
nursing facility care, for the reasons noted in the paragraphs that 
follow.
(1) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454, 
and 99457)
     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).
     CPT code 99454 (Remote monitoring of physiologic 
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; device(s) supply with daily recording(s) or 
programmed alert(s) transmission, each 30 days).
     CPT code 99457 (Remote physiologic monitoring treatment 
management services, 20 minutes or more of clinical staff/physician/
other qualified healthcare professional time in a calendar month 
requiring interactive communication with the patient/caregiver during 
the month).
    In the CY 2016 PFS final rule with comment period (80 FR 71064), we 
responded to a request to add 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) to the Medicare telehealth list. We discussed 
that the services described by CPT code 99490 can be furnished without 
the beneficiary's face-to-face presence and using any number of non-
face-to-face means of communication. We stated that it was therefore 
unnecessary to add that service to the list of Medicare telehealth 
services. Similarly, CPT codes 99453, 99454, and 99457 describe 
services that are inherently non face-to-face. As discussed in section 
II.H. of this final rule, Valuation of Specific Codes, we instead 
proposed to adopt CPT codes 99453, 99454, and 99457 for payment under 
the PFS. Because these codes describe services that are inherently non 
face-to-face, we do not consider them Medicare telehealth services 
under section 1834(m) of the Act; therefore, we did not propose to add 
them to the list of Medicare telehealth services.
(2) Interprofessional Internet Consultation (CPT Codes 99451and 99452)
     CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30 
minutes).
     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 or more minutes of medical consultative time).
    As discussed in section II.H. of this final rule, Valuation of 
Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for 
payment under the PFS as these are distinct services furnished via 
communication technology. Because these codes describe services that 
are inherently non face-to-face, we do not consider them as Medicare 
telehealth services under section 1834(m) of the Act; therefore we did 
not propose to add them to the list of Medicare telehealth services for 
CY 2019.
(3) Initial Hospital Care Services (CPT Codes 99221-99223)
     CPT code 99221 (Initial hospital care, per day, for the 
evaluation and

[[Page 59493]]

management of a patient, which requires these 3 key components: A 
detailed or comprehensive history; A detailed or comprehensive 
examination; and Medical decision making that is straightforward or of 
low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the problem(s) requiring admission are 
of low severity.)
     CPT code 99222 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity.)
     CPT code 99223 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity.)
    We have previously considered requests to add these codes to the 
telehealth list. As we stated in the CY 2011 PFS final rule with 
comment period (75 FR 73315), while initial inpatient consultation 
services are currently on the list of approved telehealth services, 
there are no services on the current list of telehealth services that 
resemble initial hospital care for an acutely ill patient by the 
admitting practitioner who has ongoing responsibility for the patient's 
treatment during the course of the hospital stay. Therefore, consistent 
with prior rulemaking, we did not propose that initial hospital care 
services be added to the Medicare telehealth services list on a 
category 1 basis.
    The initial hospital care codes describe the first visit of the 
hospitalized patient by the admitting practitioner who may or may not 
have seen the patient in the decision-making phase regarding 
hospitalization. Based on the description of the services for these 
codes, we believed it is critical that the initial hospital visit by 
the admitting practitioner be conducted in person to ensure that the 
practitioner with ongoing treatment responsibility comprehensively 
assesses the patient's condition upon admission to the hospital through 
a thorough in-person examination. Additionally, the requester submitted 
no additional research or evidence that the use of a telecommunications 
system to furnish the service produces demonstrated clinical benefit to 
the patient; therefore, we also did not propose adding initial hospital 
care services to the Medicare telehealth services list on a Category 2 
basis.
    We noted that Medicare beneficiaries who are being treated in the 
hospital setting can receive reasonable and necessary E/M services 
using other HCPCS codes that are currently on the Medicare telehealth 
list, including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well 
as initial and follow-up critical care telehealth consultations.
    Therefore, we did not propose to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services (CPT Codes 99231-99233)
     CPT code 99231 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Medical decision making that is straightforward or 
of low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is stable, recovering or 
improving. Typically, 15 minutes are spent at the bedside and on the 
patient's hospital floor or unit.).
     CPT code 99232 (Subsequent hospital care, per day, for the 
evaluation and management of a 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 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit.).
     CPT code 99233 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of high complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient is unstable or has developed a significant 
complication or a significant new problem. Typically, 35 minutes are 
spent at the bedside and on the patient's hospital floor or unit.).
    CPT codes 99231-99233 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 3 
days. The requester requested that we remove the frequency limitation. 
We stated in the CY 2011 PFS final rule with comment period (75 FR 
73316) that, although we still believed the potential acuity of 
hospital inpatients is greater than those patients likely to receive 
Medicare telehealth services that were on the list at that time, we 
also believed that it would be appropriate to permit some subsequent 
hospital care services to be furnished through telehealth in order to 
ensure that hospitalized patients have frequent encounters with their 
admitting practitioner. We also noted that we continue to believe that 
the majority of these visits should be in-person to facilitate the 
comprehensive, coordinated, and personal care that medically volatile, 
acutely ill patients require on an ongoing basis. Because of our 
concerns regarding the potential acuity of hospital inpatients, we 
finalized the addition of CPT codes 99231-99233 to the list of Medicare 
telehealth services, but limited the provision of these subsequent 
hospital care services through telehealth to once every 3 days. We 
continue to believe that admitting practitioners should continue to 
make appropriate in-person visits to all patients who need such care 
during their hospitalization. Our concerns and position on the 
provision of subsequent hospital care services via telehealth have not 
changed. Therefore, we did not propose to remove the frequency 
limitation on these codes.

[[Page 59494]]

(5) Subsequent Nursing Facility Care Services (CPT Codes 99307-99310)
     CPT code 99307 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A problem focused interval history; A 
problem focused examination; Straightforward medical decision making. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the patient is stable, recovering, or 
improving. Typically, 10 minutes are spent at the bedside and on the 
patient's facility floor or unit.).
     CPT code 99308 (Subsequent nursing facility care, per day, 
for the evaluation and management of a 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 patient is responding 
inadequately to therapy or has developed a minor complication. 
Typically, 15 minutes are spent at the bedside and on the patient's 
facility floor or unit.).
     CPT code 99309 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of moderate complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient has developed a significant complication or a 
significant new problem. Typically, 25 minutes are spent at the bedside 
and on the patient's facility floor or unit.).
     CPT code 99310 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A comprehensive interval history; a 
comprehensive examination; Medical decision making of high complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 35 minutes are spent at the bedside and on the patient's 
facility floor or unit.).
    CPT codes 99307-99310 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 
30 days. The requester requested that we remove the frequency 
limitation when these services are provided for psychiatric care. We 
stated in the CY 2011 PFS final rule with comment period (75 FR 73317) 
that we believed it would be appropriate to permit some subsequent 
nursing facility care services to be furnished through telehealth to 
ensure that complex nursing facility patients have frequent encounters 
with their admitting practitioner, but because of our concerns 
regarding the potential acuity and complexity of SNF inpatients, we 
limited the provision of subsequent nursing facility care services 
furnished through telehealth to once every 30 days. Since these codes 
are used to report care for patients with a variety of diagnoses, 
including psychiatric diagnoses, we do not think it would be 
appropriate to remove the frequency limitation only for certain 
diagnoses. The services described by these CPT codes are essentially 
the same service, regardless of the patient's diagnosis. We also 
continue to have concerns regarding the potential acuity and complexity 
of SNF inpatients, and therefore, we did not propose to remove the 
frequency limitation for subsequent nursing facility care services in 
CY 2019.
    In summary, we proposed to add the following codes to the list of 
Medicare telehealth services beginning in CY 2019 on a category 1 
basis:
     HCPCS code G0513 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; first 30 minutes (list separately in addition to code 
for preventive service).
     HCPCS code G0514 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; each additional 30 minutes (list separately in addition 
to code G0513 for additional 30 minutes of preventive service).
    Comment: Commenters were unanimously supportive of our proposal to 
add HCPCS codes G0513 and G0514 to the Medicare telehealth list. A few 
commenters noted they were disappointed that we did not propose to add 
the initial hospital care codes to the telehealth list and that we did 
not propose to lift the frequency limitation on the subsequent hospital 
care and subsequent nursing facility care codes.
    Response: We are finalizing adding HCPCS codes G0513 and G0514 to 
the Medicare telehealth list. We are not adding the initial hospital 
care codes to the telehealth list and we are not removing the frequency 
limitations on the subsequent hospital care and subsequent nursing 
facility care codes for the reasons noted above.
    Comment: Several commenters suggested that CMS conduct a pilot or 
demonstration program to evaluate the clinical benefit of physical 
therapists, occupational therapists, and speech-language pathologists 
furnishing telehealth services to Medicare beneficiaries in states that 
permit such services, noting that this would improve beneficiary access 
to therapy services, and help to inform policymakers as they consider 
whether to recognize such healthcare professionals as authorized 
providers of telehealth under the Social Security Act.
    Response: While we did not include any proposals on this topic in 
the proposed rule, we reiterate our commitment to expanding access to 
telehealth services consistent with statutory authority, and paying 
appropriately for services that maximize telecommunications technology. 
Regarding the possibility of a model or demonstration, we will consider 
the comments as we develop new models through the Center for Medicare 
and Medicaid Innovation. We note that we would need to determine 
whether such a model or demonstration would meet the statutory 
requirements, which generally require that the test be expected to 
reduce Medicare expenditures and preserve or enhance the quality of 
care for beneficiaries.
5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of 
2018
a. Expanding Access to Home Dialysis Therapy Under the Bipartisan 
Budget Act of 2018
    Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 
1834(m) of the Act to allow an individual determined to have end-stage 
renal disease receiving home dialysis to choose to receive certain 
monthly end-stage renal disease-related (ESRD-related) clinical 
assessments via telehealth on or after January 1, 2019.

[[Page 59495]]

The new section 1881(b)(3)(B)(ii) of the Act requires that such an 
individual must receive a face-to-face visit, without the use of 
telehealth, at least monthly in the case of the initial 3 months of 
home dialysis and at least once every 3 consecutive months after the 
initial 3 months.
    As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX) 
and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal 
dialysis facility and the home of an individual as telehealth 
originating sites but only for the purposes of the monthly ESRD-related 
clinical assessments furnished through telehealth provided under 
section 1881(b)(3)(B) of the Act. Section 50302(b)(1) of the BBA of 
2018, also added a new section 1834(m)(5) of the Act which provides 
that the geographic requirements for telehealth services under section 
1834(m)(4)(C)(i) of the Act do not apply to telehealth services 
furnished on or after January 1, 2019 for purposes of the monthly ESRD-
related clinical assessments where the originating site is a hospital-
based or critical access hospital-based renal dialysis center, a renal 
dialysis facility, or the home of an individual. Section 50302(b)(2) of 
the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require 
that no originating site facility fee is to be paid if the home of the 
individual is the originating site.
    Our current regulation at Sec.  410.78 specifies the conditions 
that must be met in order for Medicare Part B to pay for covered 
telehealth services included on the telehealth list when furnished by 
an interactive telecommunications system. In accordance with the new 
subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we 
proposed to revise our regulation at Sec.  410.78(b)(3) to add a renal 
dialysis facility and the home of an individual as Medicare telehealth 
originating sites, but only for purposes of the home dialysis monthly 
ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. 
We proposed to amend Sec.  414.65(b)(3) to reflect the requirement in 
section 1834(m)(2)(B)(ii) of the Act that there is no originating site 
facility fee paid when the originating site for these services is the 
patient's home. Additionally, we proposed to add new Sec.  
410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of 
the Act, added by section 50302 of the BBA of 2018, specifying that the 
geographic requirements described in section 1834(m)(4)(C)(i) of the 
Act do not apply with respect to telehealth services furnished on or 
after January 1, 2019, in originating sites that are hospital-based or 
critical access hospital-based renal dialysis centers, renal dialysis 
facilities, or the patient's home, respectively under sections 
1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section 
1881(b)(3)(B) of the Act.
    Commenters supported our proposals to revise the regulation text at 
Sec. Sec.  410.78 and 414.65 to implement the requirements of section 
50302 of the BBA of 2018 for expanding access to home dialysis therapy 
through telehealth. We are finalizing these regulation text changes as 
proposed.
b. Expanding the Use of Telehealth for Individuals With Stroke Under 
the Bipartisan Budget Act of 2018
    Section 50325 of the BBA of 2018 amended section 1834(m) of the Act 
by adding a new paragraph (6) that provides special rules for 
telehealth services furnished on or after January 1, 2019, for purposes 
of diagnosis, evaluation, or treatment of symptoms of an acute stroke 
(acute stroke telehealth services), as determined by the Secretary. 
Specifically, section 1834(m)(6)(A) of the Act removes the restrictions 
on the geographic locations and the types of originating sites where 
acute stroke telehealth services can be furnished. Section 
1834(m)(6)(B) of the Act specifies that acute stroke telehealth 
services can be furnished in any hospital, critical access hospital, 
mobile stroke units (as defined by the Secretary), or any other site 
determined appropriate by the Secretary, in addition to the current 
eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act 
limits payment of an originating site facility fee to acute stroke 
telehealth services furnished in sites that meet the usual telehealth 
restrictions under section 1834(m)(4)(C) of the Act.
    To implement these requirements, we proposed to create a new 
modifier that would be used to identify acute stroke telehealth 
services. The practitioner and, as appropriate, the originating site, 
would append this modifier when clinically appropriate to the HCPCS 
code when billing for an acute stroke telehealth service or an 
originating site facility fee, respectively. We note that section 50325 
of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act, 
which limits the scope of telehealth services to those on the Medicare 
telehealth list. Practitioners would be responsible for assessing 
whether it would be clinically appropriate to use this modifier with 
codes from the Medicare telehealth list. By billing with this modifier, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services for diagnosis, evaluation, or treatment of 
symptoms of an acute stroke. We believe that the adoption of a service 
level modifier is the least administratively burdensome means of 
implementing this provision for practitioners, while also allowing CMS 
to easily track and analyze utilization of these services.
    In accordance with section 1834(m)(6)(B) of the Act, as added by 
section 50325 of the BBA of 2018, we also proposed to revise Sec.  
410.78(b)(3) to add mobile stroke unit as a permissible originating 
site for acute stroke telehealth services. We proposed to define a 
mobile stroke unit as a mobile unit that furnishes services to 
diagnose, evaluate, and/or treat symptoms of an acute stroke and 
solicited comment on this definition, as well as additional information 
on how these units are used in current medical practice. We therefore 
proposed that mobile stroke units and the current eligible telehealth 
originating sites, which include hospitals and critical access 
hospitals as specified in section 1834(m)(6)(B) of the Act, but 
excluding renal dialysis facilities and patient homes because they are 
only allowable originating sites for purposes of home dialysis monthly 
ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, 
would be permissible originating sites for acute stroke telehealth 
services.
    We also solicited comment on other possible appropriate originating 
sites for telehealth services furnished for the diagnosis, evaluation, 
or treatment of symptoms of an acute stroke. Any additional sites would 
be adopted through future rulemaking. As required under section 
1834(m)(6)(C) of the Act, the originating site facility fee would not 
apply in instances where the originating site does not meet the 
originating site type and geographic requirements under section 
1834(m)(4)(C) of the Act. Additionally, we proposed to add Sec.  410.78 
(b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C) 
of the Act do not apply with respect to telehealth services furnished 
on or after January 1, 2019, for purposes of diagnosis, evaluation, or 
treatment of symptoms of an acute stroke.
    Comment: Commenters supported the expansions to Medicare 
telehealth. The majority of commenters agreed with our proposed 
definition of a mobile stroke unit. However, the AMA suggested that CMS 
specify in the definition that a mobile stroke unit must include a 
computed tomographic (CT) scanner and a telehealth (audio and video) 
connection or an in-person physician who is able to interpret the CT 
scan and prescribe an intravenous thrombolysis and also have a 
qualified health

[[Page 59496]]

professional who is able to administer an intravenous thrombolysis if 
the physician interpreting the CT scan and prescribing the treatment 
does so via telehealth. The AMA also suggested that CMS add as an 
originating site Emergency Medical Service (EMS) transports equipped 
with a telehealth connection to stroke specialists in order to provide 
faster national access to patients who require an accurate stroke 
diagnosis and decision about eligibility for intravenous or 
endovascular therapy, and to determine where to take them (such as a 
primary stroke or comprehensive stroke center). One commenter urged CMS 
to distinguish between a mobile stroke unit and a standard ambulance 
that is equipped with telemedicine capability and to establish separate 
payment for each, noting that a telemedicine consult on a mobile stroke 
unit may involve much greater complexity and critical care treatment 
than on a standard ambulance that is equipped with telemedicine 
capability. Another commenter recommended that CMS require specially 
trained paramedics who can evaluate an acute ischemic stroke patient 
based on national standards.
    Response: We are finalizing the changes to the regulation text and 
the definition of a mobile stroke unit as proposed without 
modification. We believe that clinicians are in the best position to 
make decisions about what equipment and professional support are 
required in furnishing these services. We plan to monitor utilization 
of these services and will consider making refinements, including those 
suggested by commenters, through future rulemaking as necessary. We 
would welcome additional information to help us understand the merits 
of the commenters' suggestions, including those regarding specific 
equipment and staffing requirements for mobile stroke units.
    In summary, we are finalizing a new modifier that will be used to 
identify acute stroke telehealth services. The practitioner and, as 
appropriate, the originating site, will append this modifier to the 
HCPCS code as clinically appropriate when billing for an acute stroke 
telehealth service or an originating site facility fee, respectively. 
We are finalizing the regulation text changes at Sec. Sec.  410.78 and 
414.65 as proposed to implement the requirements of section 50325 of 
the BBA of 2018 for acute stroke telehealth services. Mobile stroke 
units, with the definition as proposed, and the current eligible 
telehealth originating sites, which include hospitals and critical 
access hospitals, but exclude renal dialysis facilities and patient 
homes because they are originating sites only for purposes of home 
dialysis monthly ESRD-related clinical assessments in section 
1881(b)(3)(B) of the Act, will be permissible originating sites for 
acute stroke telehealth services.
6. Requirements of the Substance Use-Disorder Prevention That Promotes 
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities 
Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid 
Use Disorder and Other Substance Use Disorders--Interim Final Rule With 
Comment Period
    Section 2001(a) of the SUPPORT for Patients and Communities Act 
(Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several 
revisions to section 1834(m) of the Act. First, it removes the 
originating site geographic requirements under section 1834(m)(4)(C)(i) 
for telehealth services furnished on or after July 1, 2019 for the 
purpose of treating individuals diagnosed with a substance use disorder 
or a co-occurring mental health disorder, as determined by the 
Secretary, at an originating site described in section 
1834(m)(4)(C)(ii) of the Act, other than an originating site described 
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site 
described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is 
a renal dialysis facility, which is only an allowable originating site 
for purposes of home dialysis monthly ESRD-related clinical assessments 
in section 1881(b)(3)(B) of the Act. It also adds the home of an 
individual as a permissible originating site for these telehealth 
services. Section 2001(a) of the SUPPORT Act for Patients and 
Communities Act additionally amends 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. Section 2001(b) of 
the SUPPORT for Patients and Communities Act grants the Secretary 
specific authority to implement the amendments made by section 2001(a) 
through an interim final rule.
    Under the authority of section 2001(b) of the SUPPORT for Patients 
and Communities Act, we are issuing an interim final rule with comment 
period to implement the requirements of section 2001(a) of the SUPPORT 
for Patients and Communities Act. In accordance with section 
1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the 
SUPPORT for Patients and Communities Act, we are revising Sec.  
410.78(b)(3) on an interim final basis, by adding Sec.  
410.78(b)(3)(xii), which adds the home of an individual as a 
permissible originating site for telehealth services furnished on or 
after July 1, 2019 to individuals with a substance use disorder 
diagnosis for purposes of treatment of a substance use disorder or a 
co-occurring mental health disorder. We are amending Sec.  414.65(b)(3) 
on an interim final basis to reflect the requirement in section 
1834(m)(2)(B)(ii) of the Act that there is no originating site facility 
fee paid when the originating site for these services is the 
individual's home. Additionally, we are adding Sec.  
410.78(b)(4)(iv)(C) on an interim final basis to specify that the 
geographic requirements in section 1834(m)(4)(C)(i) of the Act do not 
apply for telehealth services furnished on or after July 1, 2019, to 
individuals with a substance use disorder diagnosis for purposes of 
treatment of a substance use disorder or a co-occurring mental health 
disorder at an originating site other than a renal dialysis facility.
    We note that section 2001 of the SUPPORT for Patients and 
Communities Act did not amend section 1834(m)(4)(F) of the Act, which 
limits the scope of telehealth services to those on the Medicare 
telehealth list. Practitioners would be responsible for assessing 
whether individuals have a substance use disorder diagnosis and whether 
it would be clinically appropriate to furnish telehealth services for 
the treatment of the individual's substance use disorder or a co-
occurring mental health disorder. By billing codes on the Medicare 
telehealth list with the telehealth place of service code, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services to individuals with a substance use 
disorder diagnosis for the purpose of treating the substance use 
disorder or a co-occurring mental health disorder. We note that we may 
issue additional subregulatory guidance in the future for billing these 
telehealth services.
    We note that there is a 60-day period following publication of this 
interim final rule for the public to comment on these interim final 
amendments to our regulations. We invite public comment on our policies 
to implement section 2001 of the SUPPORT for Patients and Communities 
Act.

[[Page 59497]]

b. Medicare Payment for Certain Services Furnished by Opioid Treatment 
Programs (OTPs)--Request for Information
    Section 2005 of the SUPPORT Act establishes a new Medicare benefit 
category for opioid use disorder treatment services furnished by OTPs 
under Medicare Part B, beginning on or after January 1, 2020. This 
provision requires that opioid use disorder treatment services would 
include FDA-approved opioid agonist and antagonist treatment 
medications, the dispensing and administration of such medications (if 
applicable), substance use disorder counseling, individual and group 
therapy, toxicology testing, and other services determined appropriate 
(but in no event to include meals and transportation). The provision 
defines OTPs as those that enroll in Medicare and are certified by the 
Substance Abuse and Mental Health Services Administration (SAMHSA), 
accredited by a SAMHSA-approved entity, and meeting additional 
conditions as the Secretary finds necessary to ensure the health and 
safety of individuals being furnished services under these programs and 
the effective and efficient furnishing of such services.
    We note that there is a 60-day period for the public to comment on 
the provisions of the interim final rule described previously to 
implement section 2001 of the SUPPORT for Patients and Communities Act. 
During that same comment period, we are requesting information 
regarding services furnished by OTPs, payments for these services, and 
additional conditions for Medicare participation for OTPs that 
stakeholders believe may be useful for us to consider for future 
rulemaking to implement this new Medicare benefit category.
7. Modifying Sec.  414.65 Regarding List of Telehealth Services
    In the CY 2015 PFS final rule with comment period, we finalized a 
proposal to change our regulation at Sec.  410.78(b) by deleting the 
description of the individual services for which Medicare payment can 
be made when furnished via telehealth, noting that we revised Sec.  
410.78(f) to indicate that a list of Medicare telehealth codes and 
descriptors is available on the CMS website (79 FR 67602). In 
accordance with that change, we proposed a technical revision to also 
delete the description of individual services and exceptions for 
Medicare payment for telehealth services in Sec.  414.65, by amending 
Sec.  414.65(a) to note that Medicare payment for telehealth services 
is addressed in Sec.  410.78 and by deleting Sec.  414.65(a)(1).
    Comment: Commenters were supportive of CMS making a technical 
revision to delete the description of individual services and 
exceptions for Medicare payment for telehealth services in Sec.  
414.65.
    Response: We are finalizing the technical revision to Sec.  414.65 
as proposed.
8. Comment Solicitation on Creating a Bundled Episode of Care for 
Management and Counseling Treatment for Substance Use Disorders
    There is an evidence base that suggests that routine counseling, 
either associated with medication assisted treatment (MAT) or on its 
own, can increase the effectiveness of treatment for substance use 
disorders (SUDs). According to a study in the Journal of Substance 
Abuse Treatment,\1\ patients treated with a combination of web-based 
counseling as part of a substance abuse treatment program demonstrated 
increased treatment adherence and satisfaction. The federal guidelines 
for opioid treatment programs describe that MAT and wrap-around 
psychosocial and support services can include the following services: 
Physical exam and assessment; psychosocial assessment; treatment 
planning; counseling; medication management; drug administration; 
comprehensive care management and supportive services; care 
coordination; management of care transitions; individual and family 
support services; and health promotion (https://store.samhsa.gov/shin/content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate 
payment for a bundled episode of care for components of MAT such as 
management and counseling treatment for substance use disorders (SUD), 
including opioid use disorder, treatment planning, and medication 
management or observing drug dosing for treatment of SUDs under the PFS 
could provide opportunities to better leverage services furnished with 
communication technology while expanding access to treatment for SUDs.
---------------------------------------------------------------------------

    \1\ Van L. King, Robert K. Brooner, Jessica M. Peirce, Ken 
Kolodner, Michael S. Kidorf, ``A randomized trial of Web based 
videoconferencing for substance abuse counseling,'' Journal of 
Substance Abuse Treatment, Volume 46, Issue 1, 2014, Pages 36-42, 
http://www.sciencedirect.com/science/article/pii/S0740547213001876.
---------------------------------------------------------------------------

    We also believe making separate payment for a bundled episode of 
care for management and counseling for SUDs could be effective in 
preventing the need for more acute services. For example, according to 
the Healthcare Cost and Utilization Project,\2\ Medicare pays for one-
third of opioid-related hospital stays, and Medicare has seen the 
largest annual increase in the number of these stays over the past 2 
decades. We believe that separate payment for a bundled episode of care 
could help avoid such hospital admissions by supporting access to 
management and counseling services that could be important in 
preventing hospital admissions and other acute care events.
---------------------------------------------------------------------------

    \2\ Pamela L. Owens, Ph.D., Marguerite L. Barrett, M.S., Audrey 
J. Weiss, Ph.D., Raynard E. Washington, Ph.D., and Richard Kronick, 
Ph.D. ``Hospital Inpatient Utilization Related to Opioid Overuse 
Among Adults 1993-2012,'' Statistical Brief #177. Healthcare Cost 
and Utilization Project (HCUP). July 2014. Agency for Healthcare 
Research and Quality, Rockville, MD, https://www.hcup-us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-Opioid-Overuse.jsp.
---------------------------------------------------------------------------

    As indicated earlier, we considered whether it would be appropriate 
to develop a separate bundled payment for an episode of care for 
treatment of SUDs. We solicited public comment on whether such a 
bundled episode-based payment would be beneficial to improve access, 
quality and efficiency for SUD treatment. Further, we solicited public 
comment on developing coding and payment for a bundled episode of care 
for treatment for SUDs that could include overall treatment management, 
any necessary counseling, and components of a MAT program such as 
treatment planning, medication management, and observation of drug 
dosing. Specifically, we solicited public comments related to what 
assumptions we might make about the typical number of counseling 
sessions as well as the duration of the service period, which types of 
practitioners could furnish these services, and what components of MAT 
could be included in the bundled episode of care. We were interested in 
stakeholder feedback regarding how to define and value this bundle and 
what conditions of payment should be attached. Additionally, we 
solicited comment on whether the concept of a global period, similar to 
the currently existing global periods for surgical procedures, might be 
applicable to treatment for SUDs.
    We also solicited comment on whether the counseling portion and 
other MAT components could also be provided by qualified practitioners 
``incident to'' the services of the billing physician who will 
administer or prescribe any necessary medications and manage the 
overall care, as well as supervise any other counselors participating 
in the treatment, similar to the structure of the Behavioral Health 
Integration codes which include

[[Page 59498]]

services provided by other members of the care team under the direction 
of the billing practitioner on an ``incident to'' basis (81 FR 80231). 
We welcomed comments on potentially creating a bundled episode of care 
for management and counseling treatment for SUDs, which we will 
consider for future rulemaking.
    Comment: We received several comments with detailed information on 
this topic. Some commenters expressed concern that the format of a 
bundled episode of care may fail to take into account the wide 
variability in patient needs for treatment of SUDs, especially given 
the chronic nature of SUDs, which like other chronic diseases, 
typically involves ongoing treatment without a definitive end point. 
Some commenters additionally noted that a global period would not lend 
itself to treatment of SUDs, because the treatment is not an acute 
intervention like surgery; rather, patients with SUDs may require 
increasing and decreasing access to care, depending on their progress 
in treatment.
    Response: We thank the commenters for all of the information 
submitted and will consider this feedback for future rulemaking. We 
agree with commenters and understand that there is wide variability in 
patient needs for treatment of SUDs, and that unlike surgical global 
periods, ongoing treatment is often necessary in the treatment of SUDs. 
While we do not necessarily believe these characteristics preclude 
payment bundles and/or global periods, we do understand they would need 
to be taken into account. We reiterate that our intention as we 
consider these issues for future rulemaking is to increase access to 
necessary care, and that any potential bundled payment would be 
developed in consideration of these comments.
    We note that there is a 60-day period for the public to comment on 
the interim final telehealth policies and revisions to our regulations 
we are adopting to implement statutory amendments to section 1834(m) of 
the Act that expand access to telehealth services used to treat 
substance use disorders. During that same comment period, we are 
requesting additional information from stakeholders and the public that 
we might consider for future rulemaking regarding payment structure and 
amounts for SUD treatment that account for ongoing treatment and wide 
variability in patient needs for treatment of SUDs while improving 
access to necessary care.
    Additionally, we invited public comment and suggestions for 
regulatory and subregulatory changes to help prevent opioid use 
disorder and improve access to treatment under the Medicare program. We 
solicited comment on methods for identifying non-opioid alternatives 
for pain treatment and management, along with identifying barriers that 
may inhibit access to these non-opioid alternatives including barriers 
related to payment or coverage. Consistent with our ``Patients Over 
Paperwork'' Initiative, we were interested in suggestions to improve 
existing requirements to more effectively address the opioid epidemic.
    Comment: We received several comments with detailed information on 
this topic.
    Response: We thank the commenters for all of the information 
submitted and will consider this for future rulemaking.
9. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002, at $20.00. 
For telehealth services furnished on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the Medicare Economic Index 
(MEI) as defined in section 1842(i)(3) of the Act. The originating site 
facility fee for telehealth services furnished in CY 2018 is $25.76. 
The MEI increase for 2019 is 1.5 percent and is based on the most 
recent historical update of the MEI through 2018Q2 (2.0 percent), and 
the most recent historical multifactor productivity adjustment (MFP) 
through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the 
payment amount for HCPCS code Q3014 (Telehealth originating site 
facility fee) is 80 percent of the lesser of the actual charge or 
$26.15. The Medicare telehealth originating site facility fee and the 
MEI increase by the applicable time period is shown in Table 10.

     Table 10--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
                                                         MEI    Facility
                     Time period                      increase     fee
------------------------------------------------------------------------
10/01/2001-12/31/2002...............................       N/A    $20.00
01/01/2003-12/31/2003...............................       3.0     20.60
01/01/2004-12/31/2004...............................       2.9     21.20
01/01/2005-12/31/2005...............................       3.1     21.86
01/01/2006-12/31/2006...............................       2.8     22.47
01/01/2007-12/31/2007...............................       2.1     22.94
01/01/2008-12/31/2008...............................       1.8     23.35
01/01/2009-12/31/2009...............................       1.6     23.72
01/01/2010-12/31/2010...............................       1.2     24.00
01/01/2011-12/31/2011...............................       0.4     24.10
01/01/2012-12/31/2012...............................       0.6     24.24
01/01/2013-12/31/2013...............................       0.8     24.43
01/01/2014-12/31/2014...............................       0.8     24.63
01/01/2015-12/31/2015...............................       0.8     24.83
01/01/2016-12/31/2016...............................       1.1     25.10
01/01/2017-12/31/2017...............................       1.2     25.40
01/01/2018-12/31/2018...............................       1.4     25.76
01/01/2019-12/31/2019...............................       1.5     26.15
------------------------------------------------------------------------

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.H. of this final 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

[[Page 59499]]

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 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.
    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 CY 2012 PFS final rule with comment period (76 FR 73052 
through 73055). 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 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 CY 2009 (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (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

[[Page 59500]]

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 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 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 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 2019 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 there have been 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 one submission that nominated several high-volume codes 
for review under the potentially misvalued code initiative. In its 
request, the submitter noted a systemic overvaluation of work RVUs in 
certain procedures and tests based ``on a number of Government 
Accountability Office (GAO) and the Medicare Payment Advisory 
Commission (MedPAC) reports, media reports regarding time inflation of 
specific services, and the January 19, 2017 Urban Institute report for 
CMS.'' The submitter suggested that the times CMS assumes in estimating 
work RVUs are inaccurate for procedures, especially due to substantial 
overestimates of preservice and postservice time, including follow-up 
inpatient and outpatient visits that do not take place. According to 
the submitter, the time estimates for tests and some other procedures 
are primarily overstated as part of the intraservice time. Furthermore, 
the submitter stated that previous RUC reviews of these services did 
not result in reductions in valuation that adequately reflected 
reductions in surveyed times.
    Based on these analyses, the submitter requested that the codes 
listed in Table 11 be prioritized for review under the potentially 
misvalued code initiative.

            Table 11--Public Nominations Due to Overvaluation
------------------------------------------------------------------------
             CPT code                         Short description
------------------------------------------------------------------------
27130.............................  Total hip arthroplasty.
27447.............................  Total knee arthroplasty.
43239.............................  Egd biopsy single/multiple.
45385.............................  Colonoscopy w/lesion removal.
70450.............................  CT head w/o contrast.
93000.............................  Electrocardiogram complete.
93306.............................  Tte w/doppler complete.
------------------------------------------------------------------------

    Another submitter requested that 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)) be reviewed under the potentially misvalued code 
initiative in order to establish national RVU values for these services 
under the MPFS. These codes are currently priced by the Medicare 
Administrative Contractors (MACs).
    We received several comments with regard to the nomination of 
several high-volume codes for review under the potentially misvalued 
code initiative.
    Comment: One commenter stated that specific details of the 
nomination of the seven high-volume codes were not provided in the CY 
2019 PFS proposed rule. Several other commenters, including the RUC, 
expressed concern that the source of the nomination of the seven high-
volume codes and its entire nomination letter was not made available. 
These commenters requested that CMS provide greater transparency and 
publicly provide all nomination requests identifying potentially 
misvalued codes.
    Response: We believe that we summarized the contents of the public 
nomination letter and provided the rationale in the CY 2019 PFS 
proposed rule with enough detail for commenters to comment 
substantively and provide supporting documentation or data to rebut the 
suggestion that these codes are potentially misvalued. We recognize the 
importance of transparency and note that under the public nomination 
process that was established in CY 2012 rulemaking, the first 
opportunity for the public to nominate codes was during the 60-day 
comment period for the CY

[[Page 59501]]

2012 final rule with comment period; therefore, public nominations were 
received via submission to www.regulations.gov. In the CY 2015 final 
rule with comment period (79 FR 67606 through 67608), we finalized a 
modified process for identifying potentially misvalued codes (fully 
effective in CY 2017), where we established a new deadline of February 
10th for receipt of public nominations for potentially misvalued codes 
to be considered for inclusion in the proposed rule. Although 
stakeholders often include public nominations of misvalued codes for 
consideration in a subsequent year's rulemaking as part of their 
comments on a current year's proposed rule, the public and stakeholders 
may nominate potentially misvalued codes for review by submitting the 
code with supporting documentation to CMS by February 10th of each 
year. In the future, public nominations that CMS receives by the 
February 10th deadline will be made available in the form of a public 
use file with the proposed rule, in the downloads section on the CMS 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We remind submitters that any information 
that might be considered proprietary or confidential should not be 
included. Additionally, we have included the submission that nominated 
these high-volume codes for review as potentially misvalued as a public 
use file for the CY 2019 PFS final rule.
    Comment: One commenter stated that because CMS did not include 
these publicly nominated codes in Table 13 of the proposed rule, it 
does not appear that CMS has agreed with the commenter on the need to 
revisit these codes. Another commenter stated that CMS did not provide 
guidance on whether these nominated codes would be considered for 
revaluation or retained at their current value.
    Response: We clarify that the codes for which we received public 
nominations as potentially misvalued were not included in Table 13 of 
the proposed rule because that table contains a list of codes for which 
we proposed work RVUs for CY 2019 (the list does not include codes for 
which we received nominations discussed in the proposed rule for 
consideration as potentially misvalued). As previously indicated, in 
the proposed rule we publish the list of codes nominated as potentially 
misvalued, which allows the public the opportunity to comment on these 
codes; then, in the final rule, we finalize our list of potentially 
misvalued codes. No new valuations were proposed for these codes in the 
CY 2019 PFS proposed rule. Any revaluation of these codes would be 
proposed in future rulemaking.
    Comment: One commenter stated that the codes in Table 8 in the 
proposed rule and their respective code families should be prioritized 
for review as potentially misvalued. The commenter suggested revisiting 
two recent efforts funded by CMS, reports by Urban Institute and RAND 
Corporation (https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_1.pdf, and, https://www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/RAND_RR662.pdf), for prioritization of codes for review to expand the 
misvalued codes initiative list. The commenter referenced a June 2018 
MedPAC report that stated that CMS' review of potentially misvalued 
codes has not addressed services that account for a substantial share 
of fee schedule spending and is hampered by the lack of current, 
accurate, and objective data on clinician work time and practice 
expenses. Consequently, according to the MedPAC report, work RVUs for 
procedures, imaging, and tests are systemically overvalued relative to 
other services, such as ambulatory evaluation and management (E/M) 
services.
    Response: We appreciate the commenters' recommendations for 
expanding the misvalued codes list. We will consider whether to address 
these suggestions in future rulemaking.
    Comment: One commenter recommended that additional research be 
conducted on the analytic products available that could be used to 
create transparency into the RUC process and allow for greater external 
participation in misvalued cost evaluation. The commenter also stated 
that CMS should reconsider reliance on the RUC altogether given the 
inherent conflicts of interest in the RUC-based process.
    Response: We acknowledge that the RUC provides critically important 
information that factors into our review process. However, our review 
of recommended work RVUs and time inputs is also informed by review of 
various alternate sources of information, in addition to the RUC. 
Examples of these alternate sources of information include information 
provided by other public commenters, Medicare claims data, comparative 
databases, medical literature, as well as consultation with other 
physicians and healthcare professionals within CMS and the federal 
government. We also reiterate that we continue to be open to reviewing 
additional and supplemental sources of data furnished by stakeholders, 
and providing such information to CMS is not limited to the public 
nomination process for potentially misvalued codes. We encourage 
stakeholders to continue to provide such information for our 
consideration in establishing work RVUs.
    Comment: One commenter stated concerns with CMS' use of a non-
relative measuring approach for the seven codes nominated for review 
when generally the RUC-valued and CMS-approved codes are based on the 
concept of relativity. The commenter stated that using such an 
inconsistent approach on select codes will potentially cause disruption 
and instability in code valuations. The commenter also stated that 
determining reimbursement in value-based care delivery models must rely 
on the carefully cultivated RUC process for fairness and 
accountability.
    Response: We are unclear about the commenter's claim that CMS is 
using a non-relative measuring approach for the seven high volume codes 
that have been nominated as potentially misvalued. We did not propose a 
valuation for the nominated codes, nor did we propose to use a non-
relative measuring approach. Rather, as part of our statutory 
obligation to identify and review potentially misvalued codes, we 
implemented an annual process whereby the public can nominate 
potentially misvalued codes with supporting documentation; we then 
publish the list of nominated codes and the public has the opportunity 
to comment on these nominations. We continue to maintain that 
adjustments to work RVUs should be based on the resources involved with 
each procedure or service, and reiterate that our review of work RVUs 
and time inputs utilizes information from various resources, including 
the RUC. We continue to seek information on the best sources of 
objective, routinely-updated, auditable, and robust data regarding the 
resource costs of furnishing PFS services.
    Comment: Several commenters stated that CPT codes 27130 and 27447 
should not be considered potentially misvalued and do not warrant any 
further action because the current valuation for the codes was 
established after review by the RUC and CMS in 2013, and since that 
time there are no new data to indicate a change in the work of 
performing the procedure or the number of post-operative follow up 
visits. Another commenter stated that CMS should not subject 
professions to code

[[Page 59502]]

valuations and analysis so frequently, and that doing so calls into 
question the validity of the RUC process in the first place.
    Response: We do not agree that recent review of a code should 
preclude it from being considered as potentially misvalued, nor that it 
calls into question the validity of the RUC process. We have a 
responsibility to identify and review potentially misvalued codes, and 
believe there is value in consistent and routine review of high-volume 
services, particularly considering that a minor adjustment to the work 
RVU of a high-volume code may have a significant dollar impact. We also 
note that review of high-volume services does not need to be predicated 
on the suspicion of overvaluation.
    Comment: One commenter stated that if CMS decides to reexamine 
these nominated codes in the future, then the agency should provide 
ample opportunity for public comments, and in the event of such review, 
CMS should consider supplemental sources of information, including 
hospital anesthesia time in addition to any RUC recommendations in 
order to support accurate valuations of these procedures.
    Response: Any revaluations of these codes would be undertaken 
through notice and comment rulemaking. Notice and comment rulemaking 
provides for an open process whereby we welcome input from all 
interested parties, and we encourage commenters to provide feedback 
including supplemental sources of information regarding potentially 
misvalued codes, as well as input on our annual proposed valuations.
    Comment: One commenter disagreed that CPT codes 43239 and 45385 are 
misvalued and stated that while the Urban Institute report provides 
insights into potential flaws in the RUC survey process, it should not 
be considered proof that these codes are overvalued. The commenter 
stated that these code valuations were recently revised, and the RUC 
survey responses from gastroenterologists informed revisions to the 
work RVUs for both services. The commenter stated that for CPT code 
43239, CMS finalized work RVUs that were less than the RUC's 
recommended work RVUs, and for CPT code 45385, CMS finalized the RUC-
recommended work RVUs, which were lower than the work RVUs prior to 
reevaluation. Therefore, the commenter stated that CMS should reject 
the nominations of these codes as potentially misvalued.
    Response: We note that the nomination referenced the Urban 
Institute report as only one of the sources regarding the issue of time 
inflation of specific services. Additionally, as previously indicated, 
we do not agree that recent review of a code should preclude it from 
being considered as potentially misvalued. We believe there is value in 
consistent and routine review of high-volume services, particularly 
considering that a minor adjustment to the work RVU of a high-volume 
code may have a significant dollar impact. Therefore, we do not agree 
that we should reject nominations of these codes as potentially 
misvalued because they were previously reviewed and refinements were 
made.
    Comment: A few commenters stated that the current work RVU 
valuation of 0.85 for CPT code 70450 is inadequate. The commenters 
stated that the level of effort associated with CPT code 70450 
increased between the time the code was originally valued and the 2012 
survey, and this increase continued through 2016. The commenters stated 
that over time, advances in technology led to many more images being 
created than existed historically. The commenters also stated that 
volume acquisitions, a CT scan technique that allows for multiple two-
dimensional images, has resulted in thinner reconstructions and 
effortless multiplanar reformats, and other technological advancements 
have increased the amount of professional work associated with 
interpreting a non-contrast head CT and should be considered in the 
work RVU. The commenters expressed concern that the nomination by a 
single entity threatens the integrity of how physician services are 
valued generally.
    Response: We disagree with the commenter that a nomination by a 
single entity threatens the integrity of how physician services are 
valued generally, and reiterate that a public nomination process was 
established through rulemaking as a way for the public and stakeholders 
to nominate potentially misvalued codes for consideration. Any future 
proposed valuations of specific codes are open for public comment, and 
we encourage stakeholders to submit data that would indicate that the 
current valuation is insufficient.
    Comment: One commenter stated that with regard to CPT code 70450, 
the times prior to survey were CMS/other times and were not subdivided 
into pre-service, intra-service, and post-service categories. 
Therefore, the commenter stated that drawing comparisons between prior 
RUC database times and the surveyed times is invalid because the source 
of the prior RUC database times are unknown and completely different 
from the surveyed times. The commenter also stated that selecting as 
potentially misvalued only certain CPT codes that have undergone the 
RUC process with validated surveys is not a rational approach because 
if the times assumed based on the RUC approved survey data are invalid 
for these codes, they should be invalid for the entire fee schedule so 
that consistent methodology is applied to all CPT codes.
    Response: We typically rely on RUC survey values because we believe 
they are the closest to accurate values, as they are the best data 
available in some cases. Although we do not agree that we should not 
consider comparisons of RUC database times to the newly surveyed times 
as described by the commenter, on a case-by-case basis we can consider 
the existence of previous inaccuracies. However, we also note that 
previous valuations established based on those inaccuracies would also 
indicate that the payments would have been inaccurate as well. The goal 
of the identification and review of potentially misvalued services is 
to facilitate accurate payment for PFS services. We also disagree with 
the commenter's characterization that selecting codes that have 
undergone the RUC process with validated surveys is not rational, and 
note that just because a code has been reviewed by the RUC does not 
preclude it from being identified and/or publically nominated as 
potentially misvalued.
    Comment: With regard to CPT codes 93000 and 93306, one commenter 
stated that while the Urban Institute report concludes that the 
intraservice time to interpret an electrocardiogram is 6 seconds, 
practitioners who furnish the service do not believe it is possible to 
completely interpret a study so quickly. The commenter expressed 
concern about the large emphasis placed on service time by CMS and some 
stakeholders when it comes to valuation. The commenter suggested that 
frequent reviews of long-established mature services like 
electrocardiography and echocardiography will produce two outcomes--the 
inputs will remain the same or circumstances at some point will align 
such that it appears they take less time, which will open the window 
for payers to try to reduce payment for services that have not actually 
changed, and eventually these reductive re-valuations produce 
underpayment. A few commenters stated that CPT code 93306 was recently 
reviewed and valued in CY 2018. One commenter stated that the current 
valuation is reflective of numerous accreditation body requirements 
that were implemented since the service was last valued in 2007, which 
increased the

[[Page 59503]]

work required per study. The commenter stated that the Urban Institute 
report should not be considered proof that the CPT code is overvalued, 
and given the recent RUC review of this service, CMS' acceptance of the 
RUC recommendation, and no change in the physician work of performing 
the service in the past year, this code should not be included in the 
potentially misvalued codes list.
    Response: We reiterate that it is our practice to consider all 
elements of the relative work when we are reviewing and determining 
work RVU valuations. Additionally, our review of recommended work RVUs 
and time inputs generally includes review of various sources such as 
information provided by the RUC, and other public commenters, medical 
literature, and comparative databases. As previously stated, we believe 
there is great value in consistent and routine review of high-volume 
services. Additionally, as previously indicated, we do not agree that 
recent review of a code should preclude it from being considered as 
potentially misvalued, and therefore, do not agree that CMS should not 
include a code in the list of potentially misvalued services because it 
was previously reviewed.
    Comment: One commenter disagreed that the time allocated to CPT 
code 93306 is overstated. The commenter stated that the Intersocietal 
Accreditation Commission for Echocardiography Guidelines regarding time 
standards indicated that more time is necessary from patient encounter 
to departure than is stipulated in the CMS time file. The commenter 
also stated there is more and more information being gathered with the 
introduction of technology that is labor and time intensive. The 
commenter suggested that if anything is revised, CMS times should be 
increased, not decreased.
    Response: We reiterate that we are interested in receiving 
resource-based data from stakeholders and not just the RUC and we 
encourage stakeholders to submit data that would indicate that the 
current valuations are insufficient.
    Although we appreciate the comments that were received regarding 
the seven high-volume codes, we believe that the nominator presented 
some concerns that have merit, such as the observation that in many 
cases time is reduced substantially but the work RVU only minimally, 
which results in an implied increase in the intensity of work that does 
not appear to be valid, and ultimately creates work intensity anomalies 
that are difficult to defend, and further review of these high-volume 
codes is the best way to determine the validity of the concerns 
articulated by the submitter. Therefore, we are adding CPT codes 27130, 
27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially 
misvalued codes and anticipate reviewing recommendations from the RUC 
and other stakeholders. We reiterate that we do not believe that the 
inclusion of a code on a potentially misvalued code list necessarily 
means that a particular code is misvalued. Instead, the list is 
intended to prioritize codes to be reviewed under the misvalued code 
initiative.
    In addition to comments on the nomination of the seven high-volume 
codes, we also received comments on the nomination of two contractor-
priced codes for review under the potentially misvalued code 
initiative.
    Comment: We received a few comments with regard to CPT codes 92992 
and 92993, which were requested for review under the potentially 
misvalued code initiative in order to establish national RVU values for 
these services under the PFS. One of the commenters, the RUC, stated 
that these contractor-priced services, which are typically performed on 
children, would be discussed at the October 2018 Relativity Assessment 
Workgroup meeting.
    Response: We appreciate the information from the RUC on their plans 
to discuss these codes. Given the plans by the RUC to consider CPT 
codes 92992 and 92993 we will wait for the RUC's review and will not 
add these codes to the list of potentially misvalued codes.
b. Update on the Global Surgery Data Collection
    Payment for postoperative care is currently bundled within 10 or 90 
days after many surgical procedures. Historically, we have not 
collected data on how many postoperative visits are actually performed 
during the global period. Section 523 of the MACRA added a new 
paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS 
to use notice and comment rulemaking to implement a process to collect 
data on the number and level of postoperative visits and use these data 
to assess the accuracy of global surgical package valuation. In the CY 
2017 PFS final rule, we adopted a policy to collect postoperative visit 
data. Beginning July 1, 2017, we required practitioners in groups with 
10 or more practitioners in nine states (Florida, Kentucky, Louisiana, 
Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to 
use the no-pay CPT code 99024 (Postoperative follow-up visit, normally 
included in the surgical package, to indicate that an E/M service was 
performed during a postoperative period for a reason(s) related to the 
original procedure) to report postoperative visits. Practitioners who 
only practice in groups with fewer than 10 practitioners are exempted 
from required reporting, but are encouraged to report if feasible. The 
293 procedures for which reporting is required are those 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. A list of the procedures for which reporting is 
required is updated annually to reflect any coding changes and is 
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.
    In these nine states, from July 1, 2017 through December 31, 2017, 
there were 990,581 postoperative visits reported using CPT code 99024. 
Of the 32,573 practitioners who furnished at least one of the 293 
procedures during this period and who, based on Tax Identification 
Numbers in claims data, were likely to meet the practice size 
threshold, only 45 percent reported one or more visit using CPT code 
99024 during this 6-month period. The share of practitioners who 
reported any CPT code 99024 claims varied by specialty. Among surgical 
oncology, hand surgery, and orthopedic surgeons, reporting rates were 
92, 90, and 87 percent, respectively. In contrast, the reporting rate 
for emergency medicine physicians was 4 percent.
    Among 10-day global procedures performed from July 1, 2017 through 
December 31, 2017, where it is possible to clearly match postoperative 
visits to specific procedures, only 4 percent had one or more matched 
visit reported with CPT code 99024. The percentage of 10-day global 
procedures with a matched visit reported with CPT code 99024 varied by 
specialty. Among procedures with 10-day global periods performed by 
hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23 
percent, respectively, of procedures had a matched visit reported using 
CPT code 99024. In contrast, less than 5 percent of 10-day global 
procedures performed by many other specialties had a matched visit 
reported using CPT code 99024. Among 90-day global procedures performed 
from July 1, 2017 through December 31, 2017, where it is possible to 
clearly match postoperative visits to specific procedures, 67 percent 
had one or more matched visits reported using CPT code 99024.
    In the CY 2019 PFS proposed rule, we suggested one potential 
explanation for

[[Page 59504]]

these findings is that many practitioners are not consistently 
reporting postoperative visits using CPT code 99024. We sought comment 
on how to encourage reporting to ensure the validity of the data 
without imposing undue burden. Specifically, we sought comment on 
whether we need to do more to make practitioners aware of their 
obligation and whether we should consider implementing an enforcement 
mechanism.
    We sought comment on several other issues. Given the very small 
number of postoperative visits reported using CPT code 99024 during 10-
day global periods, we sought comment on whether or not it might be 
reasonable to assume that many visits included in the valuation of 10-
day global packages are not being furnished, or whether there are 
alternative explanations for what could be a significant level of 
underreporting of postoperative visits. Alternatively, we sought 
comment on whether it is possible that some or all of the postoperative 
visits are occurring after the global period ends and are, therefore, 
reported and paid separately.
    We sought comment on whether we should consider requiring use of 
modifiers -54 and -55 in cases where the surgeon does not expect to 
perform the postoperative visits, regardless of whether or not the 
transfer of care is formalized. We also sought comment on the best 
approach to 10-day global codes for which the preliminary data suggest 
that postoperative visits are rarely performed by the practitioner 
reporting the global code and whether we should consider changing the 
global period and reviewing the code valuation.
    The following is a summary of the comments we received on 
collecting data on global surgery and reporting.
    Comment: The majority of commenters, including the RUC, noted that 
more time was needed for physicians to become aware of reporting and 
prepare for reporting. Moreover, they opposed implementing an 
enforcement mechanism, but supported more efforts by CMS to make 
physicians aware of the requirement. A few commenters objected to 
reporting and noted that CMS had complied with the statute. MedPAC, 
which supported converting all 10- and 90-day global codes to 0-day 
global codes and revaluing these codes as 0-day codes, suggested that 
these findings are consistent with the OIG's three studies that showed 
post-operative visits were not occurring at the rate that we estimated. 
MedPAC noted support for converting all codes with 10- and 90-day 
global periods to 0-day global codes and revaluing these codes as 0-day 
codes, most other commenters were opposed to creating 0-day global 
services out of 10-day global services. Of those who commented on 
reporting of post-operative visits, most suggested that improving 
reporting of these visits is essential if the data is to be used to 
improve the accuracy of the existing codes.
    Response: We will evaluate the public comments received and 
consider whether to propose action at a future date. For the comment 
calling for additional efforts to make physicians aware of the 
requirement, we sent a letter describing the requirement to 
practitioners who are required to report in the 9 affected states and 
we plan to send another such letter to these practitioners. We will 
also consider other actions to make sure affected practitioners are 
aware of the requirement.

F. Radiologist Assistants

    In accordance with Sec.  410.32(b)(3), except as otherwise 
provided, all diagnostic X-ray and other diagnostic tests covered under 
section 1861(s)(3) of the Act and payable under the PFS must be 
furnished under at least a general level of physician supervision as 
defined in paragraph (b)(3)(i) of that regulation. In addition, some of 
these tests require either direct or personal supervision as defined in 
paragraphs (b)(3)(ii) or (iii) of Sec.  410.32, respectively. We list 
the required minimum physician supervision level for each diagnostic X-
ray and other diagnostic test service along with the codes and relative 
values for these services in the PFS Relative Value File, which is 
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.html. 
For most diagnostic imaging procedures, this required physician 
supervision level applies only to the technical component (TC) of the 
procedure.
    In response to the Request for Information on CMS Flexibilities and 
Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82 
FR 34172 through 34173), many commenters recommended that we revise the 
physician supervision requirements at Sec.  410.32(b) for diagnostic 
tests with a focus on those that are typically furnished by a 
radiologist assistant (RA) under the supervision of a physician. 
Specifically, the commenters stated that all diagnostic tests, when 
performed by RAs, can be furnished under direct supervision rather than 
personal supervision of a physician, and that we should revise the 
Medicare supervision requirements so that when RAs conduct diagnostic 
imaging tests that would otherwise require personal supervision, they 
only need to do so under direct supervision. In addition to increasing 
efficiency, stakeholders suggested that the current supervision 
requirements for certain diagnostic imaging services unduly restrict 
RAs from conducting tests that they are permitted to do under current 
law in many states.
    After consideration of these comments on the RFI, as well as 
information provided by stakeholders, we proposed to revise our 
regulations to specify that all diagnostic imaging tests may be 
furnished under the direct supervision of a physician when performed by 
an RA in accordance with state law and state scope of practice rules. 
Stakeholders representing the radiology community have provided us with 
information showing that the RA designation includes registered 
radiologist assistants (RRAs) who are certified by The American 
Registry of Radiologic Technologists, and radiology practitioner 
assistants (RPAs) who are certified by the Certification Board for 
Radiology Practitioner Assistants. We proposed to revise our regulation 
at Sec.  410.32 to add a new paragraph (b)(4) to state that diagnostic 
tests performed by an RRA or an RPA require only a direct level of 
physician supervision, when permitted by state law and state scope of 
practice regulations. We noted that for diagnostic imaging tests 
requiring a general level of physician supervision, this proposal would 
not change the level of physician supervision to direct supervision. 
Otherwise, the diagnostic imaging tests must be performed as specified 
elsewhere under Sec.  410.32(b). We based this proposal on 
recommendations from the practitioner community that included specific 
recommendations on how to implement the change. Representatives of the 
practitioner community submitted information on the education and 
clinical experience of RAs, which we took into consideration in 
determining whether the proposal would pose a significant risk to 
patient safety, and we determined that it would not. In addition, we 
considered information provided by stakeholders that indicated that 28 
states have statutes or regulations that recognize RAs, and these 
states have general or direct supervision requirements for RAs.
    Comment: Many commenters supported our proposed changes to the 
regulations and stated that they agreed that diagnostic tests performed 
by RAs be performed under at most direct supervision rather than 
personal

[[Page 59505]]

supervision where permitted by state law and state scope of practice 
regulations. According to these commenters, the change would allow for 
greater efficiency, improved patient access, more dedicated time with 
patients, increased quality of care, and increased patient 
satisfaction.
    Response: We appreciate the comments received in support of this 
proposal. As discussed in the proposed rule, for diagnostic imaging 
tests requiring a general level of physician supervision, we are not 
changing the level of physician supervision to direct supervision. 
Otherwise, the diagnostic imaging tests must be performed as specified 
elsewhere under Sec.  410.32(b). In order to provide further clarity, 
we are modifying the regulation to clarify that diagnostic tests 
performed by an RRA who is certified and registered by the American 
Registry of Radiologic Technologists or an RPA who is certified by the 
Certification Board for Radiology Practitioner Assistants, and that 
would otherwise require a personal level of supervision as specified in 
Sec.  410.32(b)(3), may be furnished under a direct level of physician 
supervision to the extent permitted by state law and state scope of 
practice regulations.
    Comment: Many commenters requested that CMS ensure that the 
proposed policy be effective January 1, 2019 by providing any necessary 
administrative guidance. Many commenters requested that CMS clarify in 
its final regulation that all services within the RA scope of practice, 
including procedures, may be performed under direct supervision.
    Response: In implementing these changes to the regulation, we will 
be updating guidance contained in Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 23 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/Pub100_23.html). Medicare supervision rules are only 
directly applicable to diagnostic tests, not procedures. We note that 
for procedures provided by auxiliary personnel (such as a radiologist 
assistant) incident to the services of the billing physician or 
practitioner, Medicare generally requires direct supervision in 
accordance with the regulation at Sec.  410.26(b)(5).
    Comment: One commenter suggested that CMS require verbal assurances 
to patients as to the credentials of the health care professional 
conducting the procedure, when the procedure is performed by an RA. The 
commenter stated that requiring this verbal assurance will minimize 
confusion about who the physician is when there are multiple 
individuals furnishing the procedure.
    Response: We believe such a requirement would be unwarranted and 
overly restrictive. We do not generally require practitioners to 
provide such assurances to Medicare beneficiaries, nor did we propose 
such a requirement in the proposed rule.
    Comment: Several commenters suggested that CMS should 
operationalize the proposal starting January 1, 2019 by using a 
radiologist supervision indicator to recognize the RA under direct 
supervision rather than personal supervision when they provide Medicare 
services under their state scope of practice. These commenters 
requested the creation of a new supervision indicator that would be 
applied to specific codes and would indicate that the procedure may be 
performed under the direct supervision of a radiologist when performed 
by an RRA who is certified by The American Registry of Radiologic 
Technologists, and an RPA who is certified by the Certification Board 
for Radiology Practitioner Assistants.
    Response: Our approach to effectuating this policy change was based 
on recommendations we received from the practitioner community. Under 
this approach, we allow for direct supervision for tests performed in 
part by an RA, which avoids the need to identify which CPT codes would 
be appropriate for inclusion under a new indicator. We believe our 
approach offers the most flexibility, ease of implementation, and 
subsequently reduces burden for billing practitioners and radiologist 
assistants.
    After consideration of the public comments received, we are 
finalizing, with refinements for further clarity, our proposed 
revisions to Sec.  410.32, by adding a new paragraph (b)(4) that states 
that diagnostic tests that are performed by a registered radiologist 
assistant (RRA) who is certified and registered by the American 
Registry of Radiologic Technologists or a radiology practitioner 
assistant (RPA) who is certified by the Certification Board for 
Radiology Practitioner Assistants, and that would otherwise require a 
personal level of supervision as specified in paragraph (3), may be 
furnished under a direct level of physician supervision to the extent 
permitted by state law and state scope of practice regulations.

G. Payment Rates Under the Medicare PFS for Nonexcepted Items and 
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments 
of a Hospital

1. Background
    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that 
certain items and services furnished by certain off-campus provider-
based departments (PBDs) (collectively referenced here as nonexcepted 
items and services furnished by nonexcepted off-campus PBDs) shall not 
be considered covered outpatient department (OPD) services for purposes 
of payment under the Hospital Outpatient Prospective Payment System 
(OPPS), and payment for those nonexcepted items and services furnished 
on or after January 1, 2017 shall be made under the applicable payment 
system under Medicare Part B if the requirements for such payment are 
otherwise met. These requirements were enacted in section 603 of the 
Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 
2015).
    In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule 
with comment period (81 FR 79699 through 79719), we established several 
policies and provisions to define the scope of nonexcepted items and 
services in nonexcepted off-campus PBDs. We also finalized the PFS as 
the applicable payment system for most nonexcepted items and services 
furnished by nonexcepted off-campus PBDs. At the same time, we issued 
an interim final rule with comment period (81 FR 79720 through 79729) 
in which we established payment policies under the PFS for nonexcepted 
items and services furnished on or after January 1, 2017. In the 
following paragraphs, we summarize the policies that we adopted for CY 
2017 and CY 2018. We also summarize proposals for CY 2019, respond to 
public comments, and finalize payment policies for CY 2019. For issues 
related to the excepted status of off-campus PBDs or the excepted 
status of items and services, please see the CY 2019 OPPS/ASC final 
rule.
2. Payment Mechanism
    In establishing the PFS as the applicable payment system for most 
nonexcepted items and services in nonexcepted off-campus PBDs under 
sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that 
there was no technological capability, at least in the near term, to 
allow off-campus PBDs to bill under the PFS for those nonexcepted items 
and services. Off-campus PBDs bill under the OPPS for their services on 
an institutional claim,

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while physicians and other suppliers bill under the PFS on a 
practitioner claim. The two systems that process these different types 
of claims, the Fiscal Intermediary Standard System (FISS) and the 
Multi-Carrier System (MCS) system, respectively, were not designed to 
accept or process claims of a different type. To permit an off-campus 
PBD to bill directly under a different payment system than the OPPS 
would have required significant changes to these complex systems as 
well as other systems involved in the processing of Medicare Part B 
claims. Consequently, we proposed and finalized a policy for CY 2017 
and CY 2018 in which nonexcepted off-campus PBDs continue to bill for 
nonexcepted items and services on the institutional claim utilizing a 
new claim line modifier ``PN'' to indicate that an item or service is a 
nonexcepted item or service.
    We implemented requirements under section 1833(t)(1)(B) of the Act 
for CY 2017 and CY 2018 by applying an overall downward scaling factor, 
called the PFS Relativity Adjuster to payments for nonexcepted items 
and services furnished in nonexcepted off-campus PBDs. The PFS 
Relativity Adjuster generally reflects the average (weighted by claim 
line volume times rate) of the site-specific rate under the PFS 
compared to the rate under the OPPS (weighted by claim line volume 
times rate) for nonexcepted items and services furnished in nonexcepted 
off-campus PBDs. As we have discussed extensively in prior rulemaking 
(81 FR 97920 through 97929 and 82 FR 53021), we established a new set 
of site-specific payment rates under the PFS that reflect the relative 
resource cost of furnishing the technical component (TC) of services 
furnished in nonexcepted off-campus PBDs. For the majority of HCPCS 
codes, these rates are based on either (1) the difference between the 
PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or 
(3) in instances where payment would have been made only to the 
facility or to the physician, the full nonfacility rate. The PFS 
Relativity Adjuster refers to the percentage of the OPPS payment amount 
paid under the PFS for a nonexcepted item or service to the nonexcepted 
off-campus PBD.
    To operationalize the PFS Relativity Adjuster as a mechanism to pay 
for nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, we adopted the packaging payment rates and multiple procedure 
payment reduction (MPPR) percentage that applies under the OPPS. We 
also incorporated the claims processing logic that is used for payments 
under the OPPS for comprehensive Ambulatory Payment Classifications (C-
APCs), conditionally and unconditionally packaged items and services, 
and major procedures. As we noted in the CY 2017 PFS final rule (82 FR 
53024), we believe that this maintains the integrity of the cost-
specific relativity of current payments under the OPPS compared with 
those under the PFS.
    In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent 
of the OPPS rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 50 percent for CY 2017, 
including assumptions and exclusions, we refer readers to the CY 2017 
OPPS/ASC interim final rule with comment period (81 FR 79720 through 
79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of 
40 percent of the OPPS rate. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 40 percent, we refer readers 
to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief 
overview of the general approach we took for CY 2018 and how it differs 
from the proposal for CY 2019 appears in this section.
3. The PFS Relativity Adjuster
    The PFS Relativity Adjuster reflects the overall relativity of the 
applicable payment rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs under the PFS compared with the rate under 
the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did 
not have all of the claims data needed to identify the mix of items and 
services that would be billed using the ``PN'' modifier. Instead, we 
analyzed hospital outpatient claims data from January 1 through August 
25, 2016, that contained the ``PO'' modifier, which was a new mandatory 
reporting requirement for CY 2016 for claims that were billed by an 
off-campus department of a hospital. We limited our analysis to those 
claims billed on the 13X Type of Bill because those claims were used 
for Medicare Part B billing under the OPPS. We then identified the 25 
most frequently billed major codes that were billed by claim line; that 
is, items and services that were separately payable or conditionally 
packaged. Specifically, we restricted our analysis to codes with OPPS 
status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', 
``T'', or ``V''. The most frequently billed service with the ``PO'' 
modifier in CY 2016 was described by HCPCS code G0463 (Hospital 
outpatient clinic visit for the assessment and management of a 
patient), which, in CY 2016, was paid under APC 5012 at a rate of 
$102.12; the total number of claim lines for this service was 
approximately 6.7 million as of August 2016. Under the PFS, there are 
10 CPT codes describing different levels of office visits for new and 
established payments. We compared the payment rate under OPPS for HCPCS 
code G0463 ($102.12) to the average of the difference between the 
nonfacility and facility rates for CPT code 99213 (Level III office 
visit for an established patient) and CPT code 99214 (Level IV office 
visit for an established patient) in CY 2016 and found that the 
relative payment difference was approximately 22 percent. We did not 
include HCPCS code G0463 in our calculation of the PFS Relativity 
Adjuster for CY 2017 because we were concerned that there was no 
single, directly comparable code under the PFS. As we stated in the CY 
2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of 
underestimating the overall relativity between the PFS and OPPS rates. 
From the remaining top 24 most frequently billed codes, we excluded 
HCPCS code 36591 (Collection of blood specimen from a completely 
implantable venous access device) because, under PFS policies, the 
service was only separately payable under the PFS when no other code 
was on the claim. We also removed HCPCS code G0009 (Administration of 
Pneumococcal Vaccine) because there was no payment for this code under 
the PFS. For the remaining top 22 codes furnished with the ``PO'' 
modifier in CY 2016, the average (weighted by claim line volume times 
rate) of the nonfacility payment rate estimate for the PFS compared to 
the estimate for the OPPS was 45 percent. We indicated that, because of 
our inability to estimate the effect of the packaging difference 
between the OPPS and the PFS, we would assume a 5 percentage point 
adjustment upward from the calculated amount of 45 percent; therefore, 
we established the PFS Relativity Adjuster of 50 percent for CY 2017.
    In establishing the PFS Relativity Adjuster for CY 2018, we still 
did not have claims data for items and services furnished reported with 
a ``PN'' modifier. However, we updated the list of the 25 most 
frequently billed HCPCS codes using an entire year (CY 2016) of claims 
data for services submitted with a ``PO'' modifier and we updated the 
corresponding utilization weights for the codes used in the analysis. 
The order and composition of the top 25 separately payable HCPCS codes, 
based on the full year of claims from CY 2016

[[Page 59507]]

submitted with the ``PO'' modifier, changed minimally from the codes we 
used in our original analysis for the CY 2017 OPPS/ASC interim final 
rule with comment period. For a detailed list of the HCPCS codes we 
used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018 
PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule 
(82 FR 53030 through 53031). As noted earlier, in establishing the PFS 
Relativity Adjuster of 50 percent for CY 2017, we did not include in 
the weighted average code comparison, the relative rate for the most 
frequently billed service furnished in off-campus PBDs, HCPCS code 
G0463 (Hospital outpatient clinic visit for assessment and management 
of a patient), in part to ensure that we were not underestimating the 
overall relativity between the PFS and the OPPS. In contrast, in the CY 
2018 PFS final rule, we stated that our objective for CY 2018 was to 
ensure that we did not overestimate the appropriate overall payment 
relativity, and that the payment made to nonexcepted off-campus PBDs 
better aligned with the services that are most frequently furnished in 
the setting. Therefore, in addition to using updated claims data, we 
revised the PFS Relativity Adjuster to incorporate the relative payment 
rate for HCPCS code G0463 into our analysis. We followed all other 
exclusions and assumptions that were made in calculating the CY 2017 
PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative 
difference in payment rates. Similar to our stated rationale in the CY 
2017 PFS final rule, we increased the PFS Relativity Adjuster to 40 
percent, acknowledging the difficulty of estimating the effect of the 
packaging differences between the OPPS and the PFS.
4. Payment Policies for CY 2019
    In prior rulemaking, we stated our expectation that our general 
approach of adjusting OPPS payments using a single scaling factor, the 
PFS Relativity Adjuster, would continue to be an appropriate payment 
mechanism to implement provisions of section 603 of the Bipartisan 
Budget Act of 2015, and would remain in place until we are able to 
establish code-specific reductions that represent the TC of services 
furnished under the PFS or until we are able to implement system 
changes needed to enable nonexcepted off-campus PBDs to bill for 
nonexcepted items and services under the PFS directly (82 FR 53029). As 
we continue to explore alternative options related to requirements 
under section 1833(t)(21)(C) of the Act, we believed that this overall 
approach is still appropriate, and we are finalizing our proposal to 
continue to allow nonexcepted off-campus PBDs to bill for nonexcepted 
items and services on an institutional claim using a ``PN'' modifier 
until we identify a workable alternative mechanism to improve payment 
accuracy.
    We made several adjustments to our methodology for calculating the 
PFS Relativity Adjuster for CY 2019. Most importantly, we had access to 
a full year of claims data from CY 2017 for services submitted with the 
``PN'' modifier. Incorporating these data allows us to improve the 
accuracy of the PFS Relativity Adjuster by accounting for the specific 
mix of nonexcepted items and services furnished in nonexcepted off-
campus PBDs. In analyzing the CY 2017 claims data, we identified just 
under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs 
reported in CY 2017 with status indicators ``J1'', ``J2'', ``Q1'', 
``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The data reinforce our previous 
observation that the single most frequently reported service furnished 
in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half 
of all claim lines for separately payable or conditionally packaged 
services furnished by nonexcepted off-campus PBDs included HCPCS code 
G0463 in CY 2017, representing over 30 percent of total Medicare 
payments for separately payable or conditionally packaged services. The 
top 30 HCPCS/SI code combinations accounted for over 80 percent of all 
claim lines and approximately 70 percent of Medicare payments for 
services that are separately billable or conditionally packaged. In 
contrast with prior analyses, we also looked at claims units, which 
reflect HCPCS/SI code combinations that are billed more than once on a 
claim line. Certain HCPCS codes are much more frequently billed in 
multiple units than others. The largest differences between the number 
of claim lines and the number of claims units are for injections and 
immunizations, which are not typically separately payable or 
conditionally packaged under the OPPS. For instance, HCPCS code Q9967 
(Low osmolar contrast material, 300-399 mg/ml iodine concentration, per 
ml) was reported in 12,268 claim lines, but 1,168,393 times (claims 
units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator 
of ``N'', meaning that there is no separate payment under OPPS (items 
and services are packaged into APC rates). To calculate the PFS 
Relativity Adjuster using the full range of claims data submitted with 
a ``PN'' modifier in CY 2017, we first established site-specific rates 
under the PFS that reflect the TC of items and services furnished by 
nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect 
our best current estimate of the amount that would have been paid for 
the service in the office setting under the PFS for practice expenses 
(PEs) not associated with the professional component (PC) of the 
service. As discussed in prior rulemaking (81 FR 79720 through 79729), 
we believe the most appropriate code-level comparison would reflect the 
TC of each HCPCS code under the PFS. However, we do not currently 
calculate a separate TC rate for all HCPCS codes under the PFS--only 
for those for which the PC and TC of the service are distinct and can 
be separately billed by two different practitioners or other suppliers 
under the PFS. For most of the remainder of services that do not have a 
separately payable TC under the PFS, we estimated the site-specific 
rate as (1) the difference between the PFS nonfacility rate and the PFS 
facility rate, or (2) in instances where payment would have been made 
only to the facility or only to the physician, the full nonfacility 
rate. As with the PFS rates that we developed when calculating the PFS 
Relativity Adjuster for CY 2017 and CY 2018, there were large code-
level differences between the applicable PFS rate and the OPPS rate.
    In calculating the proposed PFS Relativity Adjuster for CY 2019, we 
employed the same fundamental methodology that we used to calculate the 
PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting 
our analysis to the items and services billed in CY 2017 with a ``PN'' 
modifier that are separately payable or conditionally packaged under 
the OPPS (status indicator = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', 
``S'', ``T'', or ``V'') and compared the rates for these codes under 
the OPPS with the site-specific rates under the PFS. Next, we imputed 
PFS rates for a limited number of items and services that are 
separately payable or conditionally packaged under the OPPS but are 
contractor priced under the PFS. We also imputed PFS rates for some 
HCPCS codes that are not separately payable under the OPPS (SI = 
``N''), but are separately payable under the PFS. This includes items 
and services with an indicator status of ``X'' under the PFS, which are 
statutorily excluded from payment under the PFS, but may be paid under 
a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS). 
We summed the HCPCS-level

[[Page 59508]]

rates under the PFS across all nonexcepted items and services, weighted 
by the number of HCPCS code claims units for each service. Next, we 
calculated the sum of the HCPCS-level OPPS rate for items and services 
that are separately payable or conditionally packaged, also weighted by 
the number of HCPCS code claims units. We compared the weighted sum of 
the site-specific PFS rate with the weighted sum of the OPPS rate for 
items and services reported in CY 2017 and we found that our updated 
analysis supports maintaining a PFS Relativity Adjuster of 40 percent. 
In view of this analysis, we proposed to continue applying a PFS 
Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to 
maintain this PFS Relativity Adjuster for future years until updated 
data or other considerations indicate that an alternative adjuster or a 
change to our approach is warranted, which we will then propose through 
notice and comment rulemaking. We discuss some of our ongoing data 
analyses and future plans regarding implementation of section 603 of 
the Bipartisan Budget Act of 2015 in this section.
    Comment: Several commenters were disappointed that CMS did not 
provide the same level of detail regarding the data and methodology 
used in calculating the PFS Relativity Adjuster for CY 2019 as we had 
in prior rulemaking (CY 2017 and CY 2018). In particular, these 
commenters noted that we had previously included specific HCPCS codes 
that comprised the top 25 reported, the number of claims lines for each 
HCPCS code, and the associated PFS payment rates we used to estimate 
the appropriate adjuster. Some commenters maintained that the lack of 
specific HCPCS codes and associated PFS payment rates prevented them 
from replicating our analysis and commenting on the merits of 
maintaining the 40 percent PFS Relativity Adjuster.
    Response: We understand and appreciate commenters' interest in 
replicating our analysis using the full set of claims data and PFS 
payment rates we used to conduct our analysis. However, we do not agree 
that commenters were not able to conduct their own analysis for 
purposes of evaluating our proposal. The principal data sources in the 
analysis are the OPPS CY 2017 rates, the CY 2017 PFS rates, and 
institutional claims data for items and services furnished in CY 2017 
that included the ``PN'' modifier, which are publicly available 
resources. We did not receive specific inquiries indicating that 
commenters tried to reproduce our results using these data sources (or 
other data sources), nor did we receive any specific alternatives for 
consideration. As we noted in the proposed rule, the methodological 
aspects of our proposed PFS Relativity Adjuster calculation for CY 2019 
differ from the calculation for CY 2017 and CY 2018 by the following 
two adjustments: (1) Development of site specific technical-equivalent 
rates under the PFS for all HCPCS codes reported on a claim with the 
``PN'' modifier in CY 2017; and (2) the addition of OPPS SI ``N'' 
claims data to the PFS component of the PFS Relativity Adjuster 
equation to reflect items and services that are packaged under OPPS but 
paid separately under the PFS. We imputed certain PFS rates, such as 
for codes that are contractor priced under the PFS, because those would 
be paid at the contractor price if the claim had been submitted in a 
freestanding office. We remind commenters that adding PFS rates to the 
analysis, where such rates would not have otherwise been included, has 
the effect of increasing the PFS Relativity Adjuster since the 
aggregate PFS payment amount increases relative to the aggregate OPPS 
payment amount. Nonetheless, we appreciate the commenters' interest in 
validating the results of our analysis. For the convenience of 
commenters wishing to conduct analysis of differences in payment rates 
between off-campus PBDs and freestanding offices for similar services, 
we are providing a public use file (PUF), available on the CMS website 
under the ``downloads'' section for this final rule containing the CY 
2017 PFS technical-equivalent payment rates for all HCPCS codes 
reported on an institutional claim with the ``PN'' modifier, as well as 
the OPPS payment rate and the number of claims units by OPPS SI (see 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched).
    Comment: Commenters posed specific questions about our PFS 
Relativity Adjuster calculations and requested that CMS provide 
additional detail about the calendar year we used for OPPS and PFS 
rates, the specific HCPCS codes for which we imputed PFS rates, our 
rationale for weighting the data using claims units instead of claims 
lines, and if our analysis accounted for the more extensive packaging 
that occurs under the OPPS compared with the PFS.
    Response: Although we addressed much, if not all, of the 
information requested by these commenters in the discussion of our 
methodology in the proposed rule, we provide the following summary, 
along with additional detail on specific aspects of our analysis to 
respond explicitly to commenters' questions. We began our analysis to 
identify the proposed CY 2019 PFS Relativity Adjuster by examining a 
full year of claims data for services furnished in CY 2017 that were 
reported on an institutional claim form and appended with the ``PN'' 
modifier. Because claims processed through the institutional setting 
are adjudicated based on the OPPS SI, our unit of analysis was the 
number of claims units at the HCPCS/SI code level. We used claim units 
instead of claim lines because this metric accounts for instances when 
a HCPCS code is reported multiple times on the same claim line. We made 
this methodological change in formulating our proposal for CY 2019 in 
large part to address commenters' concerns from prior years that our 
calculations may underrepresent PFS payment for HCPCS codes that would 
have been paid multiple times under the PFS if they were reported 
separately. For the majority of HCPCS/SI code combinations that were 
reported with the ``PN'' modifier, there is little difference between 
the number of claim lines and claim units. However, because more units 
are separately paid under the PFS than under the OPPS, using claims 
units rather than claims lines yielded a slightly higher PFS Relativity 
Adjuster.
    For CY 2019, our proposed PFS Relativity Adjuster was based on all 
HCPCS codes that were submitted on an institutional claim form in CY 
2017, appended with the ``PN'' modifier in order to improve the 
accuracy of the overall payment comparison using the best data 
available regarding the actual mix of services furnished in nonexcepted 
off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a 
subset of claims from CY 2016 because of known limitations regarding 
the data available at the time. In particular, the data from CY 2016 
were based on claims that were appended with the ``PO'' modifier, which 
was a new reporting requirement for CY 2016. Although the ``PO'' 
modifier allowed us to distinguish items and services furnished in off-
campus PBDs in CY 2016, it did not allow us to distinguish between 
excepted and nonexcepted off-campus PBDs. The ``PN'' modifier, which 
was a new reporting requirement for CY 2017, allows us to make the 
distinction between excepted and nonexcepted off-campus PBDs.
    In updating our analysis for calculating the proposed PFS 
Relativity Adjuster for CY 2019 to include all HCPCS codes that were 
reported on an institutional claim with the ``PN'' modifier, we also 
extended to all HCPCS

[[Page 59509]]

codes our earlier logic with regard to calculating the site specific 
rates that represent the technical-equivalent of the resource costs of 
furnishing a service under the PFS. This amount, as we discussed in the 
proposed rule, generally reflected: (1) The difference between the PFS 
nonfacility payment rate and the PFS facility rate; (2) the TC; or (3) 
in instances where payment would have been made only to the facility or 
only to the physician, the full nonfacility rate. Applying the same 
logic to the fuller range of HCPCS codes, we developed site specific 
rates for all HCPCS codes that are nationally priced under the PFS and 
we referred to them as the technical-equivalent rates.
    To continue with our analysis, we combined the CY 2017 OPPS rates 
at the HCPCS code level with the CY 2017 claims data representing 
nonexcepted items and services furnished in nonexcepted off-campus 
PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS 
code, calculated using the approach described above. For both the OPPS 
and the PFS portions of the PFS Relativity Adjuster calculations, we 
weighted our analysis of HCPCS/SI code combinations by the number of 
claims units. For the OPPS component of the calculation, we restricted 
our analysis to HCPCS/SI code combinations that had OPPS SI indicators 
``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'', which 
are separately payable or conditionally packaged codes under the OPPS. 
We multiplied the number of claims units for each HCPCS/SI code 
combination by the OPPS rate for each HCPCS/SI code combination and 
summed across the weighted rates. To calculate the PFS component of the 
PFS Relativity Adjuster, we used the same OPPS/SI code combinations, 
but we also included claims for HCPCS codes with OPPS SI ``N'', which 
indicates that, under the OPPS, payment for these services is packaged 
into payment for other services. We multiplied the number of claims 
units for each HCPCS/SI code combination by the technical-equivalent 
PFS rate for each HCPCS code and summed across the HCPCS/SI code 
combinations. We believe that adding weighted rates for HCPCS codes 
with OPPS SI ``N'' to the PFS allows us to better adjust, although 
imprecisely, for the packaging under the OPPS of nonexcepted items and 
services for which separate payment would typically be made under the 
PFS in the office setting. Although we did not conduct code-level 
analysis to estimate packaging under the OPPS, we believe that the 
combination of using the full range of claims data for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs, using 
claim units rather than claim lines to weight rates on both the OPPS 
and PFS, and adding PFS rates for HCPCS codes with OPPS status 
indicator ``N'' is an improved approach to the PFS Relativity Adjuster 
that better accounts for OPPS packaging policies.
    To increase the precision of our analysis, we imputed payment rates 
under the PFS for certain HCPCS codes for which payment is based on 
rates other than national PFS pricing. For services that are 
contractor-priced under the PFS, as indicated by a PFS status indicator 
of ``C'', we applied the national median allowed charge for these 
services in CY 2017. For a limited number of other services, where 
appropriate, we incorporated rates from the applicable fee schedule 
under which the service may have been paid if furnished in a 
freestanding office. For instance, HCPCS codes with a PFS status 
indicator of either ``X'' (service is statutorily excluded for payment 
under PFS) or ``E'' (service is excluded from payment under PFS by 
regulation), may be paid under the CLFS or the National Limitation 
Amount (NLA). The imputed values that we used, both from contractor 
priced codes and other fee schedules, are included in the data file 
that will be posted with this final rule, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Although there remains a certain level of imprecision inherent in 
our analysis, we believe the margin of error is relatively small and 
would likely affect the PFS and OPPS amounts similarly. For instance, 
we did not take into account the several MPPRs that would reduce 
payment on the PFS side when multiple codes are billed together. In 
many cases, these codes are packaged under the OPPS, so not including 
the PFS MPPRs in our analysis has the effect of increasing the PFS 
component of the calculation by a marginal amount. Likewise, we 
recognize that because of existing packaging rules under the OPPS, 
there is likely to be underreporting of codes on institutional claims 
for which the hospital does not receive separate payment, but for which 
the practitioner might receive separate payment if furnished in a 
freestanding office and reported on a professional claim form. This 
would effectively reduce the PFS Relativity Adjuster, but only to the 
extent hospitals are not appropriately reporting furnished items and 
services.
    Comment: Many commenters expressed that the appropriate point of 
comparison for PFS technical-equivalent rates is the full nonfacility 
rate rather than the difference between the nonfacility rate and the 
facility rate. The commenters stated that since hospitals, like 
freestanding offices, incur both direct and indirect costs when 
services are furnished in nonexcepted off-campus PBDs, the difference 
between the nonfacility rate and the facility rate does not 
appropriately account for indirect costs incurred by the facility.
    Response: We believe the commenters misunderstood the methodology 
for allocating direct and indirect costs as part of the PFS ratesetting 
process. Under the PFS algorithm for allocating indirect costs, 
nonfacility PFS rates include indirect PE that is directly related to 
the resources associated with the professional portion of the service 
alone. In other words, this is the indirect PE that is also paid by 
Medicare to professionals like physicians when they report services in 
the hospital setting. In addition to these indirect PE RVUs, 
nonfacility PFS rates include indirect PE RVUs allocated based on the 
direct PE inputs. We believe these indirect costs, those associated 
with provision of the technical aspects of the service alone, are 
analogous to those incurred by facilities when professionals furnish 
services there. To be clear, even when the total nonfacility rates are 
reduced by the facility rates, there are remaining PE RVUs that result 
from both direct inputs and indirect allocations under the established 
PFS methodology. We agree with the commenters that nonexcepted off-
campus PBDs incur indirect costs, but we believe our calculation for 
the technical-equivalent PFS rates includes the relative resource costs 
of indirect expenses involved in furnishing the services. We also note 
that CMS makes corresponding payments under the PFS at the facility 
rate for nonexcepted items and services furnished in nonexcepted off-
campus PBD settings, meaning that CMS is already paying for some of the 
indirect expenses associated with the PCs of the service. If CMS were 
to use the full nonfacility PE RVUs as the basis for comparing PFS 
rates to OPPS rates, we would effectively be paying twice for a portion 
of indirect costs, once under the PFS for the PC of services and again 
through the PFS Relativity Adjusted payment under the OPPS to off-
campus PBDs for the facility part of the same service.
    We recognize that the process of allocating indirect costs under 
the PFS is built on assumptions about

[[Page 59510]]

organizational practices and healthcare payment structures that may not 
fully reflect the current health care delivery environment, especially 
where physicians and other professionals are paid under salaried 
arrangements by institutions such as hospitals. Under the current PFS 
payment methodology, we assume that indirect costs associated with 
professional services furnished in institutions like hospital PBDs are 
incurred by the individual practitioners and not by the institutions. 
We may consider this issue for future rulemaking.
    Comment: A commenter requested that CMS clarify how, in calculating 
the PFS Relativity Adjuster, CMS treated codes that are valued under 
the PFS only in a facility setting. Because these HCPCS codes do not 
have PE inputs reflecting the specific costs of furnishing a service in 
a freestanding office, the commenter stated concern that these codes 
may have been incorrectly incorporated in the analysis at a PFS payment 
rate of zero.
    Response: We appreciate the commenter's concern and the opportunity 
to clarify the way we treated services not priced in the nonfacility 
setting in calculating the PFS Relativity Adjuster. Because there are 
no PFS payment rates for these services in the nonfacility setting, we 
incorporated the OPPS rate as the technical equivalent rate under the 
PFS.
    Comment: Several commenters were opposed to our proposal to 
maintain the PFS Relativity Adjuster at 40 percent, citing both the 
lack of transparency in our methodology and prior analyses provided by 
the American Hospital Association (AHA) in earlier notice and comment 
rulemaking, suggesting that a 65 percent PFS Relativity Adjuster would 
appropriately incorporate into the Adjuster the additional packaging 
that occurs under the OPPS. Two commenters urged CMS to implement a 75 
percent PFS Relativity Adjuster for CY 2019, although no specific 
rationale was given.
    Response: We accounted for packaging under the OPPS by including 
PFS payment rates for HCPCS codes that were reported with OPPS SI 
``N''. Our analysis does not support a PFS Relativity Adjuster of 65 or 
75 percent, but rather indicates that a PFS Relativity Adjuster of 40 
percent appropriately accounts for packaging of services under the 
OPPS. For additional discussion of the challenges related to 
incorporating the effect of packaging into the PFS Relativity Adjuster, 
we refer readers to the CY 2018 PFS final rule (82 FR 53024 through 
53022).
    Comment: A commenter stated that CMS has not provided sufficient 
justification for continuation of a reduction in payment of 60 percent 
for nonexcepted items and services furnished in nonexcepted off campus 
PBDs. Commenters noted that the first 2017 claims from the initial 
period of implementation of this policy are only now being incorporated 
into CMS claims files. The commenter indicated that there is an 
insufficient volume of claims to determine the impact this policy is 
having on beneficiary access to services in the PBD setting, 
particularly at the 40 percent Relativity Adjuster. The commenter 
stated that CMS should, at minimum, restore the 50 percent PFS 
Relativity Adjuster that was in place for CY 2017.
    Response: We appreciate the commenter's suggestions, but we do not 
agree that there is insufficient data to support the PFS Relativity 
Adjuster of 40 percent. We have no reason to believe that the CY 2017 
claims data are not as robust as any other claims based analysis and, 
to the extent that we recognize, acknowledge, and try to account for 
difference in payment policies between the PFS and OPPS, we believe our 
analysis demonstrates that a PFS Relativity Adjuster of 40 percent is 
appropriate.
    Comment: Several commenters supported the 40 percent PFS Relativity 
Adjuster for CY 2019 and future years because this will provide 
stability for clinicians practicing in these settings and not disrupt 
patient access to care. One commenter cited the importance of making 
gradual changes to site neutrality policies to ensure alignment with 
other rapid changes in Medicare and the private sector regarding 
provider payment, including the movement to value-based purchasing and 
alternative payment systems.
    Response: We agree with the commenter that there is value in the 
stability of maintaining the PFS Relativity Adjuster at 40 percent, 
particularly to the extent that this enables continuity of care for 
beneficiaries. We appreciate the support from commenters.
    Comment: Some commenters, rather than opposing any particular PFS 
Relativity Adjuster, expressed disappointment that CMS did not propose 
to make broader changes to implement site-neutrality under section 603 
of the Bipartisan Budget Act of 2015. Commenters were displeased that 
CMS is continuing to implement the requirements of the legislation 
using a single scaling factor applied to payment rates under the OPPS. 
Instead, they stated CMS should revise the applicable payment rates to 
appropriately reimburse for services provided by off-campus PBDs. 
Commenters did not provide specific suggestions for implementing 
alternative policies, but several commenters noted that a single 
overall scaling factor was intended by CMS to be an interim, not a long 
term policy solution. A few commenters suggested that the PFS 
Relativity Adjuster as a mechanism for implementing section 603 of the 
Bipartisan Budget Act of 2015 is not consistent with the requirement 
under that section to pay for nonexcepted items and services under the 
applicable payment system because this approach is still fundamentally 
based on OPPS payment rates. Other commenters stated that nonexcepted 
off-campus PBDs differ from one another in the mix of services 
furnished and the beneficiary population and that CMS payment policies 
should reflect those variances.
    Despite concerns about the appropriateness of the PFS Relativity 
Adjuster for implementing requirements under section 603 of the 
Bipartisan Budget Act of 2015, several of the same commenters pointed 
out that there are significant advantages of continuing to allow 
hospitals to bill for items and services furnished in nonexcepted PBDs 
using the institutional claim form. In particular, they stated, this 
allows PBDs to properly use cost reporting procedures and to accurately 
reconcile the cost report to hospital ledgers for all services and 
departments and to correctly allow revenue for nonexcepted PBDs to flow 
through the Provider Statistical and Reimbursement (PS&R) report.
    Response: We previously expressed interest in exploring how 
hospitals might report and receive payment for nonexcepted items and 
services furnished in nonexcepted off-campus PBDs using the standard 
PFS payment rates based on HCPCS-specific RVUs. However, CMS does not 
currently develop as part of the PFS ratesetting process separate 
payment rates for the technical aspects of the full range of 
nonexcepted items and services furnished in nonexcepted off-campus PBDs 
specifically for services for which there are not separately valued PCs 
and TCs. As such, we do not have a consistent way for nonexcepted off-
campus PBDs and the professionals who furnish services in those 
settings to bill for the respective portions of the services for which 
they incurred costs. Additionally, while the statute was amended to 
change the nature and payment of nonexcepted items and services 
furnished in nonexcepted off-campus PBDs, the amendments did not

[[Page 59511]]

alter the status of non-excepted off-campus PBDs as parts of hospitals. 
Nonexcepted off-campus PBDs are still required to follow all reporting 
and regulatory policies consistent with hospital settings.
    We continue to explore options that would allow hospitals to report 
nonexcepted items and services on an institutional claim form but 
receive payments that more directly reflect the technical aspect of 
services under the PFS. In general, we believe there may be additional 
utility, especially in the context of improving price transparency for 
Medicare beneficiaries, in establishing and displaying a set of payment 
rates, recalculated annually as part of the annual PFS rulemaking 
cycle, that reflect the relative resource costs of the technical 
aspects of furnishing PFS services.
    Along with this final rule, we are including the technical-
equivalent rates that we developed specifically for calculating the PFS 
Relativity Adjuster for CY 2019, which is the current mechanism for 
implementing the PFS as the applicable payment system for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs. This 
information is being made available under the downloads section for 
this final rule on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Several commenters supported our ongoing efforts to 
implement site neutral payments in the context of section 603 of the 
Bipartisan Budget Act of 2015. Several commenters indicated their 
support for additional policies that would equalize payment across 
freestanding offices and hospital PBDs, both on-campus and off-campus.
    Response: We recognize that this is a topic of great interest to 
many commenters and we welcome the range of perspectives and ideas 
posed by commenters.
    Comment: Some commenters disagreed with our view that the 
amendments under section 603 of the Bipartisan Budget Act of 2015 were 
intended to produce site neutral payments between freestanding offices 
and off-campus PBDs with the goal of removing incentives for hospitals 
to purchase physician offices. These commenters noted that hospital 
PBDs face higher costs than freestanding offices, such as those 
associated with regulatory requirements, and reducing payment to 
nonexcepted off-campus PBDs threatens the viability of hospitals that 
serve a vital role in providing services to rural and underserved 
communities in these off-campus settings. We received several comment 
letters from Medicare beneficiaries expressing concern about reduced 
payments to their community's major medical hospital offsite locations. 
The commenters stated that without the hospital's offsite locations 
community members would be forced to drive unreasonable distances to 
seek basic and immediate care.
    Response: We understand the commenters' concerns, especially with 
regard to maintaining access to appropriate care. CMS continues to 
evaluate data regarding beneficiary access to care to identify possible 
issues. We also agree that hospitals face additional regulatory and 
operational costs not generally incurred by physician offices, and that 
OPDs of a hospital function as an important and integral part of the 
Medicare care delivery infrastructure. However, many off-campus PBDs 
are similar to physician's offices and do not necessarily have the same 
operational costs as the main hospital. We believe that the amendments 
made to the statute by section 603 of the Bipartisan Budget Act of 2015 
were intended to reduce Medicare payment incentives for hospitals to 
purchase physician offices, convert them to off-campus PBDs, and bill 
under the OPPS for items and services furnished there.
    Comment: Several commenters opposed our inclusion of the proposal 
related to payment for nonexcepted off-campus PBDs under the CY 2019 
PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that 
proposals related to the payment rate for nonexcepted items and 
services furnished in nonexcepted off-campus PBDs are inseparable from 
proposals and comment solicitations in the OPPS/ASC rule related to 
service line expansions and other payment policies related to 
implementation of the amendments under section 603 of the Bipartisan 
Budget Act of 2015. Some commenters suggested that, for purposes of 
administrative simplification, the discussion of any changes to site-
of-service payments regarding PBDs of a hospital should be fully 
maintained within a single rule and recommended this be included in the 
OPPS rule. Some commenters expressed concern that the PFS and OPPS 
proposed rules were not released at the same time and that this 
presents challenges for them in reconciling and preparing their 
comments on each rule.
    Response: We appreciate commenters' concerns about responding to 
two separate rules for policies associated with payment for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs. However, 
we note that in finalizing the PFS as the applicable payment system for 
most nonexcepted items and services, proposals related to the 
implementation of payment rates under the PFS fall reasonably under the 
purview of PFS rulemaking, while proposals related to the applicability 
of those rates are more appropriately addressed in OPPS/ASC rulemaking. 
We will consider these concerns for future rulemaking.
    We believe that our proposal to maintain the PFS Relativity 
Adjuster at 40 percent for CY 2019 and for future years reflects an 
analysis that accounts for many of the concerns expressed by commenters 
regarding the PFS Relativity Adjuster in prior rules. Therefore, we are 
finalizing the proposal to maintain the PFS Relativity Adjuster at 40 
percent for CY 2019 and beyond until there is an appropriate reason and 
process for implementing an alternative to our current policy, at which 
time we will make a proposal through notice and comment rulemaking.
5. Policies Related to Supervision, Beneficiary Cost-Sharing, and 
Geographic Adjustments
    In the CY 2018 PFS final rule (81FR 53019 through 53031), we 
finalized policies related to supervision rules, beneficiary cost 
sharing, and geographic adjustments. We finalized that supervision 
rules in nonexcepted off-campus PBDs that furnish nonexcepted items and 
services are the same as those that apply for hospitals, in general. We 
also finalized that all beneficiary cost sharing rules that apply under 
the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the 
Act continue to apply when payment is made under the PFS for 
nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we 
finalized the policy to apply the same geographic adjustments used 
under the OPPS to nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. We are maintaining these policies for CY 
2019, as finalized in the CY 2018 PFS final rule.
6. Partial Hospitalization
a. Partial Hospitalization Services
    Partial hospitalization programs (PHPs) are intensive outpatient 
psychiatric day treatment programs furnished to patients as an 
alternative to inpatient psychiatric hospitalization, or as a stepdown 
to shorten an inpatient stay and transition a patient to a less 
intensive level of care. Section

[[Page 59512]]

1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished 
by a hospital, to its outpatients, or by a community mental health 
center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in 
the discussion of the proposed implementation of section 603 of 
Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish 
PHP services and are ineligible to be provider-based to a hospital, a 
nonexcepted off-campus PBD would be eligible for PHP payment if the 
entity enrolls and bills as a CMHC for payment under the OPPS. We 
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and 
conditions of participation.
    In response to that rule, commenters expressed concern that without 
a clear payment mechanism for PHP services furnished by nonexcepted 
off-campus PBDs, access to partial hospitalization services would be 
limited, and pointed out the critical role PHPs play in the continuum 
of mental health care. Many commenters noted that the Congress did not 
intend for partial hospitalization services to no longer be paid for by 
Medicare when such services are furnished by nonexcepted off-campus 
PBDs. Several commenters disagreed with the notion of enrolling as a 
CMHC in order to receive payment for PHP services. The commenters 
stated that hospital-based PHPs and CMHCs are inherently different in 
structure, operation, and payment, and noted that the conditions of 
participation for hospital departments and CMHCs are different. Several 
commenters requested that CMS find a mechanism to pay hospital-based 
PHPs in nonexcepted off-campus PBDs.
    We agreed with the commenters' concerns and adopted payment for 
partial hospitalization items and services furnished by nonexcepted 
off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with 
comment period and interim final rule with comment period (81 FR 79715, 
79717, and 79727). When billed in accordance with the CY 2017 PFS final 
rule, these partial hospitalization services are paid at the CMHC per 
diem rate for APC 5853, for providing three or more partial 
hospitalization services per day (81 FR 79727).
    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), and the CY 
2017 OPPS/ASC final rule with comment period/interim final rule with 
comment period (81 FR 79717 and 79727), we noted that when a 
beneficiary receives outpatient services in an off-campus department of 
a hospital, the total Medicare payment for those services is generally 
higher than when those same services are provided in a physician's 
office. Similarly, when partial hospitalization services are provided 
in a hospital-based PHP, Medicare pays more than when those same 
services are provided by a CMHC. Our rationale for adopting the CMHC 
per diem rate for APC 5853 as the PFS payment amount for nonexcepted 
off-campus PBDs providing PHP services is because CMHCs are 
freestanding entities that are not part of a hospital, but they provide 
the same PHP services as hospital-based PHPs (81 FR 79727). This is 
similar to the differences between freestanding entities paid under the 
PFS that furnish other services also provided by hospital-based 
entities. Similar to other entities currently paid for their TC 
services under the PFS, we believe CMHCs would typically have lower 
cost structures than hospital-based PHPs, largely due to lower overhead 
costs and other indirect costs such as administration, personnel, and 
security. We believe that paying for nonexcepted hospital-based partial 
hospitalization services at the lower CMHC per diem rate aligns with 
section 603 of Bipartisan Budget Act of 2015, while also preserving 
access to PHP services. In addition, nonexcepted off-campus PBDs will 
not be required to enroll as CMHCs in order to bill and be paid for 
providing partial hospitalization services. However, a nonexcepted off-
campus PBD that wishes to provide PHP services may still enroll as a 
CMHC if it chooses to do so and meets the relevant requirements. 
Finally, we recognize that because hospital-based PHPs are providing 
partial hospitalization services in the hospital outpatient setting, 
they can offer benefits that CMHCs do not have, such as an easier 
patient transition to and from inpatient care, and easier sharing of 
health information between the PHP and the inpatient staff.
    In the CY 2018 PFS final rule, we did not require these PHPs to 
enroll as CMHCs but instead we continued to pay nonexcepted off-campus 
PBDs providing PHP items and services under the PFS. Further, in that 
CY 2018 PFS final rule (82 FR 53025 to 53026), we continued to adopt 
the CMHC per diem rate for APC 5853 as the PFS payment amount for 
nonexcepted off-campus PBDs providing three or more PHP services per 
day in CY 2018.
    For CY 2019, we proposed to continue to identify the PFS as the 
applicable payment system for PHP services furnished by nonexcepted 
off-campus PBDs, and proposed to continue to set the PFS payment rate 
for these PHP services as the per diem rate that will be paid to a CMHC 
in CY 2019. We further proposed to maintain these policies for future 
years until updated data or other considerations indicate that a change 
to our approach is warranted, which we will then propose through notice 
and comment rulemaking.
    We received no comments on our PHP proposals for CY 2019 and future 
years, and are finalizing our policies as proposed.
7. Future Years
    We continue to believe the amendments made by section 603 of the 
Bipartisan Budget Act of 2015 were intended to reduce the Medicare 
payment incentive for hospitals to purchase physician offices, convert 
them to off-campus PBDs, and bill under the OPPS for items and services 
they furnish there. Therefore, we continue to believe the payment 
policy under this provision should ultimately equalize payment rates 
between nonexcepted off-campus PBDs and physician offices to the 
greatest extent possible, while allowing nonexcepted off-campus PBDs to 
bill in a straight-forward way for services they furnish.
    In developing our proposal for CY 2019 as described previously, we 
incorporated all HCPCS codes that appeared in CY 2017 claims data from 
nonexcepted off-campus PBDs. We also expanded the number of site 
specific, technical-equivalent rates for nonexcepted items and services 
furnished in nonexcepted off-campus PBDs, in order to ensure that 
Medicare payment to hospitals billing for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs reflects the relative 
resources involved in furnishing the items and services. We recognize 
that for certain specialties, service lines, and nonexcepted off-campus 
PBDs, total Medicare payments for the same services might be either 
higher or lower when furnished by a nonexcepted off-campus PBD rather 
than in a physician office.
    We intend to continue to examine the claims data in order to assess 
whether a different PFS Relativity Adjuster is warranted and also to 
consider whether additional adjustments to the methodology are 
appropriate. In particular, we are monitoring claims for shifts in the 
mix of services furnished in nonexcepted off-campus PBDs that may 
affect the relativity between the PFS and OPPS. An increase over time 
in the share of nonexcepted items and services with lower technical-
equivalent rates under the PFS compared with APC rates

[[Page 59513]]

under the OPPS might result in a lower PFS Relativity Adjuster, for 
example. We will also carefully assess annual payment policy updates to 
the PFS and OPPS, respectively, to identify changes in overall 
relativity resulting from any new or modified policies, such as 
expanded packaging under the OPPS or an increase in the number of HCPCS 
codes with global periods under the PFS. As part of these ongoing 
efforts, we are also analyzing PFS claims data to identify patterns of 
services furnished together on the same day. We anticipate that this 
will ultimately allow us to make refinements to the PFS Relativity 
Adjuster to better account for the more extensive packaging of services 
under the OPPS and the potential underreporting of services that are 
not separately payable under the OPPS but are paid separately under the 
PFS.
    Another dimension of our ongoing efforts to improve implementation 
of section 603 of the Bipartisan Budget Act of 2015 is the development 
and refinement of a new set of payment rates under the PFS that reflect 
the relative resource costs of furnishing the TC of items and services 
furnished in nonexcepted off-campus PBDs. Although we believe that our 
site-specific HCPCS code-level rates reflect the best available 
estimate of the amount that would have been paid for the service in the 
office setting under the PFS for practice expenses not associated with 
the PC of the service, for the majority of HCPCS codes there is no 
established methodology for separately valuing the resource costs 
incurred by a provider while furnishing a service from those incurred 
exclusively by the facility in which the service is furnished. We 
continue to explore alternatives to our current estimates that would 
better reflect the TC of services furnished in nonexcepted off-campus 
PBDs. We are broadly interested in stakeholder feedback and 
recommendations for ways in which CMS can improve pricing and 
transparency with regard to the differences in the payment rates across 
sites of service.
    We expect that our continued analyses of claims data and our 
ongoing exploration of systems changes that are needed to allow 
nonexcepted off-campus PBDs to bill directly for the TC portion of 
nonexcepted items and services may lead us to consider a different 
approach for implementing section 603 of the Bipartisan Budget Act of 
2015. On the whole, however, we believe that a PFS Relativity Adjuster 
for CY 2019 of 40 percent advances efforts to equalize payment rates in 
the aggregate between physician offices and nonexcepted off-campus 
PBDs. Maintaining our policy of applying an overall scaling factor to 
OPPS payments allows hospitals to continue billing through a facility 
claim form and permits continued use of the packaging rules and cost 
report-based relative payment rate determinations for nonexcepted 
services.

H. 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 final rule, Potentially Misvalued Services under the PFS. 
Historically, when we received RUC recommendations, our process had 
been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule with comment period for a year. Then, during 
the 60-day period following the publication of the final rule with 
comment period, we 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, 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, 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, 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period, and re-proposed values for those codes in the CY 2017 PFS 
proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values. For CY 2017, we 
did not identify any new codes that described such wholly new services. 
Therefore, we did not establish any code values on an interim final 
basis.
    For CY 2018, we generally proposed the RUC-recommended work RVUs 
for new, revised, and potentially misvalued codes. We proposed these 
values based on our understanding that the RUC generally considers the 
kinds of concerns we historically raised regarding appropriate 
valuation of work RVUs. However, during our review of these recommended 
values, we identified some concerns similar to those we recognized in 
prior years. Given the relative nature of the PFS and our obligation to 
ensure that the RVUs reflect relative resource use, we included 
descriptions of potential alternative approaches we might have taken in 
developing work RVUs that differed from the RUC-recommended values. We 
sought comment on both the RUC-recommended values, as well as the 
alternatives considered. Several commenters generally supported the 
proposed use of the RUC-recommended work RVUs, without refinement. 
Other commenters expressed concern about the effect of the misvalued 
code reviews on particular specialties and settings and disappointment 
with our proposed

[[Page 59514]]

approach for valuing codes for CY 2018. A detailed summary of the 
comments and our responses can be found in the CY 2018 PFS final rule 
(82 FR 53033-53035).
    We clarified in response to commenters that we are not 
relinquishing our obligation to independently establish appropriate 
RVUs for services paid under the PFS. We will continue to thoroughly 
review and consider information we receive from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
federal government as part of our process for establishing valuations. 
Although generally proposing the RUC-recommended work RVUs for new, 
revised, and potentially misvalued codes was our approach for CY 2018, 
we note that we also included alternative values where we believed 
there was a possible opportunity for increased precision. We also 
clarified that as part of our obligation to establish RVUs for the PFS, 
we annually make an independent assessment of the available 
recommendations, supporting documentation, and other available 
information from the RUC and other commenters to determine the 
appropriate 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 will continue to 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 conducted 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 included, but had 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 assessed 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 used in the building block approach may have 
included 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 used 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 utilized 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 refined 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 adjusted 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 removed 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 removed a work RVU 
of 0.09 (4 minutes x 0.0224 IWPUT) if we did 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

[[Page 59515]]

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 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 used 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 believed that such changes in time were 
already accounted for in the RUC's recommendation, then we did not make 
such adjustments. Likewise, we did not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We used the ratios 
to identify potential work RVUs and considered 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 have believed 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, 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 is 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.
    Following the publication of the CY 2019 PFS proposed rule, we 
received several comments noting that there was some confusion in the 
terminology between ``reference services'' and ``crosswalks.'' 
Commenters stated that ``reference services'' are services indicated by 
the specialty society or the RUC as a good comparator that demonstrates 
relativity using magnitude estimation as requiring similar physician 
work, time, intensity and complexity. ``Key reference services'' are 
the top two services selected by the survey respondents as most similar 
to the code being surveyed. By contrast, ``crosswalks'' are services 
that have similar or exact intraservice time and require the same 
physician work (that is, have the same work RVU), and the term 
``crosswalk'' should only be used when making a comparison to a CPT 
code with the identical work RVU. The commenters noted that these terms 
were used interchangeably in the proposed rule when they have distinct 
and separate meanings.
    In response to the commenters, we would like to clarify that the 
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 final 
valuation considered for specific codes. Table 13 contains a list of 
codes for which we are finalizing work RVUs; this includes all codes 
for which we received RUC recommendations by February 10, 2018. The 
finalized work RVUs, work time and other payment information for all CY 
2019 payable codes are available on the CMS website under downloads for 
the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html). Table 13 also 
contains the CPT code descriptors for all new, revised, and potentially 
misvalued codes discussed in this section.

[[Page 59516]]

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 RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 14 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, we address several refinements that 
are common across codes, and refinements to particular codes are 
addressed in the portions of this section that are dedicated to 
particular codes. We note 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 $0.30 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 nearly half of the refinements 
listed in Table 14 result in changes under the $0.30 threshold and are 
unlikely to result in a change to the RVUs.
    We also note that the finalized direct PE inputs for CY 2019 are 
displayed in the CY 2019 direct PE input database, available on the CMS 
website under the 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 inputs 
displayed there have been used in developing the final CY 2019 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 final rule, Determination 
of Practice

[[Page 59517]]

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. Some recommendations, however, 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 2019, we received invoices for several new supply and 
equipment items. Tables 14 and 15 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final rule, 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.
    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 14 and 15 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 lists on 
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 
2019 are available 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. 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 74261-74263). 
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-
69662).
4. Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 
10007, 10008, 10009, 10010, 10011, 10012, 76492, 77002 and 77021)
    CPT code 10021 was identified as part of the OPPS cap payment 
proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC 
for direct PE inputs only as part of the CY 2016 rule cycle. 
Afterwards, CPT codes 10021 and 10022 were referred to the CPT 
Editorial Panel to consider adding additional clarifying language to 
the code descriptors and to include bundled imaging guidance due to the 
fact that imaging had become typical with these services. In June 2017, 
the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, 
and created nine new codes to describe fine needle aspiration 
procedures with and without imaging guidance. These ten codes were 
surveyed and reviewed for the October 2017 and January 2018 RUC 
meetings. Several imaging services were also reviewed along with the 
rest of the code family, although only CPT code 77021 was subject to a 
new survey.
    For CY 2019, we proposed the RUC-recommended work RVU for seven of 
the ten codes in this family. Specifically, we proposed a work RVU of 
0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging 
guidance; each additional lesion), a work RVU of 1.00 for CPT code 
10006 (Fine needle aspiration biopsy, including ultrasound guidance; 
each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine 
needle aspiration biopsy, including fluoroscopic guidance; first 
lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration 
biopsy, including fluoroscopic guidance; each additional lesion), and a 
work RVU of

[[Page 59518]]

1.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT 
guidance; each additional lesion). We also proposed to assign the 
recommended contractor-priced status to CPT codes 10011 (Fine needle 
aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine 
needle aspiration biopsy, including MR guidance; each additional 
lesion) due to low utilization until these services are more widely 
utilized. In addition, we proposed the recommended work RVU of 1.50 for 
CPT code 77021 (Magnetic resonance guidance for needle placement (e.g., 
for biopsy, fine needle aspiration biopsy, injection, or placement of 
localization device) radiological supervision and interpretation), as 
well as proposed to reaffirm the current work RVUs of 0.67 for CPT code 
76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine 
needle aspiration biopsy, injection, localization device), imaging 
supervision and interpretation) and 0.54 for 77002 (Fluoroscopic 
guidance for needle placement (e.g., biopsy, fine needle aspiration 
biopsy, injection, localization device)).
    We disagreed with the RUC-recommended work RVU of 1.20 for CPT code 
10021 (Fine needle aspiration biopsy; without imaging guidance; first 
lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to 
CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code 
36440 is a recently reviewed code with the same intraservice time of 15 
minutes and 2 additional minutes of total time. In reviewing CPT code 
10021, we noted that the recommended intraservice time is decreasing 
from 17 minutes to 15 minutes (12 percent reduction), and the 
recommended total time is decreasing from 48 minutes to 33 minutes (32 
percent reduction); however, the RUC-recommended work RVU is only 
decreasing from 1.27 to 1.20, which is a reduction of just over 5 
percent. Although we did not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be appropriately reflected in decreases to work RVUs. In 
the case of CPT code 10021, we believed that it was more accurate to 
propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to 
account for these decreases in the surveyed work time.
    We disagreed with the RUC-recommended work RVU of 1.63 for CPT code 
10005 (Fine needle aspiration biopsy, including ultrasound guidance; 
first lesion) and proposed a work RVU of 1.46. Although we disagreed 
with the RUC-recommended work RVU, we concurred that the relative 
difference in work between CPT codes 10021 and 10005 is equivalent to 
the recommended interval of 0.43 RVUs. Therefore, we proposed a work 
RVU of 1.46 for CPT code 10005, based on the recommended interval of 
0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code 
10021. The proposed increment of 0.43 RVUs above CPT code 10021 was 
also based on the use of two crosswalk codes: CPT code 99225 
(Subsequent observation care, per day, for the evaluation and 
management of a patient, which requires at least 2 of 3 key 
components); and CPT code 99232 (Subsequent hospital care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of 3 key components). Both of these codes have the same intraservice 
time and 1 additional minute of total time as compared with CPT code 
10005, and both crosswalk codes share a work RVU of 1.39.
    We disagreed with the RUC-recommended work RVU of 2.43 for CPT code 
10009 (Fine needle aspiration biopsy, including CT guidance; first 
lesion) and we proposed a work RVU of 2.26. Although we disagreed with 
the RUC-recommended work RVU, we concurred that the relative difference 
in work between CPT codes 10021 and 10009 is equivalent to the 
recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of 
2.26 for CPT code 10009, based on the recommended interval of 1.23 
additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. 
The proposed use of the recommended increment from CPT code 10021 was 
also based on the use of a crosswalk to CPT code 74263 (Computed 
tomographic (CT) colonography, screening, including image 
postprocessing), another CT procedure with 38 minutes of intraservice 
time and 50 minutes of total time at a work RVU of 2.28.
    We noted that the recommended work pool is increasing by 
approximately 20 percent for the Fine Needle Aspiration family as a 
whole, while the recommended work time pool for the same codes is only 
increasing by about 2 percent. Since time is defined as one of the two 
components of work, we believed that this indicated a discrepancy in 
the recommended work values. 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 recommended work values for all of the codes in this 
family. We believe that, generally speaking, the recoding of a family 
of services should maintain the same total work pool, as the services 
themselves are not changing, only the coding structure under which they 
are being reported. We also noted 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 will not be carrying out the 
full preservice work twice for CPT codes 10022 and 76942, but 
preservice times were assigned to both of the codes under the old 
coding. We believe the new coding assigns more accurate work times and 
thus reflects efficiencies in resource costs that existed regardless of 
how the services were previously reported.
    For the direct PE inputs, we proposed 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 for CPT code 
77021. This code did not previously have clinical labor time assigned 
for the ``Confirm order, protocol exam'' clinical labor task, and we do 
not have any reason to believe that the services being furnished by the 
clinical staff have changed, only the way in which this clinical labor 
time has been presented on the PE worksheets. We also noted 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 also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Fine Needle Aspiration family of codes.
    Comment: Several commenters disagreed with the CMS statement in the 
proposed rule that the RUC-recommended work pool was increasing by 
approximately 20 percent for this family of codes. Commenters stated 
that the work pool based on the RUC-recommended values would actually 
decrease by 15 percent and that the CMS work valuations were based on a 
flawed methodology that did not account for the associated savings with 
bundling the image guidance codes. One of the commenters supplied a 
table with data to support the claim that the work

[[Page 59519]]

pool based on the RUC-recommended values would decrease by 15 percent 
rather than increasing by 20 percent.
    Response: We disagree with the commenters that the work pool would 
decrease by 15 percent if we were to finalize the RUC recommendations. 
We investigated the data in the table submitted by the commenters, and 
we believe that there are several methodological flaws in the analysis 
it contains. First, there are a number of 0.00 work RVUs listed in the 
``RUC Recommended RVUs'' column for the new codes, which results in an 
incorrect amount of ``New/Rev Total RVUs'' when multiplied by the 
utilization for the new codes. As an example, CPT code 10005 has 
approximately 135,000 services that are counted as having a work RVU of 
0.00 in this table instead of the RUC-recommended work RVU of 1.63, 
which undercounts the total number of RVUs by a wide margin. Second, 
the values in the ``Total Source RVUs'' include the ratios from the 
utilization crosswalk (listed on the table as ``Percent''). We do not 
understand why these ratios would be used to calculate the total source 
RVUs, as this side of the work pool comparison is calculated from the 
utilization of the source codes times the work RVUs of the source 
codes. Third, the imaging guidance codes are not fully included in both 
sides of the comparison on this table, with their work RVUs included in 
the source RVU total but not in the new/revised RVU total. This uneven 
comparison results in an inaccurate tally of the work pools from before 
and after the coding revisions take place.
    In the interest of providing transparency, we are including Table 
12 with our work pool comparison for the Fine Needle Aspiration code 
family.

                                                  Table 12--Fine Needle Aspiration Work Pool Comparison
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Utilization   Utilization    Work RVU      Work pool     Work RVU      Work pool     Work pool    Work pool %
               HCPCS code                    source      destination     source        source      destination   destination   RVU change      change
--------------------------------------------------------------------------------------------------------------------------------------------------------
10021...................................        23,755        21,380          1.27        30,169          1.20        25,655        -4,513           -15
10004...................................             0         2,376          0.00             0          0.80         1,900         1,900  ............
10005...................................             0       270,753          0.00             0          1.63       441,327       441,327  ............
10006...................................             0        30,621          0.00             0          1.00        30,621        30,621  ............
10007...................................             0         6,857          0.00             0          1.81        12,411        12,411  ............
10008...................................             0           873          0.00             0          1.18         1,030         1,030  ............
10009...................................             0        60,665          0.00             0          2.43       147,416       147,416  ............
10010...................................             0         6,831          0.00             0          1.65        11,271        11,271  ............
10011...................................             0            83          0.00             0             C             0             0  ............
10012...................................             0             3          0.00             0             C             0             0  ............
10022...................................       186,455             0          1.27       236,798          0.00             0      -236,798          -100
76942...................................       558,081       488,321          0.67       373,914          0.67       327,175       -46,739           -13
7694226.................................       641,346       561,178          0.67       429,702          0.67       375,989       -53,713           -13
76942TC.................................         8,588         7,515          0.00             0          0.00             0             0  ............
77002...................................       311,280       308,790          0.54       168,091          0.54       166,746        -1,345            -1
7700226.................................       180,964       179,516          0.54        97,721          0.54        96,939          -782            -1
77002TC.................................         7,936         7,873          0.00             0          0.00             0             0  ............
77012...................................         9,343         7,792          1.16        10,838          1.50        11,688           850             8
7701226.................................       194,611       162,306          1.16       225,749          1.50       243,458        17,710             8
77012TC.................................           469           391          0.00             0          0.00             0             0  ............
77021...................................         1,481         1,432          1.50         2,222          1.50         2,148           -73            -3
7702126.................................         1,038         1,004          1.50         1,557          1.50         1,506           -51            -3
77021TC.................................            67            65          0.00             0          0.00             0             0  ............
                                         ---------------------------------------------------------------------------------------------------------------
    Totals..............................     2,125,414     2,126,622  ............     1,576,760  ............     1,897,282       320,523            20
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We continue to believe that the RUC-recommended work pool is 
increasing by approximately 20 percent for the Fine Needle Aspiration 
family as a whole, and that this percentage increase suggests that CPT 
codes 10021, 10005, and 10009 are more accurately valued at the CMS 
proposed work RVUs.
    Comment: Several commenters disagreed that this code family will 
achieve savings via elimination of duplicative assumptions of the 
resources involved in furnishing particular services. Commenters stated 
that there is no overlap between the current descriptions of work for 
the bundled codes, and that CPT code 10022 is never performed on the 
same patient without an image guidance code and the image guidance 
codes are never performed on the same patient without a corresponding 
procedure code. The commenters stated that any associated reduction in 
payment would be due to other factors, not due to the code bundling.
    Response: We disagree with the commenters that there would be no 
savings achieved via elimination of duplicative assumptions of the 
resources involved in furnishing particular services. As we stated in 
the proposed rule, a practitioner will not be carrying out the full 
preservice work twice for CPT codes 10022 and 76942, but preservice 
times were assigned to both of the codes under the old coding. In 
similar fashion, these codes both separately include immediate 
postservice work time for dictating a report in their clinical 
vignettes. This is an example of how savings are achieved via 
elimination of duplicative assumptions of resources, as the 
practitioner will only dictate a single report in the newly created CPT 
code 10005 that bundles these two services together. We continue to 
believe that the new coding assigns more accurate work times and thus 
reflects efficiencies in resource costs that existed regardless of how 
the services were previously reported.
    Comment: One commenter stated that while it may be true 
mathematically that the work pool for this family of codes was 
increasing by 20 percent, using this observation as the sole basis to 
implement work value relies on incorrect assumptions which do not 
adhere to current relativity-based RUC methodologies. The commenter 
stated that the rationale proposed by CMS incorrectly implies 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 fails to 
recognize changes in intensity that have taken place over time.
    Response: We disagree with the commenter that our analysis of 
changes in the work pool for this family of codes was the sole basis 
for the proposed refinements to the work RVUs. While

[[Page 59520]]

this was an important factor in our analysis of the work valuation of 
individual codes, we also detailed in the proposed rule our use of time 
ratios, increments, and crosswalk codes as part of our larger 
methodology to determine work RVUs. We specifically stated that we did 
not imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, but rather that 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. We do consider 
changes in intensity that have taken place over time as part of our 
analysis of work valuation, as demonstrated by the fact that we 
proposed the RUC-recommended work RVUs for seven of the ten codes in 
this family.
    Comment: One commenter disagreed that the work pool for a family of 
revised codes should be similar before and after the valuation of the 
new codes. The commenter stated that by separating different modalities 
into their own codes, the appropriate time and intensity differences 
for these services were more accurately reflected in the recommended 
RVUs, and the work pool appropriately expanded to reflect these 
differences. The commenter cited the example of CPT code 10022 being 
unable to account for different patients receiving a biopsy using 
ultrasound or CT technology.
    Response: We agree with the commenter that the work pool for a 
revised code family does not always need to be similar before and after 
the valuation of the new codes. However, the commenter did not address 
our rationale for why we believe that an increase in the work pool 
would be inaccurate for this particular family of codes, which was 
based on the observation that the RUC-recommended work pool was 
increasing by approximately 20 percent while the RUC-recommended work 
time pool for the same codes was only increasing by about 2 percent. In 
a situation where prior coding was unable to account for newer and more 
complex forms of treatment, we would expect the work time pool to 
expand alongside the work pool, since these more complex and intensive 
procedures would take more time to furnish.
    Comment: A few commenters stated that since CMS changed the 
multiple procedure indicator from ``0'' to ``2'' for all Fine Needle 
Aspiration biopsy initial lesion codes for CY 2019, the commenter 
believes that using XXX global codes as references was incorrect. The 
commenter instead recommended that CMS review similar minor procedures 
that have a 0-day global designation, which suggested that a higher 
work RVU could have been supported.
    Response: We continue to believe that codes should generally be 
compared to codes with the same global period. Codes with a 0-day 
global period bundle other services that take place on the same day as 
the procedure into the valuation of the code, whereas such bundling is 
not included in codes with an XXX global period. We do not agree that 
it would have been more accurate to use codes with a 0-day global 
period as references for the codes in this family.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.03 for CPT code 10021 and stated that CMS should finalize the RUC-
recommended work RVU of 1.20. Commenters stated that this service has a 
new coding structure as compared to the past, and that the prior review 
was last carried out in 1995 when physician work time was evaluated 
with much less rigor. Commenters stated that the old time values were 
also based on a crosswalk and not a survey, and that therefore the drop 
in work time did not warrant a proportional change in work RVU as the 
previous times were inaccurate.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we 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).
    Comment: Several commenters stated the CMS rationale for the 
proposed work RVU for CPT code 10021 incorrectly implies that the 
decreased time reflected in survey values should have a one-to-one 
decrease in value, or a linear decrease in the valuation of work RVUs. 
Commenters stated that CMS incorrectly assumed that there are no 
differences in how work was valued in 1995 and how it is valued now.
    Response: We do not agree with the commenters' characterization of 
our statements, and believe it misinterprets our view on this matter. 
We specifically stated in the CY 2019 PFS proposed rule that we were 
not implying that the decrease in time as reflected in survey values 
must necessarily equate to a one-to-one or linear decrease in the 
valuation of work RVUs, both generally speaking and with regards to 
this particular CPT code (83 FR 35747). We recognize that intensity for 
any given procedure may change over several years or within the 
intraservice period. Nevertheless, since the two components of work are 
time and intensity, we believe that absent an obvious or explicitly 
stated rationale for why the relative intensity of a given procedure 
has specifically increased or the reduction in time occurs 
disproportionally in the less-intensive portions of the procedure, 
significant decreases in time should generally be reflected as 
decreases to work RVUs.
    Comment: Several commenters disagreed with the use of CPT code 
36440 as a crosswalk for the work RVU of CPT code 10021. Commenters 
stated that there were differences in site of service, patient 
population, and utilization between these two codes, which made CPT 
code 36440 a poor choice to use for work valuation. One commenter 
stated that CPT code 36440 is used to report a push transfusion of 
blood through an already established

[[Page 59521]]

access in a vessel, and does not carry the same risk and intensity as 
CPT code 10021, which involves accessing a lesion in the neck multiple 
times to aspirate biopsy specimens. Commenters supplied a chart 
depicting several comparator codes for 10021 that they stated were more 
appropriate choices for a crosswalk.
    Response: We disagree with the commenters that CPT code 36440 is an 
inappropriate choice for a crosswalk code. While it is true that this 
code is typically performed on an inpatient basis and the patient 
population comprises neonates instead of adults, we note that these 
factors suggest that the patient population for CPT code 36440 is 
likely sicker and more complex than the patient population for CPT code 
10021. These differences would, if anything, be grounds for a lower 
work RVU for CPT code 10021, not a higher work RVU. We continue to 
believe that CPT code 36440 is an appropriate choice for a crosswalk 
due to the highly similar work times and intensity as compared to CPT 
code 10021. As for the other comparator codes provided by the 
commenters, we do not agree that they would be more appropriate choices 
for a crosswalk as we believe that they have a higher intensity than 
the service described by CPT code 10021. In more general terms, we 
continue to believe that the nature of the PFS relative value system 
necessarily involves comparisons of all services to one another. 
Although codes that describe clinically similar services are sometimes 
stronger comparator codes, we do not agree that codes must share the 
same site of service, patient population, or utilization level to serve 
as an appropriate crosswalk.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.46 for CPT code 10005 and stated that CMS should finalize the RUC-
recommended work RVU of 1.63. Commenters stated that CMS should use 
valid methods of evaluating services, such as survey data and magnitude 
estimation, instead of relying on an incremental difference in work 
RVUs between CPT codes 10021 and 10005.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 10005, 
supporting our proposed valuation with the use of two reference codes: 
CPT codes 99225 and 99232. Both of these codes have the same 
intraservice time and 1 additional minute of total time as compared 
with CPT code 10005, and both reference codes share a work RVU of 1.39.
    Comment: One commenter stated that they did not object to the CMS 
designation of 0.43 RVUs as the increment over CPT code 10021 for 
adding ultrasound guidance; however, the commenter objected to the 
assumption that the work value for CPT code 36440 offers an acceptable 
baseline.
    Response: We continue to believe that a crosswalk to the work RVU 
of CPT code 36440 produces the most accurate valuation for baseline CPT 
code 10021.
    Comment: Commenters disagreed with the proposed work RVU of 2.26 
for CPT code 10009 and stated that CMS should finalize the RUC-
recommended work RVU of 2.43. Commenters provided similar comments for 
CPT code 10009 as they provided for CPT code 10005, suggesting that the 
use of an incremental methodology was inaccurate and that CMS should 
use more valid methods of evaluating services, such as survey data and 
magnitude estimation.
    Response: We continue to disagree with the commenters that the use 
of an increment is a less valid methodology for valuing services. As 
detailed in the response to the comment summary above for CPT code 
10005, we believe the use of an incremental difference is appropriate, 
especially in valuing services within a family of revised codes where 
it is important to maintain appropriate intra-family relativity. We 
further note that we did not rely solely on an increment for our 
proposed work RVU for CPT code 10009, supporting our proposed valuation 
with the use of a reference to CPT code 74263.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT codes 77012 and 77021, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We address this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
77012 and 77021, we are finalizing these clinical labor refinements as 
proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for all of the codes in the Fine Needle 
Aspiration family as proposed.
(2) Biopsy of Nail (CPT Code 11755)
    CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix, 
hyponychium, proximal and lateral nail folds) (separate procedure)) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, the HCPAC recommended a 
work RVU of 1.25 based on the survey median value.
    We disagreed with the recommended value and proposed a work RVU of 
1.08 for CPT code 11755 based on the survey 25th percentile value. We 
noted that the recommended intraservice time for CPT code 11755 is 
decreasing from 25 minutes to 15 minutes (40 percent reduction), and 
the recommended total time for CPT code 11755 is decreasing from 55 
minutes to 39 minutes (29 percent reduction); however, the recommended 
work RVU is only decreasing from 1.31 to 1.25, which is a reduction of 
less than 5 percent. Although we did not imply that the decrease in 
time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work are time and intensity, significant 
decreases in time should be reflected in decreases to work RVUs. In the 
case of CPT code 11755, we believed that it would be more accurate to 
propose the survey 25th percentile work RVU than the survey median to 
account for these decreases in the surveyed work time.
    The proposed work RVU of 1.08 is also based on a crosswalk to CPT 
code 11042 (Debridement, subcutaneous tissue (includes epidermis and 
dermis, if performed); first 20 sq cm or less), which has a work RVU of 
1.01, the same intraservice time of 15 minutes, and a similar total 
time of 36 minutes. We also noted that, generally speaking, working 
with extremities like nails tends to be less intensive in clinical 
terms than other services, especially as compared to surgical 
procedures. We believe that

[[Page 59522]]

this further supports our proposal of a work RVU of 1.08 for CPT code 
11755.
    We proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 11755.
    Comment: A few commenters stated that section 1848(c)(7) of the 
Act, as amended by section 220(e) of the Protecting Access to Medicare 
Act of 2014 (PAMA), specifies that for services that are not described 
by new and revised codes, if the total RVU for a service would be 
decreased by 20 percent or more as compared to the total RVUs for the 
previous year, the applicable adjustments must be phased in over a 2-
year period. These commenters stated that, according to this 
requirement, CPT code 11755 should be subject to the phase-in for CY 
2019.
    Response: We agree that CPT code 11755 should be subject to the 
phase-in for CY 2019. Due to a technical error, we inadvertently 
neglected to apply the phase-in to the total RVU of this code in the 
facility setting for the proposed rule, and we are correcting this for 
the final rule.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.08 for CPT code 11755 and stated that CMS should finalize the RUC-
recommended work RVU of 1.25. Commenters urged CMS to view the survey 
and the HCPAC's recommendation for the survey median work value of 1.25 
apart from the current work time and work RVU because the primary 
specialty that currently performs the service was not included in the 
prior survey conducted in 1993.
    Response: We disagree with the commenters that the current work 
time and work RVU for CPT code 11755 should be viewed separately from 
the new recommended values. We do not pay differentially for services 
on the basis of specialty, and a change in the dominant specialty since 
the time of the last survey is not a reason to disregard the current 
work time and work RVUs in developing proposed work RVUs.
    Comment: Commenters compared the proposed work RVU of CPT code 
11755 to the work valuation of the top key reference service, CPT code 
11730 (Avulsion of nail plate, partial or complete, simple; single). 
Commenters stated that the increment of work between CPT code 11730 of 
1.05 and the CMS proposed value for CPT code 11755 of 1.08 was only 
0.03 RVUs, which was not enough to account for the additional work 
involved in CPT code 11755 given that the latter code also had 50 
percent more intraservice time. Commenters also expressed concerns with 
the CMS reference to CPT code 11042 at a work RVU of 1.01, stating that 
it required less physician work time and a less refined technique. 
Commenters stated that the service described by CPT code 11755 was more 
intense to perform because the physician has to be extremely careful 
not to accidentally hit the patient's bone while taking the biopsy. 
Commenters stated that the nail plate is typically difficult to remove 
during the process of the biopsy performed in the service described by 
CPT code 11755, and that the biopsy must be performed with extreme care 
to avoid injury to the surgeon or extension of the incision to the 
underlying bone, which carries the potential for an osteomyelitis and 
significant post-operative pain. Commenters again urged CMS to finalize 
the RUC-recommended values for this code.
    Response: After reviewing the additional information about the 
risks inherent in the service provided by the commenters, we agree that 
it would be more accurate to finalize the RUC-recommended work RVU of 
1.25 for CPT code 11755 to reflect the intensity of the procedure.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic instrument pack (EQ137) equipment, we 
removed the clinical labor for the CA024, CA027, CA029, and CA035 
clinical labor activities in accordance with our standard equipment 
time formula for surgical instrument packs. For the other three 
equipment items, we removed the clinical labor for the CA027 and CA035 
clinical labor activity codes in accordance with our standard equipment 
time formula for non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing 
the direct PE inputs for this code as proposed.
(3) Skin Biopsy (CPT Codes 11102, 11103, 11104, 11105, 11106, and 
11107)
    In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; each separate/additional lesion) were identified as potentially 
misvalued using a high expenditure services screen across specialties 
with Medicare allowed charges of $10 million or more. Prior to the 
January 2016 RUC meeting, the specialty society notified the RUC that 
its survey data displayed a bimodal distribution of responses with more 
outliers than usual. The RUC referred CPT codes 11100 and 11101 to the 
CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted 
these two codes and created six new codes for primary and additional 
biopsy based on the thickness of the sample and the technique utilized.
    For CY 2019, we proposed the RUC-recommended work RVUs for five of 
the six codes in the family. We proposed a work RVU of 0.66 for CPT 
code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, 
curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch 
biopsy of skin, (including simple closure when performed), single 
lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin, 
(including simple closure when performed), each separate/additional 
lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of 
skin (e.g., wedge), (including simple closure when performed), single 
lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy 
of skin (e.g., wedge), (including simple closure when performed), each 
separate/additional lesion).
    For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop, 
saucerize, curette), each separate/additional lesion), we disagreed 
with the RUC-recommended work RVU of 0.38 and proposed a work RVU of 
0.29. When we compared the RUC-recommended work RVU of 0.38 to other 
add-on codes in the RUC database, we found that CPT code 11103 would 
have the second-highest work RVU for any code with 7 minutes or less of 
total time, with the recommended work RVU noticeably higher than other 
related add-on codes, and we did not agree that the tangential biopsy 
service being performed should have an anomalously high work value in 
comparison to other similar add-on codes. Our proposed work RVU of 0.29 
was based on a crosswalk to CPT code 11201 (Removal of skin tags, 
multiple fibrocutaneous tags, any area; each additional 10 lesions, or 
part thereof), a clinically related add-on procedure with 5 minutes of 
intraservice and total time as opposed to the surveyed 6 minutes for

[[Page 59523]]

CPT code 11103. We also noted that the intraservice time ratio between 
CPT code 11103 and the recommended reference code, CPT code 11732 
(Avulsion of nail plate, partial or complete, simple; each additional 
nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75 
percent ratio when applied to the work RVU of CPT code 11732 also 
produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we also 
supported the proposed work RVU through a crosswalk to CPT code 33508 
(Endoscopy, surgical, including video-assisted harvest of vein(s) for 
coronary artery bypass procedure), which has a higher intraservice time 
of 10 minutes but a similar work RVU of 0.31. We believed that our 
proposed work RVU of 0.29 for CPT code 11103 better serves the 
interests of relativity, as well as better fitting with the other 
recommended work RVUs within this family of codes.
    For the direct PE inputs, we proposed to remove the 2 minutes of 
clinical labor time for the ``Review home care instructions, coordinate 
visits/prescriptions'' (CA035) activity for CPT codes 11102, 11104, and 
11106. These codes are typically billed with a same day E/M service, 
and we believe that it would be duplicative to assign clinical labor 
time for reviewing home care instructions given that this task would 
typically be done during the same day E/M service. We also proposed to 
refine the equipment times in accordance with our standard equipment 
time formulas.
    We proposed to refine the quantity of the ``gown, staff, 
impervious'' (SB024) and the ``mask, surgical, with face shield'' 
(SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We 
proposed to remove one gown and one surgical mask from these codes as 
duplicative since these supplies are also included within the surgical 
instrument cleaning pack (SA043). We also proposed to remove all of the 
supplies in the three add-on procedures (CPT codes 11103, 11105, and 
11107) that were not contained in the previous add-on procedure for 
this family, CPT code 11101. We do not believe that the use of these 
supplies would be typical for the ``each additional lesion'' add-on 
codes, as these supplies are all included in the base codes and are not 
currently utilized in CPT code 11101. We noted that the recommended 
direct PE costs for the three new add-on codes represent an increase of 
approximately 500 percent from the direct PE costs for CPT code 11101, 
and believe that this is largely due to the addition of these new 
supplies.
    The following is a summary of the public comments we received on 
our proposals involving the Skin Biopsy family of codes.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.29 for CPT code 11103 and stated that CMS should finalize the RUC-
recommended work RVU of 0.38. Commenters disagreed that CPT code 11103 
would have the second-highest work RVU for any code with 7 minutes or 
less of total time, stating that the total number of add-on codes with 
RUC total time of 7 minutes or less is 18. Commenters stated that only 
five of these services have total time of 6 or 7 minutes and the rest 
were lower, thus the majority of the work RVUs among these services 
were lower and not comparable. Commenters stressed that the RUC-
recommended work RVU of 0.38 for CPT code 11103 was appropriate since 
the service is performed on a separate site than the base code and 
there is additional physician work to transition to a different site. 
Commenters stated that the RUC's direct crosswalk to CPT code 11732 
(Avulsion of nail plate, partial or complete, simple; each additional 
nail plate), which describes procedures with significant physician 
effort in removing a nail plate with its anesthesia and hemostasis 
challenges, was a much better comparator to CPT code 11103 which 
involves the biopsy of a vascular tumor, typically on the face. 
Commenters stated that the proposed crosswalk to CPT code 11201 at a 
work RVU of 0.29 was too low to maintain relativity within the family 
of codes. One commenter stated that the type of skin biopsies performed 
in CPT code 11103 can result in the detection of carcinoma, melanoma, 
sarcoma/lymphoma, and other dangerous pathologies, and that making 
these diagnoses can save lives and ultimately decrease Medicare 
spending.
    Response: After reviewing the additional information provided by 
the commenters, we agree that it would be more accurate to finalize the 
RUC-recommended work RVU of 0.38 for CPT code 11103 as the proposed 
work RVU was too low to maintain relativity within the family of codes.
    Comment: Commenters disagreed with many of the refinements made by 
CMS to the direct PE inputs for this family of codes. Commenters stated 
that it was not appropriate to only include equipment and supply items 
in the new biopsy add-on codes that were included in the old add-on 
code (CPT code 11101) because the old codes were not specific enough to 
accurately distinguish between the three types of biopsies. Commenters 
cited as an example the fact that the predecessor CPT code 11101 did 
not include supply items that are necessary for the performance of the 
incisional biopsy.
    Response: We appreciate the feedback from the commenters clarifying 
some of the differences between the predecessor code and the newly 
created add-on codes. We evaluated these differences on an individual 
case-by-case basis when determining whether or not to finalize the 
proposed refinements to the direct PE inputs.
    Comment: Several commenters disagreed with the proposed refinements 
to the ``Review home care instructions, coordinate visits/
prescriptions'' (CA035) clinical labor time. Commenters stated that 
home care instructions furnished in an E/M visit do not typically 
include wound care instructions, and that this instruction would be 
above and beyond instructions proved during an E/M visit in which no 
procedure is performed.
    Response: We disagree with the commenters that wound care 
instructions would not be provided during the same day E/M visit. We 
continue to believe that it would be duplicative to assign clinical 
labor time for this task given the fact that a same day E/M visit is 
typical for these services. We believe that these instructions would be 
provided during the same day E/M visit.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the ``gown, staff, impervious'' (SB024) and the 
``mask, surgical, with face shield'' (SB034) supplies from 2 to 1 for 
CPT codes 11102, 11104, and 11106 since these supplies are also 
included within the surgical instrument cleaning pack (SA043). 
Commenters stated that the SA043 instrument cleaning pack is used in 
the dirty instrument room as part of the instrument cleaning and 
sterilization process and therefore cannot be used during a patient 
procedure as the instrument cleaning occurs after the procedure has 
been completed. Commenters stated that the personal protective 
equipment used during the patient procedure is considered contaminated 
after the procedure is concluded, and that personal protective 
equipment must be removed and disposed of prior to leaving the 
procedure room. As a result, these supplies were not duplicative and 
should not be removed.
    Response: We disagree with the commenter and we continue to believe 
that the impervious staff gown and the surgical mask with face shield 
would be duplicative supplies given that they are also contained within 
the instrument cleaning pack. We do not believe that it

[[Page 59524]]

would be typical to remove the staff gown and face shield used during a 
procedure and put on new items afterwards for the purposes of cleaning 
instruments.
    Comment: Commenters also disagreed with the CMS proposal to remove 
all of the supplies in the three add-on procedures (CPT codes 11103, 
11105, and 11107) that were not contained in the previous add-on 
procedure for this family, CPT code 11101. For the ``drape, sterile, 
fenestrated 16in x 29in'' (SB011) supply, commenters stated that 
draping the new body site with a new sterile disposable drape was 
clinically indicated and would be typically done rather than take a 
drape used on one body site and then reposition it to a new body site 
for a new procedure. Commenters made the same claim for the sterile 
gloves (SB024) supply. For the ``needle, OSHA compliant (SafetyGlide)'' 
(SC080) and the ``scalpel, safety, surgical, with blade (#10-20)'' 
(SF047) supplies, commenters stated that the add-on represented a 
completely new body site and completely new skin lesion which would not 
allow the needle or scalpel to be un-sheathed and then reused at a 
separate body site out of fear of contamination. For the ``dressing, 
12-7mm (Gelfoam)'' (SG033), ``dressing, 3in x 4in (Telfa, Release)'' 
(SG035), and ``gauze, sterile 4in x 4in (10 pack uou)'' (SG056) 
supplies, commenters stated that the add-on procedure is a second 
biopsy of a completely different body location and that these 
dressings/gauze pads would not be retained and then used on the second 
procedure out of fear of contamination. For the ``tape, surgical paper 
1in (Micropore)'' (SG079) supply, commenters stated that the quantity 
of this supply in the base code was sufficient for one lesion, but not 
more than one lesion due to the simple fact that two lesions required 
more surgical tape than one lesion. Finally, for the ``swab, patient 
prep, 1.5 ml (chloraprep)'' (SJ081) supply, commenters stated that the 
process of skin prep starts with the center of the lesion and moves 
outward in concentric circles to avoid bringing pathogens back into the 
field. Commenters stated that the prep sponge cannot be reused on a 
separate area of skin as it will contaminate that area by transporting 
pathogens from the last concentric circle of the prior area, and that 
the supply quantity in the base code contained an amount insufficient 
to prep more than one area. Commenters requested CMS not to finalize 
the proposal to remove these supplies from the add-on codes.
    Response: After considering the new information provided by the 
commenters regarding the clinical use of these supplies, we will not 
finalize our proposal to remove these supplies from the three add-on 
procedures (CPT codes 11103, 11105, and 11107). We will restore the 
RUC-recommended supplies for these three codes.
    Comment: Several commenters disagreed with the refinements to the 
equipment time in CPT codes 11102, 11104, and 11106. The commenters 
stated that the removal of 2 minutes of equipment time was not 
appropriate and that equipment time needs to match clinical staff time.
    Response: We agree with the commenter that changes in clinical 
labor time should be matched with corresponding changes in equipment 
time. However, since we continue to believe that the clinical labor to 
the ``Review home care instructions, coordinate visits/prescriptions'' 
(CA035) clinical labor time should be removed as duplicative with the 
same day E/M visit, we also continue to believe that the equipment 
times are accurate as proposed.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for all of the codes in the Skin Biopsy 
family. We are finalizing the direct PE inputs as proposed, with the 
exception of the supplies from the three add-on procedures (CPT codes 
11103, 11105, and 11107) as detailed above.
(4) Injection Tendon Origin-Insertion (CPT Code 20551)
    CPT code 20551 (Injection(s); single tendon origin/insertion) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 20551.
    We proposed to maintain the current work RVU for many of the CPT 
codes identified as potentially misvalued on the screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more. We 
noted that regardless of the proposed work valuations for individual 
codes, which may or may not retain the same work RVU, we continue to 
have reservations about the valuation of 0-day global services that are 
typically billed with a separate E/M service with the use of Modifier 
25 (indicating that a significant and separately identifiable E/M 
service was provided on the same day). As we stated in the CY 2017 PFS 
final rule (81 FR 80204), we continue to believe that the routine 
billing of separate E/M services in conjunction with a particular code 
may indicate a possible problem with the valuation of the code bundle, 
which is intended to include all the routine care associated with the 
service. We will continue to consider additional ways to address the 
appropriate valuation for these services.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Provide education/obtain consent'' (CA011) and the 
``Review home care instructions, coordinate visits/prescriptions'' 
(CA035) activities for CPT code 20551. This code is typically billed 
with a same day E/M service, and we believe that it will be duplicative 
to assign clinical labor time for obtaining consent or reviewing home 
care instructions given that these tasks will typically be done during 
the same day E/M service. We also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 20551.
    Comment: A few commenters supported our proposal to maintain the 
current work RVU for this code, as recommended by the RUC.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposed direct PE 
refinements to CPT code 20551. Commenters stated that they did not 
agree that the clinical labor taking place in activity codes CA011 and 
CA035 were duplicative and that the RUC is careful to remove any 
duplication with E/M visits. Commenters stated that the home care 
instructions in activity code CA035 refer directly to the tendon 
injection and may include discussion of care for the affected area and 
home restrictions. Commenters stated that this injection is more 
involved and invasive than a vaccination such as the ones taking place 
in CPT codes 90470 and 90471, which were allowed 3 minutes for ``F/u on 
physician's discussion w/patient/parent & obtain actual consent 
signature'' and an additional 3 minutes for home care instructions and 
recording vaccine information.
    Response: For the CA011 clinical labor activity, we agree with the 
commenters that there would be a need for some additional time to 
obtain consent for the injection, but we do not agree that it would be 
typical to require the full 3 minutes because we believe there would be 
some overlap with the same day E/M visit. In similar fashion, we 
believe that there would also be some overlap with the same-day E/M

[[Page 59525]]

visit for the home care instructions described in activity code CA035. 
We also note that there is 1 minute of clinical labor time assigned to 
the ``Check dressings & wound/home care instructions/coordinate office 
visits/prescriptions'' clinical labor task for CPT code 90471 
referenced by the commenters. As a result, we are finalizing the 
assignment of 1 minute of clinical labor time to both of the CA011 and 
CA035 activities for CPT code 20551. We are also finalizing an increase 
of 1 minute in the equipment time for the exam table (EF023) to a total 
of 15 minutes, in accordance with our standard time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing our 
proposal to maintain the current work RVU for CPT code 20551. We are 
finalizing the direct PE inputs with the refinements detailed above.
(5) Structural Allograft (CPT Codes 20932, 20933, and 20934)
    In February 2017, the CPT Editorial Panel created three new codes 
to describe allografts. These codes were designated as add-on codes and 
revised to more accurately describe the structural allograft procedures 
they represent. For CY 2019, we proposed the RUC-recommended work RVUs 
for all three codes. We proposed a work RVU of 13.01 for CPT code 20932 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; osteoarticular, including articular surface 
and contiguous bone), a work RVU of 11.94 for CPT code 20933 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; hemicortical intercalary, partial (i.e., 
hemicylindrical)), and a work RVU of 13.00 for CPT code 20934 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; intercalary, complete (i.e., cylindrical)).
    These three new codes are all facility-only procedures with no 
recommended direct PE inputs.
    We did not receive any comments on our proposals involving the 
Structural Allograft family of codes. Therefore we are finalizing the 
work RVUs for the codes in this family as proposed.
(6) Knee Arthrography Injection (CPT Code 27369)
    CPT code 27370 (Injection of contrast for knee arthrography) 
repeatedly appeared on high volume growth screens between 2008 and 
2016, and the RUC expressed concern that the high volume growth for 
this procedure was likely due to its being reported incorrectly as 
arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel 
deleted CPT code 27370 and replaced it with a new code, 27369, to 
report injection procedure for knee arthrography or enhanced CT/MRI 
knee arthrography.
    The RUC recommended a work RVU of 0.96 for CPT code 27369, which is 
identical to the work RVU for CPT code 27370 (Injection of contrast for 
knee arthrography). The RUC's recommendation is based on key reference 
service, CPT code 23350 (Injection procedure for shoulder arthrography 
or enhanced CT/MRI shoulder arthrography), with identical intraservice 
time (15 minutes) and total time (28 minutes) as the new CPT code and a 
work RVU of 1.00. The RUC notes that its recommendation is lower than 
the 25th percentile from the survey results, but that the work 
described by the service should be valued identically with the CPT code 
being replaced. We disagreed with the RUC's recommended work RVU for 
CPT code 27369. Both the total (28 minutes) and intraservice (15 
minutes) times for the new CPT code are considerably lower than the 
deleted CPT code 27370. Based on the reduced times and the projected 
work RVU from the reverse building block methodology (0.60 work RVUs), 
we believe this CPT code should be valued at 0.77 work RVUs, supported 
by a crosswalk to CPT code 29075 (Application, cast; elbow to finger 
(short arm)), with total time of 27 minutes and intraservice time of 15 
minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.
    For the direct PE inputs, we proposed 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. The predecessor 
code for 27369, CPT code 27370, did not have clinical labor time 
assigned for the ``Confirm order, protocol exam'' clinical labor task, 
and we do not have any reason to believe that the services being 
furnished by the clinical staff have changed, only the way in which 
this clinical labor time has been presented on the PE worksheets. We 
also noted 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 proposed to remove the clinical labor time for the ``Scan exam 
documents into PACS. Complete exam in RIS system to populate images 
into work queue'' (CA032) activity. CPT code 27369 does not include a 
PACS workstation among the recommended equipment, and the predecessor 
code 27370 did not previously include time for this clinical labor 
activity. We believe that data entry activities such as this task would 
be classified as indirect PE, as they are considered administrative 
activities and are not individually allocable to a particular patient 
for a particular service. We also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 27369.
    Comment: We received one comment regarding our proposed work RVU 
for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's 
reference to CPT code 27370, which is being deleted, as a basis for 
evaluating whether the RUC's proposed work RVU for this CPT code (0.96) 
adequately accounts for the large reduction in time between the deleted 
code, CPT code 27370 and the new code, CPT code 27369. The commenter 
noted that it is particularly inappropriate for CMS to value codes on 
the basis of time differences when the comparison code had not been 
previously surveyed by the RUC. The commenter urged CMS to finalize the 
RUC-recommended work RVU for CPT code 27369 of 0.96.
    Response: We use several parameters to review the work RVU for 
codes including, where applicable, refining the work RVUs in direct 
proportion to either total time or intraservice time based on the best 
available information regarding the time resources involved in 
furnishing particular services. We note that the reason the CPT 
Editorial Panel was asked to review the code was to prevent incorrect 
reporting of the code, not to reflect a fundamentally different 
service. The work involved in furnishing the service described by CPT 
code 27369 is not fundamentally different from the work involved in 
furnishing the service described by the deleted code. In such cases we 
do not believe it is inappropriate to compare the survey times for the 
new code to the existing time for the code that it is intended to 
replace as one of several parameters we consider in our review. We are 
finalizing a work RVU for CPT code 27369 of 0.77 as proposed.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-

[[Page 59526]]

recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
27369, we are finalizing these clinical labor refinements as proposed.
    Comment: One commenter agreed with the proposed CMS refinement to 
the CA032 clinical labor activity.
    Response: We appreciate the support for our proposal from the 
commenter.
    After consideration of the public comments, we are finalizing the 
direct PE inputs for CPT code 27369 as proposed.
(7) Application of Long Arm Splint (CPT Code 29105)
    CPT code 29105 (Application of long arm splint (shoulder to hand)) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.80 for CPT code 29105. For the direct PE 
inputs, we proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 29105.
    Comment: Some commenters expressed support for our proposal to 
accept the RUC-recommended work RVU for this code.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the five equipment items utilized in CPT code 29105, 
we removed the clinical labor for the CA035 clinical labor activity 
code in accordance with our standard equipment time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 29105 as proposed.
(8) Strapping Lower Extremity (CPT Codes 29540 and 29550)
    CPT codes 29540 (Strapping; ankle and/or foot) and 29550 
(Strapping; toes) were identified as potentially misvalued on a screen 
of 0-day global services reported with an E/M visit 50 percent of the 
time or more, on the same day of service by the same patient and the 
same practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-
recommended work RVU of 0.25 for CPT code 29550.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Provide education/obtain consent'' (CA011) activity from 
3 minutes to 2 minutes for both codes, as this is the standard clinical 
labor time assigned for patient education and consent. We also proposed 
to remove the 2 minutes of clinical labor time for the ``Review home 
care instructions, coordinate visits/prescriptions'' (CA035) activity 
for both codes. CPT codes 29540 and 29550 are both typically billed 
with a same day E/M service, and we believe that it would be 
duplicative to assign clinical labor time for reviewing home care 
instructions given that this task would typically be done during the 
same day E/M service. We also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Strapping Lower Extremity family of codes.
    Comment: A few commenters supported our proposal to accept the 
HCPAC-recommended work RVUs.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposed direct PE 
refinements to CPT codes 29540 and 29550. Commenters stated that CMS 
mistakenly cited a standard for this activity of 2 minutes, however 
there is no set standard for CA011, and that 3 minutes is needed for 
clinical staff to perform this clinical activity.
    Response: We disagree with the commenters that 3 minutes would be 
typically needed for the clinical staff to provide education and obtain 
consent in these procedures. We have typically assigned 2 minutes for 
this clinical labor activity unless we had a specific rationale for a 
higher amount of clinical labor time, and we continue to believe that 
this standard amount of clinical labor time would be the most accurate 
value for CPT codes 29540 and 29550.
    Comment: Several commenters disagreed that the clinical labor for 
home care instructions and coordinating visits/prescriptions would be 
duplicative with the same day E/M office visit in these services. 
Commenters stated that these home care instructions directly pertain to 
the strapping procedure and would not be provided during an evaluation 
of the patient. Commenters stated that the strappings do not work 
unless left alone and taken care of in a specific manner, and that this 
important information is included in the home care instructions that 
the patient receives from clinical staff.
    Response: We disagree with the commenters and we continue to 
believe that this clinical labor would be duplicative with the same day 
E/M visit. We believe that this clinical labor would take place during 
the same day E/M visit. Due to the way patients typically present in 
these procedures, we do not believe that the patients would typically 
need additional home care instructions above and beyond the E/M visit. 
We also note that these strapping procedures are frequently repeated 
for the same patient multiple times, and there would not be a need for 
repeated home care instructions for subsequent strapping procedures for 
the same patient. Any home care instructions taking place outside of 
the same day E/M visit would only be needed the first time that these 
procedures are performed on a patient, and as a result they would not 
be typical. As a result, we continue to believe that this clinical 
labor would not be typical.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the two equipment items utilized in these CPT codes, 
we removed the clinical labor for the CA035 clinical labor activity 
code in accordance with our standard equipment time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT codes 29540 and 29550 as 
proposed.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
    CPT code 31623 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; with

[[Page 59527]]

brushing or protected brushings) was identified on a high growth screen 
of services with total Medicare utilization of 10,000 or more that have 
increased by at least 100 percent from 2009 through 2014. CPT code 
31624 (Bronchoscopy, rigid or flexible, including fluoroscopic 
guidance, when performed; with bronchial alveolar lavage) was also 
included for review as part of the same family of codes. For CY 2019, 
we proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623 
and 31624.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Complete post-procedure diagnostic forms, lab and x-ray 
requisitions'' (CA027) activity from 4 minutes to 2 minutes for CPT 
codes 31623 and 31624. Two minutes is the standard time, as well as the 
current time for this clinical labor activity, and we have no reason to 
believe that the time to perform this task has increased since the 
codes were last reviewed. We did not receive any explanation in the 
recommendations as to why the time for this activity would be doubling 
over the current values. We also proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Bronchoscopy family of codes.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Complete post-procedure diagnostic 
forms, lab and x-ray requisitions'' (CA027) activity from 4 minutes to 
2 minutes for CPT codes 31623 and 31624. Commenters stated that there 
is no standard for the CA027 clinical labor activity and that the CMS 
logic to conform to such a standard lacks merit. Commenters also stated 
that these services require verification of samples, and completion of 
several lab forms and clearly requires more than the standard time for 
completing forms.
    Response: We disagree with the commenters. While it is true that we 
have not formalized 2 minutes as a standard through rulemaking for this 
clinical labor activity code, we have typically assigned 2 minutes for 
the CA027 activity across a wide variety of codes. Out of the 168 HCPCS 
codes that have clinical labor time for the CA027 clinical labor 
activity in our database, 64 codes have 2 minutes of assigned clinical 
labor time while only 9 codes have 4 minutes of assigned clinical labor 
time, which indicates that 2 minutes is far more typical for this 
activity. More importantly, commenters did not address our statement 
that 2 minutes is the current time for this clinical labor activity, 
and we had no reason to believe that the time to perform this task has 
increased since the codes were last reviewed. As a result, we are 
finalizing our refinement to 2 minutes of clinical labor time for the 
CA027 activity.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT codes 31623 and 31624 as 
proposed.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and 
93264)
    In September 2017, the CPT Editorial Panel created a code to 
describe pulmonary wireless sensor implantation and another code for 
remote care management of patients with an implantable, wireless 
pulmonary artery pressure sensor monitor. For CY 2019, we proposed the 
RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter 
implantation of wireless pulmonary artery pressure sensor for long term 
hemodynamic monitoring, including deployment and calibration of the 
sensor, right heart catheterization, selective pulmonary 
catheterization, radiological supervision and interpretation, and 
pulmonary artery angiography, when performed), and the RUC-recommended 
work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless 
pulmonary artery pressure sensor for up to 30 days including at least 
weekly downloads of pulmonary artery pressure recordings, 
interpretation(s), trend analysis, and report(s) by a physician or 
other qualified health care professional).
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Pulmonary Wireless Pressure Sensor Services 
family of codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.
(11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)
    In February 2017, the CPT Editorial Panel created two new codes 
replacing cardiac event recorder codes to reflect new technology. For 
CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code 
33285 (Insertion, subcutaneous cardiac rhythm monitor, including 
programming) and the RUC-recommended work RVU of 1.50 for CPT code 
33286 (Removal, subcutaneous cardiac rhythm monitor).
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Cardiac Event Recorder Procedures family of 
codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and 
33286 as proposed.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)
    In September 2017, the CPT Editorial Panel created one new code to 
combine the efforts of aortic valve and root replacement with 
subvalvular left ventricular outflow tract enlargement to allow for an 
unobstructed left ventricular outflow tract.
    For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for 
CPT code 33440 (Replacement, aortic valve; by translocation of 
autologous pulmonary valve and transventricular aortic annulus 
enlargement of the left ventricular outflow tract with valved conduit 
replacement of pulmonary valve (Ross-Konno procedure)). When this code 
is re-reviewed in a few years as part of the new technology screen, we 
look forward to receiving new recommendations on the whole family, 
including the related Ross and Konno procedures (CPT codes 33413 and 
33412 respectively) that were used as references for CPT code 33440.
    For the direct PE inputs, we proposed to refine the preservice 
clinical labor times to match our standards for 90-day global 
procedures. We proposed to refine the clinical labor time for the 
``Coordinate pre-surgery services (including test results)'' (CA002) 
activity from 25 minutes to 20 minutes, to refine the clinical labor 
time for the ``Schedule space and equipment in facility'' (CA003) 
activity from 12 minutes to 8 minutes, and to refine the clinical labor 
time for the ``Provide pre-service education/obtain consent'' (CA004) 
activity from 26 minutes to 20 minutes. We also proposed to add 15 
minutes of clinical labor time for the ``Perform regulatory mandated 
quality assurance activity (pre-service)'' (CA008) activity. We agreed 
with the recommendation that the total preservice clinical labor

[[Page 59528]]

time for CPT code 33440 is unchanged from the two reference codes at 75 
minutes. However, we believed that the clinical labor associated with 
additional coordination between multiple specialties prior to patient 
arrival is more accurately described through the use of the CA008 
activity code than by distributing this 15 minutes amongst the other 
preservice clinical labor activities. We previously established 
standard preservice times for 90-day global procedures, and did not 
want to propose clinical labor times above those standards for CPT code 
33440. We also noted that there is no effect on the total clinical 
labor direct costs in this situation, since the same 15 minutes of 
preservice clinical labor time is still being furnished.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 33440.
    Comment: A few commenters stated that they had no objections to the 
CMS proposal to refine the preservice clinical labor times for the 
direct PE inputs for code 33440 to match the 90-day global procedure 
standards and to add 15 minutes of clinical labor time to clinical 
labor activity code CA008. The commenters stated that they believed the 
RUC-recommended allocation of the preservice activities was 
appropriate, whereas activity code CA008 was not an accurate 
description of the additional work being done, and hoped that CMS would 
not use the allocation of time to CA008 as a way to reduce the 
preservice time in future rulemaking.
    Response: We appreciate the feedback on our proposed direct PE 
refinements from the commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for CPT code 33440 as proposed.
(13) Hemi-Aortic Arch Replacement (CPT Code 33866)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
created one new add-on code to report hemi-aortic arch graft 
replacement. For CY 2019, we proposed the RUC-recommended work RVU of 
19.74 for 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). CPT code 33866 is a facility-
only procedure with no recommended direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 33866.
    Comment: We received several comments, including comments from the 
RUC. The RUC noted in its comment letter that at the April 2018 RUC 
meeting, the specialty societies determined that the family of services 
encompassing CPT code 33866 should be submitted to the CPT Editorial 
Panel for the following revisions: (1) To develop distinct codes for 
ascending aortic report for dissection and ascending aortic repair for 
other ascending aortic disease such as aneurysms and congenital 
anomalies. The specialties noted that there is a difference in the work 
associated with these procedures and now there is sufficient volume to 
allow for more accurate capture of the work and outcomes data for these 
distinct patient populations, which was not the case when the code was 
first developed, (2) Revise the descriptor for transverse arch code, 
CPT code 33870, to further clarify the difference in work between the 
new add on code, CPT code 33866, and (3) Revise the guidelines to 
provide additional instructions on the appropriate use of these codes. 
The RUC further noted that the specialty societies had already 
submitted a new coding proposal for consideration at the May 2018 CPT 
Editorial Panel for CPT 2020, which the RUC supported. Following the 
April 2018 RUC meeting, the RUC rescinded its interim value 
recommendation (work RVU of 19.74) to us for CPT code 33866 for CY 
2019. One commenter noted, that although the RUC rescinded the interim 
work RVU of 19.74 due to a specialty societies' recommendation to 
submit the family of services to the CPT Editorial Panel, they 
encouraged CMS to consider using the work RVU of 19.74 as an interim 
value until the code can be re-surveyed and reviewed by the RUC. The 
commenter further noted that using the RUC-recommended value would 
allow physicians to be paid for the service in CY 2019, decreasing the 
burden of reporting a carrier-priced service to both the carriers and 
providers.
    Response: While we recognize that the RUC rescinded its work RVU 
recommendation, we note that we proposed the RUC-recommended work RVU 
for valuation in CY 2019. We also want to remind commenters that we no 
longer establish interim valuations on a routine basis, and we are not 
convinced that establishing an interim valuation for CPT code 33866 is 
necessary. We will review any new coding that the CPT Editorial Panel 
provides for 2020, and will review any recommendations we receive 
timely from the RUC or other stakeholders for valuation through CY 2020 
rulemaking.
    After consideration of the public comments received, we are 
finalizing the RUC-recommended work RVUs for CPT code 33866 as 
proposed.
(14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
replaced the five leadless pacemaker services, Category III codes, with 
the addition of two new CPT codes to report transcatheter leadless 
pacemaker procedures and revised five codes to include evaluation and 
interrogation services of leadless pacemaker systems.
    For CPT code 33274 (Transcatheter insertion or replacement of 
permanent leadless pacemaker, right ventricular, including imaging 
guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, 
femoral venography) and device evaluation (e.g., interrogation or 
programming), when performed), we disagreed with the recommended work 
RVU of 8.77 and we proposed a work RVU of 7.80 based on a direct 
crosswalk to one of the top reference codes selected by the RUC survey 
participants, CPT code 33207 (Insertion of new or replacement of 
permanent pacemaker with transvenous electrode(s); ventricular). This 
code has the same 60 minutes of intraservice time as CPT code 33274 and 
an additional 61 minutes of total time at a work RVU of 7.80. In our 
review of CPT code 33274, we noted that this reference code had an 
additional inpatient hospital visit of CPT code 99232 (Subsequent 
hospital care, per day, for the evaluation and management of a patient, 
which requires at least 2 of 3 key components) and a full instead of a 
half discharge visit of CPT code 99238 (Hospital discharge day 
management; 30 minutes or less) included in its 90-day global period. 
The combined work RVU of these two visits would be equal to 2.03. 
However, the recommended work RVU for CPT code 33274 was 0.97 work RVUs 
higher than CPT code 33207, despite having fewer of these visits and 
significantly less surveyed total time. While we acknowledge that CPT 
code 33274 is a more intense procedure than CPT code 33207, we do not 
believe that it should be valued almost a full RVU higher than the 
reference code given the fewer visits in the global period and the 
lower surveyed work time.
    Therefore, we proposed to crosswalk CPT code 33274 to CPT code 
33207 at the same work RVU of 7.80. The proposed work RVU was also 
supported through a reference crosswalk to CPT code 38542 (Dissection, 
deep jugular node(s)), which has 60 minutes of intraservice time, 198 
minutes of total time, and a work RVU of 7.95. We believe that our 
proposed work RVU of

[[Page 59529]]

7.80 is a more accurate valuation for CPT code 33274, while still 
recognizing the greater intensity of this procedure in comparison to 
its reference code.
    For CPT code 33275 (Transcatheter removal of permanent leadless 
pacemaker, right ventricular), we disagreed with the RUC-recommended 
work RVU of 9.56 and we proposed a work RVU of 8.59. Although we 
disagreed with the RUC-recommended work RVU, we concurred that the 
relative difference in work between CPT codes 33274 and 33275 is 
equivalent to the recommended interval of 0.79 RVUs. Therefore, we 
proposed a work RVU of 8.59 for CPT code 33275, based on the 
recommended interval of 0.79 additional RVUs above our proposed work 
RVU of 7.80 for CPT code 33274. We also noted that our proposed work 
RVU for CPT code 33275 situates it approximately halfway between the 
two reference codes from the survey, with CPT code 33270 (Insertion or 
replacement of permanent subcutaneous implantable defibrillator system, 
with subcutaneous electrode, including defibrillation threshold 
evaluation, induction of arrhythmia, evaluation of sensing for 
arrhythmia termination, and programming or reprogramming of sensing or 
therapeutic parameters, when performed) having an intraservice time of 
90 minutes and a work RVU of 9.10, and CPT code 33207 having an 
intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275 
has a surveyed intraservice time of 75 minutes and nearly splits the 
difference between them at our proposed work RVU of 8.59.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Leadless Pacemaker Procedures family of 
codes.
    Comment: One commenter recommended that CMS adopt the RUC-
recommended RVUs for both codes due to the newness of the procedures. 
The commenter stated that there might not be sufficient evidence or 
rationale for CMS to disagree with the RUC-recommended values, and 
again cited the newness of these procedures.
    Response: We disagree with the commenter that the newness of a 
procedure would provide a sufficient rationale for finalizing the RUC-
recommended work RVU for a new CPT code without any further 
consideration. Establishing valuations for newly created CPT codes is a 
routine part of maintaining the PFS, and we have historically valued 
new services since the inception of the resource-based relative value 
system. We also believe that RUC surveys are less likely to be 
representative of practitioners when evaluating new services, due to 
the fact that practitioners are not yet sufficiently experienced with 
the services to provide accurate evaluations, which is why we have been 
supportive of the RUC's policy to resurvey new services a few years 
after their creation when typical practice patterns have been more 
firmly established.
    Comment: Many commenters disagreed with the proposed work RVUs for 
CPT codes 33274 and 33275 and stated that CMS should instead finalize 
the RUC-recommended work RVUs for these services. Commenters stated 
that CMS provided no qualitative or quantitative rationale to support 
their assumption that the difference in time between CPT codes 33274 
and the top key reference from the survey (CPT code 33207) completely 
reflects the difference in intensity. Commenters stated that patients 
receiving leadless pacemakers are more complex and have more 
comorbidities and contraindications than transvenous patients, with 
more significant groin complications and more commonly present 
tamponade. Commenters stated that there were other issues that make CPT 
code 33274 more challenging, including: (1) Capture thresholds tend to 
change more than with transvenous devices; (2) There is a higher risk 
for complications including embolization and groin complications, which 
are not associated with tranvenous implants; and (3) Patients 
undergoing leadless pacemaker procedures are more likely to have 
chronic atrial fibrillation and poor venous access. Commenters 
emphasized that they believed the leadless pacemaker procedure 
described by CPT code 33274 was more intensive than the CMS crosswalk 
to CPT code 33207.
    Response: We disagree with the commenters' assertion that we 
provided no qualitative or quantitative rationale to support our choice 
of a crosswalk to CPT code 33207. We stated in the proposed rule that 
in our review of CPT code 33274, we noted that this reference code had 
an additional inpatient hospital visit of CPT code 99232 and a full, 
instead of a half, discharge visit of CPT code 99238 included in its 
90-day global period. We acknowledged that CPT code 33274 is a more 
intense procedure than CPT code 33207; however, we did not believe that 
it should be valued almost a full RVU higher than the reference code. 
We also supported the proposed work RVU through the use of a reference 
code, CPT code 38542, which was not addressed by the commenters.
    We also disagree with the commenters that CPT code 33274 has so 
much additional intensity and complexity as compared to key reference 
CPT code 33207 that they should be valued at the same work RVU of 8.77. 
We note that the RUC's research panel selected preservice package 3, 
``a straightforward patient and a difficult procedure'' for CPT code 
33274. We believe this indicates that the patient population for CPT 
code 33274 would not be unusually difficult or complex as suggested by 
the commenters. We further note that the summary of recommendations for 
CPT code 33274 states that these patients are typically sent home from 
the facility the next day. In contrast, reference CPT code 33207 
includes a full hospital inpatient day of post procedure care 
associated with CPT code 99322, as well as a full discharge visit 
instead of half of a discharge visit. We believe that this further 
suggests that the patient population for CPT code 33274 would not be 
more difficult or complex than the patient population for CPT code 
33207. As we stated in the proposed rule, we continue to acknowledge 
that CPT code 33274 is a more intense procedure than CPT code 33207, 
but we do not believe that it should be valued almost a full RVU higher 
than the reference code given the fewer visits in the global period and 
the lower surveyed work time.
    Comment: Commenters stated that CMS should use valid methods of 
evaluating services, such as survey data and magnitude estimation, 
instead of relying on an incremental difference in work RVUs between 
CPT codes 33274 and 33275.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 33275, 
supporting our proposed valuation by noting that the CMS work RVU of 
8.59 situated the code approximately halfway between the two reference 
codes from the survey, with CPT code 33270 having an intraservice time 
of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an 
intraservice

[[Page 59530]]

time of 60 minutes and a work RVU of 7.80.
    Comment: Several commenters stated that while these procedures 
described in CPT code 33275 will be rare, these patients will still 
have the elevated risk factors mentioned in discussion of CPT code 
33274 and warranted the additional work indicated by survey respondents 
at the 25th percentile of the survey.
    Response: We continue to believe that the patients in CPT code 
33274 would not be more difficult or complex than the patients in CPT 
code 33207 for the reasons detailed above. We continue to believe that 
the relative difference in work between CPT codes 33274 and 33275 is 
equivalent to the recommended interval of 0.79 RVUs.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Leadless Pacemaker 
Procedures family as proposed.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, and 
36584)
    In CY 2016, CPT code 36569 (Insertion of peripherally inserted 
central venous catheter (PICC), without subcutaneous port or pump, 
without imaging guidance; age 5 years or older) was identified as 
potentially misvalued using a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. CPT 
code 36569 is typically reported with CPT codes 76937 (Ultrasound 
guidance for vascular access requiring ultrasound evaluation of 
potential access sites, documentation of selected vessel patency, 
concurrent real-time ultrasound visualization of vascular needle entry, 
with permanent recording and reporting) and 77001 (Fluoroscopic 
guidance for central venous access device placement, replacement 
(catheter only or complete), or removal) and was referred to the CPT 
Editorial Panel to have the two common imaging codes bundled into the 
code. In September 2017, the CPT Editorial Panel revised CPT codes 
36568 (Insertion of peripherally inserted central venous catheter 
(PICC), without subcutaneous port or pump; younger than 5 years of 
age), 36569 and 36584 (Replacement, complete, of a peripherally 
inserted central venous catheter (PICC), without subcutaneous port or 
pump, through same venous access, including all imaging guidance, image 
documentation, and all associated radiological supervision and 
interpretation required to perform the replacement) and created two new 
CPT codes to specify the insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion.
    For CY 2019, we proposed the RUC-recommended work RVU for two of 
the CPT codes in the family. We proposed the RUC-recommended work RVU 
of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for 
CPT code 36569.
    For CPT code 36572 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; younger than 5 years of age), we disagreed with the RUC-
recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a 
direct crosswalk to CPT code 50435 (Exchange 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 50435 is a recently reviewed code that also includes radiological 
supervision and interpretation with similar intraservice and total time 
values. In our review of CPT code 36572, we were concerned about the 
possibility that the recommended work RVU of 2.00 could create a rank 
order anomaly in terms of intensity with the other codes in the family. 
We noted that the recommended intraservice time for CPT code 36572 as 
compared to CPT code 36568, the most similar code in the family, is 
decreasing from 38 minutes to 22 minutes (42 percent), and the 
recommended total time is decreasing from 71 minutes to 51 minutes (38 
percent); however, the recommended work RVU is only decreasing from 
2.11 to 2.00, which is a reduction of just over 5 percent. We also 
noted that CPT code 36572 has a lower recommended intraservice time and 
total time as compared to CPT code 36569, yet has a higher recommended 
work RVU. Although we did not imply that the decreases 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 reflected in decreases to work RVUs.
    In the case of CPT code 36572, we believed that it would be more 
accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 
50435 to better fit with the recommended work RVUs for CPT codes 36568 
and 36569. The proposed work valuation was also based on the use of 
three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle 
or catheter, aspiration of the pleural space; without imaging 
guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with 
biopsy, single or multiple), and CPT code 64644 (Chemodenervation of 
one extremity; 5 or more muscles). All of these codes were recently 
reviewed with similar intensity, intraservice time, and total time 
values, and all three of them share a work RVU of 1.82.
    For CPT code 36573 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; age 5 years or older), we disagreed with the RUC-recommended 
work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining 
the current work RVU of CPT code 36569. In our review of CPT code 
36573, we were again concerned about the possibility that the 
recommended work RVU of 1.90 could create a rank order anomaly in terms 
of intensity with the other codes in the family. We noted that the 
recommended intraservice time for CPT code 36573 as compared to CPT 
code 36569, the most similar code in the family, was decreasing from 27 
minutes to 15 minutes (45 percent), and the recommended total time was 
decreasing from 60 minutes to 40 minutes (33 percent); however, the 
RUC-recommended work RVU was exactly the same for these two codes at 
1.90. Although we did not imply that the decreases 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 
reflected in decreases to work RVUs.
    In the case of CPT code 36573, we believed that it would be more 
accurate to propose a work RVU of 1.70 based on maintaining the current 
work RVU of CPT code 36569. These two CPT codes describe the same 
procedure done with (CPT code 36573) and without (CPT code 35659) 
imaging guidance and radiological supervision and interpretation. 
Because the inclusion of the imaging described by CPT code 36573 has 
now become the typical case for this service, we believe that it is 
more accurate to maintain the current work RVU of 1.70 as opposed to

[[Page 59531]]

increasing the work RVU to 1.90, especially considering that the new 
surveyed work time for CPT code 36573 is lower than the current work 
time for CPT code 36569. The proposed work RVU of 1.70 was also based 
on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally 
inserted central venous catheter; age 5 years or older). This is a 
recently reviewed code with the same 15 minutes of intraservice time 
and the same 40 minutes of total time with a work RVU of 1.75.
    For CPT code 36584, we disagreed with the RUC-recommended work RVU 
of 1.47 and proposed a work RVU of 1.20 based on maintaining the 
current work RVU. We noted that the recommended intraservice time for 
CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent 
reduction), and the recommended total time was decreasing from 45 
minutes to 34 minutes (25 percent reduction); however, the recommended 
work RVU was increasing from 1.20 to 1.47, an increase of approximately 
23 percent. Although we did not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believed that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. We were especially 
concerned when the recommended work RVU is increasing despite survey 
results indicating that the work time is decreasing due to a 
combination of improving technology and greater efficiencies in 
practice patterns.
    In the case of CPT code 36584, we believed that it would be more 
accurate to propose a work RVU of 1.20 based on maintaining the current 
work RVU for the code. Because the inclusion of the imaging has now 
become the typical case for this service, we believed that it was more 
accurate to maintain the current work RVU of 1.20 as opposed to 
increasing the work RVU to 1.47, especially considering that the new 
surveyed work time for CPT code 36584 was decreasing from the current 
work time. The proposed work RVU of 1.20 was also based on a crosswalk 
to CPT code 40490 (Biopsy of lip), which has the same total time of 34 
minutes and slightly higher intraservice time at a work RVU of 1.22.
    We noted that the RUC-recommended work pool was increasing by 
approximately 68 percent for the PICC Line Procedures family as a 
whole, while the RUC-recommended work time pool for the same codes was 
only increasing by about 22 percent. Since time is defined as one of 
the two components of work, we believe that this indicated a 
discrepancy in the recommended work values. 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 did 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 believe that, generally speaking, 
the recoding of a family of services should maintain the same total 
work pool, as the services themselves are not changing, only the coding 
structure under which they are being reported. We also noted 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 three times for CPT codes 
36568, 76937, and 77001, but preservice times were assigned to all of 
the codes under the old coding. We believed 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.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity from 4 minutes to 2 minutes 
for CPT codes 36572 and 36573. We noted that the two reference codes 
for the two new codes, CPT codes 36568 and 36569, currently have 2 
minutes assigned for this activity, and CPT code 36584 also has a 
recommended 2 minutes assigned to this same activity. We did not agree 
that the patient positioning would take twice as long for CPT codes 
36572 and 36573 as compared to the rest of the family, and therefore 
proposed to refine both of them to the same 2 minutes of clinical labor 
time. We also proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the PICC Line Procedures family of codes.
    Comment: One commenter stated that CMS believes it is not accurate 
to ``increase'' work RVUs when survey results indicate that work time 
is ``decreasing'' due to improving technology and greater efficiencies 
in practice patterns. The commenter disagreed that the difference 
between the current codes (without imaging guidance) and the new 
bundled codes (with imaging guidance) could be characterized as an 
``increase'' or a ``decrease,'' as it was inappropriate simply to 
compare the RVUs of the bundled codes to the existing codes, because 
the bundled codes include imaging services that involve significantly 
more intense physician work than PICC line insertion without imaging 
guidance.
    Response: We disagree with the commenter that it is 
methodologically inappropriate to characterize changes in surveyed work 
time as ``increases'' or ``decreases''. As we stated in the proposed 
rule, we do not believe that the revised coding of the services in this 
family has changed the services themselves or resulted in an increase 
in their intensity, only changed in the way in which they will be 
reported under the new coding. CPT code 36572 is a new code resulting 
from the bundling together of CPT code 36568 with imaging guidance. The 
same services that were previously reported through a combination of 
CPT codes 36568 and 76397 will now be reported under CPT code 36572. We 
believe that it is highly relevant to note how the recommended work 
times for CPT code 36572 compare to the recommended work times for CPT 
code 36568, which includes noting that the intraservice time is 
decreasing from 38 minutes to 22 minutes (42 percent), and the 
recommended total time is decreasing from 71 minutes to 51 minutes (38 
percent). We also do not agree that it is inappropriate to compare the 
RVUs of the bundled codes to the existing codes, as all of these 
procedures describe clinically similar procedures that together 
comprise a family of codes. In more general terms, we continue to 
believe that the nature of the PFS relative value system is such that 
all services are appropriately subject to comparisons to one another. 
Although codes with clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must both include imaging 
guidance or not include imaging guidance to be used as a crosswalk.
    Comment: Several commenters disagreed that the recoding of the 
services in the PICC line code family had only resulted in a change in 
the way that services will be reported, and stated that that the 
imaging-related services now bundled into CPT codes 36572, 36573, and 
36584 are significantly more intense than PICC line insertion standing 
alone. One commenter stated that valuing a code using imaging guidance 
the same or less than the same code without imaging guidance is

[[Page 59532]]

specious and treats the use of imaging guidance as a negative work 
component when in fact there is additional work required in using 
imaging guidance. Commenters stated that the RUC-recommended values 
already reflect efficiencies in radiology work, and that the efficiency 
of radiologists should not diminish the RUC's recognition that their 
work is significantly more intense in these procedures.
    Response: We disagree with the commenters that the addition of 
imaging guidance has made CPT codes 36572, 36573, and 36584 
significantly more intense than the non-imaging guidance version of 
these procedures. While the incorporation of new technology can 
sometimes make services more complex and difficult to perform, it can 
also have the opposite effect by making services less reliant on manual 
skill and technique. We believe that if these procedures were 
significantly more intensive to perform, this would be reflected in the 
surveyed work times associated with these codes. However, the surveyed 
work times are instead decreasing in all three cases in comparison to 
the current non-imaging guidance version of the same services. As we 
stated in the proposed rule, we believe that the work times for these 
services are decreasing due to a combination of improving technology 
and greater efficiencies in practice patterns. Based on the RUC-
recommended utilization crosswalk for these services, which has 90 to 
95 percent of the utilization expected to be reported under the new 
codes that include imaging guidance, we believe that the use of imaging 
guidance has become typical for these services and does not represent a 
dramatic increase in intensity.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.82 for CPT code 36572 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that the CMS use of a 
crosswalk to CPT code 50435 was unsupported on a clinical basis, with 
significant differences in work intensity and patient population. 
Commenters stated that CPT code 36572 involves establishing new deep 
venous access on a pediatric patient while ensuring maximum sterile 
barrier technique so as to prevent a hospital acquired infection, 
whereas CPT code 50435 involves the exchange of an existing catheter in 
an adult who understands the procedure involved and has had previous 
catheter exchanges to maintain patency. One commenter stated that the 
RUC crosswalk to CPT code 19283 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds)) was a more accurate choice because this service also uses 
imaging guidance to obtain de novo percutaneous access to a target and 
perform an intervention. Commenters stated that the crosswalk code 
would frequently be less intense than CPT code 36572.
    Response: We disagree with the commenters that the work involved in 
CPT code 50435 would be less clinically intense than the work in CPT 
code 36572. We believe that the exchange of a nephrostomy catheter 
taking place in CPT code 50435 is more difficult than the placement of 
a breast localization device as in the RUC crosswalk to CPT code 19283, 
percutaneous; first lesion, including stereotactic guidance). We also 
disagree with the commenters that the crosswalk we identified lacks 
clinical similarity to CPT code 36572. Both the reviewed code and the 
crosswalk to CPT code 50435 involve the percutaneous placement of a 
catheter in a deep structure; we believe that this crosswalk code is 
more clinically similar than the RUC's choice of a crosswalk to CPT 
code 19283, which does not involve catheter placement at all.
    Commenter: Several commenters disagreed that the RUC-recommended 
work RVU of 2.00 for CPT code 36572 would create a rank order anomaly 
within the family of codes. Commenters stated that since CPT code 36568 
requires more physician time to complete than CPT code 36572 (38 versus 
22 minutes intra-service time), the recommended work RVU of 2.00 for 
CPT code 36572 maintains the proper rank order within this family of 
services considering differences in patient population and differences 
in clinical intensity of work.
    Response: The commenters did not address the concerns we expressed 
regarding a potential rank order anomaly within the family. We noted in 
the proposed rule that CPT code 36572 had a lower recommended 
intraservice time and total time as compared to CPT code 36569 (not CPT 
code 36568), yet had a higher recommended work RVU. We continue to 
believe that this creates the potential for a rank order anomaly within 
the family, and we do not believe that this discrepancy can be 
justified by differences in patient population and differences in 
clinical intensity of work.
    Comment: Several commenters disagreed with the CMS statement that 
the reduced intraservice and total times in CPT code 36572 as compared 
to CPT code 36568 should result in a lower work value. Commenters 
stated that this was a simplistic comparison based on time, and that 
these were two technically different procedures, involving different 
patient populations and different service intensity. Commenters stated 
that each step in the non-image guided CPT code 36568 takes longer, 
though involves more periods of low intensity intraservice work as 
compared to CPT code 36572, where each procedural step is performed 
sequentially without the less intense intraservice work of the non-
image guided CPT code 36568.
    Response: We disagree with the commenters that the reductions in 
intraservice and total work time in CPT code 36572 as compared to CPT 
code 36568 should not result in a lower work value. Although we do not 
imply that the decreases in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we continue to believe that, since the two components of work are 
time and intensity, significant decreases in time should typically be 
reflected in decreases to work RVUs. We disagree that this is a 
simplistic comparison, and chose a crosswalk to CPT code 50435 to 
better fit with the recommended work RVUs for CPT codes 36568 and 
36569.
    We also do not agree that CPT codes 36568 and 36572 have 
significantly different patient populations and different service 
intensity. As we stated in the proposed rule, we do not believe that 
the revised coding of the services in this family has changed the 
services themselves or resulted in an increase in their intensity, only 
changed in the way in which they will be reported under the new coding. 
CPT code 36572 is a new code resulting from the bundling together of 
CPT code 36568 with imaging guidance. The same services that were 
previously reported through a combination of CPT codes 36568 and 76397 
will now be reported under CPT code 36572. Given that 90 percent of the 
services that were formerly reported using CPT code 36568 will now be 
reported using CPT code 36572, we do not agree that these codes 
represent significantly different patient populations.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.70 for CPT code 36573 and stated that CMS should finalize the RUC-
recommended work RVU of 1.90. Commenters stated that CMS should not use 
a code value that is no longer in existence as the service (CPT code 
36569) itself has been revised and is currently under review in this 
family. Commenters stated that the reference was therefore not valid to 
the old work RVU.

[[Page 59533]]

    Response: We disagree with the commenters that it is somehow 
invalid to use a crosswalk to the current work RVU for CPT code 36569. 
It is not accurate to state that this code is no longer in existence, 
as it is being revised for CY 2019, not deleted. The RUC frequently 
recommends maintaining the current work RVU for reviewed codes rather 
than using a new work RVU from survey results when it believes that 
there is appropriate rationale to do so. Given that CPT code 36573 is a 
new code resulting from the bundling together of CPT code 36569 with 
imaging guidance, and that the use of imaging guidance has become 
typical in the performance of this service, we believe that it is 
appropriate to maintain the same work RVU for these services when they 
are reported under the new coding, especially in light of the fact that 
the surveyed intraservice work time for CPT code 36573 remains the same 
15 minutes as the current intraservice work time for CPT code 36569.
    Comment: Several commenters stated that CPT code 36573 involves a 
different patient population than CPT code 36569, as the patient 
population for CPT code 36573 does not have peripheral venous access 
present that can be used to obtain central venous access. Commenters 
stated that there is no evidence for a rank order anomaly within the 
codes in the family considering the differences in intensity and 
patient population.
    Response: As we stated previously with regard to CPT codes 36568 
and 36572, we also do not agree that CPT codes 36569 and 36573 have 
significantly different patient populations and different service 
intensity. As we stated in the proposed rule, we do not believe that 
the revised coding of the services in this family has changed the 
services themselves or resulted in an increase in their intensity, only 
changed in the way in which they will be reported under the new coding. 
CPT code 36573 is a new code resulting from the bundling together of 
CPT code 36569 with imaging guidance. The same services that were 
previously reported through a combination of CPT codes 36569 and 76397 
will now be reported under CPT code 36573. Given that 95 percent of the 
services that were formerly reported using CPT code 36569 are expected 
to be reported using CPT code 36573, we do not agree that these codes 
represent noticeably different patient populations.
    Comment: Several commenters disagreed with our use of CPT code 
36556 as a reference code. Commenters stated that CPT code 36556 
describes line placement in a larger and more central vein such as the 
internal jugular vein with known anatomical landmarks and a shorter 
distance between access and where the tip terminates centrally while 
CPT code 36573 describes access into a smaller vein without anatomic 
landmarks. Commenters stated that although imaging is inherent to CPT 
code 36573, the catheter is longer and there is a need to navigate the 
catheter through these peripheral and central veins for adequate 
placement, all of which would require more work.
    Response: We disagree with the commenters that CPT code 36556 would 
not be an accurate reference code for CPT code 36573. CPT code 36556 
describes the insertion of non-tunneled centrally inserted central 
venous catheter whereas CPT code 36573 describes the insertion of a 
peripherally inserted central venous catheter (PICC). We believe that 
these two codes, which both describe the insertion of central venous 
catheters, are highly similar to one another on a clinical basis and 
also from the perspective of work time, as they share the identical 
intraservice work time and total work time. Moreover, after further 
consideration, we are not able to identify any other more appropriate 
reference code for CPT code 36573 than CPT code 36556.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.20 for CPT code 36584 and stated that CMS should finalize the RUC-
recommended work RVU of 1.47. Commenters stated that CMS was completely 
dismissing the additional work that was bundled in with CPT code 36584 
as part of the imaging guidance. Commenters stated that the RUC agreed 
that the recommended work RVU of 1.47 involves less time but involves a 
significant increase in intensity, and that the work RVU should not 
remain at the current work RVU of 1.20 as CPT code 36584 is now a 
bundled service.
    Response: We disagree with the commenters that the bundling of a 
service or the addition of imaging guidance must necessarily increase 
the intensity of the service or the work RVU. As we stated above, while 
the incorporation of new technology can sometimes make services more 
complex and difficult to perform, it can also have the opposite effect 
by making services less reliant on manual skill and technique. We 
believe that if CPT code 36584 had become significantly more intensive 
to perform, this would be reflected in the surveyed work times 
associated with the code. However, the surveyed intraservice work time 
and total work time for CPT code 36584 are both decreasing from their 
current values. As we stated in the proposed rule, we believe that 
these work times are decreasing due to a combination of improving 
technology and greater efficiencies in practice patterns, and we 
believe that the use of imaging guidance has become now typical for CPT 
code 36584 and does not represent a dramatic increase in intensity.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Prepare, set-up and start IV, initial 
positioning and monitoring of patient'' (CA016) activity from 4 minutes 
to 2 minutes for CPT codes 36572 and 36573. Commenters stated that this 
additional clinical labor time would be typical since it included 
positioning of the patient as well as positioning the two forms of 
imaging equipment which are being bundled into the code (fluoroscopy 
and ultrasound). Commenters stated that the equipment needs to be 
positioned in a manner that is specific to the procedure and the chosen 
extremity, and that it takes approximately 2 additional minutes to 
position the patient and the equipment for those codes which are 
imaging-guided as opposed to those procedures which are not. Commenters 
stated that this difference applies to the two new placement codes (CPT 
code 36572 and 36573) but not to the replacement code (CPT code 36584) 
as the equipment is limited to fluoroscopy and the positioning is 
slightly simpler as the site already contains a PICC line.
    Response: After consideration of the new information provided by 
the commenters regarding the need for additional positioning time, we 
are not finalizing our proposed refinement to the CA016 clinical labor 
time. Due to this change in clinical labor time, we are also not 
finalizing any changes to the RUC-recommended equipment times.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the PICC Line Procedures family as proposed. 
After considering public comments, we are not finalizing our proposed 
direct PE refinements, and we are instead finalizing the RUC-
recommended direct PE inputs for all five codes.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)
    In September 2017, the CPT Editorial Panel created a new code to 
describe biopsy or excision of inguinofemoral node(s). A parenthetical 
was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 
(Vulvectomy, radical, complete) to instruct separate reporting of CPT 
code 38531 with radical

[[Page 59534]]

vulvectomy. This service was previously reported with unlisted codes.
    CPT code 38531 (Biopsy or excision of lymph node(s); open, 
inguinofemoral node(s)) is a new CPT code describing a lymph node 
biopsy without complete lymphadenectomy. The RUC recommended a work RVU 
of 6.74 for CPT code 38531, with 223 minutes of total time and 65 
minutes of intraservice time. We proposed the RUC-recommended work RVU 
of 6.74 for CPT code 38531. However, we were concerned that this CPT 
code is described as having a 10-day global period. The two CPT codes 
that are often reported together with this code, CPT codes 56630 and 
56633, are both 90-day global codes. In addition, CPT code 38531 has a 
discharge visit and two follow up visits in the global period. This is 
consistent with the number of postoperative visits typically associated 
with 90-day global codes. Therefore, we proposed to assign a 90-day 
global indicator for CPT code 38531 rather than the 10-day global time 
period reflected in the RUC recommendation.
    We did not propose any direct PE refinements for this code family.
    Comment: Several commenters thanked us for proposing the RUC-
recommended work RVU of 6.74 for CPT code 38531.
    Response: We appreciate the support from commenters.
    Comment: Several stakeholders disagreed with CMS's proposal to 
change the global status of this code from a 10-day global code to a 
90-day global code. They maintained that there are no claims data 
available to assess how often CPT code 38531 will be billed together 
with CPT codes 56630 or 56633. Commenters also noted that there is no 
necessary direct correlation between the two codes (CPT code 56630 and 
CPT code 56633) having a 90-day global period and the new code having a 
90-day global period.
    Response: We agree with commenters that when two or more closely 
related CPT codes are billed together, there is no requirement for them 
to share the same global period. However, the amount of post service 
time and the number of visits in CPT code 38531 are consistent with 
other 90-day global codes. We continue to believe that CPT code 38531 
should have a 90-day global period and we are finalizing that change as 
proposed.
    Comment: A few commenters pointed out that CMS has the opportunity 
to review the global periods for new codes directly after CPT Editorial 
Panel meetings, and that CMS should have provided input regarding the 
code's global period at that time.
    Response: While some of our staff have the opportunity to review 
global periods for new or modified CPT codes immediately after the CPT 
Editorial Panel meeting, the Agency does not systematically review or 
provide feedback on components of a CPT code, including global period, 
until we fully consider and address the code as part of the annual PFS 
notice-and-comment rulemaking process.
    After consideration of the public comments, we are finalizing a 
work RVU of 6.74 for CPT code 38531 as proposed.
(17) Radioactive Tracer (CPT Code 38792)
    CPT code 38792 (Injection procedure; radioactive tracer for 
identification of sentinel node) 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. For CY 2019, we proposed the RUC-recommended 
work RVU of 0.65 for CPT code 38792.
    For the direct PE inputs, we proposed 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. CPT code 38792, 
as well as its alternate reference code, CPT code 78300 (Bone and/or 
joint imaging; limited area), did not previously have clinical labor 
time assigned for the ``Confirm order, protocol exam'' clinical labor 
task, and we do not have any reason to believe that the services being 
furnished by the clinical staff have changed, only the way in which 
this clinical labor time has been presented on the PE worksheets. 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 also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 38792.
    Comment: A commenter stated that they appreciated and supported our 
proposal to adopt the RUC-recommended work RVU of 0.65. The commenter 
also stated that they agreed with and supported the changes CMS 
proposed in clinical labor time and the standardized equipment time 
formulas.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 38792 as proposed.
(18) Percutaneous Change of G-Tube (CPT Code 43760)
    CPT code 43760 (Change of gastrostomy tube, percutaneous, without 
imaging or endoscopic guidance) was identified as potentially misvalued 
on a screen of 0-day global services reported with an E/M visit 50 
percent of the time or more, on the same day of service by the same 
patient and the same practitioner, that have not been reviewed in the 
last 5 years with Medicare utilization greater than 20,000. It was 
surveyed for the April 2017 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS. However, the RUC also noted 
that because the data for CPT code 43760 were bimodal, it might be 
appropriate to consider changes in the CPT descriptors to better 
differentiate physician work. In September 2017, the CPT Editorial 
Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes 
43762 and 43763, which describe replacement of gastrostomy tube, with 
and without revision of gastrostomy tract, respectively. (See 
discussion of these codes below.) Therefore, we did not propose work or 
direct PE values for CPT code 43760.
    Due to the impending deletion of CPT code 43760, we received no 
comments on this code.
(19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)
    In September 2017, the CPT Editorial Panel created two new codes 
that describe replacement of gastrostomy tube, with and without 
revision of gastrostomy tract, respectively. These two new codes were 
surveyed for the January 2018 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS.
    We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of 
gastrostomy tube, percutaneous, includes removal, when performed, 
without imaging or endoscopic guidance; not requiring revision of 
gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763 
(Replacement of gastrostomy tube, percutaneous, includes removal, when 
performed, without imaging or endoscopic guidance; requiring revision 
of gastrostomy tract.), consistent with the RUC's recommendations for 
these new CPT codes.

[[Page 59535]]

    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the codes in the Gastrostomy Tube Replacement 
code family.
    Comment: Several commenters stated that they appreciated CMS 
proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was added to the calculation of the equipment 
time, and that this made it difficult to determine the accuracy of the 
refinements. The commenter requested more information about this 
change.
    Response: For the four equipment items where we made time 
refinements, we added the clinical labor for the CA029 clinical labor 
activity in accordance with our standard equipment time formula for 
non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for the codes in the as Gastrostomy Tube 
Replacement code family as proposed.
(20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)
    CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or 
without collection of specimen(s) by brushing or washing (separate 
procedure)) was identified as potentially misvalued on a screen of 0-
day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years, with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.80 for CPT code 45300.
    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 45300.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the four equipment items where we made time 
refinements, we removed the clinical labor for the CA035 clinical labor 
activity in accordance with our standard equipment time formula for 
non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 45300 as proposed.
(21) Hemorrhoid Injection (CPT Code 46500)
    CPT code 46500 (Injection of sclerosing solution, hemorrhoids) 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.
    For CPT code 46500, we disagreed with the RUC-recommended work RVU 
of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk 
to CPT code 68811 (Probing of nasolacrimal duct, with or without 
irrigation; requiring general anesthesia). This crosswalk code is 
another recently-reviewed 10-day global code with the same 10 minutes 
of intraservice time and slightly higher total time. When CPT code 
46500 was previously reviewed as described in the CY 2016 PFS final 
rule with comment period (80 FR 70963), we finalized a proposal to 
reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by 
the same ratio as the reduction in the total work time. In light of the 
additional evidence provided by this new survey, we agree that the work 
RVU should be increased from the current value of 1.42. However, we 
believe that our proposed work RVU of 1.74 based on a crosswalk to CPT 
code 68811 is more accurate than the RUC-recommended work RVU of 2.00.
    In the most recent survey of CPT code 46500, the intraservice work 
time remained unchanged at 10 minutes while the total time increased by 
only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent). 
However, the RUC-recommended work RVU is increasing from 1.42 to 2.00, 
an increase of 41 percent, and also an increase of 19 percent over the 
historic value of 1.69 for CPT code 46500. Although we did not imply 
that the increase in time as reflected in survey values must equate to 
a one-to-one or linear increase in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
minimal increases in surveyed work time typically should not be 
reflected in disproportionately large increases to work RVUs. In the 
case of CPT code 46500, we believe that our crosswalk to CPT code 68811 
at a work RVU of 1.74 more accurately maintains relativity with other 
10-day global codes on the PFS. We also noted that the 3 percent 
increase in surveyed work time for CPT code 46500 matches a 3 percent 
increase in the historic work RVU of the code, from 1.69 to 1.74. 
Therefore, we proposed a work RVU of 1.74 for CPT code 46500 based on 
the aforementioned crosswalk.
    For the direct PE inputs, we proposed to remove 10 minutes of 
clinical labor time for the ``Assist physician or other qualified 
healthcare professional--directly related to physician work time 
(100%)'' (CA018) activity. This clinical labor time is listed twice in 
the recommendations along with a statement that although the clinical 
labor has not changed from prior reviews, time for both clinical staff 
members was inadvertently not included in the previous spreadsheets. We 
appreciated this notification in the recommendations, and therefore, we 
requested more information about why the clinical labor associated with 
this additional staff member was left out for previous reviews. We were 
particularly interested in knowing what activities the additional staff 
member would be undertaking during the procedure. We proposed to remove 
the clinical labor associated with this additional clinical staff 
member pending the receipt of additional information. We also proposed 
to remove 1 impervious staff gown (SB027), 1 surgical mask with face 
shield (SB034), and 1 pair of shoe covers (SB039) pending more 
information about the additional clinical staff member.
    We proposed to remove the clinical labor time for the ``Review home 
care instructions, coordinate visits/prescriptions'' (CA035) activity. 
CPT code 46500 is typically billed with a same day E/M service, and we 
believe that it would be duplicative to assign clinical labor time for 
reviewing home care instructions given that this task would typically 
be done during the same day E/M service. We also proposed to refine the 
equipment times in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 46500.
    Comment: Many commenters disagreed with the proposed work RVU

[[Page 59536]]

of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that they disagreed 
with CMS calculating intraservice time ratios to account for changes in 
work time, and that CPT code 46500 possesses a negative IWPUT, which 
makes the use of time ratios particularly inappropriate.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several reasonable methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values do not account for information 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology, we direct readers to the CY 
2017 PFS final rule (81 FR 80272 through 80277). We also note that in 
the case of CPT code 46500, we derived our proposed work RVU of 1.74 by 
using a direct crosswalk to CPT code 68811 and not a time ratio.
    Comment: Several commenters stated that the RUC compared CPT code 
46500 to the two key reference services: CPT code 46221 
(Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code 
46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g., 
infrared coagulation, cautery, radiofrequency)). Commenters stated that 
the RUC-recommended work RVU of 2.00 places the value correctly between 
the key reference services and results in similar procedure intensity, 
whereas the CMS crosswalk to CPT code 68811 was not well aligned with 
the top two key reference services due to having a lower intensity.
    Response: We disagree with the commenters that our crosswalk to CPT 
code 68811 would be less accurate for work valuation than the two key 
references chosen by the survey respondents. We note, for example, that 
CPT code 46221 has 50 percent more intraservice time than CPT code 
46500, and CPT code 46930 has 50 percent less intraservice time than 
CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the 
same 10 minutes of intraservice time as CPT code 46500. We believe that 
this closer match in the work time values makes CPT code 68811 a more 
appropriate choice for a crosswalk code. We also note that at the RUC 
meeting when CPT code 46500 was under review, the specialty presenters 
stated that the work RVU had not changed from the historical value of 
1.69 before the recommendation was changed to the final value of 2.00. 
As we stated in the proposed rule, the 3 percent increase in surveyed 
work time for CPT code 46500 matches a 3 percent increase in the 
historic work RVU of the code, from 1.69 to 1.74. We continue to 
believe that this is the most accurate value to finalize for CPT code 
46500.
    Comment: Several commenters compared CPT code 46500 to CPT code 
68810 (Probing of nasolacrimal duct, with or without irrigation) and 
noted that these codes have the same intraservice work time but the 
comparison code includes a lower level follow-up visit and therefore 
correctly has a lower work RVU. Commenters stated that CPT code 46500 
includes a follow-up office visit with an anoscopy to determine the 
effectiveness of the treatment and to monitor for infection or sepsis 
which adds work to the visit. Commenters stated that the proposed CMS 
crosswalk to CPT code 68811 includes an even lower level office visit 
(CPT code 99211) than the office visit in CPT code 68810, which 
indicated that it was an inappropriate choice for a crosswalk.
    Response: We continue to disagree with the commenters that the CMS 
crosswalk to CPT code 68811 would provide an inappropriate work 
valuation for CPT code 46500 based on the differences in postoperative 
work and work time. We would like to clarify again that we used CPT 
code 68811 as our crosswalk, not CPT code 68810, and we do not 
understand the comparisons to CPT code 68810 suggested by the 
commenters. Regarding our crosswalk code, while it is true that CPT 
code 68811 does not contain a level three (CPT code 99213) office visit 
in its global period like CPT code 46500, the code does include half of 
a discharge visit (CPT code 99238) in its global period, which is 
missing from the reviewed code. Under the building block methodology, 
the combined work RVU and the work time of a half discharge visit (CPT 
code 99238) and a level 1 office visit (CPT code 99211) would equal 
0.82 RVUs and 26 minutes. This is approximately equal to the level 3 
office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work 
time) in the global period of CPT code 46500. As a result, we do not 
agree with the commenters that CPT code 46500 has a significantly 
greater amount of postservice work and postservice work time than our 
crosswalk code.
    Comment: Several commenters responded to our request for more 
information about why the clinical labor associated with the additional 
staff member was left out of previous reviews and what activities the 
additional staff member would be undertaking during the procedure. 
Commenters stated that two clinical staff are needed to assist the 
physician during the intraservice portion of the service: one staff 
person is handling suction and holding the retractor while the surgeon 
identifies and injects anesthetic and sclerosant into the poles of the 
hemorrhoids, and the second staff person is handing supplies (syringes, 
gauze) and taking soiled supplies away. The commenters stated that one 
staff person will assist with tasks such as irrigation, suction, etc. 
and one circulating staff person will hand syringes, sponges, etc. to 
the physician.
    Response: We appreciate the additional feedback from the commenters 
regarding what activities the additional staff member would be 
undertaking during the procedure, although we note that we did not 
receive a response regarding why the clinical labor associated with 
this additional staff member was left out of previous reviews. After 
reviewing the

[[Page 59537]]

additional information supplied by the commenters, we are not 
finalizing our proposal to remove the clinical labor time for the 
``Assist physician or other qualified healthcare professional'' (CA018) 
activity or the proposal to remove 1 impervious staff gown (SB027), 1 
surgical mask with face shield (SB034), and 1 pair of shoe covers 
(SB039). We are finalizing the RUC-recommended values for these direct 
PE inputs.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Review home care instructions, 
coordinate visits/prescriptions'' (CA035) activity. Commenters stated 
that this clinical activity was not duplicative with the same day E/M 
office visit, as the home care instructions directly pertain to the 
procedure and would not be provided during an evaluation of the 
patient.
    Response: We disagree with the commenters that home care 
instructions would not be provided during the same day E/M visit. The 
commenters did not provide a rationale to explain why home care 
instructions would not be provided during the same day E/M visit, which 
also directly pertains to the procedure. We continue to believe that it 
would be duplicative to assign clinical labor time for this task, as we 
believe that the home care instructions would be furnished during the 
same day E/M visit.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the anoscope with light source (ES002) equipment, we 
removed the clinical labor for the CA029 and CA035 clinical labor 
activities in accordance with our standard equipment time formula for 
scopes.
    After consideration of the public comments, we are finalizing the 
work RVU for CPT code 46500 as proposed. We are finalizing the RUC-
recommended direct PE inputs for this code, with the exception of our 
refinement to the CA035 clinical labor activity and standard equipment 
time refinements as detailed above.
(22) Removal of Intraperitoneal Catheter (CPT Code 49422)
    In October 2016, CPT code 49422 (Removal of tunneled 
intraperitoneal catheter) was identified as a site of service anomaly 
because Medicare data from 2012-2014 indicated that it was performed 
less than 50 percent of the time in the inpatient setting, yet it 
included inpatient hospital E/M services within the 10-day global 
period. The code was resurveyed using a 0-day global period for the 
April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended 
work RVU of 4.00 for CPT code 49422.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 49422.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs. Commenters also supported the change in global 
period to a 0-day global.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU and direct PE inputs for CPT code 49422 as 
proposed.
(23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and 
74485)
    In October 2014, the CPT Editorial Panel deleted 6 codes and 
created 12 new codes to describe genitourinary catheter procedures and 
bundle inherent imaging services. In January 2015, the specialty 
societies indicated that CPT code 50395 (Introduction of guide into 
renal pelvis and/or ureter with dilation to establish nephrostomy 
tract, percutaneous), which was identified as part of the family, would 
be referred to the CPT Editorial Panel to clear up any confusion with 
overlap in physician work with CPT code 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). In September 2017, the CPT Editorial Panel deleted CPT 
code 50395 and created 2 new codes to report dilation of existing 
tract, and establishment of new access to the collecting system, 
including percutaneous, for an endourologic procedure including imaging 
guidance (e.g., ultrasound and/or fluoroscopy), all associated 
radiological supervision and interpretation, as well as post procedure 
tube placement when performed.
    The specialty society surveyed the new CPT code 50436 (Dilation of 
existing tract, percutaneous, for an endourologic procedure including 
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all 
associated radiological supervision and interpretation, as well as post 
procedure tube placement, when performed), and the RUC recommended a 
total time of 70 minutes, intraservice time of 30 minutes, and a work 
RVU of 3.37. The RUC indicated that its recommended work RVU for this 
CPT code is identical to the work RVU of the CPT code being deleted, 
even though imaging guidance CPT code 74485 has now been bundled into 
the valuation of the CPT code. The RUC provided two key reference CPT 
codes to support its recommendation: CPT code 50694 (Placement of 
ureteral stent, percutaneous, including diagnostic nephrostogram and/or 
ureterogram when performed, imaging guidance (e.g., ultrasound and/or 
fluoroscopy), and all associated radiological supervision and 
interpretation; new access, without separate nephrostomy catheter) with 
total time of 111 minutes, intraservice time of 62 minutes, and a work 
RVU of 5.25; and CPT code 50695 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, with separate nephrostomy catheter), with total time of 124 
minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To 
further support its recommendation, the RUC also referenced CPT code 
52287 (Cystourethroscopy, with injection(s) for chemodenervation of the 
bladder) with total time of 58 minutes, intraservice time of 21 
minutes, and a work RVU of 3.37.
    We disagreed with the RUC that the work RVU for this CPT code 
should be the same as the CPT code being deleted. Survey respondents 
indicated that the total time for completing the service described by 
the new CPT code is nearly 30 minutes less than the existing CPT code, 
even though imaging guidance was described as part of the procedure. We 
also noted that the reference CPT codes both have substantially higher 
total and intraservice times than CPT code 50436. We considered a 
number of parameters to arrive at our proposed work RVU of 2.78, 
supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or 
flexible, including fluoroscopic guidance, when performed; with 
therapeutic aspiration of tracheobronchial tree, subsequent, same 
hospital stay). We examined the intraservice time ratio for the new CPT 
code in relation to the combination of CPT codes that the service 
represents and found that this would support a work RVU of 2.55. We 
also calculated the intraservice time ratio for the new CPT code in 
relation to each of the two

[[Page 59538]]

reference CPT codes. For the comparison with CPT code 50694, the 
intraservice time ratio is 2.54, while the comparison with the second 
reference CPT code 50695 yields an intraservice time ratio of 2.72. We 
took the highest of these three values, 2.72, and found a corresponding 
crosswalk that we believe appropriately values the service described by 
the new CPT code. Therefore, we proposed a work RVU of 2.78 for CPT 
code 50436.
    The specialty society also surveyed the new CPT code 50437 
(Dilation of existing tract, percutaneous, for an endourologic 
procedure including imaging guidance (e.g., ultrasound and/or 
fluoroscopy) and all associated radiological supervision and 
interpretation, as well as post procedure tube placement, when 
performed; including new access into the renal collecting system) and 
the RUC recommended a total time of 100 minutes, an intraservice time 
of 60 minutes, and a work RVU of 5.44. The recommended intraservice 
time of 60 minutes reflects the 75th percentile of survey results, 
rather than the median survey time, which is typically used for 
determining the intraservice time for new CPT codes. The RUC justified 
the use of the higher intraservice time because they believe the time 
better represents the additional time needed to introduce the guidewire 
into the renal pelvis and/or ureter, above and beyond the work involved 
in performing CPT code 50436. The RUC compared this CPT code to CPT 
code 52235 (Cystourethroscopy, with fulguration (including cryosurgery 
or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to 
5.0 cm)), with total time of 94 minutes, intraservice time of 45 
minutes, and a work RVU of 5.44. The RUC also cited as support the 
second key reference CPT code 50694 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, without separate nephrostomy catheter) with total time 111 
minutes, intraservice time 62 minutes, and a work RVU of 5.25.
    We did not agree with the RUC's recommended work RVU because we 
believed that the intraservice time for this CPT code should reflect 
the survey median rather than the 75th percentile. There is no 
indication that the additional work of imaging guidance was 
systematically excluded by survey respondents when estimating the time 
needed to furnish the service. Therefore, we proposed to reduce the 
intraservice time for CPT code 50437 from the RUC- recommended 60 
minutes to the survey median time of 45 minutes. We noted that this is 
still 15 minutes more than the intraservice time for CPT code 50436, 
primarily for the provider to introduce the guidewire into the renal 
pelvis and/or ureter. We welcomed comments about the amount of time 
needed to furnish this procedure.
    With the revised intraservice time of 45 minutes and a total time 
of 85 minutes, we believed that the RUC-recommended work RVU for this 
CPT code is overstated. When we applied the increment between the RUC-
recommended values for between CPT codes 50436 and 50437 (2.07 work 
RVUs) in addition to our proposed work RVU for CPT code 50436, we 
estimated that this CPT code was more accurately represented by a work 
RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 
(Introduction of needle(s) and/or catheter(s), dialysis circuit, with 
diagnostic angiography of the dialysis circuit, including all direct 
puncture(s) and catheter placement(s), injection(s) of contrast, all 
necessary imaging from the arterial anastomosis and adjacent artery 
through entire venous outflow including the inferior or superior vena 
cava, fluoroscopic guidance, radiological supervision and 
interpretation and image documentation and report; with transluminal 
balloon angioplasty, peripheral dialysis segment, including all imaging 
and radiological supervision and interpretation necessary to perform 
the angioplasty), which has an intraservice time of 40 minutes and a 
total time of 86 minutes. We believed that CPT code 36902 describes a 
service that is similar to the new CPT code 50437) and therefore 
provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT 
code 50437.
    We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334 
(Cystourethroscopy with insertion of ureteral guide wire through kidney 
to establish a percutaneous nephrostomy, retrograde) and the RUC-
recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s) 
or urethra, radiological supervision and interpretation).
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Confirm availability of prior images/studies'' (CA006) 
activity for CPT code 52334. This code does not currently include this 
clinical labor time, and unlike the two new codes in the family (CPT 
codes 50436 and 50437), CPT code 52334 does not include imaging 
guidance in its code descriptor. When CPT code 52334 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, we believed that it would be 
duplicative to include this clinical labor time in CPT code 52334.
    The following is a summary of the public comments we received on 
our proposals involving the Dilation of Urinary Tract family of codes.
    Comment: Several commenters responded to our proposals regarding 
work RVUs for this family of codes. In general, commenters expressed 
support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83 
for CPT code 74485.
    Response: We are finalizing the work RVUs for each of these codes 
as proposed.
    Comment: Several commenters did not support our proposals regarding 
the work RVU for CPT codes 50436 and 50437. The RUC and other 
commenters stated that CMS misunderstood the RUC's summary of results 
(SOR) and the purpose of the reference codes and the code comparisons 
as part of their review process. They suggested that our rejection of 
the RUC recommendation for CPT code 50436 was based on a mistake about 
the codes that the RUC cited as reference codes.
    Response: We consider a variety of documents and data during our 
review of the RUC's recommended work RVU for a code. The two reference 
codes cited in the excel summary work RVU spreadsheet for CPT code 
50436 were CPT codes 50694 and 50695, while the two reference codes 
cited in the SOR were CPT codes 52287 52214. In other words, there was 
an inconsistency in the documentation. We believe that any of the four 
reference codes cited in the documentation and/or data are valid points 
of comparison for evaluating whether the RUC's recommended work RVUs 
are appropriate.
    Comment: Some commenters did not agree with CMS's use of 
intraservice time ratios as a factor in determining whether a CPT code 
is appropriately valued. The commenters maintained that CMS's use of 
these parameters is inappropriate and demonstrates our prioritization 
of time-related factors above the intensity and complexity of the 
service.
    Response: We routinely use intraservice time ratios to determine 
whether a recommended work RVU for a new CPT code adequately reflects 
efficiencies gained when codes are bundled and/or providers become more 
efficient at furnishing services and we disagree with commenters that 
time

[[Page 59539]]

ratios are an inappropriate metric. We identify a crosswalk for the 
purpose of establishing the work RVU by comparing the survey code to 
other codes in the PFS with similar intraservice and total times and 
also by considering the intensity among codes with similar times. We 
disagree that this means we are prioritizing time parameters over other 
factors that are relevant in considering a code's value.
    Comment: Commenters disagreed with CMS's proposed work RVU of 2.78 
for CPT code 50436, citing CMS's inappropriate use of time parameters 
in comparing this code with the deleted CPT code 50395.
    Response: Even after taking into consideration the bundling of the 
deleted code, CPT 50395, with CPT code 74485, we believe that there are 
efficiencies in the work that are not adequately reflected in the RUC-
recommended work RVU for this new code, CPT 50436. We examined a number 
of parameters in seeking an appropriate crosswalk code for CPT 50436, 
including the intraservice time ratio for this new code in relation to 
the combination of CPT codes that the service represents and the 
intraservice time ratio for the new code in relation to each of the 
RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the 
work RVU (2.78) corresponding to the most appropriate, and the highest, 
work RVU (2.72) associated with these calculations. Our identification 
of a crosswalk code is not dictated by the time parameter calculations 
alone, but rather is based on a combination of the time parameters and 
our understanding of the intensity involved in furnishing the service. 
If we had been looking only at time parameters, we might have chosen a 
CPT code with a work RVU closest to the lowest of the time parameter 
calculations (2.54). We continue to believe that the most appropriate 
crosswalk is CPT code 31646, and we are finalizing our proposed work 
RVU of 2.78 for CPT code 50436.
    Comment: As with CPT code 50436, commenters suggested that CMS 
mistook the codes included in the SOR as the codes that the RUC cited 
as reference codes.
    Response: As we indicated in our response to this comment for CPT 
code 50436, we consider all documentation and data provided by the RUC 
in our assessment of the work RVU for a code. The reference and 
comparison CPT codes cited in the SOR did not match those in the 
summary work RVU spreadsheet.
    Comment: Several commenters disagreed with our method of proposing 
a work RVU based on the incremental differences in the RUC-recommended 
work RVU between codes. Commenters stated that this erroneously 
considers all time components as having equal intensity.
    Response: We generally apply this methodology where we agree with, 
and seek to maintain the relativity between two codes reflected in the 
RUC recommendations, but we disagree with the RUC-recommended work RVU 
for one or both of the codes. We also considered, as an alternative, 
whether it would be more appropriate to use proportional increments 
rather than absolute differences between two RUC-recommended work RVUs. 
Under that scenario, we would have proposed a work RVU of 4.49 for CPT 
code 50437 [(2.78 * 5.44)/3.37 = 4.49]. However, since our general 
approach involves applying the absolute difference in work RVUs, our 
proposed value for CPT code 50437 was 4.83 work RVUs. We thank the 
commenter for pointing out our calculation error, due to which our 
proposed work RVU should have been 4.85 instead of 4.83. We continue to 
believe that relative difference in the RUC's recommendations for work 
RVUs between codes is a useful and appropriate tool for determining 
work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for 
CPT code 50437 based on a comparison with CPT code 36902, which has a 
work RVU of 4.83.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Confirm availability of prior images/
studies'' (CA006) activity for CPT code 52334. Commenters stated that 
the equivalent of the CA006 clinical labor activity did not exist when 
this service was last reviewed by the Practice Expense subcommittee in 
2002, and that many surgical procedures and other types of services 
that do not have imaging bundled involve the physician reviewing images 
and studies before performing the service. Commenters stated that this 
review is not duplicative with image-guidance codes as it instead 
involves reviewing distinct previous studies.
    Response: We continue to believe that this clinical labor time 
should be removed because it is duplicative, as CPT code 52334 would be 
billed together with a separate imaging code that already includes 
clinical labor time for confirming the availability of prior images 
when it is performed with imaging guidance. We believe that the 
commenters may be conflating the absence of the CA006 clinical labor 
activity when CPT code 52334 was previously reviewed with the lack of 
any clinical labor for reviewing images that did not exist previously 
in this specific code. There were hundreds of procedures that included 
clinical labor for reviewing images prior to the creation of the CA006 
clinical labor code, and CPT code 52334 was not one of them. Similarly, 
while we agree that there are many services that do not have bundled 
imaging and nonetheless include the physician reviewing images and 
studies before performing the service, this does not explain why CPT 
code 52334 would require clinical labor time for confirming the 
availability of prior images and studies when the service did not 
include this clinical labor time previously. We continue to believe 
that the inclusion of this clinical labor time would be duplicative for 
this service.
    Comment: One commenter requested that CPT code 52334 be added to 
the phase-in list for codes with significant PE RVU reductions.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. We proposed to exempt 
CPT code 52334 from the phase-in due to the fact that it is part of the 
same family of codes that included new CPT codes 50436 and 50437. We 
have previously finalized this policy through rulemaking, stating that 
significant coding revisions within a family of codes can change the 
relationships among codes to the extent that it changes the way that 
all services in the group are reported, even if some individual codes 
retain the same number or, in some cases, the same descriptor. 
Excluding codes from the phase-in when there are significant revisions 
to the code family also helps to maintain the appropriate rank order 
among codes in the family, avoiding years for which RVU changes for 
some codes in a family are in transition while others were fully 
implemented. For additional information regarding the phase-in of 
significant RVU reductions, we direct readers to the CY 2016 PFS final 
rule with comment period (80 FR 70927 through 70929).
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 
53852, and 53854)
    In September 2017, the CPT Editorial Panel created a new code (CPT 
code

[[Page 59540]]

53854) to report transurethral destruction of prostate tissue by 
radiofrequency-generated water vapor thermotherapy. CPT codes 53850 
(Transurethral destruction of prostate tissue; by microwave 
thermotherapy) and 53852 (Transurethral destruction of prostate tissue; 
by radiofrequency thermotherapy) were also included for review as part 
of the same family of codes.
    For CPT code 53850 (Transurethral destruction of prostate tissue; 
by microwave thermotherapy), the RUC recommended a work RVU of 5.42, 
supported by a direct crosswalk to CPT code 33272 (Removal of 
subcutaneous implantable defibrillator electrode) with a total time of 
151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. 
The RUC indicated that a work RVU of 5.42 accurately reflects the 
lowest value of the three CPT codes in this family. We proposed the 
work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
    The RUC recommended a work RVU of 5.93 for CPT code 53852 
(Transurethral destruction of prostate tissue; by radiofrequency 
thermotherapy) and for CPT code 53854 (Transurethral destruction of 
prostate tissue; by radiofrequency generated water vapor 
thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for 
CPT code 53852.
    CPT code 53854 is a service reflecting the use of a new technology, 
``radiofrequency generated water vapor thermotherapy,'' as distinct 
from CPT code 53852, which describes destruction of tissue by 
``radiofrequency thermotherapy.'' The RUC indicated that this CPT code 
is the most intense of the three CPT codes in this family, thereby 
justifying a work RVU identical to that of CPT code 53852, despite 
lower intraservice and total times. The RUC stated that 15 minutes of 
post service time is appropriate due to greater occurrence of post-
procedure hematuria necessitating a longer monitoring time. However, 
the post-service monitoring time for this CPT code, 15 minutes, is 
identical to that for CPT code 53852. We did not agree with the 
explanation provided by the RUC for recommending a work RVU identical 
to that of CPT code 53852, given that the total time is 5 minutes 
lower, and the post service times are identical. Both the intraservice 
time ratio between this new CPT code and CPT code 53852 (4.94) and the 
total time ratio between the two CPT codes (5.72) suggest that the RUC-
recommended work RVU of 5.93 overestimates the work involved in 
furnishing this service. We reviewed other 90-day global CPT codes with 
similar times and identified CPT code 24071 (Excision, tumor, soft 
tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with 
a total time of 183 minutes, intraservice time of 45 minutes, and a 
work RVU of 5.70 as an appropriate crosswalk. We believed that this 
would be a better reflection of the work involved in furnishing CPT 
code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT 
code. We welcomed comments about the time and intensity required to 
furnish this new service. Since this CPT code reflects the use of a new 
technology, it will be reviewed again in 3 years.
    For the direct PE inputs, we proposed to add a new supply (SA128: 
``kit, Rezum delivery device''), a new equipment item (EQ389: 
``generator, water thermotherapy procedure''), and proposed to update 
the price of two supplies (SA036: ``kit, transurethral microwave 
thermotherapy'' and SA037: ``kit, transurethral needle ablation 
(TUNA)'') after reviewing invoices that we received. We noted that 
these invoices were submitted along with additional information listing 
the vendor discount for these supplies and equipment. We appreciated 
the inclusion of the discounted prices on these invoices, and we 
encouraged other invoice submissions to provide the discounted price as 
well, where available. Based on market research on supply and equipment 
pricing carried out by our contractors, we believe that a vendor 
discount of 10-15 percent is common on many supplies and equipment. 
Since we are obligated by statute to establish RVUs for each service as 
required based on the resource inputs required to furnish the typical 
case of a service, we have concerns that relying on invoices for supply 
and equipment pricing absent these vendor discounts may overestimate 
the resource cost of some services. We encouraged the submission of 
additional invoices that include the discounted price of supplies and 
equipment to more accurately assess the market cost of these resources.
    The following is a summary of the public comments we received on 
our proposals involving the Transurethral Destruction of Prostate 
Tissue family of codes.
    Comment: Several commenters expressed support for our proposed work 
RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which 
reflect the RUC's recommendations for these two codes.
    Response: We appreciate the commenters' support and we are 
finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93 
for CPT code 53852.
    Comment: A commenter pointed out that there is an error in our 
description of the RUC's time components for this code. We stated that 
there was less post service time for CPT code 53854 than for CPT code 
53852 when, in fact, both codes have a post service time of 15 minutes. 
The intraservice time between the two codes differs by 5 minutes, with 
CPT code 53854 having 5 fewer minutes than CPT code 53852.
    Response: We thank the commenter for informing us of the error. We 
note, however, that this does not affect our proposal which is based on 
a comparison of both intraservice and total time ratios.
    Comment: Several commenters, ranging from device manufacturers and 
professional associations, disagreed with our proposed value of 5.70 
for CPT code 53854 instead of the RUC-recommended work RVU of 5.93. 
Commenters stated that the work involved in furnishing the service 
described by CPT code 53854 is the most intense of the three CPT codes 
in this family because of the added risk of bleeding, urinary retention 
and damage to the external urinary sphincter with resultant 
incontinence of urine if not performed properly. Commenters also urged 
CMS to approach the time results from the survey for this code with 
caution, as few practitioners are likely to have had much experience 
with the new technology described by this service.
    Response: In our proposal, we requested additional information from 
stakeholders about the time and intensity required to furnish this 
service because we were not convinced that the work involved in 
furnishing the service described by CPT code 53854 is more intense than 
the work involved in furnishing CPT code 53852, which the RUC used as a 
reference code in developing their recommendation. We were convinced by 
commenters, however, that the additional risk in furnishing this 
service supports a higher work RVU than what we proposed. Therefore, we 
are finalizing a work RVU of 5.93 for this CPT code, as recommended by 
the RUC.
    Comment: One commenter stated that both CPT codes should be subject 
to the phase-in for CY 2019 because they will decrease more than 20 
percent and are not new or revised codes. The commenter urged CMS to 
add CPT codes 52380 and 52382 to the list of codes subject to the 
phase-in.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that

[[Page 59541]]

are not new or revised codes, if the total RVUs for a service for a 
year would otherwise be decreased by an estimated 20 percent or more as 
compared to the total RVUs for the previous year, the applicable 
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year 
period. We proposed to exempt CPT codes 52380 and 52382 from the phase-
in of significant RVU reductions required by section 1848(b)(11) of the 
Act because these codes are part of the same family of codes that 
included new CPT code 53854. We have previously finalized this policy 
through rulemaking, stating that significant coding revisions within a 
family of codes can change the relationships among codes to the extent 
that it changes the way that all services in the group are reported, 
even if some individual codes retain the same number or, in some cases, 
the same descriptor. Excluding codes from the phase-in when there are 
significant revisions to the code family also helps to maintain the 
appropriate rank order among codes in the family, avoiding years for 
which RVU changes for some codes in a family are in transition while 
others were fully implemented. For additional information regarding the 
phase-in of significant RVU reductions, we direct readers to the CY 
2016 PFS final rule with comment period (80 FR 70927 through 70929).
    Comment: One commenter stated that they were concerned about 
substantial reductions in billable staff time and supply costs 
associated with CPT codes 53850 and 53852. The commenter stated that 
reductions in billable staff time will require treating physicians to 
minimize non-procedural time which may include: Comfort control 
protocols; patient expectation management; patient post-procedure 
instructions; and recommended best practices for follow-up care. The 
commenter stated that they were concerned that the proposed supply 
costs are not in line with actual pricing or with actual cost increases 
for manufacturing of the product, and indicated that significant 
reductions in reimbursement will limit patient access to a therapy with 
demonstrated safety, effectiveness, and cost efficacy.
    Response: We appreciate the feedback from the commenter, and we are 
sensitive to the need for accurate payment under the PFS to ensure that 
beneficiaries maintain access to care. However, we note that we 
proposed the RUC-recommended direct PE inputs for this family of codes 
without refinement, and the decreases in clinical staff time for these 
procedures were almost entirely due to shorter surveyed intraservice 
work times and the removal of office visits in the postoperative 
portion of the global period as identified by the RUC. We agree with 
the RUC that fewer follow-up office visits and shorter intraservice 
times are now typical for these procedures, and we do not believe that 
the resulting decreases in clinical labor time will create barriers to 
accessing care. With regard to changes in the proposed supply costs, we 
direct readers to our discussion of the market-based supply and 
equipment pricing update in section II.B. of this final rule. We 
encourage stakeholders to continue to provide feedback concerning 
accurate supply and equipment pricing.
    After consideration of the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for the three codes in the 
Transurethral Destruction of Prostate Tissue family of codes.
(25) Vaginal Treatments (CPT Codes 57150 and 57160)
    CPT codes 57150 (Irrigation of vagina and/or application of 
medicament for treatment of bacterial, parasitic, or fungoid disease) 
and 57160 (Fitting and insertion of pessary or other intravaginal 
support device) were identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-
recommended work RVU of 0.89 for CPT code 57160.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Vaginal Treatments family of codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and 
57160 as proposed.
(26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)
    CPT code 58100 (Endometrial sampling (biopsy) with or without 
endocervical sampling (biopsy), without cervical dilation, any method) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. CPT code 58110 (Endometrial sampling 
(biopsy) performed in conjunction with colposcopy) was also included 
for review as part of the same family of codes. For CY 2019, we 
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and 
the RUC-recommended work RVU of 0.77 for CPT code 58110.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Review/read post-procedure x-ray, lab and pathology 
reports'' (CA028) activity for CPT code 58100. This code is typically 
billed with a same day E/M service, and we believe that it would be 
duplicative to assign clinical labor time for reviewing reports given 
that this task would typically be done during the same day E/M service. 
We also proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Biopsy of Uterus Lining family of codes.
    Comment: Several commenters stated that they appreciated that CMS 
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and 
the RUC-recommended work RVU of 0.77 for CPT code 58110.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters disagreed with the CMS proposal to 
remove the clinical labor time for the ``Review/read post-procedure x-
ray, lab and pathology reports'' (CA028) activity for CPT code 58100. 
Commenters stated that this clinical labor activity was not 
duplicative, as CA028 is designed specifically for post-procedure 
activity during the postservice of the service period which would not 
overlap with activities in the E/M office visit, which typically occur 
prior to the procedure and are listed as a preservice clinical labor 
activity. Commenters stated that the clinical description of the 
service for CPT code 58100 clearly notes that the E/M service is done 
the day before the service and that the patient returns for the biopsy.
    Response: We disagree with the commenters' statements about the 
timing of the E/M office visit. The same day billing data indicates 
that CPT code 58100 is typically billed with an E/M office visit on the 
same day (59 percent of the time), and it therefore seems clear that 
the E/M office visit typically takes place during the day of the 
procedure,

[[Page 59542]]

not the day before. We do not understand how the claims analysis fits 
with the statement from the commenters that the E/M service happens the 
day before the procedure, especially since CPT code 58100 has a 0-day 
global period that does not include preoperative care that takes place 
the day before the procedure. We continue to believe that it would be 
duplicative to assign clinical labor time for reviewing reports given 
that this task would typically be done during the same day E/M service. 
We believe that this clinical labor would be carried out during the 
same day E/M visit.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Biopsy of 
Uterus Lining family of codes as proposed.
(27) Injection Greater Occipital Nerve (CPT Code 64405)
    CPT code 64405 (Injection, anesthetic agent; greater occipital 
nerve) was identified as potentially misvalued on a screen of 0-day 
global services reported with an E/M visit 50 percent of the time or 
more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.94 for CPT code 64405.
    For the direct PE inputs, we proposed to refine the equipment time 
for the exam table (EF023) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 64405.
    Comment: Some commenters expressed support for our proposal to 
accept the RUC-recommended work RVU for this code.
    Response: We appreciate the support from the commenters for our 
proposals.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 64405 as proposed.
(28) Injection Digital Nerves (CPT Code 64455)
    CPT code 64455 (Injection(s), anesthetic agent and/or steroid, 
plantar common digital nerve(s) (e.g., Morton's neuroma)) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 64455.
    For the direct PE inputs, we proposed to refine the equipment time 
for the exam table (EF023) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 64455.
    Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 0.75.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 64455 as proposed.
(29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)
    CPT codes 65205 (Removal of foreign body, external eye; 
conjunctival superficial) and 65210 (Removal of foreign body, external 
eye; conjunctival embedded (includes concretions), subconjunctival, or 
scleral nonperforating) were identified as potentially misvalued on a 
screen of 0-day global services reported with an E/M visit 50 percent 
of the time or more, on the same day of service by the same patient and 
the same practitioner, that have not been reviewed in the last 5 years 
with Medicare utilization greater than 20,000.
    For CY 2019, we proposed the RUC-recommended work RVU of 0.49 for 
CPT code 65205. We noted that the recommendations for this code 
included a statement that the work required to perform CPT code 65205 
and the procedure itself had not fundamentally changed since the time 
of the last review. However, due to the fact that the surveyed 
intraservice time had decreased from 5 minutes to 3 minutes, the work 
RVU was lowered from the current value of 0.71 to the recommended work 
RVU of 0.49, based on a direct crosswalk to CPT code 68200 
(Subconjunctival injection). We noted that this recommendation appears 
to have been developed under a methodology similar to our ongoing use 
of time ratios as one of several methods used to evaluate work. We used 
time ratios to identify potential work RVUs and considered these work 
RVUs as potential options relative to the values developed through 
other options. As we have stated in past rulemaking (such as 82 FR 
53032-53033), we did not imply that the decrease in time as reflected 
in survey values must equate to a one-to-one or linear decrease in 
newly valued work RVUs, as indeed it does not in the case of CPT code 
65205 here. Instead, we believed that, since the two components of work 
are time and intensity, significant decreases in time should be 
reflected in decreases to work RVUs. We appreciate that the RUC-
recommended work RVU for CPT code 65205 has taken these changes in work 
time into account, and we support the use of similar methodologies, 
where appropriate, in future work valuations.
    For CPT code 65210, we disagreed with the RUC-recommended work RVU 
of 0.75 and we proposed a work RVU of 0.61 based on a direct crosswalk 
to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk 
code has the same intraservice time of 5 minutes and 4 additional 
minutes of total time as compared to CPT code 65210. We noted that the 
recommended intraservice time for CPT code 65210 is decreasing from 13 
minutes to 5 minutes (62 percent reduction), and the recommended total 
time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48 
percent reduction); however, the RUC-recommended work RVU is only 
decreasing from 0.84 to 0.75, which is a reduction of about 11 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 did not propose a linear 
decrease in the work valuation based on these time ratios. However, we 
believe that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs, and we do not believe that the recommended work RVU of 0.75 
appropriately reflects these decreases in surveyed work time.
    Our proposed work RVU of 0.61 is also based on a crosswalk to CPT 
code 51700 (Bladder irrigation, simple, lavage and/or instillation), 
another recently reviewed code with higher time values and a work RVU 
of 0.60. We also noted that two injection codes (CPT codes 20551 and 
64455) were reviewed at the same RUC meeting as CPT code 65210, each of 
which shared the same intraservice time of 5 minutes and had a higher 
total time of 21 minutes. Both of these codes had a RUC-recommended 
work RVU of 0.75, which we proposed without refinement for CY 2019. Due 
to the fact that CPT code 65210 has a lower total time and a lower 
intensity than both of these injection procedures, we did not agree 
that CPT code 65210 should be valued at the same work RVU of 0.75. We 
believe that our proposed work RVU of 0.61 based on a crosswalk to CPT 
code 92511 is a more accurate value for this code.
    For the direct PE inputs, we noted that the RUC-recommended 
equipment time for the screening lane (EL006)

[[Page 59543]]

equipment in CPT codes 65205 and 65210 was equal to the total work time 
in addition to the clinical labor time needed to set up and clean the 
equipment. We disagreed that the screening lane would typically be in 
use for the total work time, given that this includes the preservice 
evaluation time and the immediate postservice time. Although we did not 
currently propose to refine the equipment time for the screening lane 
in these two codes, we solicited comments on whether the use of the 
intraservice work time would be more typical than the total work time 
for CPT codes 65205 and 65210.
    The following is a summary of the public comments we received on 
our proposals involving the Removal of Foreign Body--Eye family of 
codes.
    Comment: Commenters agreed with the CMS proposal of the RUC-
recommended work RVU for CPT code 65205.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with our statement that the 
RUC-recommended work RVU for CPT code 65205 appeared to have been 
developed under a methodology similar to the use of time ratios. 
Commenters stated that time ratios were not used in arriving at the 
value of 0.49 for CPT code 65205, and that the recommended work RVU was 
based instead on a crosswalk to the second key reference code from the 
survey, CPT code 68200, which requires the same total time to perform 
and shares identical intensity and complexity.
    Response: We appreciate the additional information provided by the 
commenters regarding the methodology behind the recommended work RVU 
for CPT code 65205. As we noted in the proposed rule, this 
recommendation appeared to have been developed under a methodology 
similar to our ongoing use of time ratios; we did not state that the 
recommendation was explicitly based on the use of a time ratio.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.61 for CPT code 65210 and stated that CMS should finalize the RUC-
recommended work RVU of 0.75. Commenters stated that CMS should not use 
intraservice time ratios for work valuation as this methodology ignored 
the work estimates present in the survey data and the RUC review of 
those work estimates. Commenters stated that the RUC-recommended work 
values consider intensity and complexity of the work, while CMS 
substituted an arbitrary determination of work values based on time and 
a subjective estimate of intensity and complexity based on an unknown 
and clinically uninformed opinion.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion in the CY 2017 PFS final rule (81 FR 
80272 through 80277). We also note that in the case of CPT code 65210, 
we derived our proposed work RVU of 0.61 by using a direct crosswalk to 
CPT code 92511 and not a time ratio.
    Comment: Several commenters noted that CPT code 65210 had never 
been surveyed and was based on Harvard time which contributed to the 
median survey intraservice time of 5 minutes being less than half of 
the current value of 13 minutes. Commenters stated that Harvard times 
should be not be used for any sort of time comparison, especially when 
the code was not originally surveyed by Harvard, and any comparisons 
with these work times were inappropriate.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we 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 
current work time values in our methodology, we refer readers to our 
discussion of the subject in the CY 2017 final rule (81 FR 80273 
through 80274).
    Comment: Several commenters stated that the procedure described by 
CPT code 65210 has not fundamentally changed, and therefore the RUC had 
recommended a work RVU at the 25th percentile in accordance with the 
recent survey. One commenter stated that the

[[Page 59544]]

intensity of the procedure was also unchanged. Commenters stated that 
the crosswalk and reference codes chosen by CMS were clearly not as 
intense as the removal of an embedded foreign body described by CPT 
code 65210, in which an incision into ocular tissue is required.
    Response: We disagree with the commenters that CPT code 65210 has 
not fundamentally changed. We note for example that the surveyed work 
times have decreased drastically from the prior valuation, and 
similarly, the intensity of the service as measured by the survey more 
than doubled. These factors do not comport with the statement from the 
commenters that intensity of this service is unchanged. We also note 
that the RUC-recommended work RVU of 0.75 was a decrease from the 
current work RVU of 0.84, which also does not appear to reflect the 
idea that the intensity of the service has not changed. We similarly 
disagree with the commenters that our crosswalk and reference codes are 
not as intense as CPT code 65210. CPT code 92511 in particular 
describes a nasopharyngoscopy with endoscope that requires removing 
secretions and dried mucus blocking passage to the nasopharynx with 
suction and/or forceps. We disagree with the commenters that this 
procedure would be less intensive than the removal of a foreign body as 
described in CPT code 65210.
    Comment: Several commenters disagreed with the CMS comparison of 
CPT code 65210 to two injection codes (CPT codes 20551 and 64455) which 
were reviewed at the same RUC meeting as CPT code 65210. Commenters 
stated that the two referenced codes both have a lower intensity than 
CPT code 65210 and therefore they were not appropriate references for 
work valuation. Commenters stated that CPT code 65210 has a lower total 
time and a higher intensity than both of these injection procedures, 
justifying the recommended work RVU of 0.75.
    Response: We disagree with the commenters that CPT code 65210 would 
typically have a higher intensity than CPT codes 20551 and 64455. These 
codes both describe injection procedures, with CPT code 20551 
describing an injection into the tendon and CPT code 64455 describing 
an injection into the plantar common digital nerve. We do not agree 
that the removal of a foreign body from the eye as described in CPT 
code 65210 would have such greater intensity that it warrants a work 
RVU of 0.75 (to match CPT codes 20551 and 64455) despite having 
approximately 40 percent less total work time.
    Comment: Several commenters stated in response to the CMS comment 
solicitation that the screening lane (EL006) equipment would typically 
be in use for the total work time of CPT codes 65205 and 65210. 
Commenters stated that the screening lane is the ophthalmic equivalent 
of an exam room in the non-facility setting which would be needed for 
the total time of the procedure. Commenters stated that this equipment 
time represented the total time taken by the physician to perform the 
service in the screening lane (which would be not be available for use 
by another patient during the time of the procedure), plus the time 
inputs for the technician work as listed above.
    Response: We appreciate the additional information provided by the 
commenters regarding the use of the screening lane (EL006) equipment.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Removal of 
Foreign Body--Eye family of codes as proposed.
(30) Injection--Eye (CPT Codes 67500, 67505, and 67515)
    CPT code 67515 (Injection of medication or other substance into 
Tenon's capsule) was identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar 
injection; medication (separate procedure, does not include supply of 
medication)) and 67505 (Retrobulbar injection; alcohol) were also 
included for review as part of the same family of codes. For CY 2019, 
we proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.
    For CPT code 67505, we disagreed with the RUC-recommended work RVU 
of 1.18 and we proposed a work RVU of 0.94 based on a direct crosswalk 
to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a 
recently reviewed code with the same intraservice time of 5 minutes and 
2 fewer minutes of total time as compared to CPT code 67505. We 
disagreed with the recommendation to propose the same work RVU of 1.18 
for both CPT code 67500 and 67505 for several reasons. We noted that 
the current work RVU of 1.44 for CPT code 67500 is higher than the 
current work RVU of 1.27 for CPT code 67505, while the current work 
time of CPT code 67500 is less than the current work time for CPT code 
67505. This supported the view that CPT code 67500 should be valued 
higher than CPT code 67505 due to its greater intensity, which we also 
found to be supportable on clinical grounds. The typical patient for 
CPT code 67505 has already lost their sight, and there is less of a 
concern about accidental blindness as compared to CPT code 67500. At 
the recommended identical work RVUs, CPT code 67500 has almost triple 
the intensity of CPT code 67505. Similarly, the intensity does not 
match our clinical understanding of the complexity and difficulty of 
the two procedures.
    We also noted that the surveyed total time for CPT code 67505 was 7 
minutes less than the surveyed time for CPT code 67500, approximately 
21 percent lower. If we were to take the total time ratio between the 
two codes, it would produce a suggested work RVU of 0.93 (26 minutes 
divided by 33 minutes times a work RVU of 1.18). This time ratio 
suggested a work RVU almost identical to the 0.94 value that we 
determined via a crosswalk to CPT code 31575. Based on the preceding 
rationale, we proposed a work RVU of 0.94 for CPT code 67505.
    For CPT code 67515, we disagreed with the RUC-recommended work RVU 
of 0.84 and we proposed a work RVU of 0.75 based on a crosswalk to CPT 
code 64450 (Injection, anesthetic agent; other peripheral nerve or 
branch). The recommended work RVU is based on a direct crosswalk to CPT 
code 65222 (Removal of foreign body, external eye; corneal, with slit 
lamp) at a work RVU of 0.84. However, the recommended crosswalk code 
has more than double the intraservice time of CPT code 67515 at 7 
minutes, and we believe that it would be more accurate to use a 
crosswalk to a code with a more similar intraservice time such as CPT 
code 64450, which is another type of injection procedure. The proposed 
work RVU of 0.75 is also based on the use of the intraservice time 
ratio with the first code in the family, CPT code 67500. The 
intraservice time ratio between these codes is 0.60 (3 minutes divided 
by 5 minutes), which yields a suggested work RVU of 0.71 when 
multiplied by the recommended work RVU of 1.18 for CPT code 67500. We 
believe that this provides further rationale for our proposed work RVU 
of 0.75 for CPT code 67515.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Injection--Eye family of codes.

[[Page 59545]]

    Comment: Commenters were supportive of the CMS proposal of the RUC-
recommended work RVU of 1.18 for CPT code 67500.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.94 for CPT code 67505 and stated that CMS should finalize the RUC-
recommended work RVU of 1.18. Commenters were confused by the CMS 
statement that, at the recommended identical work RVUs, CPT code 67500 
has almost triple the intensity of CPT code 67505. Commenters stated 
that the RUC recommendation for CPT code 67505 has less total time and 
slightly higher intensity than CPT code 67500.
    Response: We agree with the commenters that this was an inaccurate 
statement; we intended to state that the current intensity of CPT code 
67500 prior to review is almost triple the current intensity of CPT 
code 67505. We regret any resulting confusion on this subject.
    Comment: Several commenters disagreed with the use of a time ratio 
analysis to support the CMS proposed work value. Commenters stated that 
time ratios do not adequately account for intensity and complexity of 
work, which can only be addressed through the survey and the RUC 
process.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277). We also note that in the case of CPT code 65210, we 
derived our proposed work RVU of 0.61 by using a direct crosswalk to 
CPT code 31575 and not a time ratio.
    Comment: Several commenters stated that while it was true that the 
current work value for CPT code 67500 is higher than that of CPT code 
67505, the survey 25th percentiles indicated that the physician work of 
CPT code 67505 (work RVU = 1.30) is higher than that of CPT code 67500 
(work RVU = 1.18). Commenters stated that the reason for performing 
surveys is to adjust for changes in physician work that have occurred 
since the prior survey, and that it was inappropriate to put more 
weight on old data than on the most recent data. Commenters also 
disagreed with the proposed work RVU on clinical grounds, stating that 
CPT code 67505 has a higher intensity than CPT code 67500, not because 
of potential vision loss, but because of the risk of death if the 
absolute alcohol is injected accidentally into the optic nerve sheath. 
Commenters stated that the alcohol injection involved in CPT code 67505 
is typically very painful, even after a local anesthetic injection, and 
carries with it the risk of death which therefore makes it a high-
intensity procedure for both patient and physician.
    Response: We appreciate the additional clinical details involving 
CPT code 67505 from the commenters. After reviewing the information 
provided by the commenters, we are not finalizing our proposed work RVU 
of 0.94 for CPT code 67505, and we are finalizing the RUC-recommended 
work RVU of 1.18 instead due to the additional risks carried by the 
procedure.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.75 for CPT code 67515 and stated that CMS should finalize the RUC-
recommended work RVU of 0.84. Commenters disagreed with the CMS 
crosswalk to CPT code 64450 and stated that the intensity of an 
injection adjacent to the eye in which the physician is unable to see 
the needle tip is clearly greater than that of an injection into a 
peripheral nerve as in the code for the CMS proposed crosswalk. 
Commenters stated that the use of a time ratio methodology for CPT code 
67515 was particularly inappropriate due to changes in the RUC survey 
methodology since the last survey for this service was performed, and 
that increases in the intensity of CPT code 67515 should not be of 
concern due to the 0-day global period and short intraservice work 
time.
    Response: We continue to believe that the use of time ratios is one 
of several appropriate methods for identifying potential work RVUs, as 
described in more detail in our response to the comments for CPT code 
67505 above. We also disagree with the commenters on their objections 
on clinical grounds concerning our crosswalk to CPT code 64450. CPT 
code 64450 describes the injection of an anesthetic agent into a 
peripheral nerve or branch, and the practitioner performing this 
service also cannot see a needle tip when injecting into a peripheral 
nerve. In other words, this is the same situation as that described in 
CPT code 67515: The practitioner performing the service is unable to 
see the needle tip in both cases. We continue to note that the RUC-
recommended crosswalk code (CPT code 65222) has more than double the 
intraservice time of CPT code 67515 at 7 minutes, and we continue to 
believe that it would be more accurate to use a crosswalk to a code 
with a similar intraservice time such as CPT code 64450.
    After consideration of the public comments, we are finalizing the 
work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing 
the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also 
finalizing the direct PE inputs for all three codes as proposed.
(31) X-Ray 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 on a screen of CMS or

[[Page 59546]]

Other source codes with Medicare utilization greater than 100,000 
services annually. The code family was expanded to include ten 
additional CPT codes to be reviewed together as a group: CPT codes 
72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050 
(Radiologic examination, spine, cervical; 4 or 5 views), 72052 
(Radiologic examination, spine, cervical; 6 or more views), 72070 
(Radiologic examination, spine; thoracic, 2 views), 72074 (Radiologic 
examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic 
examination, spine; thoracolumbar junction, minimum of 2 views), 72100 
(Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110 
(Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114 
(Radiologic examination, spine, lumbosacral; complete, including 
bending views, minimum of 6 views), and 72120 (Radiologic examination, 
spine, lumbosacral; bending views only, 2 or 3 views).
    The radiologic examination procedures described by CPT codes 72020 
(Radiologic examination, spine, single view, specify level), 72040 
(Radiologic examination, spine, cervical; 2 or 3 views), 72050 
(Radiologic examination, spine, cervical; 4 or 5 views), 72052 
(Radiologic examination, spine, cervical; 6 or more views), 72070 
(Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic 
examination, spine; thoracic, 3 views), 72074 (Radiologic examination, 
spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, 
spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic 
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic 
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic 
examination, spine, lumbosacral; complete, including bending views, 
minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral; 
bending views only, 2 or 3 views), 72200 (Radiologic examination, 
sacroiliac joints; less than 3 views), 72202 (Radiologic examination, 
sacroiliac joints; 3 or more views), 72220 (Radiologic examination, 
sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination, 
elbow; 2 views), 73080 (Radiologic examination, elbow; complete, 
minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views), 
73650 (Radiologic examination; calcaneus, minimum of 2 views), and 
73660 (Radiologic examination; toe(s), minimum of 2 views) were all 
identified as potentially misvalued through a screen for CPT codes with 
high utilization.
    With approval from the RUC Research Subcommittee, the specialty 
societies responsible for reviewing these CPT codes did not conduct 
surveys, but instead employed a ``crosswalk methodology,'' in which 
they derived physician work and time components for CPT codes by 
comparing them to similar CPT codes. We recognize that a substantial 
amount of time and effort is involved in conducting surveys of 
potentially misvalued CPT codes; however, we had concerns about the 
quality of the underlying data used to value these CPT codes. The 
descriptors and other information on which the recommendations are 
based have themselves not been surveyed, in several instances, since 
1995. Without the benefit of a survey or other external source of data 
about these CPT codes, there is no information that would allow us to 
detect any potential improvements in efficiency of furnishing the 
service or evaluate whether changes in practice patterns have affected 
time and intensity. We are not categorically opposed to changes in the 
RUC process or methodology that might reduce the burden of conducting 
surveys, but without the benefit of any additional data, through 
surveys or otherwise, we were not convinced that there was a basis for 
evaluating the RUC's recommendations for work RVUs for each of these 
CPT codes.
    Since all 20 of the CPT codes in this group have very similar 
intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes) 
times, we proposed to use an alternative approach to the valuation of 
work RVUs for these CPT codes. We calculated the utilization-weighted 
average RUC-recommended work RVU for the 20 CPT codes. The result of 
this calculation was a work RVU of 0.23, which we proposed to apply 
uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072, 
72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070, 
73080, 73090, 73650, and 73660. We recognized that the proposed work 
RVU for some of these CPT codes might be somewhat lower at the code 
level than the RUC's recommendation, while the proposed work RVU for 
other CPT codes might be slightly higher than the RUC's recommended 
value. We nevertheless believe that the alternative, accepting the 
RUC's recommendation for each separate CPT code implied a level of 
precision about the time and intensity of the CPT codes that we had no 
way to validate.
    For the direct PE inputs, we proposed to add a patient gown (SB026) 
supply to CPT code 72120. We noted that all of the other codes in the 
family that included clinical labor time for the ``Greet patient, 
provide gowning, ensure appropriate medical records are available'' 
(CA009) task included a patient gown, and we proposed to add the 
patient gown to match the other codes in the family. We believed that 
the exclusion of the patient gown for CPT code 72120 was most likely 
due to a clerical error in the recommendations. We also proposed to 
refine the equipment time for the basic radiology room (EL012) in 
accordance with our standard equipment time formulas.
    In our review of the clinical labor time recommended for the 
``Perform procedure/service--NOT directly related to physician work 
time'' (CA021) task, we noted that the standard convention for this 
family of codes seemed to be 3 minutes of clinical labor time per view 
being conducted. For example, CPT code 72020 with a single view had 3 
minutes of recommended clinical labor time for this activity, while CPT 
code 72070 with two views had 6 minutes. However, we also noted that 
for the codes with 2-3 views such as CPT codes 72040 and 72100, the 
recommended clinical labor time of 9 minutes appears to assume that 3 
views would always be typical for the procedure. The same pattern 
occurred for codes with 4-5 views, which have a recommended clinical 
labor time of 15 minutes (assuming 5 views is typical), and for codes 
with 6 or more views, which have a recommended clinical labor time of 
21 minutes (assuming 7 views is typical).
    We did not propose to refine the clinical labor times for this task 
as we did not have data available to know how many views would be 
typical for these CPT codes. However, we noted that the intraservice 
clinical labor time has not changed in roughly 2 decades for these X-
ray services, including during this most recent review, and we believed 
that improving technology during this span of time may have resulted in 
greater efficiencies in the procedures. We continue to be interested in 
data sources regarding the intraservice clinical labor times for 
services such as these that do not match the physician intraservice 
time, and we welcomed any comments that may be able to provide 
additional details for the 12 codes under review in this family.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Spine family of codes.

[[Page 59547]]

    Comment: A number of commenters disagreed with our proposal to 
apply an identical work RVU, calculated as the utilization-weighted 
average RUC-recommended work RVU for each of the 20 CPT codes, to each 
of the CPT codes in this group. Commenters defended the crosswalk 
methodology, stating that it is the best approach for valuing work RVUs 
for codes in which the service times are very low and therefore 
difficult to survey. The commenters noted that the specialty societies 
have tried to survey codes such as this in the past with results that 
yielded substantial inconsistencies.
    Response: We share the commenters' concerns about the validity of 
surveying services with very low intraservice and total time, but we 
have even more substantial concerns about a methodology that introduces 
no new information about the work involved in furnishing these CPT 
codes and then states their accuracy to the hundredth of a work RVU. 
Survey data from the specialty societies is often the only data source 
available to us that reflects the experiences of a cross-section of 
providers. We remind stakeholders that we welcome additional 
information or data from all sources to assist us in making proposals 
and finalizing values.
    Comment: In response to our proposal, the RUC offered to survey 
each code in the expanded family of X-ray codes to which CMS applied 
the weighted average methodology and provide survey based 
recommendations for CY 2020.
    Response: We appreciate the recognition on the part of the RUC of 
our serious concerns about the crosswalk methodology and the integrity 
of the resulting RUC recommended work RVUs. We welcome the submission 
of any additional data or information that would allow us to consider 
these codes for review at a future time. Commenters raised concerns 
that assigning a single weighted average work RVU across this broad 
family of x-ray codes inadequately reflects meaningful differences 
among the codes, including the number of views and the complexity of 
positioning for some x-ray services. In response to commenters' 
concerns, we are instead maintaining the CY 2018 work RVUs for each CPT 
code as follows: Work RVU of 0.15 for CPT code 72020, 0.22 for CPT 
72040, 0.31 for CPT code 72050, 0.36 for CPT code 72052, 0.22 for CPT 
code 72070, 0.22 for CPT code 72072, 0.22 for CPT code 72074, 0.22 for 
CPT code 72080, 0.22 for CPT code 72100, 0.31 for CPT code 72110, 0.32 
for CPT code 72114, and 0.22 for CPT code 72120.
    Comment: Several commenters indicated that it was inappropriate for 
CMS to value the practice expense portion of the 20 CPT codes 
identically because the resources required to furnish each of the 
services differ in accordance with the number of X-rays or views and 
other factors.
    Response: We did not propose to value the practice expense portion 
of these codes identically. The proposal regarding the weighted average 
for these codes refers to the work component of RVUs only.
    Comment: One commenter stated that they appreciated and agreed with 
adding a patient gown (SB026) supply to CPT code 72120.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: Several commenters stated that they would like to provide 
clarity on the typical number of films obtained for the X-ray spine 
codes and the rationale for the number of minutes and assumed number of 
views that would be typical. Commenters stated that a minimum of 3 
views would be needed in order to adequately assess the cervical spine 
as described by CPT code 72040. Commenters stated that the open mouth 
odontoid view helps in the assessment of the atlanto-occipital joint, 
and that the AP and lateral views of the vertebral bodies are required 
to assess the alignment of the vertebral bodies in two planes, the disc 
spaces, the spinal canal, fractures, and widening of different joints. 
Commenters provided a similar level of clinical detail regarding the 
typical number of views required for CPT codes 72050 and 72052.
    Response: We appreciate the detailed information provided by the 
commenters in response to our request for data sources regarding the 
intraservice clinical labor times in those services that do not match 
the physician intraservice time.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(32) X-Ray 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 or Other source codes 
with Medicare utilization greater than 100,000 services 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. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 
72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a 
discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the basic radiology room (EL012) in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Sacrum family of codes.
    Comment: Comments regarding our proposed work RVU for this family 
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVUs for each code in this family as follows: Work RVU of 0.17 for CPT 
code 72200, 0.19 for CPT Code 72202, and 0.17 for CPT code 72220.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(33) 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 or Other source codes with Medicare utilization greater than 
100,000 services annually. CPT code 73080 (Radiologic examination, 
elbow; complete, minimum of 3 views) was also included for review as 
part of the same family of codes. See (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120) above for a discussion of proposed work RVUs for 
these codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the

[[Page 59548]]

basic radiology room (EL012) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Elbow-Forearm family of codes.
    Comment: Comments regarding our proposed work RVU for this family 
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVUs for each code in this family as follows: Work RVU of 0.15 for CPT 
code 73070, 0.17 for CPT code 73080, 0.17 for CPT code 73090.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of 
codes. We are finalizing the direct PE inputs for these codes as 
proposed.
(34) X-Ray Heel (CPT Code 73650)
    CPT code 73650 (Radiologic examination; calcaneus, minimum of 2 
views) was identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. See (31) 
X-Ray Spine above for a discussion of proposed work RVUs for these 
codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the basic radiology room (EL012) in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 73650.
    Comment: Comments regarding our proposed work RVU for this code 
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 
and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVU of 0.16 for CPT code 73650.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(35) X-Ray Toe (CPT Code 73660)
    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. See (31) X-Ray 
Spine above for a discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we proposed to add a patient gown (SB026) 
supply to CPT code 73660. We noted that the other codes in related X-
ray code families that included clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) task included a patient gown, and we proposed to 
add the patient gown to match the other codes in these families. We 
also proposed to refine the equipment time for the basic radiology room 
(EL012) in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 73660.
    Comment: Comments regarding our proposed work RVU for this code 
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 
and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVU of 0.13 for CPT code 73660.
    Comment: Several commenters stated that the typical patient for 
this service would not require a patient gown. Commenters stated that 
this was different than other codes in the family where the patient may 
need to be rotated lateral and prone for different views.
    Response: We appreciate the feedback from the commenters. In light 
of the information supplied by commenters, we will not finalize our 
proposal to add a patient gown (SB026) supply to CPT code 73660.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We 
are finalizing the direct PE inputs as proposed with the exception of 
the patient gown (SB026) supply as detailed above.
(36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)
    CPT code 74220 (Radiologic examination; esophagus) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. CPT codes 74210 (Radiologic 
examination; pharynx and/or cervical esophagus) and 74230 (Swallowing 
function, with cineradiography/videoradiography) were also included for 
review as part of the same family of codes.
    We proposed the work RVUs recommended by the RUC for the CPT codes 
in this family as follows: A work RVU 0.59 for CPT code 74210 
(Radiologic examination; pharynx and/or cervical esophagus), a work RVU 
of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a 
work RVU of 0.53 for CPT code 74230 (Swallowing function, with 
cineradiography/videoradiography).
    For the direct PE inputs, we noted that the recommended quantity of 
the Polibar barium suspension (SH016) supply is increasing from 1 ml to 
150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220, 
which did not previously include this supply. The RUC recommendation 
states that this supply quantity increase is due to clinical necessity, 
but does not go into further details about the typical use of the 
supply. Although we did not propose to refine the quantity of the 
Polibar barium suspension at this time, we solicited additional comment 
about the typical use of the supply in these procedures. We also 
proposed to refine the equipment times for all three codes in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our

[[Page 59549]]

proposals involving the X-Ray Esophagus family of codes.
    Comment: We received no specific comments regarding our proposals 
for work RVUs in this family.
    Response: As a result, we are finalizing a work RVU of 0.59 for CPT 
code 74210, a work RVU of 0.67 for CPT code 74220, and a work RVU of 
0.53 for CPT code 74230 as proposed.
    Comment: Several commenters responded to the comment solicitation 
about the typical use of the Polibar barium suspension (SH016) supply 
in these procedures. Commenters stated that the barium suspension 
quantity listed for CPT code 74210 prior to review was only 1 ml which 
appeared to be a technical error in mistaking number of milliliters for 
number of items, as this was an insufficient quantity of barium for the 
procedure. Commenters stated that CPT code 74220 did not have barium 
suspension listed as a supply item, which appeared to be an oversight. 
The commenters described how the patient swallows a small quantity of 
high density barium to outline the esophagus, followed by multiple 
subsequent swallows of normal density barium that are assessed under 
fluoroscopy from different angles to evaluate the esophageal anatomy 
and mucosa.
    Response: We appreciate the additional details provided by the 
commenters regarding the use of the Polibar barium suspension (SH016) 
supply, and the clarification that the previous supply quantities in 
these procedures appear to have been in error.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for the codes in the X-Ray Esophagus 
family of codes as proposed.
(37) X-Ray Urinary Tract (CPT Code 74420)
    CPT code 74420 (Urography, retrograde, with or without KUB) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. We proposed the 
RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography, 
retrograde, with or without KUB).
    For the direct PE inputs, we proposed to remove the 1 minute of 
clinical labor time for the ``Confirm order, protocol exam'' (CA014) 
activity. The clinical labor time recommended for this activity is not 
included in the reference code, nor is it included in any of the two 
dozen other X-ray codes that were reviewed at the same RUC meeting. 
There is also no explanation in the recommended materials as to why 
this clinical labor time would need to be added. We do not believe that 
this clinical labor would be typical for CPT code 74420, and we 
proposed to remove it to match the rest of the X-ray codes. We also 
proposed to refine the equipment times in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 74420.
    Comment: We received no specific comments regarding our proposal 
for the work RVU for CPT code 74420.
    Response: We are finalizing a work RVU of 0.52 for CPT code 74420.
    Comment: Several commenters disagreed with the proposal to remove 
the 1 minute of clinical labor time for the ``Confirm order, protocol 
exam'' (CA014) activity. The commenters stated that this service was 
distinct from the other X-ray services reviewed during this cycle and 
encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
74420, we are finalizing these clinical labor refinements as proposed 
as there is no clinical labor assigned to the ``Review patient clinical 
extant information and questionnaire'' (CA007) activity. We also note 
that commenters did not provide a rationale as to what made CPT code 
74420 distinct from the other X-ray services reviewed during this cycle 
and would justify this additional clinical labor time.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 74420 as proposed.
(38) Fluoroscopy (CPT Code 76000)
    CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour 
physician or other qualified health care professional time) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. CPT code 76001 
(Fluoroscopy, physician or other qualified health care professional 
time more than 1 hour, assisting a nonradiologic physician or other 
qualified health care professional) was also included for review as 
part of the same family of codes. However, due to the fact that 
supervision and interpretation services have been increasingly bundled 
into the underlying procedure codes, the RUC concluded that this 
practice is rare, if not obsolete, and CPT code 76001 was recommended 
for deletion by the CPT Editorial Panel for CY 2019.
    We proposed the RUC-recommended work RVU of 0.30 for CPT code 76000 
(Fluoroscopy (separate procedure), up to 1 hour physician or other 
qualified health care professional time, other than 71023 or 71034 
(e.g., cardiac fluoroscopy)). For the direct PE inputs, we proposed to 
refine the equipment times in accordance with our standard equipment 
time formulas.
    We did not receive specific comments regarding our proposals for 
CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE 
inputs for CPT code 76000 as proposed.
(39) Echo Exam of Eye Thickness (CPT Code 76514)
    CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal 
pachymetry, unilateral or bilateral (determination of corneal 
thickness)) 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.
    For CPT code 76514, we disagreed with the RUC-recommended work RVU 
of 0.17 and we proposed a work RVU of 0.14. We noted that the 
recommended intraservice time for CPT code 76514 is decreasing from 5 
minutes to 3 minutes (40 percent reduction), and the recommended total 
time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67 
percent reduction); however, the RUC-recommended work RVU is not 
decreasing at all and remains at 0.17. Although we did not imply that 
the decrease in time as reflected in survey values must equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs.
    We also noted that the RUC recommendations for CPT code 76514 
stated that, although the steps in the procedure are unchanged since it 
was first valued, the workflow has changed. With the advent of smaller 
and easier to use pachymeters, the technician now typically takes the 
measurements that used to be taken by the practitioner for CPT code 
76514, and the intraservice time was reduced by two minutes to account 
for the technician performing this service. We believe that this change 
in workflow indicates that the work RVU for the code should be reduced 
in some fashion, since some of the work

[[Page 59550]]

that was previously done by the practitioner is now typically performed 
by the technician. We have no reason to believe that there is more 
intensive cognitive work being performed by the practitioner after 
these measurements are taken since the recommendations indicated that 
the steps in the procedure are unchanged since this code was first 
valued.
    Therefore, we proposed a work RVU of 0.14 for CPT code 76514, which 
is based on taking half of the intraservice time ratio. We considered 
applying the intraservice time ratio to CPT code 76514, which would 
reduce the work RVU to 0.10 based on taking the change in intraservice 
time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60 
times the current work RVU of 0.17. However, we recognized that the 
minutes shifted to the clinical staff were less intense than the 
minutes that remained in CPT code 76514, and therefore, we applied half 
of the intraservice time ratio for a reduction of 0.03 RVUs to arrive 
at a proposed work RVU of 0.14. We believe that this proposed value 
more accurately takes into account the changes in workflow that have 
caused substantial reductions in the surveyed work time for the 
procedure.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76514.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.14 for CPT code 76514 and stated that CMS should finalize the RUC-
recommended work RVU of 0.17. Commenters stated that using an approach 
that takes a fraction of the intraservice time ratio in lieu of strong 
crosswalks and input from the RUC and physicians providing these 
services is unfounded. Commenters restated the key reference codes 
chosen by the survey participants and urged CMS to use survey data and 
supportive relative reference services when valuing services.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277). We also note that in the case of CPT code 76514, we 
recognized that the minutes shifted to the clinical staff were less 
intense than the minutes that remained in CPT code 76514, and 
therefore, we applied only half of the intraservice time ratio instead 
of the full ratio.
    Comment: Several commenters stated that while it is true that 
changes in workflow as a result of smaller, portable, easier to use 
pachymeters now mean that the technician typically takes the 
measurements that used to be taken by the physician, the remaining 3 
minutes of intraservice work time reflect the more intense cognitive 
work performed by the physician after the measurements are taken. 
Commenters agreed that the procedure has not fundamentally changed and 
that maintaining a work RVU of 0.17 was warranted.
    Response: We disagree with the commenters and continue to believe 
that CPT code 76514 does not require more intensive cognitive work 
being performed by the practitioner after these measurements are taken, 
since the recommendations indicated that the steps in the procedure are 
unchanged since this code was first valued. While the incorporation of 
new technology can sometimes make services more complex and difficult 
to perform, it can also have the opposite effect by making services 
less reliant on manual skill and technique, and we believe that for CPT 
code 76514 the latter case is true since the same work previously 
carried out by the practitioner is now being carried out by the 
technician.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 76514 as proposed.
(40) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)
    In September 2017, the CPT Editorial Panel created three new codes 
describing the use of ultrasound elastography to assess organ 
parenchyma and focal lesions: CPT codes 76981 (Ultrasound, 
elastography; parenchyma), 76982 (Ultrasound, elastography; first 
target lesion) and 76983 (Ultrasound, elastography; each additional 
target lesion). The most common use of this code set will be for 
preparing patients with disease of solid organs, like the liver, or 
lesions within solid organs.
    The RUC recommended a work RVU of 0.59 for CPT code 76981 
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 
0.59 for CPT code 76982 (Ultrasound, elastography; first target 
lesion), and a work RVU of 0.50 for add-on CPT code 76983 (Ultrasound, 
elastography; each additional target lesion). We are proposing the RUC- 
recommended work RVUs for each of these new CPT codes.
    For the direct PE inputs, we proposed 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 for CPT codes 
76981 and 76982. CPT code 76700 (Ultrasound, abdominal, real time with 
image documentation; complete), the reference code for these two new 
codes, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new codes, only the 
way in which this clinical labor time has been presented on the PE

[[Page 59551]]

worksheets. We also noted 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 in CPT codes 76981 and 
76982. We also proposed to refine the equipment times in accordance 
with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Ultrasound Elastography family of codes.
    Comment: Several commenters expressed support for our proposed work 
RVUs for each of the three CPT codes in this family.
    Response: We appreciate the support of commenters.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT codes 76981 and 76982, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
76981 and 76982, we are not finalizing these clinical labor refinements 
as proposed, as these codes have the ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' task in predecessor CPT code 76700 
on the old PE worksheet as well as 1 minutes of CA007 clinical labor 
time. We are instead finalizing the RUC-recommended clinical labor 
times for CA013 and CA014 for CPT codes 76981 and 76982. We are also 
not finalizing our refinements to the corresponding equipment times as 
a result.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Ultrasound Elastography family of codes 
as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT 
code 76982, and 0.50 work RVUs for CPT code 76983. We are not 
finalizing our proposed direct PE inputs and are instead finalizing the 
RUC-recommended direct PE inputs for these three codes.
(41) Ultrasound Exam--Scrotum (CPT Code 76870)
    CPT code 76870 (Ultrasound, scrotum and contents) was identified on 
a screen of CMS or Other source codes with Medicare utilization greater 
than 100,000 services annually. We proposed a work RVU of 0.64 for CPT 
code 76870 (Ultrasound, scrotum and contents), as recommended by the 
RUC.
    For the direct PE inputs, we proposed 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. CPT code 76870 
did not previously have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we did not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets. We also noted that there was 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 under the CA013 room preparation activity. We also proposed 
to refine the equipment times in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76870.
    Comment: We received general support from commenters for our 
proposed work RVU of 0.64 for CPT code 76870, as recommended by the 
RUC.
    Response: We thank commenters for their support.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 76870, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
76870, we are finalizing these clinical labor refinements as proposed.
    After consideration of the public comments, we are finalizing the 
work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76978 and 76979)
    In September 2017, the CPT Editorial Panel created two new CPT 
codes describing the use of intravenous microbubble agents to evaluate 
suspicious lesions by ultrasound. CPT code 76978 (Ultrasound, targeted 
dynamic microbubble sonographic contrast characterization (non-
cardiac); initial lesion) is a stand-alone procedure for the evaluation 
of a single target lesion. CPT code 76979 (Ultrasound, targeted dynamic 
microbubble sonographic contrast characterization (non-cardiac); each 
additional lesion with separate injection) is an add-on code for the 
evaluation of each additional lesion.
    The two new CPT codes in this family represent a new technology 
that involves the use of intravenous microbubble agents to evaluate 
suspicious lesions by ultrasound. The first new CPT code 76978 
(Ultrasound, targeted dynamic microbubble sonographic contrast 
characterization (non-cardiac); initial lesion), is the base code for 
the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble 
sonographic contrast characterization (non-cardiac); each additional 
lesion with separate injection). The RUC reviewed the survey results 
for CPT code 76978 and recommended total time of 30 minutes and 
intraservice time of 20 minutes. Their recommendation for a work RVU of 
1.62 is based neither on the median of the survey results (1.82) nor 
the 25th percentile of the survey results (1.27). Instead, the RUC-
recommended work RVU is based on a crosswalk to CPT code 73719 
(Magnetic resonance (e.g., proton) imaging, lower extremity other than 
joint; with contrast material(s)), which has identical intraservice and 
total times as the survey CPT code. The RUC also identified a 
comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton) 
imaging, any joint of upper extremity; with contrast material(s)) with 
work RVU 1.62 and similar times. For add-on CPT code 76979, the RUC 
recommended a work RVU of 0.85, which is the 25th percentile of survey 
results, with total and intraservice times of 15 minutes.
    Although we generally agree that, particularly in instances where a 
CPT code represents a new technology or procedure, there may be reason 
to deviate from survey metrics, we are confused by the logic behind the 
RUC's recommendation of a work RVU of 1.62 for CPT code 76978. When we 
considered the range of existing CPT codes with 30 minutes total time 
and 20 minutes intraservice time, we noted that a work RVU of 1.62 is 
among the highest potential crosswalks. We also noted that the RUC 
agreed with the 25th percentile of survey results for the new add-on 
CPT code, 76979, and we did not see

[[Page 59552]]

why the 25th percentile would not also be appropriate for the base CPT 
code, 76978. Therefore, we proposed a work RVU of 1.27 for CPT code 
76978. We identified two CPT codes with total time of 30 minutes and 
intraservice time of 20 minutes that bracket the proposed work RVU of 
1.27: CPT code 93975 (Duplex scan of arterial inflow and venous outflow 
of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; 
complete study) has a work RVU of 1.16, and CPT code 72270 
(Myelography, 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical), radiological 
supervision and interpretation) has a work RVU of 1.33. We proposed the 
RUC-recommended work RVU of 0.85 for add-on CPT code 76979.
    For the direct PE inputs, we proposed 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 for CPT code 
76978. CPT codes 76700 (Ultrasound, abdominal, real time with image 
documentation; complete) and 76705 (Ultrasound, abdominal, real time 
with image documentation; limited), the reference codes for this new 
code, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we did not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new code, only the 
way in which this clinical labor time has been presented on the PE 
worksheets. We also noted 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 in CPT code 76978.
    We proposed to remove the 50 ml of the phosphate buffered saline 
(SL180) for CPT codes 76978 and 76979. When these codes were reviewed 
by the RUC, the conclusion that was reached was to remove this supply 
and replace it with normal saline. Since the phosphate buffered saline 
remained in the recommended direct PE inputs, we believe its inclusion 
may have been a clerical error. We proposed to remove the supply and 
solicited comments on the phosphate buffered saline or a replacement 
saline solution. We also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Contrast-Enhanced Ultrasound family of 
codes.
    Comment: Commenters were supportive of our proposed work RVU of 
0.85 for CPT code 76979, as recommended by the RUC.
    Response: We thank the commenters for their support of our proposal 
regarding the work RVU for this CPT code.
    Comment: A few commenters expressed opposition to our proposed work 
RVU of 1.27 for new CPT code 76978. Commenters acknowledged that the 
code is valued at the high end of the range of values for a given 
intraservice time. However, they stated, being on the high end of a 
range of comparison codes is not necessarily in itself a reason to 
reduce the work RVU. They cite this as an illustration of CMS's 
discounting the importance of intensity in valuing physician services 
in favor of considering only time. The same commenters also noted that 
the new technology used in furnishing the service, Contrast Enhanced 
Ultrasound (CEUS), requires more technical skill and time than other 
established ultrasound services.
    Response: Our observation that a survey code is on the high end of 
codes on the PFS with similar intraservice and total times is only one 
among several factors we consider when we perceive that the code is not 
properly valued in relation to other similar codes. We agree that there 
are instances in which valuing a code at the high range of work RVUs 
for codes with similar times is appropriate. However, on the whole, if 
a recommended work RVU places the code on the very high end of work 
RVUs with similar time parameters, we expect that the code would be of 
notably higher intensity than most other codes with those time 
parameters. We were not convinced that this was the case with CPT code 
76978.
    We were, however, persuaded by commenters that the higher technical 
skill and time involved in using the new technology, CEUS, compared 
with other established ultrasound services, is better reflected by the 
RUC's recommended work RVU than our proposed value. Consequently we are 
finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 76978, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
76978, we are not finalizing these clinical labor refinements as 
proposed, as this code has the ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' task in predecessor CPT code 76700 
on the old PE worksheet as well as 1 minutes of CA007 clinical labor 
time. We are therefore finalizing the RUC-recommended clinical labor 
times for CA013 and CA014 for CPT code 76978. We are also not 
finalizing our refinements to the corresponding equipment times as a 
result.
    Comment: Several commenters disagreed with the proposal to remove 
the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978 
and 76979. Commenters stated that the SL180 supply can be replaced with 
``normal saline'', however the change was not made because an 
appropriate replacement could not be identified. Commenters stated that 
the SL180 phosphate buffered saline (PBS) had been removed but ``normal 
saline'' has not replaced it. Commenters agreed that this change was 
appropriate and urged CMS to add the correct supply item for the 
appropriate type of saline.
    Response: We disagree with the commenters that the ``normal 
saline'' was not added to these procedures. Both of these CPT codes 
include the ``sodium chloride 0.9% inj bacteriostatic (30ml uou)'' 
(SH068) supply which would function as a form of normal saline. We do 
not believe that it would be typical for these procedures to contain 50 
ml of the phosphate buffered saline (SL180) in addition to the ``normal 
saline'' described by the SH068 supply.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for both codes in this family as follows: 
Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code 
76978. We are also finalizing the RUC-recommended direct PE inputs for 
these codes, with the exception of the refinement to the phosphate 
buffered saline (SL180) supply as detailed above.
(43) Magnetic Resonance Elastography (CPT Code 76391)
    The CPT Editorial Panel created new stand-alone CPT code 76391 
describing the use of magnetic resonance elastography for the 
evaluation of organ parenchymal pathology. This code will most often be 
used to evaluate patients

[[Page 59553]]

with disease of solid organs (for example, cirrhosis of the liver) or 
pathology within solid organs that manifest with increasing fibrosis or 
scarring. The goal with magnetic resonance elastography is to evaluate 
the degree of fibrosis/scarring (that is, stiffness) without having to 
perform more invasive procedures (for example, biopsy). This technique 
can be used to characterize the severity of parenchymal disease, follow 
disease progression, or response to therapy.
    The RUC recommended a work RVU for new CPT code 76391 (Magnetic 
resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of 
intraservice time and 25 minutes of total time. The recommendation is 
based on a comparison with two reference CPT codes, CPT code 74183 
(Magnetic resonance (e.g., proton) imaging, abdomen; without contrast 
material(s), followed by with contrast material(s) and further 
sequences) with total time of 40 minutes, intraservice time of 30 
minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance 
(e.g., proton) imaging, abdomen; without contrast material(s)), which 
has a total time of 30 minutes, intraservice time of 20 minutes, and a 
work RVU of 1.46. The RUC stated that both reference CPT codes have 
higher work values than the new CPT code, which is justified in both 
cases by higher intra-service times. They noted that, despite shorter 
intraservice and total time, CPT code 76391 is slightly more intense to 
perform due to the evaluation of wave propagation images and 
quantitative stiffness measures. We did not agree with the RUC's 
recommended work RVU for this CPT code. Using the RUC's two top 
reference CPT codes as a point of comparison, the intraservice time 
ratio in both instances suggests that a work RVU closer to 1.10 would 
be more appropriate. We recognize that the RUC believes the new CPT 
code is slightly more intense to furnish, but we are concerned about 
the relativity of this code in comparison with other imaging procedures 
that have similar intraservice and total times. Instead of the RUC-
recommended work RVU of 1.29 for CPT code 76391, we proposed a work RVU 
of 1.10, which is based on a direct crosswalk to CPT code 71250 
(Computed tomography, thorax; without contrast material). CPT code 
71250 has identical intraservice time (15 minutes) and total time (25 
minutes) compared to CPT code 76391, and we believe that the work 
involved in furnishing both services is similar. We note that CPT code 
76391 describes a new technology and will be reviewed again by the RUC 
in 3 years.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
from 6 minutes to 5 minutes, and for the ``Prepare, set-up and start 
IV, initial positioning and monitoring of patient'' (CA016) activity 
from 4 minutes to 3 minutes. We disagreed that this additional clinical 
labor time would be typical for these activities, which are already 
above the standard times for these tasks. In both cases, we proposed to 
maintain the current time from the reference CPT code 72195 (Magnetic 
resonance (e.g., proton) imaging, pelvis; without contrast material(s)) 
for these clinical labor activities. We also proposed to refine the 
equipment times in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76391.
    Comment: A commenter stated that CMS misunderstood the role of 
reference CPT codes in the RUC's valuation process, and therefore our 
proposed work RVU for CPT code 76391 is premised on a false time 
comparison and a methodology that is invalid.
    Response: In the materials provided to us, the RUC explicitly 
compared the two key reference services to CPT 76391 and stated that 
the higher work values for these codes are justified by higher 
intraservice times. The RUC did not provide a crosswalk code for CPT 
76391. Because of the RUC's justification of the higher work RVUs in 
the reference services in relation to the higher intraservice times for 
these codes, and because the RUC did not provide a crosswalk CPT code 
for us to review, we believe it is an entirely appropriate methodology 
to calculate the intraservice time ratios using those reference codes. 
We acknowledged that the survey code is slightly more intense to 
perform than the reference codes, according to the RUC's SOR, which is 
why our calculation of intraservice time ratios is only a starting 
point in our review of the code's recommended work RVU. We considered 
the intraservice time ratios for both reference codes, which were not 
identical, and compared these values to other CPT codes in the PFS with 
similar intraservice and total times. For this particular CPT code 
76391, we identified a crosswalk to CPT code 71250, which, as we 
stated, achieved an overall balance of similar times and similar 
intensity as the survey code and has a work RVU of 1.10.
    Comment: Some commenters stated that our proposed value of 1.10 
work RVUs for CPT code 76391 creates a rank order anomaly between an 
MRI code and CPT code, CPT code 74160.
    Response: We do not agree that our proposed work RVU of 1.10 for 
this code creates a rank order anomaly between an MRI code and CT code 
because this service is described as being unlike a routine magnetic 
resonance imaging. This service also involves use of a new technology, 
which makes it difficult to compare directly to services involving 
magnetic resonance imaging. We are finalizing a work RVU of 1.10 for 
CPT code 76391.
    Comment: One commenter agreed with the refinements to the direct PE 
inputs.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVU of 1.10 and the direct PE inputs for CPT code 76391 as 
proposed.
(44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)
    CPT code 77012 (Computed tomography guidance for needle placement 
(e.g., biopsy, aspiration, injection, localization device), 
radiological supervision and interpretation) was identified on a screen 
of CMS or Other source codes with Medicare utilization greater than 
100,000 services annually.
    We proposed the RUC-recommended work RVU of 1.50 for CPT code 77012 
(Computed tomography guidance for needle placement (e.g., biopsy, 
aspiration, injection, localization device), radiological supervision 
and interpretation).
    For the direct PE inputs, we proposed 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. CPT code 77012 
did not previously have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we did not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets. We also noted 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 under the CA013 room preparation activity.
    We proposed to refine the equipment time for the CT room (EL007) to 
maintain the current time of 9 minutes. CPT code 77012 is a 
radiological supervision and interpretation

[[Page 59554]]

procedure and there has been a longstanding convention in the direct PE 
inputs, shared by 38 other codes, to assign an equipment time of 9 
minutes for the equipment room in these procedures. We do not believe 
that it would serve the interests of relativity to increase the 
equipment time for the CT room in CPT code 77012 without also 
addressing the equipment room time for the other radiological 
supervision and interpretation procedures. Therefore, we proposed to 
maintain the current equipment room time of 9 minutes until this group 
of procedures can be subject to a more comprehensive review. We also 
proposed to refine the equipment time for the Technologist PACS 
workstation (ED050) in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 77012.
    Comment: We received support from a few commenters for our proposed 
work RVU for CPT code 77012, as recommended by the RUC.
    Response: We appreciate commenters' support. We are finalizing a 
work RVU of 1.50 for CPT code 77012.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 77012 CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
77012, we are finalizing these clinical labor refinements as proposed.
    Comment: Several commenters disagreed with the proposal to refine 
the equipment time for the CT room (EL007) to maintain the current time 
of 9 minutes. Commenters stated that the room time is included in CT 
guidance, as it is in US guidance (such as in CPT code 76942) because 
that is the room the procedure is performed in. Commenters stated that 
they agreed with CMS that other RS&I codes use the 9 minutes for room 
time as a precedent, but this was specific to angiographic rooms and 
referred to language from 2013 regarding angiographic rooms.
    Response: We disagree with the commenters regarding the equipment 
time for the CT room (EL007) due to the longstanding convention in the 
direct PE inputs, shared by 38 other codes, to assign an equipment time 
of 9 minutes for the equipment room in radiological supervision and 
interpretation procedure. We agree with the commenters that at least 
some portion of the procedure is performed in the CT room, but we 
continue to believe that it would not serve the interests of relativity 
to increase the equipment time for the CT room in CPT code 77012 
without also addressing the equipment room time for the other 
radiological supervision and interpretation procedures in a more 
comprehensive fashion. We also disagree with the commenters that this 
policy is specific to angiography rooms, as CPT codes 75989 and 77012 
both employ CT rooms and currently utilize the standardized 9 minutes 
of equipment time for radiological supervision and interpretation 
procedures.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 77012 as proposed.
(45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)
    CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone 
density study, 1 or more sites; appendicular skeleton (peripheral) 
(e.g., radius, wrist, heel)) 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. For CY 2019, we proposed the RUC-recommended work RVU of 0.20 
for CPT code 77081.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 77081.
    Comment: Commenters were supportive of our proposal regarding the 
work RVU for CPT code 77081.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77046, 77047, 
77048, and 77049)
    CPT codes 77058 (Magnetic resonance imaging, breast, without and/or 
with contrast material(s); unilateral) and 77059 (Magnetic resonance 
imaging, breast, without and/or with contrast material(s); bilateral) 
were identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. When 
preparing to survey these codes, the specialties noted that the 
clinical indications had changed for these exams. The technology had 
advanced to make computer-aided detection (CAD) typical and these codes 
did not parallel the structure of other magnetic resonance imaging 
(MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes 
0159T, 77058, and 77059 and created four new CPT codes to report breast 
MRI with and without contrast (including computer-aided detection).
    The RUC recommended a work RVU of 1.45 for CPT code 77046 (Magnetic 
resonance imaging, breast, without contrast material; unilateral). This 
recommendation was based on a comparison with CPT codes 74176 (Computed 
tomography, abdomen and pelvis; without contrast material) and 74177 
(Computed tomography, abdomen and pelvis; with contrast material(s)), 
which both have similar intraservice and total times in relation to CPT 
code 77046. We disagreed with the RUC's recommended work RVU because we 
did not believe that the reduction in total time of 15 minutes between 
the new CPT code 77046 and the deleted CPT code 77058 was adequately 
reflected in its recommendation. Although total time has decreased by 
15 minutes, the only other difference between the two CPT codes is the 
change in the descriptor from the phrase `without and/or with contrast 
material(s)' to `without contrast material,' suggesting that there is 
less work involved in the new CPT code than in the deleted CPT code. 
Instead, we proposed a work RVU of 1.15 for CPT code 77046, which is 
similar to the total time ratio between the new CPT code and the 
deleted CPT code. It is also supported by a crosswalk to CPT code 77334 
(Treatment devices, design and construction; complex (irregular blocks, 
special shields, compensators, wedges, molds or casts)). CPT code 77334 
has total time of 35 minutes, intraservice time of 30 minutes, and a 
work RVU of 1.15.
    CPT code 77047 (Magnetic resonance imaging, breast, without 
contrast material; bilateral) describes the same work as CPT code 
77046, but reflects a bilateral rather than the unilateral procedure. 
The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we 
proposed a different work RVU for the unilateral procedure than the 
value proposed by the RUC, we believe it is appropriate to recalibrate 
the work RVU for CPT code 77047 relative to the RUC's recommended 
difference in work between the two CPT codes. The RUC's recommendation 
for

[[Page 59555]]

the bilateral procedure is 0.15 work RVUs larger than for the 
unilateral procedure. Therefore, we proposed a work RVU of 1.30 for CPT 
code 77047.
    The RUC recommended a work RVU of 2.10 for CPT code 77048 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral). CPT code 77048 is a new CPT code that bundles the deleted 
CPT code for unilateral breast MRI without and/or with contrast 
material(s) with CAD, which was previously reported, in addition to the 
primary procedure CPT code, as CPT code 0159T (computer aided 
detection, including computer algorithm analysis of MRI image data for 
lesion detection/characterization, pharmacokinetic analysis, with 
further physician review for interpretation, breast MRI). Consistent 
with our belief that the proposed value for the base CPT code in this 
series of new CPT codes (CPT code 77046) should be a work RVU of 1.15, 
we are proposing a work RVU for CPT code 77048 that adds the RUC-
recommended difference in RUC-recommended work RVUs between CPT codes 
77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code 
77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.
    The last new CPT code in this series, CPT code 77049 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmoacokinetic analysis) when performed; 
bilateral) describes the same work as CPT code 77048, but reflects a 
bilateral rather than a unilateral procedure. The RUC recommended a 
work RVU of 2.30 for this CPT code. Similar to the process for valuing 
work RVUs for CPT code 77047 and CPT code 77048, we believe that a more 
appropriate work RVU is calculated by adding the difference in the RUC 
recommended work RVU for CPT codes 77046 and 77049, to the proposed 
value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for 
CPT code 77049.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity from 7 minutes to 3 minutes 
for CPT codes 77046 and 77047, and from 9 minutes to 5 minutes for CPT 
codes 77048 and 77049. We noted that when the MRI of Lower Extremity 
codes were reviewed during the previous rule cycle (CPT codes 73718-
73720), these codes contained either 3 minutes or 5 minutes of 
recommended time for this same clinical labor activity. We also noted 
that the current Breast MRI codes that are being deleted and replaced 
with these four new codes, CPT codes 77058 and 77059, contain 5 minutes 
of clinical labor time for this same activity. We had no reason to 
believe that the new codes would require additional clinical labor time 
for patient positioning, especially given that the recommended clinical 
labor times are decreasing in comparison to the reference codes for 
obtaining patient consent (CA011) and preparing the room (CA013). 
Therefore, we refined the clinical labor time for the CA016 activity as 
detailed earlier to maintain relativity with the current clinical labor 
times in the reference codes, as well as with other recently reviewed 
MRI procedures.
    Included in the recommendations for this code family were five new 
equipment items: CAD Server (ED057), CAD Software (ED058), CAD 
Software--Additional User License (ED059), Breast coil (EQ388), and CAD 
Workstation (CPU + Color Monitor) (ED056). We did not receive any 
invoices for these five equipment items, and as such we do not have any 
direct pricing information to use in their valuation. We proposed to 
use crosswalks to similar equipment items as proxies for three of these 
new types of equipment until we do have pricing information:
     CAD software (ED058) is crosswalked to flow cytometry 
analytics software (EQ380).
     Breast coil (EQ388) is crosswalked to Breast biopsy device 
(coil) (EQ371).
     CAD Workstation (CPU + Color Monitor) (ED056) is 
crosswalked to Professional PACS workstation (ED053).
    We welcomed the submission of invoices with pricing information for 
these three new equipment items for our consideration to replace the 
use of these proxies. For the other two equipment items (CAD Server 
(ED057) and CAD Software--Additional User License (ED059)), we did not 
propose to establish a price at this time as we believe both of them 
would constitute forms of indirect PE under our methodology. We do not 
believe that the CAD Server or Additional User License would be 
allocated to the use of an individual patient for an individual 
service, and can be better understood as forms of indirect costs 
similar to office rent or administrative expenses. We understand that 
as the PE data age, these issues involving the use of software and 
other forms of digital tools become more complex. However, the use of 
new technology does not change the statutory requirement under which 
indirect PE is assigned on the basis of direct costs that must be 
individually allocable to a particular patient for a particular 
service. We look forward to continuing to seek out new data sources to 
help in updating the PE methodology.
    We also proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Breast MRI with Computer-Aided Detection 
(CAD) family of codes.
    Comment: A commenter disagreed with our use of deleted CPT code 
77058 as a point of reference for considering whether the reduction in 
work RVU in the new code, CPT code 77046, is commensurate with the 
reduction in work time between the two codes. The commenter stated that 
CMS should not compare these new services with the old deleted 
services, as indicated by the specialty society having demonstrated 
compelling evidence that the work involved in the breast MRI code 
family has fundamentally changed.
    Response: We disagree that it is inappropriate to use time 
comparisons with a code that is being deleted as a guide for assessing 
whether the reduction in work RVU recommended by the RUC is 
commensurate with the reduction in time based on survey results. The 
description of the work involved in furnishing CPT code 77046 has not 
changed substantively from the code being deleted. The compelling 
evidence that the commenter cites is related to the two new codes, CPT 
code 77048 and 77049, which are newly bundled with CAD. The main 
distinction in the description of physician work for this CPT code is 
that the new code specifies `without contrast', while the deleted code 
described the service `without and/or with contrast.' The change in 
patient population, also cited by the commenter, actually suggests that 
the more complex patients will be screened using the advanced 
technologies, such as is described by CPT code 77048. We recognize that 
changes in technology and work flow for the work described by CPT code 
77046 have affected the work involved in furnishing these services. 
This is why we use the time ratios as a starting point for code 
comparisons rather than the end point.
    Comment: One commenter stated that our proposed crosswalk code for 
CPT 77046, CPT code 77334, is inappropriate because of different 
preservice and intraservice times between the two codes, and because 
there is more low-

[[Page 59556]]

intensity time in CPT code 77334 compared with CPT code 77046. The 
commenter also indicated that our proposed work RVU for CPT code 77046 
would create a rank order anomaly with other MRI codes.
    Response: As a matter of principle, we do not agree that a chosen 
crosswalk for a CPT code is required to be clinically similar or to 
have identical intraservice and/or total time as the code being valued. 
However, in this instance, after further consideration, we agree with 
the commenter that our crosswalk code, CPT 77334, is not a particularly 
good comparison, in terms of intensity, to CPT 77046. We also agree 
with the commenter that our proposed work RVU for CPT code 77046 would 
create an anomaly among other CPT codes involving MRI. We are 
finalizing a work RVU for CPT code 77046 of 1.45, as recommended by the 
RUC.
    Comment: A commenter disagreed with our use of increments in 
recalibrating work RVUs for codes that precede or follow a new or 
revalued CPT code, as was the process underlying our proposed work RVUs 
for CPT codes 77047, 77048, and 77049.
    Response: The recalibration of CPT codes based on incremental 
difference in the work RVUs recommended by the RUC is an established 
methodology used by CMS to value the work involved in furnishing a 
service. There are certain types of code groups, particularly those 
with clear stepwise changes in intensity, as described by the RUC, for 
which we believe this is entirely appropriate. We continue to believe 
that this is an appropriate approach. However, having agreed with the 
commenter that our proposed work RVU for CPT code 77046 should be 
finalized at the RUC recommended work RVU of 1.45, we also believe that 
it is unnecessary to recalibrate the RUC's recommended work RVUs for 
the remainder of the three codes in the series. Therefore, we are 
finalizing a work RVU of 1.60 for CPT code 77047, 2.10 for CPT code 
77048, and 2.30 for CPT code 77049.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Prepare, set-up and start IV, 
initial positioning and monitoring of patient'' (CA016) activity from 7 
minutes to 3 minutes for CPT codes 77046 and 77047, and from 9 minutes 
to 5 minutes for CPT codes 77048 and 77049. Commenters stated that the 
rationale for this change was likely derived from reference to the 
lower clinical labor times for this activity associated with lower 
extremity MRI codes, and that it was an error to treat the clinical 
labor time for this activity as akin to that for lower extremity MRI. 
Commenters requested that CMS consider the experience of an 80-year-old 
patient who needs assistance on and off the table, along with 
reassurance, added explanation, IV insertion into delicate skin, and 
other anxiety needs. Commenters stated that another major distinction 
between breast MRI and extremity MRI is that the patient lies prone on 
the coil, which requires an awkward process of positioning and causes 
the need for additional clinical labor time.
    Response: We continue to disagree with the commenters that the RUC-
recommended clinical labor time would be typical for these procedures. 
As part of our review, we compared the clinical labor times for the 
CA016 activity not only to the codes in the MRI of Lower Extremity 
family, but also to the current Breast MRI codes that are being deleted 
and replaced with these four new codes. CPT codes 77058 and 77059 
contain 5 minutes of clinical labor time for this same activity, and we 
do not agree that the clinical labor times would be increasing to 7 and 
9 minutes in the newly created CPT codes, especially given that 
commenters did not provide a rationale as to why time would be 
increasing. We also note that while some patients will have conditions 
that are more difficult than the typical case, such as the 80-year-old 
patient described by the commenters, other patients would have 
conditions that are less difficult than the typical case. We remind the 
reader that valuation of services under the PFS is based on the typical 
case and not the most difficult cases that may arise. We further note 
that the clinical vignette for CPT code 77047 describes a 53-year old 
female patient, not an 80-year old patient, and was stated to be 
typical by 96 percent of the survey respondents.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for these four CPT codes, CMS proposed to remove 1 
minute from the CA014 activity code and proposed to add 1 minute to the 
CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We believe that the commenter may have been confused with 
several of the other code families that included these clinical labor 
refinements, which we described in the PE section of this final rule 
under the Changes to Direct PE Inputs for Specific Services heading 
(section II.B.3. of this final rule). We did not propose any 
refinements to the CA014 clinical labor for the codes in this family.
    Comment: Several commenters requested that CMS add 5 minutes to CPT 
codes 77048 and 77049 to account for the time required to obtain vital 
signs. Commenters stated that to maintain consistency within the codes 
for MRI with contrast, they requested that new codes for breast MRI 
with contrast receive an additional two minutes of time for MRI 
technologist (L047A) bringing the total time for obtain vital signs to 
5 minutes.
    Response: We proposed in CY 2018 to assign 5 minutes of clinical 
labor time for all codes that include the ``Obtain vital signs'' task, 
that included at least 1 minute previously assigned to this task 
regardless of the date of last review. After considering the comments, 
we did not finalize our proposal to establish 5 minutes as the new 
standard for the ``Obtain vital signs'' clinical labor task. As a 
result, we do not agree with the commenters that the clinical labor 
time for the CA010 activity should be increased to 5 minutes for CPT 
codes 77048 and 77049, especially given that we did not make a proposal 
to do so. We refer readers to the CY 2018 PFS final rule (82 FR 52990-
52991) for additional details about last year's proposal on this issue.
    Comment: One commenter requested that CMS assign additional 
clinical labor time for MRI procedures with contrast in order to 
account for time spent counseling patients. Commenters stated that 
because of the increased public awareness of the risk relating to 
gadolinium, additional time is required to explain the benefits and 
risks of the procedure.
    Response: We note that the MRI procedures in this family that are 
done with contrast (CPT codes 77048 and 77049) already contain more 
clinical labor than the MRI procedures that are done without contrast 
(CPT codes 77046 and 77047). Specifically, these procedures already 
contain two additional minutes for ``Provide education/obtain consent'' 
(CA011) clinical labor than the non-contrast versions of the 
procedures, which we believe indicates that the concerns of the 
commenters have been taken into account.
    Comment: Several commenters stated that the lack of invoices for 
the new equipment items may have been an oversight and enclosed new 
invoices with their comment letter. Commenters also stated that the CAD 
Software equipment (ED058) is actually synonymous with the ``breast 
biopsy software'' (EQ370) equipment, and recognized that in hindsight 
they should

[[Page 59557]]

have been consistent in identifying the equipment item between the 
breast biopsy codes and the MR breast codes. One commenter disagreed 
that the CAD Server or Additional User License equipment constituted 
forms of direct PE, and requested that CMS consider the cost of CAD 
service contracts and ``C-view'' costs in order to accurately access 
the calculation of indirect practice expenses.
    Response: We appreciate the submission of additional invoices from 
the commenters to assist in pricing these new equipment items. As we 
detailed in the Practice Expense portion of this final rule (section 
II.B. of this final rule), we are finalizing an update in the price of 
the CAD Software (ED058) equipment to $43,308.12 based on the new 
invoice submission and additional review by the StrategyGen contractor. 
We are also finalizing a price of $83,200 for the Breast coil (EQ388) 
equipment and a price of $12,031.52 for the CAD Workstation (CPU + 
Color Monitor) (ED056) based on the invoices submitted by the 
commenters. For the other two equipment items (CAD Server (ED057) and 
CAD Software--Additional User License (ED059)), we continue to believe 
that both of them would constitute forms of indirect PE under our 
methodology. The submitted invoices indicated that the CAD Server was a 
server type used in a data center while the user license was for a 
third license above and beyond the two licenses included in the price 
of the CAD software. As we stated in the proposed rule, we do not 
believe that these types of equipment would be allocated to the use of 
an individual patient for an individual service, and can be better 
understood as forms of indirect costs similar to office rent or 
administrative expenses.
    Comment: Several commenters stated that CMS had overstated the 
useful life of a breast coil. The commenters stated that a coil will 
start to display signs of wear, such as cracking of its case, flex 
spots, exposed wiring, or a degradation of its attenuated field causing 
a loss in image quality after about three to four years. Commenters 
stated that a useful life of 5 years would be more appropriate and 
consistent with the experience of their members.
    Response: We appreciate the additional information regarding the 
useful life of the breast coil equipment from the commenters. Our 
proposal to use 10 years as the useful life for this new equipment was 
based on our use of the breast biopsy device (EQ371) equipment as a 
proxy. We agree with the commenters that it would be more accurate to 
update the useful life to 5 years in light of this new information.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for the codes in the Breast MRI with 
Computer-Aided Detection family of codes. We are finalizing the direct 
PE inputs as proposed, with the updates to the pricing of the new 
equipment as detailed above.
(47) Blood Smear Interpretation (CPT Code 85060)
    CPT code 85060 (Blood smear, peripheral, interpretation by 
physician with written report) was identified on a screen of CMS or 
Other source codes with Medicare utilization greater than 100,000 
services annually. For CY 2019, the RUC recommended a work RVU of 0.45 
based on maintaining the current work RVU.
    We disagreed with the recommended value and proposed a work RVU of 
0.36 for CPT code 85060 based on the total time ratio between the 
current time of 15 minutes and the recommended time established by the 
survey of 12 minutes. This ratio equals 80 percent, and 80 percent of 
the current work RVU of 0.45 equals a work RVU of 0.36. When we 
reviewed CPT code 85060, we found that the recommended work RVU was 
higher than nearly all of the other global XXX codes with similar time 
values, and we do not believe that this blood smear interpretation 
procedure would have an anomalously high intensity. Although we did not 
imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs. In the case of CPT code 85060, we believe that 
it would be more accurate to propose the total time ratio at a work RVU 
of 0.36 to account for these decreases in the surveyed work time.
    The proposed work RVU was also based on the use of three crosswalk 
codes. We directly supported the proposed valuation through a crosswalk 
to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash 
testing, central nervous system except glaucoma, with interpretation 
and report), which has a work RVU of 0.35 along with 10 minutes of 
intraservice time and 14 minutes of total time. We also explained the 
proposed valuation by bracketing it between two other crosswalks, with 
CPT code 99152 (Moderate sedation services provided by the same 
physician or other qualified health care professional performing the 
diagnostic or therapeutic service that the sedation supports; initial 
15 minutes of intraservice time, patient age 5 years or older) on the 
lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral 
noninvasive physiologic studies of upper or lower extremity arteries, 3 
or more levels, or single level study with provocative functional 
maneuvers) on the higher end at a work RVU of 0.45.
    The RUC recommended no direct PE inputs for CPT code 85060 and we 
proposed none.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85060.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.36 for CPT code 85060 and stated that CMS should finalize the RUC-
recommended work RVU of 0.45. Commenters stated that a time ratio 
should not be used because any decrease will result in a large ratio 
and a corresponding but inappropriate decrease to the physician work 
RVU. Commenters stated that rather than using time ratios CMS should 
examine the magnitude estimation between the physician work, time, and 
intensity. Commenters also stated that the current time was not based 
on a survey and it was unclear how the time was determined.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual

[[Page 59558]]

procedures. Were we to disregard intensity altogether, the work RVUs 
for all services would be developed based solely on time values and 
that is definitively not the case, as indicated by the many services 
that share the same time values but have different work RVUs. (As an 
example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share 
identical CY 2019 work times with 15 minutes of preservice time, 30 
minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277).
    Comment: Several commenters disagreed with our statement that the 
recommended work value of 0.45 is higher than nearly all of the other 
global XXX codes with similar time values. Commenters stated that a 
search of the RUC database contradicted this finding, showing that 
eleven XXX codes with 12 minutes of intraservice time have values lower 
than 0.45 and thirteen XXX codes with 12 minutes of intraservice time 
have values the same or higher than 0.45 RVUs. Commenters stated that 
none of these services are pathology services and were not comparable, 
except for CPT code 88388 (Macroscopic examination, dissection, and 
preparation of tissue for non-microscopic analytical studies (e.g., 
nucleic acid-based molecular studies)) which has identical work value 
and intra-service time and was the reference code cited in the RUC 
recommendation. Commenters also disagreed with the CMS crosswalk to CPT 
code 95930 due to the fact that it is not a pathology service.
    Response: We disagree with the commenters' statement that pathology 
services are only comparable to other pathology services. Although we 
agree that the unique nature of pathology and laboratory services can 
make comparisons across codes more difficult than in other services, we 
believe the comparison of codes with similar work RVUs across different 
specialties is important to maintaining the relativity of the PFS. We 
disagree with the commenters that the crosswalk to CPT code 95930 would 
be methodologically inappropriate solely on the grounds that it is not 
a pathology service.
    Comment: Several commenters stated that there are a number of 
variables that must be considered in the evaluation of a blood smear 
when compared to others, including red blood cell count, size and 
morphology, platelet morphology and number, white blood cell morphology 
and the presence of white blood cell precursors. Commenters stated that 
other services with identical physician work include CPT code 88314 
(Special stain including interpretation and report; histochemical stain 
on frozen tissue block) and CPT code 93923 (Complete bilateral 
noninvasive physiologic studies of upper or lower extremity arteries, 3 
or more levels). Commenters stated the proposed work value would create 
significant rank order anomalies within the array of pathology 
services, as CPT code 85060 has nearly identical work time to CPT code 
88314 but would be valued lower at the proposed work RVU.
    Response: We appreciate the detailed information about CPT code 
85060 provided by the commenters regarding the clinical comparisons to 
CPT codes 88314 and 93923.
    After consideration of the public comments, we are not finalizing 
our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the 
RUC-recommended work RVU of 0.45 instead.
(48) Bone Marrow Interpretation (CPT Code 85097)
    CPT code 85097 (Bone marrow, smear interpretation) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. For CY 2019, the RUC 
recommended a work RVU of 1.00 based on a direct crosswalk to CPT code 
88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract 
specimen with morphometric analysis, 3-5 molecular probes, each 
specimen; using computer-assisted technology).
    We disagreed with the RUC-recommended value and we proposed a work 
RVU of 0.94 for CPT code 85097 based on maintaining the current work 
valuation. We noted that the survey indicated that CPT code 85097 
typically takes 25 minutes of work time to perform, down from a 
previous work time of 30 minutes, and, generally speaking, since the 
two components of work are time and intensity, we believe that 
significant decreases in time should be reflected in decreases to work 
RVUs. For the specific case of CPT code 85097, we supported our 
proposed work RVU of 0.94 through a crosswalk to CPT code 88361 
(Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, 
estrogen receptor/progesterone receptor), quantitative or 
semiquantitative, per specimen, each single antibody stain procedure; 
using computer-assisted technology), a recently reviewed code from CY 
2018 with the identical time values and a work RVU of 0.95.
    We also considered a work RVU of 0.90 based on double the 
recommended work RVU of 0.45 for CPT code 85060 (Blood smear, 
peripheral, interpretation by physician with written report). When both 
of these CPT codes were under review, the explanation was offered that 
in a peripheral blood smear, typically, the practitioner does not have 
the approximately 12 precursor cells to review, whereas in an aspirate 
from the bone marrow, the practitioner is examining all the precursor 
cells. Additionally, for CPT code 85097, there are more cell types to 
look at as well as more slides, usually four, whereas with CPT code 
85060 the practitioner would typically only look at one slide. Although 
we did not propose to value CPT code 85097 at twice the work RVU of CPT 
code 85060, we believe this analysis also supports maintaining the 
current work RVU of 0.94 as opposed to raising it to 1.00.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Accession and enter information'' (PA001) and ``File 
specimen, supplies, and other materials'' (PA008) activities. As we 
stated previously, information entry and specimen filing tasks are not 
individually allocable to a particular patient for a particular service 
and are considered to be forms of indirect PE. Although we agree that 
these are necessary tasks, under our established methodology we believe 
that they are more appropriately classified as indirect PE.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85097.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.94 for CPT code 85097 and stated that CMS should finalize the RUC-
recommended work RVU of 1.00. Commenters stated that the CMS rationale 
about changes in work time was out of place in this context because the 
survey respondents indicate that the service requires 25 minutes to 
perform rather than the current time of 30 minutes, yet CMS proposed to 
maintain the current work value. The commenters suggested that 
maintaining the current work RVU of 0.94 was therefore inappropriate. 
Commenters also stated that the current work time for CPT code 85097 
was not based on a survey and that it was unknown how this time was

[[Page 59559]]

determined and what it actually represents.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we 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 old 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 final rule (81 FR 80273 through 80274). 
With regard to the specific case of CPT code 85097, we proposed to 
maintain the current work RVU rather than decreasing the work RVU due 
to some of the same concerns about the historical work times for this 
code raised by the commenters. We believe that the logic provided by 
the commenters suggests that the decreases in the work time of CPT code 
85097 should have been reflected in decreases to the work RVU (as 
opposed to maintaining the current value), which we do not believe was 
their intention.
    Comment: Several commenters stated that given the total work, time, 
intensity, and complexity of the patient case, the current work RVU of 
0.94 was too low for CPT code 85097. Commenters stated that the RUC 
chose a crosswalk to CPT code 88121 (Cytopathology, in situ 
hybridization (e.g., FISH), urinary tract specimen with morphometric 
analysis, 3-5 molecular probes, each specimen; using computer-assisted 
technology) specifically because it is a similar pathology code with a 
value between the current work value of 0.94 and the survey 25th 
percentile of 1.15. Commenters stated that the CMS reference code (CPT 
code 88361) was less intense and complex to perform as it involves 
evaluating a single antibody and determining the percentage of tumor 
cells that are positive for that antibody, as opposed to the work of 
CPT code 85097 which involves evaluating all blood cell precursors for 
quantitative and morphologic abnormalities, as well as evaluating for 
metastatic tumor cells, evidence of infection, or evidence of lymphoid 
neoplasms.
    Response: We disagree with the commenters that the current work RVU 
of 0.94 or the work RVU of our reference code of 88361 are too low in 
comparison to CPT code 85097. All three of the codes under discussion 
(CPT codes 85097, 88121, and 88361) are clinically similar procedures 
that involve the practitioner using their eyes to look at staining 
patterns. We do not agree with the commenters that the RUC's use of CPT 
code 88121 as a crosswalk would be any more accurate on clinical 
grounds that the reference code of 88361 that we chose in the proposed 
rule. Overall, we do not believe that there is a significant difference 
between these three procedures given their nearly identical work RVUs, 
intensities, and work times. However, given the decrease in surveyed 
work time, we continue to believe that it is more appropriate to 
maintain the current work RVU of 0.94 than to increase it to 1.00 due 
to our longstanding belief that decreases in work time should typically 
be not be reflected in increases to the work RVU. We note that we are 
not proposing to decrease the work RVU for CPT code 85097 despite this 
decrease in the surveyed work time, only to maintain the current 
valuation.
    Comment: Several commenters responded to the CMS consideration of a 
work RVU of 0.90 based on double the recommended work RVU of 0.45 for 
CPT code 85060. Commenters stated that they wished to clarify that this 
explanation was put forward to a RUC member whom was simply questioning 
why this service requires twice the time of CPT code 85060. Commenters 
stated that simply doubling the RUC-recommended work RVU of 0.45 for 
CPT code 85060 based on the amount of time does not account for the 
considerably greater intensity and complexity of CPT code 85097 over 
CPT code 85060 as described elsewhere in their comments.
    Response: We appreciate the clarification on this issue from the 
commenters.
    Comment: Several commenters disagreed with the CMS proposal remove 
the clinical labor time for the ``Accession and enter information'' 
(PA001) and ``File specimen, supplies, and other materials'' (PA008) 
activities. Commenters stated that although the descriptions for the 
PA001 and PA008 clinical labor activities appeared to describe data 
entry and filing activities, these tasks are very different in the 
pathology lab. Commenters stated that it is crucial for the performance 
of these tasks be executed accurately according to rigid patient 
laboratory protocols, standards, and legal processes associated with 
specimen/patient care and they should not be considered a form of 
indirect expense.
    Response: Although we agree that the unique nature of pathology and 
laboratory services can make comparisons across codes more difficult 
than for other services, we believe the comparison of similar clinical 
labor activities across different services is important to maintaining 
the relativity of the direct PE inputs. As we stated in the CY 2017 PFS 
final rule (81 FR 80324), we agree with the commenters that entering 
patient data into information systems and filing specimens are 
important tasks, and we agree that these would take more than zero 
minutes to perform. However, we continue to believe that these 
activities are correctly categorized as indirect PE as administrative 
functions, and therefore, we do not recognize the entry of patient data 
or the filing of specimens as direct PE inputs, and we do not consider 
this task as typically performed by clinical labor on a per-service 
basis.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 85097 as proposed.
(49) Fibrinolysins Screen (CPT Code 85390)
    CPT code 85390 (Fibrinolysins or coagulopathy screen, 
interpretation and report) was identified as potentially misvalued on a 
screen of codes with a negative IWPUT, with 2016 estimated Medicare 
utilization over 10,000 for

[[Page 59560]]

RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other 
source codes. For CY 2019, we are proposing the RUC-recommended work 
RVU of 0.75 for CPT code 85390. Because this is a work only code, the 
RUC did not recommend, and we did not propose any direct PE inputs for 
CPT code 85390.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85390.
    Comment: A commenter expressed support for our proposal to accept 
the RUC-recommended work RVU for this code.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing our 
proposal to accept the RUC-recommended work RVU for this code.
(50) Electroretinography (CPT Codes 92273, 92274, and 0509T)
    CPT code 92275 (Electroretinography with interpretation and report) 
was identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. In 
January 2016, the specialty society noted that they became aware of 
inappropriate use of CPT code 92275 for a less intensive version of 
this test for diagnosis and indications that are not clinically proven 
and for which less expensive and less intensive tests already exist. 
CPT changes were necessary to ensure that the service for which CPT 
code 92275 was intended was clearly described, as well as an accurate 
vignette and work descriptor were developed. In September 2017, the CPT 
Editorial Panel deleted CPT code 92275 and replaced it with two new 
codes to describe electroretinography full field and multi focal. A 
category III code was retained for pattern electroretinography.
    For CPT code 92273 (Electroretinography (ERG) with interpretation 
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we 
disagreed with the recommended work RVU of 0.80 and we instead proposed 
a work RVU of 0.69 based on a direct crosswalk to CPT code 88172 
(Cytopathology, evaluation of fine needle aspirate; immediate 
cytohistologic study to determine adequacy for diagnosis, first 
evaluation episode, each site). CPT code 88172 is another 
interpretation procedure with the same 20 minutes of intraservice time, 
which we believe is a more accurate comparison for CPT code 92273 than 
the two reference codes chosen by the survey participants due to their 
significantly higher and lower intraservice times. We noted that the 
recommended intraservice time for CPT code 92273 as compared to its 
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes 
(56 percent reduction), and the recommended total time is decreasing 
from 71 minutes to 22 minutes (69 percent reduction); however, the work 
RVU is only decreasing from 1.01 to 0.80, which is a reduction of just 
over 20 percent. Although we did not imply that the decreases 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 reflected in decreases to work RVUs. In the case of CPT 
code 92273, we have reason to believe that the significant drops in 
surveyed work time as compared to CPT code 92275 are a result of 
improvements in technology since the predecessor code was reviewed. The 
older machines used for electroretinography were slower and more 
cumbersome, and now the same work for the service can be performed in 
significantly less time. Therefore, we proposed a work RVU of 0.69 
based on the direct crosswalk to CPT code 88172, which we believe more 
accurately accounts for these decreases in surveyed work time.
    For CPT code 92274 (Electroretinography (ERG) with interpretation 
and report; multifocal (mfERG)), we disagreed with the RUC-recommended 
work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the 
relative difference in work between CPT code 92273 and 92274 is 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we 
proposed a work RVU of 0.61 for CPT code 92274, based on the 
recommended interval of 0.08 fewer RVUs below our proposed work RVU of 
0.69 for CPT code 92273. The proposed work RVU is also based on the use 
of two crosswalk codes: CPT code 88387 (Macroscopic examination, 
dissection, and preparation of tissue for non-microscopic analytical 
studies; each tissue preparation); and CPT code 92100 (Serial tonometry 
(separate procedure) with multiple measurements of intraocular pressure 
over an extended time period with interpretation and report, same day). 
Both codes share the same 20 minutes of intraservice and 20 minutes of 
total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU 
of 0.61 for CPT code 92100.
    The recommendations for this code family also include CPT Category 
III code 0509T (Electroretinography (ERG) with interpretation and 
report, pattern (PERG)). We typically assign contractor pricing for 
Category III codes since they are temporary codes assigned to emerging 
technology and services. However, in cases where there is an unusually 
high volume of services that will be performed under a Category III 
code, we have sometimes assigned an active status to the procedure and 
developed RVUs before a formal CPT code is created. In the case of CPT 
code 0509T, the recommendations indicate that approximately 80 percent 
of the services currently reported under CPT code 92275 will be 
reported under the new Category III code. Since this will involve an 
estimated 100,000 services for CY 2019, we believe that the interests 
of relativity would be better served by assigning an active status to 
CPT code 0509T and creating RVUs through the use of a proxy crosswalk 
to a similar existing service. Therefore, we proposed to assign an 
active status to CPT Category III code 0509T for CY 2019, with a work 
RVU and work time values crosswalked from CPT code 92250 (Fundus 
photography with interpretation and report). CPT code 92250 is a 
clinically similar procedure that was recently reviewed during the CY 
2017 rule cycle. We proposed a work RVU of 0.40 and work times of 10 
minutes of intraservice and 12 minutes of total time for CPT code 0509T 
based on this crosswalk to CPT code 92250.
    For the direct PE inputs, we proposed to remove the preservice 
clinical labor in the facility setting for CPT codes 92273 and 92274. 
Both of these codes are diagnostic tests under which the professional 
(26 modifier) and technical (TC modifier) components will be separately 
billable, and codes that have these professional and technical 
components typically will not have direct PE inputs in the facility 
setting since the technical component is only valued in the nonfacility 
setting. We also noted on this subject that the predecessor code, CPT 
code 92275, does not currently include any preservice clinical labor, 
nor any facility direct PE inputs.
    We proposed to remove the clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) and the ``Provide education/obtain consent'' 
(CA011) activities for CPT codes 92273 and 92274. Both of these CPT 
codes will typically be reported with a same day E/M service, and we 
believe that these clinical labor tasks will be carried out during the 
E/M service. We believe that their inclusion in CPT codes 92273 and 
92274 would be duplicative. We also proposed to refine the clinical 
labor time for the

[[Page 59561]]

``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 for both codes. The predecessor 
CPT code 92275 did not previously have clinical labor time assigned for 
the ``Confirm order, protocol exam'' clinical labor task, and we did 
not have any reason to believe that the services being furnished by the 
clinical staff had changed in the new codes, only the way in which this 
clinical labor time has been presented on the PE worksheets. We also 
noted 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 proposed to refine the clinical labor time for the ``Clean room/
equipment by clinical staff'' (CA024) activity from 12 minutes to 8 
minutes for CPT codes 92273 and 92274. The recommendations for these 
codes stated that cleaning is carried out in several steps: The patient 
is first cleaned for 2 minutes, followed by wires and electrodes being 
scrubbed carefully with detergent, soaked, and then rinsed with sterile 
water. We agree with the need for 2 minutes of patient cleaning time 
and for the cleaning of the wires and electrodes to take place in two 
different steps. However, our standard clinical labor time for room/
equipment cleaning is 3 minutes, and therefore, we proposed a total 
time of 8 minutes for these codes, based on 2 minutes for patient 
cleaning and then 3 minutes for each of the two steps of wire and 
electrode cleaning.
    We proposed to refine the clinical labor time for the 
``Technologist QC's images in PACS, checking for all images, reformats, 
and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT 
codes 92273 and 92274. We finalized in the CY 2017 PFS final rule (81 
FR 80184-80186) a range of appropriate standard minutes for this 
clinical labor activity, ranging from 2 minutes for simple services up 
to 5 minutes for highly complex services. We believe that the 
complexity of the imaging in CPT codes 92273 and 92274 is comparable to 
the CT and magnetic resonance (MR) codes that have been recently 
reviewed, such as CPT code 76391 (Magnetic resonance (e.g., vibration) 
elastography). Therefore, in order to maintain relativity, we proposed 
the same clinical labor time of 3 minutes for CPT codes 92273 and 92274 
that has been recommended for these CT and MR codes. We also proposed 
to refine the clinical labor time for the ``Review examination with 
interpreting MD/DO'' (CA031) activity from 5 minutes to 2 minutes for 
CPT codes 92273 and 92274. We also finalized in the CY 2017 PFS final 
rule a standard time of 2 minutes for reviewing examinations with the 
interpreting MD, and we have no reason to believe that these codes 
would typically require additional clinical labor at more than double 
the standard time.
    We noted that the new equipment item ``Contact lens electrode for 
mfERG and ffERG'' (EQ391) was listed twice for CPT code 92273 but only 
a single time for CPT code 92274. We solicited additional information 
about whether the recommendations intended this equipment item to be 
listed twice, with one contact intended for each eye, or whether this 
was a clerical mistake. We are also interested in additional 
information as to why the contact lens electrode was listed twice for 
CPT code 92273 but only a single time for CPT code 92274. Finally, we 
also proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    We proposed to use the direct PE inputs for CPT code 92274, 
including the refinements detailed above, as a proxy for CPT Category 
III code 0509T until it can be separately reviewed by the RUC.
    The following is a summary of the public comments we received on 
our proposals involving the Electroretinography family of codes.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.69 for CPT code 92273 and stated that CMS should finalize the RUC-
recommended work RVU of 0.80. Commenters stated that the RUC-
recommended work RVU was based on the survey 25th percentile and CMS 
should use survey data in establishing the work RVU. Commenters stated 
that the decrease in intraservice work time of deleted CPT code 92275 
from when it was last surveyed in 1995 was due to the fact that the 
physician no longer participates in the acquisition of the data or 
performing the test on the patient, which has become the technician's 
work. Commenters stated that the RUC determined that the physician work 
is not the same as it was with CPT code 92275 and the recommended 
decrease in work RVUs appropriately addresses the decrease in physician 
time to perform this service.
    Response: We disagree with the commenters that the RUC-recommended 
decrease in work RVUs appropriately addresses the decrease in physician 
time to perform this service. As we stated in the proposed rule, the 
recommended intraservice time for CPT code 92273 as compared to its 
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes 
(56 percent reduction), and the recommended total time is decreasing 
from 71 minutes to 22 minutes (69 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.01 to 0.80, which is a 
reduction of just over 20 percent. Although we did not imply that the 
decreases 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 reflected in decreases to work 
RVUs. As a result, we believe that our proposed work RVU of 0.69 more 
accurately captures the changes in work that have taken place since the 
previous survey.
    Comment: Several commenters stated that while the time required for 
CPT code 92273 is less than the time required for CPT code 92275, the 
code it replaced, the intensity and complexity of the work involved in 
interpreting the test has increased significantly. Commenters stated 
that the newer machines are easily programmed to produce more images 
and numbers for interpretation (double or more) than the machines in 
use in 1995 when the procedure was last valued and that advances in 
medical knowledge have identified more specific retinal dystrophy 
diagnoses with specific genotypes that the clinician must consider when 
interpreting the test. Commenters emphasized that while the machine may 
be more efficient as stated by CMS, the cognitive work required by the 
physician interpreting the test has increased significantly.
    Response: We disagree with the commenters that all of the 
efficiencies gained in work time via improved technology would be 
offset via higher intensity (that is, greater cognitive work on the 
part of the practitioner). While the incorporation of new technology 
can sometimes make services more complex and difficult to perform, it 
can also have the opposite effect by making services less reliant on 
manual skill and technique. At the RUC-recommended work RVU of 0.80, 
the intensity of CPT code 92273 would increase by nearly 300 percent, 
and we do not agree that the cognitive intensity of the procedure would 
have increased by this amount. We continue to believe that our proposed 
work RVU of 0.69 more accurately captures the changes in work taking 
place as a result of greater technological efficiencies in the service.

[[Page 59562]]

    Comment: Many commenters disagreed with the proposed work RVU of 
0.61 for CPT code 92274 and stated that CMS should finalize the RUC-
recommended work RVU of 0.72. Commenters stated that CMS should use 
valid methods of evaluating services, such as survey data and magnitude 
estimation, instead of relying on an incremental difference in work 
RVUs between codes 92273 and 92274.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 92274, as the 
proposed work RVU was also based on the use of a reference code (CPT 
code 88387) and a crosswalk code (CPT code 92100). Both codes share the 
same 20 minutes of intraservice and 20 minutes of total time, with a 
work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code 
92100.
    Comment: Several commenters stated that while there was no 
predecessor code for direct comparison, the intensity and complexity of 
the work involved in interpreting the test has increased significantly 
compared to 1995, when CPT code 92275 was last valued. Commenters 
restated the same arguments they expressed for CPT code 92273: The new 
machines used in CPT code 92274 have become more efficient but the 
cognitive work required by the physician interpreting the test has 
increased significantly.
    Response: As we stated with regard to CPT code 92273, we continue 
to disagree with the commenters that all of the efficiencies gained in 
work time via improved technology would be offset via higher intensity 
(that is, greater cognitive work on the part of the practitioner). At 
the RUC-recommended work RVU of 0.72, the intensity of CPT code 92274 
would also increase by nearly 300 percent, and we do not agree that the 
cognitive intensity of the procedure would have increased by this 
amount. We continue to believe that our proposed work RVU of 0.61 more 
accurately captures the changes in work taking place as a result of 
greater technological efficiencies in the service.
    Comment: Several commenters stated that CPT code 92274 requires 
more physician work than the crosswalks we identified. Commenters 
stated that CPT code 88387 is a straightforward manual dissection that 
does not require interpretation of multiple images and numeric values 
to arrive at a diagnosis. Commenters stated that CPT code 92100 also 
requires less physician work, as CPT code 92274 requires interpretation 
of significantly more data and consideration of many more diagnostic 
possibilities.
    Response: We disagree with the commenters that our reference and 
crosswalk codes require less work than CPT code 92274. While it is true 
that CPT code 88387 does not require interpretation of multiple images 
and numeric values, this is because it is not an imaging service, and 
it is inappropriate to state that the work of CPT code 88387 is lower 
than CPT code 92274 based on this criteria. We do not agree that the 
macroscopic examination, dissection, and preparation of tissue taking 
place in CPT code 88387 would inherently constitute less work than CPT 
code 92274. Similarly, we do not agree that the serial tonometry with 
multiple measurements of intraocular pressure taking place in CPT code 
92100 would involve less work than CPT code 92274, especially due to 
the nearly identical intraservice and total work times shared by these 
procedures.
    Comment: One commenter disagreed with our proposal to assign active 
pricing to Category III code 0509T. The commenter stated that this code 
should go through the regular vetting process that other new technology 
typically follows, including development of appropriate clinical 
literature that would qualify it for elevation to a full Category I CPT 
code, and then a RUC survey in order to develop accurate valuation for 
work and practice expense. The commenter was concerned that CMS would 
single out and put forward a value for a technology that has not gone 
through the same scrutiny as other new technologies.
    Response: We understand the concerns expressed by the commenter. As 
we stated in the proposed rule, we typically assign contractor pricing 
for Category III codes since they are temporary codes assigned to 
emerging technology and services. However, in cases where there is an 
unusually high volume of services that will be performed under a 
Category III code, we have sometimes assigned an active status to the 
procedure, and in the case of Category III code 0509T the 
recommendations indicated that approximately 80 percent of the services 
currently reported under CPT code 92275 will be reported under the new 
Category III code. Since this will involve an estimated 100,000 
services for CY 2019, we continue to believe that the interests of 
relativity would be better served by assigning an active status to 
Category III code 0509T and creating RVUs through the use of a proxy 
crosswalk to a similar existing service. We agree with the commenter 
that this code should still go through the regular vetting process that 
other new technology typically follows, and we look forward to 
receiving recommendations for work and practice expense inputs in the 
future.
    Comment: One commenter stated that many of the proposed changes to 
the direct PE inputs were made with the intent to standardize inputs. 
The commenter stated that although the RUC has created many standards, 
they have always acknowledged that there are and will be exceptions to 
those standards. The commenter stated that these important diagnostic 
tests are unusual services that require significant amounts of 
preservice clinical labor time in whichever setting they are performed, 
and that the recommended direct PE inputs were carefully prepared based 
upon documented personal observation and time motion studies. The 
commenter stated that the predecessor CPT code 92275 had an over-
simplified PE spreadsheet with very few data inputs, each comprising 
substantial amounts of time that are now broken out into separate 
inputs, and as a result the work required had not changed substantially 
but there had been additional granularity in the direct PE inputs.
    Response: As we noted in the CY 2015 PFS final rule with comment 
period (79 FR 67640 through 67641), we continue to make improvements to 
the direct PE input database to provide the number of clinical labor 
minutes assigned for each task for every code in the database instead 
of only including the number of clinical labor minutes for the 
preservice, service, and postservice periods for each code. We have 
stated that we believe this additional level of detail helps to 
facilitate transparency, allows us to more easily compare clinical 
labor times across the PFS to maintain relativity, and helps in 
maintaining standard times for particular clinical labor tasks that can 
be applied consistently to many codes as they are valued over several 
years. However, we have always recognized that standards for clinical 
labor cannot be applied universally due to the differences between 
individual services, and we have frequently finalized

[[Page 59563]]

clinical labor times above the standard values where we believed that 
there was sufficient reason to establish these values as the typical 
case. In the case of CPT code 92273 and 92274, we detailed our 
rationale in the proposed rule for why we believed that some of the 
RUC-recommended direct PE inputs should be refined to a standard 
clinical labor time. We also note that we did not propose the standard 
clinical labor time for all activities, such as the ``Clean room/
equipment by clinical staff'' (CA024) activity.
    Comment: Several commenters disagreed with the proposal to remove 
the preservice clinical labor in the facility setting for CPT codes 
92273 and 92274. Commenters stated that these procedures, when done in 
a facility, must be scheduled in the operating room. Commenters stated 
that these procedures would typically be done in the facility only when 
it is not clinically appropriate for them to be performed in the 
clinic, such as for children or the cognitively impaired; and it takes 
substantial amounts of time for the staff to accomplish this 
coordination of care for these higher-needs patients.
    Response: We recognize that these procedures are rarely performed 
in the facility setting, with approximately 1 percent of the 
utilization of predecessor CPT code 92275 taking place in this setting. 
However, we disagree that these procedures would typically be performed 
in the operating room when furnished in the facility, and therefore, we 
do not agree that these procedures would typically require preservice 
clinical labor for coordination of care. We also noted on this subject 
that the predecessor code, CPT code 92275, does not currently include 
any preservice clinical labor, nor any facility direct PE inputs, and 
we did not receive an explanation from the commenters as to why this 
was the case. Furthermore, both of these codes are diagnostic tests 
under which the professional (26 modifier) and technical (TC modifier) 
components will be separately billable, and codes that have these 
professional and technical components typically will not have direct PE 
inputs in the facility setting since the technical component is only 
valued in the nonfacility setting.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Greet patient, provide gowning, 
ensure appropriate medical records are available'' (CA009) and the 
``Provide education/obtain consent'' (CA011) activities for CPT codes 
92273 and 92274. Commenters stated that although slightly more than 50 
percent of these services are done on the same day as an office visit, 
the clinical staff time involved is completely divorced from the office 
visit and the staff performing the test are different from the staff 
assisting in the office visit. Commenters stated that the machine used 
for these procedures is housed in a different room, the patient needs 
to be transported from the ophthalmic exam lane to the ERG room and 
back, additional instructions are required that are never done during a 
typical office visit, and the nature of this test requires extra 
supplies and work in addition to those used for the office visit. 
Commenters emphasized that these clinical tasks are not duplicative 
with an E/M, as they represent separate actions by a different 
technician in a different room.
    Response: We disagree with the commenters and continue to believe 
that this clinical labor would be duplicative with the same day E/M 
office visit. While it is true that there is a different clinical labor 
staff type used by CPT codes 92273 and 92274, we are not suggesting 
that all clinical labor is duplicative with the same day E/M visit, 
only that clinical labor activities such as greeting and gowning the 
patient would only be done a single time. We also note that we do not 
include patient transportation as a form of direct PE, as it is not 
individually allocable to a single service and would instead be 
classified as an administrative task under indirect PE. However, we do 
agree with the commenters that additional instructions would be 
required for these electroretinography services, and as a result we 
will restore the 1 minute of clinical labor time for the ``Provide 
education/obtain consent'' (CA011) activity. We agree that this would 
not be duplicative with the same day E/M office visit.
    Comment: Several commenters stated that in our refinements to the 
direct PE inputs for CPT codes 92273 and 92274, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor. One commenter 
stated that this work is done by a different technician in a different 
room typically in a busy clinical setting and this work was separate 
from that being done during the office visit.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
92273 and 92274, we are finalizing these clinical labor refinements as 
proposed. We also note in response to the one commenter that our 
refinements to the CA013 and CA014 clinical labor activities were not 
based on the premise on being duplicative with the same day E/M visit.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Clean room/equipment by clinical 
staff'' (CA024) activity from 12 minutes to 8 minutes for CPT codes 
92273 and 92274. Commenters stated that this was the time that the 
specialty society found when directly shadowing the process to clean 
the patient and the equipment. Commenters stated that the technician 
needs to clean the patient's skin, rinse their eyes, and clean around 
the patient and escort them out. Commenters stated that the expensive 
and delicate eye electrodes require a significant amount of time to 
remove and clean the conductive paste and Goniosol without damaging the 
electrodes, which needs to be performed after each procedure so that 
the electrodes can be re-used for the next procedure. Commenters 
emphasized that the equipment cleaning process requires meticulous care 
and a significant amount of technician time.
    Response: We agree with the commenters that these procedures 
require more time for cleaning the room and equipment than the standard 
for the CA024 activity. This is the reason we proposed 8 minutes of 
clinical labor time instead of 3 minutes, almost triple the standard 
value for this activity code. As we stated in the proposed rule, we 
agreed with the need for 2 minutes of patient cleaning time and for the 
cleaning of the wires and electrodes to take place in two different 
steps. Since our standard clinical labor time for room/equipment 
cleaning is 3 minutes, we therefore proposed a total time of 8 minutes 
for these codes, based on 2 minutes for patient cleaning and then 3 
minutes for each of the two steps of wire and electrode cleaning. We 
continue to believe that 8 minutes would be the typical amount of 
clinical labor used for these procedures.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Technologist QC's images in PACS, 
checking for all images, reformats, and dose page'' (CA030) activity 
from 10 minutes to 3 minutes for CPT codes 92273 and 92274. Commenters 
stated that the machine used for the ERG codes is not typically 
integrated into the clinic's electronic medical record. Commenters 
stated that this machine requires printing all images created by the 
testing

[[Page 59564]]

machine and uploading them into the EMR for subsequent review by the 
physician and that it is not unusual for re-printing using a different 
scale or limits to be necessary. Commenters stated that this clinical 
labor differed from a typical radiology scenario because the procedure 
is in fact different from a typical imaging study.
    Response: We disagree with the commenters that the full recommended 
time of 10 minutes would be typical for this clinical labor activity. 
We do not agree that it would be typical to physically print out all of 
the images produced by the machine, and note that we do not include 
additional direct PE inputs for inefficiencies in practice operations. 
We continue to believe that the complexity of the imaging in CPT codes 
92273 and 92274 is comparable to the CT and magnetic resonance (MR) 
codes, and that in order to maintain relativity, we proposed the same 
clinical labor time of 3 minutes.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Review examination with interpreting 
MD/DO'' (CA031) activity from 5 minutes to 2 minutes for CPT codes 
92273 and 92274. Commenters stated that this input was calculated by 
direct observation of typical procedures with a stopwatch. Commenters 
stated that this test is performed in a different room than the office 
visit, and the technician needs to take time to find the ordering/
interpreting physician and review the quality of the gain and results.
    Response: We disagree with the commenters that the full recommended 
time of 5 minutes would be typical for this clinical labor activity. We 
note again that we do not include additional direct PE inputs for 
inefficiencies in practice operations, and that we would not increase 
the clinical labor to include time that the technician needs to find 
the ordering/interpreting physician. We finalized in the CY 2017 PFS 
final rule a standard time of 2 minutes for reviewing examinations with 
the interpreting MD, and we have no reason to believe that these codes 
would typically require additional clinical labor at more than double 
the standard time.
    Comment: Several commenters responded to the comment solicitation 
regarding additional information about whether the recommendations for 
the ``Contact lens electrode for mfERG and ffERG'' (EQ391) equipment 
intended this equipment item to be listed twice, with one contact 
intended for each eye, or whether this was a clerical mistake. 
Commenters stated that this was not an error but was intentional and 
reflects typical practice. Commenters stated that the test carried out 
in CPT code 92273 is performed with two contact lenses in place (one in 
each eye at the same time) in a simultaneous testing fashion. 
Commenters stated that the test carried out in CPT code 92274 is 
typically performed sequentially one eye at a time, re-using the same 
contact lens for each eye. Commenters stated that this discrepancy is 
primarily due to the dark and light-adaptation needs for the ffERG, 
which if done sequentially would double the amount of clinical time.
    Response: We appreciate the additional information supplied by the 
commenters in response to our comment solicitation.
    Comment: One commenter stated that the highly technical equipment 
formula should be used for the mfERG and ffERG electrodiagnostic unit 
(EQ390) equipment item.
    Response: We did not propose to classify the EQ390 equipment as 
highly technical. We note that if we were to use the highly technical 
equipment formula for the EQ390 equipment, the total equipment time for 
this item would decrease, and we do not believe that this was what the 
commenter intended.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Electroretinography family of codes as 
proposed. We are also finalizing the direct PE inputs as proposed, with 
the exception of the CA011 clinical labor activity as described above.
(51) Cardiac Output Measurement (CPT Codes 93561 and 93562)
    CPT codes 93561 (Indicator dilution studies such as dye or 
thermodilution, including arterial and/or venous catheterization; with 
cardiac output measurement) and 93562 (Indicator dilution studies such 
as dye or thermodilution, including arterial and/or venous 
catheterization; subsequent measurement of cardiac output) were 
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. The specialty societies noted that CPT codes 93561 and 
93562 are primarily performed in the pediatric population, thus the 
Medicare utilization for these Harvard-source services is not over 
1,000. However, the specialty societies requested and the RUC agreed 
that these services should be reviewed under this negative IWPUT 
screen.
    For CPT code 93561, we disagreed with the RUC-recommended work RVU 
of 0.95 and we proposed a work RVU of 0.60 based on a crosswalk to CPT 
code 77003 (Fluoroscopic guidance and localization of needle or 
catheter tip for spine or paraspinous diagnostic or therapeutic 
injection procedures (epidural or subarachnoid)). CPT Code 77003 is 
another recently-reviewed add-on global code with the same 15 minutes 
of intraservice time and 2 additional minutes of preservice evaluation 
time. In our review of CPT code 93561, we found that there was a 
particularly unusual relationship between the surveyed work times and 
the RUC-recommended work RVU. We noted that the recommended 
intraservice time for CPT code 93561 was decreasing from 29 minutes to 
15 minutes (48 percent reduction), and the recommended total time for 
CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent 
reduction); however, the recommended work RVU was instead increasing 
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although 
we did not imply that the decrease in time as reflected in survey 
values must equate to a one-to-one or linear decrease in the valuation 
of work RVUs, we believe that since the two components of work are time 
and intensity, significant decreases in time should typically be 
reflected in decreases to work RVUs, not increases in valuation. We 
recognized that CPT code 93561 is an unusual case, as it is shifting 
from 0-day global status to add-on code status. However, when the work 
time for a code is going down and the unit of service is being reduced, 
we would not expect to see an increased work RVU under these 
circumstances, and especially not such a large work RVU increase. 
Therefore, we proposed instead to crosswalk CPT code 93561 to CPT code 
77003 at a work RVU of 0.60, which we believe is a more accurate 
valuation in relation to other recently-reviewed add-on codes on the 
PFS. We believe that this proposed work RVU of 0.60 better preserves 
relativity with other clinically similar codes with similar surveyed 
work times.
    For CPT code 93562, we disagreed with the recommended work RVU of 
0.77 and proposed a work RVU of 0.48 based on the intraservice time 
ratio with CPT code 93561. We observed a similar pattern taking place 
with CPT code 93562 as with the first code in the family, noting that 
the recommended intraservice time was decreasing from 16 minutes to 12 
minutes (25 percent reduction), and the recommended total time was 
decreasing from 44 minutes to

[[Page 59565]]

12 minutes (73 percent reduction); however, the RUC-recommended work 
RVU was instead increasing from 0.01 to 0.77. We recognized that CPT 
code 93562 is another unusual case, as it is also shifting from 0-day 
global status to add-on code status, and the current work RVU of 0.01 
is a decrease from the code's former valuation of 0.16 following the 
removal of moderate sedation in the CY 2017 rule cycle. However, when 
the work time for a code is going down and the unit of service is being 
reduced, we typically would not expect to see a work RVU increase under 
these circumstances, and especially not such a large work RVU increase. 
Therefore, we proposed instead to apply the intraservice time ratio 
from CPT code 93561, for a ratio of 0.80 (12 minutes divided by 15 
minutes) multiplied by the proposed work RVU of 0.60 for CPT code 
93561, which results in the proposed work RVU of 0.48 for CPT code 
93562. We noted that the RUC-recommended work values also line up 
according to the same intraservice time ratio, with the recommended 
work RVU of 0.77 for CPT code 93562 existing in a ratio of 0.81 with 
the recommended work RVU of 0.95 for CPT code 93561. We believe that 
this provides further rationale for our proposal to value the work RVU 
of CPT code 93562 at 80 percent of the work RVU of CPT code 93561.
    There are no recommended direct PE inputs for the codes in this 
family and we did not propose any direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving the Cardiac Output Measurement family of codes.
    Comment: Commenters stated that there were three intertwined flawed 
assumptions that CMS considered when proposing values for CPT codes 
93561 and 93562, which if finalized would lead to continued 
misvaluation of these services. Commenters stated that the first of 
these flawed assumptions was a comparison of the survey data to Harvard 
data: The current time data for these codes came from the Harvard 
studies, has zero validity and should not be used to compare to current 
valid survey data. Commenters stated that the second of these flawed 
assumptions was a comparison of the recommended physician work RVUs to 
old work RVUs: The negative intensity of these codes confirmed that 
this previous methodology in which the current work RVU was derived 
from is flawed. Commenters stated that the third of these flawed 
assumptions was the use of an intraservice time ratio: This 
inaccurately treated all components of the physician time as having 
identical intensity and is incorrect. Other commenters identified 
changes in the global period from 0-day to add-on status and changes in 
the patient population from adult patients to pediatric patients as a 
rationale for why the increases in valuation were appropriate.
    Many commenters disagreed with the proposed work RVU of 0.60 for 
CPT code 93561 and stated that CMS should finalize the RUC-recommended 
work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT 
code 77003, stating that it was not a good crosswalk despite having the 
same intraservice work time. Commenters stated that CPT code 77003 is 
the imaging guidance code for needle placement for the epidural 
injection, and that placing a catheter in the heart and lungs of a 
child is not merely an imaging procedure. Commenters stated that a more 
appropriate injection procedure comparison would be the actual epidural 
injection procedure code, CPT code 62320 (Injection(s), of diagnostic 
or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, 
steroid, other solution), not including neurolytic substances, 
including needle or catheter placement, interlaminar epidural or 
subarachnoid, cervical or thoracic; without imaging guidance) at a work 
RVU of 1.80 or to the top key reference CPT code 93567 (Injection 
procedure during cardiac catheterization including imaging supervision, 
interpretation, and report; for supravalvular aortography) at a work 
RVU of 0.97.
    Many commenters also disagreed with the proposed work RVU of 0.48 
for CPT code 93562 and stated that CMS should finalize the RUC-
recommended work RVU of 0.77. Commenters stated that using an 
incremental approach in lieu of strong crosswalks and input from the 
RUC and physicians providing these services was an unfounded 
methodology. Commenters stated that CMS should rely on the survey data 
instead of the use of an increment, and commenters listed the reference 
codes chosen by the RUC which they stated were more appropriate for 
valuation.
    Response: We appreciate the detailed feedback from the commenters 
regarding CPT Codes 93561 and 93562. We agree with the commenters that 
the proposed crosswalk to CPT code 77003 would result in an 
inappropriately low intensity for CPT code 93561.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-
recommended work RVU of 0.77 for CPT code 93562. We are also finalizing 
our proposal to have no direct PE inputs for these codes.
(52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)
    CPT code 93571 (Intravascular Doppler velocity and/or pressure 
derived coronary flow reserve measurement (coronary vessel or graft) 
during coronary angiography including pharmacologically induced stress; 
initial vessel) was identified on a list of all services with total 
Medicare utilization of 10,000 or more that have increased by at least 
100 percent from 2009 through 2014. CPT code 93572 (Intravascular 
Doppler velocity and/or pressure derived coronary flow reserve 
measurement (coronary vessel or graft) during coronary angiography 
including pharmacologically induced stress; each additional vessel) was 
also included for review as part of the same family of CPT codes. The 
RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower 
than the current work RVU of 1.80. The total time for this service 
decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's 
recommendation is based on a crosswalk to CPT code 15136 (Dermal 
autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits; each additional 100 sq cm, or each 
additional 1% of body area of infants and children, or part thereof), 
which has an identical intraservice and total time as CPT code 93571 of 
15 minutes.
    We disagreed with the recommended work RVU of 1.50 for this CPT 
code because we did not believe that a reduction in work RVU from 1.80 
to 1.50 was commensurate with the reduction in time for this service of 
5 minutes. Using the building block methodology, we believed the work 
RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to 
CPT code 61517 (Implantation of brain intracavitary chemotherapy agent 
(List separately in addition to CPT code for primary procedure)) with a 
work RVU of 1.38 was more appropriate because it has an identical 
intraservice and total time (15 minutes) as CPT code 93571, described 
work that is similar, and was closer to the calculations for 
intraservice time ratio, total time ratio, and the building block 
method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.
    We proposed the RUC-recommended work RVU for CPT code 93572 
(Intravascular Doppler velocity and/or pressure derived coronary flow 
reserve measurement (coronary vessel or graft)

[[Page 59566]]

during coronary angiography including pharmacologically induced stress; 
each additional vessel) of 1.00.
    Both of these codes are facility-only procedures with no 
recommended direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving the Coronary Flow Reserve Measurement family of 
codes.
    Comment: We received several comments regarding our proposed work 
RVU of 1.38 for CPT 93571. Commenters generally did not agree with the 
use of time based metrics in our assessment of the work RVU for this 
code. In particular, they opposed CMS's reduction of work RVUs in 
proportion to the total reduction in time for furnishing this service. 
This methodology, they maintain, ignores the fact that the time 
reduction of 5 minutes in furnishing this service is associated with 
the low intensity portion of the work.
    Response: We do not agree that a reduction in work RVU proportional 
to the total time decrease for this code, which has essentially only 
one time parameter since the intraservice time and total time are the 
same, is not appropriate. We continue to believe that this calculated 
value of 1.35 (a 75 percent reduction in both time and work RVU) 
accounts more appropriately for the reduction in time for a service in 
which the work to perform the service has not changed. We therefore 
continue to believe that our crosswalk to CPT code 61517 is similar in 
both work and time to CPT code 93571, and we are finalizing our 
proposed work RVU for CPT code 93571 of 1.38.
    Comment: We received support from commenters regarding our proposed 
work RVU of 1.00 for CPT code 93572.
    Response: We appreciate the support and are finalizing a work RVU 
of 1.00 for CPT code 93572 as proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Coronary Flow Reserve Measurement family 
of codes as proposed.
(53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
    During 2017, we issued a national coverage determination (NCD) for 
Medicare coverage of supervised exercise therapy (SET) for the 
treatment of peripheral artery disease (PAD). Previously, the service 
had been assigned noncovered status under the PFS. CPT code 93668 
(Peripheral arterial disease (PAD) rehabilitation, per session) was 
payable before the end of CY 2017, retroactive to the effective date of 
the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-
covered SET for the treatment of PAD, consistent with the NCD, reported 
with CPT code 93668. We used the most recent RUC-recommended work and 
direct PE inputs and requested that the RUC review the service, which 
had not been reviewed since 2001, for direct PE inputs. The RUC did not 
recommend a work RVU for CPT code 93668 due to the belief that there is 
no physician work involved in this service. After reviewing this code, 
we proposed a work RVU of 0.00 for CPT code 93668 and proposed to 
continue valuing the code for PE only.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 93688.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs and PE inputs.
    Response: We thank commenters for their support.
    Comment: Several commenters noted that the proposed reductions in 
payment would impact their ability to perform the service in an office 
setting and that this would force them to perform the service in a 
hospital setting. They further noted that this would ultimately 
increase costs and impact patient satisfaction as well as impact their 
ability to provide the service to rural and under insured patients.
    Response: We appreciate the feedback these commenters provided. We 
note that we accepted the RUC-recommended work RVU of 0.00 and the RUC-
recommended direct PE inputs without refinements for CPT code 93668. We 
further note that the RUC has generally provided recommendations on 
work, work time, and direct PE inputs. We do not believe that the work 
or direct PE inputs assigned to these services are inaccurate. We 
further note that if commenters believe an additional RUC review would 
serve to address the issues they identified in our proposal, we would 
consider this information or recommendations from other interested 
stakeholders for future rulemaking.
    After consideration of the public comments received, we are 
finalizing the RUC-recommended work RVUs and direct PE inputs for CPT 
code 93668 as proposed.
(54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)
    CPT codes 95800 (Sleep study, unattended, simultaneous recording; 
heart rate, oxygen saturation, respiratory analysis (e.g., by airflow 
or peripheral arterial tone), and sleep time), 95801 (Sleep study, 
unattended, simultaneous recording; minimum of heart rate, oxygen 
saturation, and respiratory analysis (e.g., by airflow or peripheral 
arterial tone)), and 95806 (Sleep study, unattended, simultaneous 
recording of, heart rate, oxygen saturation, respiratory airflow, and 
respiratory effort (e.g., thoracoabdominal movement)) were flagged by 
the CPT Editorial Panel and reviewed at the October 2014 Relativity 
Assessment Workgroup meeting. Due to rapid growth in service volume, 
the RUC recommended that these services be reviewed after 2 more years 
of Medicare utilization data (2014 and 2015 data). These three codes 
were surveyed for the April 2017 RUC meeting and new recommendations 
for work and direct PE inputs were submitted to CMS.
    For CPT code 95800, the RUC recommended a work RVU of 1.00 based on 
the survey 25th percentile value. We disagreed with the recommended 
value and proposed a work RVU of 0.85 based on a pair of crosswalk 
codes: CPT code 93281 (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 pacemaker system) and CPT code 93260 
(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; implantable 
subcutaneous lead defibrillator system). Both of these codes have a 
work RVU of 0.85, as well as having the same intraservice time of 15 
minutes, similar total times to CPT code 95800, and recent review dates 
within the last few years.
    In reviewing CPT code 95800, 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 
50 minutes to 31 minutes (38 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.05 to 1.00, which is a 
reduction of less than 5 percent. Although we did not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be reflected in decreases to work RVUs. In the 
case of CPT code 95800, we believe that it would be more accurate to 
propose a work RVU of 0.85

[[Page 59567]]

based on the aforementioned crosswalk codes to account for these 
decreases in the surveyed work time. We also noted that in this case 
where the surveyed times are decreasing and the utilization of CPT code 
95800 is increasingly significantly (quadrupling in the last 5 years), 
we had reason to believe that practitioners are becoming more efficient 
at performing the procedure, which, under the resource-based nature of 
the RVU system, lends further support for a reduction in the work RVU.
    For CPT code 95801, the RUC proposed a work RVU of 1.00 again based 
on the survey 25th percentile. We disagreed with the recommended value 
and we proposed a work RVU of 0.85 based on the same pair of crosswalk 
codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and 
95801 had identical recommended work RVUs and identical recommended 
survey work times. Given that these two codes also have extremely 
similar work descriptors, we interpreted this to mean that the two 
codes could have the same work RVU, and therefore, we proposed the same 
work RVU of 0.85 for both codes.
    For CPT code 95806, the RUC recommended a work RVU of 1.08 based on 
a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including 
recording awake and asleep). Although we disagreed with the RUC-
recommended work RVU of 1.08, we concurred that the relative difference 
in work between CPT codes 95800 and 95801 and CPT code 95806 was 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we 
proposed a work RVU of 0.93 for CPT code 95806, based on the 
recommended interval of 0.08 additional RVUs above our proposed work 
RVU of 0.85 for CPT codes 95800 and 95801. We also noted that CPT code 
95806 is experiencing a similar change in the recommended work and time 
values comparable to CPT code 95800. The recommended intraservice time 
for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40 
percent), and the recommended total time is decreasing from 50 minutes 
to 31 minutes (38 percent); however, the recommended work RVU is only 
decreasing from 1.25 to 1.08, which is a reduction of only 14 percent. 
As we stated for CPT code 95800, we do not believe that decreases in 
work time must equate to a one-to-one or linear decrease in the 
valuation of work RVUs, but we do believe that these changes in 
surveyed work time suggest that practitioners are becoming more 
efficient at performing the procedure, and that it would be more 
accurate to maintain the recommended work interval with CPT codes 95800 
and 95801 by proposing a work RVU of 0.93 for CPT code 95806.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Home Sleep Apnea Testing family of codes.
    Comment: One commenter stated that the obesity epidemic has 
contributed to the rising prevalence of obstructive sleep apnea, and 
sleep centers have already worked to reduce costs in diagnosis of 
obstructive sleep apnea by utilizing out-of-center, or home, sleep 
apnea testing. The commenter stated that further reduction in work 
RVUs, and hence payments for home sleep apnea testing services, may 
endanger the sustainability of sleep centers to provide this service to 
Medicare beneficiaries and may thus deny beneficiaries access to 
testing for obstructive sleep apnea. A different commenter stated that 
a reduction in work RVUs for home sleep apnea testing services will 
discourage vendors from producing technically better home sleep apnea 
testing devices and software.
    Response: We agree with the commenter regarding the importance of 
sleep centers in helping to diagnose and treat the occurrence of 
obstructive sleep apnea. However, we remind the commenter that we are 
obligated under the statute to consider both time and intensity in 
establishing work RVUs for PFS services. As explained in the CY 2017 
PFS final rule (81 FR 80272 through 80277), 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. 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. For the codes 
in the Home Sleep Apnea Testing family, we believe that the decreases 
in the surveyed work times should be reflected in decreases to the work 
RVUs.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.85 for CPT codes 95800 and 95801, and stated that CMS should finalize 
the RUC-recommended work RVU of 1.00 for these services. Commenters 
stated that it was unclear why CMS chose to employ the crosswalk to CPT 
codes 93281 and 93260, which the commenters stated were not at all 
similar to the home sleep apnea test codes and are cardiovascular 
implantable recording device codes, not diagnostic studies.
    Response: We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes with clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must both constitute diagnostic studies to be used as 
a crosswalk. In the case of our specific crosswalk to CPT codes 93281 
and 93260, we noted in the proposed rule that both of these codes have 
a work RVU of 0.85, as well as having the same intraservice time of 15 
minutes and similar total times to CPT codes 95800 and 95801, and 
recent review dates within the last few years.
    Comment: Several commenters stated that the existing times for CPT 
codes 95800 and 95801 were likely an overestimate due to the lack of 
experience providing these services when they were first valued as new 
codes in April 2010. Commenters stated that physicians are now more 
familiar with home sleep apnea testing and the new survey times were 
more reflective of this family of services.
    Response: This information from the commenters appears to suggest 
that the current work RVUs for CPT codes 95800 and 95801 are also 
overestimates. If practitioners have become more familiar and efficient 
in the practice of home sleep apnea testing, we believe that the work 
RVUs should also be decreased to reflect the fact that the procedures 
can now be performed faster. We remind the commenters that we are 
obligated under the statute to consider both time and intensity in 
establishing work RVUs for PFS services, and we have no reason to 
believe that the intensity of these procedures has increased to the 
point of offsetting these gains in time efficiency.
    Comment: Several commenters stated that, despite the fact that we 
indicated we did not intend to imply that the decrease in time should 
equate to a linear decrease in the valuation of work RVUs, this seems 
to be the approach taken in the proposed rule. Commenters stated that 
modifications to work RVUs should be based on empirical evidence, 
gathered through the survey process, which takes into consideration the 
amount of time required to provide a service as well as the complexity 
and intensity of each service.
    Response: We disagree with the commenters, and we note that the 
proposed work RVUs for both CPT codes 95800 and 95801 were not based on 
pure time ratios on a one-to-one or linear basis. For CPT code 95800, 
use of

[[Page 59568]]

the intraservice time ratio alone would have yielded a work RVU of 0.79 
and the total time ratio would have yielded a work RVU of 0.65. For CPT 
code 95801, use of the intraservice time ratio would have yielded a 
work RVU of 1.00 and the total time ratio would have yielded a work RVU 
of 0.78. We did not propose these values and instead proposed a work 
RVU of 0.85 for both codes specifically because the consideration of 
time ratios is only one component of our review process. We believe 
that our proposed work RVU of 0.85 for these services based on a pair 
of crosswalk codes, CPT codes 93281 and 93260 is appropriate, and note 
that we recognized that the use of pure time ratios at a one-to-one or 
linear basis would not accurately capture the changes in work taking 
place in these codes since their last valuation.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.93 for CPT code 95806, and stated that CMS should finalize the RUC-
recommended work RVU of 1.08. Commenters stated that the survey process 
values a service compared to other similar services, and that using an 
incremental approach in lieu of strong crosswalks and input from the 
RUC and physicians providing these services was unfounded.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We continue to believe that the proposed 
work RVU of 0.93 would be the most accurate valuation for CPT code 
95806.
    Comment: Several commenters stated that CPT code 95806 has become a 
more complex study and requires more time as well as greater levels of 
skill and training to perform the interpretation for this study. 
Commenters stated that more complex patients with a wider variety of 
sleep problems and more severe conditions are being studied with this 
modality, which means that the skills and continuing updates to 
education required to interpret these studies have dramatically 
increased.
    Response: We agree with the commenters that due to the decreasing 
surveyed work times and rapidly increasing utilization for these codes, 
we had reason to believe that practitioners are becoming more efficient 
at performing the procedure. While the incorporation of new technology 
can sometimes make services more complex and difficult to perform, it 
can also have the opposite effect by making services less reliant on 
manual skill and technique. We do not agree with the commenter that the 
need for additional training to use the equipment would necessarily be 
grounds for an increase in the work RVU, as improvements in technology 
are commonplace across many different services and are not specific to 
this procedure. As detailed above, we also have reason to believe that 
the improved technology has led to greater efficiencies in the 
procedure which, under the resource-based nature of the RVU system, 
lends further support for a reduction in the work RVU.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Home Sleep 
Apnea Testing family of codes as proposed.
(55) Neurostimulator Services (CPT Codes 95970, 95976, 95977, 95983, 
and 95984)
    In October 2013, CPT code 95971 (Electronic analysis of implanted 
neurostimulator pulse generator system; simple spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
neurostimulator pulse generator/transmitter, with intraoperative or 
subsequent programming) was identified in the second iteration of the 
High Volume Growth screen. In January 2014, the RUC recommended that 
CPT codes 95971, 95972 (Electronic analysis of implanted 
neurostimulator pulse generator system; complex spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
(except cranial nerve) neurostimulator pulse generator/transmitter, 
with intraoperative or subsequent programming) and 95974 (Electronic 
analysis of implanted neurostimulator pulse generator system; complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour) be referred to the CPT Editorial Panel 
to address the entire family regarding the time referenced in the CPT 
code descriptors. In June 2017, the CPT Editorial Panel revised CPT 
codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975 
(Electronic analysis of implanted neurostimulator pulse generator 
system; complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each 
additional 30 minutes after first hour), 95978 (Electronic analysis of 
implanted neurostimulator pulse generator system, complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; first hour), and 95979 (Electronic analysis of implanted 
neurostimulator pulse generator system, complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; each additional 30 minutes after first hour) and created 
four new CPT codes for analysis and programming of implanted cranial 
nerve neurostimulator pulse generator, analysis, and programming of 
brain neurostimulator pulse generator systems and analysis of stored 
neurophysiology recording data.
    The RUC recommended a work RVU of 0.45 for CPT code 95970 
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group(s),interleaving, amplitude, pulse 
width, frequency (Hz), on/off cycling, burst, magnet mode, dose 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters by 
physician or other qualified health care professional; with brain, 
cranial nerve, spinal cord, peripheral nerve, or sacral nerve 
neurostimulator pulse generator/transmitter, without programming)), 
which is identical to the current work RVU for this CPT code. The 
descriptor for this CPT code has been modified slightly, but the 
specialty societies affirmed that the work itself has not changed. To 
justify its recommendation, the RUC provided two references: 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), 
with intraservice time of 15 minutes, total time of 27 minutes, and a 
work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit 
for the evaluation and management of an established patient, which 
requires at least 2 of these 3 key components: An expanded problem 
focused history; An expanded problem focused examination; or Medical 
decision making of low complexity. Counseling and 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

[[Page 59569]]

presenting problem(s) are of low to moderate severity. Typically, 15 
minutes are spent face-to-face with the patient and/or family), with 
intraservice time of 15 minutes, total time of 23 minutes, and a work 
RVU of 0.97.
    We disagreed with the RUC's recommendation because we did not 
believe that maintaining the work RVU, given a decrease of four minutes 
in total time, was appropriate. In addition, we noted that the 
reference CPT codes chosen have much higher intraservice and total 
times than CPT code 95970, and also have higher work RVUs, making them 
poor comparisons. Instead, we identified a crosswalk to CPT code 95930 
(Visual evoked potential (VEP) checkerboard or flash testing, central 
nervous system except glaucoma, with interpretation and report) with 10 
minutes intraservice time, 14 minutes total time, and a work RVU of 
0.35. Therefore, we proposed a work RVU of 0.35 for CPT code 95970.
    CPT code 95976 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, dose lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with simple cranial nerve neurostimulator pulse 
generator/transmitter programming by physician or other qualified 
health care professional) is a new CPT code replacing CPT code 95974 
(Electronic analysis of implanted neurostimulator pulse generator 
system (e.g., rate, pulse amplitude, pulse duration, configuration of 
wave form, battery status, electrode selectability, output modulation, 
cycling, impedance and patient compliance measurements); complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour). The description of the work involved in 
furnishing CPT code 95976 differs from that of the deleted CPT code in 
a few important ways, notably that the time parameter has been removed 
so that the CPT code no longer describes the first hour of programming. 
In addition, the new CPT code refers to simple rather than complex 
programming. Accordingly, the intraservice and total times for this CPT 
code are substantively different from those of the deleted CPT code. 
CPT code 95976 has an intraservice time of 11 minutes and a total time 
of 24 minutes, while CPT code 95974 has an intraservice time of 60 
minutes and a total time of 110 minutes. The RUC recommended a work RVU 
of 0.95 for CPT code 95976. The RUC's top reference CPT code as chosen 
by the RUC survey participants was CPT code 95816 (Electroencephalogram 
(EEG); including recording awake and drowsy), with an intraservice time 
of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC 
indicated that the service is similar, but somewhat more complex than 
CPT code 95976.
    We disagreed with the RUC's recommended work RVU for this CPT code 
because we did not believe that the large difference in time between 
the new CPT code and CPT code 95974 was reflected in the slightly 
smaller proportional decrease in work RVUs. The reduction in total 
time, from 110 minutes to 24 minutes is nearly 80 percent. However, the 
RUC's recommended work RVU reflects a reduction of just under 70 
percent. We believe that a more appropriate crosswalk would be CPT code 
76641 (Ultrasound, breast, unilateral, real time with image 
documentation, including axilla when performed; complete) with 
intraservice time of 12 minutes, total time of 22 minutes, and a work 
RVU of 0.73. Therefore, we proposed a work RVU of 0.73 for CPT code 
95976.
    CPT code 95977 describes the same work as CPT code 95976, but with 
complex rather than simple programming. The CPT Editorial Panel refers 
to simple programming of a neurostimulator pulse generator/transmitter 
as the adjustment of one to three parameter(s), while complex 
programming includes adjustment of more than three parameters. For 
purposes of applying the building block methodology and calculating 
intraservice and total time ratios, the RUC compared CPT code 94X84 
with CPT code 95975 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude, pulse duration, 
configuration of wave form, battery status, electrode selectability, 
output modulation, cycling, impedance and patient compliance 
measurements); complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each 
additional 30 minutes after first hour), which is being deleted by the 
CPT Editorial Panel. We believe that this was an inappropriate 
comparison since it is time based (first hour of programming) and is an 
add-on code. Instead we believe that the RUC intended to compare CPT 
code 95977 with CPT code 95974 (Electronic analysis of implanted 
neurostimulator pulse generator system (e.g., rate, pulse amplitude, 
pulse duration, configuration of wave form, battery status, electrode 
selectability, output modulation, cycling, impedance and patient 
compliance measurements); complex cranial nerve neurostimulator pulse 
generator/transmitter, with intraoperative or subsequent programming, 
with or without nerve interface testing, first hour), which has been 
recommended for deletion by the CPT Editorial Panel and is also the 
comparison for CPT code 95976. The RUC recommended a work RVU of 1.19 
for CPT code 95977. The RUC disagreed with the two top reference 
services CPT code 99215 (Office or other outpatient visit for the 
evaluation and management of an established patient, which requires at 
least 2 of these 3 key components: A comprehensive history; A 
comprehensive examination; or Medical decision making of high 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of 
moderate to high severity. Typically, 40 minutes are spent face-to-face 
with the patient and/or family) and CPT code 99202 (Office or other 
outpatient visit for the evaluation and management of a new patient, 
which requires these 3 key components: An expanded problem focused 
history; an expanded problem focused examination; or straightforward 
medical decision making. 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, 20 minutes are spent face-
to-face with the patient and/or family) and instead compared CPT code 
95977 to CPT code 99308 (Subsequent nursing facility care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of these 3 key components: An expanded problem focused interval 
history; An expanded problem focused examination; or 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 patient is responding 
inadequately to therapy or has developed a minor complication.

[[Page 59570]]

Typically, 15 minutes are spent at the bedside and on the patient's 
facility floor or unit.) with total time of 31 minutes, intraservice 
time of 15 minutes, and a work RVU of 1.16; and 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), with total time of 27 minutes, 
intraservice time of 15 minutes, and a work RVU of 1.22.
    We disagreed with the RUC's recommended work RVU of 1.19 for CPT 
code 95977. Once the comparison CPT code is corrected to CPT code 
95974, the reverse building block calculation indicates that a lower 
work RVU (close to 0.82) would be a better reflection of the work 
involved in furnishing this service. As an alternative to the RUC's 
recommendation, we added the difference in RUC-recommended work RVUs 
between CPT codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU 
of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97 
for CPT code 95977.
    CPT code 95983 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, doe lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with brain neurostimulator pulse generator/transmitter 
programming, first 15 minutes face-to-face time with physician or other 
qualified health care professional) is the base code for add-on CPT 
code 95984 (Electronic analysis of implanted neurostimulator pulse 
generator/transmitter (e.g., contact group(s), interleaving, amplitude, 
pulse width, frequency (Hz), on/off cycling, burst, magnet mode, doe 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters) 
by physician or other qualified health care professional; with brain 
neurostimulator pulse generator/transmitter programming, each 
additional 15 minutes face-to-face time with physician or other 
qualified health care professional), which is an add-on CPT code and 
can only be billed with CPT code 95983. The RUC compared CPT code 95983 
with CPT code 95978 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude and duration, 
battery status, electrode selectability and polarity, impedance and 
patient compliance measurements), complex deep brain neurostimulator 
pulse generator/transmitter, with initial or subsequent programming; 
first hour), which the CPT Editorial Panel is recommending for 
deletion. The primary distinction between the new and old CPT codes is 
that the new CPT code describes the first 15 minutes of programming 
while the deleted CPT code describes up to one hour of programming. The 
RUC recommended a work RVU of 1.25 for CPT code 95983 and a work RVU of 
1.00 for CPT code 95984. For CPT code 95983, the RUC's recommendation 
is based on reference CPT codes 12013 (Simple repair of superficial 
wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 
cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15 
minutes, and a work RVU of 1.22; and CPT code 70470 (Computed 
tomography, head or brain; without contrast material, followed by 
contrast material(s) and further sections) with 25 minutes of total 
time, 15 minutes of intraservice time, and a work RVU of 1.27.
    We disagreed with the RUC's recommended work RVU for CPT code 95983 
because we did not believe that the reduction in work RVU reflected the 
change in time described by the CPT code. Using the reverse building 
block methodology, we estimated that a work RVU of nearer to 1.11 would 
be more appropriate. In addition, if we were to sum the RUC-recommended 
RVUs for a single hour of programming using one of the base CPT codes 
and three of the 15 minute follow-on CPT codes, 1 hour of programming 
would be valued at 4.25 work RVUs. This contrasts sharply from the work 
RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978. 
We believe that a more appropriate valuation of the work involved in 
furnishing this service is reflected by a crosswalk to CPT code 93886 
(Transcranial Doppler study of the intracranial arteries; complete 
study), with total time 27 minutes, intraservice time of 17 minutes, 
and a work RVU of 0.91. Therefore, we proposed a work RVU of 0.91 for 
CPT code 95983.
    The RUC's recommended work RVU of 1.00 for CPT code 95984 is based 
on the key reference service CPT code 64645 (Chemodenervation of one 
extremity; each additional extremity, 5 or more muscles), which has 
total time of 26 minutes, intraservice time of 25 minutes, and a work 
RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic 
analysis of implanted neurostimulator pulse generator system (e.g., 
rate, pulse amplitude and duration, battery status, electrode 
selectability and polarity, impedance and patient compliance 
measurements), complex deep brain neurostimulator pulse generator/
transmitter, with initial or subsequent programming; first hour), which 
is being deleted by the CPT Editorial Panel. If we were to add the 
incremental difference between CPT codes 95983 and 95984 to the 
proposed value for the base CPT code (95983, work RVU = 0.91), we 
estimated that this add-on CPT code would have a work RVU of 0.75. The 
building block methodology results in a recommendation of a slightly 
higher work RVU of 0.82. We proposed a work RVU of 0.80 for CPT code 
95984, which falls between the calculated value using incremental 
differences and the calculation from the reverse building block, and is 
supported by a crosswalk to CPT code 51797 (Voiding pressure studies, 
intra-abdominal (ie, rectal, gastric, intraperitoneal)), which is an 
add-on CPT code with identical total and intraservice times (15 
minutes) as CPT code 95984.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Neurostimulator Services family of codes.
    Comment: We received a number of comments regarding our proposed 
work RVUs for CPT codes 95970, 95976, 95977, 95983, and 95984. 
Commenters suggested that CMS misunderstood the role of reference codes 
in the RUC's process, and that CMS should not be comparing the times 
for the surveyed code to the reference codes because they are not 
specifically intended to match in time.
    Response: We appreciate the opportunity to clarify that we do not 
believe the reference codes provided by the RUC in the summary 
documents are being provided as a crosswalk. We did not state that we 
thought the two top reference codes, CPT code 62368 (total time of 27 
minutes) and CPT code 99213 (total time of 23 minutes) were being used 
by the RUC as crosswalk codes (as that term is used in the RUC 
process). Instead, we pointed out that the two reference codes are 
generally not a particularly good comparison for a survey code with 15 
minutes of total time. We understand that survey respondents, not the 
RUC, chose the reference codes, and that survey respondents do not have 
the physician times readily available when choosing from among services 
that they are familiar with. Nonetheless, we expect reference codes to 
generally have physician work times that are more similar to the survey 
code than an 80 percent difference (in the case of CPT

[[Page 59571]]

code 62368). When we make such an observation with regard to the times 
for reference codes in relation to a survey code, we are not 
disregarding parameters other than time. We also note that the RUC 
compares reference codes in terms of time or intensity relative to the 
survey code as a matter of common practice. We understand those 
comparisons to be intended by the RUC as one of several dimensions of a 
code's work RVU valuation.
    As we have stated in the past, we believe that practitioners become 
more efficient at furnishing some services over time, shortening the 
amount of clinical time required. We still believe this is the case 
with regard to CPT code 95970, which has decreased in time without a 
significant change in intensity. We maintain that our crosswalk to CPT 
code 95930 with a work RVU of 0.35 for this CPT code is appropriate.
    Comment: A commenter stated that, since CMS acknowledges that CPT 
code 95976 is different from CPT code 95974, which is being deleted, 
CMS should not compare the two codes for purpose of evaluating whether 
the decreased work time in the new code is appropriate in relation to 
the work involved in furnishing CPT code 95930. The commenter urged CMS 
to finalize the work RVU proposed by the RUC, which is 0.95.
    Response: The major difference in the description of work involved 
in furnishing CPT code 95974 and CPT code 95976 involves a change from 
`complex' to `simple' programming. We do not believe that this change, 
which indicates a lower level of intensity for new CPT code 95976 than 
for deleted CPT code 95974, precludes us from using the deleted CPT 
code as the basis for evaluating whether the comparatively lower time 
involved in furnishing CPT code 95976 is adequately reflected by the 
RUC-recommended work RVU for this new CPT code. We continue to believe 
that the lower time in furnishing the work described by CPT code 95976, 
compared with the time in furnishing the service described by deleted 
CPT code 95974, should result in a lower work RVU than the value 
recommended by the RUC. Therefore, we are finalizing the work RVU for 
CPT code 95976 of 0.73 based on a crosswalk to CPT code 76641.
    Comment: A commenter clarified that we incorrectly stated that the 
RUC compared the new CPT code 95977 with deleted CPT code 95975, which 
is an add-on code and would therefore not be an acceptable point of 
comparison.
    Response: We appreciate the commenter informing us of the error and 
we agree that the RUC did not compare CPT code 95977 with the deleted 
code, CPT code 95975. Instead, the RUC compared the new code with 
several other codes: CPT code 99308 (Subsequent nursing facility care, 
per day, for the evaluation and management of a patient) with a work 
RVU of 1.16, 15 minutes of intra-service time and 31 minutes total time 
and 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) with a 
work RVU of 1.22, 15 minutes of intra-service time and 27 minutes total 
time. The RUC also cited the following two CPT codes for support: CPT 
code 93975 (Duplex scan of arterial inflow and venous outflow of 
abdominal, pelvic, scrotal contents and/or retroperitoneal organs; 
complete study) with a work RVU of 1.16, 20 minutes of intra-service 
time and 30 minutes total time, and 67810 (Incisional biopsy of eyelid 
skin including lid margin), with a work RVU of 1.18, 13 minutes of 
intra-service time and 27 minutes total time. Despite having cited 
these numerous CPT codes as support for their recommended work RVU for 
CPT code 95977, we do not see why CPT code 95974 is not an entirely 
appropriate point of comparison for CPT code 95977 as we explained in 
making our proposal. The only difference between new CPT code 95977 and 
new CPT code 95976 is complex vs. simple programming and, since as we 
explained in response to comments above, we believe it is appropriate 
to use the deleted CPT code 95974 for a time comparison with CPT code 
95976, we believe that code is equally valid as the basis for 
comparison to CPT code 95977. The building block methodology between 
CPT code 95977 and CPT code 95974 suggests that a work RVU in the area 
of 0.82 would better reflect both the time and intensity of furnishing 
this service. In identifying a more appropriate work RVU, we looked at 
the difference in the RUC-recommended work RVU between CPT codes 95976 
and 95977, which differ by simple vs. complex programming, and added 
the increment to our proposed value for CPT code 95976. We continue to 
believe the use of an incremental difference between codes is a valid 
methodology for setting values, especially in valuing services within a 
family of revised codes where it is important to maintain appropriate 
intra-family relativity. Given that we are finalizing our proposed work 
RVU for CPT code 95976 of 0.73, we believe a work RVU of 0.97 for CPT 
code 95977 is appropriate. We are finalizing a work RVU of 0.97 for CPT 
code 95977 as proposed.
    Comment: A commenter expressed opposition to our use of the reverse 
building block methodology to evaluate the RUC-recommended work RVU for 
CPT code 95983 and to identify possible alternative crosswalk CPT 
codes. Consequently, the commenter stated that our crosswalk of CPT 
code 93886 is based on invalid reasoning about how the time parameter 
factors into the code valuation. The work involved in furnishing the 
service described by the crosswalk code, according to the commenter, is 
less intense than the work described by the survey code.
    Response: We disagree with the commenter that the reverse building 
block methodology not an appropriate approach to assessing whether the 
RUC-recommended work RVU for a code is appropriate. We employed a 
reverse building block methodology to assess the reasonableness of the 
RUC's recommendation, not to value the code in the first instance. As 
the commenter noted, the work described by new CPT code 95983 is 
difficult to value in relation to both the deleted code and other codes 
on the fee schedule because of the 15 minute time parameter. However, 
having looked carefully at the work involved in furnishing the service 
described by our crosswalk code, CPT code 93886, we do not believe it 
is less intense than the survey code. The service described by CPT code 
93886 is performed on patients with recent brain hemorrhage, which we 
believe is as complex to study as the work involved in programming 
adjustments to multiple parameters in real time. We continue to believe 
that CPT code 93886 is an appropriate crosswalk for CPT code 95983, and 
we are finalizing a work RVU for this code of 0.91.
    Comment: A commenter stated that our approach for valuing CPT code 
95984 ignored physician work intensity and complexity in favor of a 
random calculation involving code increments, which is a flawed 
methodology. CMS's choice of crosswalk code, according to the 
commenter, is invalid because it is based on this incorrect approach.
    Response: We disagree that the use of incremental differences in 
work RVU between codes that have an established pattern of intensity or 
time, is inappropriate. We remind the commenter that our calculation of 
increments is based on the RUC's recommended work RVUs for the relevant 
CPT codes. We continue to believe that this approach is necessary to 
maintain intra-family relativity of the PFS, and we maintain that CPT 
code 51797 is an appropriate crosswalk to the

[[Page 59572]]

add-on CPT code 95984. We are finalizing a work RVU for CPT 95984 of 
0.80.
    Comment: One commenter stated that CMS reduced the nonfacility 
service cost for clinical labor for CPT code 95970 to zero. The 
commenter stated that this may be a potential oversight, given that the 
RUC recommended nonfacility clinical labor time be reduced from 44 to 
15 minutes. The commenter stated that it was not consistent for CMS to 
recommend a nonfacility service cost of zero in light of the 
nonfacility exam table (EF023) equipment time of 15 minutes, and that 
this clinical labor should still be reflected in this service.
    Response: We disagree with the commenter and note that the RUC did 
not recommend any clinical labor time for CPT code 95970, as we 
proposed the RUC-recommended direct PE inputs without refinement. We 
believe that the equipment time assigned for the exam table (EF023) and 
the neurostimulator programmer (EQ209) indicate that these equipment 
items are in use by the practitioner and not the clinical staff.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Neurostimulator 
Services family of codes as proposed.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105, 
96110, 96116, 96125, 96127, 96112, 96113, 96121, 96130, 96131, 96132, 
96133, 96136, 96137, 9613896138, 96139, 96X11, and 96146)
    In CY 2016, the Psychological and Neuropsychological Testing family 
of codes were identified as potentially misvalued using a high 
expenditure services screen across specialties with Medicare allowed 
charges of $10 million or more. The entire family of codes was referred 
to the CPT Editorial Panel to be revised, as the testing practices had 
been significantly altered by the growth and availability of 
technology, leading to confusion about how to report the codes. In June 
2017, the CPT Editorial Panel revised five existing codes, added 13 
codes to provide better description of psychological and 
neuropsychological testing, and deleted CPT codes 96101, 96102, 96103, 
96111, 96118, 96119, and 96120. The RUC and HCPAC submitted 
recommendations for the 13 new codes and for the existing CPT codes 
96105, 96110, 96116, 96125, and 96127.
    We proposed the RUC- and HCPAC-recommend work RVUs for several of 
the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a 
work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code 
96125; a work RVU of 1.71 for CPT code 96121; a work RVU of 0.55 for 
CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU 
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and 
96146 were valued by the RUC for PE only.
    This code family contains a subset of codes that describe 
psychological and neuropsychological testing administration and 
evaluation, not including assessment of aphasia, developmental 
screening, or developmental testing. The CPT Editorial Panel's 
recommended coding for this subset of services consists of seven new 
codes: Two that describe either psychological or neuropsychological 
testing when administered by physicians or other qualified health 
professionals (CPT codes 96136 and 96137), and two for either type of 
testing when administered by technicians (CPT codes 96138 and 96139); 
and four new codes that describe testing evaluation by physicians or 
other qualified health care professionals (CPT codes 96130 through 
96133). This new coding effectively unbundles codes that currently 
report the full course of testing into separate codes for testing 
administration (CPT codes 96136, 96137, 96138, and 96139) and 
evaluation (CPT codes 96130, 96131, and 96132). According to a 
stakeholder that represents the psychologist and neuropsychologist 
community, this new coding will result in significant reductions in 
payment for these services due to the unbundling of the testing codes 
into codes for physician-administered tests and technician-administered 
tests. The stakeholder noted that because the new coding includes 
testing codes with zero work RVUs for the technician administered tests 
and the work RVUs are lower than they believe to be accurate, this new 
valuation would ignore the clinical evaluation and decision making 
performed by the physician or other qualified health professional 
during the course of testing administration and evaluation. 
Furthermore, the net result of the code valuations for these new codes 
is a reduction in the overall work RVUs for this family of codes. In 
other words, the stakeholder's analysis found that the RUC 
recommendations result in a reduction in total work RVUs, even though 
the actual physician work of a testing battery has not changed.
    In the interest of payment stability for these high-volume 
services, we proposed to implement work RVUs for this code family, 
which would eliminate the approximately 2 percent reduction in work 
spending. We proposed to achieve work neutrality for this code family 
by scaling the work RVUs upward from the RUC-recommended values so that 
the size of the pool of work RVUs would be essentially unchanged for 
this family of services. Therefore, we proposed: A work RVU of 2.56 for 
CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a 
work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended 
work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than 
the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code 
96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of 
2.56 for CPT code 96132, rather than the RUC-recommended work RVU of 
2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-
recommended work RVU of 1.90. We saw no evidence that the typical 
practice for these services has changed to merit a reduction in 
valuation of professional services.
    The RUC made several revisions to the recommended direct PE inputs 
for the administration codes from their respective predecessor codes, 
including revisions to quantities of testing forms. For the supply 
item, ``psych testing forms, average'' there is a quantity of 0.10 in 
the predecessor CPT code 96101, and a quantity of 0.33 in the 
predecessor CPT code 96102. For the supply item ``neurobehavioral 
status forms, average,'' there is a quantity of 1.0 in the predecessor 
CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119, 
and for the supply item ``aphasia assessment forms, average,'' there is 
a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 
0.30 in predecessor CPT code 96119. The RUC recommendation does not 
include any forms for CPT codes 96132 and 96133. The RUC has replaced 
the corresponding predecessor supply items with new items ``WAIS-IV 
Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response 
Booklet #2,'' and assigned quantities of 0.165 for each of these new 
supply items for CPT codes 96136 through 96139. In our analysis, we 
found that the RUC-recommended direct PE refinements contributed 
significantly to the reduction in the overall payment for this code 
family. We saw no compelling evidence that the quantities of testing 
forms used in a typical course of testing would have been reduced 
dramatically and, in the interest of payment stability, we proposed to 
refine the direct PE inputs for CPT codes 96132 through 96139 by 
including 1.0 quantity each of the supply items ``WAIS-IV Record

[[Page 59573]]

Form,'' ``WAIS-IV Response Booklet #1'', and ``WAIS-IV Response Booklet 
#2.'' We believe that a typical course of testing would involve use of 
one booklet for each of the relevant codes. In addition, these proposed 
refinements would largely mitigate potentially destabilizing payment 
reductions for these services. We solicited comments on our proposed 
work RVUs and proposed PE refinements for this family of services.
    We also proposed to remove the equipment time for the CANTAB Mobile 
(ED055) equipment item from CPT code 96146. This item was listed at 
different points in the recommendations as a supply item with a cost of 
$28 per assessment and as an equipment item for a software license with 
a cost of $2,800 that could be used for up to 100 assessments. We were 
unclear as to how the CANTAB Mobile would typically be used in this 
procedure, and we proposed to remove the equipment time pending the 
submission of more data about the item. We solicited additional 
information about the use of this item and how it should best be 
included into the PE methodology. We were also interested in 
information as to whether the submitted invoice refers to the cost of 
the mobile device itself, or the cost of user licenses for the mobile 
device, which was unclear from the information submitted with the 
recommendations.
    The following is a summary of the comments we received regarding 
our proposed work RVUs and proposed direct PE refinements for this 
family of services.
    Comment: Many commenters supported our proposal to increase payment 
from the RUC recommendations in the interest of payment stability. 
These commenters stated this proposal will help mitigate reductions in 
reimbursement rates for psychologists.
    According to some commenters, some psychologists will see slight 
decreases for neuropsychological testing services due to the new coding 
structure, which they say aligns psychological and neuropsychological 
testing services with other testing services in the program. Some 
commenters said that, due to the new coding structure, reimbursement 
will be lower for neuropsychological evaluation services that are 
provided by physicians than those provided by technicians. These 
commenters stated that physicians should not be reimbursed at a lesser 
rate than EEG or MRI technicians or other physician extenders.
    Response: We note that our proposed values for the evaluation CPT 
codes 96130 through 96133 and the administration and scoring CPT codes 
96136 through 96139 are generally higher for the physician-administered 
codes than for the analogous technician-administered codes. According 
to our proposed rates, however, the valuation of the add-on code for 
each additional 30 minutes of administration and scoring when performed 
by a technician reported with CPT code 96139 is, however, slightly 
higher than the valuation of the add-on code for each additional 30 
minutes of administration and scoring when performed by a physician or 
other qualified health care professional, reported with CPT code 96137. 
We thank commenters for bringing this potential rank-order anomaly to 
our attention. We believe that clinical staff will typically be 
providing some support when the physician or other qualified health 
care professional is performing testing administration as described by 
CPT codes 96136 and 96137. We are therefore refining the direct PE 
inputs for these services by adding 10 minutes of clinical labor time 
for the CA021 clinical labor activity, ``Perform procedure/service--NOT 
directly related to physician work time'' for these codes. We believe 
this will more accurately reflect the clinical staff support that is 
typical when a physician is performing test administration, and it will 
preserve appropriate rank-order among this subset of services, while 
mitigating reductions to payment rates for testing administration 
services.
    Comment: The RUC noted that in the February 5, 2018 RUC submission 
to CMS, the RUC rescinded its interim recommendation from October 2017, 
and stated that CPT code 96X11 is deleted and will not be a CPT code 
for CPT 2019. The RUC recommended that CMS delete this service and work 
RVU recommendation for the 2019 PFS.
    Response: As CPT code 96X11 will not be a CPT code for CY 2019, we 
are deleting this code. Based on the RUC-recommended utilization 
crosswalk, our proposed rates included utilization assumptions that for 
all services currently reported with CPT codes 96103 and 96120, half of 
these services will be reported with the new CPT code 96X11 and half 
will be reported with CPT code 96146. As we are not finalizing 96X11, 
for the purposes of ratesetting, our utilization for these service will 
include the assumption that half of the services currently reported 
with 96103 and 96120 will be reported with CPT code 96136 and half with 
CPT code 96146.
    Comment: A commenter requested clarification on how much time is 
considered typical for the neuropsychologist to perform record review 
and test selection in newly created CPT codes 96132 and 96133.
    Response: For CPT code 96132, we proposed the RUC-recommended 5 
minutes of pre-service work time which reflects activities such as 
preliminary selection of tests and record review. As CPT code 96133 is 
an add-on code for reporting each additional hour, it does not include 
additional pre-service work time, as the latter would be considered to 
be included in the corresponding base code.
    Comment: Several commenters disagreed with the proposal to remove 
the equipment time for the CANTAB Mobile (ED055) equipment item from 
CPT code 96146. Commenters stated that the PE Subcommittee determined 
that this was a software license and it would be more appropriately 
classified as equipment than as a supply. Commenters stated that they 
had submitted paid invoices for two additional software license-based 
automated instruments typically used when furnishing CPT code 96146, 
and that they were resubmitting these same invoices with their comment 
letter.
    Response: We appreciate the feedback from the commenter that the 
CANTAB Mobile (ED055) equipment item referred to a software license. We 
continue to believe that software licenses would typically be 
classified as a form of indirect PE under our methodology, and as a 
result we are finalizing our proposal to remove this equipment time 
from CPT code 96146.
    Comment: A commenter requested clarification on why new CPT codes 
96138, 96139, and 96146 do not include a facility fee, despite the fact 
that their respective source CPT codes 96102, 96119, 96103, and 96120 
do have RVUs in the facility setting.
    Response: The source codes mentioned by the commenter have 
associated work RVUs, while the new CPT codes do not, and they do not 
include physician work time. The new CPT coding effectively unbundles 
professional and technical services for some of these codes. Codes that 
do not have a physician work component would typically not be valued in 
the facility setting.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Psychological and Neuropsychological 
Testing family of codes as proposed. We are also finalizing the direct 
PE inputs as proposed, with the exception of the refinement to the 
CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.

[[Page 59574]]

(57) Electrocorticography (CPT Code 95836)
    CPT Code 95829 is used for Electrocorticogram performed at the time 
of surgery; however, a new code was needed to account for this non-
face-to-face service for the review of a month's worth or more of 
stored data. CPT code 95836 (Electrocorticogram from an implanted brain 
neurostimulator pulse generator/transmitter, including recording, with 
interpretation and written report, up to 30 days) is a new code 
approved at the September 2017 CPT Editorial Panel Meeting to describe 
this service.
    We disagreed with the RUC-recommended work RVU of 2.30 for CPT code 
95836 and proposed a work RVU of 1.98 based on a direct crosswalk to 
the top reference, CPT code 95957 (Digital analysis of 
electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This 
is a recently-reviewed code with the same intraservice time of 30 
minutes and a total time only 2 minutes lower than CPT code 95836. We 
agreed with the survey respondents that CPT code 95957 was an accurate 
valuation for this new code, and due to the clinically similar nature 
of the two procedures and their near-identical time values, we proposed 
to value both of them at the same work RVU of 1.98.
    The RUC did not recommend, and we did not propose, any direct PE 
inputs for CPT code 95836.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 95836.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.98 for CPT code 95836 and stated that CMS should finalize the RUC-
recommended work RVU of 2.30. Commenters stated that the survey 
respondents chose CPT code 95957 as a reference service and not as a 
direct crosswalk. Commenters stated that the survey respondents pick 
from a list of 10-20 services to use as a comparison and then recommend 
a work RVU based on the intensity, complexity and physician time 
required to perform the surveyed code. Commenters stated that the 
median survey work RVU was actually 2.97, much higher than the key 
reference service, and that the respondents specifically indicated that 
CPT code 95836 is more intense and complex than CPT code 95957 on all 
measures.
    Response: We disagree with the commenters that the key reference 
service of CPT code 95957 would be an inappropriate choice for a direct 
crosswalk, not least because the RUC commonly uses one of the key 
reference services in exactly this fashion. While it is true that the 
median survey work RVU was 2.97, we note that the RUC did not recommend 
this work valuation either, instead choosing to recommend a work RVU of 
2.30 in recognition that the survey median would be a value that is too 
high to maintain relativity. Similarly, while the survey respondents 
specifically indicated that CPT code 95836 is more intense and complex 
than CPT code 95957 on all measures, we note that the survey 
respondents also indicated that CPT code 95836 is more intense and 
complex than the second key reference code, CPT code 95810 
(Polysomnography; age 6 years or older, sleep staging with 4 or more 
additional parameters of sleep, attended by a technologist) which has a 
work RVU of 2.50. We proposed to use a crosswalk to CPT code 95957 not 
only because it was selected by the survey participants as the top key 
reference, but also because it is a recently-reviewed code with the 
same intraservice time of 30 minutes and a total time only 2 minutes 
lower than CPT code 95836. We continue to believe that this is the most 
accurate choice for work valuation.
    Comment: Several commenters stated that although the specialty 
society did not submit any direct PE inputs, it is not a facility only 
code. Commenters stated that CPT code 95836 can be performed in both 
the nonfacility and the facility setting, and that the nonfacility is 
actually the typical setting for this service. Commenters stated that 
they understood that there would be no direct staffing, equipment or 
supply costs associated with this service and that indirect costs would 
be similar regardless of the setting in which the service is performed, 
but there would still be indirect practice expense associated with 
providing the service in the nonfacility. Commenters apologized for the 
misunderstanding and requested that CPT code 95836 should be valued in 
the nonfacility setting.
    Response: We appreciate the additional information supplied by the 
commenters on this issue. We will remove the ``NA'' designation from 
the nonfacility setting for CPT code 95836. Due to the fact that there 
are no direct PE inputs for CPT code 95836, the PE RVU will be the same 
in both the nonfacility and facility settings because it is based 
solely on the indirect PE methodology.
    After consideration of the public comments, we are finalizing the 
work RVU for CPT code 95836 as proposed. We are not finalizing any 
direct PE inputs for this code, but we will value it in both the 
facility and nonfacility settings as noted above.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 
99454, and 99457)
    In the CY 2018 PFS final rule, we finalized separate payment for 
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) (82 FR 53014). In that rule, we indicated that there 
would be new coding describing remote monitoring forthcoming from the 
CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the 
CPT Editorial Panel revised one code and created three new codes to 
describe remote physiologic monitoring and management, and the RUC 
provided valuation recommendations through our standard rulemaking 
process.
    CPT codes 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 99454 
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood 
pressure, pulse oximetry, respiratory flow rate), initial; device(s) 
supply with daily recording(s) or programmed alert(s) transmission, 
each 30 days) are both PE-only codes. We proposed the RUC-recommended 
work RVU of 0.61 for CPT code 99457 (Remote physiologic monitoring 
treatment management services, 20 minutes or more of clinical staff/
physician/other qualified healthcare professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month).
    For the direct PE inputs, we proposed to accept the RUC-recommended 
direct PE inputs for CPT code 99453 and to remove the ``Monthly 
cellular and licensing service fee'' supply from CPT code 99454. We do 
not believe that these licensing fees will be allocated to the use of 
an individual patient for an individual service, and instead believe 
they can be better understood as forms of indirect costs similar to 
office rent or administrative expenses. Therefore, we proposed to 
remove this supply input as a form of indirect PE. We proposed the 
direct PE inputs for CPT code 99457 without refinement.
    The following is a summary of the public comments we received on 
our

[[Page 59575]]

proposals involving the Chronic Care Remote Physiologic Monitoring 
family of codes.
    Comment: Commenters were very supportive of CMS making separate 
payment for these services. Several commenters supported the proposal 
of the RUC-recommended work RVU of 0.61 for CPT code 99457. A few 
commenters stated that the proposed rates for these services were too 
low, and that given industry standards, reimbursement should be 
increased.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposal to remove 
the ``Monthly cellular and licensing service fee'' supply from CPT code 
99454. Commenters stated that the monthly cellular and licensing 
service fee was a direct practice expense input as it is allocable to 
the patient for this service. Commenters stated that this fee is not a 
license for the entire practice; rather it is an individually allocable 
fee for the period that the patients is monitored and the physician 
would not incur such fees if the patient did have the wireless monitor. 
Commenters clarified that the fee is comprised of the monthly cost 
associated with encryption of data for safe HIPAA compliant transfer, 
programmed alerts, and the monthly cost of pre-loaded connectivity used 
to transmit patient generated physiological data from a specific 
patient to the provider's software. Commenters stated that reliance 
upon a patient's cellular connectivity or WIFI, which may or may not be 
operating based on patient technology capabilities, was not reliable 
for medical delivery purposes.
    Response: We disagree with the commenters and we continue to 
believe that the monthly cellular and licensing service fee constitutes 
a form of indirect PE. We believe that licensing and data costs are 
administrative costs that are not unique to individual procedures, in 
the same fashion that we do not assign separate direct PE for higher 
electricity costs to diagnostic imaging procedures as compared to 
cognitive evaluation procedures. We continue to believe that these data 
costs are appropriately captured via the indirect PE methodology as 
opposed to being included as a separate direct PE input. We also note 
that other services that require around-the-clock monitoring, such as 
the home PT/INR monitoring described in HCPCS code G0249 (Provision of 
test materials and equipment for home inr monitoring of patient with 
either mechanical heart valve(s), chronic atrial fibrillation, or 
venous thromboembolism who meets Medicare coverage criteria; includes: 
Provision of materials for use in the home and reporting of test 
results to physician; testing not occurring more frequently than once a 
week; testing materials, billing units of service include 4 tests), do 
not include additional direct PE inputs for data costs, and we do not 
believe it would be appropriate to include them for CPT code 99454.
    Comment: One commenter stated that CMS should add the cost of 
equipment sanitation and reprocessing as a one-time cost that is 
directly attributable to a patient. The commenter stated that FDA 
device guidelines require that a reusable medical device be 
reprocessed, which includes sanitation or sterilization and ensuring 
that all personal data is `wiped' or removed from the device. The 
commenter stated that this cost was not considered by the RUC, however, 
it is routinely part of the `set up' costs that are onetime costs 
directly attributable to a patient.
    Response: We disagree with the commenter that these expenses would 
constitute a separate form of direct PE. We agree with the RUC, which 
discussed the specialty society's recommended supply items, shipping 
costs and a device reprocessing fee, and determined that these expenses 
are not specifically allocable to the patient for this service, and 
would be considered indirect practice expenses.
    Comment: One commenter stated that there was direct time spent by 
pharmacists for each patient, and the commenter requested that CMS 
factor pharmacist time into the PE valuation for CPT codes 99453, 
99454, 99091, and 99457.
    Response: We typically do not consider time spent by a pharmacist 
to be a part of the clinical labor time for purposes of direct PE. For 
additional information, we direct readers to the Practice Expense 
portion of this final rule (section II.B. of this final rule).
    Comment: Many commenters pointed out that beneficiary cost sharing 
is a significant barrier to the use of non-face-to-face services, like 
remote patient monitoring. Commenters requested that CMS waive the cost 
sharing requirements for these codes.
    Response: We do not have the authority to make changes to the 
applicable beneficiary cost sharing for most physicians' services, 
including these.
    Comment: Many commenters requested that CMS clarify the kinds of 
technology covered under CPT codes 99453, 99454, and 99457. Commenters 
provided examples of the kinds of technology these codes should cover 
including software applications that could be integrated into a 
beneficiary's smart phone, Holter-Monitors, Fit-Bits, or artificial 
intelligence messaging. One commenter suggested that behavioral health 
data and data from wellness applications be included as well. Another 
commenter stated that the descriptor should include results of 
patients' self-care tasks. Many commenters stated that CMS should 
clarify certain elements in the scope of service and code descriptors 
and issue appropriate sub-regulatory guidance. Commenters inquired as 
to whether CPT code 99453 can be furnished via telecommunication 
technology, if it can be billed again if the number of parameters 
changed in the future. Commenters requested that CMS clarify the 
meaning of ``programmed alerts transmission'' in the descriptor for CPT 
code 99454, and whether it included transmissions that occurred other 
than daily. Commenters also encouraged CMS to allow flexibility in the 
time frame covered by these services.
    Response: We plan to issue guidance to help inform practitioners 
and stakeholders on these issues.
    Comment: Commenters requested that CMS clarify whether CPT code 
99457 can be billed incident to a practitioner's professional services 
and asked that CMS make an exception to the direct supervision 
requirements, stating that general supervision is sufficient for these 
services.
    Response: We note that CPT code 99457 describes professional time 
and therefore cannot be furnished by auxiliary personnel incident to a 
practitioner's professional services.
    Comment: A few commenters suggested that additional medical 
professionals, including pharmacists, paramedics, chiropractors, 
physical therapists, occupational therapists and dentists should be 
allowed to bill Medicare for these services. Other commenters requested 
that CMS clarify the practitioners referred to as ``other qualified 
healthcare professionals'' in the code descriptor.
    Response: We note that all practitioners must practice in 
accordance with applicable state law and scope of practice laws, and 
that some of the practitioners identified by the commenters are not 
authorized to bill Medicare independently for their services. We note 
that the term, ``other qualified healthcare professionals,'' used in 
the code descriptor is a defined by CPT, and that definition can be 
found in the CPT Codebook.
    Comment: A few commenters provided specific suggestions for 
revising the code descriptors, including

[[Page 59576]]

the addition of secure messaging platforms, revision of the time 
thresholds, specifying that the follow-up should be written in all 
instances, including ``for medical consultative discussion and review'' 
in the descriptor for CPT codes 99446 through 99449, and striking 
``referral services'' and rather, including language similar to the 
other codes regarding ``assessment and management'' services. Other 
commenters requested CMS clarify the definition of ``health record 
assessment'' in the descriptors for CPT codes 99451 and 99452. One 
commenter suggested that CMS add language about use of EHR to the 
existing CPT codes, rather than finalize separate payment for CPT codes 
99451 and 99452.
    Response: While we appreciate all of the specific suggestions 
regarding the code descriptions, we defer to the CPT to maintain code 
descriptors for CPT codes. Where additional clarification is needed, we 
may provide guidance in the future.
    Comment: A few commenters urged CMS not to be prescriptive 
regarding the technology that could be used to perform consultations, 
including real-time video, a store-and-forward visit, or simply a 
patient-provider message via a patient portal.
    Response: While we are sympathetic to the commenters' desire not to 
be overly prescriptive about the technology used to furnish these 
services, especially given the speed at which technology evolves, we 
note that we refer to the CPT code descriptors and guidance to 
ascertain the scope of technology that is used to furnish these 
services.
    Comment: One commenter asked whether there were geographic 
restrictions on these services.
    Response: There are no geographic restrictions, as these services 
are not Medicare telehealth services.
    After considering the public comments, we are finalizing the RUC-
recommended work RVU of 0.61 for CPT code 99457 and the direct PE 
inputs for all three codes as proposed.
(59) Interprofessional Internet Consultation (CPT Codes 99451, 99452, 
99446, 99447, 99448, and 99449)
    In September 2017, the CPT Editorial Panel revised four codes and 
created two codes to describe interprofessional telephone/internet/
electronic medical record consultation services. CPT codes 99446 
(Interprofessional telephone/internet 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; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet 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; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet 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; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet 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; 31 minutes or more of medical 
consultative discussion and review) describe assessment and management 
services in which a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a physician with specific specialty expertise to assist with the 
diagnosis and/or management of the patient's problem without the need 
for the face-to-face interaction between the patient and the 
consultant. These CPT codes are currently assigned a procedure status 
of B (bundled) and are not separately payable under Medicare. The CPT 
Editorial Panel revised these codes to include electronic health record 
consultations, and the RUC reaffirmed the work RVUs it had previously 
submitted for these codes. We reevaluated the submitted recommendations 
and, in light of changes in medical practice and technology, we 
proposed to change the procedure status for CPT codes 99446, 99447, 
99448, and 99449 from B (bundled) to A (active). We also proposed the 
RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code 
99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.
    The CPT Editorial Panel also created two new codes, CPT code 99452 
(Interprofessional telephone/internet/electronic health record referral 
service(s) provided by a treating/requesting physician or qualified 
health care professional, 30 minutes) and 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 or more 
minutes of medical consultative time). The RUC-recommended work RVUs 
are 0.50 for CPT code 99452 and 0.70 for 99451. Since the CPT code for 
the treating/requesting physician or qualified healthcare professional 
and the CPT code for the consultative physician have similar 
intraservice times, we believe that these CPT codes should have equal 
values for work. Therefore, we proposed a work RVU of 0.50 for both CPT 
codes 99452 and 99451.
    We welcomed comments on this proposal. We also direct readers to 
section II.D. of this final rule, Modernizing Medicare Physician 
Payment by Recognizing Communication Technology-Based Services, which 
includes additional detail regarding our policies for modernizing 
Medicare physician payment by recognizing communication technology-
based services.
    There are no recommended direct PE inputs for the codes in this 
family.
    The following is a summary of the public comments we received on 
our proposals involving the Interprofessional Internet Consultation 
family of codes.
    Comment: Almost all commenters were supportive of CMS' proposal to 
unbundle CPT codes 99446 through 99449 and make separate payment for 
CPT codes 99452 and 99451. Almost all commenters did not support 
lowering the RVU of CPT code 99451 to 0.50 as the work of the 
consulting physician in CPT code 99451 is more intense than the work of 
the treating physician in CPT code 99452. Commenters stated that the 
consulting practitioner exercises greater effort, both in judgment and 
technical skill to make a recommendation for the treatment of a 
previously unknown patient than the treating physician does in 
conveying the relevant information. A few commenters expressed concern 
that the proposed work RVU for CPT code 99452 is too low, and does not 
accurately reflect the resources associated with the work of the 
treating physician.
    Response: We agree with commenters that the work of the consulting 
physician is significant, and we are persuaded by the additional 
descriptions of that work provided by commenters. We also agree with 
the commenters who suggested that the proposed work RVU of 0.50 for CPT 
code 99452 undervalues the work associated with aggregating patient 
information, communicating with the consulting practitioner, and

[[Page 59577]]

implementing the results of the consultation. We continue, however, to 
have concerns regarding the valuation of these services. We note that 
there are instances where the patient would not be new to the 
consulting practitioner, and therefore the intensity of the work would 
be reduced. We are also concerned that, given the similarity of 
intraservice times, CPT code 99452 is undervalued relative to CPT code 
99451, especially since the code descriptor for CPT code 99452 
specifies that the consulting practitioner can spend a minimum of 5 
minutes providing the consultation. We believe that a work RVU of 0.50 
more accurately describes the work associated with both services. Given 
the similarity of intraservice times and the information indicating 
that both codes may be undervalued at 0.50 RVUs, we are finalizing a 
work RVU of 0.70 for CPT codes 99451 and 99452.
    Comment: A few commenters expressed concern that these codes were 
only payable in the facility setting.
    Response: These codes are payable in both facility and non-facility 
settings.
    Comment: One commenter requested that CMS include pharmacists as 
clinical staff in the direct PE.
    Response: We direct readers to the discussion of this issue in the 
PE section of the rule (Section II.B. of this final rule). We also note 
that these codes do not have direct PE inputs.
(60) Chronic Care Management Services (CPT Code 99491)
    In February 2017, the CPT Editorial Panel created a new code to 
describe at least 30 minutes of chronic care management services 
performed personally by the physician or qualified health care 
professional over one calendar month. CMS began making separate payment 
for 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) in CY 2015 
(79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff 
time spent on care management services for patients with 2 or more 
chronic conditions. CPT code 99490 also includes 15 minutes of 
physician time for supervision of clinical staff. For CY 2019, the CPT 
Editorial Panel created CPT code 99491 (Chronic care management 
services, provided personally by a physician or other qualified health 
care professional, at least 30 minutes of physician or other qualified 
health care professional time, per calendar month, with the following 
required elements: Multiple (two or more) chronic conditions expected 
to last at least 12 months, or until the death of the patient, chronic 
conditions place the patient at significant risk of death, acute 
exacerbation/decompensation, or functional decline; comprehensive care 
plan established, implemented, revised, or monitored) to describe 
situations when the billing practitioner is doing the care coordination 
work that is attributed to clinical staff in CPT code 99490. For CPT 
code 99491, the RUC recommended a work RVU of 1.45 for 30 minutes of 
physician time.
    We believe this work RVU overvalues the resource costs associated 
with the physician performing the same care coordination activities 
that are performed by clinical staff in the service described by CPT 
code 99490. Additionally, this valuation of the work is higher than 
that of 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 a physician or other qualified health 
care professional, per calendar month), which includes 60 minutes of 
clinical staff time, creating a rank order anomaly within the family of 
codes if we were to accept the RUC-recommended value.
    CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician 
time. Therefore, as CPT code 99491 describes 30 minutes of physician 
time, we proposed a work RVU of 1.22, which is double the work RVU of 
CPT code 99490.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 99491.
    Comment: Almost all commenters recommended that CMS finalize the 
RUC-recommended work value of 1.45 for 99491. The RUC stated that CPT 
code 99491 is different from the existing chronic care management (CCM) 
services codes because those codes are performed by clinical staff 
under the supervision of a physician, while CPT code 99491 is performed 
by the physicians themselves. Commenters also stated that the typical 
patient requiring that the physician personally perform the care 
management services is of greater acuity than the typical patient for 
whom CCM may be performed by clinical staff. Additionally, CPT code 
99491 cannot be reported with CPT code 99490 or CPT code 99487, and 
must therefore account for all of the care management work in the 
month. Commenters also pointed out that there are multiple examples of 
CMS valuing the work of a physician more highly than clinical staff 
when they perform the same services, for example CPT codes 96101 
(Psychological testing (includes psychodiagnostic assessment of 
emotionality, intellectual abilities, personality and psychopathology, 
e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or 
physician's time, both face-to-face time administering tests to the 
patient and time interpreting these test results and preparing the 
report) and 96102 (Psychological testing (includes psychodiagnostic 
assessment of emotionality, intellectual abilities, personality and 
psychopathology, e.g., MMPI and WAIS), with qualified health care 
professional interpretation and report, administered by technician, per 
hour of technician time, face-to-face.)
    Response: We agree with commenters that a work RVU of 1.45 
accurately captures the resources associated when a physician furnishes 
CCM. We agree that in most cases, the physician would perform CCM on 
patients with higher acuity and therefore the care planning and medical 
decision making would be of greater intensity. We also agree with 
commenters that the work associated with personally performing CCM as 
opposed to supervising clinical staff is also of greater intensity. 
Therefore, we are finalizing that value based on our review of comments 
received.
    Comment: A few commenters requested that CMS clarify that CPT code 
99491 can be performed incident to a practitioner's professional 
services.
    Response: CPT code 99491 is specifically for use when the billing 
practitioner personally performs care management services, so this code 
cannot be furnished incident to a practitioner's professional services.
(61) Diabetes Management Training (HCPCS Codes G0108 and G0109)
    HCPCS codes G0108 (Diabetes outpatient self-management training 
services, individual, per 30 minutes) and G0109 (Diabetes outpatient 
self-

[[Page 59578]]

management training services, group session (2 or more), per 30 
minutes) were identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. For CY 
2019, we proposed the HCPAC-recommended work RVU of 0.90 for HCPCS code 
G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109.
    For the direct PE inputs, we noted that there was a significant 
disparity between the specialty recommendation and the final 
recommendation submitted by the HCPAC. We were concerned about the 
significant decreases in direct PE inputs in the final recommendation 
when compared to the current makeup of the two codes. The final HCPAC 
recommendation removed a series of different syringes and the patient 
education booklet that currently accompanies the procedure. We believe 
that injection training is part of these services and that the supplies 
associated with that training would typically be included in the 
procedures. Due to these concerns, we proposed to maintain the current 
direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we 
proposed not to add the new supply item ``20x30 inch self-stick easel 
pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109 that was 
included in the final HCPAC recommendation, as it was not a current 
supply for HCPCS code G0109; however, we proposed to accept the 
submitted invoice price and to add the supply to our direct PE 
database.
    The following is a summary of the public comments we received on 
our proposals involving the Diabetes Management Training family of 
codes.
    Comment: Several commenters supported the proposal of the HCPAC-
recommended work RVUs. Commenters also stated that they applauded CMS 
for recognizing and addressing the significant disparity in direct PE 
inputs between the specialty recommendations and the final 
recommendations submitted to CMS by the HCPAC.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter expressed disappointment that CMS did not 
address barriers in Medicare that impact beneficiary utilization of the 
diabetes self-management training (DSMT) benefit. The commenter stated 
that CMS solicited comments from stakeholders in the CY 2017 PFS 
proposed rule on this subject, and the commenter has been part of 
ongoing conversations with CMS about this issue, through in-person 
meetings and written communications, over the past two years. The 
commenter stated that they were hopeful CMS would use this opportunity 
to address barriers to DSMT given that utilization of the DSMT benefit 
stands at only 5 percent of eligible Medicare beneficiaries.
    Response: We appreciate the feedback from the commenter, and we 
will consider these issues for future rulemaking. However, we note that 
we did not specifically make any proposals associated with these 
subjects in the CY 2019 proposed rule.
    Comment: One commenter stated that the final HCPAC recommendations 
removed a series of different syringes and the patient education 
booklet that currently accompany these procedures. The commenter stated 
that several anti-glycemic medications other than insulin require 
injection with a syringe and a significant number of persons with both 
type 1 and type 2 diabetes are prescribed these medications, however 
the list of supplies in the current direct PE inputs does not include 
syringes. The commenter therefore recommended that CMS add a series of 
different syringes to the direct PE inputs for HCPCS codes G0108 and 
G0109.
    Response: We proposed to maintain the current direct PE inputs for 
HCPCS codes G0108 and G0109, which do not currently include the syringe 
supplies described by the commenter (supply codes SC051, SC052, and 
SC055). Although we are sensitive to the concerns raised by the 
commenter, we do not believe that adding these syringe supplies to the 
procedures would be consistent with our policy of maintaining the 
current direct PE inputs.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Diabetes 
Management Training family of codes as proposed.
(62) External Counterpulsation (HCPCS Code G0166)
    HCPCS code G0166 (External counterpulsation, per treatment session) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. The RUC is not 
recommending a work RVU for HCPCS code G0166 because they found that 
there is no physician work involved in this service. After reviewing 
this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and 
proposed to make the code valued for PE only. For the direct PE inputs, 
we proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0166.
    Comment: A commenter agreed with the proposal that an individual 
treatment session would have no physician work and supported the 
proposed direct PE inputs. However, the commenter stated that future 
coding solutions may be necessary to recognize management of these 
services that is additional to that captured by E/M coding.
    Response: We appreciate the feedback from the commenter, and we 
will consider this information for future rulemaking.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0166 as proposed.
(63) Wound Closure by Adhesive (HCPCS Code G0168)
    HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, the RUC recommended a 
work RVU of 0.45 based on maintaining the current work RVU.
    We disagreed with the recommended value and we proposed a work RVU 
of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code 
93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single, 
dual, or multiple lead pacemaker system, includes recording with and 
without magnet application with analysis, review and report(s) by a 
physician or other qualified health care professional, up to 90 days). 
CPT code 93293 is a recently-reviewed code with the same 5 minutes of 
intraservice time and 1 fewer minute of total time. In reviewing HCPCS 
code G0168, the recommendations stated that the work involved in the 
service had not changed even though the surveyed intraservice time was 
decreasing by 50 percent, from 10 minutes to 5 minutes. Although we did 
not imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs. In the case of HCPCS code G0168, we believe 
that it would be more accurate to propose a work RVU of 0.31 based on

[[Page 59579]]

the aforementioned crosswalk to CPT code 93293 to account for these 
decreases in the surveyed work time. Maintaining the current work RVU 
of 0.45 despite a 50 percent decrease in the surveyed intraservice time 
would result in a significant increase in the intensity of HCPCS code 
G0168, and we have no reason to believe that the procedure has 
increased in intensity since the last time that it was valued.
    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0168.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.31 for HCPCS code G0168 and stated that CMS should finalize the 
HCPAC-recommended work RVU of 0.45. Commenters stated that CMS should 
not compare the valid survey time to the current work time because the 
initial CMS/Other source data is flawed and maintains zero validity for 
comparison. Commenters stated that surveyed time was never obtained 
from physicians who perform this service and should not be used as a 
comparison.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important element 
in PFS ratesetting, both as points of comparison in establishing work 
RVUs and in the allocation of indirect PE RVUs by specialty. If we were 
to operate under the assumption that previously recommended work times 
had routinely been overestimated, this would undermine the relativity 
of the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times and 
it undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS. Instead, we believe that it is 
crucial that the code valuation process take place with the 
understanding that the existing work times, used in the PFS ratesetting 
processes, are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we 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 old 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
    Comment: Several commenters stated that HCPCS code G0168 should not 
be crosswalked to CPT code 93293, as this is an evaluation of pacemaker 
strips over a 90 day period. Commenters stated that the skill of 
closing a facial laceration, typically near the eye, using a surgical 
tissue adhesive for HCPCS code G0168 is more intense and complex to 
perform than CPT code 93293 and thus should be valued higher. 
Commenters stated that CPT code 51702 (Insertion of temporary 
indwelling bladder catheter; simple (e.g., Foley)) would be a better 
reference service.
    Response: We disagree with the commenters that CPT code 93293 would 
be an inappropriate choice for a crosswalk. CPT code 93293 describes a 
transtelephonic rhythm strip pacemaker evaluation(s) for a single, 
dual, or multiple lead pacemaker system. We do not agree that this 
crosswalk code has lower intensity or complexity due to the cognitive 
work involved in evaluating the patient correctly. Both CPT code 93293 
and HCPCS code G0168 require skill on the part of the practitioner, 
only of different types. We also believe that our crosswalk to CPT code 
92393 is a more accurate choice because it has the same intraservice 
work time (5 minutes) closely matches the total work time (13 minutes 
as opposed to 14 minutes) of HCPCS code G0168. By contrast, CPT code 
51702 has nearly double the total work time at 25 minutes, which 
accounts for its higher work RVU of 0.50.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0168 as proposed.
(64) Removal of Impacted Cerumen (HCPCS Code G0268)
    HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by 
physician on same date of service as audiologic function testing) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Clean surgical instrument package'' (CA026) activity. 
There is no surgical instrument pack included in the recommended 
equipment for HCPCS code G0268, and this code already includes the 
standard 3 minutes allocated for cleaning the room and equipment. In 
addition, all of the instruments used in the procedure appear to be 
disposable supplies that would not require cleaning since they would 
only be used a single time.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0268.
    Comment: Several commenters supported our proposal of the HCPAC-
recommended work RVU as well as the refinement to the direct PE inputs.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0268 as proposed.
(65) Structured Assessment, Brief Intervention, and Referral to 
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and 
G2011)
    In response to the Request for Information in the CY 2018 PFS 
proposed rule (82 FR 34172), commenters requested that CMS pay 
separately for assessment and referral related to substance use 
disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two 
G-codes to allow for appropriate Medicare reporting and payment for 
alcohol and substance abuse assessment and intervention services that 
are not provided as screening services, but that are performed in the 
context of the diagnosis or treatment of illness or injury. The codes 
are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) 
abuse structured assessment (e.g., AUDIT, DAST) and brief intervention, 
15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance 
(other than tobacco) abuse structured assessment (e.g., AUDIT, DAST) 
and intervention greater than 30 minutes)). In 2008, we instructed 
Medicare contractors to pay for these codes only when the services were 
considered reasonable and necessary.

[[Page 59580]]

    Given the ongoing opioid epidemic and the current needs of the 
Medicare population, we expect that these services would often be 
reasonable and necessary. However, the utilization for these services 
is relatively low, which we believe is in part due to the service-
specific documentation requirements for these codes (the current 
requirements are available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional 
documentation requirements will also ease the administrative burden on 
providers. Therefore, for CY 2019, we proposed to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398. We welcomed comments on our proposal to change the documentation 
requirements for these codes.
    The following is a summary of the comments we received regarding 
our proposal to change the documentation requirements for these codes.
    Comment: The majority of commenters were supportive of this 
proposal, some noting that this will ease administrative burden and 
some noting that this will incentivize providers to deliver SBIRT 
services, thereby increasing access to this service. One commenter 
stated they believe that practitioners are not utilizing SBIRT for 
illicit drug use due to the absence of conclusive evidence to support 
use of this service for illicit drug use and therefore, support 
removing the service documentation requirements for SBIRT when used to 
screen for unhealthy alcohol use, but not when used to screen for 
illicit drug use.
    Response: We thank the commenters for their feedback. We note that 
the services described by HCPCS codes G0397 and G0398 describe services 
for alcohol and/or substance abuse; we believe it would be 
administratively burdensome for practitioners were we to create varying 
rules for different diagnoses. Additionally, it is our intention to 
increase access to care for services that may be of use in addressing 
all substance use disorders, especially in light of the ongoing opioid 
epidemic. Therefore, we are finalizing our proposal to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398.
    Additionally, we proposed to create a third HCPCS code G2011with a 
lower time threshold in order to accurately account for the resource 
costs when practitioners furnish these services, but do not meet the 
minimum time requirements of the existing codes. We note that in the 
proposed rule we referred to this service as HCPCS code GSBR1, which 
was a placeholder code. The code will be described as G2011: Alcohol 
and/or substance (other than tobacco) abuse structured assessment 
(e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We proposed 
a work RVU of 0.33, based on the intraservice time ratio between HCPCS 
codes G0396 and G0397. We welcomed comments on this code descriptor and 
proposed valuation for HCPCS code G2011.
    The following is a summary of the comments we received on this code 
descriptor and proposed valuation for HCPCS code G2011.
    Comment: Commenters were supportive of creating this code and the 
valuation proposed, and noted the lower time threshold will allow 
physicians the opportunity to provide brief counseling rather than 15 
or more minutes of discussion, which requires extended interest from a 
patient who may not yet be ready for prolonged discussion and/or is 
receptive to being referred to another health care provider for 
treatment. One commenter recommended finalizing guidance that allows 
the newly proposed SBIRT HCPCS code to be used for alcohol, but not 
illicit drug use.
    Response: We thank the commenters for their feedback. After 
considering these comments, we are finalizing the code descriptor and 
valuation for HCPCS code G2011 as proposed. We believe the code 
descriptor and guidance for this new SBIRT HCPCS code should be 
consistent with the existing SBIRT HCPCS codes. For future rulemaking 
we would consider recommendations on how to refine this family of codes 
under our standard process of reviewing codes.
(66) Prolonged Services (HCPCS Code GPRO1)
    CPT codes 99354 (Prolonged evaluation and management or 
psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; first hour (List 
separately in addition to code for office or other outpatient 
Evaluation and Management or psychotherapy service)) and 99355 
(Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; each additional 30 minutes (List separately 
in addition to code for prolonged service)) describe additional time 
spent face-to-face with a patient. Stakeholders have shared with us 
that the threshold of 60 minutes for CPT code 99354 is difficult to 
meet and is an impediment to billing these codes. In response to 
stakeholder feedback and as part of our proposal as discussed in 
section II.I. of this final rule, Evaluation and Management Services, 
to implement a single PFS rate for E/M visit levels 2-5 while 
maintaining payment stability across the specialties, we proposed HCPCS 
code GPRO1 (Prolonged evaluation and management or psychotherapy 
service(s) (beyond the typical service time of the primary procedure) 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; 30 minutes (List separately in 
addition to code for office or other outpatient Evaluation and 
Management or psychotherapy service)), which could be billed with any 
level of E/M code. We noted that we did not propose to make any changes 
to CPT codes 99354 and 99355, which can still be billed, as needed, 
when their time thresholds and all other requirements are met. We 
proposed a work RVU of 1.17, which is equal to half of the work RVU 
assigned to CPT code 99354. Additionally, we proposed direct PE inputs 
for HCPCS code GPRO1 that are equal to one half of the values assigned 
to CPT code 99354, which can be found in the Direct PE Inputs public 
use file for this final rule.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals, we did not receive many comments with 
specific suggestions on valuation for HCPCS code GPRO1. Of the 
commenters that supported creation of the code, most supported the 
proposed valuation while others, while supporting the creation of a 30-
minute prolonged services code in principle, encouraged CMS to wait for 
recommendations from the CPT Editorial Panel and the RUC.
    Response: For CY 2021, we are finalizing the proposed add-on code 
for HCPCS code GPRO1 using the input values, as proposed. We note that 
prior to implementation for 2021, we could consider, through 
rulemaking, the code and its valuation in the context of any potential 
changes to CPT codes and/or recommendations offered by stakeholders, 
including the RUC, as part of our annual process for valuing PFS 
services. See section II.I. of this final rule for further discussion 
of the E/M policy.

[[Page 59581]]

(67) Remote Pre-Recorded Services (HCPCS Code G2010)
    For CY 2019, we proposed to make separate payment for remote 
evaluation services when a physician uses pre-recorded video and/or 
images submitted by a patient in order to evaluate a patient's 
condition through new HCPCS G-code G2010 (Remote evaluation of recorded 
video and/or images submitted by the patient (e.g., store and forward), 
including interpretation with verbal 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). We proposed 
to value this service by a direct crosswalk to CPT code 93793 
(Anticoagulant management for a patient taking warfarin, must include 
review and interpretation of a new home, office, or lab international 
normalized ratio (INR) test result, patient instructions, dosage 
adjustment (as needed), and scheduling of additional test(s), when 
performed), as we believe the work described is similar in kind and 
intensity to the work performed as part of HCPCS code G2010. Therefore, 
we proposed a work RVU of 0.18, preservice time of 3 minutes, 
intraservice time of 4 minutes, and post service time of 2 minutes. We 
also proposed to add 6 minutes of clinical labor (L037D) in the service 
period. We solicited comment on the code descriptor and valuation for 
HCPCS code G2010. We direct readers to section II.D. of this final 
rule, which includes additional detail regarding our proposed policies 
for modernizing Medicare physician payment by recognizing communication 
technology-based services.
    The following is a summary of the comments we received on the code 
descriptor and valuation for HCPCS code G2010.
    Comment: Several commenters stated that the proposed payment rate 
is too low, citing that it is below market compared to the rate many 
asynchronous telemedicine companies pay their contracted/employed 
physician staff, and noted that new patients in particular require more 
resources, whereas others stated that the proposed valuation was 
appropriate.
    Response: We believe that the proposed valuation accurately 
reflects the resources involved in furnishing this service and note 
that we are finalizing limiting this service to established patients. 
We also note that we plan to monitor the utilization of this code and 
routinely address recommended changes in values for codes paid under 
the PFS.
    After considering the public comments, we are finalizing the work 
RVU and direct PE inputs for HCPCS code G2010 as proposed.
(68) Brief Communication Technology-Based Service, e.g. Virtual Check-
In (HCPCS Code G2012)
    We proposed to create a G-code, HCPCS code G2012 (Brief 
communication technology based service, e.g. virtual check-in, by a 
physician or other qualified health care professional who may 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) to facilitate payment for these brief communication 
technology-based services. We proposed to base the code descriptor and 
valuation for HCPCS code G2012 on existing CPT code 99441 (Telephone 
evaluation and management service by a physician or other qualified 
health care professional who may report evaluation and management 
services provided to an established patient, parent, or guardian 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), which is currently not separately payable under the PFS. 
As CPT code 99441 only describes telephone calls, we are proposing to 
create a new HCPCS code G2012 to encompass a broader array of 
communication modalities. We do, however, believe that the resource 
assumptions for CPT code 99441 would accurately account for the costs 
associated with providing the proposed virtual check-in service, 
regardless of the technology. We proposed a work RVU of 0.25, based on 
a direct crosswalk to CPT code 99441. For the direct PE inputs for 
HCPCS code G2012, we also proposed the direct PE inputs assigned to CPT 
code 99441. Given the breadth of technologies that could be described 
as telecommunications, we anticipated receiving public comments and 
working with the CPT Editorial Panel and the RUC to evaluate whether 
separate coding and payment is needed to account for differentiation 
between communication modalities. We solicited comment on the code 
descriptor, as well as the proposed valuation for HCPCS code G2012. We 
direct readers to section II.D. of this final rule, which includes 
additional detail regarding our proposed policies for modernizing 
Medicare physician payment by recognizing communication technology-
based services.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code G2012.
    Comment: Several commenters stated that the proposed payment rate 
would be inadequate for modalities that are both audio and visual 
capable, whereas other commenters stated that the proposed valuation 
was appropriate.
    Response: We appreciate the input provided by the commenters. As 
noted in section II.D. of this final rule, we are finalizing the 
valuation for this service as proposed. We note that we are finalizing 
allowing audio-only real-time telephone interactions in addition to 
synchronous, two-way audio interactions that are enhanced with video or 
other kinds of data transmission. We believe the proposed valuation 
reflects the low work time and intensity and accounts for the resource 
costs and efficiencies associated with the use of communication 
technology. We recognize that the valuation of this service is 
relatively modest, especially compared to in-person services, however, 
we believe that the proposed valuation accurately reflects the 
resources involved in furnishing this service.
    We plan to monitor the utilization of this code and note that we 
routinely address recommended changes in values for codes paid under 
the PFS and would expect to do this in future rulemaking.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G2012 as proposed.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code 
GCG0X)
    We proposed to create a HCPCS G-code to be reported with an E/M 
service to describe the additional resource costs for specialties for 
whom E/M visit codes make up a large percentage of their total allowed 
charges and who we believe primarily bill level 4 and level 5 visits. 
The treatment approaches for these specialties generally do not have 
separate coding and are generally reported using the E/M visit codes. 
We proposed to create HCPCS code, GCG0X (Visit complexity inherent to 
evaluation and management associated with endocrinology, rheumatology, 
hematology/oncology, urology, neurology, obstetrics/gynecology, 
allergy/immunology, otolaryngology, or

[[Page 59582]]

interventional pain management-centered care (Add-on code, list 
separately in addition to an evaluation and management visit)). We 
proposed a valuation for HCPCS code GCG0X based on a crosswalk to 75 
percent of the work RVU and time of CPT code 90785 (Interactive 
complexity), which would result in a proposed work RVU of 0.25 and a 
physician time of 8.25 minutes for HCPCS code GCG0X. CPT code 90785 has 
no direct PE inputs. 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. We believe that this work 
RVU and physician time would be an accurate representation of the 
additional work associated with the higher level complex visits. For 
further discussion of proposals relating to this code, see section 
II.I. of this final rule. We solicited comment on the code descriptor, 
as well as the proposed valuation for HCPCS code GCG0X.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code GCG0X.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals, we did not receive comments with specific 
suggestions on valuation for HCPCS code GCG0X.
    Response: For CY 2021, we are finalizing the proposed add-on code 
for visit complexity inherent to non-procedural specialty care using 
the input values, as proposed. We note that prior to implementation for 
CY 2021, we could consider, through rulemaking, the code and its 
valuation in the context of any potential changes to CPT codes and/or 
recommendations offered by stakeholders, including the RUC, as part of 
our annual process for valuing PFS services. See section II.I. of this 
final rule for further discussion of the E/M policy.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code 
GPC1X)
    We proposed to create a HCPCS G-code for primary care services, 
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 an evaluation and management 
visit)). This code describes furnishing a visit to a new or existing 
patient, and can include aspects of care management, counseling, or 
treatment of acute or chronic conditions not accounted for by other 
coding. HCPCS code GPC1X would be billed in addition to the E/M visit 
code when the visit involved primary care-focused services. We proposed 
a work RVU of 0.07, physician time of 1.75 minutes. This proposed 
valuation accounts for the additional work resource costs associated 
with furnishing primary care that distinguishes E/M primary care visits 
from other types of E/M visits and maintains work budget neutrality 
across the office/outpatient E/M code set. For further discussion of 
proposals relating to this code, see section II.I. of this final rule. 
We solicited comment on the code descriptor, as well as the proposed 
valuation for HCPCS code GPC1X.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code GPC1X.
    Comment: We received a few comments suggesting that the primary 
care add-on was undervalued, particularly in comparison to the add-on 
code for specialty visit complexity. A few commenters suggested that, 
at the very least, we should equalize the value for these codes.
    Response: We agree that the proposed inputs do not reflect the 
resources associated with furnishing primary care visits. For CY 2021, 
we are finalizing the proposed add-on code for visit complexity 
inherent to primary care using the inputs associated with HCPCS code 
GCG1X: A work RVU of 0.25 and a physician time of 8.25 minutes. We note 
that prior to implementation for 2021, we could consider, through 
rulemaking, the code and its valuation in the context of any potential 
changes to CPT codes and/or recommendations offered by stakeholders, 
including the RUC, as part of our annual process for valuing PFS 
services. See section II.I. of this final rule for further discussion 
of the E/M policy.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X 
and GPD1X)
    We proposed to create two HCPCS G-codes, HCPCS codes GPD0X 
(Podiatry services, medical examination and evaluation with initiation 
of diagnostic and treatment program, new patient) and GPD1X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, established patient), to describe 
podiatric evaluation and management services. We proposed a work RVU of 
1.36, a physician time of 28.19 minutes, and direct costs summing to 
$21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 
21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X. 
These values are based on the average rate for CPT codes 99201-99203 
and CPT codes 99211-99212 respectively, weighted by podiatric volume. 
For further discussion of proposals relating to these codes, see 
section II.I. of this final rule.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals and these codes specifically, we did not 
receive comments with specific suggestions on valuation.
    Response: In response to comments, we are not finalizing HCPCS 
codes GPD0X and GPD1X for CY 2019. See section X of this final rule for 
further discussion of the E/M policy.
(72) Comment Solicitation on Superficial Radiation Treatment Planning 
and Management
    In the CY 2015 PFS final rule with comment period (79 FR 67666 
through 67667), we noted that changes to the CPT prefatory language 
limited the codes that could be reported when describing services 
associated with superficial radiation treatment (SRT) delivery, 
described by CPT code 77401 (radiation treatment delivery, superficial 
and/or ortho voltage, per day). The changes effectively meant that many 
other related services were bundled with CPT code 77401, instead of 
being separately reported. For example, CPT guidance clarified that 
certain codes used to describe clinical treatment planning, treatment 
devices, isodose planning, physics consultation, and radiation 
treatment management cannot be reported when furnished in association 
with SRT. Stakeholders informed us that these changes to the CPT 
prefatory language prevented them from billing Medicare for codes that 
were previously frequently billed with CPT code 77401. We solicited 
comments as to whether the revised bundled coding for SRT allowed for 
accurate reporting of the associated services. In the CY 2016 PFS final 
rule with comment period (80 FR 70955), we noted that the RUC did not 
review the inputs for SRT procedures, and therefore, did not assess 
whether changes in valuation were appropriate in light of the bundling 
of associated services. In addition, we solicited recommendations from 
stakeholders regarding whether it would be appropriate to add physician 
work for this service, even though physician work is not included in 
other radiation treatment services. In the CY 2018 PFS proposed rule 
(82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted 
that the 2016 National Correct

[[Page 59583]]

Coding Initiative (NCCI) Policy Manual for Medicare Services states 
that radiation oncology services may not be separately reported with E/
M codes. While this NCCI edit is no longer active stakeholders have 
stated that MACs have denied claims for E/M services associated with 
SRT based on the NCCI policy manual language. According to 
stakeholders, the bundling of SRT with associated services, as well as 
coding confusion regarding the appropriate use of E/M coding to report 
associated physician work, meant that practitioners were not being paid 
appropriately for planning and treatment management associated with 
furnishing SRT. Due to these concerns regarding reporting of services 
associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012 
through 34013), we proposed to make separate payment for the 
professional planning and management associated with SRT using HCPCS 
code GRRR1 (Superficial radiation treatment planning and management 
related services, including but not limited to, when performed, 
clinical treatment planning (for example, 77261, 77262, 77263), 
therapeutic radiology simulation-aided field setting (for example, 
77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for 
example, 77300), treatment devices (for example, 77332, 77333, 77334), 
isodose planning (for example, 77306, 77307, 77316, 77317, 77318), 
radiation treatment management (for example, 77427, 77431, 77432, 
77435, 77469, 77470, 77499), and associated E/M per course of 
treatment). We proposed that this code would describe the range of 
professional services associated with a course of SRT, including 
services similar to those not otherwise separately reportable under CPT 
guidance. Furthermore, we proposed that this code would have included 
several inputs associated with related professional services such as 
treatment planning, treatment devices, and treatment management. Many 
commenters did not support our proposal to make separate payment for 
HCPCS code GRRR1 for CY 2018, stating that our proposed valuation of 
HCPCS code GRRR1 would represent a significant payment reduction for 
the associated services as compared with the list of services that they 
could previously bill in association with SRT. Commenters voiced 
concern that the proposed coding would inhibit access to care and 
discourage the use of SRT as a non-surgical alternative to Mohs 
surgery. We received comments recommending a variety of potential 
coding solutions but without a consistent preferred alternative. In the 
CY 2018 PFS final rule (82 FR 53081-53083), we solicited further 
comment, and stated that we would continue our dialogue with 
stakeholders to address appropriate coding and payment for professional 
services associated with SRT.
    Given stakeholder feedback that we have continued to receive 
following the publication of the CY 2018 PFS final rule, we continue to 
believe that there are potential coding gaps for SRT-related 
professional services. We generally rely on the CPT process to 
determine coding specificity, and we believe that deferring to this 
process in addressing potential coding gaps is generally preferable. As 
our previous attempt at designing a coding solution in the CY 2018 PFS 
proposed rule did not gain stakeholder consensus, and given that there 
were various, in some cases diverging, suggestions on a coding solution 
from stakeholders, we did not propose changes relating to SRT coding, 
SRT-related professional codes, or payment policies for CY 2019. 
However, we solicited comment on the possibility of creating multiple 
G-codes specific to services associated with SRT, as was suggested by 
one stakeholder following the CY 2018 PFS final rule. These codes would 
be used separately to report services including SRT planning, initial 
patient simulation visit, treatment device design and construction 
associated with SRT, SRT management, and medical physics consultation. 
We solicited comment on whether we should create such G-codes to 
separately report each of the services described previously, mirroring 
the coding of other types of radiation treatment delivery. For 
instance, HCPCS code G6003 (Radiation treatment delivery, single 
treatment area, single port or parallel opposed ports, simple blocks or 
no blocks: Up to 5 mev) is used to report radiation treatment delivery, 
while associated professional services are billed with codes such as 
CPT codes 77427 (Radiation treatment management, 5 treatments), 77261 
(Therapeutic radiology treatment planning; simple), 77332 (Treatment 
devices, design and construction; simple (simple block, simple bolus), 
and 77300 (Basic radiation dosimetry calculation, central axis depth 
dose calculation, TDF, NSD, gap calculation, off axis factor, tissue 
inhomogeneity factors, calculation of non-ionizing radiation surface 
and depth dose, as required during course of treatment, only when 
prescribed by the treating physician).
    We stated that we consider contractor pricing such codes for CY 
2019 because we believe that the preferable method to develop new 
coding is with multi-specialty input through the CPT and RUC process, 
and we prefer to defer nationally pricing such codes pending input from 
the CPT Editorial Panel and the RUC process to assist in determining 
the appropriate level of coding specificity for SRT-related 
professional services. Based on stakeholder feedback, we continue to 
believe there may be a coding gap for these services, and therefore, we 
solicited comment on whether we should create these G-codes and allow 
them to be contractor priced for CY 2019. This would be an interim 
approach for addressing the potential coding gap until the CPT 
Editorial Panel and the RUC can address coding for SRT and SRT-related 
professional services, giving the CPT Editorial Panel and the RUC an 
opportunity to develop a coding solution that could be addressed in 
future rulemaking.
    The following is a summary of the comments we received on the 
possibility of creating multiple G-codes specific to services 
associated with SRT, which could be used separately to report services 
including SRT planning, initial patient simulation visit, treatment 
device design and construction associated with SRT, SRT management, and 
medical physics consultation, which would be contractor priced for CY 
2019.
    Comment: Many commenters urged CMS to make appropriate payment for 
SRT-related services, stating that it is a vital non-surgical 
alternative treatment for skin cancer. Many commenters also said that 
coding should recognize newer generation, Image Guided Superficial 
Radiation (IGSRT), stating that IGSRT is the most advanced form of this 
technology, and has far better outcomes compared to those achieved with 
SRT.
    Some commenters recommended implementation of G-codes for SRT-
related professional services, and they submitted alternative G-code 
scenarios that they believe would be preferable to adopting contractor-
priced G-codes. These scenarios include one in which there would be one 
code for SRT-related treatment planning, with a value based on a 
crosswalk to CPT code 77261 (Therapeutic radiology treatment planning; 
simple), a code for SRT treatment device construction, with a value 
based on a crosswalk to CPT code 77332 (Treatment devices, design and 
construction; simple (simple block, simple bolus), and a code for SRT 
treatment management billed once per treatment, valued with a crosswalk 
to CPT code 99213 (Office or other outpatient visit for the evaluation 
and management of an established patient,

[[Page 59584]]

which requires at least 2 of these 3 key components: An expanded 
problem focused history; An expanded problem focused examination; 
Medical decision making of low complexity. Counseling and 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, 15 
minutes are spent face-to-face with the patient and/or family.). 
According to this commenter, image guidance and tracking should not be 
billed with superficial treatments. Another commenter suggested a 
single code bundling SRT-related treatment management with SRT-related 
device construction as well as a code for SRT-related radiation 
treatment management, and a code representing treatment for multiple 
lesions. This commenter also urged us to either revalue CPT code 77401 
or to create an additional G-code billable with CPT code 77401 to 
represent professional services associated with SRT. Another commenter 
suggested a code for SRT-related radiology treatment planning, and an 
SRT management code including five treatments. A commenter suggested a 
coding structure that recognizes Image-Guided Superficial Radiation 
Therapy as a newer generation of SRT, and would consist of CPT code 
77401 for practitioners that utilize the SRT technologies; relying on 
human visualization for lesion(s) simulation, treatment and tracking, 
and a new G-code for providers who provide the newer generation 
technology relying on image-guided lesion simulation, treatment and 
tracking per fraction with Record and Verify precision tracking of 
treatment progress.
    A commenter stated that any codes utilized as part of superficial 
radiation treatment delivery that include medical physics time should 
require that a qualified medical physicist perform the physics work.
    A commenter stated that adopting contractor-priced G codes would be 
appropriate. Some other commenters, however, did not support our 
suggested adoption of contractor-priced codes. According to these 
commenters, we are correct in our belief that there are coding gaps in 
the current reimbursement structure, however a fuller evaluation that 
does not defer to Medicare contractors in determining reimbursement 
rates is appropriate. According to a commenter, contractor pricing 
creates unnecessary work for the Medicare Administrative Contractors 
and can also lead to wide variances in the valuing of codes across 
jurisdictions. Commenters expressed preference that coding for these 
services be developed through the CPT and RUC processes. Many 
commenters urged us not to change coding for CY 2019 for these 
services.
    Response: We expect to take these comments into consideration for 
future rulemaking and we hope to continue a dialogue with stakeholders 
on these important services. We reiterate that we believe multi-
specialty input through the CPT and RUC processes is the ideal way to 
develop coding specificity and evaluation, and we are not making any 
changes to payment policy based on this comment solicitation. In the 
interim, we refer readers to CPT guidance that states that CPT code 
77401, when performed, may be reported with appropriate E/M codes, and 
this is the appropriate way to currently report professional work 
associated with SRT. Going forward, we will attempt to determine 
whether MACs are inappropriately denying billing of E/M codes with CPT 
code 77401, and we will instruct MACs accordingly.
(73) Adaptive Behavior Analysis Services
    We note that we intended to assign a contractor price status in the 
Addendum B file of the proposed rule for the following CPT codes that 
describe adaptive behavior analysis services: CPT codes 97151, 97152, 
97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly 
contractor priced Category III CPT codes that were converted to 
Category I for CY 2019. We inadvertently excluded these codes in the 
Addendum B file of the proposed rule, and have updated the Addendum B 
file for this final rule.
BILLING CODE 4120-01-P

[[Page 59585]]

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[[Page 59624]]



                                            Table 15--CY 2019 Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Estimated
                                                                                                                                                 non-
                                                                                                                                               facility
                                                                                                  Current    Updated    Percent   Number of    allowed
              CPT/HCPCS codes                        Item name                  CMS code           price      price      change    invoices    services
                                                                                                                                              for HCPCS
                                                                                                                                             codes using
                                                                                                                                              this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
53850.....................................  kit, transurethral          SA036                     1,149.00   1,000.00        -13          1        5,608
                                             microwave thermotherapy.
53852.....................................  kit, transurethral needle   SA037                     1,050.00     900.00        -14          2        2,476
                                             ablation (TUNA).
85097.....................................  stain, Wright's Pack (per   SL140                         0.05       0.16        235          1       43,183
                                             slide).
96116, 96118, 96119, 96125................  neurobehavioral status      SK050                         5.77       4.00        -31          3      414,139
                                             forms, average.
258 codes.................................  scope video system          ES031                    33,391.00  36,306.00          9  .........    2,480,515
                                             (monitor, processor,
                                             digital capture, cart,
                                             printer, LED light).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             Table 16--CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Number of      NF Allowed
             CPT/HCPCS codes                         Item name                       CMS code              Average price     invoices        services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10011, 10012.............................  MREYE Chiba Biopsy Needle...  SC106                                     37.00               1               0
33285....................................  subcutaneous cardiac rhythm   SA127                                  5,032.50               4             280
                                            monitor system.
36572, 36573, 36584......................  Turbo-Ject PICC Line........  SD331                                    170.00               1          24,402
53854....................................  kit, Rezum delivery device..  SA128                                  1,150.00               1             121
53854....................................  generator, water              EQ389                                 27,538.00              10             121
                                            thermotherapy procedure.
58100....................................  Uterine Sound...............  SD329                                      3.17               1          59,152
58100....................................  Tenaculum...................  SD330                                      3.77               1          59,152
76391....................................  MR Elastography Package.....  EL050                                200,684.50               1             350
76978, 76979.............................  bubble contrast.............  SD332                                    126.59               1              89
76978, 76979.............................  Ultrasound Contrast Imaging   ER108                                  5,760.00               1              89
                                            Package.
76981, 76982, 76983......................  sheer wave elastography       ED060                                  9,600.00               1             493
                                            software.
77048, 77049.............................  CAD Software................  ED058                                 43,308.12               1          36,675
77046, 77047, 77048, 77049...............  Breast coil.................  EQ388                                 83,200.00               1          39,785
77048, 77049.............................  CAD Workstation (CPU + Color  ED056                                 12,031.52               1          36,675
                                            Monitor).
85097....................................  slide stainer, automated,     EP121                                  8,649.43               1          34,559
                                            hematology.
92273....................................  Sleep mask..................  SK133                                      9.95               1          10,266
92273, 92274.............................  mfERG and ffERG               EQ390                                102,400.00               1          25,602
                                            electrodiagnostic unit.
92273, 92274.............................  Contact lens electrode for    EQ391                                  1,440.00               1          25,602
                                            mfERG and ffERG.
96136, 96137, 96138, 96139...............  WAIS-IV Record Form.........  SK130                                      5.25               1         301,452
96136, 96137, 96138, 96139...............  WAIS-IV Response Booklet #1.  SK131                                      3.30               1         301,452
96136, 96137, 96138, 96139...............  WMS-IV Response Booklet #2..  SK132                                      2.00               1         301,452
96136, 96137, 96138, 96139...............  Wechsler Adult Intelligence   EQ387                                    971.30               1         301,452
                                            Scale--Fourth Edition (WAIS-
                                            IV) Kit (less forms).
99454....................................  heart failure patient         EQ392                                  1,000.00               1              58
                                            physiologic monitoring
                                            equipment package.
G0109....................................  20x30 inch self-stick easel   SK129                                      0.00               0          93,576
                                            pad, white, 30 sheets/pad.
none.....................................  needle holder, Mayo Hegar,    SC105                                      3.03               1               0
                                            6''.
--------------------------------------------------------------------------------------------------------------------------------------------------------


                   Table 17--CY 2019 No PE Refinements
------------------------------------------------------------------------
               HCPCS                             Description
------------------------------------------------------------------------
10004.............................  Fna bx w/o img gdn ea addl.
10006.............................  Fna bx w/us gdn ea addl.
10008.............................  Fna bx w/fluor gdn ea addl.
10010.............................  Fna bx w/ct gdn ea addl.
10011.............................  Fna bx w/mr gdn 1st les.
10012.............................  Fna bx w/mr gdn ea addl.
11103.............................  Tangntl bx skin ea sep/addl.
11105.............................  Punch bx skin ea sep/addl.
11107.............................  Incal bx skn ea sep/addl.
33274.............................  Tcat insj/rpl perm ldls pm.
33275.............................  Tcat rmvl perm ldls pm.
33285.............................  Insj subq car rhythm mntr.
33286.............................  Rmvl subq car rhythm mntr.
33289.............................  Tcat impl wrls p-art prs snr.
36568.............................  Insj picc <5 yr w/o imaging.
36569.............................  Insj picc 5 yr+ w/o imaging.
36572.............................  Insj picc rs&i <5 yr.
36573.............................  Insj picc rs&i 5 yr+.
36584.............................  Compl rplcmt picc rs&i.
38531.............................  Open bx/exc inguinofem nodes.
49422.............................  Remove tunneled ip cath.
50436.............................  Dilat xst trc ndurlgc px.
50437.............................  Dilat xst trc new access rcs.
53850.............................  Prostatic microwave thermotx.
53852.............................  Prostatic rf thermotx.
53854.............................  Trurl dstrj prst8 tiss rf wv.
57150.............................  Treat vagina infection.
57160.............................  Insert pessary/other device.
58110.............................  Bx done w/colposcopy add-on.
65205.............................  Remove foreign body from eye.
65210.............................  Remove foreign body from eye.
67500.............................  Inject/treat eye socket
67505.............................  Inject/treat eye socket.
67515.............................  Inject/treat eye socket.
74485.............................  Dilation urtr/urt rs&i.
76514.............................  Echo exam of eye thickness.

[[Page 59625]]

 
76942.............................  Echo guide for biopsy.
76981.............................  Use parenchyma.
76982.............................  Use 1st target lesion.
76983.............................  Use ea addl. target lesion.
77081.............................  Dxa bone density/peripheral.
93264.............................  Rem mntr wrls p-art prs snr.
93668.............................  Peripheral vascular rehab.
95800.............................  Slp stdy unattended.
95801.............................  Slp stdy unatnd w/anal.
95806.............................  Sleep study unatt&resp efft.
95836.............................  Ecog impltd brn npgt <30 d.
95970.............................  Alys npgt w/o prgrmg.
95976.............................  Alys smpl cn npgt prgrmg.
95977.............................  Alys cplx cn npgt prgrmg.
95983.............................  Alys brn npgt prgrmg 15 min.
95984.............................  Alys brn npgt prgrmg addl 15.
96105.............................  Assessment of aphasia.
96110.............................  Developmental screen w/score.
96112.............................  Devel tst phys/qhp 1st hr.
96113.............................  Devel tst phys/qhp ea addl.
96116.............................  Neurobehavioral status exam.
96121.............................  Nubhvl xm phy/qhp ea addl hr.
96125.............................  Cognitive test by hc pro.
96127.............................  Brief emotional/behav assmt.
96130.............................  Psycl tst eval phys/qhp 1st.
96131.............................  Psycl tst eval phys/qhp ea.
99453.............................  Rem mntr physiol param setup.
99457.............................  Rem physiol mntr 20 min mo.
99491.............................  Chrnc care mgmt svc 30 min.
G0166.............................  Extrnl counterpulse, per tx.
------------------------------------------------------------------------

I. Evaluation & Management (E/M) Visits

1. Background
a. E/M Visits Coding Structure
    Physicians and other practitioners 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. The CPT codes have three 
key components:
     History of Present Illness (History),
     Physical Examination (Exam) and
     Medical Decision Making (MDM).
    These codes are broadly referred to as E/M visit codes. There are 
three to five E/M visit code levels, depending on site of service and 
the extent of the three components of history, exam and MDM. For 
example, there are three to four levels of E/M visit codes in the 
inpatient hospital and nursing facility settings, based on a relatively 
narrow degree of complexity in those settings. In contrast, there are 
five levels of E/M visit codes in the office or other outpatient 
setting based on a broader range of complexity in those settings.
    Current PFS payment rates for E/M visit codes increase with the 
level of visit billed. As for all services under the PFS, the rates are 
based on the resources in terms of work (time and intensity), PE and 
malpractice expense required to furnish the typical case of the 
service. The current payment rates reflect typical service times for 
each code that are based on RUC recommendations.
    In total, E/M visits comprise approximately 40 percent of allowed 
charges for PFS services, and office/outpatient E/M visits comprise 
approximately 20 percent of allowed charges for PFS services. Within 
these percentages, there is significant variation among 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 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.
    Potential misvaluation of E/M codes is an issue that we have been 
carefully considering for several years. We have discussed at length in 
our recent PFS proposed and final rules that the E/M visit code set is 
outdated and needs to be revised and revalued (for example: 81 FR 46200 
and 76 FR 42793). We have noted that this code set represents a high 
proportion of PFS expenditures, but has not been recently revalued to 
account for significant changes in the disease burden of the Medicare 
patient population and changes in health care practice that are 
underway to meet the Medicare population's health care needs (81 FR 
46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M 
codes to the RUC for review as potentially misvalued (76 FR 42793). 
Many commenters to that rule were concerned about the possible 
inadequacies of the current E/M coding and documentation structure to 
address evolving chronic care management and to support primary care 
(76 FR 73060 through 73064). We did not finalize our proposal to refer 
the E/M codes for RUC review at that time. Instead, we stated that we 
would allow time for consideration of the findings of certain 
demonstrations and other initiatives to provide improved information 
for the valuation of chronic care management, primary care, and care 
transitions. We stated that we would also continue to consider the 
numerous policy alternatives that commenters offered, such as separate 
E/M codes for established visits for patients with chronic disease 
versus a post-surgical follow-up office visit.
    Many stakeholders continue to similarly express to us through 
letters, meetings, public comments in past rulemaking cycles, and other 
avenues, that the E/M code set is outdated and needs to be revised. For 
example, some stakeholders recommend an extensive research effort to 
revise and revalue E/M services, especially physician work inputs (CY 
2017 PFS final rule, 81 FR 80227-80228). In recent years, we have 
continued to consider the best ways to recognize the significant 
changes in health care practice, especially innovations in the active 
management and ongoing care of chronically ill patients, under the PFS. 
We have been engaged in an ongoing, incremental effort to identify gaps 
in appropriate coding and payment.
b. E/M Documentation Guidelines
    For 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. These 
guidelines are available on the CMS website.\3\ They 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 that 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 are the same. However, the 1995 and 1997 guidelines 
include extensive examples of clinical work that comprise different 
levels of medical decision-making and 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 18.
---------------------------------------------------------------------------

    \3\ 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.
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 59626]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.287

BILLING CODE 4120-01-C
    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. L. 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 2017 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Public Law 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.B states, ``Instruct 
physicians to select the code for the service based 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

[[Page 59627]]

to justify the selection of the specific code if time is the basis for 
selection of the code.''
    Both the 1995 and 1997 E/M guidelines contain guidelines that 
address time, which state 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.'' \4\
---------------------------------------------------------------------------

    \4\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997 
guidelines.
---------------------------------------------------------------------------

    We note that other manual provisions regarding E/M visits that are 
cited in this final rule are housed separately within Medicare's 
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.
    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. The Medicare Claims 
Processing Manual 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'' (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter 
12, Section 30.6.1.A., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    Stakeholders have long maintained that all of the E/M documentation 
guidelines are administratively burdensome and outdated with respect to 
the practice of medicine. Stakeholders have provided CMS with examples 
of such outdated material (on history, exam and MDM) that can be found 
within all versions of the E/M guidelines (the AMA's CPT codebook, the 
1995 guidelines and the 1997 guidelines). Stakeholders have told CMS 
that they believe the guidelines are too complex, ambiguous, fail to 
meaningfully distinguish differences among code levels, and are not 
updated for changes in technology, especially electronic health record 
(EHR) use. Prior attempts to revise the E/M guidelines were 
unsuccessful or resulted in additional complexity due to lack of 
stakeholder consensus (with widely varying views among specialties), 
and differing perspectives on whether code revaluation would be 
necessary under the PFS as a result of revising the guidelines, which 
contributed another layer of complexity to the considerations. For 
example, an early attempt to revise the guidelines resulted in an 
additional version designed for use by certain specialties (the 1997 
version), and in CMS allowing the use of either the 1995 or 1997 
versions for purposes of documentation and billing to Medicare. Another 
complication in revising the guidelines is that they are also used by 
many other payers, which have their own payment rules and audit 
protocols. Moreover, stakeholders have suggested that there is 
sometimes variation in how Medicare's own contractors (Medicare 
Administrative Contractors (MACs)) interpret and apply the guidelines 
as part of their audit processes.
    As previously mentioned, in recent years, some clinicians and other 
stakeholders have requested a major CMS research initiative to overhaul 
not only the E/M documentation guidelines, but also the underlying 
coding structure and valuation. Stakeholders have reported to CMS that 
they believe the E/M visit codes themselves need substantial updating 
and revaluation to reflect changes in the practice of medicine, and 
that revising the documentation guidelines without addressing the codes 
themselves simply preserves an antiquated framework for payment of E/M 
services.
    Last year, CMS sought public comment on potential changes to the E/
M documentation rules, deferring making any changes to E/M coding 
itself in order to immediately focus on revision of the E/M guidelines 
to reduce unnecessary administrative burden (82 FR 34078 through 
34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we 
summarized the public comments we received and stated that we would 
take that feedback into consideration for future rulemaking. In 
response to commenters' request that we provide additional venues for 
stakeholder input, we held a listening session this year on March 18, 
2018 (transcript and materials are available on the CMS website at 
https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-and-Burden-Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We 
also sought input by participating in several listening sessions 
recently hosted by the Office of the National Coordinator for Health 
Information Technology (ONC) in the course of implementing section 
4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision 
requires the Department of Health and Human Services to establish a 
goal, develop a strategy, and make recommendations to reduce regulatory 
or administrative burdens relating to the use of EHRs. The ONC 
listening sessions sought public input on the E/M guidelines as one 
part of broader, related and unrelated burdens associated with EHRs.
    Several themes emerged from this recent stakeholder input. 
Stakeholders commended CMS for undertaking efforts to revise the E/M 
guidelines and recommended a multi-year process. Many commenters 
advised CMS to obtain further input across specialties. They 
recommended town halls, open door forums or a task force that would 
come up with replacement guidelines that would work for all specialties 
over the course of several years. They urged CMS to proceed cautiously 
given the magnitude of the undertaking; past failed reform attempts by 
the AMA, CMS, and other payers; and the wide-ranging impact of any 
changes (for example, how other payers approach the issue).
    We received substantially different recommendations by specialty. 
Based on this feedback, it is clear that any changes would have 
meaningful specialty-specific impacts, both clinical and financial. 
Based on this feedback, it also seems that the history and exam 
portions of the guidelines are most significantly outdated with respect 
to current clinical practice.
    A few stakeholders seemed to indicate that the documentation 
guidelines on history and exam should be kept in their current form. 
Many stakeholders believed they should be simplified or reduced, but 
not eliminated. Some stakeholders indicated that the documentation 
guidelines on history and exam could be eliminated altogether, and/or 
that documentation of these parts of an E/M visit could be left

[[Page 59628]]

to practitioner discretion. We also heard from stakeholders that the 
degree to which an extended history and exam enables a given 
practitioner to reach a certain level of coding (and payment) varies 
according to their specialty. Many commenters advised CMS to increase 
reliance on medical decision-making (MDM) and time in determining the 
appropriate level of E/M visit, or to use MDM by itself, but many of 
these commenters noted that the MDM portions of the guidelines would 
need to be altered before being used alone. Commenters were divided on 
the role of time in distinguishing among E/M visit levels, and 
expressed some concern about potential abuse or inequities among more- 
or less-efficient practitioners. Some commenters expressed support for 
simplifying E/M coding generally into three levels such as low, medium 
and high, and potentially distinguishing those levels on the basis of 
time.
2. CY 2019 Final Policies
a. Overview
    Having considered the public feedback to the CY 2018 PFS proposed 
rule (82 FR 53163 through 53166) and our other outreach efforts 
described above, in our CY 2019 proposed rule, we proposed several 
changes to E/M visit documentation and payment. We proposed that the 
changes would only apply to office/outpatient visit codes (CPT codes 
99201 through 99215), except where we specify otherwise. We agreed with 
commenters that we should take a step-wise approach to these issues, 
and therefore, we limited proposed changes to the office/outpatient E/M 
code set. We understood from commenters that there are more unique 
issues to consider for the E/M code sets used in other settings such as 
inpatient hospital or emergency department care, such as unique 
clinical and legal issues and the potential intersection with hospital 
Conditions of Participation (CoPs). We may consider expanding our 
efforts more broadly to address sections of the E/M code set beyond the 
office/outpatient codes in future years.
    We emphasized that, this year, we included our proposed E/M 
documentation changes in a proposed rule due to the longstanding nature 
of our instruction that practitioners may use either the 1995 or 1997 
versions of the E/M guidelines to document E/M visits billed to 
Medicare, the magnitude of the proposed changes, and the associated 
payment policy proposals that require notice and comment rulemaking. We 
believed our proposed documentation changes for E/M visits were 
intrinsically related to our proposal to alter PFS payment for E/M 
visits, and the PFS payment proposal for E/M visits required notice and 
comment rulemaking. We noted that we were proposing a relatively broad 
outline of changes, and anticipated that many details related to 
program integrity and ongoing refinement would need to be developed 
over time through subregulatory guidance. This would afford flexibility 
and enable us to more nimbly and quickly make ongoing clarifications, 
changes and refinements in response to continued practitioner 
experience moving forward.
    We put forth a key proposal that, at its core, strived to reduce 
the significant burden associated with documentation for payment 
purposes by eliminating the payment rules associated with the current 
primary means of varying payment among office/outpatient visits. 
Specifically, we proposed to develop single payment rates for the 
office/outpatient E/M visit levels 2 through 5 (one rate for 
established patients, and one rate for new patients), in order to 
mitigate the need for physicians and other practitioners to adhere to 
complex payment-specific documentation rules for each and every visit 
furnished to a Medicare beneficiary. If there were minimal payment 
variation based on the level of visit billed, then there would be 
minimal need to engage with the burdensome and outdated documentation 
guidelines and E/M visit coding to justify that the appropriate level 
visit was reported. Though we acknowledged a continued need to document 
information in the medical record for clinical and other purposes, our 
understanding based on extensive feedback from medical professionals 
was that the documentation specific to justifying the visit level 
reported to payers, including Medicare, was unduly and 
disproportionately burdensome among the many administrative burdens in 
current medical practice. To avoid the administrative burden and 
disruption of establishing a new G code to describe the level 2 through 
5 combined visit, under our proposal practitioners would continue to 
report on the claim the CPT code associated with the level of visit the 
practitioner believed they furnished.
    Along with eliminating payment variation for office/outpatient E/M 
visit levels 2 through 5, we proposed a series of corollary policies 
intended to vary payment for these visits based on a more meaningful 
set of attributes for visits. Our goal was that these payment 
variations, accomplished through new add-on and other coding changes, 
and multiple procedure payment reductions, would reflect the relative 
resource costs of furnishing E/M visits without requiring detailed 
documentation for purposes of justifying particular payment rates. We 
also expected these adjustments to offset some of the more significant 
potentially redistributive impacts of this proposal, especially among 
physicians and practitioners of different specialties. The potential 
redistributive impacts helped us to determine potential, initial values 
for the proposed add-on codes providing for the adjustments. Again, 
these proposals were intended to provide a more meaningful avenue for 
payment variation that would ease the documentation burdens currently 
faced by clinicians to justify the visit level that is reported for 
each and every visit with a beneficiary. These proposals reflected our 
longstanding beliefs that: There are certain complexities inherent in 
furnishing some kinds of E/M visits that are not currently accounted 
for in valuations for the current E/M code set, there are unaccounted-
for efficiencies when E/M visits are billed on the same day as global 
procedure codes that are already valued to include resources associated 
with E/M services, and the current E/M coding system does not fully 
account for the variety of legitimate circumstances when the needs of 
individual patients require more time with their physicians. We also 
proposed to establish unique E/M visit codes for podiatric care and 
make changes to the PE methodology in order to standardize the amount 
of PE RVUs allocated for this series of codes, regardless of which 
specialties were assumed to bill them.
    In conjunction with our proposal to effectively eliminate the 
variation in payment of choosing from among E/M visit levels 2 through 
5 for office/outpatient visits, we proposed a minimum level of 
associated documentation that would apply for payment purposes across 
all level 2 through 5 office/outpatient E/M visits. We also proposed to 
allow practitioners a choice regarding the basis for their 
documentation for these visits: Current documentation guidelines 
(history, exam and MDM); MDM alone; or time alone. We proposed that, 
when using current documentation guidelines or MDM, the current 
guidelines for level 2 visits would apply. When using time to document 
a visit, the practitioner would be required to demonstrate the medical 
necessity of the visit and report the total amount of face-to-face time 
they spent with the beneficiary. We solicited public comment on what 
the total time

[[Page 59629]]

requirement should be when using time to document a level 2 through 5 
visit. We presented several alternatives for determining the amount of 
time associated with each visit level: The new intra-service times 
associated with setting the payment rate for the visit codes, the 
midpoint of these new times, or the typical time for the CPT code 
reported on the claim (the time listed in the AMA/CPT codebook for that 
code) (83 FR 35837).
    We sought feedback in particular on the option to document using 
time when prolonged E/M services are billed. We proposed that when a 
practitioner uses time to document the visit and also reports prolonged 
E/M services, we would require the practitioner to document that the 
typical time required for the base or ``companion'' visit is exceeded 
by the amount required to report prolonged services (83 FR 35837). We 
did not propose any changes to CPT codes 99354 and 99355, and under our 
proposal these codes could still be billed, as needed, when their time 
thresholds and all other requirements are met (83 FR 35774).
    Since we proposed to create a single payment rate under the PFS 
that would be paid for services billed using the current CPT codes for 
level 2 through 5 visits, it would not be material to Medicare's 
payment decision which CPT code (of levels 2 through 5) would be 
reported on the claim, except to justify billing a level 2 or higher 
visit in comparison to a level 1 visit (providing the visit itself was 
reasonable and necessary) and when using certain potential approaches 
to documenting the visit using time (83 FR 35836 through 35837). 
However, we expected that for record keeping purposes or to meet 
requirements of other payers, practitioners would continue to choose 
and report the level of E/M visit they believed to be appropriate under 
the current CPT coding structure.
    We also proposed to remove an existing manual provision for home 
visits requiring documentation in the patient's medical record of the 
medical necessity of furnishing the visit in the home. For all office/
outpatient E/M visits, we also proposed several simplifications 
centered on reducing the need for duplicative, redundant data entry in 
the medical record.
    Several thousand commenters responded to this series of proposals. 
Generally, the commenters stated appreciation for CMS' goal of reducing 
administrative burden and reforming E/M coding and payment, but 
expressed concern about many impacts of the proposals. Commenters 
largely objected to our proposal to eliminate payment differences for 
office/outpatient E/M visit levels 2 through 5 based on the level of 
visit complexity. Many commenters stated that they would experience 
payment cuts relative to the current payment structure. Commenters 
generally stated that the implementation timeframe for the changes as 
proposed was too aggressive, especially since stakeholders were 
uncertain as to whether other payers would follow Medicare's proposed 
policies. Many commenters suggested that CMS could implement the 
proposed documentation reduction without the coding/payment policies, 
or that these policies could be adopted on separate timeframes.
    Many commenters suggested that the proposals did not specify the 
circumstances in which the proposed add-on codes for office/outpatient 
E/M visits could be used, and what documentation requirements might be 
adopted for them. Many commenters stated that it would be better if the 
physician community could consider a range of alternative coding and 
payment options to be modeled and thoroughly evaluated over several 
years instead of a single alternative during a 60-day public comment 
period.
    Many commenters opposed our proposal to establish that clinicians 
billing an office/outpatient E/M visit level 2 through 5 need only 
document medical necessity as specified for a level 2 visit (unless 
time is used as the basis for the visit level). Some commenters 
supported allowing a choice of documentation methodologies, while 
others opposed it. The vast majority of commenters did not support 
having only a single