[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Proposed Rules]
[Pages 35704-36368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14985]



[[Page 35703]]

Vol. 83

Friday,

No. 145

July 27, 2018

Part II

Book 2 of 2 Books

Pages 35703-36398





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; and Medicaid 
Promoting Interoperability Program; Proposed Rules

Federal Register / Vol. 83 , No. 145 / Friday, July 27, 2018 / 
Proposed Rules

[[Page 35704]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-1693-P]
RIN 0938-AT31


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; 
and Medicaid Promoting Interoperability Program

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

ACTION: Proposed rule.

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SUMMARY: This major proposed 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.

DATES: Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on September 10, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1693-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1693-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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.
    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, or Donta Henson, (410) 786-1947, 
for issues related to geographic price cost indices (GPCIs).
    Geri Mondowney, (410) 786-1172, or 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.
    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.
    David Koppel, (214) 767-4403, for issues related to Medicaid 
Promoting Interoperability Program.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
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).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Provisions of the Proposed 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
    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. Solicitation of Public Comments on the Low Expenditure 
Threshold Component of the Applicable Laboratory Definition Under 
the Medicare Clinical Laboratory Fee Schedule (CLFS)
    L. GPCI Comment Solicitation
    M. Therapy Services
    N. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
III. Other Provisions of the Proposed Rule
    A. Clinical Laboratory Fee Schedule
    B. Proposed 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 (EPs)
    F. Medicare Shared Savings Program Quality Measures
    G. Physician Self-Referral Law
    H. CY 2019 Updates to the Quality Payment Program
IV. Requests for Information
    A. 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
    B. Request for Information on Price Transparency: Improving 
Beneficiary Access to Provider and Supplier Charge Information
V. Collection of Information Requirements
VI. Response to Comments
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Proposed 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 proposed rule are available on the CMS website at 
http://www.cms.gov/Medicare/Medicare-Fee-

[[Page 35705]]

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 
Proposed Rule, refer to item CMS-1693-P. Readers with questions related 
to accessing any of the Addenda or other supporting documents 
referenced in this proposed rule and posted on the CMS website 
identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2017 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and make other policy changes, including proposals to 
implement certain provisions of the Bipartisan Budget Act of 2018 (Pub. 
L. 115-123, enacted on February 9, 2018), related to Medicare Part B 
payment, applicable to services furnished in CY 2019. In addition, this 
proposed rule includes proposals related to payment policy changes that 
are addressed in section III. of this proposed rule. We are requesting 
public comments on all of the proposals being made in this proposed 
rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas. In this major 
proposed rule, we are proposing to establish RVUs for CY 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 
proposed rule includes discussions and proposals regarding:
     Potentially Misvalued Codes.
     Communication Technology-Based Services.
     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.
     E/M Visits.
     Therapy Services.
     Clinical Laboratory Fee Schedule.
     Ambulance Fee Schedule--Provisions in the Bipartisan 
Budget Act of 2018.
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     Medicaid Promoting Interoperability Program Requirements 
for Eligible Professionals (EPs).
     Medicare Shared Savings Program Quality Measures.
     Physician Self-Referral Law.
     CY 2019 Updates to the Quality Payment Program.
     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.
     Request for Information on Price Transparency: Improving 
Beneficiary Access to Provider and Supplier Charge Information.
2. Summary of Costs and Benefits
    We have determined that this major proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII. of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, practice expense (PE), and malpractice (MP), which are adjusted 
for geographic cost variations. These values are multiplied by a 
conversion factor (CF) to convert the relative value units (RVUs) into 
payment rates. The concepts and methodology underlying the PFS were 
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. 
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus 
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 
5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 
FR 59502) set forth the first fee schedule used for payment for 
physicians' services.
    We note that throughout this major proposed rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for the services they furnish to Medicare 
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other

[[Page 35706]]

public commenters, and the rationale for their recommendations. In the 
CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), 
we discussed a variety of methodologies and approaches used to develop 
work RVUs, including survey data, building blocks, crosswalk to key 
reference or similar codes, and magnitude estimation. More information 
on these issues is available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and 
required us to develop resource-based PE RVUs for each physicians' 
service beginning in 1998. We were required to consider general 
categories of expenses (such as office rent and wages of personnel, but 
excluding MP expenses) comprising PEs. The PE RVUs continue to 
represent the portion of these resources involved in furnishing PFS 
services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA provided for a 4-year transition period from 
the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some costs are borne by the facility. 
Medicare's payment to the facility (such as the outpatient prospective 
payment system (OPPS) payment to the HOPD) would reflect costs 
typically incurred by the facility. Thus, payment associated with those 
facility resources is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and published in the Federal 
Register (65 FR 65376) as part of a November 1, 2000 final rule. The 
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 
and 68 FR 63196) extended the period during which we would accept these 
supplemental data through March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA amended section 1848(c) of the Act to 
require that we implement resource-based MP RVUs for services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' MP insurance premium data from all the states, the District 
of Columbia, and Puerto Rico. For more information on MP RVUs, see 
section II.C. of this proposed rule.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently. We completed 5-year 
reviews of work RVUs that were effective for calendar years 1997, 2002, 
2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC identified and reviewed a number of potentially misvalued codes 
on an annual basis based on various identification screens. This annual 
review of work and PE RVUs for potentially misvalued codes was 
supplemented by the amendments to section 1848 of the Act, as enacted 
by section 3134 of the Affordable Care Act, that require the agency to 
periodically identify, review and adjust values for potentially 
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
    As described in section VII. of this proposed rule, in accordance 
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs 
cause expenditures for the year to change by more than $20 million, we 
make adjustments to ensure that expenditures do not increase or 
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each

[[Page 35707]]

component. Please refer to the CY 2017 PFS final rule with comment 
period for a discussion of the last GPCI update (81 FR 80261 through 
80270).
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS's Office of 
the Actuary (OACT). The formula for calculating the Medicare PFS 
payment amount for a given service and fee schedule area can be 
expressed as:

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

B. Determination of 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).
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 Proposed Rule PE/HR'' on the 
CMS website under downloads for the CY

[[Page 35708]]

2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    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 are proposing to use proxy 
PE/HR values for these new specialties, as there are no PPIS data for 
these specialties, by crosswalking the PE/HR as follows from 
specialties that furnish similar services in the Medicare claims data:
     Hospitalists from Emergency Medicine.
     Advanced Heart Failure and Transplant Cardiology from 
Cardiology.
    The proposal is reflected in the ``CY 2019 PFS Proposed Rule PE/
HR'' file available on the CMS website under the supporting data files 
for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs to 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 proposed 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.
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: A 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a global service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum of the payment for the TC and PC. To achieve 
this, we use a weighted average of the ratio of indirect to direct 
costs across all the specialties that furnish the global service, TCs, 
and PCs; that is, we apply the same weighted average indirect 
percentage factor to allocate indirect expenses to the global service, 
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum 
to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct readers to the file called ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.

[[Page 35709]]

    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 proposed 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 
proposal 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 proposal to apply these service-level 
overrides for both PE and MP, rather than one or the other category.
    For CY 2019, we are proposing to add 28 additional codes that we 
have 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 are proposing 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 are proposing to add is displayed in Table 1.

                    Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
                                                                                                       2017
           CPT code                Mod           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 obstruction  Gastroenterology.......              10
74301........................          26  X-rays at surgery add-on....  Diagnostic Radiology...              73
74355........................          26  X-ray guide intestinal tube.  Diagnostic Radiology...              11
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/leg.  Diagnostic Radiology...              41
75805........................          26  Lymph vessel x-ray trunk....  Diagnostic Radiology...              50
75810........................          26  Vein x-ray spleen/liver.....  Diagnostic Radiology...              46
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 assay.  Pathology..............              24
87164........................          26  Dark field examination......  Pathology..............              30
88371........................          26  Protein western blot tissue.  Pathology..............               2
93532........................          26  R & l heart cath congenital.  Cardiology.............              28
93533........................          26  R & l heart cath congenital.  Cardiology.............              36
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
----------------------------------------------------------------------------------------------------------------


[[Page 35710]]

    The complete list of expected specialty assignments for individual 
low volume services, including the proposed assignments for the codes 
identified in Table 1, is available on our website under downloads for 
the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE 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.

[[Page 35711]]



       Table 2--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
        Specialty code                   Specialty description
------------------------------------------------------------------------
49...........................  Ambulatory surgical center.
50...........................  Nurse practitioner.
51...........................  Medical supply company with certified
                                orthotist.
52...........................  Medical supply company with certified
                                prosthetist.
53...........................  Medical supply company with certified
                                prosthetist[dash]orthotist.
54...........................  Medical supply company not included in
                                51, 52, or 53.
55...........................  Individual certified orthotist.
56...........................  Individual certified prosthetist.
57...........................  Individual certified
                                prosthetist[dash]orthotist.
58...........................  Medical supply company with registered
                                pharmacist.
59...........................  Ambulance service supplier, e.g., private
                                ambulance companies, funeral homes, etc.
60...........................  Public health or welfare agencies.
61...........................  Voluntary health or charitable agencies.
73...........................  Mass immunization roster biller.
74...........................  Radiation therapy centers.
87...........................  All other suppliers (e.g., drug and
                                department stores).
88...........................  Unknown supplier/provider specialty.
89...........................  Certified clinical nurse specialist.
96...........................  Optician.
97...........................  Physician assistant.
A0...........................  Hospital.
A1...........................  SNF.
A2...........................  Intermediate care nursing facility.
A3...........................  Nursing facility, other.
A4...........................  HHA.
A5...........................  Pharmacy.
A6...........................  Medical supply company with respiratory
                                therapist.
A7...........................  Department store.
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 only  Preoperative +            Preoperative +
                                                                Intraoperative            Intraoperative
                                                                Percentages on the        portion.
                                                                payment files used by
                                                                Medicare contractors to
                                                                process Medicare claims.
55.................................  Postoperative Care only.  Postoperative Percentage  Postoperative portion.
                                                                on the payment files
                                                                used by Medicare
                                                                contractors to process
                                                                Medicare claims.

[[Page 35712]]

 
62.................................  Co-surgeons.............  62.5%...................  50%.
66.................................  Team Surgeons...........  33%.....................  33%.
----------------------------------------------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
proposed rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

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

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

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that illustrates an alternative rate.
    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 
maintenance factor, we do not believe that we have sufficient 
information at present to propose a variable maintenance factor for 
equipment cost per minute pricing. We continue to investigate potential 
avenues for determining equipment maintenance costs across a broad 
range of equipment items.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
are not proposing any changes to these interest rates for CY 2019. The 
interest rates are listed in Table 4.

                   Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                                Interest
                Price                       Useful life         rate (%)
------------------------------------------------------------------------
<$25K...............................  <7 Years...............       7.50
$25K to $50K........................  <7 Years...............       6.50
>$50K...............................  <7 Years...............       5.50
<$25K...............................  7+ Years...............       8.00
$25K to $50K........................  7+ Years...............       7.00
>$50K...............................  7+ Years...............       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 
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database instead of only including 
the number of clinical labor minutes for the preservice, service, and 
postservice periods for each code. In addition to increasing the 
transparency of the information used to set PE RVUs, this level of 
detail would allow us to compare clinical labor times for activities 
associated with services across the PFS, which we believe is important 
to maintaining the relativity of the direct PE inputs. This information 
would facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of

[[Page 35713]]

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 proposal 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 proposal 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 proposed 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 are proposing 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 
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.
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

[[Page 35714]]

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 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. But, 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 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 are proposing 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,

[[Page 35715]]

we are proposing 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 are also proposing to 
update the name of the ES031 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.
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.
    We appreciate the information supplied by the stakeholders 
regarding the use of the balloon sinus surgery kit. When CPT codes 
31295-31297 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 are soliciting comments on two aspects of the use of 
the balloon sinus surgery kit (SA106) supply. First, we are soliciting 
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 are 
soliciting 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,       ..............  kit...............................        $2599.86
 frontal, 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
----------------------------------------------------------------------------------------------------------------

    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.
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 are proposing to correct these inconsistencies 
as described in this proposed rule and reflected in the CY 2019 
proposed direct PE input database displayed on the CMS website under 
downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2019, we are proposing 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

[[Page 35716]]

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 are proposing 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      nonfacility     nonfacility
                            CPT code                              post-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
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

[[Page 35717]]

 
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
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

[[Page 35718]]

 
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
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 are proposing to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits 
included in these codes. We are not proposing any supply pack quantity 
refinements for CPT codes 11100, 95974, or 95978 since they are being 
deleted for CY 2019. We are also not proposing 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.
     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 
propose to revise the direct PE inputs to reflect the ones previously 
finalized through rulemaking 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 are proposing 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 are also proposing 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.
     We received a letter from a stakeholder alerting us to an 
anomaly in

[[Page 35719]]

the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate 
procedure)). The stakeholder 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 
stakeholder requested that this essential 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 agree with 
the stakeholder and we are proposing 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.
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 are proposing the following price updates for existing direct PE 
inputs.
    We are proposing 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 are proposing 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 proposed rule Table 16: 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) 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 the 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 proposed 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 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.
    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

[[Page 35720]]

RVU reduction for codes that are not new or revised to 19 percent in 
any individual calendar year.
    After reviewing the StrategyGen report, we are proposing to adopt 
the updated direct PE input prices for supplies and equipment as 
recommended by StrategyGen. 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 are proposing 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 are proposing 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 are 
proposing 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 are proposing 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 are 
also proposing 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 are 
proposing to implement the established invoice price as the updated 
price and to phase in the new price over the remaining years of the 
proposed 4-year pricing transition. During the proposed transition 
period, where price changes for supplies and equipment are adopted 
without a formal review of the HCPCS codes that include them (as is the 
case for the many updated prices we are proposing 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 are also 
proposing to phase in any updated pricing we establish during 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 is 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 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. We welcome 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration. We are 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 as it is 
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

[[Page 35721]]

under downloads for the CY 2019 PFS proposed 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 seek 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.
(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 the CY 2014 PFS rule, 
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 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 77X51 (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 77X52 (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 are not proposing 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 77X51 and 77X52 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.
(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 note 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 
this proposed rule, and would consider any invoices received after 
February 10 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 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 are proposing to continue with the second 
year of the transition of this adjustment to the standard process for 
allocating indirect PE.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that 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

[[Page 35722]]

PFS final rule with comment period, we implemented the third review and 
update of MP RVUs. For a comprehensive discussion of the third review 
and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 
through 40355) and final rule with comment period (79 FR 67591 through 
67596).
    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 incurred by 
practitioners; (2) service level risk factors derived from Medicare 
claims data of the weighted average risk factors of the specialties 
that furnish each service; and (3) an intensity/complexity of service 
adjustment to the service level risk factor based on either the higher 
of the work RVU or clinical labor 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, 
and we are seeking additional comment regarding the next MP RVU update 
which must occur by CY 2020. Specifically, we are seeking 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.

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, CMS has also established several PFS policies to 
explicitly pay for non-face-to-face services included as part of 
ongoing care management.
    While 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 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) 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, we sought 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

[[Page 35723]]

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 recognize 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 are aiming 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 have several proposals for 
modernizing Medicare physician payment for communication technology-
based services, described below. These services would 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 would be paid under the PFS 
like other physicians' services. Additionally, we note that in 
furnishing these proposed services, practitioners would 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 GVCI1)
    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 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 are proposing to pay separately, beginning January 1, 
2019, for a newly defined type of physicians' service furnished using 
communication technology. 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 kinds 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 are seeking 
comment on what types of communication technology are utilized by 
physicians or other qualified health care professionals in furnishing 
these

[[Page 35724]]

services, including whether audio-only telephone interactions are 
sufficient compared to interactions that are enhanced with video or 
other kinds of data transmission.
    The proposed code would be described as GVCI1 (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 further propose 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 
propose that in instances when the brief communication technology-based 
service leads to an E/M in-person 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 
note that this service could be used as part of a treatment regimen for 
opioid use disorders and other substance use disorders, since there are 
several components of Medication Assisted Therapy (MAT) that could be 
done virtually, or to assess whether the patient's condition requires 
an office visit.
    We propose pricing this distinct service at a rate lower than 
existing 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 would 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, and we are 
specifically seeking comment on whether we should require, for example, 
verbal consent that would be noted in the medical record for each 
service. We are also proposing 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. We are not proposing 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 are seeking 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. 
We are also seeking 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 are seeking 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 note that these services, like any other 
physicians' service, would need to be medically reasonable and 
necessary in order to be paid by Medicare. We are seeking 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. For 
details related to developing utilization estimates for these services, 
see section VII. Regulatory Impact Analysis, of this proposed rule. For 
additional details related to valuation of these services, see section 
II.H. Valuation of Specific Codes, of this proposed rule. We are 
seeking comment on our proposed definition and valuation of this code.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code 
GRAS1)
    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 note 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. Under section 1834(m) of 
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. Much like the virtual check-in 
described above, these services are not meant to substitute for an in-
person service currently separately payable under the PFS, and 
therefore, are distinct from the telehealth services described under 
section 1834(m) of the Act. Effective January 1, 2019, we are proposing 
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. These 
services would not be subject to the Medicare telehealth restrictions 
in section 1834(m) of the Act, and the valuation would reflect the 
resource costs associated with furnishing services utilizing 
communication technology.
    Much like the brief communication technology-based services 
discussed above, these services may be used to determine whether or not 
an office visit or other service is warranted. 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 
propose that this remote service would be considered bundled into that 
office visit and therefore would not be separately billable. We further 
propose

[[Page 35725]]

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 would be 
considered bundled into that previous E/M service and also would not be 
separately billable. In summary, we propose 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. 
The proposed 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. The proposed code for this service 
would be described as GRAS1 (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 are 
seeking 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 note that this 
service is distinct from the brief communication technology-based 
service described above in that this service involves the 
practitioner's evaluation of a patient-generated still or video image, 
and the subsequent communication of the resulting response to the 
patient, while the brief communication technology-based service 
describes a service that occurs in real time and does not involve the 
transmission of any recorded image.
    For details related to developing utilization estimates for these 
services, see section VII. Regulatory Impact Analysis, of this proposed 
rule. For further discussion related to valuation of this service, 
please see the section II.H. Valuation of Specific Codes, of this 
proposed rule. We are seeking public comment on our proposed definition 
and valuation of the code.
3. Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 
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 make 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 994X0 (Interprofessional 
telephone/internet/electronic health record referral service(s) 
provided by a treating/requesting physician or qualified health care 
professional, 30 minutes) and 994X6 (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)

[[Page 35726]]

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 are 
proposing separate payment for these services, discussed in section 
II.H. Valuation of Specific Codes, of this proposed rule.
    While we are proposing 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 would 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 are therefore seeking 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 note 
that there are program integrity concerns around making separate 
payment for these interprofessional consultation services, including 
around CMS' or its contractors' ability to evaluate whether an 
interprofessional consultation is reasonable and necessary under the 
particular circumstances. We are seeking comment on how best to 
minimize potential program integrity issues, and are 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.
    Additionally, since these codes describe services that are 
furnished without the beneficiary being present, we are proposing 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. 
Obtaining advance consent includes ensuring that the patient is aware 
of applicable cost sharing. We welcome comments on this proposal.
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 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 below, 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 
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

[[Page 35727]]

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 
are proposing 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 would 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 are 
not proposing 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
     CPT code 990X0 (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 990X1 (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 994X9 (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 990X0, 990X1, and 994X9 describe 
services that are inherently non face-to-face. As discussed in section 
II.H. Valuation of Specific Codes, we instead are proposing to adopt 
CPT codes 990X0, 990X1, and 994X9 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 are not proposing to add them to the list of 
Medicare telehealth services.
(2) Interprofessional Internet Consultation: CPT Codes
     CPT code 994X0 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30 
minutes).
     CPT code 994X6 (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. Valuation of Specific Codes, we are 
proposing to adopt CPT codes 994X0 and 994X6 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 are not proposing to add them 
to the list of Medicare telehealth services for CY 2019.
(3) Initial Hospital Care Services: CPT Codes
     CPT code 99221 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care

[[Page 35728]]

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 do 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 do not propose adding initial hospital 
care services to the Medicare telehealth services list on a Category 2 
basis.
    We note 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 are not proposing to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services: CPT Codes
     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 asked that we remove the frequency limitation. We 
stated in the CY 2011 PFS final rule with comment period (75 FR 73316) 
that, while 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 are not proposing to remove the frequency 
limitation on these codes.
(5) Subsequent Nursing Facility Care Services: CPT Codes
     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

[[Page 35729]]

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 asked 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 are not proposing to remove the frequency 
limitation for subsequent nursing facility care services in CY 2019.
    In summary, we are proposing 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).
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. 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) 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 are 
proposing 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 propose 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 are proposing 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

[[Page 35730]]

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.
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 are proposing 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 are also proposing to revise Sec.  
410.78(b)(3) of our regulations to add mobile stroke unit as a 
permissible originating site for acute stroke telehealth services. We 
are proposing 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 are seeking comment on this definition, as well as 
additional information on how these units are used in current medical 
practice. We are therefore proposing 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 seek 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 are proposing 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.
6. 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 are proposing 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).
7. 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

[[Page 35731]]

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 above, we are considering whether it would be 
appropriate to develop a separate bundled payment for an episode of 
care for treatment of SUDs. We are seeking public comment on whether 
such a bundled episode-based payment would be beneficial to improve 
access, quality and efficiency for SUD treatment. Further, we are 
seeking 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 are seeking 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 are interested in stakeholder feedback regarding how to define 
and value this bundle and what conditions of payment should be 
attached. Additionally, we are seeking 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 seek 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 would 
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 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 welcome comments on potentially 
creating a bundled episode of care for management and counseling 
treatment for SUDs, which we will consider for future rulemaking.
    Additionally, we invite 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 
seek 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 are interested in suggestions to improve 
existing requirements in order to more effectively address the opioid 
epidemic.

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 proposed rule, 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 Physician 
Quality Reporting System (PQRS) databases. In addition to considering 
the most recently available data, we assess the results of physician 
surveys and specialty recommendations submitted to us by the RUC for 
our review. We also consider information provided by other 
stakeholders. We conduct a review to assess the appropriate RVUs in the 
context of contemporary medical practice. We note that section 
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available and requires us to take into 
account the results of consultations with organizations representing 
physicians who provide the services. In accordance with section 1848(c) 
of the Act, we determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/congressional-testimony/testimony-report-to-the-congress-medicare-payment-policy-march-2006-.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

[[Page 35732]]

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 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. The public and stakeholders may nominate potentially misvalued 
codes for review by submitting the code with supporting documentation 
by February 10 of each year. Supporting documentation for codes 
nominated for the annual review of potentially misvalued codes may 
include the following:

[[Page 35733]]

     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 PQRS databases).
     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 whether we proposed each nominated code 
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 their 
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 8 be prioritized for reviewed under the potentially 
misvalued code initiative.

            Table 8--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 commenter 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).
b. Update on the Global Surgery Data Collection
    CMS currently bundles payment for postoperative care 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, CMS 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 practices 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. (See Table 9.)

[[Page 35734]]



              Table 9--Share of Practitioners Who Reported Any CPT Code 99024 Claims, by Specialty
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                  Practitioner specialty                        Number of         reporting          Percent
                                                             practitioners *  practitioners **      reporting
----------------------------------------------------------------------------------------------------------------
ALL.......................................................            32,642            14,627                45
Family practice...........................................             3,912               707                18
Emergency medicine........................................             3,612               153                 4
Physician Assistant.......................................             2,751               758                28
Orthopedic surgery........................................             2,725             2,360                87
General surgery...........................................             2,317             1,879                81
Nurse Practitioner........................................             2,217               438                20
Internal medicine.........................................             1,476               161                11
Ophthalmology.............................................             1,319             1,069                81
Urology...................................................             1,186             1,014                85
Dermatology...............................................             1,025               698                68
Diagnostic radiology......................................               982                34                 3
Obstetrics/gynecology.....................................               966               612                63
Otolaryngology............................................               872               652                75
Podiatry..................................................               761               502                66
Neurosurgery..............................................               614               512                83
Cardiology................................................               574               307                53
Neurology.................................................               525                19                 4
Vascular surgery..........................................               405               342                84
Pathologic anatomy, clinical pathology....................               355               281                79
Thoracic surgery..........................................               320               270                84
Gastroenterology..........................................               315                 6                 2
Plastic and reconstructive surgery........................               303               250                83
Physical medicine and rehabilitation......................               275                63                23
Anesthesiology............................................               254                73                29
Optometry.................................................               247               158                64
Pain Management...........................................               247                98                40
Colorectal surgery........................................               225               189                84
Hand surgery..............................................               214               193                90
Interventional radiology..................................               201                19                 9
Interventional Cardiology.................................               195               114                58
Cardiac surgery...........................................               176               148                84
Interventional Pain Management............................               165                55                33
Surgical oncology.........................................               154               141                92
Gynecologist/oncologist...................................               143               121                85
General practice..........................................               115                37                32
Peripheral vascular disease, medical or surgical..........               106                84                79
Nephrology................................................                74                 9                12
Critical care.............................................                54                34                63
Pediatric medicine........................................                39                 4                10
Infectious disease........................................                34                 3                 9
Maxillofacial surgery.....................................                25                18                72
Oral surgery..............................................                20                11                55
Osteopathic manipulative therapy..........................                18                 6                33
Hematology/oncology.......................................                16                 5                31
Geriatric medicine........................................                15                 2                13
Certified clinical nurse specialist.......................                12                 1                 8
Unknown physician specialty...............................                12                 9                75
----------------------------------------------------------------------------------------------------------------
* Limited to practitioners who performed at least one of the 293 relevant global procedures and were affiliated
  with a tax identification number with 10 or more practitioners.
** Practitioners who submitted one or more CPT code 99024 claims between July 1st, 2017 and December 31st, 2017.

    The share of practitioners who reported CPT code 99024 on any 
claims also varied by state as shown in Table 10.

Table 10--Share of Practitioners Who Reported Any CPT Code 99024 Claims,
                                by State
------------------------------------------------------------------------
                                                          Percentage of
                         State                           practitioners *
                                                          reporting **
------------------------------------------------------------------------
ALL...................................................                45
North Dakota..........................................                56
Ohio..................................................                49
Rhode Island..........................................                49
Florida...............................................                48
New Jersey............................................                43
Louisiana.............................................                42
Kentucky..............................................                41
Oregon................................................                35
Nevada................................................                30
------------------------------------------------------------------------
* Limited to practitioners who performed at least one of the 293
  relevant global procedures and were affiliated with a tax
  identification number with 10 or more practitioners.

[[Page 35735]]

 
** Practitioners who submitted one or more CPT code 99024 claims between
  July 1st, 2017 and December 31st, 2017.

    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. (See Table 11.)

                        Table 11--Share of Procedures With Matched Post-Operative Visits
----------------------------------------------------------------------------------------------------------------
                                                                              Number of 10-day  Percentage of 10-
                                                                                   global          day global
                                                            Number of 10-day   procedures with   procedures with
                    Provider specialty                           global           1 or more         1 or more
                                                              procedures *      matched 99024     matched 99024
                                                                                  claims **         claims **
----------------------------------------------------------------------------------------------------------------
ALL.......................................................           436,063            16,802                 4
Dermatology...............................................           205,594             6,920                 3
Physician Assistant.......................................            57,749               908                 2
Nurse Practitioner........................................            31,937               509                 2
Family practice...........................................            16,770               629                 4
Ophthalmology.............................................            16,087             1,239                 8
Podiatry..................................................            12,639               547                 4
General surgery...........................................            12,113             2,095                17
Diagnostic radiology......................................            11,650               298                 3
Neurology.................................................             8,075                68                 1
Pain Management...........................................             6,923               210                 3
Emergency medicine........................................             6,012               209                 3
Internal medicine.........................................             5,883               201                 3
Interventional Pain Management............................             5,210               106                 2
Anesthesiology............................................             4,666               105                 2
Otolaryngology............................................             4,598               383                 8
Interventional radiology..................................             4,197                89                 2
Physical medicine and rehabilitation......................             3,546                53                 1
Vascular surgery..........................................             3,447               256                 7
Gastroenterology..........................................             2,264                 7                 0
Plastic and reconstructive surgery........................             1,939               403                21
Colorectal surgery........................................             1,851                83                 4
General practice..........................................             1,807                45                 2
Orthopedic surgery........................................             1,688               318                19
Optometry.................................................             1,563                45                 3
Urology...................................................             1,276               277                22
Neurosurgery..............................................             1,148               241                21
Nephrology................................................             1,008                25                 2
Obstetrics/gynecology.....................................               760               171                23
Cardiology................................................               456                14                 3
Surgical oncology.........................................               440                41                 9
Pathology.................................................               395                76                19
Pediatric medicine........................................               323                 4                 1
Neuropsychiatry...........................................               296                 2                 1
Thoracic surgery..........................................               276                40                14
Gynecologist/oncologist...................................               266                47                18
Interventional Cardiology.................................               192                 5                 3
Peripheral vascular disease, medical or surgical..........               162                 5                 3
Cardiac surgery...........................................               144                25                17
Hand surgery..............................................               124                54                44
Critical care.............................................                85                30                35
Infectious disease........................................                67                 3                 4
Osteopathic manipulative therapy..........................                55                 1                 2
Psychiatry................................................                44                 0                 0
Geriatric medicine........................................                43                 0                 0
Hospitalist...............................................                42                 0                 0
Maxillofacial surgery.....................................                37                 5                14
Oral surgery..............................................                34                 1                 3
Radiation oncology........................................                31                 1                 3
Certified clinical nurse specialist.......................                26                 2                 8
Pulmonary disease.........................................                20                 2                10
Hematology/oncology.......................................                19                 0                 0
Peripheral vascular disease...............................                17                 0                 0
Preventive medicine.......................................                15                 0                 0
Pathologic anatomy, clinical pathology....................                12                 1                 8

[[Page 35736]]

 
Unknown physician specialty...............................                10                 3                30
----------------------------------------------------------------------------------------------------------------
* Limited to the 293 procedures where postoperative visit reporting is required and to those performed by
  practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these
  circumstances, multiple procedures performed on a single day and procedures with overlapping global periods
  were excluded.
** Matching was based on patient, service dates, and global period duration.

    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 visit 
reported using CPT code 99024. Again, this rate varied by specialty as 
shown in Table 12. Under the PFS, procedures with 90-day global periods 
have more than one postoperative visit. It should be noted that the 
rates described in this and prior paragraphs are based on any matched 
postoperative visit reported using CPT code 99024.

Table 12--Share of Procedures With Matched Post-Operative Visits, for Procedure Codes With 90-Day Global Periods
----------------------------------------------------------------------------------------------------------------
                                                                              Number of 90-day  Percentage of 90-
                                                                                   global          day global
                                                            Number of 90-day   procedures with   procedures with
                    Provider specialty                           global           1 or more         1 or more
                                                               procedures*      matched 99024     matched 99024
                                                                                  claims**          claims**
----------------------------------------------------------------------------------------------------------------
ALL.......................................................           232,235           156,727                67
Orthopedic surgery........................................            71,991            54,876                76
Ophthalmology.............................................            63,333            41,700                66
General surgery...........................................            25,593            17,559                69
Pathologic anatomy, clinical pathology....................            10,149             4,371                43
Urology...................................................             8,481             4,828                57
Dermatology...............................................             7,692             4,160                54
Neurosurgery..............................................             6,993             5,256                75
Cardiology................................................             5,932             2,388                40
Vascular surgery..........................................             5,400             3,552                66
Hand surgery..............................................             4,783             3,718                78
Thoracic surgery..........................................             3,700             2,859                77
Cardiac surgery...........................................             2,764             2,183                79
Plastic and reconstructive surgery........................             2,500             1,670                67
Podiatry..................................................             2,383             1,393                58
Otolaryngology............................................             1,692             1,014                60
Physician Assistant.......................................             1,492               903                61
Colorectal surgery........................................             1,316               869                66
Interventional Cardiology.................................             1,123               500                45
Peripheral vascular disease, medical or surgical..........               753               524                70
Obstetrics/gynecology.....................................               752               469                62
Surgical oncology.........................................               716               511                71
Optometry.................................................               402               248                62
Gynecologist/oncologist...................................               322               219                68
Internal medicine.........................................               317               133                42
Emergency medicine........................................               258                62                24
Nurse Practitioner........................................               243               153                63
General practice..........................................               217               125                58
Gastroenterology..........................................               139                13                 9
Osteopathic manipulative therapy..........................               131                94                72
Family practice...........................................               115                65                57
Critical care.............................................                98                77                79
Neurology.................................................                87                64                74
Interventional radiology..................................                65                22                34
Unknown physician specialty...............................                60                34                57
Diagnostic radiology......................................                50                 6                12
Nephrology................................................                33                21                64
Maxillofacial surgery.....................................                29                23                79
Physical medicine and rehabilitation......................                26                16                62
Interventional Pain Management............................                14                 2                14
Pathology.................................................                13                 3                23
Hematology/oncology.......................................                12                12               100

[[Page 35737]]

 
Peripheral vascular disease...............................                10                 5                50
----------------------------------------------------------------------------------------------------------------
* Limited to the 293 procedures where post-operative visit reporting is required and to those performed by
  practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these
  circumstances, multiple procedures performed on a single day and procedures with overlapping global periods
  were excluded.
** Matching was based on patient, service dates, and global period duration.

    One potential explanation for these findings is that many 
practitioners are not consistently reporting postoperative visits using 
CPT code 99024. We are soliciting suggestions as to how to encourage 
reporting to ensure the validity of the data without imposing undue 
burden. Specifically, we are soliciting comments on whether we need to 
do more to make practitioners aware of their obligation and whether we 
should consider implementing an enforcement mechanism.
    Given the very small number of postoperative visits reported using 
CPT code 99024 during 10-day global periods, we are seeking 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. For 
example, we are soliciting comments on whether it is likely that in 
many cases the practitioner reporting the procedure code is not 
performing the postoperative visit, or if the postoperative visit is 
being furnished by a different practitioner. Alternatively, we are 
soliciting comments 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 conducted an analysis to try to assess the extent of 
underreporting. We identified a set of ``robust reporters'' who 
appeared to be regularly reporting post-operative visits using CPT code 
99024. They were defined as practitioners who (a) furnished 10 or more 
procedures with 90-day global periods where it is possible for us to 
match specific procedures to reported post-operative visits without 
ambiguity, and (b) reported a post-operative visit using CPT code 99024 
for at least half of these 90-day global procedures. Among this subset 
of practitioners and procedures, we found that 87 percent of procedures 
with 90-day global periods had one or more associated post-operative 
visits. However, only 16 percent of procedures with a 10-day global 
period had an associated postoperative visit reported using CPT code 
99024. These findings suggest that post-operative visits following 
procedures with 10-day global periods are not typically being furnished 
rather than not being reported.
    Under current policy, in cases where practitioners agree on the 
transfer of care for the postoperative portion of the global period, 
the surgeon bills only for the surgical care using modifier 54 ``for 
surgical care only'' and the practitioner who furnishes the 
postoperative care bills using modifier 55 ``postoperative management 
only.'' The global surgery payment is then split between the two 
practitioners. However, practitioners are not required to report these 
modifiers unless there is a formal transfer of postoperative care. We 
are also soliciting comments on whether we should consider requiring 
use of the modifiers 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 are also seeking 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. 
That is, we are seeking comments on whether we should consider changing 
the global period and reviewing the code valuation.
    Finally, we note that claims-based data collection using CPT code 
99024 is intended to collect information on the number of post-
operative visits but not the level of post-operative visits. We 
anticipate beginning, in the near future, a separate survey-based data 
collection effort on the level of post-operative visits including the 
time, staff, and activities involved in furnishing post-operative 
visits and non-face-to-face services. The survey component is intended 
to address concerns from the physician community that information on 
the number of visits alone cannot capture differences between 
specialties, specific procedure codes, and setting in terms of the time 
and effort spent on post-operative visits and non-face-to-face services 
included in global periods.
    RAND developed a survey that collects information on the time, 
staff, and activities related to five post-operative visits furnished 
by sampled practitioners. The CY 2017 PFS final rule (81 FR 80222) 
described a sampling approach for the survey that would have collected 
data on post-operative visits related to the full range of procedures 
with 10-day and 90-day global periods using a stratified random sample 
of approximately 5,000 practitioners. RAND piloted the post-operative 
visit survey in a small subsample of practitioners and found a very low 
response rate. This low response rate raised concerns that the survey 
would not yield useful or representative information on post-operative 
visits if the survey were fielded in the full sample.
    In an effort to increase response rate and collect sufficient data 
on the level of visits associated with at least some procedures with 
10-day and 90-day global periods, we refocused the survey effort to 
collect information on post-operative visits and non-face-to-face 
services associated with a small number of high-volume procedure codes. 
The survey sampling frame includes practitioners who perform above a 
threshold volume of the selected high-volume procedure codes. 
Practitioner participation in the survey-based data collection effort 
is important to ensure that CMS collects useful and representative data 
to understand the range of activities, staff, and time involved in 
furnishing post-operative visits. Future survey-based data collection 
may cover post-operative visits and non-face-to-face services 
associated with a broader range of procedures with 10-day and 90-day 
global periods.

[[Page 35738]]

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 physician fee 
schedule must be furnished under at least a general level of physician 
supervision as defined in paragraph (b)(3)(i) of this regulation. In 
addition, some of these tests require either direct or personal 
supervision as defined in paragraph (b)(3)(ii) or (iii) of this 
regulation, 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 under the supervision of a physician. 
Specifically, the commenters stated that all diagnostic tests, when 
performed by radiologist assistants (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 are proposing 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 are proposing 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 note 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 which included specific 
recommendations on how to implement the change. We received information 
submitted by representatives of the practitioner community, including 
information on the education and clinical experience of RAs, which we 
took into consideration in determining if this 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 indicates that 28 states have statutes or regulations that 
recognize RAs, and these states have general or direct supervision 
requirements for RAs.

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 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). 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, and we 
propose 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 proposed 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, 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

[[Page 35739]]

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 technical 
component, 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 APCs (C-APCs), conditionally and 
unconditionally packaged items and services, and major procedures. As 
we noted in the CY 2017 interim 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 below.
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 
ten CPT codes describing different levels of office visits for new and 
established payments. We compared the payment rate under OPPS for 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 interim 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 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

[[Page 35740]]

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. Proposed 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 technical 
component 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 believe that 
this overall approach is still appropriate, and we are proposing 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 that would 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/SI 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 (Hospital outpatient clinic visit for assessment and 
management of a patient). Nearly half (49 percent) 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 30 percent of total Medicare payments for separately 
payable or conditionally packaged services. The top 30 HCPCS/SI 
combinations accounted for 80 percent of all claim lines and 
approximately 60 percent of Medicare payments for services that are 
separately billable. In contrast with prior analyses, we also looked at 
claims units, which reflects HCPCS/SI combinations that are billed more 
than once on a claim line. Certain HCPCS codes are much more frequently 
billed in multiple units than others. For instance, HCPCS code G0463, 
which appears in nearly half of all claim lines, only represents eight 
percent of all claims units with a SI for separately payable or 
conditionally packaged services. 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 
technical component (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 not 
associated with the professional component of the service. As discussed 
in prior rulemaking (81 FR 79720 through 79729), we believe the most 
appropriate code-level comparison would reflect the technical component 
(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 professional component (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 (SI = ``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 rates under the PFS across all nonexcepted items and 
services, weighted by the number of HCPCS claims 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 claims. 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 propose to continue applying a PFS 
Relativity Adjuster of 40 percent for CY 2019. Moreover, we propose to 
maintain this PFS Relativity Adjuster for future years

[[Page 35741]]

until updated data or other considerations indicate that an alternative 
adjuster or a change to our approach is warranted, which we would 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 below.
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 note that we are maintaining these 
policies as finalized in 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 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.
    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 believed 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. These 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.
    Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC 
final rule with comment period and interim final rule with comment 
period (81 FR 79715, 79717, and 79727), we adopted payment for partial 
hospitalization items and services furnished by nonexcepted off-campus 
PBDs under the PFS. When billed in accordance with the CY 2017 interim 
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), the CY 2017 
OPPS/ASC final rule with comment period, and the 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 technical 
component 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, 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 (82 FR 53025 to 
53026).
    For CY 2019, we propose to continue to identify the PFS as the 
applicable payment system for PHP services furnished by nonexcepted 
off-campus PBDs, and propose to continue to set the PFS payment rate 
for these PHP services as the per diem rate that would be paid to a 
CMHC in CY 2019. We further propose to maintain these policies for 
future years until updated data or other considerations indicate that a 
change to our approach is warranted, which we would then propose 
through notice and comment rulemaking.
7. Future Years
    We continue to believe the amendments made by section 603 of the 
Bipartisan Budget Act of 2015 were intended to eliminate the Medicare 
payment incentive for hospitals to purchase physician offices, convert 
them to off-campus PBDs, and bill

[[Page 35742]]

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.
    Under the proposed methodology for CY 2019 as described previously, 
we use updated claims data for CY 2019, in combination with the 
expanded number of site specific, technical component 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 PBD types, 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 also 
note that our approach adopts packaging rules and MPPR rules under the 
OPPS.
    As noted above, 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 component rates under the PFS compared with APC rates 
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 fee schedule rules, 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 technical component of 
items and services furnished in nonexcepted off campus PBDs. Although 
we believe that our site-specific HCPCS-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 professional component 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 the proposed PFS 
Relativity Adjuster for CY 2019 of 40 percent would advance the effort 
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 proposed rule. 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

[[Page 35743]]

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 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. 
While 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

[[Page 35744]]

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 believed 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 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 made 
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.
    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 section II.H.4 of this proposed rule for a detailed 
discussion of the proposed valuation, and alternative valuation 
considered for specific codes. Table 13 contains a list of codes for 
which we propose work RVUs; this includes all codes for which we 
received RUC recommendations by February 10, 2018. The proposed work 
RVUs, work time and other payment information for all proposed CY 2019 
payable codes are available on the CMS website under downloads for the 
CY 2019 PFS proposed rule. Table 13 also contains

[[Page 35745]]

the CPT code descriptors for all proposed, new, revised, and 
potentially misvalued codes discussed in this section.
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 proposed 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 proposed 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 proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have been used in developing the proposed CY 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

[[Page 35746]]

clinical labor tasks to avoid duplicative inputs and to reflect the 
resource costs of furnishing the typical service.
    We refer readers to section II.B. of this proposed rule 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 15 and 16 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, we encourage 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 encourage stakeholders to submit invoices or other 
information to improve the accuracy of pricing for these items in the 
direct PE database during the 60-day public comment period for this 
proposed rule. We expect that invoices received outside of the public 
comment period would be submitted by February 10th of the following 
year for consideration in future rulemaking, similar to our new 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 15 and 16 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 
proposed 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 proposed 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 both 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 proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 
For more information regarding the history of the MPPR policy, we refer 
readers to the CY 2014 PFS final rule with comment period (78 FR 74261-
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. Proposed Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10X11, 10X12, 10X13, 
10X14, 10X15, 10X16, 10X17, 10X18, 10X19, 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 are proposing the RUC-recommended work RVU for 
seven of the ten codes in this family. Specifically, we are proposing a 
work RVU of 0.80 for CPT code 10X11 (Fine needle aspiration biopsy; 
without

[[Page 35747]]

imaging guidance; each additional lesion), a work RVU of 1.00 for CPT 
code 10X13 (Fine needle aspiration biopsy, including ultrasound 
guidance; each additional lesion), a work RVU of 1.81 for CPT code 
10X14 (Fine needle aspiration biopsy, including fluoroscopic guidance; 
first lesion), a work RVU of 1.18 for CPT code 10X15 (Fine needle 
aspiration biopsy, including fluoroscopic guidance; each additional 
lesion), and a work RVU of 1.65 for CPT code 10X17 (Fine needle 
aspiration biopsy, including CT guidance; each additional lesion). We 
are also proposing to assign the recommended contractor-priced status 
to CPT codes 10X18 (Fine needle aspiration biopsy, including MR 
guidance; first lesion) and 10X19 (Fine needle aspiration biopsy, 
including MR guidance; each additional lesion) due to low utilization 
until these services are more widely utilized. In addition, we are 
proposing 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 proposing 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 disagree with the RUC-recommended work RVU of 1.20 for CPT code 
10021 (Fine needle aspiration biopsy; without imaging guidance; first 
lesion) and are proposing 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 do not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be appropriately reflected in decreases to 
work RVUs. In the case of CPT code 10021, we believe that it would be 
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 disagree with the RUC-recommended work RVU of 1.63 for CPT code 
10X12 (Fine needle aspiration biopsy, including ultrasound guidance; 
first lesion) and are proposing a work RVU of 1.46. Although we 
disagree with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 10021 and 10X12 is equivalent to 
the recommended interval of 0.43 RVUs. Therefore, we are proposing a 
work RVU of 1.46 for CPT code 10X12, 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 is 
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 
10X12, and both crosswalk codes share a work RVU of 1.39.
    We disagree with the RUC-recommended work RVU of 2.43 for CPT code 
10X16 (Fine needle aspiration biopsy, including CT guidance; first 
lesion) and we are proposing a work RVU of 2.26. Although we disagree 
with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 10021 and 10X16 is equivalent to 
the recommended interval of 1.23 RVUs. Therefore, we are proposing a 
work RVU of 2.26 for CPT code 10X16, 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 is 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 note 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 believe that this indicates 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 note that through the bundling of some of 
these frequently reported services, it is reasonable to expect that the 
new coding system will achieve savings via elimination of duplicative 
assumptions of the resources involved in furnishing particular 
servicers. For example, a practitioner would not be carrying out the 
full preservice work twice for CPT codes 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 are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes 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 note that there is no effect on the total clinical labor direct 
costs in these situations, since the same 3 minutes of clinical labor 
time is still being furnished. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(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

[[Page 35748]]

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 disagree with the recommended value and are proposing a work RVU 
of 1.08 for CPT code 11755 based on the survey 25th percentile value. 
We note 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 do not imply that the decrease in time 
as reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. In the case of CPT 
code 11755, we believe 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 note 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 this further supports our proposal of a work RVU of 1.08 
for CPT code 11755.
    We are proposing to refine the equipment times in accordance with 
our standard equipment time formulas.
(3) Skin Biopsy (CPT Codes 11X02, 11X03, 11X04, 11X05, 11X06, and 
11X07)
    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 are proposing the RUC-recommended work RVUs for 
five of the six codes in the family. We are proposing a work RVU of 
0.66 for CPT code 11X02 (Tangential biopsy of skin, (e.g., shave, 
scoop, saucerize, curette), single lesion), a work RVU of 0.83 for CPT 
code 11X04 (Punch biopsy of skin, (including simple closure when 
performed), single lesion), a work RVU of 0.45 for CPT code 11X05 
(Punch biopsy of skin, (including simple closure when performed), each 
separate/additional lesion), a work RVU of 1.01 for CPT code 11X06 
(Incisional biopsy of skin (e.g., wedge), (including simple closure 
when performed), single lesion), and a work RVU of 0.54 for CPT code 
11X07 (Incisional biopsy of skin (e.g., wedge), (including simple 
closure when performed), each separate/additional lesion).
    For CPT code 11X03 (Tangential biopsy of skin, (e.g., shave, scoop, 
saucerize, curette), each separate/additional lesion), we disagree with 
the RUC-recommended work RVU of 0.38 and are proposing 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 11X03 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 
is 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 
CPT code 11X03. We also noted that the intraservice time ratio between 
CPT code 11X03 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 are also 
supporting 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 believe that our 
proposed work RVU of 0.29 for CPT code 11X03 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 are proposing to remove the 2 minutes 
of clinical labor time for the ``Review home care instructions, 
coordinate visits/prescriptions'' (CA035) activity for CPT codes 11X02, 
11X04, and 11X06. 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 are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
    We are proposing 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 11X02, 11X04, and 11X06. We 
are proposing 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 are also proposing to 
remove all of the supplies in the three add-on procedures (CPT codes 
11X03, 11X05, and 11X07) 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 note 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.

[[Page 35749]]

(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 are proposing the RUC-
recommended work RVU of 0.75 for CPT code 20551.
    We are proposing 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 note 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 are proposing 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 would be 
duplicative to assign clinical labor time for obtaining consent or 
reviewing home care instructions given that these tasks would typically 
be done during the same day E/M service. We are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(5) Structural Allograft (CPT Codes 209X3, 209X4, and 209X5)
    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 are proposing the RUC-recommended work 
RVUs for all three codes. We are proposing a work RVU of 13.01 for CPT 
code 209X3 (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 209X4 
(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 209X5 
(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.
(6) Knee Arthrography Injection (CPT Code 27X69)
    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, 27X69, to 
report injection procedure for knee arthrography or enhanced CT/MRI 
knee arthrography.
    The RUC recommended a work RVU for CPT code 27X69 of 0.96, 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 disagree with the RUC's recommended work RVU for CPT 
code 27X69. 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 are proposing a work RVU of 0.77 for CPT code 
27X69.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. The 
predecessor code for 27X69, CPT code 27370, 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 are proposing 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 27X69 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 are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(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 are proposing the RUC-
recommended work RVU of 0.80 for CPT code 29105.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(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

[[Page 35750]]

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 are proposing 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 are proposing 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 are also proposing 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 are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
    CPT code 31623 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; with 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 are proposing the RUC-
recommended work RVU of 2.63 for CPT codes 31623 and 31624.
    For the direct PE inputs, we are proposing 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 are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 332X0 and 
93XX1)
    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 are proposing 
the RUC-recommended work RVU of 6.00 for CPT code 332X0 (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 93XX1 (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 are not proposing any direct PE refinements for this code 
family.
(11) Cardiac Event Recorder Procedures (CPT Codes 332X5 and 332X6)
    In February 2017, the CPT Editorial Panel created two new codes 
replacing cardiac event recorder codes to reflect new technology. For 
CY 2019, we are proposing the RUC-recommended work RVU of 1.53 for CPT 
code 332X5 (Insertion, subcutaneous cardiac rhythm monitor, including 
programming) and the RUC-recommended work RVU of 1.50 for CPT code 
332X6 (Removal, subcutaneous cardiac rhythm monitor).
    We are not proposing any direct PE refinements for this code 
family.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 335X1)
    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 are proposing the RUC-recommended work RVU of 64.00 
for CPT code 335X1 (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 335X1.
    For the direct PE inputs, we are proposing to refine the preservice 
clinical labor times to match our standards for 90-day global 
procedures. We are proposing 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 are also proposing to add 15 
minutes of clinical labor time for the ``Perform regulatory mandated 
quality assurance activity (pre-service)'' (CA008) activity. We agree 
with the recommendation that the total preservice clinical labor time 
for CPT code 335X1 is unchanged from the two reference codes at 75 
minutes. However, we believe 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 
335X1. We also note 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.
(13) Hemi-Aortic Arch Replacement (CPT Code 33X01)
    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 are proposing the RUC-recommended work RVU 
of 19.74 for CPT code 33X01 (Aortic hemiarch graft including isolation 
and control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion). CPT code

[[Page 35751]]

33X01 is a facility-only procedure with no recommended direct PE 
inputs.
(14) Leadless Pacemaker Procedures (CPT Codes 33X05 and 33X06)
    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 33X05 (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 disagree with the recommended work 
RVU of 8.77 and we are proposing 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 33X05 and 
an additional 61 minutes of total time at a work RVU of 7.80. In our 
review of CPT code 33X05, 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 33X05 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 33X05 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 are proposing to crosswalk CPT code 33X05 to CPT code 
33207 at the same work RVU of 7.80. The proposed work RVU is 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 7.80 is a more accurate valuation for CPT code 
33X05, while still recognizing the greater intensity of this procedure 
in comparison to its reference code.
    For CPT code 33X06 (Transcatheter removal of permanent leadless 
pacemaker, right ventricular), we disagree with the RUC-recommended 
work RVU of 9.56 and we are proposing a work RVU of 8.59. Although we 
disagree with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 33X05 and 33X06 is equivalent to 
the recommended interval of 0.79 RVUs. Therefore, we are proposing a 
work RVU of 8.59 for CPT code 33X06, based on the recommended interval 
of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT 
code 33X05. We also note that our proposed work RVU for CPT code 33X06 
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 33X06 has a surveyed intraservice time of 
75 minutes and nearly splits the difference between them at our 
proposed work RVU of 8.59.
    We are not proposing any direct PE refinements for this code 
family.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36X72, 36X73, 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 realtime 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 are proposing the RUC-recommended work RVU for two 
of the CPT codes in the family. We are proposing 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 36X72 (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 disagree with the RUC-
recommended work RVU of 2.00 and are proposing 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 36X72, 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 36X72 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

[[Page 35752]]

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 36X72 has a lower recommended intraservice time and 
total time as compared to CPT code 36569, yet has a higher recommended 
work RVU. 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 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 36X72, we believe 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 is 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 also share a work RVU of 1.82.
    For CPT code 36X73 (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 disagree with the RUC-recommended 
work RVU of 1.90 and are proposing a work RVU of 1.70 based on 
maintaining the current work RVU of CPT code 36569. In our review of 
CPT code 36X73, 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 36X73 as compared to CPT 
code 36569, the most similar code in the family, is decreasing from 27 
minutes to 15 minutes (45 percent), and the recommended total time is 
decreasing from 60 minutes to 40 minutes (33 percent); however, the 
RUC-recommended work RVU is exactly the same for these two codes at 
1.90. 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 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 36X73, we believe 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 36X73) and without (CPT code 35659) 
imaging guidance and radiological supervision and interpretation. 
Because the inclusion of the imaging described by CPT code 36X73 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 
increasing the work RVU to 1.90, especially considering that the new 
surveyed work time for CPT code 36X73 is lower than the current work 
time for CPT code 36569. The proposed work RVU of 1.70 is 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 disagree with the RUC-recommended work RVU 
of 1.47 and are proposing a work RVU of 1.20 based on maintaining the 
current work RVU. We note that the recommended intraservice time for 
CPT code 36584 is decreasing from 15 minutes to 12 minutes (20 percent 
reduction), and the recommended total time is decreasing from 45 
minutes to 34 minutes (25 percent reduction); however, the recommended 
work RVU is increasing from 1.20 to 1.47, an increase of approximately 
23 percent. 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 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 are 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 believe 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 believe that it is 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 is decreasing from the current 
work time. The proposed work RVU of 1.20 is 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 note that the RUC-recommended work pool is 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 is 
only increasing by about 22 percent. Since time is defined as one of 
the two components of work, we believe that this indicates 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 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 note that, 
through the bundling of some of these frequently reported services, it 
is reasonable to expect that the new coding system will achieve savings 
via elimination of duplicative assumptions of the resources involved in 
furnishing particular servicers. For example, a practitioner would not 
be carrying out the full preservice work three times for CPT codes 
36568, 76937, and 77001, but preservice times were assigned to all 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 but were not reflected in the services as they were 
previously reported.
    For the direct PE inputs, we are proposing 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 36X72 and 36X73. We note 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 do not agree 
that the patient positioning would take twice

[[Page 35753]]

as long for CPT codes 36X72 and 36X73 as compared to the rest of the 
family, and are therefore refining both of them to the same 2 minutes 
of clinical labor time. We are also proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 3853X)
    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 code 
3853X with radical vulvectomy. This service was previously reported 
with unlisted codes.
    CPT code 3853X (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 3853X, with 223 minutes of total time and 65 
minutes of intraservice time. We propose the RUC-recommended work RVU 
of 6.74 for CPT code 3853X. However, we are 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 code 56630 
(Vulvectomy, radical, partial) and CPT code 56633 (Vulvectomy, radical, 
complete), are both 90-day global codes. In addition, CPT code 3853X 
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 propose to assign a 
90-day global indicator for CPT code 3853X rather than the 10-day 
global time period reflected in the RUC recommendation.
    We are not proposing any direct PE refinements for this code 
family.
(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 are proposing the RUC-
recommended work RVU of 0.65 for CPT code 38792.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 38792, as well as its alternate reference code 78300 (Bone and/or 
joint imaging; limited area), both 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 are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(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 codes (43X63 and 
43X64) that describe replacement of gastrostomy tube, with and without 
revision of gastrostomy tract, respectively. (See below.) Therefore, we 
are not proposing work or direct PE values for CPT code 43760.
(19) Gastrostomy Tube Replacement (CPT Codes 43X63 and 43X64)
    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 are proposing a work RVU of 0.75 for CPT code 43X63 (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 43X64 
(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.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(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 are proposing 
the RUC-recommended work RVU of 0.80 for CPT code 45300.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(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 disagree with the RUC-recommended work RVU 
of 2.00 and we are proposing 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 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

[[Page 35754]]

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 do 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 note 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 are proposing a work RVU of 1.74 for CPT code 46500 based 
on the aforementioned crosswalk.
    For the direct PE inputs, we are proposing 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 
appreciate this notification in the recommendations, and therefore, we 
are asking for more information about why the clinical labor associated 
with this additional staff member was left out for previous reviews. We 
are particularly interested in knowing what activities the additional 
staff member would be undertaking during the procedure. We are 
proposing to remove the clinical labor associated with this additional 
clinical staff member pending the receipt of additional information. We 
are also proposing 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 are proposing 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 are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
(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 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 are proposing the RUC-recommended work RVU of 
4.00 for CPT code 49422.
    We are not proposing any direct PE refinements for this code 
family.
(23) Dilation of Urinary Tract (CPT Codes 50X39, 50X40, 52334, and 
74485)
    In October 2014, the CPT Editorial Panel deleted six codes and 
created twelve 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 two 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 50X39 (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 disagree 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 note that the reference CPT codes both 
have substantially higher total and intraservice times than CPT code 
50X39. We considered a number of parameters to arrive at our proposed 
work RVU of 2.78, supported by a

[[Page 35755]]

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 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 are proposing a work RVU of 2.78 for 
CPT code 50X39.
    The specialty society also surveyed the new CPT code 50X40 
(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 50X39. 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 do 
not agree with the RUC's recommended work RVU because we believe 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 are proposing to reduce the intraservice time 
for CPT code 50X40 from the RUC-recommended 60 minutes to the survey 
median time of 45 minutes. We note that this is still 15 minutes more 
than the intraservice time for CPT code 50X39, primarily for the 
provider to introduce the guidewire into the renal pelvis and/or 
ureter. We welcome 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 believe that the RUC-recommended work RVU 
for this CPT code is overstated. When we apply the increment between 
the RUC-recommended values for between CPT codes 50X39 and 50X40 (2.07 
work RVUs) in addition to our proposed work RVU for CPT code 50X39, we 
estimate that this CPT code is 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 intraservice time of 40 minutes and total 
time of 86 minutes. We believe that CPT code 36902 describes a service 
that is similar to the new CPT code 50X40) and therefore provides a 
reasonable crosswalk. We are proposing a work RVU of 4.83 for CPT code 
50X40.
    We are proposing 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 are proposing 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 50X39 and 50X40), CPT code 52234 does not include 
imaging guidance in its code descriptor. When CPT code 52234 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 believe 
that it would be duplicative to include this clinical labor time in CPT 
code 52234.
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 
53852, and 538X3)
    In September 2017, the CPT Editorial Panel created a new code (CPT 
code 538X3) 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 are proposing 
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 538X3 (Transurethral destruction of 
prostate tissue; by radiofrequency generated water vapor 
thermotherapy). We are proposing the RUC-recommended value of 5.93 for 
CPT code 53852.
    CPT code 538X3 (Transurethral destruction of prostate tissue; by 
radiofrequency generated water vapor thermotherapy) is a service 
reflecting

[[Page 35756]]

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 do 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 
believe that this is a better reflection of the work involved in 
furnishing CPT code 538X3, and therefore, we are proposing a work RVU 
of 5.70 for this CPT code. We welcome 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 are proposing to add a new supply 
(SA128: ``kit, Rezum delivery device''), a new equipment item (EQ389: 
``generator, water thermotherapy procedure''), and updating the price 
of two supplies (SA036: ``kit, transurethral microwave thermotherapy'' 
and SA037: ``kit, transurethral needle ablation (TUNA)'') in response 
to the submission of invoices. We note that these invoices were 
submitted along with additional information listing the vendor discount 
for these supplies and equipment. We appreciate the inclusion of the 
discounted prices on these invoices, and we encourage other invoice 
submissions to provide the discounted price as well where available. 
Based on the market research on supply and equipment pricing carried 
out by our contractors, we have reason to 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 encourage the submission of 
additional invoices that include the discounted price of supplies and 
equipment to more accurately assess the market cost of these resources. 
Furthermore, we refer readers to our discussion of the market-based 
supply and equipment pricing update detailed in section II.B. of this 
proposed rule.
(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 are proposing 
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 are not proposing any direct PE refinements for this code 
family.
(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 are 
proposing 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 are proposing 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 are also proposing to refine the equipment times in 
accordance with our standard equipment time formulas.
(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 are proposing 
the RUC-recommended work RVU of 0.94 for CPT code 64405.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the exam table (EF023) in accordance with our standard 
equipment time formulas.
(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 are proposing the RUC-
recommended work RVU of 0.75 for CPT code 64455.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the exam table (EF023) in accordance with our standard 
equipment time formulas.
(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

[[Page 35757]]

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 are proposing the RUC-recommended work RVU of 0.49 
for CPT code 65205. We note 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 note 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 do 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 disagree with the RUC-recommended work RVU 
of 0.75 and we are proposing 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 note 
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 are not proposing 
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 note 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 are proposing 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) 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 
disagree 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 are not currently 
proposing to refine the equipment time for the screening lane in these 
two codes, we are soliciting 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.
(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 are proposing the RUC-recommended work RVU of 1.18 for CPT code 
67500.
    For CPT code 67505, we disagree with the RUC-recommended work RVU 
of 1.18 and we are proposing 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 are proposing a work RVU of 0.94 for CPT code 67505.
    For CPT code 67515, we disagree with the RUC-recommended work RVU 
of 0.84 and we are proposing 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;

[[Page 35758]]

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 are not proposing any direct PE refinements for this code 
family.
(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 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 have 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. There is no new information about any of these CPT codes 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 process or methodology that might reduce the burden of 
conducting surveys, but without the benefit of any additional data, 
through surveys or otherwise, we are not convinced that there is 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 are proposing 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 is a work RVU of 0.23, which we propose 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 recognize that the proposed 
work RVU for some of these CPT codes may be somewhat lower at the code 
level than the RUC's recommendation, while the proposed work RVU for 
other CPT codes may 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 implies a level of 
precision about the time and intensity of the CPT codes that we have no 
way to validate.
    For the direct PE inputs, we are proposing 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 are proposing 
to add the patient gown to match the other codes in the family. We 
believe that the exclusion of the patient gown for CPT code 72120 was 
most likely due to a clerical error in the recommendations. We are also 
proposing 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

[[Page 35759]]

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 are not proposing to refine the clinical labor times for this 
task as we do not have data available to know how many views would be 
typical for these CPT codes. However, we note 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 believe 
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 welcome any comments that may be able to provide 
additional details for the twelve codes under review in this family.
(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 are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(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 are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(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 are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(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 are proposing 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 are 
proposing to add the patient gown to match the other codes in these 
families. We are also proposing to refine the equipment time for the 
basic radiology room (EL012) in accordance with our standard equipment 
time formulas.
(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 are proposing 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 are not proposing to refine the quantity of the 
Polibar barium suspension at this time, we are seeking additional 
comment about the typical use of the supply in these procedures. We are 
also proposing to refine the equipment times for all three codes in 
accordance with our standard equipment time formulas.
(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 are proposing the RUC-recommended work RVU of 0.52 for CPT code 
74420 (Urography, retrograde, with or without KUB).
    For the direct PE inputs, we are proposing 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 are 
proposing to remove it to match the rest of the X-ray codes. We are 
also proposing to refine the equipment times in accordance with our 
standard equipment time formulas.
(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

[[Page 35760]]

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 are proposing 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 are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(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 disagree with the RUC-recommended work RVU 
of 0.17 and we are proposing a work RVU of 0.14. We note 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 do not imply that 
the decrease in time as reflected in survey values must equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs.
    We also note 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 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 are proposing 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 recognize 
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 are not proposing any direct PE refinements for this code 
family.
(40) Ultrasound Elastography (CPT Codes 767X1, 767X2, and 767X3)
    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 767X1 (Ultrasound, 
elastography; parenchyma), 767X2 (Ultrasound, elastography; first 
target lesion) and 767X3 (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 767X1 
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 
0.59 for CPT code 767X2 (Ultrasound, elastography; first target 
lesion), and a work RVU of 0.50 for add-on CPT code 767X3 (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 are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes for CPT 
codes 767X1 and 767X2. 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 
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 in CPT codes 767X1 and 
767X2. We are also proposing to refine the equipment times in 
accordance with our standard equipment time formulas.
(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 are proposing 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 are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 76870 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 under the CA013 room preparation activity. We are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76X0X and 76X1X)
    In September 2017, the CPT Editorial Panel created two new CPT 
codes describing the use of intravenous microbubble agents to evaluate

[[Page 35761]]

suspicious lesions by ultrasound. CPT code 76X0X (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 76X1X (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, 76X0X 
(Ultrasound, targeted dynamic microbubble sonographic contrast 
characterization (non-cardiac); initial lesion), is the base code for 
the new add-on CPT code 76X1X (Ultrasound, targeted dynamic microbubble 
sonographic contrast characterization (non-cardiac); each additional 
lesion with separate injection). The RUC reviewed the survey results 
for CPT code 76X0X 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 76X1X, 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.
    While 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 76X0X. When we 
consider the range of existing CPT codes with 30 minutes total time and 
20 minutes intraservice time, we note that a work RVU of 1.62 is among 
the highest potential crosswalks. We also note that the RUC agreed with 
the 25th percentile of survey results for the new add-on CPT code, 
76X1X, and we do not see why the 25th percentile wouldn't also be 
appropriate for the base CPT code, 76X0X. Therefore, we are proposing a 
work RVU of 1.27 for CPT code 76X0X. 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 are proposing the RUC-recommended work RVU of 0.85 for add-
on CPT code 76X1X.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes for CPT 
code 76X0X. 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 do 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 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 in CPT code 76X0X.
    We are proposing to remove the 50 ml of the phosphate buffered 
saline (SL180) for CPT codes 76X0X and 76X1X. 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 are proposing to remove 
the supply and soliciting comments on the phosphate buffered saline or 
a replacement saline solution. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(43) Magnetic Resonance Elastography (CPT Code 76X01)
    The CPT Editorial Panel created a new stand-alone code (76X01) 
describing the use of magnetic resonance elastography for the 
evaluation of organ parenchymal pathology. This code will most often be 
used to evaluate patients 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 76X01 (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 note that, despite shorter 
intraservice and total time, CPT code 76X01 is slightly more intense to 
perform due to the evaluation of wave propagation images and 
quantitative stiffness measures. We do 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 76X01, we are proposing 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 76X01, and we

[[Page 35762]]

believe that the work involved in furnishing both services is similar. 
We note that CPT code 76X01 describes a new technology and will be 
reviewed again by the RUC in 3 years.
    For the direct PE inputs, we are proposing 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 disagree 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 
propose 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 are also proposing 
to refine the equipment times in accordance with our standard equipment 
time formulas.
(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 are proposing 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 are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 77012 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 under the CA013 room preparation activity.
    We are proposing 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 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 are proposing to maintain the current equipment room time 
of 9 minutes until this group of procedures can be subject to a more 
comprehensive review. We are also proposing to refine the equipment 
time for the Technologist PACS workstation (ED050) in accordance with 
our standard equipment time formulas.
(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 are proposing the RUC-recommended work RVU of 
0.20 for CPT code 77081.
    We are not proposing any direct PE refinements for this code 
family.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77X49, 77X50, 
77X51, and 77X52)
    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 77X49 (Magnetic 
resonance imaging, breast, without contrast material; unilateral). This 
recommendation is 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 77X49. We disagree with the RUC's recommended work RVU because we 
do not believe that the reduction in total time of 15 minutes between 
the new CPT code 77X49 and the deleted CPT code 74177 is adequately 
reflected in its recommendation. While 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 are proposing a work RVU of 1.15 for CPT code 77X49, 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 77X50 (Magnetic resonance imaging, breast, without 
contrast material; bilateral) describes the same work as CPT code 
77X49, but reflects a bilateral rather than the unilateral procedure. 
The RUC recommended a work RVU of 1.60 for CPT code 77X50. Since we are 
proposing 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 77X50 relative to the RUC's recommended 
difference in work between the two CPT codes. The RUC's recommendation 
for the bilateral procedure is 0.15 work RVUs larger than for the 
unilateral procedure. Therefore, we are proposing a work RVU of 1.30 
for CPT code 77X50.
    The RUC recommended a work RVU of 2.10 for CPT code 77X51 (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 77X51 is a new CPT code that bundles the deleted 
CPT code for unilateral breast

[[Page 35763]]

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 77X49) should be a work RVU of 1.15, we are proposing a work 
RVU for CPT code 77X51 that adds the RUC-recommended difference in RUC-
recommended work RVUs between CPT codes 77X49 and 77X51 (0.65 work 
RVUs) to the proposed work RVU for CPT code 77X49. Therefore, we are 
proposing a work RVU of 1.80 for CPT code 77X51.
    The last new CPT code in this series, CPT code 77X52 (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 77X51, 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 77X50 and CPT code 77X51, we believe that a more 
appropriate work RVU is calculated by adding the difference in the RUC 
recommended work RVU for CPT codes 77X49 and 77X52, to the proposed 
value for CPT code 77X49. Therefore, we are proposing a work RVU of 
2.00 for CPT code 77X52.
    For the direct PE inputs, we are proposing 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 77X49 and 77X50, and from 9 minutes to 5 minutes 
for CPT codes 77X51 and 77X52. We note 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 note 
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 have 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 are refining the clinical labor time for the CA016 
activity as detailed above 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 are proposing 
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 welcome 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 are not 
proposing 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 are also proposing to refine the equipment times in accordance 
with our standard equipment time formulas.
(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 disagree with the recommended value and are proposing 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 do not 
imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be 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 is also based on the use of three crosswalk 
codes. We are directly supporting 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 
explain 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

[[Page 35764]]

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 
are recommending none.
(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 disagree with the RUC-recommended value and we are proposing 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 are supporting 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. While we 
do 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 are proposing 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. While we agree 
that these are necessary tasks, under our established methodology we 
believe that they are more appropriately classified as indirect PE.
(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 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 
are not proposing any direct PE inputs for CPT code 85390.
(50) Electroretinography (CPT Codes 92X71, 92X73, and 03X0T)
    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 92X71 (Electroretinography (ERG) with interpretation 
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we 
disagree with the recommended work RVU of 0.80 and we are instead 
proposing 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 92X71 than 
the two reference codes chosen by the survey participants due to their 
significantly higher and lower intraservice times. We note that the 
recommended intraservice time for CPT code 92X71 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 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 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 92X71, 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 are proposing 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 92X73 (Electroretinography (ERG) with interpretation 
and report; multifocal (mfERG)), we disagree with the RUC-recommended 
work RVU of 0.72 and are proposing a work RVU of 0.61. We concur that 
the relative difference in work between CPT code 92X71 and 92X73 is 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we are 
proposing a work RVU of 0.61 for CPT code 92X73, based on the 
recommended interval of 0.08 fewer RVUs below our proposed work RVU of 
0.69 for CPT code 92X71. 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

[[Page 35765]]

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 Category III 
code 03X0T (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 
Category III code 03X0T, 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 Category III code 03X0T and creating RVUs through the 
use of a proxy crosswalk to a similar existing service. Therefore, we 
are proposing to assign an active status to Category III code 03X0T 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 are proposing a work RVU of 0.40 and 
work times of 10 minutes of intraservice and 12 minutes of total time 
for Category III code 03X0T based on this crosswalk to CPT code 92250.
    For the direct PE inputs, we are proposing to remove the preservice 
clinical labor in the facility setting for CPT codes 92X71 and 92X73. 
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 note 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 are proposing 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 92X71 and 92X73. 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 92X71 and 
92X73 would be duplicative. We are also proposing to refine the 
clinical labor time for the ``Prepare room, equipment and supplies'' 
(CA013) activity to 3 minutes and to refine the clinical labor time for 
the ``Confirm order, protocol exam'' (CA014) activity to 0 minutes 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 do not have any reason to believe that the 
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 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 are proposing 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 92X71 and 92X73. 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 are proposing 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 are proposing 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 92X71 and 92X73. 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 92X71 and 92X73 is comparable to 
the CT and magnetic resonance (MR) codes that have been recently 
reviewed, such as CPT code 76X01 (Magnetic resonance (e.g., vibration) 
elastography). Therefore, in order to maintain relativity, we are 
proposing the same clinical labor time of 3 minutes for CPT codes 92X71 
and 92X73 that has been recommended for these CT and MR codes. We are 
also proposing 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 92X71 and 92X73. 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 92X71 but only 
a single time for CPT code 92X73. We are seeking 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 92X71 but only a single time for CPT code 92X73. Finally, we 
are also proposing to refine the equipment times in accordance with our 
standard equipment time formulas.
    We are proposing to use the direct PE inputs for CPT code 92X73, 
including the refinements detailed above, as a proxy for Category III 
code 03X0T until it can be separately reviewed by the RUC.
(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

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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 disagree with the RUC-recommended work RVU 
of 0.95 and we are proposing 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 is decreasing from 29 minutes to 
15 minutes (48 percent reduction), and the recommended total time for 
CPT code 93561 is decreasing from 78 minutes to 15 minutes (81 percent 
reduction); however, the recommended work RVU is instead increasing 
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although 
we do not imply that the decrease in time as reflected in survey values 
must equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should typically be reflected 
in decreases to work RVUs, not increases in valuation. We recognize 
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 are 
proposing 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 disagree with the recommended work RVU of 
0.77 and are proposing 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 is decreasing from 16 minutes to 
12 minutes (25 percent reduction), and the recommended total time is 
decreasing from 44 minutes to 12 minutes (73 percent reduction); 
however, the RUC-recommended work RVU is instead increasing from 0.01 
to 0.77. We recognize 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 was 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 are proposing 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 note 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 are not proposing any direct PE inputs.
(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 disagree with the recommended work RVU of 1.50 for this 
CPT code because we do not believe that a reduction in work RVU from 
1.80 to 1.50 is commensurate with the reduction in time for this 
service of five minutes. Using the building block methodology, we 
believe 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 is more appropriate because it has 
an identical intraservice and total time (15 minutes) as CPT code 
93571, describes work that is similar, and is closer to the 
calculations for intraservice time ratio, total time ratio, and the 
building block method. Therefore, we are proposing a work RVU of 1.38 
for CPT code 93571.
    We are proposing the RUC-recommended work RVU for 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) of 1.00.
    Both of these codes are facility-only procedures with no 
recommended direct PE inputs.
(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,

[[Page 35767]]

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 is not recommending 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 are proposing a work RVU of 
0.00 for CPT code 93668 and are proposing to continue valuing the code 
for PE only.
(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 disagree with the recommended 
value and are proposing 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 do not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be 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 based on the aforementioned crosswalk codes 
to account for these decreases in the surveyed work time. We also note 
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 have 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 disagree with the recommended value 
and we are again proposing 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 are 
proposing 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 disagree with the RUC-
recommended work RVU of 1.08, we concur that the relative difference in 
work between CPT codes 95800 and 95801 and CPT code 95806 is equivalent 
to the recommended interval of 0.08 RVUs. Therefore, we are proposing 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 note 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 are not proposing any direct PE refinements for this code 
family.
(55) Neurostimulator Services (CPT Codes 95970, 95X83, 95X84, 95X85, 
and 95X86)
    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

[[Page 35768]]

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 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 disagree 
with the RUC's recommendation because we do not believe that 
maintaining the work RVU, given a decrease of four minutes in total 
time, is appropriate. In addition, we note 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 are proposing a work RVU of 0.35 for CPT code 95970.
    CPT code 95X83 (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 95X83 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 95X83 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 95X83. 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 95X83. We disagree with the RUC's recommended work RVU for 
this CPT code because we do not believe that the large difference in 
time between the new CPT code and CPT code 95974 is 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 are proposing a work RVU of 0.73 for CPT 
code 95X83.
    CPT code 95X84 describes the same work as CPT code 95X83, 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

[[Page 35769]]

intended to compare CPT code 95X84 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 95X83. The RUC 
recommended a work RVU of 1.19 for CPT code 95X84. 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 95X84 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. 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 disagree with the RUC's recommended work RVU of 1.19 
for CPT code 95X84. 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 code 95X83 and 95X84 (0.24 RVUs) to the proposed work RVU 
of 0.73 for CPT code 95X83. Therefore, we propose a work RVU of 0.97 
for CPT code 95X84.
    CPT code 95X85 (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 for add-on CPT code 
95X86 (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 95X85. The RUC compared CPT code 95X85 
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 95X85 and a work RVU of 
1.00 for CPT code 95X86. For CPT code 95X85, 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 
disagree with the RUC's recommended work RVU for CPT code 95X85 because 
we do not believe that the reduction in work RVU reflects the change in 
time described by the CPT code. Using the reverse building block 
methodology, we estimate 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 are proposing a work RVU of 0.91 
for CPT code 95X85.
    The RUC's recommended work RVU of 1.00 for CPT code 95X86 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

[[Page 35770]]

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 add the incremental difference between CPT codes 95X85 and 
95X86 to the proposed value for the base CPT code (95X85, work RVU = 
0.91), we estimate that this add-on CPT code should 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 are proposing a work RVU of 0.80 
for CPT code 95X86, 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 (i.e., rectal, gastric, 
intraperitoneal)), which is an add-on CPT code with identical total and 
intraservice times (15 minutes) as CPT code 95X86.
    We are not proposing any direct PE refinements for this code 
family.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105, 
96110, 96116, 96125, 96127, 963X0, 963X1, 963X2, 963X3, 963X4, 963X5, 
963X6, 963X7, 963X8, 963X9, 96X10, 96X11, 96X12)
    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 are proposing 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 963X2; a work RVU of 0.55 for 
CPT code 963X7; a work RVU of 0.46 for CPT code 963X8; and a work RVU 
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 963X9, 96X10, and 
96X12 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 963X7 and 963X8), and two for either type of 
testing when administered by technicians (CPT codes 963X9 and 96X10); 
and four new codes that describe testing evaluation by physicians or 
other qualified health care professionals (CPT codes 963X3-963X6). This 
new coding effectively unbundles codes that currently report the full 
course of testing into separate codes for testing administration (CPT 
codes 963X7, 963X8, 963X9, and 96X10) and evaluation (CPT Codes 963X3, 
963X4, and 963X5). 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 
asserts 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 are proposing to implement work RVUs for this code family, 
which would eliminate the approximately 2 percent reduction in work 
spending. We are proposing 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 are proposing: A 
work RVU of 2.56 for CPT code 963X0, rather than the RUC recommended 
work RVU of 2.50; a work RVU of 1.16 for CPT code 963X1, rather than 
the RUC-recommended work RVU of 1.10; a work RVU of 2.56 for CPT code 
963X3, rather than the RUC-recommended work RVU of 2.50; a work RVU of 
1.96 for CPT code 963X4, rather than the RUC-recommended work RVU of 
1.90; a work RVU of 2.56 for CPT code 963X5, rather than the RUC-
recommended work RVU of 2.50; and a work RVU of 1.96 for CPT code 
963X6, rather than the RUC-recommended work RVU of 1.90. We see 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 963X5 and 963X6. 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 963X7-96X10. In our analysis, we find that 
the RUC-recommended PE refinements contributes significantly to the 
reduction in the overall payment for this code family. We see no 
compelling evidence that the quantities of testing forms used in a 
typical course of testing would have reduced dramatically and, in the 
interest of payment stability, we are proposing to refine the direct PE 
inputs for CPT codes 963X5-96X10 by including 1.0 quantity each of the 
supply items ``WAIS-IV Record Form,'' ``WAIS-IV Response Booklet #1'', 
and

[[Page 35771]]

``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 are 
seeking comment on our proposed work RVUs and proposed PE refinements 
for this family of services.
    For the direct PE inputs, we are proposing to remove the equipment 
time for the CANTAB Mobile (ED055) equipment item from CPT code 96X12. 
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 are unclear as to how the CANTAB Mobile would 
typically be used in this procedure, and we are proposing to remove the 
equipment time pending the submission of more data about the item. We 
are seeking additional information about the use of this item and how 
it should best be included into the PE methodology. We are 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.
(57) Electrocorticography (CPT Code 96X00)
    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 96X00 (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 disagree with the RUC-recommended work RVU of 2.30 for CPT code 
96X00 and are proposing 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 96X00. We 
agree with the survey respondents that CPT code 95957 is 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 are 
proposing 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 96X00.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 990X0, 
990X1, and 994X9)
    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 990X0 (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 990X1 
(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 are proposing the RUC-
recommended work RVU of 0.61 for CPT code 994X9 (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 are proposing to accept the RUC-
recommended direct PE inputs for CPT code 990X0 and to remove the 
``Monthly cellular and licensing service fee'' supply from CPT code 
990X1. We do not believe that these licensing fees would 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 
are proposing to remove this supply input as a form of indirect PE. We 
are proposing the direct PE inputs for CPT code 994X9 without 
refinement.
(59) Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 
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 are 
proposing to change the procedure status for CPT codes 99446, 99447, 
99448, and 99449 from B

[[Page 35772]]

(bundled) to A (active). We are also proposing 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 994X0 
(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 994X6 
(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 994X0 and 0.70 for 994X6. 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 are proposing a work RVU of 0.50 for 
both CPT codes 994X0 and 994X6.
    We welcome comments on this proposal. We also direct readers to 
section II.D. of this proposed rule, which includes additional detail 
regarding our proposed 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.
(60) Chronic Care Management Services (CPT Code 994X7)
    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 994X7 (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 994X7, 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 994X7 describes 30 minutes of physician 
time, we are proposing a work RVU of 1.22, which is double the work RVU 
of CPT code 99490.
    We are not proposing any direct PE refinements for this code 
family.
(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-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 are proposing 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 note that there is a significant 
disparity between the specialty recommendation and the final 
recommendation submitted by the HCPAC. We are 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 are proposing to maintain the 
current direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we 
will not add the new supply item ``20x30 inch self-stick easel pad, 
white, 30 sheets/pad'' (SK129) to HCPCS code G0109, as it is not a 
current supply for HCPCS code G0109; however, we are proposing to 
accept the submitted invoice price and to add the supply to our direct 
PE database.
(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 due to the belief that 
there is no physician work involved in this service. After reviewing 
this code, we are proposing a work RVU of 0.00 for HCPCS code G0166, 
and are proposing to make the code valued for PE only.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.

[[Page 35773]]

(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 disagree with the recommended value and we are proposing 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 do not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be 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 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 are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(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 are proposing the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
    For the direct PE inputs, we are proposing 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.
(65) Structured Assessment, Brief Intervention, and Referral to 
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and 
GSBR1)
    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.
    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 can be found here: 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 are proposing to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398. We welcome comments on our proposal to change the documentation 
requirements for these codes.
    Additionally, we are proposing to create a third HCPCS code, GSBR1, 
with a lower time threshold in order to accurately account for the 
resource costs when practitioners furnish these services, but do not 
meet the requirements of the existing codes. The proposed code 
descriptor is: Alcohol and/or substance (other than tobacco) abuse 
structured assessment (e.g., AUDIT, DAST), and brief intervention, 5-14 
minutes. We are proposing a work RVU of 0.33, based on the intraservice 
time ratio between HCPCS codes G0396 and G0397. We welcome comments on 
this code descriptor and proposed valuation for HCPCS code GSBR1.
(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 claim 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 proposed rule to implement a single PFS rate for E/M visit levels 
2-5 while maintaining payment stability across the specialties, we are 
proposing HCPCS code GPRO1 (Prolonged evaluation and management or 
psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the

[[Page 35774]]

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 note that we do not propose to make any changes to CPT codes 
99354 and 99355, which could still be billed, as needed, when their 
time thresholds and all other requirements are met. We are proposing a 
work RVU of 1.17, which is equal to half of the work RVU assigned to 
CPT code 99354. Additionally, we are proposing 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 proposed rule.
(67) Remote Pre-Recorded Services (HCPCS Code GRAS1)
    For CY 2019, we are proposing to make separate payment for remote 
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 GRAS1 (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 are 
proposing 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 GRAS1. Therefore, 
we are proposing a work RVU of 0.18, preservice time of 3 minutes, 
intraservice time of 4 minutes, and post service time of 2 minutes. We 
are also proposing to add 6 minutes of clinical labor (L037D) in the 
service period. We are seeking comment on the code descriptor and 
valuation for HCPCS code GRAS1. We direct readers to section II.D. of 
this proposed rule, which includes additional detail regarding our 
proposed policies for modernizing Medicare physician payment by 
recognizing communication technology-based services.
(68) Brief Communication Technology-Based Service, e.g., Virtual Check-
in (HCPCS Code GVCI1)
    We are proposing to create a G-code, HCPCS code GVCI1 (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 propose to base the code descriptor and 
valuation for HCPCS code GVCI1 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 GVCI1 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 are proposing a work RVU of 0.25, 
based on a direct crosswalk to CPT code 99441. For the direct PE inputs 
for HCPCS code GVCI1, we are also proposing the direct PE inputs 
assigned to CPT code 99441. Given the breadth of technologies that 
could be described as telecommunications, we look forward to 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 are seeking 
comment on the code descriptor, as well as the proposed valuation for 
HCPCS code GVCI1. We direct readers to section II.D. of this proposed 
rule, which includes additional detail regarding our proposed policies 
for modernizing Medicare physician payment by recognizing communication 
technology-based services.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code 
GCG0X)
    We are proposing 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 are proposing 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 interventional pain 
management-centered care (Add-on code, list separately in addition to 
an evaluation and management visit)). We are proposing 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 proposed rule. We are 
seeking comment on the code descriptor, as well as the proposed 
valuation for HCPCS code GCG0X.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code 
GPC1X)
    We are proposing 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

[[Page 35775]]

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 are proposing 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 proposed rule. We are seeking 
comment on the code descriptor, as well as the proposed valuation for 
HCPCS code GPC1X.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X 
and GPD1X)
    We are proposing 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 are proposing 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 proposed rule.
(72) Comment Solicitation on Superficial Radiation Treatment Planning 
and Management
    In the CY 2015 PFS final rule with comment period (79 FR 67666-
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 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-
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 and found that 
there was not general agreement among commenters about a 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 are not proposing changes relating to SRT coding, 
SRT-related professional codes, or payment policies for CY 2019. 
However, we are seeking 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 are seeking comment

[[Page 35776]]

on whether we should create such G codes to separately report each of 
the services described above, 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 are interested in public comment on whether it 
would be appropriate to create separate codes for professional services 
associated with SRT in a coding structure parallel to radiation 
treatment delivery services such as HCPCS code G6003. We are seeking 
comment on creating these codes for inclusion in this update of the 
PFS. We are also interested in whether such codes should be contractor 
priced for CY 2019. We would 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 
are soliciting 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.

             Table 13--CY 2019 Proposed Work RVUs for New, Revised, and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
                                                                                                   CMS time
       HCPCS             Descriptor        Current work  RVU   RUC work  RVU   CMS work  RVU      refinement
----------------------------------------------------------------------------------------------------------------
03X0T.............  Electroretinography   NEW...............               C            0.40  No.
                     (ERG) with
                     interpretation and
                     report, pattern
                     (PERG).
10021.............  Fine needle           1.27..............            1.20            1.03  No.
                     aspiration biopsy;
                     without imaging
                     guidance; first
                     lesion.
10X11.............  Fine needle           NEW...............            0.80            0.80  No.
                     aspiration biopsy;
                     without imaging
                     guidance; each
                     additional lesion.
10X12.............  Fine needle           NEW...............            1.63            1.46  No.
                     aspiration biopsy,
                     including
                     ultrasound
                     guidance; first
                     lesion.
10X13.............  Fine needle           NEW...............            1.00            1.00  No.
                     aspiration biopsy,
                     including
                     ultrasound
                     guidance; each
                     additional lesion.
10X14.............  Fine needle           NEW...............            1.81            1.81  No.
                     aspiration biopsy,
                     including
                     fluoroscopic
                     guidance; first
                     lesion.
10X15.............  Fine needle           NEW...............            1.18            1.18  No.
                     aspiration biopsy,
                     including
                     fluoroscopic
                     guidance; each
                     additional lesion.
10X16.............  Fine needle           NEW...............            2.43            2.26  No.
                     aspiration biopsy,
                     including CT
                     guidance; first
                     lesion.
10X17.............  Fine needle           NEW...............            1.65            1.65  No.
                     aspiration biopsy,
                     including CT
                     guidance; each
                     additional lesion.
10X18.............  Fine needle           NEW...............               C               C  No.
                     aspiration biopsy,
                     including MR
                     guidance; first
                     lesion.
10X19.............  Fine needle           NEW...............               C               C  No.
                     aspiration biopsy,
                     including MR
                     guidance; each
                     additional lesion.
11755.............  Biopsy of nail unit   1.31..............            1.25            1.08  No.
                     (e.g., plate, bed,
                     matrix,
                     hyponychium,
                     proximal and
                     lateral nail folds).
11X02.............  Tangential biopsy of  NEW...............            0.66            0.66  No.
                     skin, (e.g., shave,
                     scoop, saucerize,
                     curette), single
                     lesion.
11X03.............  Tangential biopsy of  NEW...............            0.38            0.29  No.
                     skin, (e.g., shave,
                     scoop, saucerize,
                     curette), each
                     separate/additional
                     lesion.
11X04.............  Punch biopsy of       NEW...............            0.83            0.83  No.
                     skin, (including
                     simple closure when
                     performed), single
                     lesion.
11X05.............  Punch biopsy of       NEW...............            0.45            0.45  No.
                     skin, (including
                     simple closure when
                     performed), each
                     separate/additional
                     lesion.
11X06.............  Incisional biopsy of  NEW...............            1.01            1.01  No.
                     skin (e.g., wedge),
                     (including simple
                     closure when
                     performed), single
                     lesion.
11X07.............  Incisional biopsy of  NEW...............            0.54            0.54  No.
                     skin (e.g., wedge),
                     (including simple
                     closure when
                     performed), each
                     separate/additional
                     lesion.
20551.............  Injection(s); single  0.75..............            0.75            0.75  No.
                     tendon origin/
                     insertion.
209X3.............  Allograft, includes   NEW...............           13.01           13.01  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     osteoarticular,
                     including articular
                     surface and
                     contiguous bone.
209X4.............  Allograft, includes   NEW...............           11.94           11.94  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     hemicortical
                     intercalary,
                     partial (i.e.,
                     hemicylindrical).

[[Page 35777]]

 
209X5.............  Allograft, includes   NEW...............           13.00           13.00  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     intercalary,
                     complete (i.e.,
                     cylindrical).
27X69.............  Injection procedure   NEW...............            0.96            0.77  No.
                     for contrast knee
                     arthrography or
                     contrast enhanced
                     CT/MRI knee
                     arthrography.
29105.............  Application of long   0.87..............            0.80            0.80  No.
                     arm splint
                     (shoulder to hand).
29540.............  Strapping; ankle and/ 0.39..............            0.39            0.39  No.
                     or foot.
29550.............  Strapping; toes.....  0.25..............            0.25            0.25  No.
31623.............  Bronchoscopy, rigid   2.63..............            2.63            2.63  No.
                     or flexible,
                     including
                     fluoroscopic
                     guidance, when
                     performed; with
                     brushing or
                     protected brushings.
31624.............  Bronchoscopy, rigid   2.63..............            2.63            2.63  No.
                     or flexible,
                     including
                     fluoroscopic
                     guidance, when
                     performed; with
                     bronchial alveolar
                     lavage.
332X0.............  Transcatheter         NEW...............            6.00            6.00  No.
                     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.
332X5.............  Insertion,            NEW...............            1.53            1.53  No.
                     subcutaneous
                     cardiac rhythm
                     monitor, including
                     programming.
332X6.............  Removal,              NEW...............            1.50            1.50  No.
                     subcutaneous
                     cardiac rhythm
                     monitor.
335X1.............  Replacement, aortic   NEW...............           64.00           64.00  No.
                     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).
33X01.............  Aortic hemiarch       NEW...............           19.74           19.74  No.
                     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.
33X05.............  Transcatheter         NEW...............            8.77            7.80  No.
                     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.
33X06.............  Transcatheter         NEW...............            9.56            8.59  No.
                     removal of
                     permanent leadless
                     pacemaker, right
                     ventricular.
36568.............  Insertion of          1.67..............            2.11            2.11  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, without
                     imaging guidance;
                     younger than 5
                     years of age.
36569.............  Insertion of          1.70..............            1.90            1.90  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, without
                     imaging guidance;
                     age 5 years or
                     older.
36584.............  Replacement,          1.20..............            1.47            1.20  No.
                     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.
36X72.............  Insertion of          NEW...............            2.00            1.82  No.
                     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.
36X73.............  Insertion of          NEW...............            1.90            1.70  No.
                     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.
3853X.............  Biopsy or excision    NEW...............            6.74            6.74  No.
                     of lymph node(s);
                     open,
                     inguinofemoral
                     node(s).
38792.............  Injection procedure;  0.52..............            0.65            0.65  No.
                     radioactive tracer
                     for identification
                     of sentinel node.

[[Page 35778]]

 
43X63.............  Replacement of        NEW...............            0.75            0.75  No.
                     gastrostomy tube,
                     percutaneous,
                     includes removal,
                     when performed,
                     without imaging or
                     endoscopic
                     guidance; not
                     requiring revision
                     of gastrostomy
                     tract.
43X64.............  Replacement of        NEW...............            1.41            1.41  No.
                     gastrostomy tube,
                     percutaneous,
                     includes removal,
                     when performed,
                     without imaging or
                     endoscopic
                     guidance; requiring
                     revision of
                     gastrostomy tract.
45300.............  Proctosigmoidoscopy,  0.80..............            0.80            0.80  No.
                     rigid; diagnostic,
                     with or without
                     collection of
                     specimen(s) by
                     brushing or washing
                     (separate
                     procedure).
46500.............  Injection of          1.42..............            2.00            1.74  No.
                     sclerosing
                     solution,
                     hemorrhoids.
49422.............  Removal of tunneled   6.29..............            4.00            4.00  No.
                     intraperitoneal
                     catheter.
50X39.............  Dilation of existing  NEW...............            3.37            2.78  No.
                     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.
50X40.............  Dilation of existing  NEW...............            5.44            4.83  Yes.
                     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.
52334.............  Cystourethroscopy     4.82..............            3.37            3.37  No.
                     with insertion of
                     ureteral guide wire
                     through kidney to
                     establish a
                     percutaneous
                     nephrostomy,
                     retrograde.
53850.............  Transurethral         10.08.............            5.42            5.42  No.
                     destruction of
                     prostate tissue; by
                     microwave
                     thermotherapy.
53852.............  Transurethral         10.83.............            5.93            5.93  No.
                     destruction of
                     prostate tissue; by
                     radiofrequency
                     thermotherapy.
538X3.............  Transurethral         NEW...............            5.93            5.70  No.
                     destruction of
                     prostate tissue; by
                     radiofrequency
                     generated water
                     vapor thermotherapy.
57150.............  Irrigation of vagina  0.55..............            0.50            0.50  No.
                     and/or application
                     of medicament for
                     treatment of
                     bacterial,
                     parasitic, or
                     fungoid disease.
57160.............  Fitting and           0.89..............            0.89            0.89  No.
                     insertion of
                     pessary or other
                     intravaginal
                     support device.
58100.............  Endometrial sampling  1.53..............            1.21            1.21  No.
                     (biopsy) with or
                     without
                     endocervical
                     sampling (biopsy),
                     without cervical
                     dilation, any
                     method (separate
                     procedure).
58110.............  Endometrial sampling  0.77..............            0.77            0.77  No.
                     (biopsy) performed
                     in conjunction with
                     colposcopy.
64405.............  Injection,            0.94..............            0.94            0.94  No.
                     anesthetic agent;
                     greater occipital
                     nerve.
64455.............  Injection(s),         0.75..............            0.75            0.75  No.
                     anesthetic agent
                     and/or steroid,
                     plantar common
                     digital nerve(s)
                     (e.g., Morton's
                     neuroma).
65205.............  Removal of foreign    0.71..............            0.49            0.49  No.
                     body, external eye;
                     conjunctival
                     superficial.
65210.............  Removal of foreign    0.84..............            0.75            0.61  No.
                     body, external eye;
                     conjunctival
                     embedded (includes
                     concretions),
                     subconjunctival, or
                     scleral
                     nonperforating.
67500.............  Retrobulbar           1.44..............            1.18            1.18  No.
                     injection;
                     medication
                     (separate
                     procedure, does not
                     include supply of
                     medication).
67505.............  Retrobulbar           1.27..............            1.18            0.94  No.
                     injection; &
                     alcohol.
67515.............  Injection of          1.40..............            0.84            0.75  No.
                     medication or other
                     substance into
                     Tenon's capsule.
72020.............  Radiologic            0.15..............            0.15            0.23  No.
                     examination, spine,
                     single view,
                     specify level.
72040.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     cervical; 2 or 3
                     views.
72050.............  Radiologic            0.31..............            0.31            0.23  No.
                     examination, spine,
                     cervical; 4 or 5
                     views.
72052.............  Radiologic            0.36..............            0.35            0.23  No.
                     examination, spine,
                     cervical; 6 or more
                     views.
72070.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, 2 views.
72072.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, 3 views.
72074.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, minimum
                     of 4 views.
72080.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracolumbar
                     junction, minimum
                     of 2 views.
72100.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     lumbosacral; 2 or 3
                     views.
72110.............  Radiologic            0.31..............            0.31            0.23  No.
                     examination, spine,
                     lumbosacral;
                     minimum of 4 views.
72114.............  Radiologic            0.32..............            0.31            0.23  No.
                     examination, spine,
                     lumbosacral;
                     complete, including
                     bending views,
                     minimum of 6 views.

[[Page 35779]]

 
72120.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     lumbosacral;
                     bending views only,
                     2 or 3 views.
72200.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination,
                     sacroiliac joints;
                     less than 3 views.
72202.............  Radiologic            0.19..............            0.18            0.23  No.
                     examination,
                     sacroiliac joints;
                     3 or more views.
72220.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination, sacrum
                     and coccyx, minimum
                     of 2 views.
73070.............  Radiologic            0.15..............            0.15            0.23  No.
                     examination, elbow;
                     2 views.
73080.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination, elbow;
                     complete, minimum
                     of 3 views.
73090.............  Radiologic            0.16..............            0.16            0.23  No.
                     examination;
                     forearm, 2 views.
73650.............  Radiologic            0.16..............            0.16            0.23  No.
                     examination;
                     calcaneus, minimum
                     of 2 views.
73660.............  Radiologic            0.13..............            0.13            0.23  No.
                     examination;
                     toe(s), minimum of
                     2 views.
74210.............  Radiologic            0.36..............            0.59            0.59  No.
                     examination;
                     pharynx and/or
                     cervical esophagus.
74220.............  Radiologic            0.46..............            0.67            0.67  No.
                     examination;
                     esophagus.
74230.............  Swallowing function,  0.53..............            0.53            0.53  No.
                     with
                     cineradiography/
                     videoradiography.
74420.............  Urography,            0.36..............            0.52            0.52  No.
                     retrograde, with or
                     without KUB.
74485.............  Dilation of           0.54..............            0.83            0.83  No.
                     ureter(s) or
                     urethra,
                     radiological
                     supervision and
                     interpretation.
76000.............  Fluoroscopy           0.17..............            0.30            0.30  No.
                     (separate
                     procedure), up to 1
                     hour physician or
                     other qualified
                     health care
                     professional time,
                     other than 71023 or
                     71034 (e.g.,
                     cardiac
                     fluoroscopy).
76514.............  Ophthalmic            0.17..............            0.17            0.14  No.
                     ultrasound,
                     diagnostic; corneal
                     pachymetry,
                     unilateral or
                     bilateral
                     (determination of
                     corneal thickness).
767X1.............  Ultrasound,           NEW...............            0.59            0.59  No.
                     elastography;
                     parenchyma (e.g.,
                     organ).
767X2.............  Ultrasound,           NEW...............            0.59            0.59  No.
                     elastography; first
                     target lesion.
767X3.............  Ultrasound,           NEW...............            0.50            0.50  No.
                     elastography; each
                     additional target
                     lesion.
76870.............  Ultrasound, scrotum   0.64..............            0.64            0.64  No.
                     and contents.
76942.............  Ultrasonic guidance   0.67..............            0.67            0.67  No.
                     for needle
                     placement (e.g.,
                     biopsy, fine needle
                     aspiration biopsy,
                     injection,
                     localization
                     device), imaging
                     supervision and
                     interpretation.
76X01.............  Magnetic resonance    NEW...............            1.29            1.10  No.
                     (e.g., vibration)
                     elastography.
76X0X.............  Ultrasound, targeted  NEW...............            1.62            1.27  No.
                     dynamic microbubble
                     sonographic
                     contrast
                     characterization
                     (non-cardiac);
                     initial lesion.
76X1X.............  Ultrasound, targeted  NEW...............            0.85            0.85  No.
                     dynamic microbubble
                     sonographic
                     contrast
                     characterization
                     (non-cardiac); each
                     additional lesion
                     with separate
                     injection.
77012.............  Computed tomography   1.16..............            1.50            1.50  No.
                     guidance for needle
                     placement (e.g.,
                     biopsy, aspiration,
                     injection,
                     localization
                     device),
                     radiological
                     supervision and
                     interpretation.
77021.............  Magnetic resonance    1.50..............            1.50            1.50  No.
                     guidance for needle
                     placement (e.g.,
                     for biopsy, fine
                     needle aspiration
                     biopsy, injection,
                     or placement of
                     localization
                     device)
                     radiological
                     supervision and
                     interpretation.
77081.............  Dual-energy X-ray     0.22..............            0.20            0.20  No.
                     absorptiometry
                     (DXA), bone density
                     study, 1 or more
                     sites; appendicular
                     skeleton
                     (peripheral) (e.g.,
                     radius, wrist,
                     heel).
77X49.............  Magnetic resonance    NEW...............            1.45            1.15  No.
                     imaging, breast,
                     without contrast
                     material;
                     unilateral.
77X50.............  Magnetic resonance    NEW...............            1.60            1.30  No.
                     imaging, breast,
                     without contrast
                     material; bilateral.
77X51.............  Magnetic resonance    NEW...............            2.10            1.80  No.
                     imaging, breast,
                     without and with
                     contrast
                     material(s),
                     including computer-
                     aided detection
                     (CAD-real time
                     lesion detection,
                     characterization
                     and pharmacokinetic
                     analysis) when
                     performed;
                     unilateral.
77X52.............  Magnetic resonance    NEW...............            2.30            2.00  No.
                     imaging, breast,
                     without and with
                     contrast
                     material(s),
                     including computer-
                     aided detection
                     (CAD-real time
                     lesion detection,
                     characterization
                     and pharmacokinetic
                     analysis) when
                     performed;
                     bilateral.
85060.............  Blood smear,          0.45..............            0.45            0.36  No.
                     peripheral,
                     interpretation by
                     physician with
                     written report.
85097.............  Bone marrow, smear    0.94..............            1.00            0.94  No.
                     interpretation.
85390.............  Fibrinolysins or      0.37..............            0.75            0.75  No.
                     coagulopathy
                     screen,
                     interpretation and
                     report.
92X71.............  Electroretinography   NEW...............            0.80            0.69  No.
                     (ERG) with
                     interpretation and
                     report; full field
                     (e.g., ffERG, flash
                     ERG, Ganzfeld ERG).
92X73.............  Electroretinography   NEW...............            0.72            0.61  No.
                     (ERG) with
                     interpretation and
                     report; multifocal
                     (mfERG).

[[Page 35780]]

 
93561.............  Indicator dilution    0.25..............            0.95            0.60  No.
                     studies such as dye
                     or thermodilution,
                     including arterial
                     and/or venous
                     catheterization;
                     with cardiac output
                     measurement.
93562.............  Indicator dilution    0.01..............            0.77            0.48  No.
                     studies such as dye
                     or thermodilution,
                     including arterial
                     and/or venous
                     catheterization;
                     subsequent
                     measurement of
                     cardiac output.
93571.............  Intravascular         1.80..............            1.50            1.38  No.
                     Doppler velocity
                     and/or pressure
                     derived coronary
                     flow reserve
                     measurement
                     (coronary vessel or
                     graft) during
                     coronary
                     angiography
                     including
                     pharmacologically
                     induced stress;
                     initial vessel.
93572.............  Intravascular         1.44..............            1.00            1.00  No.
                     Doppler velocity
                     and/or pressure
                     derived coronary
                     flow reserve
                     measurement
                     (coronary vessel or
                     graft) during
                     coronary
                     angiography
                     including
                     pharmacologically
                     induced stress;
                     each additional
                     vessel.
93668.............  Peripheral arterial   0.00..............            0.00            0.00  No.
                     disease (PAD)
                     rehabilitation, per
                     session.
93XX1.............  Remote monitoring of  NEW...............            0.70            0.70  No.
                     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.
95800.............  Sleep study,          1.05..............            1.00            0.85  No.
                     unattended,
                     simultaneous
                     recording; heart
                     rate, oxygen
                     saturation,
                     respiratory
                     analysis (e.g., by
                     airflow or
                     peripheral arterial
                     tone), and sleep
                     time.
95801.............  Sleep study,          1.00..............            1.00            0.85  No.
                     unattended,
                     simultaneous
                     recording; minimum
                     of heart rate,
                     oxygen saturation,
                     and/respiratory
                     analysis (e.g., by
                     airflow or
                     peripheral arterial
                     tone).
95806.............  Sleep study,          1.25..............            1.08            0.93  No.
                     unattended,
                     simultaneous
                     recording of, heart
                     rate, oxygen
                     saturation,
                     respiratory
                     airflow, and
                     respiratory effort
                     (e.g.,
                     thoracoabdominal
                     movement).
95970.............  Electronic analysis   0.45..............            0.45            0.35  No.
                     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.
95X83.............  Electronic analysis   NEW...............            0.95            0.73  No.
                     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.
95X84.............  Electronic analysis   NEW...............            1.19            0.97  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with complex
                     cranial nerve
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming by
                     physician or other
                     qualified health
                     care professional.

[[Page 35781]]

 
95X85.............  Electronic analysis   NEW...............            1.25            0.91  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with brain
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming, first
                     15 minutes face-to-
                     face time with
                     physician or other
                     qualified health
                     care professional.
95X86.............  Electronic analysis   NEW...............            1.00            0.80  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with brain
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming, each
                     additional 15
                     minutes face-to-
                     face time with
                     physician or other
                     qualified health
                     care professional.
96105.............  Assessment of         1.75..............            1.75            1.75  No.
                     aphasia (includes
                     assessment of
                     expressive and
                     receptive speech
                     and language
                     function, language
                     comprehension,
                     speech production
                     ability, reading,
                     spelling, writing,
                     e.g., by boston
                     diagnostic aphasia
                     examination) with
                     interpretation and
                     report, per hour.
96110.............  Developmental         0.00..............            0.00            0.00  No.
                     screening (e.g.,
                     developmental
                     milestone survey,
                     speech and language
                     delay screen) with
                     scoring and
                     documentation, per
                     standardized
                     instrument.
96116.............  Neurobehavioral       1.86..............            1.86            1.86  No.
                     status exam
                     (clinical
                     assessment of
                     thinking, reasoning
                     and judgment, e.g.,
                     acquired knowledge,
                     attention,
                     language, memory,
                     planning and
                     problem solving,
                     and visual spatial
                     abilities), by
                     physician or other
                     qualified health
                     care professional,
                     both face-to-face
                     time with the
                     patient and time
                     interpreting test
                     results and
                     preparing the
                     report; first hour.
96125.............  Standardized          1.70..............            1.70            1.70  No.
                     cognitive
                     performance testing
                     (e.g., ross
                     information
                     processing
                     assessment) per
                     hour of a qualified
                     health care
                     professional's
                     time, both face-to-
                     face time
                     administering tests
                     to the patient and
                     time interpreting
                     these test results
                     and preparing the
                     report.
96127.............  Brief emotional/      0.00..............            0.00            0.00  No.
                     behavioral
                     assessment (e.g.,
                     depression
                     inventory,
                     attention-deficit/
                     hyperactivity
                     disorder [ADHD]
                     scale), with
                     scoring and
                     documentation, per
                     standardized
                     instrument.
963X0.............  Developmental test    NEW...............            2.50            2.56  No.
                     administration
                     (including
                     assessment of fine
                     and/or gross motor,
                     language, cognitive
                     level, social,
                     memory and/or
                     executive functions
                     by standardized
                     developmental
                     instruments when
                     performed), by
                     physician or other
                     qualified health
                     care professional,
                     with interpretation
                     and report; first
                     hour.
963X1.............  Developmental test    NEW...............            1.10            1.16  No.
                     administration
                     (including
                     assessment of fine
                     and/or gross motor,
                     language, cognitive
                     level, social,
                     memory and/or
                     executive functions
                     by standardized
                     developmental
                     instruments when
                     performed), by
                     physician or other
                     qualified health
                     care professional,
                     with interpretation
                     and report; each
                     additional 30
                     minutes.
963X2.............  Neurobehavioral       NEW...............            1.71            1.71  No.
                     status exam
                     (clinical
                     assessment of
                     thinking, reasoning
                     and judgment, e.g.,
                     acquired knowledge,
                     attention,
                     language, memory,
                     planning and
                     problem solving,
                     and visual spatial
                     abilities), by
                     physician or other
                     qualified health
                     care professional,
                     both face-to-face
                     time with the
                     patient and time
                     interpreting test
                     results and
                     preparing the
                     report; each
                     additional hour.

[[Page 35782]]

 
963X3.............  Psychological         NEW...............            2.50            2.56  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; first
                     hour.
963X4.............  Psychological         NEW...............            1.90            1.96  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; each
                     additional hour.
963X5.............  Neuropsychological    NEW...............            2.50            2.56  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; first
                     hour.
963X6.............  Neuropsychological    NEW...............            1.90            1.96  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; each
                     additional hour.
963X7.............  Psychological or      NEW...............            0.55            0.55  No.
                     neuropsychological
                     test administration
                     and scoring by
                     physician or other
                     qualified health
                     care professional,
                     two or more tests,
                     any method, first
                     30 minutes.
963X8.............  Psychological or      NEW...............            0.46            0.46  No.
                     neuropsychological
                     test administration
                     and scoring by
                     physician or other
                     qualified health
                     care professional,
                     two or more tests,
                     any method, each
                     additional 30
                     minutes.
963X9.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test administration
                     and scoring by
                     technician, two or
                     more tests, any
                     method; first 30
                     minutes.
96X00.............  Electrocorticogram    NEW...............            2.30            1.98  No.
                     from an implanted
                     brain
                     neurostimulator
                     pulse generator/
                     transmitter,
                     including
                     recording, with
                     interpretation and
                     report, up to 30
                     days.
96X10.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test administration
                     and scoring by
                     technician, two or
                     more tests, any
                     method; each
                     additional 30
                     minutes.
96X11.............  Psychological or      NEW...............            0.51            0.51  No.
                     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.
96X12.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test
                     administration,
                     with single
                     automated
                     instrument via
                     electronic
                     platform, with
                     automated result
                     only.
990X0.............  Remote monitoring of  NEW...............            0.00            0.00  No.
                     physiologic
                     parameter(s) (e.g.,
                     weight, blood
                     pressure, pulse
                     oximetry,
                     respiratory flow
                     rate), initial; set-
                     up and patient
                     education on use of
                     equipment.
990X1.............  Remote monitoring of  NEW...............            0.00            0.00  No.
                     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.

[[Page 35783]]

 
99201.............  Office or other       0.48..............            0.48            0.48  No.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     problem focused
                     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
                     presenting
                     problem(s) are self
                     limited or minor.
                     Typically, 10
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99202.............  Office or other       0.93..............            0.93            1.90  Yes.
                     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;
                     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.
99203.............  Office or other       1.42..............            1.42            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     detailed history; A
                     detailed
                     examination;
                     Medical decision
                     making of low
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate severity.
                     Typically, 30
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99204.............  Office or other       2.43..............            2.43            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     comprehensive
                     history; A
                     comprehensive
                     examination;
                     Medical decision
                     making of moderate
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 45
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99205.............  Office or other       3.17..............            3.17            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     comprehensive
                     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.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 60
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99211.............  Office or other       0.18..............            0.18            0.18  No.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, that may
                     not require the
                     presence of a
                     physician or other
                     qualified health
                     care professional.
                     Usually, the
                     presenting
                     problem(s) are
                     minimal. Typically,
                     5 minutes are spent
                     performing or
                     supervising these
                     services.

[[Page 35784]]

 
99212.............  Office or other       0.48..............            0.48            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: A
                     problem focused
                     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
                     presenting
                     problem(s) are self
                     limited or minor.
                     Typically, 10
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99213.............  Office or other       0.97..............            0.97            1.22  Yes.
                     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;
                     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.
99214.............  Office or other       1.50..............            1.50            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: A
                     detailed history; A
                     detailed
                     examination;
                     Medical decision
                     making of moderate
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 25
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99215.............  Office or other       2.11..............            2.11            1.22  Yes.
                     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;
                     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.
99446.............  Interprofessional     B.................            0.35            0.35  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 5-10
                     minutes of medical
                     consultative
                     discussion and
                     review.
99447.............  Interprofessional     B.................            0.70            0.70  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 11-20
                     minutes of medical
                     consultative
                     discussion and
                     review.
99448.............  Interprofessional     B.................            1.05            1.05  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 21-30
                     minutes of medical
                     consultative
                     discussion and
                     review.

[[Page 35785]]

 
99449.............  Interprofessional     B.................            1.40            1.40  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 31
                     minutes or more of
                     medical
                     consultative
                     discussion and
                     review.
994X0.............  Interprofessional     NEW...............            0.50            0.50  No.
                     telephone/Internet/
                     electronic health
                     record referral
                     service(s) provided
                     by a treating/
                     requesting
                     physician or
                     qualified health
                     care professional,
                     30 minutes.
994X6.............  Interprofessional     NEW...............            0.70            0.50  No.
                     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.
994X7.............  CCM provided          NEW...............            1.45            1.22  No.
                     personally by a
                     physician/QHP.
994X9.............  Remote physiologic    NEW...............            0.61            0.61  No.
                     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.
G0108.............  Diabetes outpatient   0.90..............            0.90            0.90  No.
                     self-management
                     training services,
                     individual, per 30
                     minutes.
G0109.............  Diabetes outpatient   0.25..............            0.25            0.25  No.
                     self-management
                     training services,
                     group session (2 or
                     more), per 30
                     minutes.
G0166.............  External              0.07..............            0.00            0.00  No.
                     counterpulsation,
                     per treatment
                     session.
G0168.............  Wound closure         0.45..............            0.45            0.31  No.
                     utilizing tissue
                     adhesive(s) only.
G0268.............  Removal of impacted   0.61..............            0.61            0.61  No.
                     cerumen (one or
                     both ears) by
                     physician on same
                     date of service as
                     audiologic function
                     testing.
GCG0X.............  Visit complexity      NEW...............  ..............            0.25  No.
                     inherent to
                     evaluation and
                     management
                     associated with
                     endocrinology,
                     rheumatology,
                     hematology/
                     oncology, urology,
                     neurology,
                     obstetrics/
                     gynecology, allergy/
                     immunology,
                     otolaryngology, or
                     interventional pain
                     management-centered
                     care (Add-on code,
                     list separately in
                     addition to an
                     evaluation and
                     management visit).
GPC1X.............  Visit complexity      NEW...............  ..............            0.07  No.
                     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).
GPD0X.............  Podiatry services,    NEW...............  ..............            1.35  No.
                     medical examination
                     and evaluation with
                     initiation of
                     diagnostic and
                     treatment program,
                     new patient.
GPD1X.............  Podiatry services,    NEW...............  ..............            0.85  No.
                     medical examination
                     and evaluation with
                     initiation of
                     diagnostic and
                     treatment program,
                     established patient.
GPRO1.............  Prolonged evaluation  NEW...............  ..............            1.17  No.
                     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).
GRAS1.............  Remote pre-recorded   NEW...............  ..............            0.18  No.
                     service via
                     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.
GSBR1.............  Alcohol and/or        NEW...............  ..............            0.33  No.
                     substance (other
                     than tobacco) abuse
                     structured
                     assessment (e.g.,
                     audit, dast), and
                     brief intervention,
                     5-14 minutes.

[[Page 35786]]

 
GVCI1.............  Brief communication   NEW...............  ..............            0.25  No.
                     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.
----------------------------------------------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 35787]]

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[[Page 35788]]


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[[Page 35789]]


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[[Page 35790]]


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[[Page 35794]]


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[[Page 35795]]


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[[Page 35796]]


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[[Page 35799]]


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[[Page 35800]]


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[[Page 35801]]


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[[Page 35802]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.015


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[[Page 35807]]


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[[Page 35808]]


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[GRAPHIC] [TIFF OMITTED] TP27JY18.022


[[Page 35810]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.023


[[Page 35811]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.024


[[Page 35812]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.025


[[Page 35813]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.026


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[GRAPHIC] [TIFF OMITTED] TP27JY18.027


[[Page 35815]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.028


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[[Page 35820]]


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[[Page 35828]]


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[[Page 35829]]


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[[Page 35830]]


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BILLING CODE 4120-01-C

[[Page 35831]]



                                                      Table 15--Proposed CY 2019 Existing Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Estimated
                                                                                                                                                 non-
                                                                                                                                               facility
                                                                                                                                               allowed
              CPT/HCPCS codes                        Item name                  CMS code          Current    Updated    Percent   Number of    services
                                                                                                   price      price      change    invoices   for  HCPCS
                                                                                                                                                codes
                                                                                                                                              using this
                                                                                                                                                 item
--------------------------------------------------------------------------------------------------------------------------------------------------------
19085, 19086, 19287, 19288................  Breast MRI computer aided   EQ370..................       0.00       0.00                     1        2,466
                                             detection and biopsy
                                             guidance software.
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--Proposed CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Number of      NF allowed
             CPT/HCPCS codes                         Item name                       CMS code             Average  price     invoices        services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10X18, 10X19.............................  MREYE CHIBA BIOPSY NEEDLE...  SC106..........................           37.00               1               0
332X5....................................  subcutaneous cardiac rhythm   SA127..........................        5,032.50               4             280
                                            monitor system.
36X72, 36X73, 36584......................  Turbo-Ject PICC Line........  SD331..........................          170.00               1          24,402
538X3....................................  kit, Rezum delivery device..  SA128..........................        1,150.00               1             121
538X3....................................  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
767X1, 767X2, 767X3......................  sheer wave elastography       ED060..........................        9,600.00               1             493
                                            software.
76X01....................................  MR Elastography Package.....  EL050..........................      200,684.50               1             350
76X0X, 76X1X.............................  bubble contrast.............  SD332..........................          126.59               1              89
76X0X, 76X1X.............................  Ultrasound Contrast Imaging   ER108..........................        5,760.00               1              89
                                            Package.
77X51, 77X52.............................  CAD Software................  ED058..........................       17,200.00               0          36,675
77X49, 77X50, 77X51, 77X52...............  Breast coil.................  EQ388..........................       12,238.00               0          39,785
77X51, 77X52.............................  CAD Workstation (CPU + Color  ED056..........................       14,829.62               0          36,675
                                            Monitor).
85097....................................  slide stainer, automated,     EP121..........................        8,649.43               1          34,559
                                            hematology.
92X71....................................  Sleep mask..................  SK133..........................            9.95               1          10,266
92X71, 92X73.............................  mfERG and ffERG               EQ390..........................      102,400.00               1          25,602
                                            electrodiagnostic unit.
92X71, 92X73.............................  Contact lens electrode for    EQ391..........................        1,440.00               1          25,602
                                            mfERG and ffERG.
963X7, 963X8, 963X9, 96X10...............  WAIS-IV Record Form.........  SK130..........................            5.25               1         301,452
963X7, 963X8, 963X9, 96X10...............  WAIS-IV Response Booklet #1.  SK131..........................            3.30               1         301,452
963X7, 963X8, 963X9, 96X10...............  WMS-IV Response Booklet #2..  SK132..........................            2.00               1         301,452
963X7, 963X8, 963X9, 96X10...............  Wechsler Adult Intelligence   EQ387..........................          971.30               1         301,452
                                            Scale--Fourth Edition (WAIS-
                                            IV) Kit (less forms).
96X12....................................  CANTAB Mobile (per single     ED055..........................        2,800.00               1               0
                                            automated assessment).
990X1....................................  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--Proposed CY 2019 No PE Refinements
------------------------------------------------------------------------
               HCPCS                             Description
------------------------------------------------------------------------
10X11.............................  Fna bx w/o img gdn ea addl.
10X13.............................  Fna bx w/us gdn ea addl.
10X15.............................  Fna bx w/fluor gdn ea addl.
10X17.............................  Fna bx w/ct gdn ea addl.
10X18.............................  Fna bx w/mr gdn 1st les.
10X19.............................  Fna bx w/mr gdn ea addl.
332X0.............................  Tcat impl wrls p-art prs snr.
332X5.............................  Insj subq car rhythm mntr.
332X6.............................  Rmvl subq car rhythm mntr.

[[Page 35832]]

 
33X05.............................  Tcat insj/rpl perm ldls pm.
33X06.............................  Tcat rmvl perm ldls pm.
36568.............................  Insj picc <5 yr w/o imaging.
36569.............................  Insj picc 5 yr+ w/o imaging.
36584.............................  Compl rplcmt picc rs&i.
3853X.............................  Open bx/exc inguinofem nodes.
49422.............................  Remove tunneled ip cath.
50X39.............................  Dilat xst trc ndurlgc px.
50X40.............................  Dilat xst trc new access rcs.
53850.............................  Prostatic microwave thermotx.
53852.............................  Prostatic rf thermotx.
538X3.............................  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.
767X3.............................  Use ea addl target lesion.
76942.............................  Echo guide for biopsy.
77081.............................  Dxa bone density/peripheral.
93668.............................  Peripheral vascular rehab.
93XX1.............................  Rem mntr wrls p-art prs snr.
95800.............................  Slp stdy unattended.
95801.............................  Slp stdy unatnd w/anal.
95806.............................  Sleep study unatt&resp efft.
95970.............................  Alys npgt w/o prgrmg.
95X83.............................  Alys smpl cn npgt prgrmg.
95X84.............................  Alys cplx cn npgt prgrmg.
95X85.............................  Alys brn npgt prgrmg 15 min.
95X86.............................  Alys brn npgt prgrmg addl 15.
96105.............................  Assessment of aphasia.
96110.............................  Developmental screen w/score.
96116.............................  Neurobehavioral status exam.
96125.............................  Cognitive test by hc pro.
96127.............................  Brief emotional/behav assmt.
963X0.............................  Devel tst phys/qhp 1st hr.
963X1.............................  Devel tst phys/qhp ea addl.
963X2.............................  Nubhvl xm phy/qhp ea addl hr.
963X3.............................  Psycl tst eval phys/qhp 1st.
963X4.............................  Psycl tst eval phys/qhp ea.
96X00.............................  Ecog impltd brn npgt  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

[[Page 35833]]

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).
---------------------------------------------------------------------------



                 Table 18--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit
----------------------------------------------------------------------------------------------------------------
         Key component *            Level 2 (1995)      Level 3 (1995)      Level 2 (1997)      Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present       Review of Systems   Problem Pertinent   No change from      No change from
 Illness or HPI).                  (ROS) n/a.          ROS: Inquires       1995.               1995.
                                                       about the system
                                                       directly related
                                                       to the problem(s)
                                                       identified in the
                                                       HPI.
Physical Examination (Exam).....  A limited           A limited           General multi-      General multi-
                                   examination of      examination of      system exam:        system exam:
                                   the affected body   the affected body   Performance and     Performance and
                                   area or organ       area or organ       documentation of    documentation of
                                   system.             system and other    one to five         at least six
                                                       symptomatic or      elements in one     elements in one
                                                       related organ       or more organ       or more organ
                                                       system(s).          system(s) or body   system(s) or body
                                                                           area(s).            area(s).
                                                                          Single organ        Single organ
                                                                           system exam:        system exam:
                                                                           Performance and     Performance and
                                                                           documentation of    documentation of
                                                                           one to five         at least six
                                                                           elements.           elements.
                                                                         ---------------------------------------
Medical Decision Making (MDM)     Straightforward:    Low complexity:              No change from 1995.
 Measured by: **
    1. Problem--Number of            1. Minimal.....  1. Limited.
     diagnoses/treatment options.
    2. Data--Amount and/or           2. Minimal or    2. Limited data
     complexity of data to be         no data review.  review.
     reviewed.
    3. Risk--Risk of                 3. Minimal risk  3. Low risk.
     complications and/or
     morbidity or mortality.
----------------------------------------------------------------------------------------------------------------
 * For certain settings and patient types, each of these three key components must be met or exceeded (for
  example, new patients; initial hospital visits). For others, only two of the three key components must be met
  or exceeded (for example, established patients, subsequent hospital or other visits).
** Two of three met or exceeded.

    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to 
select the code for the service based upon the content of the service. 
The duration of the visit is an ancillary factor and does not control 
the level of the service to be billed unless more than 50 percent of 
the face-to-face time (for non-inpatient services) or more than 50 
percent of the floor time (for inpatient services) is spent providing 
counseling or coordination of care as described in subsection C.'' 
Subsection C states that ``the physician may document time spent with 
the patient in conjunction with the medical decision-making involved 
and a description of the coordination of care or counseling provided. 
Documentation must be in sufficient detail to support the claim.'' The 
example included in subsection C further states, ``The code selection 
is based on the total time of the face-to-face encounter or floor time, 
not just the counseling time. The medical record must be documented in 
sufficient detail to justify the selection of the specific code if time 
is the basis for selection of the code.''
    Both the 1995 and 1997 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 proposed rule are housed separately within Medicare's 
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.

[[Page 35834]]

    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. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 30.6.1A, 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 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 
substantial 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 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 stakeholders 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 believed 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 Proposed Policies
    Having considered the public feedback to the CY 2018 PFS proposed 
rule (82 FR 53163 through 53166) and our other outreach efforts 
described above, we are proposing several changes to E/M visit 
documentation and

[[Page 35835]]

payment. The proposed changes would only apply to office/outpatient 
visit codes (CPT codes 99201 through 99215), except where we specify 
otherwise. We agree with commenters that we should take a step-wise 
approach to these issues, and therefore, we would limit initial changes 
to the office/outpatient E/M code set. We understand 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 wish to emphasize that, this year, we are including 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 
believe our proposed documentation changes for E/M visits are 
intrinsically related to our proposal to alter PFS payment for E/M 
visits (discussed below), and the PFS payment proposal for E/M visits 
requires notice and comment rulemaking. We note that we are proposing a 
relatively broad outline of changes in this proposed rule, and we 
anticipate 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.
a. Lifting Restrictions Related to E/M Documentation
(i) Eliminating Extra Documentation Requirements for Home Visits
    Medicare pays for E/M visits furnished in the home (a private 
residence) under CPT codes 99341 through 99350. The payment rates for 
these codes are slightly more than for office visits (for example, 
approximately $30 more for a level 5 established patient, non-
facility). The beneficiary need not be confined to the home to be 
eligible for such a visit. However, there is a Medicare Claims 
Processing Manual provision requiring that the medical record must 
document the medical necessity of the home visit made in lieu of an 
office or outpatient visit (Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.14.1.B, available on the CMS website 
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). Stakeholders have suggested that whether a 
visit occurs in the home or the office is best determined by the 
practitioner and the patient without applying additional rules. We 
agree, so we are proposing to remove the requirement that the medical 
record must document the medical necessity of furnishing the visit in 
the home rather than in the office. We welcome public comments on this 
proposal, including any potential, unintended consequences of 
eliminating this requirement. If we finalize this proposal in the CY 
2019 PFS final rule, we would update the manual to reflect the change.
(ii) Public Comment Solicitation on Eliminating Prohibition on Billing 
Same-Day Visits by Practitioners of the Same Group and Specialty
    The Medicare Claims Processing Manual states, ``As for all other E/
M services except where specifically noted, the Medicare Administrative 
Contractors (MACs) may not pay two E/M office visits billed by a 
physician (or physician of the same specialty from the same group 
practice) for the same beneficiary on the same day unless the physician 
documents that the visits were for unrelated problems in the office, 
off campus-outpatient hospital, or on campus-outpatient hospital 
setting which could not be provided during the same encounter'' (Pub. 
100-04, Medicare Claims Processing Manual, Chapter 12, Section 
30.6.7.B, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    This instruction was intended to reflect the idea that multiple 
visits with the same practitioner, or by practitioners in the same or 
very similar specialties within a group practice, on the same day as 
another E/M service would not be medically necessary. However, 
stakeholders have provided a few examples where this policy does not 
make sense with respect to the current practice of medicine as the 
Medicare enrollment specialty does not always coincide with all areas 
of medical expertise possessed by a practitioner--for example, a 
practitioner with the Medicare enrollment specialty of geriatrics may 
also be an endocrinologist. If such a practitioner was one of many 
geriatricians in the same group practice, they would not be able to 
bill separately for an E/M visit focused on a patient's 
endocrinological issue if that patient had another more generalized E/M 
visit by another geriatrician on the same day. Stakeholders have 
pointed out that in these circumstances, practitioners often respond to 
this instruction by scheduling the E/M visits on two separate days, 
which could unnecessarily inconvenience the patient. Given that the 
number and granularity of practitioner specialties recognized for 
purposes of Medicare enrollment continue to increase over time 
(consistent with the medical community's requests), the value to the 
Medicare program of the prohibition on same-day E/M visits billed by 
physicians in the same group and medical specialty may be diminishing, 
especially as we believe it is becoming more common for practitioners 
to have multiple specialty affiliations, but would have only one 
primary Medicare enrollment specialty. We believe that eliminating this 
policy may better recognize the changing practice of medicine while 
reducing administrative burden. The impact of this proposal on program 
expenditures and beneficiary cost sharing is unclear. To the extent 
that many of these services are currently merely scheduled and 
furnished on different days in response to the instruction, eliminating 
this manual provision may not significantly increase utilization, 
Medicare spending and beneficiary cost sharing.
    We are soliciting public comment on whether we should eliminate the 
manual provision given the changes in the practice of medicine or 
whether there is concern that eliminating it might have unintended 
consequences for practitioners and beneficiaries. We recognize that 
this instruction may be appropriate only in certain clinical 
situations, so we seek public comments on whether and how we should 
consider creating exceptions to, or modify this manual provision rather 
than eliminating it entirely. We are also requesting that the public 
provide additional examples and situations in which the current 
instruction is not clinically appropriate.
b. Documentation Changes for Office or Other Outpatient E/M Visits and 
Home Visits
(i) Providing Choices in Documentation--Medical Decision-Making, Time 
or Current Framework
    Informed by comments and examples that we have received asserting 
that the current E/M documentation guidelines

[[Page 35836]]

are outdated with respect to the current practice of medicine, and in 
our efforts to simplify documentation for the purposes of coding E/M 
visit levels, we propose to allow practitioners to choose, as an 
alternative to the current framework specified under the 1995 or 1997 
guidelines, either MDM or time as a basis to determine the appropriate 
level of E/M visit. This would allow different practitioners in 
different specialties to choose to document the factor(s) that matter 
most given the nature of their clinical practice. It would also reduce 
the impact Medicare may have on the standardized recording of history, 
exam and MDM data in medical records, since practitioners could choose 
to no longer document many aspects of an E/M visit that they currently 
document under the 1995 or 1997 guidelines for history, physical exam 
and MDM. While we initially considered reducing the number of key 
components that practitioners needed to document in choosing the 
appropriate level of E/M service to bill, feedback from the stakeholder 
community led us to believe that offering practitioners a choice to 
either retain the current framework or choose among new options that 
involve a reduced level of documentation would be less burdensome for 
practitioners, and would allow more stability for practitioners who may 
need time to prepare for any potential new documentation framework.
    We wish to be clear that as part of this proposal, practitioners 
could use MDM, or time, or they could continue to use the current 
framework to document an E/M visit. In other words, we would be 
offering the practitioner the choice to continue to use the current 
framework by applying the 1995 or 1997 documentation guidelines for all 
three key components. However, our proposals on payment for office-
based/outpatient E/M visits described later in this section would apply 
to all practitioners, regardless of their selected documentation 
approach. All practitioners, even those choosing to retain the current 
documentation framework, would be paid at the proposed new payment rate 
described in section II.I.2.c. of this proposed rule (one rate for new 
patients and another for established patients), and could also report 
applicable G-codes proposed in that section.
    We also wish to be clear that we are proposing to retain the 
current CPT coding structure for E/M visits (along with creating new 
replacement codes for podiatry office/outpatient E/M visits) as 
described later in this section. Practitioners would report on the 
professional claim whatever level of visit (1 through 5) they believe 
they furnished using CPT codes 99201-99215. We considered making an 
alternative proposal to adopt a single G-code to describe office/
outpatient E/M visit levels 2 through 5 in conjunction with our 
proposal to establish a single PFS payment rate for those visits that 
is described later in this section. Because we believe the adoption of 
a reduced number of G-codes to describe the visit levels 2 through 5 
might result in unnecessary disruption to current billing systems and 
practices, we are not proposing to modify the existing CPT coding 
structure for E/M visits. Since we are proposing to create a single 
rate under the PFS that would be paid for services billed using the 
current CPT codes for level 2 through 5 E/M visits, it would not be 
material to Medicare's payment decision which CPT code (of levels 2 
through 5) is reported on the claim, except to justify billing a level 
2 or higher visit in comparison to a level 1 visit (provided the visit 
itself was reasonable and necessary). We expect that, for record 
keeping purposes or to meet requirements of other payers, many 
practitioners would continue to choose and report the level of E/M 
visit they believe to be appropriate under the CPT coding structure.
    Even though there would be no payment differential for E/M visits 
level 2 through 5, we believe we would still need to simplify and 
change our documentation requirements to better align with the current 
practice of medicine and eliminate unnecessary aspects of the current 
documentation framework. As a corollary to our proposal to adopt a 
single payment amount for office/outpatient E/M visit levels 2 through 
5 (see section II.I.2.c. of this proposed rule), we propose to apply a 
minimum documentation standard where, for the purposes of PFS payment 
for an office/outpatient E/M visit, practitioners would only need to 
meet documentation requirements currently associated with a level 2 
visit for history, exam and/or MDM (except when using time to document 
the service, see below). Practitioners could choose to document more 
information for clinical, legal, operational or other purposes, and we 
anticipate that for those reasons, they would continue generally to 
seek to document medical record information that is consistent with the 
level of care furnished. For purposes of our medical review, however, 
for practitioners using the current documentation framework or, as we 
are proposing, MDM, Medicare would only require documentation to 
support the medical necessity of the visit and the documentation that 
is associated with the current level 2 CPT visit code.
    For example, for a practitioner choosing to document using the 
current framework (1995 or 1997 guidelines), our proposed minimum 
documentation for any billed level of E/M visit from levels 2 through 5 
could include: (1) A problem-focused history that does not include a 
review of systems or a past, family, or social history; (2) a limited 
examination of the affected body area or organ system; and (3) 
straightforward medical decision making measured by minimal problems, 
data review, and risk (two of these three). If the practitioner was 
choosing to document based on MDM alone, Medicare would only require 
documentation supporting straightforward medical decision-making 
measured by minimal problems, data review, and risk (two of these 
three).
    Some commenters have suggested that the current framework of 
guidelines for the MDM component of visits would need to be changed 
before MDM could be relied upon by itself to distinguish visit levels. 
We propose to allow practitioners to rely on MDM in its current form to 
document their visit, and are soliciting public comment on whether and 
how guidelines for MDM might be changed in subsequent years.
    As described earlier, we currently allow time or duration of visit 
to be used as the governing factor in selecting the appropriate E/M 
visit level, only 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). 
Our proposal to allow practitioners the choice of using time to 
document office/outpatient E/M visits would mean that this time-based 
standard is not limited to E/M visits in which counseling and/or care 
coordination accounts for more than 50 percent of the face-to-face 
practitioner/patient encounter. Rather, the amount of time personally 
spent by the billing practitioner face-to-face with the patient could 
be used to document the E/M visit regardless of the amount of 
counseling and/or care coordination furnished as part of the face-to-
face encounter.
    Some commenters have raised concerns with reliance on time to 
distinguish visit levels, for example the potential for abuse, 
inequities among more- or less-efficient practitioners, and specialties 
for which time is less of a factor in determining visit complexity. 
Relying on time as the basis for

[[Page 35837]]

identifying the E/M visit level also raises the issue of what would be 
required by way of supporting documentation; for example, what amount 
of time should be documented, and whether the specific activities 
comprising the time need to be documented and to what degree. However, 
a number of stakeholders have suggested that, within their specialties, 
time is a good indicator of the complexity of the visit or patient, and 
requested that we allow practitioners to use time as the single factor 
in all E/M visits, not just when counseling or care coordination 
dominate a visit. We agree that for some practitioners and patients, 
time may be a good indicator of complexity of the visit, and are 
proposing to allow practitioners the option to use time as the single 
factor in selecting visit level and documenting the E/M visit, 
regardless of whether counseling or care coordination dominate the 
visit. If finalized, we would monitor the results of this proposed 
policy for any program integrity issues, administrative burden or other 
issues.
    For practitioners choosing to support their coding and payment for 
an E/M visit by documenting the amount of time spent with the patient, 
we propose to require the practitioner to document the medical 
necessity of the visit and show the total amount of time spent by the 
billing practitioner face-to-face with the patient. We are soliciting 
public comment on what that total time should be for payment of the 
single, new rate for E/M visits levels 2 through 5. The typical time 
for our proposed new payment for E/M visit levels 2 through 5 is 31 
minutes for an established patient and 38 minutes for a new patient, 
and we could use these times. These times are weighted averages of the 
intra-service times across the current E/M visit utilization. 
Accordingly, these times are higher than the current typical time for a 
level 2, 3 or 4 visit, but lower than the current typical time for a 
level 5 visit. We note that currently the PFS does not require the 
practitioner to spend or document a specified amount of time with a 
given patient in order to receive payment for an E/M visit, unless the 
visit is dominated by counseling/care coordination and, on that 
account, the practitioner is using time as the basis for code 
selection. The times for E/M visits and most other PFS services in the 
physician time files, which are used to set PFS rates, are typical 
times rather than requirements, and were recommended by the AMA RUC and 
then reviewed and either adopted or adjusted for Medicare through our 
usual rate setting process as ``typical,'' but not strictly required.
    One alternative is to apply the AMA's CPT codebook provision that, 
for timed services, a unit of time is attained when the mid-point is 
passed,\5\ such that we would require documentation that at least 16 
minutes for an established patient (more than half of 31 minutes) and 
at least 20 minutes for a new patient (more than half of 38 minutes) 
were spent face-to-face by the billing practitioner with the patient, 
to support making payment at the proposed single rate for visit levels 
2 through 5 when the practitioner chooses to document the visit using 
time.
---------------------------------------------------------------------------

    \5\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

    Another alternative is to require documentation that the typical 
time for the CPT code that is reported (which is also the typical time 
listed in the AMA's CPT codebook for that code) was spent face-to-face 
by the billing practitioner with the patient. For example, a 
practitioner reporting CPT code 99212 (a level 2 established patient 
visit) would be required to document having spent a minimum of 10 
minutes, and a practitioner reporting CPT code 99214 (a level 4 
established patient visit) would be required to document having spent a 
minimum of 25 minutes. Under this approach, the total amount of time 
spent by the billing practitioner face-to-face with the patient would 
inform the level of E/M visit (of levels 2 through 5) coded by the 
billing practitioner. We note that in contrast to other proposed 
documentation approaches discussed above, this approach of requiring 
documentation of the typical time associated with the CPT visit code 
reported on the claim would introduce unique payment implications for 
reporting that code, especially when the time associated with the 
billed E/M code is the basis for reporting prolonged E/M services.
    We are soliciting public comments on the use of time as a framework 
for documentation of office/outpatient E/M visits, and whether we 
should adopt any of these approaches or specify other requirements with 
respect to the proposed option for documentation using time.
    In providing us with feedback, we ask commenters to take into 
consideration ways in which the time associated with, or required for, 
the billing of any add-on codes (especially the proposed prolonged E/M 
visit add-on code(s) described in section II.I.2.d.v. of this proposed 
rule) would intersect with the time spent for the base E/M visit, when 
the practitioner is documenting the E/M visit using only time. 
Currently, when reporting prolonged E/M services, we expect the 
practitioner to exceed the typical time assigned for the base E/M visit 
code (also commonly referred to as the companion code). For example, in 
the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for 
the commenters' suggestion to display the typical times associated with 
relevant services. We also discussed, and in response to those 
comments, decided to post a file annually that notes the times assumed 
to be typical for purposes of PFS ratesetting for practitioners to use 
as a reference in deciding whether time requirements for reporting 
prolonged E/M services are met. We stated that while these typical 
times are not required for a practitioner to bill the displayed base 
codes, we would expect that only time spent in excess of these times 
would be reported using a non-face-to-face prolonged service code. We 
are now proposing to formalize this policy in the case where a 
practitioner uses time to document a visit, since there would be a 
stricter time requirement associated with the base E/M code. 
Specifically, we propose that, when a practitioner chooses to document 
using time 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. See section II.I.2.d.v. of this proposed 
rule for further discussion of our proposal regarding reporting 
prolonged E/M services.
    As we discuss further in this section of the proposed rule, we 
believe that allowing practitioners to choose the most appropriate 
basis for distinguishing among the levels of E/M visits and applying a 
minimum documentation requirement, together with reducing the payment 
variation among E/M visit levels, would significantly reduce 
administrative burden for practitioners, and would avoid the current 
need to make coding and documentation decisions based on codes and 
documentation guidelines that are not a good fit with current medical 
practice. The practitioner could choose to use MDM, time or the current 
documentation framework, and could also apply the proposed policies 
below regarding redundancy and who can document information in the 
medical record.
    We heard from a few commenters on the CY 2018 PFS proposed rule 
that some practitioners rely on unofficial Marshfield clinic or other 
criteria to help them document E/M visit levels. These commenters 
conveyed that the

[[Page 35838]]

Marshfield ``point system'' is commonly used to supplement the E/M 
documentation guidelines, because of a lack of concrete criteria for 
certain elements of medical decision making in the 1995 and 1997 
guidelines or in CPT guidance. We are soliciting public comment on 
whether Medicare should use or adopt any aspects of other E/M 
documentation systems that may be in use among practitioners, such as 
the Marshfield tool. We are interested in feedback as to whether the 
1995 and 1997 guidelines contain adequate information for practitioners 
to use in documenting visits under our proposals, or whether these 
versions of the guidelines would need to be supplemented in any way.
    We are seeking public comment on these proposals to provide 
practitioners choice in the basis for documenting E/M visits in an 
effort to allow for documentation alternatives that better reflect the 
current practice of medicine and to alleviate documentation burden. We 
are also interested in public comments on practitioners' ability to 
avail themselves of these choices with respect to how they would impact 
clinical workflows, EHR templates, and other aspects of practitioner 
work. Commenters have requested that CMS not merely shift burden by 
implementing another framework that might avoid issues caused by the 
current guidelines, but that would be equally complex and burdensome. 
Our primary goal is to reduce administrative burden so that the 
practitioner can focus on the patient, and we are interested in 
commenters' opinions as to whether our E/M visit proposals would, in 
fact, support and further this goal. We believe these proposals would 
allow practitioners to exercise greater clinical judgment and 
discretion in what they document, focusing on what is clinically 
relevant and medically necessary for the patient. While we propose to 
no longer apply much of the E/M documentation guidelines involving 
history, exam and, for those choosing to document based on time, 
documentation of medical decision-making, our expectation is that 
practitioners would continue to perform and document E/M visits as 
medically necessary for the patient to ensure quality and continuity of 
care. For example, we believe that it remains an important part of care 
for the practitioner to understand the patient's social history, even 
though we would no longer require that history to be documented to bill 
Medicare for the visit.
(ii) Removing Redundancy in E/M Visit Documentation
    Stakeholders have recently expressed that CMS should not require 
documentation of information in the billing practitioner's note that is 
already present in the medical record, particularly with regard to 
history and exam. Currently, both the 1995 and 1997 guidelines provide 
such flexibility for certain parts of the history for established 
patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent 
past, family, and/or social history ``PFSH'' obtained during an earlier 
encounter does not need to be re-recorded if there is evidence that the 
physician reviewed and updated the previous information. This may occur 
when a physician updates his/her own record or in an institutional 
setting or group practice where many physicians use a common record. 
The review and update may be documented by:
     Describing any new ROS and/or PFSH information or noting 
there has been no change in the information; and
     Noting the date and location of the earlier ROS and/or 
PFSH.
    Documentation Guidelines ``DG'': The ROS and/or PFSH may be 
recorded by ancillary staff or on a form completed by the patient. To 
document that the physician reviewed the information, there must be a 
notation supplementing or confirming the information recorded by others 
(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).
    We propose to expand this policy to further simplify the 
documentation of history and exam for established patients such that, 
for both of these key components, practitioners would only be required 
to focus their documentation on what has changed since the last visit 
or on pertinent items that have not changed, rather than re-documenting 
a defined list of required elements such as review of a specified 
number of systems and family/social history. Since medical decision-
making can only be accurately formed upon a substantial basis of 
accurate and timely health information, and the CPT code descriptors 
for all E/M visits would continue to include the elements of history 
and exam, we expect that practitioners would still conduct clinically 
relevant and medically necessary elements of history and physical exam, 
and conform to the general principles of medical record documentation 
in the 1995 and 1997 guidelines. However, practitioners would not need 
to re-record these elements (or parts thereof) if there is evidence 
that the practitioner reviewed and updated the previous information.
    We are seeking comment on whether there may be ways to implement a 
similar provision for any aspects of medical decision-making, or for 
new patients, such as when prior data is available to the billing 
practitioner through an interoperable EHR or other data exchange. We 
believe there would be special challenges in realizing documentation 
efficiencies with new patients, since they may not have received exams 
or histories that were complete or relevant to the current 
complaint(s), and the information in the transferred record could be 
more likely to be incomplete, outdated or inaccurate.
    Also, we propose that for both new and established patients, 
practitioners would no longer be required to re-enter information in 
the medical record regarding the chief complaint and history that are 
already entered by ancillary staff or the beneficiary. The practitioner 
could simply indicate in the medical record that they reviewed and 
verified this information. We wish to be clear that these proposed 
policy changes would be optional, where a practitioner could choose to 
continue to use the current framework, and the more detailed 
information could continue to be entered, re-entered or brought forward 
in documenting a visit, regardless of the documentation approach 
selected by the practitioner. Our goal is to allow practitioners more 
flexibility to exercise greater clinical judgment and discretion in 
what they document, focusing on what is clinically relevant and 
medically necessary for the patient. Our expectation is that 
practitioners would continue to periodically review and assess static 
or baseline historical information at clinically appropriate intervals.
(iii) Podiatry Visits
    As described in greater detail in section II.I.2.d.iii. of this 
proposed rule, as part of our proposal to improve payment accuracy by 
creating a single PFS payment rate for E/M visit levels 2 through 5 
(with one proposed rate for new patients and one proposed rate for 
established patients), we propose to create separate coding for 
podiatry visits that are currently reported as E/M office/outpatient 
visits. We propose that, rather than reporting visits under the general 
E/M office/outpatient visit

[[Page 35839]]

code set, podiatrists would instead report visits under new G-codes 
that more specifically identify and value their services. We propose to 
apply substantially the same documentation standards for these proposed 
new podiatry-specific codes as we propose above for other office/
outpatient E/M visits.
    If a practitioner chose to use time to document a podiatry office/
outpatient E/M visit, we propose to apply substantially the same rules 
as those we are proposing for documenting on the basis of time for 
other office/outpatient E/M visits, discussed above. For practitioners 
choosing to use time to provide supporting documentation for the 
podiatry visit, we would require documentation supporting the medical 
necessity of the visit and showing the total amount of time spent by 
the billing practitioner face-to-face with the patient. We are 
soliciting public comment on what that total time would be for payment 
of the proposed new podiatry G-codes. The typical times for these 
proposed codes are 22 minutes for an established patient and 28 minutes 
for a new patient, and we could use these times. Alternatively, we 
could apply the AMA's CPT codebook provision that, for timed services, 
a unit of time is attained when the mid-point is passed,\6\ such that 
we would require documentation that at least 12 minutes for an 
established patient (more than half of 22 minutes) or at least 15 
minutes for a new patient (more than half of 28 minutes) were spent 
face-to-face by the billing practitioner with the patient, to support 
making payment for these codes when the practitioner chooses to 
document the visit using time. We are soliciting comment on the use of 
time as a basis for documentation of our proposed podiatric E/M visit 
codes, and whether we should adopt any of these approaches or further 
specify other requirements with respect to this proposed option for 
podiatric practitioners to document their visits using time.
---------------------------------------------------------------------------

    \6\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

c. Minimizing Documentation Requirements by Simplifying Payment Amounts
    As we have explained above, including in prior rulemaking, we 
believe that the coding, payment, and documentation requirements for E/
M visits are overly burdensome and no longer aligned with the current 
practice of medicine. We believe the current set of 10 CPT codes for 
new and established office-based and outpatient E/M visits and their 
respective payment rates no longer appropriately reflect the complete 
range of services and resource costs associated with furnishing E/M 
services to all patients across the different physician specialties, 
and that documenting these services using the current guidelines has 
become burdensome and out of step with the current practice of 
medicine. We have included the proposals described above to mitigate 
the burden associated with the outdated documentation guidelines for 
these services. To alleviate the effects and mitigate the burden 
associated with continued use of the outdated CPT code set, we are 
proposing to simplify the office-based and outpatient E/M payment rates 
and documentation requirements, and create new add-on codes to better 
capture the differential resources involved in furnishing certain types 
of E/M visits.
    In conjunction with our proposal to reduce the documentation 
requirements for E/M visit levels 2 through 5, we are proposing to 
simplify the payment for those services by paying a single rate for the 
level 2 through 5 E/M visits. The visit level of the E/M service is 
tied to the documentation requirements in the 1995 and 1997 
Documentation Guidelines for E/M Services, which may not be reflective 
of changes in technology or, in particular, the ways that electronic 
medical records have changed documentation and the patient's medical 
record. Additionally, current documentation requirements may not 
account for changes in care delivery, such as a growing emphasis on 
team based care, increases in the number of recognized chronic 
conditions, or increased emphasis on access to behavioral health care. 
However, based on the feedback we have received from stakeholders, it 
is clear to us that the burdens associated with documenting the 
selection of the level of E/M service arise from not only the 
documentation guidelines, but also from the coding structure itself. 
Like the documentation guidelines, the distinctions between visit 
levels reflect a reasonable assessment of variations in care, effort, 
and resource costs as identified and articulated several decades ago. 
We believe that the most important distinctions between the kinds of 
visits furnished to Medicare beneficiaries are not well reflected by 
the current E/M visit coding. Most significantly, we have understood 
from stakeholders that current E/M coding does not reflect important 
distinctions in services and differences in resources. At present, we 
believe the current payment for E/M visit levels, generally 
distinguished by common elements of patient history, physical exam, and 
MDM, that may have been good approximations for important distinctions 
in resource costs between kinds of visits in the 1990s, when the CPT 
developed the E/M code set, are increasingly outdated in the context of 
changing models of care and information technologies.
    As described earlier in this section, we are proposing to change 
the documentation requirements for E/M levels such that practitioners 
have the choice to use the 1995 guidelines, 1997 guidelines, time, or 
MDM to determine the E/M level. We believe that these proposed changes 
will better reflect the current practice of medicine and represent 
significant reductions in burdens associated with documenting visits 
using the current set of E/M codes.
    In alignment with our proposed documentation changes, we are 
proposing to develop a single set of RVUs under the PFS for E/M office-
based and outpatient visit levels 2 through 5 for new patients (CPT 
codes 99202 through 99205) and a single set of RVUs for visit levels 2 
through 5 for established patients (CPT codes 99212 through 99215). 
While we considered creating new HCPCS G-codes that would describe the 
services associated with these proposed payment rates, given the wide 
and longstanding use of these visit codes by both Medicare and private 
payers, we believe it would have created unnecessary administrative 
burden to propose new coding. Therefore, we are instead proposing to 
maintain the current code set. Of the five levels of office-based and 
outpatient E/M visits, the vast majority of visits are reported as 
levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit 
level 3 and level 4 for new patients) made up around 32 percent and 44 
percent, respectively, of the total allowed charges for CPT codes 
99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit 
level 3 and 4 for established patients) made up around 39 percent and 
50 percent, respectively, of the allowed charges for CPT codes 99211-
99215. If our proposals to simplify the documentation requirements and 
to pay a single PFS rate for new patient E/M visit levels 2 through 5 
and a single rate for established patient E/M visit levels 2 through 5 
are finalized, practitioners would still bill the CPT code for 
whichever level of E/M service they furnished and they would be paid at 
the single PFS rate. However, we believe that eliminating the 
distinction in payment between visit levels 2 through 5 will eliminate 
the need to audit against the visit levels, and therefore,

[[Page 35840]]

will provide immediate relief from the burden of documentation. A 
single payment rate will also eliminate the increasingly outdated 
distinction between the kinds of visits that are reflected in the 
current CPT code levels in both the coding and the associated 
documentation rules.
    In order to set RVUs for the proposed single payment rate for new 
and established patient office/outpatient E/M visit codes, we are 
proposing to develop resource inputs based on the current inputs for 
the individual E/M codes, generally weighted by the frequency at which 
they are currently billed, based on the 5 most recent years of Medicare 
claims data (CY 2012 through CY 2017). Specifically, we are proposing a 
work RVU of 1.90 for CPT codes 99202-99205, a physician time of 37.79 
minutes, and direct PE inputs that sum to $24.98, each based on an 
average of the current inputs for the individual codes weighted by 5 
years of accumulated utilization data. Similarly, we are proposing a 
work RVU of 1.22 for CPT codes 99212-99215, with a physician time of 
31.31 minutes and direct PE inputs that sum to $20.70. These inputs are 
based on an average of the inputs for the individual codes, weighted by 
volume based on utilization data from the past 5 years (CY 2012 through 
CY 2017). Tables 19 and 20 reflect the payment rates in dollars that 
would result from the approach described above were it to have been 
implemented for CY 2018. In other words, the dollar amounts in the 
charts below reflect how the changes we are proposing for CY 2019 would 
have impacted payment rates for CY 2018. Proposed RVUs for CY 2019 
appear in addendum B of this proposed rule, available on the CMS 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

 Table 19--Preliminary Comparison of Payment Rates for Office Visits New
                                Patients
------------------------------------------------------------------------
                                                            CY 2018 non-
                                                  CY 2018     facility
                                                   non-     payment rate
                  HCPCS code                     facility     under the
                                                  payment     proposed
                                                   rate      methodology
------------------------------------------------------------------------
99201.........................................         $45           $44
99202.........................................          76           135
99203.........................................         110  ............
99204.........................................         167  ............
99205.........................................         211  ............
------------------------------------------------------------------------


   Table 20--Preliminary Comparison of Payment Rates for Office Visits
                          Established Patients
------------------------------------------------------------------------
                                                  Current
                                                   non-     Proposed non-
                  HCPCS code                     facility     facility
                                                  payment   payment rate
                                                   rate
------------------------------------------------------------------------
99211.........................................         $22           $24
99212.........................................          45            93
99213.........................................          74  ............
99214.........................................         109  ............
99215.........................................         148  ............
------------------------------------------------------------------------

    While we believe that the proposed rates for E/M visit levels 2 
through 5 represent the valuation of a typical E/M service, we also 
recognize that the current E/M code set itself does not appropriately 
reflect differences in resource costs between certain types of E/M 
visits. As a result, we believe that the way we currently value the 
resource costs for E/M services through the existing HCPCS CPT code set 
for office-based and outpatient E/M visits does not appropriately 
reflect the resources used in furnishing the range of E/M services that 
are provided through the current the practice of medicine. Based on 
stakeholder comments and examples and our review of the literature on 
E/M services, we have identified three types of E/M visits that differ 
from the typical E/M visit and are not appropriately reflected in the 
current office/outpatient E/M code set and valuation. Rather, these 
three types of E/M visits can be distinguished by the mode of care 
provided and, as a result, have different resource costs. The three 
types of E/M visits that differ from the typical E/M service are (1) 
separately identifiable E/M visits furnished in conjunction with a 0-
day global procedure, (2) primary care E/M visits for continuous 
patient care, and (3) certain types of specialist E/M visits, including 
those with inherent visit complexity. We address each of these 
distinguishable visit types in the following proposals.
d. Recognizing the Resource Costs for Different Types of E/M Visits
    Rather than maintain distinctions in services and payment that are 
based on the current E/M visit codes, we believe we can better capture 
differential resources costs and minimize reporting and documentation 
burden by proposing several corollary payment policies and ratesetting 
adjustments. These additional proposals better reflect the important 
distinctions between the kinds of visits furnished to Medicare 
beneficiaries, and would no longer require complex and burdensome 
billing and documentation rules to effectuate payment.
    In response to the CY 2018 comment solicitation on burden reduction 
for E/M visits (82 FR 53163 through 53166), we received several 
comments that highlighted the inadequacy of the E/M code set to 
accurately pay for the resources associated with furnishing visits, 
particularly for primary care visits, and visits associated with 
treating patients with particular conditions for which there is not 
additional procedural coding. One commenter stated that the current 
structure and valuation of the E/M code set inadequately describes the 
range of services provided by different specialties, and in particular 
primary care services. This commenter noted that although the 10 
office/outpatient E/M codes make up the bulk of the services reported 
by primary care practitioners, the valuation does not reflect their 
particular resource costs. Another commenter pointed out that for 
specialties that principally rely on E/M visit codes to bill for their 
professional services, the complex medical decision making and the 
intensity of their visits is not reflected in the E/M code set or 
documentation guidelines. Additionally, we believe that when a 
separately identifiable visit is furnished in conjunction with a 
procedure, that there are certain duplicative resource costs that are 
also not accounted for by current coding and payment.
    Therefore, we are proposing the following adjustments to better 
capture the variety of resource costs associated with different types 
of care provided in E/M visits: (1) An E/M multiple procedure payment 
adjustment to account for duplicative resource costs when E/M visits 
and procedures with global periods are furnished together; (2) HCPCS G-
code add-ons to recognize additional relative resources for primary 
care visits and inherent visit complexity that require additional work 
beyond that which is accounted for in the single payment rates for new 
and established patient levels 2 through level 5 visits; (3) HCPCS G-
codes to describe podiatric E/M visits; (4) an additional prolonged 
face-to-face services add-on G code; and (5) a technical modification 
to the PE methodology to stabilize the allocation of indirect PE for 
visit services (i) Accounting for E/M Resource Overlap between Stand-
Alone Visits and Global Periods
    Under the PFS, E/M services are generally paid in one of two ways: 
As standalone visits using E/M visit codes, or included in global 
procedural codes. In both cases, RVUs are allocated to the services to 
account for the estimated relative resources involved in furnishing 
professional E/M services. In the case of procedural codes with global 
periods,

[[Page 35841]]

the overall resource inputs reflect the costs of the E/M work 
considered to be typically furnished with the procedure. Therefore, the 
standalone E/M visit codes are not billable on the same day as the 
procedure codes unless the billing professional specifically indicates 
that the visit is separately identifiable from the procedure.
    In cases where a physician furnishes a separately identifiable E/M 
visit to a beneficiary on the same day as a procedure, payment for the 
procedure and the E/M visit is based on rates generally developed under 
the assumption that these services are typically furnished 
independently. In CY 2017 PFS rulemaking, we noted that the current 
valuation for services with global periods may not accurately reflect 
much of the overlap in resource costs (81 FR 80209). We are 
particularly concerned that when a standalone E/M visit occurs on the 
same day as a 0-day global procedure, there are significant overlapping 
resource costs that are not accounted for. We believe that separately 
identifiable visits occurring on the same day as 0-day global 
procedures have resources that are sufficiently distinct from the costs 
associated with furnishing one of the 10 office/outpatient E/M visits 
to warrant payment adjustment. There are other existing policies under 
the PFS where we reduce payments if multiple procedures are furnished 
on the same day to the same patient. Medicare has a longstanding policy 
to reduce payment by 50 percent for the second and subsequent surgical 
procedures furnished to the same patient by the same physician on the 
same day, largely based on the presence of efficiencies in PE and pre- 
and post-surgical physician work. Effective January 1, 1995, the MPPR 
policy, with the same percentage reduction, was extended to nuclear 
medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 
78806, and 78807). In the CY 1995 PFS final rule with comment period 
(59 FR 63410), we indicated that we would consider applying the policy 
to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS 
proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated 
that we planned to analyze nonsurgical services commonly furnished 
together (for example, 60 to 75 percent of the time) to assess whether 
an expansion of the MPPR policy could be warranted. MedPAC encouraged 
us to consider duplicative physician work, as well as PE, in any 
expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule, 
CMS finalized the application of the MPPR to always-therapy services on 
the justification that there was significant overlap in the PE portion 
of these services (75 FR 73233).
    Using the surgical MPPR as a template, we are proposing that, as 
part of our proposal to make payment for the E/M levels 2 through 5 at 
a single PFS rate, we would reduce payment by 50 percent for the least 
expensive procedure or visit that the same physician (or a physician in 
the same group practice) furnishes on the same day as a separately 
identifiable E/M visit, currently identified on the claim by an 
appended modifier -25. We believe that the efficiencies associated with 
furnishing an E/M visit in combination with a same-day procedure are 
similar enough to those accounted for by the surgical MPPR to merit a 
reduction in the relative resources of 50 percent. We estimate based on 
CY 2017 Medicare claims data that applying a 50 percent MPPR to E/M 
visits furnished as separately identifiable services in the same day as 
a procedure would reduce expenditures under the PFS by approximately 
6.7 million RVUs. To accurately reflect resource costs of the different 
types of E/M visits that we previously identified while maintaining 
work budget neutrality within this proposal, we are proposing to 
allocate those RVUs toward the values of the add-on codes that reflect 
the additional resources associated with E/M visits for primary care 
and inherent visit complexity, similar to existing policies. As we 
articulated in the CY 2012 PFS final rule with comment period, where 
the aggregate work RVUs within a code family change but the overall 
actual physician work associated with those services does not change, 
we make work budget neutrality adjustments to hold the aggregate work 
RVUs constant within the code family, while maintaining the relativity 
of values for the individual codes within that set (76 FR 73105).
(ii) Proposed HCPCS G-Code Add-Ons To Recognize Additional Relative 
Resources for Certain Kinds of Visits
    The distribution of E/M visits is not uniform across medical 
specialties. We have found that certain specialists, like neurologists 
and endocrinologists, for example, bill higher level E/M codes more 
frequently than procedural specialists, such as dermatology. We believe 
this tendency reflects a significant and important distinction between 
the kinds of visits furnished by professionals whose treatment 
approaches are primarily reported using visit codes versus those 
professionals whose treatment approaches are primarily reported using 
available procedural or testing codes. However, based on feedback we 
received from the medical professionals who furnish primary care and 
have visits with greater complexity, such as the comments cited above, 
we do not believe the current visit definitions and the associated 
documentation burdens are the most accurate descriptions of the 
variation in work. Instead, we believe these professionals have been 
particularly burdened by the documentation requirements given that so 
much of their medical treatment is described imperfectly by relatively 
generic visit codes.
    Similarly stakeholders, such as the commenters responding to the CY 
2018 PFS proposed rule, have articulated persuasively that visits 
furnished for the purpose of primary care also involve distinct 
resource costs. In developing this proposal, we consulted a variety of 
resources, including the American Academy of Family Physicians (AAFP) 
definition of primary care that states that the resource costs 
associated with furnishing primary care services particularly include 
time spent coordinating patient care, collaborating with other 
physicians, and communicating with patients (see https://www.aafp.org/about/policies/all/primary-care.html). Despite our efforts in recent 
years to pay separately for certain aspects of primary care services, 
such as through the chronic care management or the transitional care 
management services, the currently available coding still does not 
adequately reflect the full range of primary care services, nor does it 
allow payment to fully capture the resource costs involved in 
furnishing a face-to-face primary care E/M visit. We recognize that 
primary care services frequently involve substantial non-face-to-face 
work, and note that there is currently coding available to account for 
many of those resources, such as chronic care management (CCM), 
behavioral health integration (BHI), and prolonged non-face-to-face 
services. In light of the existing coding, this proposal only addresses 
the additional resources involved in furnishing the face-to-face 
portion of a primary care service. As the point of entry for many 
patients into the healthcare system, primary care visits frequently 
require additional time for communicating with the patient, patient 
education, consideration and review of the patient's medical needs. We 
believe the proposed value for the single payment rate for the E/M 
levels 2 through 5 new and established patient visit codes does

[[Page 35842]]

not reflect these additional resources inherent to primary care visits, 
as evidenced by the fact that primary care visits are generally 
reported using level 4 E/M codes Therefore, to more accurately account 
for the type and intensity of E/M work performed in primary care-
focused visits, we are proposing to create a HCPCS add-on G-code that 
may be billed with the generic E/M code set to adjust payment to 
account for additional costs beyond the typical resources accounted for 
in the single payment rate for the levels 2 through 5 visits.
    We are proposing 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 established patient evaluation 
and management visit)). As we believe a primary care visit is partially 
defined by an ongoing relationship with the patient, this code would 
describe furnishing a visit to an established patient. HCPCS code GPC1X 
can also be reported for other forms of face-to-face care management, 
counseling, or treatment of acute or chronic conditions not accounted 
for by other coding. We note that we believe the additional resources 
to address inherent complexity in E/M visits associated with primary 
care services are associated only with stand-alone E/M visits as 
opposed to separately identifiable visits furnished within the global 
period of a procedure. Separately identifiable visits furnished within 
a global period are identified on the claim using modifier -25, and 
would be subject to the MPPR. We note that we have created separate 
coding that describes non-face-to-face care management and 
coordination, such as CCM and BHI; however, these services describe 
non-face-to-face care and can be provided by any specialty so long as 
they meet the requirements for those codes. HCPCS code GPC1X is 
intended to capture the additional resource costs, beyond those 
involved in the base E/M codes, of providing face-to-face primary care 
services for established patients. HCPCS code GPC1X would be billed in 
addition to the E/M visit for an established patient when the visit 
includes primary care services. For HCPCS code GPC1X, we are proposing 
a work RVU of 0.07, physician time of 1.75 minutes, a PE RVU of 0.07, 
and an MP RVU of 0.01. This proposed valuation accounts for the 
additional 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. Furthermore, the proposed add-on G-code for primary care-
focused E/M services would help to mitigate potential payment 
instability that could result from our adoption of single payment rates 
that apply for E/M code levels 2 through 5. As this add-on G-code would 
account for the inherent resource costs associated with furnishing 
primary care E/M services, we anticipate that it would be billed with 
every primary care-focused E/M visit for an established patient. While 
we expect that this code will mostly be utilized by the primary care 
specialties, such as family practice or pediatrics, we are also aware 
that, in some instances, certain specialists function as primary care 
practitioners--for example, an OB/GYN or a cardiologist. Although the 
definition of primary care is widely agreed upon by the medical 
community and we intend for this G-code to account for the resource 
costs of performing those types of visits, regardless of Medicare 
enrollment specialty, we are also seeking comment on how best to 
identify whether or not a primary care visit was furnished particularly 
in cases where a specialist is providing those services. For especially 
complex patients, we also expect that it may be billed alongside the 
proposed new code for prolonged E/M services described later in this 
section. We are also seeking comment on whether this policy adequately 
addresses the deficiencies in CPT coding for E/M services in describing 
current medical practice, and concerns about the impact on payment for 
primary care and other services under the PFS. Given the broad scope of 
our proposals related to E/M services, we are seeking feedback on any 
unintended consequences of those proposals. We are also seeking comment 
on any other concerns related to primary care that we might consider 
for future rulemaking.
    We are also proposing to create a HCPCS G-code to be reported with 
an E/M service to describe the additional resource costs for specialty 
professionals for whom E/M visit codes make up a large percentage of 
their overall allowed charges and whose treatment approaches we believe 
are generally reported using the level 4 and level 5 E/M visit codes 
rather than procedural coding. Due to these factors, the proposed 
single payment rate for E/M levels 2 through 5 visit codes would not 
necessarily reflect the resource costs of those types of visits. 
Therefore, we are proposing to create a new HCPCS code GCG0X (Visit 
complexity inherent to evaluation and management associated with 
endocrinology, rheumatology, hematology/oncology, urology, neurology, 
obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, 
or interventional pain management-centered care (Add-on code, list 
separately in addition to an evaluation and management visit)). Given 
their billing patterns, we believe that these are specialties that 
apply predominantly non-procedural approaches to complex conditions 
that are intrinsically diffuse to multi-organ or neurologic diseases. 
While some of these specialties are surgical in nature, we believe 
these surgical specialties are providing increased non-procedural care 
of high complexity in the Medicare population. The high complexity of 
these services is reflected in the large proportion of level 4 and 
level 5 visits that we believe are reported by these specialties, and 
the extent to which E/M visits are a high proportion of these 
specialties' total allowed charges. Consequently, these are specialties 
for which the resource costs of the visits they typically perform are 
not fully captured in the proposed single payment rate for the levels 2 
through level 5 office/outpatient visit codes. When billed in 
conjunction with standalone office/outpatient E/M visits for new and 
established patients, the combined valuation more accurately accounts 
for the intensity associated with higher level E/M visits. To establish 
a value for this add-on service to be applied with a standalone E/M 
visit, we are proposing a crosswalk to 75 percent of the work and time 
of CPT code 90785 (Interactive complexity), which results in a work RVU 
of 0.25, a PE RVU of 0.07, and an MP RVU of 0.01, as well as 8.25 
minutes of physician time based on the CY 2018 valuation for CPT code 
90785. Interactive complexity is an add-on code that may be billed when 
a psychotherapy or psychiatric service requires more resources due to 
the complexity of the patient. We believe that the proposed valuation 
for CPT code 90785 would be an accurate representation of the 
additional work associated with the higher level complex visits. We 
note that we believe the additional resources to address inherent 
complexity in E/M visits are associated with stand-alone E/M visits. 
Additionally, we acknowledge that resource costs for primary care are 
reflected with the proposed HCPCS code GPC1X, as opposed to the

[[Page 35843]]

proposed HCPCS code GCG0X. We note that there are additional codes 
available that include face-to-face and non-face-to-face work, 
depending on the code, that previously would have been considered part 
of an E/M visit, such as the codes for CCM, BHI, and CPT code 99483 
(Assessment of and care planning for a patient with cognitive 
impairment, requiring an independent historian, in the office or other 
outpatient, home or domiciliary or rest home, with all of the following 
required elements: Cognition-focused evaluation including a pertinent 
history and examination; Medical decision making of moderate or high 
complexity; Functional assessment (e.g., basic and instrumental 
activities of daily living), including decision-making capacity; Use of 
standardized instruments for staging of dementia (e.g., functional 
assessment staging test [FAST], clinical dementia rating [CDR]); 
Medication reconciliation and review for high-risk medications; 
Evaluation for neuropsychiatric and behavioral symptoms, including 
depression, including use of standardized screening instrument(s); 
Evaluation of safety (e.g., home), including motor vehicle operation; 
Identification of caregiver(s), caregiver knowledge, caregiver needs, 
social supports, and the willingness of caregiver to take on caregiving 
tasks; Development, updating or revision, or review of an Advance Care 
Plan; Creation of a written care plan, including initial plans to 
address any neuropsychiatric symptoms, neuro-cognitive symptoms, 
functional limitations, and referral to community resources as needed 
(e.g., rehabilitation services, adult day programs, support groups) 
shared with the patient and/or caregiver with initial education and 
support. Typically, 50 minutes are spent face-to-face with the patient 
and/or family or caregiver), which were developed to reflect the 
additional work of those practitioners furnishing primary care visits. 
Likewise, we are proposing that practitioners in the specialty of 
psychiatry would not use either add-on code because psychiatrists may 
utilize CPT code 90785 to describe work that might otherwise be 
reported with a level 4 or level 5 E/M visit.
    We are seeking comment on both of these proposals.
(iii) Proposed HCPCS G-Code To Describe Podiatric E/M Visits
    As described earlier, the vast majority of podiatric visits are 
reported using lower level E/M codes, with most E/M visits billed at a 
level 2 or 3, reflecting the type of work done by podiatrists as part 
of an E/M visit. Therefore, while the proposed consolidation of 
documentation and payment for E/M code levels 2 through 5 is intended 
to better reflect the universal elements of E/M visits across 
specialties and patients, we believe that podiatric E/M visits are not 
accurately represented by the consolidated E/M structure. In order for 
payment to reflect the resource costs of podiatric visits, we are also 
proposing 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 E/M services. Under this proposal, podiatric E/M services 
would be billed using these G-codes instead of the generic office/
outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211 
through 99215). We propose to create these separate G-codes for 
podiatric E/M services to differentiate the resources associated with 
podiatric E/M visits rather than proposing a negative add-on adjustment 
relative to the proposed single payment rates for the generic E/M 
levels 2 through 5 codes. Therefore, we are proposing to create 
separate coding to describe these services, taking into account that 
most podiatric visits are billed as level 2 or 3 E/M codes. We based 
the coding structure and code descriptor on CPT codes 92004 
(Ophthalmological services: Medical examination and evaluation with 
initiation of diagnostic and treatment program; comprehensive, new 
patient, 1 or more visits) and 92012 (Ophthalmological services: 
medical examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; intermediate, established patient), 
which describe visits specific to ophthalmology. To accurately reflect 
payment for the resource costs associated with podiatric E/M visits, we 
are proposing a work RVU of 1.35, a physician time of 28.11 minutes, 
and direct PE inputs totaling $22.53 for HCPCS code GPD0X, and a work 
RVU of 0.85, physician time of 21.60 minutes, and direct PE inputs 
totaling $17.07 for HCPCS code GPD1X. These values are based on the 
average rate for the level 2 and 3 E/M codes (CPT codes 99201-99203 and 
CPT codes 99211-99212, respectively), weighted by podiatric volume.
(iv) Proposed Adjustment to the PE/HR Calculation
    As we explain in section II.B. Determination of Practice Expense 
(PE) Relative Value Units (RVUs), of this proposed rule, we generally 
allocate indirect costs for each code 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. Indirect expenses include 
administrative labor, office expense, and all other PEs that are not 
directly attributable to a particular service for a particular patient. 
Generally, the proportion of indirect PE allocated to a service is 
determined by calculating a PE/HR based upon the mix of specialties 
that bill for a service.
    As described earlier, E/M visits comprise a significant portion of 
allowable charges under the PFS and are used broadly across specialties 
such that our proposed changes can greatly impact the change in payment 
at the specialty level and at the practitioner level. Our proposals 
seek to simplify payment for E/M visit levels 2 through 5, and to 
additionally take into consideration that there are inherent 
differences in primary care-focused E/M services and in more complex E/
M services such that those visits involve greater relative resources, 
while seeking to maintain overall payment stability across specialties. 
However, establishing a single PFS rate for new and established patient 
E/M levels 2 through-5 would have a large and unintended effect on many 
specialties due to the way that indirect PE is allocated based on the 
mixture of specialties that furnish a service. The single payment rates 
proposed for E/M levels 2 through 5 cannot reflect the indirect PE 
previously allocated differentially across those 8 codes. Historically, 
a broad blend of specialties and associated PE/HR has been used in the 
allocation of indirect PE and MP RVUs to E/M services to determine 
payment rates for these services. As this proposal significantly alters 
the PE/HR allocation for the office/outpatient E/M codes and any 
previous opportunities for the public to comment on the data would not 
have applied to these kinds of E/M services, we do not believe it is in 
the public interest to allow the allocation of indirect PE to have such 
an outsized impact on the payment rates for this proposal. Due to the 
magnitude of the proposed coding and payment changes for E/M visits, it 
is unclear how the distribution of specialties across E/M services 
would change. We are concerned that such changes could produce 
anomalous results for indirect PE allocations since we do not yet know 
the extent to which specialties would utilize the proposed simplified 
E/M codes and proposed G-codes. In the past, when utilization data are 
not

[[Page 35844]]

available or do not accurately reflect the expected specialty mix of a 
new service, we have proposed to crosswalk the PE/HR value from another 
specialty (76 FR 73036). As such, we are proposing to create a single 
PE/HR value for E/M visits (including all of the proposed HCPCS G-codes 
discussed above) of approximately $136, based on an average of the PE/
HR across all specialties that bill these E/M codes, weighted by the 
volume of those specialties' allowed E/M services. We believe that this 
is consistent with the methodology used to develop the inputs for the 
proposed simplified E/M payment for the levels 2 through 5 E/M visit 
codes, and that, for purposes of consistency, the new PE/HR should be 
applied across the additional E/M codes. We believe a new PE/HR value 
would more accurately reflect the mix of specialties billing both the 
generic E/M code set and the add-on codes. If we finalize this 
proposal, we will consider revisiting the PE/HR after several years of 
claims data become available.
(v) Proposed HCPCS G-Code for Prolonged Services
    Time is often an important determining factor in the level of care, 
which we consider in our proposal described earlier that physicians and 
other practitioners can use time as the basis for documenting and 
billing the appropriate level of E/M visit for purposes of Medicare 
payment. Currently there is inadequate coding to describe services 
where the primary resource of a service is physician time. 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 and may be 
billed when the applicable amount of time exceeds the typical service 
time of the primary procedure.
    Stakeholders have informed CMS that the ``first hour'' time 
threshold in the descriptor for CPT code 99354 is difficult to meet and 
is an impediment to billing these codes (81 FR 80228). In response to 
stakeholder feedback and as part of our proposal to implement a single 
payment rate for E/M visit levels 2 through 5 while maintaining payment 
accuracy across the specialties, we are proposing to create a new 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)). Given that the physician time of 
HCPCS code GPRO1 is half of the physician time assigned to CPT code 
99354, we are proposing a work RVU of 1.17, which is half the work RVU 
of CPT code 99354.
    In order to estimate the potential impact of these proposed 
changes, we modeled the results of several options and examined the 
estimated resulting impacts in overall Medicare allowed charges by 
physician specialty. In order to isolate the potential impact of these 
changes from other concurrent proposed changes, we conducted this 
analysis largely using the code set, policies, and input data that we 
developed in establishing PFS rates for CY 2018. However, we used the 
suite of ratesetting programs that included several updates relevant 
for CY 2019 rulemaking. Consequently, we conducted our analysis 
regarding potential specialty-level impacts in order to identify the 
specialties with allowed charges most likely to be impacted by the 
potential change. We believe these estimates illustrate the magnitude 
of potential changes for certain physician specialties. However, 
because our modeling did not account for the full range of technical 
changes in the input data used in PFS ratesetting, the potential 
impacts for these isolated policies are relatively imprecise, 
especially compared to the specialty-level impacts displayed in section 
VII. of this proposed rule.
    Tables 21, 22, and 23 show the estimated changes, for certain 
physician specialties, and isolated from other proposed changes, in 
expenditures for PFS services based on potential changes for E/M coding 
and payment. We note that we are making additional data available to 
the public to inform our modeling on our E/M coding and payment 
proposals, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

 Table 21--Unadjusted Estimated Specialty Impacts of Proposed Single RVU
          Amounts for Office/Outpatient E/M 2 Through 5 Levels
------------------------------------------------------------------------
                                                     Estimated potential
                                        Allowed       impact of valuing
             Specialty               charges  (in   levels 2-5 together,
                                       millions)     without additional
                                                         adjustments
------------------------------------------------------------------------
PODIATRY..........................          $2,022  12%.
DERMATOLOGY.......................           3,525  7%.
HAND SURGERY......................             202  6%.
OTOLARNGOLOGY.....................           1,220  5%.
ORTHOPEDIC SURGERY................           3,815  4%.
ORAL/MAXILLOFACIAL SURGERY........              57  4%.
COLON AND RECTAL SURGERY..........             168  Less than 3%
                                                     estimated increase
                                                     in overall payment.
OBSTETRICS/GYNECOLOGY.............             664
OPTOMETRY.........................           1,276
PHYSICIAN ASSISTANT...............           2,253
PLASTIC SURGERY...................             387
ALLERGY/IMMUNOLOGY................             240  Minimal change to
                                                     overall payment.
ANESTHESIOLOGY....................           1,995
AUDIOLOGIST.......................              67
CARDIAC SURGERY...................             313

[[Page 35845]]

 
CHIROPRACTOR......................             789
CRITICAL CARE.....................             334
EMERGENCY MEDICINE................           3,196
FAMILY PRACTICE...................           6,382
GASTROENTEROLOGY..................           1,807
GENERAL PRACTICE..................             461
GENERAL SURGERY...................           2,182
INFECTIOUS DISEASE................             663
INTERVENTIONAL PAIN MGMT..........             839
INTERVENTIONAL RADIOLOGY..........             362
MULTISPECIALTY CLINIC/OTHER PHYS..             141
NEUROSURGERY......................             812
NUCLEAR MEDICINE..................              50
NURSE PRACTITIONER................           3,586
OPHTHALMOLOGY.....................           5,542
OTHER.............................              30
PATHOLOGY.........................           1,151
PHYSICAL MEDICINE.................           1,120
PSYCHIATRY........................           1,260
RADIATION ONCOLOGY AND RADIATION             1,776
 THERAPY CENTERS.
RADIOLOGY.........................           4,898
THORACIC SURGERY..................             360
UROLOGY...........................           1,772
VASCULAR SURGERY..................           1,132
CARDIOLOGY........................           6,723  Less than 3%
                                                     estimated decrease
                                                     in overall payment.
INTERNAL MEDICINE.................          11,173
NEPHROLOGY........................           2,285
PEDIATRICS........................              64
PULMONARY DISEASE.................           1,767
GERIATRICS........................             214  -4%.
RHEUMATOLOGY......................             559  -7%.
NEUROLOGY.........................           1,565  -7%.
HEMATOLOGY/ONCOLOGY...............           1,813  -7%.
ENDOCRINOLOGY.....................             482  -10%.
                                   -------------------------------------
    TOTAL.........................          93,486  0.
------------------------------------------------------------------------

    Table 21 characterizes the estimated overall impact for certain 
physician specialties, of establishing single payment rates for the new 
and established patient E/M code levels 2 through 5, without any of the 
additional coding or proposed payment adjustments, including the 
estimated percentage change for the specialties with an estimated 
increase or decrease in payment greater than 3 percent. Those 
specialties that tend to bill lower level E/M visits would benefit the 
most from the proposed change to single PFS payment rates, while those 
specialties that tend to bill more higher level E/M visits would see 
the largest decreases in payment with the change to a single PFS rate. 
The single payment rate for E/M code levels 2 through 5 would benefit 
podiatry the most because, due to the nature of most podiatric E/M 
visits, they tend to bill only level 2 and 3 E/M visits.

     Table 22--Specialty Specific Impacts Including Payment Accuracy
                               Adjustments
------------------------------------------------------------------------
                                                     Estimated potential
                                        Allowed       impact of valuing
             Specialty               charges  (in   levels 2-5 together,
                                       millions)       with additional
                                                         adjustments
------------------------------------------------------------------------
OBSTETRICS/GYNECOLOGY.............            $664  4%.
NURSE PRACTITIONER................           3,586  3%.
HAND SURGERY......................             202  Less than 3%
                                                     estimated increase
                                                     in overall payment.
INTERVENTIONAL PAIN MGMT..........             839
OPTOMETRY.........................           1,276
PHYSICIAN ASSISTANT...............           2,253
PSYCHIATRY........................           1,260
UROLOGY...........................           1,772
ANESTHESIOLOGY....................           1,995  Minimal change to
                                                     overall payment.
CARDIAC SURGERY...................             313
CARDIOLOGY........................           6,723
CHIROPRACTOR......................             789

[[Page 35846]]

 
COLON AND RECTAL SURGERY..........             168
CRITICAL CARE.....................             334
EMERGENCY MEDICINE................           3,196
ENDOCRINOLOGY.....................             482
FAMILY PRACTICE...................           6,382
GASTROENTEROLOGY..................           1,807
GENERAL PRACTICE..................             461
GENERAL SURGERY...................           2,182
GERIATRICS........................             214
INFECTIOUS DISEASE................             663
INTERNAL MEDICINE.................          11,173
INTERVENTIONAL RADIOLOGY..........             362
MULTISPECIALTY CLINIC/OTHER PHYS..             141
NEPHROLOGY........................           2,285
NEUROSURGERY......................             812
NUCLEAR MEDICINE..................              50
OPHTHALMOLOGY.....................           5,542
ORAL/MAXILLOFACIAL SURGERY........              57
ORTHOPEDIC SURGERY................           3,815
OTHER.............................              30
PATHOLOGY.........................           1,151
PEDIATRICS........................              64
PHYSICAL MEDICINE.................           1,120
PLASTIC SURGERY...................             387
RADIOLOGY.........................           4,898
THORACIC SURGERY..................             360
VASCULAR SURGERY..................           1,132
ALLERGY/IMMUNOLOGY................             240  Less than 3%
                                                     estimated decrease
                                                     in overall payment.
AUDIOLOGIST.......................              67
HEMATOLOGY/ONCOLOGY...............           1,813
NEUROLOGY.........................           1,565
OTOLARNGOLOGY.....................           1,220
PULMONARY DISEASE.................           1,767
RADIATION ONCOLOGY AND RADIATION             1,776
 THERAPY CENTERS.
RHEUMATOLOGY......................             559  -3.
DERMATOLOGY.......................           3,525  -4.
PODIATRY..........................           2,022  -4.
                                   -------------------------------------
    TOTAL.........................          93,486  0.
------------------------------------------------------------------------

    Table 22 characterizes the estimated overall impact for certain 
physician specialties, including the proposed adjustments have been 
made to reflect the distinctions in resource costs among certain types 
of E/M visits. In other words, Table 22 shows the proposed impacts of 
adopting the proposed single payment rates for new and established 
patient E/M visit levels 2 through 5, the application of a MPPR to E/M 
visits when furnished by the same practitioner (or practitioner in the 
same practice) on the same-day as a global procedure code, the add-on 
G-codes for primary care-focused services and inherent visit 
complexity, and the technical adjustments to the PE/HR value. Table 22 
includes the estimated percentage change for the specialties with an 
estimated increase or decrease in payment greater than three percent. 
In our modeling, we assumed E/M visits for specialties that provide a 
significant portion of primary care like family practice, internal 
medicine, pediatrics and geriatrics utilized the G-code for visit 
complexity inherent to evaluation and management associated with 
primary medical care services with every office/outpatient visit 
furnished. Also for the purposes of our modeling, we assumed that 
specialties including endocrinology, rheumatology, hematology/oncology, 
urology, neurology, obstetrics/gynecology, allergy/immunology, 
otolaryngology, or interventional pain management-centered care 
utilized the G-code for visit complexity inherent to evaluation and 
management with every office/outpatient E/M visit. Table 22 does not 
include the impact of the use of the additional prolonged services 
code. The specialties that we estimate would experience a decrease in 
payments are those that bill a large portion of E/M visits on the same 
day as procedures, and would see a reduction based on the application 
of the MPPR adjustments. Some of these specialties, such as allergy/
immunology and cardiology are also negatively impacted by the proposed 
single payment rates themselves, although not to the same degree as 
they would have been without any adjustments to provide alternate 
coding to reflect their resource costs, as illustrated in Table 21. The 
specialties that we estimate will see an increase in payments from 
these proposals, like psychiatry, nurse practitioner, and 
endocrinology, are seeing payment increases due to a combination of the 
single payment rate and the add-on codes for inherent visit complexity.
    As an example, in CY 2018, a physician would bill a level 4 E/M 
visit and document using the existing documentation framework for a 
level 4 E/M visit. Their payment rate would be approximately $109 in 
the office setting.

[[Page 35847]]

If these proposals are finalized, the physician would bill the same 
visit code for a level 4 E/M visit, documenting the visit according to 
the minimum documentation requirements for a level 2 E/M visit and/or 
based on their choice of using time, MDM, or the 1995 or 1997 
guidelines, plus either of the proposed add-on codes (HCPCS codes GPC1X 
or GCG0X) depending on the type of patient care furnished, and could 
bill one unit of the proposed prolonged services code (HCPCS code 
GPRO1) if they meet the time threshold for this code. The combined 
payment rate for the generic E/M code and HCPCS code GPRO1 would be 
approximately $165 with HCPCS code GPC1X and approximately $177 with 
HCPCS code GCG0X.
    We welcome comments on all of these proposals.
(vi) Alternatives Considered
    We considered a number of other options for simplifying coding and 
payment for E/M services to align with the proposed reduction in 
documentation requirements and better account for the resources 
associated with inherent complexity, visit complexity, and visits 
furnished on the same day as a 0-day global procedure. For example, we 
considered establishing single payment rates for new and established 
patients for combined E/M visit levels 2 through 4, as opposed to 
combined E/M visit levels 2 through 5. This option would have retained 
a separately valued payment rate for level 5 visits that would be 
reserved for the most complex visits or patients. However, maintaining 
a separately valued payment rate for this higher level visit based on 
the current CPT code definition has the consequence of preserving some 
of the current coding distinctions within the billing systems. 
Ultimately we believe that providing for two levels of payment and 
documentation (setting aside level 1 visits which are primarily visits 
by clinical staff) relieves more burden than three levels, and that two 
levels plus the proposed add-on coding more accurately captures the 
differential resource costs involved in furnishing E/M services to all 
patients. If we retained a coding scheme involving three or more levels 
of E/M visits, it would not be appropriate to apply a minimum 
documentation requirement as we propose to do. We would need to develop 
documentation requirements unique to each of the higher level visits. 
There would be a greater need for program integrity mechanisms to 
prevent upcoding and ensure that practitioners who chose to report the 
highest level visit justified their selection of code level. We could 
still simplify the documentation requirements for E/M visits relative 
to the current framework, but would need a more extensive, differential 
documentation framework than what we propose in this rule, in order to 
distinguish among visit levels. We are interested in stakeholder input 
on the best number of E/M visit levels and how to best achieve a 
balance between number of visit levels and simpler, updated 
documentation rules. We are seeking input as to whether these two 
aspects of our proposals together can reduce burden and ensure accurate 
payment across the broad range of E/M visits, including those for 
complex and high need beneficiaries.

 Table 23--Unadjusted Estimated Specialty Impacts of Single PFS Rate for
                Office/Outpatient E/M Levels 2 Through 4
------------------------------------------------------------------------
                                                  Allowed
                  Specialty                       charges       Impact
                                                (millions)     (percent)
------------------------------------------------------------------------
Podiatry....................................          $2,022          10
Dermatology.................................           3,525           6
Hand Surgery................................             202           5
Oral/Maxillofacial Surgery..................              57           4
Otolaryngology..............................           1,220           4
Cardiology..................................           6,723          -3
Hematology/Oncology.........................           1,813          -3
Neurology...................................           1,565          -3
Rheumatology................................             559          -6
Endocrinology...............................             482          -8
------------------------------------------------------------------------
Note: All other specialty level impacts were within +/- 3%.

    Table 23 shows the specialties that would experience the greatest 
increase or decrease by establishing single payment rates for E/M visit 
levels 2 through 4, while maintaining the value of the level 1 and the 
level 5 E/M visits. The specialty level impacts are similar to those in 
Table 21 as the specialties that bill more higher level visits do not 
benefit by maintaining a distinct payment for the level 5 visit as much 
as they experience a reduction in the rate for a level 4 visit. 
Similarly, the specialties that bill predominantly lower level visits 
would still benefit disproportionally to the increase in rate for the 
level 2 and level 3 visits.
    Section 101(f) of the MACRA, enacted on April 16, 2015, added a new 
subsection (r) under section 1848 of the Act entitled Collaborating 
with the Physician, Practitioner, and Other Stakeholder Communities to 
Improve Resource Use Measurement. Section 1848(r) of the Act requires 
the establishment and use of classification code sets: Care episode and 
patient condition groups and codes; and patient relationship categories 
and codes. As described in the CY 2018 PFS final rule, we finalized use 
of Level II HCPCS Modifiers as the patient relationship codes and 
finalized that Medicare claims submitted for items and services 
furnished by a physician or applicable practitioner on or after January 
1, 2018, should include the applicable patient relationship codes, as 
well as the NPI of the ordering physician or applicable practitioner 
(if different from the billing physician or applicable practitioner). 
We noted that for CY 2018, reporting of the patient relationship 
modifiers would be voluntary and the use and selection of the modifiers 
would not be a condition of payment (82 FR 53234). The patient 
relationship codes are as follows: X1: Continuous/broad; X2: 
Continuous/focused; X3: Episodic/focused; X4: Episodic/broad; and X5: 
Only as ordered by another physician. These codes are to be used to 
help define and distinguish the relationship and responsibility of a 
clinician with a patient at the time of furnishing an item or service, 
facilitate the attribution of patients and episodes to one or more 
clinicians, and to allow clinicians to self-identify their patient 
relationships.
    We considered proposing the use of these codes to adjust payment 
for E/M visits to the extent that these codes are indicative of 
differentiated resources provided in E/M visits, and we considered 
using these codes as an alternative to the proposed use of G-codes to 
reflect visit complexity inherent to evaluation and management in 
primary care and certain other specialist services, as a way to more 
accurately reflect the resource costs associated with furnishing 
different kinds of E/M visits. We are seeking comment on this 
alternative. We are particularly interested in whether the modifiers 
would accurately reflect the differences between resources for E/M 
visits across specialties and would therefore be useful to adjust 
payment differentially for the different types of E/M visits that we 
previously identified.
e. Emergency Department and Other E/M Visit Settings
    As we mentioned above, the E/M visit code set is comprised of 
individual subsets of codes that are specific to various clinical 
settings including office/outpatient, observation, hospital inpatient, 
emergency department, critical care, nursing facility, domiciliary or 
rest home, and home services. Some of these code subsets have three E/M 
levels of care, while

[[Page 35848]]

others have five. Some of these E/M code subsets distinguish among 
levels based heavily on time, while others do not. Recent public 
comments have asserted that some E/M code subsets intersect more 
heavily than others with hospital conditions of participation (CoP). 
For example, the American Psychiatric Association (APA) submitted a 
letter to CMS indicating that Medicare requires specific documentation 
in the medical record as part of the CoPs for inpatient psychiatric 
facilities. The APA believed that the required initial psychiatric 
evaluation for inpatients currently closely follows the E/M criteria 
for CPT codes 99221-99223, which are the codes that would be used to 
bill for these services. The APA stated that any changes in these E/M 
codes, without corresponding changes in the CoPs, could lead to the 
unintended consequence of adding to the burden of documentation by 
essentially requiring two different sets of data or areas of focus to 
be included, or two different documentation formats being required.
    Regarding emergency department visits (CPT codes 99281-99285), we 
received more recent feedback through our coordinated efforts with ONC 
this year, emphasizing that these codes may benefit from a coding or 
payment compression into fewer levels of codes, or that documentation 
rules may need to be reduced or altered. However, in public comments to 
the CY 2018 PFS proposed rule, commenters noted several issues unique 
to the emergency department setting that we believe require further 
consideration. For example, commenters stated that intensity, and not 
time, is the main determinant of code level in emergency departments. 
They requested that CMS use caution in changing required elements for 
documentation so that medical information used for legal purposes (for 
example, meeting the prudent layperson standard) is not lost. They 
urged caution and requested that CMS not immediately implement any 
major changes. They recommended refocusing documentation on presenting 
conditions and medical decision-making. Some commenters were supportive 
of leaving it largely to the discretion of individual practitioners to 
determine the degree to which they should perform and document the 
history and physical exam in the emergency department setting. Other 
commenters suggested that CMS encourage use of standardized guidelines 
and minimum documentation requirements to facilitate post-treatment 
evaluation, as well as analysis of records for various clinical, legal, 
operational and other purposes. The commenters discussed the importance 
of extensive histories and exams in emergency departments, where 
usually there is no established relationship with the patient and 
differential diagnosis is critical to rule out many life-threatening 
conditions. They were cognizant of the need for a clear record of 
services rendered and the medical necessity for each service, 
procedure, diagnostic test, and MDM performed for every patient 
encounter.
    In addition, although the RUC is in the process of revaluing this 
code set, some commenters stated that the main issue is not that the 
emergency department visit codes themselves are undervalued. Rather, 
these commenters believed that a greater percentage of emergency 
department visits are at a higher acuity level, yet payers often do not 
pay at a higher level of care and the visit is often inappropriately 
down-coded based on retrospective review. These commenters believed 
that the documentation needed to support a higher level of care is too 
burdensome or subjective. In addition, it seems that policy proposals 
regarding emergency department visits billed by physicians might best 
be coordinated with parallel changes to payment policy for facility 
billing of these codes, which would require more time and analyses.
    Accordingly, we are not proposing any changes to the emergency 
department E/M code set or to the E/M code sets for settings of care 
other than office-based and outpatient settings at this time. However, 
we are seeking public comment on whether we should make any changes to 
it in future years, whether by way of documentation, coding, and/or 
payment and, if so, what the changes should be.
    Consistent with public feedback to date, we are taking a step-wise 
approach and limiting our policy proposals this year to the office/
outpatient E/M code set (and the limited proposal above regarding 
documentation of medical necessity for home visits in lieu of office 
visits). We may consider expanding our efforts more broadly to 
additional sections of the E/M visit code set in future years, and are 
seeking public comment broadly on how we might proceed in this regard.
f. Proposed Implementation Date
    We propose that these proposed E/M visit policies would be 
effective January 1, 2019. However, we are sensitive to commenters' 
suggestions that we should consider a multi-year process and proceed 
cautiously, allowing adequate time to educate practitioners and their 
staff; and to transition clinical workflows, EHR templates, 
institutional processes and policies (such as those for provider-based 
practitioners), and other aspects of practitioner work that would be 
impacted by these policy changes. Our proposed documentation changes 
for office/outpatient E/M visits would be optional, and practitioners 
could choose to continue to document these visits using the current 
framework and rules, which may reduce the need for a delayed 
implementation. Nevertheless, practitioners who choose a new 
documentation framework may need time to deploy it. A delayed 
implementation date for our documentation proposals would also allow 
the AMA time to develop changes to the CPT coding definitions and 
guidance prior to our implementation, such as changes to MDM or code 
definitions that we could then consider for adoption. It would also 
allow other payers time to react and potentially adjust their policies. 
Accordingly, we are seeking comment on whether a delayed implementation 
date, such as January 1, 2020, would be appropriate for our proposals.

J. Teaching Physician Documentation Requirements for Evaluation and 
Management Services

1. Background
    Per 42 CFR part 415, subpart D, Medicare Part B makes payment under 
the PFS for teaching physician services when certain conditions are 
met, including that medical record documentation must reflect the 
teaching physician's participation in the review and direction of 
services performed by residents in teaching settings. Under Sec.  
415.172(b), for certain procedural services, the participation of the 
teaching physician may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse; and for E/M visits, 
the teaching physician is required to personally document their 
participation in the medical record. We received stakeholder feedback 
suggesting that documentation requirements for E/M services furnished 
by teaching physicians are burdensome and duplicative of notations that 
may have previously been included in the medical records by residents 
or other members of the medical team.
2. Proposed Implementation
    We are proposing to revise our regulations to eliminate potentially 
duplicative requirements for notations that may have previously been 
included in the medical records by residents or

[[Page 35849]]

other members of the medical team. These proposed changes are intended 
to align and simplify teaching physician E/M service documentation 
requirements. We believe these proposed changes will reduce burden and 
duplication of effort for teaching physicians. We are proposing to 
amend Sec.  415.172(b) to provide that, except for services furnished 
as set forth in Sec. Sec.  415.174 (concerning an exception for 
services furnished in hospital outpatient and certain other ambulatory 
settings), 415.176 (concerning renal dialysis services), and 415.184 
(concerning psychiatric services), the medical records must document 
that the teaching physician was present at the time the service is 
furnished. Additionally, the revised paragraph would specify that the 
presence of the teaching physician during procedures and evaluation and 
management services may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse. We are also proposing 
to amend Sec.  415.174, by deleting paragraph (a)(3)(v) which currently 
requires the teaching physician to document the extent of their 
participation in the review and direction of the services furnished to 
each beneficiary, and adding new paragraph (a)(6), to provide that the 
medical record must document the extent of the teaching physician's 
participation in the review and direction of services furnished to each 
beneficiary, and that the extent of the teaching physician's 
participation may be demonstrated by the notes in the medical records 
made by a physician, resident, or nurse.

K. Solicitation of Public Comments on the Low Expenditure Threshold 
Component of the Applicable Laboratory Definition Under the Medicare 
Clinical Laboratory Fee Schedule (CLFS)

    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for clinical diagnostic laboratory tests 
(CDLTs) under the CLFS. The CLFS final rule titled, Medicare Clinical 
Diagnostic Laboratory Tests Payment System final rule (CLFS final 
rule), published in the Federal Register on June 23, 2016, implemented 
section 1834A of the Act. Under the CLFS final rule (81 FR 41036), 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' (that is, certain private payer 
data) collected for a ``data collection period'' for their component 
``applicable laboratories.'' In general, the payment amount for each 
CDLT on the CLFS furnished beginning January 1, 2018, is based on the 
applicable information collected for the 6-month data collection period 
and reported to us in the 3-month data reporting period, and is equal 
to the weighted median of the private payor rates for the CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the PFS. We refer to this component of the 
applicable laboratory definition as the ``majority of Medicare revenues 
threshold.'' The definition of applicable laboratory also includes a 
``low expenditure threshold'' component, which requires an entity to 
receive at least $12,500 of its Medicare revenues from the CLFS in a 
data collection period for its CDLTs that are not advanced diagnostic 
laboratory tests (ADLTs).
    We established $12,500 as the low expenditure threshold because we 
believed it achieved a balance between collecting sufficient data to 
calculate a weighted median that appropriately reflects the private 
market rate for a CDLT, and minimizing the reporting burden for 
laboratories that receive a relatively small amount of revenues under 
the CLFS. In the CLFS final rule (81 FR 41051), we estimated that 95 
percent of physician office laboratories and 55 percent of independent 
laboratories would not be required to report applicable information 
under our low expenditure threshold criterion. Although we 
substantially reduced the number of laboratories qualifying as 
applicable laboratories (that is, approximately 5 percent of physician 
office laboratories and approximately 45 percent of independent 
laboratories) we estimated that the percentage of Medicare utilization 
would remain high. That is, approximately 5 percent of physician office 
laboratories would account for approximately 92 percent of CLFS 
spending on physician office laboratories and approximately 45 percent 
of independent laboratories would account for approximately 99 percent 
of CLFS spending on independent laboratories (81 FR 41051).
    Recently, we have heard from some laboratory stakeholders that the 
low expenditure threshold excludes most physician office laboratories 
and many small independent laboratories from reporting applicable 
information, and that by excluding so many laboratories, the payment 
rates under the new private payor rate-based CLFS reflects incomplete 
data, and therefore, inaccurate CLFS pricing. However, it is our 
understanding that physician offices are generally not prepared to 
identify, collect, and report each unique private payor rate from each 
private payor for each laboratory test code on the CLFS and the volume 
associated with each unique private payor rate. As such, we believe 
revising the low expenditure threshold so that more physician office 
laboratories are required to report applicable information would be a 
very significant administrative burden on physician's offices. We also 
believe that increasing participation from physician office 
laboratories would have minimal overall impact on payment rates given 
that the weighted median of private payor rates is dominated by the 
laboratories with the largest test volume.
    However, we recognize from stakeholders that some physician office 
laboratories and small independent laboratories that are not applicable 
laboratories because they do not meet the current low expenditure 
threshold may still want to report applicable information, despite the 
administrative burden associated with qualifying as an applicable 
laboratory. Therefore, we are seeking public comments on reducing the 
low expenditure threshold by 50 percent, from $12,500 to $6,250, in 
CLFS revenues during a data collection period. Since more physician 
office laboratories would meet the low expenditure threshold, we would 
expect such an approach to increase the level of applicable information 
reported by physician office laboratories and small independent 
laboratories. We are seeking public comments regarding the potential 
administrative burden on physician office laboratories and small 
independent laboratories that would result from reducing the low 
expenditure threshold. We are also soliciting public comments on an 
approach that would increase the low expenditure threshold by 50 
percent, from $12,500 to $18,750, in CLFS revenues received in a data 
collection period. Since fewer physician office laboratories and small 
independent laboratories would meet the definition of applicable 
laboratory, we would expect such an approach to result in a decreased 
level of applicable information reported. For a complete discussion of 
our solicitation of comments on the low expenditure threshold component 
of the definition

[[Page 35850]]

of applicable laboratory under the Medicare CLFS, we refer readers to 
section III.A. of this proposed rule.

L. GPCI Comment Solicitation

    Section 1848(e)(1)(C) of the Act requires us to review and, if 
necessary, adjust the GPCIs at least every 3 years. Section 
1848(e)(1)(D) of the Act requires us to establish the GPCIs using the 
most recent data available. The last GPCI update was implemented in CY 
2017; therefore, we are required to review and make any necessary 
revisions to the GPCIs for CY 2020. Please refer to the CY 2017 PFS 
final rule with comment period for a discussion of the last GPCI update 
(81 FR 80261 through 80270). Some stakeholders have continued to 
express concerns regarding some of the data sources used in developing 
the indices for PFS geographic adjustment purposes, specifically that 
we use residential rent data as a proxy for commercial rent in the rent 
index component of the PE GPCI--that is, the data that are used to 
develop the office rent component of the PE GPCI. We will continue our 
efforts to identify a nationally representative commercial rent data 
source that could be made available to CMS. In support of that effort, 
we are particularly interested in, and seek comments regarding 
potential sources of commercial rent data for potential use in the next 
GPCI update for CY 2020.

M. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate 
Therapy
    Section 50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
amended section 1833(g) of the Act, effective January 1, 2018, to 
repeal the application of the Medicare outpatient therapy caps and the 
therapy cap exceptions process while retaining and adding limitations 
to ensure therapy services are furnished when appropriate. Section 
50202 also adds section 1833(g)(7)(A) of the Act to require that after 
expenses incurred for the beneficiary's outpatient therapy services for 
the year have exceeded one or both of the previous therapy cap amounts, 
all therapy suppliers and providers must continue to use an appropriate 
modifier such as the KX modifier on claims for subsequent services in 
order for Medicare to pay for the services. We implemented this 
provision by continuing to use the KX modifier. By applying the KX 
modifier to the claim, the therapist or therapy provider is confirming 
that the services are medically necessary as justified by appropriate 
documentation in the medical record. Just as with the incurred expenses 
for the prior therapy cap amounts, there is one amount for physical 
therapy (PT) and speech language pathology (SLP) services combined and 
a separate amount for occupational therapy (OT) services. These KX 
modifier threshold amounts are indexed annually by the Medicare 
Economic Index (MEI). For CY 2018, this KX modifier threshold amount is 
$2,010 for PT and SLP services combined, and $2,010 for OT After the 
beneficiary's incurred expenditures for outpatient therapy services 
exceed the KX modifier threshold amount for the year, claims for 
outpatient therapy services without the KX modifier are denied.
    Along with the KX modifier thresholds, section 50202 also adds 
section 1833(g)(7)(B) of the Act that retains the targeted medical 
review (MR) process (first established through section 202 of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a 
lower threshold amount of $3,000. For CY 2018 (and each successive 
calendar year until 2028, at which time it is indexed annually by the 
MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for 
OT services. The targeted MR process means that not all claims 
exceeding the MR threshold amount are subject to review as they once 
were.
    Section 1833(g)(8) of the Act, as redesignated by section 50202 of 
the BBA of 2018, retains the provider liability procedures which first 
became effective January 1, 2013, extending limitation of liability 
protections to beneficiaries who receive outpatient therapy services, 
when services are denied for certain reasons, including failure to 
include a necessary KX modifier.
2. Proposed Payment for Outpatient PT and OT Services Furnished by 
Therapy Assistants
    Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
amended the Act to add a new subsection 1834(v) that addresses payment 
for outpatient therapy services for which payment is made under section 
1848 or section 1834(k) of the Act that are furnished on or after 
January 1, 2022, in whole or in part by a therapy assistant (as defined 
by the Secretary). The new section 1834(v)(1) of the Act provides for 
payment of those services at 85 percent of the otherwise applicable 
Part B payment amount for the service. In accordance with section 
1834(v)(1) of the Act, the reduced payment amount for such outpatient 
therapy services is applicable when payment is made directly under the 
PFS as specified in section 1848 of the Act, for example when payment 
is made to therapists in private practice (TPPs); and when payment is 
made based on the PFS as specified in section 1834(k)(3) of the Act, 
for example, when payment is made for outpatient therapy services 
identified in sections 1833(a)(8) and (9) of the Act, including payment 
to providers that submit institutional claims for therapy services such 
as outpatient hospitals, rehabilitation agencies, skilled nursing 
facilities, home health agencies and comprehensive outpatient 
rehabilitation facilities (CORFs). The reduced payment rate under 
section 1834(v)(1) of the Act for outpatient therapy services when 
furnished in whole or in part by a therapy assistant is not applicable 
to outpatient therapy services furnished by critical access hospitals 
for which payment is made as specified in section 1834(g) of the Act.
    To implement this payment reduction, section 1834(v)(2)(A) of the 
Act requires us to establish a new modifier, in a form and manner 
specified by the Secretary, by January 1, 2019 to indicate, in the case 
of an outpatient therapy service furnished in whole or in part by a 
therapy assistant, that the service was furnished by a therapy 
assistant. Although we generally consider all genres of outpatient 
therapy services together (PT/OT/SLP), we do not believe there are 
``therapy assistants'' in the case of SLP services, so we propose to 
apply the new modifier only to services furnished in whole or in part 
by a physical therapist assistant (PTA) or an occupational therapist 
assistant (OTA). Section 1834(v)(2)(B) of the Act requires that each 
request for payment or bill submitted for an outpatient PT or OT 
service furnished in whole or in part by a therapy assistant on or 
after January 1, 2020, must include the established modifier. As such, 
the modifier will be required to be reported on claims for outpatient 
PT and OT services with dates of service on and after January 1, 2020, 
when the service is furnished in whole or in part by a therapy 
assistant, regardless of whether the reduced payment under section 
1834(v)(1) of the Act is applicable. However, the required payment 
reductions do not apply for these services until January 1, 2022, as 
required by section 1834(v)(1) of the Act.
    To implement this provision, we are proposing to establish two new 
modifiers to separately identify PT and OT services that are furnished 
in whole or in part by PTAs and OTAs,

[[Page 35851]]

respectively. We are proposing to establish two modifiers because the 
incurred expenses for PT and OT services are tracked and accrued 
separately in order to apply the two different KX modifier threshold 
amounts as specified by section 1833(g)(2) of the Act; and the use of 
the two proposed modifiers will facilitate appropriate tracking and 
accrual of services furnished in whole or in part by PTAs and OTAs. We 
additionally propose that these two therapy modifiers would be added to 
the existing three therapy modifiers--GP, GO, and GN--that are 
currently used to identify all therapy services delivered under a PT, 
OT or SLP plan of care, respectively. The GP, GO, and GN modifiers have 
existed since 1998 to track outpatient therapy services that were 
subject to the therapy caps. Although the therapy caps were repealed 
through amendments made to section 1833(g) of the Act by section 50202 
of the BBA of 2018, as discussed in the above section, the statute 
continues to require that we track and accrue incurred expenses for all 
PT, OT, and SLP services, including those above the specified per 
beneficiary amounts for medically necessary therapy services for each 
calendar year; one amount for PT and SLP services combined, and another 
for OT services.
    For purposes of implementing section 1834(v) of the Act through 
rulemaking as required under section 1834(v)(2)(C) of the Act, we are 
proposing to define ``therapy assistant'' as an individual who meets 
the personnel qualifications set forth at Sec.  484.4 of our 
regulations for a physical therapist assistant and an occupational 
therapy assistant (PTA and OTA, respectively). We are proposing that 
the two new therapy modifiers would be used to identify services 
furnished in whole or in part by a PTA or an OTA; and, that these new 
therapy modifiers would be used instead of the GP and GO modifiers that 
are currently used to report PT and OT services delivered under the 
respective plan of care whenever the service is furnished in whole or 
in part by a PTA or OTA.
    Effective for dates of service on and after January 1, 2020, the 
new therapy modifiers that identify services furnished in whole or in 
part by a PTA or OTA would be required to be used on all therapy claims 
instead of the existing modifiers GP and GO, respectively. As a result, 
in order to implement the provisions of the new subsection 1834(v) of 
the Act and carry out the continuing provisions of section 1833(g) of 
the Act as amended, we are proposing that, beginning in CY 2020, five 
therapy modifiers be used to track outpatient therapy services instead 
of the current three. These five therapy modifiers include two new 
therapy modifiers to identify PT and OT services furnished by PTAs and 
OTAs, respectively, and three existing therapy modifiers--GP, GO and 
GN--that will be used when PT, OT, and SLP services, respectively, are 
fully furnished by therapists or when fully furnished by or incident to 
physicians and NPPs.
    The creation of therapy modifiers specific to PT or OT services 
delivered under a plan of care furnished in whole or in part by a PTA 
or OTA would necessitate that we make changes to the descriptors of the 
existing GP and GO modifiers to clarify which qualified professionals, 
for example, therapist, physician, or NPP, can furnish the PT and OT 
services identified by these modifiers, and to differentiate them from 
the therapy modifiers specific to the services of PTAs and OTAs. We 
also propose to revise the GN modifier descriptor to conform to the 
changes to the GP and GO modifiers by clarifying the qualified 
professionals that furnish SLP therapy services.
    We are proposing to define the new therapy modifiers for services 
furnished in whole or in part by therapy assistants and to revise the 
existing therapy modifier descriptors as follows:
     New--PT Assistant services modifier (to be used instead of 
the GP modifier currently reported when a PTA furnishes services in 
whole or in part): Services furnished in whole or in part by a physical 
therapist assistant under an outpatient physical therapy plan of care;
     New--OT Assistant services modifier (to be used instead of 
the GO modifier currently reported when an OTA furnishes services in 
whole or in part): Services furnished in whole or in part by 
occupational therapy assistant under an outpatient occupational therapy 
plan of care;
    We are proposing that the existing GP modifier ``Services delivered 
under an outpatient physical therapy plan of care'' be revised to read 
as follows:
     Revised GP modifier: Services fully furnished by a 
physical therapist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
physical therapy plan of care;
    We are proposing that the existing GO modifier ``Services delivered 
under an outpatient occupational therapy plan of care'' be revised to 
read as follows:
     Revised GO modifier: Services fully furnished by an 
occupational therapist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
occupational therapy plan of care; and
    We are proposing that the existing GN modifier that currently reads 
``Services delivered under an outpatient speech-language pathology plan 
of care'' be revised to be consistent with the revisions to the GP and 
GO modifiers to read as follows:
     Revised GN modifier: Services fully furnished by a speech-
language pathologist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
speech-language pathology plan of care.
    As finalized in CY 2005 PFS final rule with comment (69 FR 66351 
through 66354), and as required as a condition of payment under our 
regulations at Sec. Sec.  410.59(a)(3)(iii), 410.60(a)(3)(iii), and 
410.62(a)(3)(iii), the person furnishing outpatient therapy services 
incident to the physician, PA, NP or CNS service must meet the 
therapist personnel qualification and standards at Sec.  484.4, except 
for licensure per section 1862(a)(20) of the Act. As such, we note that 
only a therapist, not a therapy assistant, can furnish outpatient 
therapy services incident to the services of a physician or a non-
physician practitioner (NPP), so the new PT- and OT-Assistant therapy 
modifiers cannot be used on the line of service when the rendering 
practitioner identified on the claim is a physician or an NPP. For 
therapy services billed by physicians or NPPs, whether furnished 
personally or incident to their professional services, the GP or GO 
modifier is required for those PT or OT services furnished under an 
outpatient therapy plan.
    We propose that all services that are furnished ``in whole or in 
part'' by a PTA or OTA are subject to the use of the new therapy 
modifiers. A new therapy modifier would be required to be used whenever 
a PTA or OTA furnishes all or part of any covered outpatient therapy 
service. However, we do not believe the provisions of section 1834(v) 
of the Act were intended to apply when a PTA or OTA performs portions 
of the service such as administrative tasks that are not related to 
their qualifications as a PTA or OTA. Rather, we believe the provisions 
of section 1834(v) were meant to apply when a PTA or OTA is involved in 
providing some or all of the therapeutic portions of an outpatient 
therapy service. We are proposing to define ``in part,'' for purposes 
of the proposed new modifiers, to mean any

[[Page 35852]]

minute of the outpatient therapy service that is therapeutic in nature, 
and that is provided by the PTA or OTA when acting as an extension of 
the therapist. Therefore, a service furnished ``in part'' by a therapy 
assistant would not include a service for which the PTA or OTA 
furnished only non-therapeutic services that others without the PTA's 
or OTA's training can do, such as scheduling the next appointment, 
greeting and gowning the patient, preparing or cleaning the room. We 
remind therapists and therapy providers that we do not recognize PTAs 
and OTAs to wholly furnish PT and OT evaluations and re-evaluations, 
that is, CPT codes 97161 through 97164 for PT and CPT codes 97165 
through 97168 for OT; but to the extent that they do furnish part of an 
evaluative service, the appropriate therapy modifier must be used on 
the claim to signal that the service was furnished in part by the PTA 
or OTA, and the payment reduction should be applied once it goes into 
effect. We continue to believe that the clinical judgment and decision 
making involved in furnishing an evaluation or re-evaluation is similar 
to that involved with establishing the therapy plan that can only be 
established by a therapist, physician, or NPP (NP, CNS, or PA) as 
specified in Sec.  410.61 of our regulations. In addition, PTAs and 
OTAs are not recognized separately in the statute to enroll as 
practitioners for purposes of independently billing for their services 
under the Medicare program. For these reasons, Pub. 100-02, Medicare 
Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2 state that 
PTAs and OTAs ``. . . may not provide evaluative or assessment 
services, make clinical judgments or decisions; develop, manage, or 
furnish skilled maintenance program services; or take responsibility 
for the service.'' While we expect that the therapist will continue to 
furnish the majority of an evaluative procedure service, section 
1834(v)(1) of the Act requires that the adjusted payment amount (85 
percent of the otherwise applicable Part B payment amount) be applied 
when a therapy assistant furnishes a therapy service ``in part,'' 
including part of an evaluative service.
    Additionally, we would like to clarify that the requirements for 
evaluations, including those for documentation, are separate and 
distinct from those for plans of care (plans). The plan is a statutory 
requirement under section 1861(p) of the Act for outpatient PT services 
(and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient 
OT and SLP services, respectively) and may only be established by a 
therapist or physician. Through Sec.  410.61(b)(5), NPs, CNSs, and PAs 
are also permitted to establish the plan. This means that if the 
evaluative procedure is furnished in part by an assistant, the new 
therapy modifiers that distinguish services furnished by PTAs or OTAs 
must be applied to the claim; however, the plan, which is not 
separately reported or paid, must be established by the supervising 
therapist who furnished part of the evaluation services as specified at 
Sec.  410.61(b). When an evaluative therapy service is billed by a 
physician or an NPP as the rendering provider, either the physician/NPP 
or the therapist furnishing the service incident to the services of the 
physician or NPP, may establish the therapy plan in accordance with 
Sec.  410.61(b). All regulatory and subregulatory plan requirements 
continue to apply.
    To implement the new statutory provision at section 1834(v)(2)(A) 
of the Act, we are proposing to establish two new therapy modifiers to 
identify the services furnished in whole or in part by PTAs and OTAs. 
As required under section 1834(v)(2)(B) of the Act, claims from all 
providers of PT and OT services furnished on and after January 1, 2020, 
will be required to include these new PT- and OT-Assistant therapy 
modifiers for services furnished in whole or in part by a PTA or OTA. 
We propose that these modifiers will be required, when applicable, in 
place of the GP and GO modifiers currently used to identify PT and OT 
services furnished under an outpatient plan of care. To test our 
systems ahead of the required implementation date of January 1, 2020, 
we anticipate allowing voluntary reporting of the new modifiers at some 
point during CY 2019, which we will announce to our contractors and 
therapy providers through a Change Request, as part of our usual change 
management process.
    We seek comments on these proposals.
3. Proposed Functional Reporting Modifications
    Since January 1, 2013, all providers of outpatient therapy 
services, including PT, OT, and SLP services, have been required to 
include functional status information on claims for therapy services. 
In response to the Request for Information (RFI) on CMS Flexibilities 
and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 
FR 34172 through 34173), we received comments requesting burden 
reduction related to the reporting of the functional reporting 
requirements that were adopted to implement the requirements of section 
3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) 
of 2012, effective January 1, 2013.
    After considering comments received through the CY 2013 PFS final 
rule with comment period (77 FR 68598-68978), we finalized the design 
of the functional reporting system. The MCTRJCA required us to 
implement a claims-based data collection strategy in order to collect 
data on patient function over the course of PT, OT, and SLP services in 
order to better understand patient condition and outcomes. The 
functional reporting system we implemented collects data using non-
payable HCPCS G-codes (HCPCS codes G8978 through G8999 and G9158 
through G9186) and modifiers (in the range CH through CN) to describe a 
patient's functional limitation and severity at: (a) The time of the 
initial service, (b) at periodic intervals in sync with existing 
progress reporting intervals, (c) at discharge, and (d) when reporting 
certain evaluative and re-evaluative procedures (often times billed at 
time of initial service). Claims without the required functional 
reporting information are returned to therapy services providers, 
rather than denied, so that they can add the required information and 
resubmit claims. Therapy services providers must also document 
functional reporting information in the patient's medical record each 
time it is reported. The MCTRJCA also specified that data from the 
functional reporting system were to be used to aid us in recommending 
changes to, and reforming Medicare payment for outpatient therapy 
services that were then subject to the therapy caps under section 
1833(g) of the Act. We conducted an analysis that focused on the 
functional reporting data that have been submitted through the claims-
based system, both by therapy discipline and by episodes of care by 
discipline using a similar episode definition (for example, clean 60 
calendar day period) that was used in our prior utilization reports for 
CY 2008 through CY 2010 that can be found on the Therapy Services web 
page in the Studies and Reports page at https://www.cms.gov/Medicare/Billing/TherapyServices/Studies-and-Reports.html). However, we did not 
find the results compelling enough to use as a basis to recommend or 
undertake administrative reforms of the current payment mechanism for 
therapy services. Furthermore, going forward, the functional reporting 
data we would collect may be even less useful for purposes of 
recommending or reforming payment for therapy services because, as 
described earlier, section 50202 of the

[[Page 35853]]

Bipartisan Budget Act of 2018 (BBA of 2018) amended section 1833(g) of 
the Act to repeal the application of the Medicare outpatient therapy 
caps and associated exceptions process, while imposing protections to 
ensure therapy services are furnished when appropriate.
    The general consensus of the commenters (organizations of physical 
therapists, occupational therapists, and speech-language pathologists, 
as well as other organizations of providers of therapy services and 
individual stakeholders) who responded to our RFI on burden reduction 
was that the functional reporting requirements for outpatient therapy 
services are overly complex and burdensome. The majority of commenters 
urged us to substantially revise and repurpose our functional reporting 
requirements for other programmatic purposes or to eliminate the 
functional reporting requirements all together. Most commenters to the 
RFI on burden reduction criticized us for not having shared with them 
an analysis of the functional reporting data we had collected to date, 
even though MCTRJCA does not require that we share any such analysis. A 
couple of commenters recommended we evolve our functional reporting 
requirements, at least in the short-term, with the following three 
changes: (a) Require reporting only at intake and discharge; (b) permit 
reporting through clinical data registries, electronic health records 
(EHRs), facility-based submission vehicles, etc., instead of the 
claims-based reporting required by section 3005(g) of MCTRJCA; and (c) 
allow functional reporting by therapy providers under MIPS as a 
clinical practice improvement activity. The short-term recommendation 
for reduced reporting was based on an independent analysis by one 
specialty society using a sample of our CY 2014 claims. That analysis 
noted that over an episode of care: (a) 93 percent reported when an 
evaluation code was reported; (b) 12 percent to 16 percent reported at 
the time of progress reporting interval; and (c) 36 percent of the 
episodes reported discharge data. In the long-term, these same RFI 
commenters believe our functional reporting system should be eliminated 
in favor of CMS policies that move therapy providers toward reporting 
using standardized measures of function. Other commenters suggested 
that we use standardized measures that reflect global function, or that 
are condition-specific. Some commenters would like to see CMS develop 
setting-appropriate quality measures for outpatient therapy that can be 
used to both (a) measure functionality and (b) meld patient assessment 
data and functional measures with relevant measures developed in 
response to the Improving Medicare Post-Acute Care Transformation Act 
of 2014 (IMPACT Act of 2014) (Pub. L. 113-185) that is applicable to 
CMS post-acute care (PAC) settings.
    As part of the requirements of section 3005(g) of MCTRJCA, we 
established our functional reporting claims-based data collection 
strategy effective January 1, 2013 in the CY 2013 PFS final rule (77 FR 
689580 through 68978) and will have been collecting these functional 
reporting data for the last 5 years at the close of CY 2018. Because 
the data from the functional reporting system were to be used to inform 
our recommendations and reform of Medicare payment for outpatient 
therapy services that are subject to the therapy caps under section 
1833(g) of the Act, we reviewed and analyzed the data internally but 
did not find them particularly useful in considering how to reform 
payment for therapy services as an alternative to the therapy caps. In 
the meantime, section 50202 of BBA of 2018, as discussed previously, 
amended section 1833(g) of the Act to reform therapy payment. Because 
section 3005(g) of MCTRJCA was not codified into the Act, and did not 
specify how long the data collection strategy should last, we do not 
believe it was intended to last indefinitely. We note that we share 
commenters' concerns, including those who favor the elimination of 
functional reporting because it is overly complex and burdensome to 
report, and that those that questioned the utility of the collected 
data given the lack of standardized measures used to report the 
severity of the functional limitation being reported. In response to 
commenters' concerns that we have not yet shared an analysis of the 
collected functional reporting data with them, we note that we have not 
published or shared the results to date because we did not find the 
results informative when reviewing them for purpose of the section 
3005(g) of MCTRJCA requirement. A few commenters requested that we 
continue to collect functional reporting data in a reduced format--at 
the outset and at discharge of the therapy episode--as a collective 
short-term solution, while favoring the elimination of functional 
reporting in the long-term because, according to our data and the 
commenters' own data, the discharge data are only infrequently 
reported. However, we do not believe that collecting additional years 
of functional reporting data in this reduced format would add utility 
to our data collection efforts. After consideration of these comments 
on the RFI along with a review of all of the requirements under section 
3005(g) of MCTRJCA, and in light of the recent statutory amendments to 
section 1833(g) of the Act, we have concluded that continuing to 
collect more years of these functional reporting data, whether through 
the same or a reduced format, will not yield additional information 
that would be useful to inform future analyses, and that allowing the 
current functional reporting requirements to remain in place could 
result in unnecessary burden for providers of therapy services without 
providing further benefit to the Medicare program in the form of 
additional data.
    As a result, we are proposing to discontinue the functional 
reporting requirements for services furnished on or after January 1, 
2019. Specifically, we are proposing to amend our regulations by 
removing the following: (1) Conditions of payment at Sec. Sec.  
410.59(a)(4), 410.60(a)(4), 410.62(a)(4), and 410.105(d) that require 
claims for OT, PT, SLP, and Comprehensive Outpatient Rehabilitation 
Facility (CORF) PT, OT, and SLP services, respectively, to contain 
prescribed information on patient functional limitations; and, (2) the 
functional reporting-related phrase that requires the plan's goals to 
be consistent with functional information on the claim at Sec.  
410.61(c) for outpatient PT, OT, and SLP services and at Sec.  
410.105(c)(1)(ii) for the PT, OT, and SLP services in CORFs. In 
addition, we would: (1) Remove the functional reporting subregulatory 
requirements implemented primarily through Change Request 8005 last 
issued on December 21, 2012, via Transmittal 2622; (2) eliminate the 
functional reporting standard systems edits we have applied to claims; 
and (3) remove the functional reporting requirement provisions in our 
internet Only Manual (IOM) provisions including the Medicare Claims 
Processing Manual, Chapter 5; and, the functional reporting 
requirements in Chapters 12 and 15 of the Medicare Benefits Policy 
Manual.
    If finalized, our proposal would end the requirements for the 
reporting and documentation of functional limitation G-codes (HCPCS 
codes G8978 through G8999 and G9158 through G9186) and severity 
modifiers (in the range CH through CN) for outpatient therapy claims 
with dates of service on and after January 1, 2019. Accordingly, with 
the conclusion of our functional reporting system for dates of service 
after

[[Page 35854]]

December 31, 2018, we would delete the applicable non-payable HCPCS G-
codes specifically developed to implement that system through the CY 
2013 PFS final rule with comment period (77 FR 68598 through 68978).
    We are seeking comment on these proposals.

N. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments

    Consistent with statutory provisions in section 1847A of the Act, 
many current Medicare Fee For Service (FFS) payments for separately 
payable drugs and biologicals furnished by providers and suppliers 
include an add-on set at 6 percent of the volume-weighted average sales 
price (ASP) or wholesale acquisition cost (WAC) for the drug or 
biological (the ``6 percent add-on''). Although section 1847A of the 
Act does not specifically state what the 6 percent add-on represents, 
it is widely believed to include services associated with drug 
acquisition that are not separately paid for, such as handling, and 
storage, as well as additional mark-ups in drug distribution channels. 
The 6 percent add-on described in section 1847A of the Act has raised 
concerns because more revenue can be generated from percentage-based 
add-on payments for expensive drugs, and an opportunity to generate 
more revenue may create an incentive for the use of more expensive 
drugs (MedPAC Report to the Congress: Medicare and the Health Care 
Delivery System June 2015, http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf, pages 65 through 72). Also, the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) March 8, 2016, 
Issue Briefing pointed out that that administrative complexity and 
overhead costs are not exactly proportional to the price of a drug 
(https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives). Thus, the suitability of using a percentage of the volume-
weighted average sales price or WAC of the drug or biological for an 
add-on payment may vary depending on the price of the drug or how the 
payment rate has been determined.
    While the add-on percentage for drug payments made under section 
1847A of the Act is typically applied to the ASP, the same 6 percent 
add-on is also applied to the WAC to determine the Part B drug payment 
allowances in the following situations. First, for single source drugs 
as authorized in section 1847A(b)(4) of the Act, payment is made using 
the lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires 
that a 6 percent add-on be applied regardless of whether WAC or ASP is 
less. Second, for drugs and biologicals where average sales price 
during first quarter of sales is unavailable, section 1847A(c)(4) of 
the Act allows the Secretary to determine the payment amount for the 
drug or biological based on the WAC or payment methodologies in effect 
on November 1, 2003. We note that this provision does not specify that 
an add-on percentage be applied if WAC-based payment is used, nor is an 
add-on percentage specified in the implementing regulations at Sec.  
414.904(e)(4). The application of the add-on percentage to WAC-based 
payments during a period where partial quarter ASP data was available 
was discussed in the 2011 PFS final rule with comment (75 FR 73465 
through 73466). Third, in situations where Medicare Administrative 
Contractors (MACs) determine pricing for drugs that do not appear on 
the ASP pricing files and for new drugs, WAC-based payment amounts may 
also be used, as discussed in Chapter 17, Section 20.1.3 of the 
Medicare Claims Processing Manual. This section of the Manual describes 
the use of a 6 percent add-on.
    The incorporation of discounts in the determination of payment 
amounts made for Part B drug varies. Most Part B drug payments are 
based on the drug's or biological's ASP; as provided in section 
1847A(c)(3) of the Act, the ASP is net of many discounts such as volume 
discounts, prompt pay discounts, cash discounts, free goods that are 
contingent on any purchase, chargebacks, rebates (other than rebates 
under Medicaid drug rebate program), etc. In contrast, the WAC of a 
drug or biological is defined in section 1847A(c)(6)(B) of the Act as 
the manufacturer's list price for the drug or biological to wholesalers 
or direct purchasers in the United States, not including prompt pay or 
other discounts, rebates or reductions in price, for the most recent 
month for which the information is available, as reported in wholesale 
price guides or other publications of drug or biological pricing data. 
Because the WAC does not include discounts, it typically exceeds ASP, 
and the use of a WAC-based payment amount for the same drug results in 
higher dollar payments than the use of an ASP-based payment amount.
    Although discussions about the add-on tend to focus on ASP-based 
payments (because ASP-based payments are more common than WAC-based 
payments), the add-on for WAC-based payments has also been raised in 
the June 2017 MedPAC Report to the Congress (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 42 
through 44). The MedPAC report focused on how the 2 quarter lag in 
payments determined under section 1847A of the Act led to a situation 
where undiscounted WAC-based payment amounts determined using 
information from 2 quarters earlier were used to pay for drugs that 
providers purchased at a discount. To determine the extent of the 
discounts, MedPAC sampled new, high-expenditure Part B drugs and found 
that these drugs' ASPs were generally lower than their WACs. Seven out 
of the 8 drugs showed pricing declines from initial WAC to ASP one year 
after being listed in the ASP pricing files with the remaining product 
showing no change, which suggests purchasers received discounts that 
WAC did not reflect. MedPAC further cited a 2014 OIG report (OIG, 
Limitations in Manufacturer Reporting of Average Sales Price Data for 
Part B Drugs, (OEI-12-13-00040), July 2014) to illustrate that there 
may be differences between WAC and ASP in other instances in which CMS 
utilizes WAC instead of ASP and noted that OIG found that ``WACs often 
do not reflect actual market prices for drugs.'' MedPAC also 
characterized Part B payments based on undiscounted list prices for 
products that were available at a discount as excessive. The report 
suggested that greater parity between ASP-based acquisition costs and 
WAC-based payments for Part B drugs could be achieved and recommended 
changing the 6 percent add-on for WAC-based payments to 3 percent. A 3 
percent change was recommended based on statements made by industry, 
MedPAC's analysis of new drug pricing, and OIG data. The report also 
mentioned that discounts on WAC, such as prompt pay discounts, were 
available soon after the drug went on the market.
    In the case of a drug or biological during an initial sales period 
in which data on the prices for sales for the drug or biological is not 
sufficiently available from the manufacturer, section 1847A(c)(4) of 
the Act permits the Secretary to make payments that are based on WAC. 
In other words, although payments under this section may be based on 
WAC, unlike section 1847A(b) of the Act (which specifies that certain 
payments must be made with a 6 percent add-on), section 1847A(c)(4) of 
the Act does not require that a particular add-on amount be applied to 
partial quarter WAC-based pricing. Consistent with section 1847A(c)(4) 
of the Act, we are proposing that effective January 1,

[[Page 35855]]

2019, WAC based payments for Part B drugs made under section 
1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6 
percent add-on that is currently being used. We are proposing a 3 
percent add-on because this percentage is consistent with MedPAC's 
analysis and recommendations discussed in the paragraph above and cited 
in their June 2017 Report to the Congress. Although other approaches 
for modifying the add-on amount, such as a flat fee, or percentages 
that vary with the cost of a drug, are possible, we are proposing a 
fixed percentage in order to be consistent with other provisions in 
section 1847A of the Act which specify fixed add-on percentages of 6 
percent (1847A(b)) or 3 percent (section 1847A(d)(3)(C) of the Act). A 
fixed percentage is also administratively simple to implement and 
administer, is predictable, and is easy for manufacturers, providers 
and the public to understand.
    We have also reviewed corresponding regulation text at Sec.  
414.904(e)(4). To conform the regulation text more closely to the 
statutory language at section 1847A(c)(4) of the Act, we are also 
proposing to strike the word ``applicable'' from paragraph (e)(4). 
Section 1847A(c)(4) of the Act does not use the term ``applicable'' to 
describe the payment methodologies in effect on November 1, 2003.
    If we were to finalize these proposals, we would also change the 
policy articulated in the Claims Processing Manual that describes the 
application of the 6 percent add-on to payment determinations made by 
MACs for new drugs and biologicals. Chapter 17 section 20.1.3 of the 
Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf) states that WAC-based payment 
limits for drugs and biologicals that are produced or distributed under 
a new drug application (or other new application) approved by the Food 
and Drug Administration, and that are not included in the ASP Medicare 
Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing 
File, are based on 106 percent of WAC. Invoice-based pricing is used if 
the WAC is not published. In OPPS, the payment allowance limit is 95 
percent of the published Average Wholesale Price (AWP). We would change 
our policy to permit MACs to use an add-on percentage of up to 3 
percent for WAC-based payments for new drugs. MACs have longstanding 
authority to make payment determinations when we do not publish a 
payment limit in our national Part B drug pricing files and when new a 
drug becomes available. This proposal would preserve consistency with 
our proposed national pricing policy and would apply when MACs perform 
pricing determinations, for example during the period when ASPs have 
not been reported. This proposed policy would not alter OPPS payment 
limits.
    We note that these proposals do not include WAC-based payments for 
single source drugs under section 1847A(b) of the Act, that is, where 
the statute specifies that the payment limit is 106 percent of the 
lesser of ASP or WAC.
    We have stated in previous rulemaking that it is desirable to have 
fair reimbursement in a healthy marketplace that encourages product 
development (80 FR 71101). We have also stated that we seek to promote 
innovation to provide more options to patients and physicians, and 
competition to drive prices down (82 FR 53183). These positions have 
not changed. However, since 2011, concern about the impact of drug 
pricing and spending on Part B drugs has continued to grow. From 2011 
to 2016, Medicare Part B drug spending increased from $17.6 billion to 
$28.0 billion, representing a compound annual growth rate of 9.8 
percent, with per capita spending increasing 54 percent, from $532 to 
$818 (Based on Spending and Enrollment Data from Centers for Medicare 
and Medicaid Services Office of Enterprise Data and Analytics). These 
increases affect the spending by Medicare and beneficiary out-of-pocket 
costs. In the context of these concerns, we believe that implementation 
of these proposals will improve Medicare payment rates by better 
aligning payments with drug acquisition costs, especially for the 
growing number of drugs with high annual spending and high launch 
prices where single doses can cost tens or even hundreds of thousands 
of dollars. The proposals will also decrease beneficiary cost sharing. 
A 3 percentage point reduction in the total payment allowance will 
reduce a patient's 20 percent Medicare Part B copayment--for a drug 
that costs many thousands of dollars per dose, this can result in 
significant savings to an individual. The proposed approach would help 
Medicare beneficiaries afford to pay for new drugs by reducing out of 
pocket expenses and would help counteract the effects of increasing 
launch prices for newly approved drugs and biologicals. Finally, the 
proposals are consistent with recent MedPAC recommendations.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule

1. Background
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) 
under sections 1832, 1833(a), (b) and (h), and 1861 of the Social 
Security Act (the Act). Under the previous methodology, CDLTs were paid 
based on the lesser of: (1) The amount billed; (2) the local fee 
schedule amount established by the Medicare Administrative Contractor 
(MAC); or (3) a national limitation amount (NLA), which is a percentage 
of the median of all the local fee schedule amounts (or 100 percent of 
the median for new tests furnished on or after January 1, 2001). In 
practice, most tests were paid at the NLA. Under the previous system, 
the CLFS amounts were updated for inflation based on the percentage 
change in the Consumer Price Index for All Urban Consumers (CPI-U), and 
reduced by a multi-factor productivity adjustment and other statutory 
adjustments, but were not otherwise updated or changed.
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final 
rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment 
System (CLFS final rule), published in the Federal Register on June 23, 
2016, implemented section 1834A of the Act. Under the CLFS final rule, 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' collected during a ``data 
collection period'' for their component ``applicable laboratories.'' 
Applicable information is defined at Sec.  414.402 as, with respect to 
each CDLT for a data collection period: Each private payor rate for 
which final payment has been made during the data collection period; 
the associated volume of tests performed corresponding to each private 
payor rate; and the specific Healthcare Common Procedure Coding System 
(HCPCS) code associated with the test. Applicable information does not 
include information about a test for which payment is made on a 
capitated basis. An applicable laboratory is defined at Sec.  414.502, 
in part, as an entity that is a laboratory (as defined under the 
Clinical Laboratory Improvement Amendments (CLIA) definition at Sec.  
493.2) that bills Medicare Part B under its own National Provider 
Identifier

[[Page 35856]]

(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the Physician Fee Schedule (PFS). We refer 
to this component of the applicable laboratory definition as the 
``majority of Medicare revenues threshold.'' The definition of 
applicable laboratory also includes a ``low expenditure threshold'' 
component which requires an entity to receive at least $12,500 of its 
Medicare revenues from the CLFS for its CDLTs that are not advanced 
diagnostic laboratory tests (ADLTs).
    The first data collection period, for which applicable information 
was collected, occurred from January 1, 2016 through June 30, 2016. The 
first data reporting period, during which reporting entities reported 
applicable information to CMS, occurred January 1, 2017 through March 
31, 2017. On March 30, 2017, we announced a 60-day enforcement 
discretion period of the assessment of Civil Monetary Penalties (CMPs) 
for reporting entities that failed to report applicable information. 
Additional information about the 60-day enforcement discretion period 
may be found on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
    In general, the payment amount for each CDLT on the CLFS furnished 
beginning January 1, 2018, is based on the applicable information 
collected during the data collection period and reported to us during 
the data reporting period, and is equal to the weighted median of the 
private payor rates for the test. The weighted median is calculated by 
arraying the distribution of all private payor rates, weighted by the 
volume for each payor and each laboratory. The payment amounts 
established under the CLFS are not subject to any other adjustment, 
such as geographic, budget neutrality, or annual update, as required by 
section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of 
the Act, implemented at Sec.  414.507(d), provides a phase-in of 
payment reductions, limiting the amounts the CLFS rates for each CDLT 
(that is not a new ADLT or new CDLT) can be reduced as compared to the 
payment rates for the preceding year. For the first 3 years after 
implementation (CY 2018 through CY 2020), the reduction cannot be more 
than 10 percent per year, and for the next 3 years (CY 2021 through CY 
2023), the reduction cannot be more than 15 percent per year. For most 
CDLTs, the data collection period, data reporting period, and payment 
rate update occur every 3 years. As such, the next data collection 
period for most CDLTs will be January 1, 2019 through June 30, 2019, 
and the next data reporting period will be January 1, 2020 through 
March 31, 2020, with the next update to CLFS occurring on January 1, 
2021. Additional information on the private payor rate-based CLFS is 
detailed in the CLFS final rule (81 FR 41036 through 41101).
2. Recent Stakeholder Feedback
    After the initial data collection and data reporting periods, we 
received stakeholder feedback on a range of topics related to the 
private payor rate-based CLFS. Some stakeholders expressed concern that 
the CY 2018 CLFS payments rates are based on applicable information 
from only a relatively small number of laboratories. Some stakeholders 
stated that, because most hospital-based laboratories were not 
applicable laboratories, and therefore, did not report applicable 
information during the initial data reporting period, the CY 2018 CLFS 
payment rates do not reflect their information and are inaccurate. 
Other stakeholders were concerned that the low expenditure threshold 
excluded most physician office laboratories and many small independent 
laboratories from reporting applicable information.
    In determining payment rates under the private payor rate-based 
CLFS, one of our objectives is to obtain as much applicable information 
as possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. As we noted throughout the CLFS final rule, we believe it is 
important to achieve a balance between collecting sufficient data to 
calculate a weighted median that appropriately reflects the private 
market rate for a CDLT, and minimizing the reporting burden for 
entities. In response to stakeholder feedback and in the interest of 
facilitating our goal, we are proposing one change, discussed below, to 
the Medicare CLFS for CY 2019. We believe this proposal may result in 
more data being used on which to base CLFS payment rates.
    In addition to this proposal, we are soliciting public comments on 
other approaches that have been requested by some stakeholders who 
suggested that such approaches would result in CMS receiving even more 
applicable information to use in establishing CLFS payment rates. The 
approaches include revising the definition of applicable laboratory and 
changing the low expenditure threshold. These topics are discussed 
below.
3. Proposed Change to the Majority of Medicare Revenues Threshold in 
Definition of Applicable Laboratory
    In order for a laboratory to meet the majority of Medicare revenues 
threshold, section 1834A(a)(2) of the Act requires that, ``with respect 
to its revenues under this title, a majority of such revenues are 
from'' the CLFS and the PFS in a data collection period. In the CLFS 
final rule, we stated that ``revenues under this title'' are payments 
received from the Medicare program, which includes fee-for-service 
payments under Medicare Parts A and B, as well as Medicare Advantage 
(MA) payments under Medicare Part C, and prescription drug payments 
under Medicare Part D, and any associated Medicare beneficiary 
deductible or coinsurance amounts for Medicare services furnished 
during the data collection period (81 FR 41043). This total Medicare 
revenues amount (the denominator in the majority of Medicare revenues 
threshold calculation) is compared to the total of Medicare revenues 
received from the CLFS and/or PFS (the numerator in the majority of 
Medicare revenues threshold calculation). If the numerator is greater 
than 50 percent of the denominator for a data collection period, the 
entity has met the majority of Medicare revenues threshold criterion. 
We reflected that requirement in Sec.  414.502 in the third paragraph 
of the definition of applicable laboratory.
    We have considered that our current interpretation of total 
Medicare revenues may have the effect of excluding laboratories that 
furnish Medicare services to a significant number of beneficiaries 
enrolled in MA plans under Medicare Part C from meeting the majority of 
Medicare revenues threshold criterion, and therefore, from qualifying 
as applicable laboratories. For instance, if a laboratory has a 
significant enough Part C component so that it is receiving greater 
than 50 percent of its total Medicare revenues from MA payments under 
Part C, it would not meet the majority of Medicare revenues threshold 
because its revenues derived from the CLFS and/or PFS would not 
constitute a majority of its total Medicare revenues. We believe that 
if we were to exclude MA plan revenues from total Medicare revenues, 
more laboratories of all types may meet the majority of Medicare 
revenues threshold, and therefore, the definition

[[Page 35857]]

of applicable laboratory, because it would have the effect of 
decreasing the amount of total Medicare revenues and increase the 
likelihood that a laboratory's CLFS and PFS revenues would constitute a 
majority of its Medicare revenues.
    We believe section 1834A of the Act permits an interpretation that 
MA plan payments to laboratories not be included in the total Medicare 
revenues component of the majority of Medicare revenues threshold 
calculation. Rather, MA plan payments to laboratories can be considered 
to only be private payor payments under the CLFS. We emphasize here 
that this characterization of MA plan payments is limited to only the 
CLFS for purposes of defining applicable laboratory. Whether MA plan 
payments to laboratories or other entities are considered Medicare 
``revenues'' or ``private payor payments'' in other contexts in the 
Medicare program is irrelevant here. Nor does our characterization of 
MA plan payments as private payor payments for purposes of the CLFS 
have any bearing on any aspect of the Medicare program other than the 
CLFS. This is because of language included in section 1834A of the Act 
that is specifically targeted to the CLFS, explained below.
    As noted above, we defined total Medicare revenues for purposes of 
the majority of Medicare revenues threshold calculation to include fee-
for-service payments under Medicare Parts A and B, as well as MA 
payments under Medicare Part C, and prescription drug payments under 
Medicare Part D, and any associated Medicare beneficiary deductible or 
coinsurance amounts for Medicare services furnished during the data 
collection period. However, section 1834A(a)(8) of the Act, which 
defines the term ``private payor,'' identifies at section 
1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of 
private payor. Under the private payor rate-based CLFS, CLFS payment 
amounts are based on private payor rates that are reported to CMS. So, 
an applicable laboratory that receives Medicare Advantage (MA) plan 
payments is to consider those MA plan payments in identifying its 
applicable information, which must be reported to CMS. We believe it is 
more logical to not consider MA plan payments under Part C to be both 
Medicare revenues for determining applicable laboratory status and 
private payor rates for purposes of reporting applicable information. 
Congress contemplated that applicable laboratories would furnish MA 
services, as reflected in the requirement that private payor rates must 
be reported for MA services. However, under our current definition of 
applicable laboratory, laboratories that furnish MA services, 
particularly those that furnish a significant amount, are less likely 
to meet the majority of Medicare revenues threshold, which means they 
would be less likely to qualify as applicable laboratories, and 
therefore, to report private payor rates for MA services.
    Therefore, after further review and consideration of the new 
private payor rate-based CLFS, we believe it is appropriate to include 
MA plan revenues as only private payor payments rather than both 
Medicare revenues, for the purpose of determining applicable laboratory 
status, and private payor payments, for the purpose of specifying what 
is applicable information. Such a change would have the effect of 
eliminating the laboratory revenue generated from a laboratory's Part 
C-enrolled patient population as a factor in determining whether a 
majority of the laboratory's Medicare revenues are comprised of 
services paid under the CLFS or PFS. We believe this change would 
permit a laboratory with a significant Medicare Part C revenue 
component to be more likely to meet the majority of Medicare revenues 
threshold and qualify as an applicable laboratory. In other words, MA 
payments are currently included as total Medicare revenues (the 
denominator). In order to meet the majority of Medicare revenues 
threshold, the statute requires a laboratory to receive the majority of 
its Medicare revenues from the CLFS and or PFS. If MA plan payments 
were excluded from the total Medicare revenues calculation, the 
denominator amount would decrease. If the denominator amount decreases, 
the likelihood increases that a laboratory would qualify as an 
applicable laboratory. Therefore, we believe this proposal responds 
directly to stakeholders' concerns regarding the number of laboratories 
for which applicable information must be reported because a broader 
representation of the laboratory industry may qualify as applicable 
laboratories, which means we would receive more applicable information 
to use in setting CLFS payment rates.
    For these reasons, we are proposing that MA plan payments under 
Part C would not be considered Medicare revenues for purposes of the 
applicable laboratory definition. We would revise paragraph (3) of the 
definition of applicable laboratory at Sec.  414.502 accordingly. We 
reiterate that not characterizing MA plan payments under Medicare Part 
C as Medicare revenues would be limited to the definition of applicable 
laboratory under the CLFS, and would not affect, reflect on, or 
otherwise have any bearing on any other aspect of the Medicare program.
    In an effort to provide stakeholders a better understanding of the 
potential reporting burden that may result from this proposal, we are 
providing a summary of the distribution of data reporting that occurred 
for the first data reporting period. If we were to finalize the 
proposed change to the majority of Medicare revenues threshold 
component of the definition of applicable laboratory, additional 
laboratories of all types serving a significant population of 
beneficiaries enrolled in Medicare Part C could potentially qualify as 
applicable laboratories, in which case their data would be reported to 
us. As discussed previously, we received over 4.9 million records from 
1,942 applicable laboratories for the initial data reporting period, 
which we used to set CY 2018 CLFS rates. Additional analysis shows that 
the average number of records reported for an applicable laboratory was 
2,573. The largest number of records reported for an applicable 
laboratory was 457,585 while the smallest amount was 1 record. A 
summary of the distribution of reported records from the first data 
collection period is illustrated in the Table 24.

                                          Table 24--Summary of Records Reported for First Data Reporting Period
                                                               [By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Percentile distribution of records
              Total records                  Average     Min records   Max records ---------------------------------------------------------------------
                                             records                                    10th          25th          50th          75th          90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877...............................        2,573             1       457,585            23            79           294         1,345         4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 35858]]

    Assuming a similar distribution of data reporting for the next data 
reporting period, the mid-point of reported records for an applicable 
laboratory would be approximately 300 (50th percentile for the first 
data reporting period was 294). However, as illustrated in Table 24, 
the number of records reported varies greatly, depending on the volume 
of services performed by a given laboratory. Laboratories with larger 
test volumes, for instance at the 90th percentile, should expect to 
report more records as compared to the midpoint used for this analysis. 
Likewise, laboratories with smaller test volume, for instance at the 
10th percentile, should expect to report less records as compared to 
the midpoint.
    We welcome comments on our proposal to modify the definition of 
applicable laboratory to exclude MA plan payments under Part C as 
Medicare revenues.
4. Solicitation of Public Comments on Other Approaches to Defining 
Applicable Laboratory
    As noted previously, we define applicable laboratory at the NPI 
level, which means the laboratory's own billing NPI is used to identify 
a laboratory's revenues for purposes of determining whether it meets 
the majority of Medicare revenues threshold and the low expenditure 
threshold components of the applicable laboratory definition. For 
background purposes, the following summarizes some of the 
considerations we made in establishing this policy.
    In the CLFS proposed rule, entitled Medicare Clinical Diagnostic 
Laboratory Tests Payment System, published in the October 1, 2015 
Federal Register, we proposed to define applicable laboratory at the 
TIN level so that an applicable laboratory would be an entity that 
reports tax-related information to the IRS under a TIN with which all 
of the NPIs in the entity are associated, and was itself a laboratory 
or had at least one component that was a laboratory, as defined in 
Sec.  493.2. In the CLFS proposed rule, we discussed that we considered 
proposing to define applicable laboratory at the NPI level. However, we 
did not propose that approach because we believed private payor rates 
for CDLTs are negotiated at the TIN level and not by individual 
laboratory locations at the NPI level. Numerous stakeholders had 
indicated that the TIN-level entity is the entity negotiating pricing, 
and therefore, is the entity in the best position to compile and report 
applicable information across its multiple NPIs when there are multiple 
NPIs associated with a TIN-level entity. We stated that we believed 
defining applicable laboratory by TIN rather than NPI would result in 
the same applicable information being reported, and would require 
reporting by fewer entities, and therefore, would be less burdensome to 
applicable laboratories. In addition, we stated that we did not believe 
reporting at the TIN level would affect or diminish the quality of the 
applicable information reported. To the extent the information is 
accurately reported, we expected reporting at a higher organizational 
level to produce exactly the same applicable information as reporting 
at a lower level (80 FR 59391 through 59393).
    Commenters who objected to our proposal to define applicable 
laboratory at the TIN level stated that our definition would exclude 
hospital laboratories because, in calculating the applicable 
laboratory's majority of Medicare revenues amount, which looks at the 
percentage of Medicare revenues from the PFS and CLFS across the entire 
TIN-level entity, virtually all hospital laboratories would not be 
considered an applicable laboratory. Many commenters expressed 
particular concern that our proposed definition would exclude hospital 
outreach laboratories, stating that hospital outreach laboratories, 
which do not provide laboratory services to hospital patients, are 
direct competitors of the broader independent laboratory market, and 
therefore, excluding them from the definition of applicable laboratory 
would result in incomplete and inappropriate applicable information, 
which would skew CLFS payment rates. Commenters maintained that CMS 
needed to ensure reporting by a broad scope of the laboratory market to 
meet what they viewed as Congressional intent that all sectors of the 
laboratory market be included to establish accurate market-based rates 
(81 FR 41045).
    In issuing the CLFS final rule, we found particularly compelling 
the comments that urged us to adopt a policy that would better enable 
hospital outreach laboratories to be applicable laboratories because we 
agreed hospital outreach laboratories should be accounted for in the 
new CLFS payment rates. We noted that hospital outreach laboratories 
are laboratories that furnish laboratory tests for patients who are not 
admitted hospital inpatients or registered outpatients of the hospital 
and who are enrolled in Medicare separately from the hospital of which 
they are a part as independent laboratories that do not serve hospital 
patients. We believed it was important to facilitate reporting of 
private payor rates for hospital outreach laboratories to ensure a 
broader representation of the national laboratory market to use in 
setting CLFS payment amounts (81 FR 41045).
    We were clear in the CLFS final rule, however, that we believe 
Congressional intent was to effectively exclude hospital laboratories 
as applicable laboratories, which was apparent from the statutory 
language, in particular, the majority of Medicare revenues threshold 
criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the 
Act provides that, to qualify as an applicable laboratory, an entity's 
revenues from the CLFS and the PFS needs to constitute a majority of 
its total Medicare payments received from the Medicare program for a 
data collection period. What we found significant was that most 
hospital laboratories would not meet that majority of Medicare revenues 
threshold because their revenues under the IPPS and OPPS alone would 
likely far exceed the revenues they received under the CLFS and PFS. 
Therefore, we believe the statute intended to limit reporting primarily 
to independent laboratories and physician offices (81 FR 41045 through 
41047). For a more complete discussion of the definition of applicable 
laboratory, see the CLFS final rule (81 FR 41041 through 41051).
a. Stakeholder Continuing Comments and Stakeholder-Suggested 
Alternative Approaches
    As noted above, in response to public comments, we finalized that 
an applicable laboratory is the NPI-level entity so that a hospital 
outreach laboratory assigned a unique NPI, separate from the hospital 
of which it is a part, is able to meet the definition of applicable 
laboratory and its applicable information can be used for CLFS rate-
setting. We continue to believe that the NPI is the most effective 
mechanism for identifying Medicare revenues for purposes of determining 
applicable laboratory status and identifying private payor rates for 
purposes of reporting applicable information. Once a hospital outreach 
laboratory obtains its own unique billing NPI and bills for services 
using its own unique NPI, Medicare and private payor revenues are 
directly attributable to the hospital outreach laboratory. By defining 
applicable laboratory using the NPI, Medicare payments (for purposes of 
determining applicable laboratory status) and private payor rates and 
the associated volume of CDLTs can be more easily identified and 
reported to us. We also believe that, if finalized, our proposal to 
exclude MA plan revenues under Medicare Part C from total Medicare 
revenues in the

[[Page 35859]]

definition of applicable laboratory may increase the number of entities 
meeting the majority of Medicare revenues threshold, and therefore, 
qualifying for applicable laboratory status. In summary, we believe the 
proposed change to the total Medicare revenues component of the 
applicable laboratory definition and our current policy that requires 
an entity to bill Medicare Part B under its own NPI, may increase the 
number of hospital outreach laboratories qualifying as applicable 
laboratories.
    In addition, we are confident that our current policy supports our 
collecting sufficient applicable information in the next data reporting 
period, and that we received sufficient and reliable applicable 
information with which we set CY 2018 CLFS rates, and that those rates 
are accurate. For instance, we received applicable information from 
laboratories in every state, the District of Columbia, and Puerto Rico. 
This data included private payor rates for almost 248 million 
laboratory tests conducted by 1,942 applicable laboratories, with over 
4 million records of applicable information. In addition, as we've 
noted, the largest laboratories dominate the market, and therefore, 
most significantly affect the payment weights (81 FR 41049). Given that 
the largest laboratories reported their applicable information to CMS 
in the initial data reporting period, along with many smaller 
laboratories, we believe the data we used to calculate the CY 2018 CLFS 
rates was sufficient and resulted in accurate weighted medians of 
private payor rates.
    However, we continue to consider refinements to our policies that 
could lead to including even more applicable information for the next 
data reporting period. To that end, the comments and alternative 
approaches suggested by stakeholders, even though some were first 
raised prior to the CLFS final rule, are presented and considered for 
comment now.
(1) Using Form CMS-1450 Bill Type 14x To Determine Majority of Medicare 
Revenues and Low Expenditure Thresholds
    Some stakeholders that expressed concern over the CY 2018 CLFS 
payments rates stated that the NPI-based definition of applicable 
laboratory reduces the number of hospital outreach laboratories 
reporting data. These stakeholders suggested we revise the definition 
specifically for the purpose of including more hospital outreach 
laboratories. Under a suggested approach, a laboratory could determine 
whether it meets the majority of Medicare revenues threshold and low 
expenditure threshold using only the revenues from services reported on 
the Form CMS-1450 (approved Office of Management and Budget number 
0938-0997) 14x bill type, which is used only by hospital outreach 
laboratories. Therefore, per the stakeholder suggestions, we are 
seeking public comments on the following approach.
    This approach would revise the definition of applicable laboratory 
to permit the revenues identified on the Form CMS-1450 14x bill type to 
be used instead of the revenues associated with the NPI the laboratory 
uses, to determine whether it meets the majority of Medicare revenues 
threshold (and the low expenditure threshold). Under this approach, the 
applicable revenues would be based on the bills used for hospital 
laboratory services provided to non-patients, which are paid under 
Medicare Part B (that is, the 14x bill type). If we pursued this 
approach, we would have to modify the definition of applicable 
laboratory in Sec.  414.502 by indicating that an applicable laboratory 
may include an entity that bills Medicare Part B on the Form CMS-1450 
14x bill type.
    Although using the 14x bill type could alleviate some initial, 
albeit limited, administrative burden on hospital outreach laboratories 
to obtain a unique billing NPI, we would have operational and statutory 
authority concerns about defining applicable laboratory by the Form 
CMS-1450 14x bill type.
    First, defining applicable laboratory using the Form CMS-1450 14x 
bill type does not identify an entity the way an NPI does. Whereas an 
NPI is associated with a provider or supplier to determine specific 
Medicare revenues, the 14x bill type is merely a billing mechanism that 
is currently used only for a limited set of services. Under an approach 
that permits laboratories to meet the majority of Medicare revenues 
threshold using the 14x bill type, private payor rates (and the volume 
of tests paid at those rates) would have to be identified that are 
associated with only the outreach laboratory services of a hospital's 
laboratory business. However, some private payors, such as MA plans, 
may not require hospital laboratories to use the 14x bill type for 
their outreach laboratory services. To the extent a private payor does 
not require hospital outreach laboratory services to be billed on a 14x 
bill type (which specifically identifies outreach services), hospitals 
may need to develop their own mechanism for identifying and reporting 
only the applicable information associated with its hospital outreach 
laboratory services. In light of this possible scenario, we are 
interested in public comments about the utility of using the 14x bill 
type in the way we have described and on the level of administrative 
burden created if we defined applicable laboratory using the Form CMS-
1450 14x bill type.
    Second, we question whether hospitals would have sufficient time 
after publication of a new final rule that included using the Form CMS-
1450 14x bill type, and any related subregulatory guidance, to develop 
and implement the information systems necessary to collect private 
payor rate data before the start of the next data collection period, 
that is, January 1, 2019. To that end, we are interested in public 
comments as to whether revising the definition of applicable laboratory 
to use the Form CMS-1450 14x bill type would allow laboratories 
sufficient time to make the necessary systems changes to identify 
applicable information before the start of the next data collection 
period.
    Third, we believe defining applicable laboratory at the NPI level, 
as we currently do, provides flexibility for hospital outreach 
laboratories to not obtain a unique billing NPI, which may be 
significant particularly where a hospital outreach laboratory performs 
relatively few outreach services under Medicare Part B. For example, 
under the current definition of applicable laboratory, if a hospital 
outreach laboratory's CLFS revenues in a data collection period are 
typically much less than the low expenditure threshold, the hospital of 
which it is a part could choose not to obtain a separate NPI for its 
outreach laboratory and could thus avoid determining applicable 
laboratory status for its outreach laboratory component. In contrast, 
if laboratories were permitted to use the Form CMS-1450 14x bill type, 
revenues attributed to the hospital outreach laboratory would have to 
be calculated in every instance where those services exceeded the low 
expenditure threshold. This would be true even for a hospital outreach 
laboratory that performs relatively few outreach services under 
Medicare Part B. Therefore, we are interested in comments concerning 
this aspect of using the 14x bill type definition.
    Fourth, and significantly, we believe that if we were to utilize 
such an approach in defining applicable laboratory, all hospital 
outreach laboratories would meet the majority of Medicare revenues 
threshold. At this time, we believe that this approach would be 
inconsistent with the statute. By virtue of the majority of Medicare 
revenues threshold, the statute defines applicable laboratory in such a 
way that

[[Page 35860]]

not all laboratories qualify as applicable laboratories. However, if we 
were to use the CMS-1450 14x bill type to define an applicable 
laboratory, all hospital outreach laboratories that use the 14x bill 
type would meet the majority of Medicare revenues threshold. 
Accordingly, we are interested in public comments regarding whether 
this definition would indeed be inconsistent with the statute, as well 
as comments that can identify circumstances under this definition 
whereby a hospital outreach laboratory would not meet the majority of 
Medicare revenues threshold.
(2) Using CLIA Certificate To Define Applicable Laboratories
    Some industry stakeholders have requested that we use the CLIA 
certificate rather than the NPI to identify a laboratory that would be 
considered an applicable laboratory. We discussed in the CLFS proposed 
rule (80 FR 59392) why not all entities that meet the CLIA regulatory 
definition at Sec.  493.2 would be applicable laboratories, and 
therefore, we did not propose to use CLIA as the mechanism for defining 
applicable laboratory. However, some commenters to the CLFS proposed 
rule suggested we use the CLIA certificate to identify the 
organizational entity that would be considered an applicable laboratory 
so that each entity that had a CLIA certificate would be an applicable 
laboratory (81 FR 41045). We considered those comments in the CLFS 
final rule and discussed why we chose not to adopt that approach.
    Among other reasons, we explained in the CLFS final rule that we 
believed a CLIA certificate-based definition of applicable laboratory 
would be overly inclusive by including all hospital laboratories, as 
opposed to just hospital outreach laboratories. In addition, the CLIA 
certificate is used to certify that a laboratory meets applicable 
health and safety regulations in order to furnish laboratory services. 
It is not associated with Medicare billing so, unlike for example, the 
NPI, with which revenues for specific services can easily be 
identified, the CLIA certificate cannot be used to identify revenues 
for specific services. We also indicated that we did not see how a 
hospital would determine whether its laboratories would meet the 
majority of Medicare revenues threshold (and the low expenditure 
threshold) using the CLIA certificate as the basis for defining an 
applicable laboratory. In addition, we stated that, given the 
difficulties many hospitals would likely have in determining whether 
their laboratories are applicable laboratories, we also believed 
hospitals may object to using the CLIA certificate (81 FR 41045).
    However, in light of stakeholders' suggestions to use the CLIA 
certificate to include hospital outreach laboratories in the definition 
of applicable laboratories, we are soliciting public comments on that 
approach. Under such approach, the majority of Medicare revenues 
threshold and low expenditure threshold components of the definition of 
applicable laboratory would be determined at the CLIA certificate level 
instead of the NPI level. If we pursued such approach, we would have to 
modify the definition of applicable laboratory in Sec.  414.502 to 
indicate that an applicable laboratory is one that holds a CLIA 
certificate under Sec.  493.2 of the chapter. We would have concerns, 
however, about defining applicable laboratory by the CLIA certificate.
    First, as we discussed in the CLFS final rule, given that 
information regarding the CLIA certificate is not required on the Form 
CMS-1450 14x bill type, which is the billing form used by hospitals for 
their laboratory outreach services, it is not clear how a hospital 
would identify and distinguish revenues generated by its separately 
CLIA-certified laboratories for their outreach services. We are 
interested in public comments regarding the mechanisms a hospital would 
need to develop to identify revenues if we used the CLIA certificate 
for purposes of determining applicable laboratory status, as well as 
comments about the administrative burden associated with developing 
such mechanisms.
    In addition, we understand there could be a scenario where one CLIA 
certificate is assigned to a hospital's entire laboratory business, 
which would include laboratory tests performed for hospital patients as 
well as non-patients (that is, patients who are not admitted inpatients 
or registered outpatients of the hospital). For example, hospital 
laboratories with an outreach laboratory component would be assigned a 
single CLIA certificate if the hospital outreach laboratory has the 
same mailing address or location as the hospital laboratory. In this 
scenario, the majority of Medicare revenues threshold would be applied 
to the entire hospital laboratory, not just its outreach laboratory 
component. If a single CLIA certificate is assigned to the hospital's 
entire laboratory business, the hospital laboratory would be unlikely 
to meet the majority of Medicare revenues threshold because its 
laboratory revenues under the IPPS and OPPS alone would likely far 
exceed the revenues it receives under the CLFS and PFS. As a result, a 
hospital outreach laboratory that could otherwise meet the definition 
of applicable laboratory, as currently defined at the NPI level, would 
not be an applicable laboratory if we were to require the CLIA 
certificate to define applicable laboratory. Given that this approach 
could have the effect of decreasing as opposed to increasing the number 
of applicable laboratories, we are requesting public comments on this 
potential drawback of defining applicable laboratory at the CLIA 
certificate level.
    We believe that feedback on the topics discussed in this section 
could help inform us regarding potential refinements to the definition 
of applicable laboratory. We welcome comments on these topics from the 
public, including, physicians, laboratories, hospitals, and other 
interested stakeholders. We are especially interested in comments 
regarding the administrative burden of using the Form CMS-1450 14x bill 
type or CLIA certificate to identify applicable information attributed 
only to the hospital outreach laboratory portion of a hospital's total 
laboratory business. Depending on the comments we receive, it is 
possible we would consider approaches described in this section.
    Again, we continue to believe that our current regulatory 
definitions and data collection processes are reasonable pursuant to 
governing law. The above public comments are solicited as part of the 
agency's ongoing engagement with stakeholders to receive the most up-
to-date information and comments from those affected by the CLFS fee 
schedule.
5. Solicitation of Public Comments on the Low Expenditure Threshold in 
the Definition of Applicable Laboratory
a. Decreasing the Low Expenditure Threshold
    In the CLFS final rule, we established a low expenditure threshold 
component in the definition of applicable laboratory at Sec.  414.502, 
which is reflected in paragraph (4). To be an applicable laboratory, at 
least $12,500 of an entity's Medicare revenues in a data collection 
period must be CLFS revenues (with the exception that there is no low 
expenditure threshold for an entity with respect to the ADLTs it 
furnishes). We established $12,500 as the low expenditure threshold 
because we believed it achieved a balance between collecting sufficient 
data to calculate a weighted median that appropriately reflects the 
private market rate for a test, and minimizing the reporting burden for 
laboratories that receive a relatively small amount of revenues under 
the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once 
we

[[Page 35861]]

obtained applicable information under the new payment system, we may 
decide to reevaluate the low expenditure threshold in future years and 
propose a different threshold amount through notice and comment 
rulemaking.
    Recently, we have heard from some laboratory stakeholders that the 
low expenditure threshold excludes most physician office laboratories 
and many small independent laboratories from reporting applicable 
information, and that by excluding so many laboratories, the payment 
rates under the new private payor rate-based CLFS reflect incomplete 
data, and therefore, inaccurate CLFS pricing.
    As noted above, we discussed in the CLFS final rule that we 
believed a $12,500 low expenditure threshold would reduce the reporting 
burden on small laboratories. In the CLFS final rule (81 FR 41051), we 
estimated that 95 percent of physician office laboratories and 55 
percent of independent laboratories would not be required to report 
applicable information under our low expenditure criterion. Although we 
substantially reduced the number of laboratories qualifying as 
applicable laboratories (that is, approximately 5 percent of physician 
office laboratories and approximately 45 percent of independent 
laboratories), we estimated that the percentage of Medicare utilization 
would remain high. That is, approximately 5 percent of physician office 
laboratories would account for approximately 92 percent of CLFS 
spending on physician office laboratories and approximately 45 percent 
of independent laboratories would account for approximately 99 percent 
of CLFS spending on independent laboratories (81 FR 41051).
    It is our understanding that physician offices are generally not 
prepared to identify, collect, and report each unique private payor 
rate from each private payor for each laboratory test code subject to 
the data collection and reporting requirements, and the volume 
associated with each unique private payor rate. As such, we believe 
revising the low expenditure threshold so that more physician office 
laboratories are required to report applicable information would likely 
impose significant administrative burdens on physician offices. We also 
believe that increasing participation from physician office 
laboratories would have minimal overall impact on payment rates given 
that the weighted median of private payor rates is dominated by the 
laboratories with the largest test volume. We note that our 
participation simulations from the first data reporting period show 
that increasing the volume of physician office laboratories reporting 
applicable information has minimal overall impact on the weighted 
median of private payor rates. For more information on our 
participation simulations, please visit the CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
    We continue to believe the current low expenditure threshold 
strikes an appropriate balance between collecting enough private payor 
rate data to accurately represent the weighted median of private payor 
rates while limiting the administrative burden on small laboratories. 
In addition, as discussed previously in this section, we are proposing 
to exclude MA plan revenues under Part C from total Medicare revenues 
in the definition of applicable laboratory, and if we finalize that 
proposal, we expect more laboratories of all types, including physician 
office laboratories, may meet the majority of Medicare revenues 
threshold.
    However, we recognize from stakeholders that some physician office 
laboratories and small independent laboratories that are not applicable 
laboratories because they do not meet the current low expenditure 
threshold may still want to report applicable information despite the 
administrative burden associated with qualifying as an applicable 
laboratory. Therefore, we are seeking public comments on revising the 
low expenditure threshold to increase the level of participation among 
physician office laboratories and small independent laboratories. One 
approach could be for us to decrease the low expenditure threshold by 
50 percent, from $12,500 to $6,250, in CLFS revenues during a data 
collection period. Under such approach, a laboratory would need to 
receive at least $6,250 in CLFS revenues in a data collection period. 
If we were to adopt such an approach, we would need to revise paragraph 
(4) of the definition of applicable laboratory at Sec.  414.502 to 
replace $12,500 with $6,250. We are seeking public comments on this 
approach.
    We are particularly interested in comments from the physician 
community and small independent laboratories as to the administrative 
burden associated with such a revision to the low expenditure 
threshold. Specifically, we are requesting comments on the following 
issues: (1) Whether physician offices and small independent 
laboratories currently have adequate staff levels to meet the data 
collection and data reporting requirements; (2) whether data systems 
are currently in place to identify, collect, and report each unique 
private payor rate from each private payor for each CLFS test code and 
the volume of tests associated with each unique private payor rate; (3) 
if physician offices and small independent laboratories are generally 
not prepared to conduct the data collection and data reporting 
requirements, what is the anticipated timeframe needed for physician 
office and small independent laboratories to be able to meet the data 
collection and data reporting requirements; and (4) any other 
administrative concerns that decreasing the low expenditure threshold 
may impose on offices and small independent laboratories.
b. Increasing the Low Expenditure Threshold
    We recognize that many small laboratories may not want the 
additional administrative burden of data collection and reporting and, 
because their test volume is relatively low, their data is unlikely to 
have a meaningful impact on the weighted median of private payor rates 
for CDLTs under the CLFS. Mindful of stakeholder feedback from smaller 
laboratories that prefer to not be applicable laboratories because of 
the burden of collecting and reporting applicable information, we could 
increase the low expenditure threshold in the definition of applicable 
laboratory by 50 percent, from $12,500 to $18,750, in CLFS revenues 
during a data collection period. Because physician office laboratories 
would be less likely to meet a higher threshold, such approach would 
decrease the number of physician office laboratories and small 
independent laboratories required to collect and report applicable 
information. We expect decreasing the number of physician office 
laboratories and small independent laboratories reporting applicable 
information will have minimal impact on determining CLFS rates because 
we believe the largest laboratories with the highest test volumes will 
continue to dominate the weighted median of private payor rates.
    If we were to adopt such an approach, we would need to revise 
paragraph (4) of the definition of applicable laboratory at Sec.  
414.502 to replace $12,500 with $18,750. We are seeking public comments 
on this approach. We are particularly interested in comments from the 
physician community and small independent laboratories on the 
administrative burden and relief of increasing the low expenditure

[[Page 35862]]

threshold. We believe that feedback on the topics discussed in this 
section will help inform us regarding potential refinements to the low 
expenditure threshold. We welcome comments on these topics from the 
public including, physicians, laboratories, hospitals, and other 
interested stakeholders. We are particularly interested in receiving 
comments from the physician community and small independent 
laboratories as to the administrative burden and relief associated with 
revisions to the low expenditure threshold. Depending on the comments 
we receive, it is possible we would consider approaches described in 
this section.

B. Proposed Changes to the Regulations Associated With the Ambulance 
Fee Schedule

1. Overview of Ambulance Services
a. Ambulance Services
    Under the ambulance fee schedule, the Medicare program pays for 
ambulance transportation services for Medicare beneficiaries under 
Medicare Part B when other means of transportation are contraindicated 
by the beneficiary's medical condition and all other coverage 
requirements are met. Ambulance services are classified into different 
levels of ground (including water) and air ambulance services based on 
the medically necessary treatment provided during transport.
    These services include the following levels of service:
     For Ground--

++ Basic Life Support (BLS) (emergency and non-emergency)
++ Advanced Life Support, Level 1 (ALS1) (emergency and non-emergency)
++ Advanced Life Support, Level 2 (ALS2)
++ Paramedic ALS Intercept (PI)
++ Specialty Care Transport (SCT)

     For Air--

++ Fixed Wing Air Ambulance (FW)
++ Rotary Wing Air Ambulance (RW)
b. Statutory Coverage of Ambulance Services
    Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B 
(Supplemental Medical Insurance) covers and pays for ambulance 
services, to the extent prescribed in regulations, when the use of 
other methods of transportation would be contraindicated by the 
beneficiary's medical condition.
    The House Ways and Means Committee and Senate Finance Committee 
Reports that accompanied the 1965 Social Security Amendments suggest 
that the Congress intended that--
     The ambulance benefit cover transportation services only 
if other means of transportation are contraindicated by the 
beneficiary's medical condition; and
     Only ambulance service to local facilities be covered 
unless necessary services are not available locally, in which case, 
transportation to the nearest facility furnishing those services is 
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 
89th Cong., 1st Sess. Pt 1, 43 (1965)).
    The reports indicate that transportation may also be provided from 
one hospital to another, to the beneficiary's home, or to an extended 
care facility.
c. Medicare Regulations for Ambulance Services
    The regulations relating to ambulance services are set forth at 42 
CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 
410.10(i) lists ambulance services as one of the covered medical and 
other health services under Medicare Part B. Therefore, ambulance 
services are subject to basic conditions and limitations set forth at 
Sec.  410.12 and to specific conditions and limitations included at 
Sec. Sec.  410.40 and 410.41. Part 414, subpart H, describes how 
payment is made for ambulance services covered by Medicare Part B.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
    Section 146(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (MIPPA), (Pub. L. 110-275) amended section 
1834(l)(13)(A) of the Act to specify that, effective for ground 
ambulance services furnished on or after July 1, 2008, and before 
January 1, 2010, the ambulance fee schedule amounts for ground 
ambulance services shall be increased as follows:
     For covered ground ambulance transports that originate in 
a rural area or in a rural census tract of a metropolitan statistical 
area, the fee schedule amounts shall be increased by 3 percent.
     For covered ground ambulance transports that do not 
originate in a rural area or in a rural census tract of a metropolitan 
statistical area, the fee schedule amounts shall be increased by 2 
percent.
    The payment add-ons under section 1834(l)(13)(A) of the Act have 
been extended several times. Most recently, section 50203(a)(1) of the 
Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted on 
February 9, 2018) amended section 1834(l)(13)(A) of the Act to extend 
the payment add-ons through December 31, 2022. Thus, these payment add-
ons apply to covered ground ambulance transports furnished before 
January 1, 2023. We are proposing to revise Sec.  414.610(c)(1)(ii) to 
conform the regulations to this statutory requirement. (For further 
information regarding the implementation of this provision for claims 
processing, please see CR 10531. For a discussion of past legislation 
extending section 1834(l)(13) of the Act, please see the CY 2014 PFS 
final rule with comment period (78 FR 74438 through 74439), the CY 2015 
PFS final rule with comment period (79 FR 67743) and the CY 2016 PFS 
final rule with comment period (80 FR 71071 through 71072)).
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate increase, and does not require any substantive exercise of 
discretion on the part of the Secretary.
b. Amendment to Section 1834(l)(12) of the Act
    Section 414(c) of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 
2003) (MMA) added section 1834(l)(12) to the Act, which specified that, 
in the case of ground ambulance services furnished on or after July 1, 
2004, and before January 1, 2010, for which transportation originates 
in a qualified rural area (as described in the statute), the Secretary 
shall provide for a percent increase in the base rate of the fee 
schedule for such transports. The statute requires this percent 
increase to be based on the Secretary's estimate of the average cost 
per trip for such services (not taking into account mileage) in the 
lowest quartile of all rural county populations as compared to the 
average cost per trip for such services (not taking into account 
mileage) in the highest quartile of rural county populations. Using the 
methodology specified in the July 1, 2004 interim final rule (69 FR 
40288), we determined that this percent increase was equal to 22.6 
percent. As required by the MMA, this payment increase was applied to 
ground ambulance transports that originated in a ``qualified rural 
area,'' that is, to transports that originated in a rural area included 
in those areas comprising the lowest 25th percentile of all rural 
populations arrayed by population density. For this purpose, rural 
areas included Goldsmith areas (a type of

[[Page 35863]]

rural census tract). This rural bonus is sometimes referred to as the 
``Super Rural Bonus'' and the qualified rural areas (also known as 
``super rural'' areas) are identified during the claims adjudicative 
process via the use of a data field included in the CMS-supplied ZIP 
code file.
    The Super Rural Bonus under section 1834(l)(12) of the Act has been 
extended several times. Most recently, section 50203(a)(2) of the BBA 
amended section 1834(l)(12)(A) of the Act to extend this rural bonus 
through December 31, 2022. Therefore, we are continuing to apply the 
22.6 percent rural bonus described in this section (in the same manner 
as in previous years) to ground ambulance services with dates of 
service before January 1, 2023 where transportation originates in a 
qualified rural area. Accordingly, we are proposing to revise Sec.  
414.610(c)(5)(ii) to conform the regulations to this statutory 
requirement. (For further information regarding the implementation of 
this provision for claims processing, please see CR 10531. For a 
discussion of past legislation extending section 1834(l)(12) of the 
Act, please see the CY 2014 PFS final rule with comment period (78 FR 
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 
67743 through 67744) and the CY 2016 PFS final rule with comment period 
(80 FR 71072)).
    This statutory provision is self-implementing. It requires an 
extension of this rural bonus (which was previously established by the 
Secretary) through December 31, 2022, and does not require any 
substantive exercise of discretion on the part of the Secretary.
3. Amendment to Section 1834(l)(15) of the Act
    Section 637 of the American Taxpayer Relief Act of 2012 (ATRA) 
(Pub.L. 112-240), added section 1834(l)(15) of the Act to specify that 
the fee schedule amount otherwise applicable under the preceding 
provisions of section 1834(l) of the Act shall be reduced by 10 percent 
for ambulance services furnished on or after October 1, 2013, 
consisting of non-emergency basic life support (BLS) services involving 
transport of an individual with end-stage renal disease for renal 
dialysis services (as described in section 1881(b)(14)(B) of the Act) 
furnished other than on an emergency basis by a provider of services or 
a renal dialysis facility. In the CY 2014 PFS final rule with comment 
period (78 FR 74440), we revised Sec.  414.610 by adding paragraph 
(c)(8) to conform the regulations to this statutory requirement.
    Section 53108 of the BBA amended section 1834(l)(15) of the Act to 
increase the reduction from 10 percent to 23 percent effective for 
ambulance services (as described in section 1834(l)(15) of the Act) 
furnished on or after October 1, 2018. The 10 percent reduction applies 
for ambulance services (as described in section 1834(l)(15) of the Act) 
furnished during the period beginning on October 1, 2013 and ending on 
September 30, 2018. Accordingly, we are proposing to revise Sec.  
414.610(c)(8) to conform the regulations to this statutory requirement.
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate decrease, and does not require any substantive exercise of 
discretion on the part of the Secretary. Accordingly, for ambulance 
services described in section 1834(l)(15) of the Act furnished during 
the period beginning on October 1, 2013 and ending on September 30, 
2018, the fee schedule amount otherwise applicable (both base rate and 
mileage) is reduced by 10 percent, and for ambulance services described 
in section 1834(l)(15) of the Act furnished on or after October 1, 
2018, the fee schedule amount otherwise applicable (both base rate and 
mileage) is reduced by 23 percent. (For further information regarding 
application of this mandated rate decrease, please see CR 10549.)

C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)

1. Payment for Care Management Services
    In the CY 2018 PFS final rule, we revised the payment methodology 
for Chronic Care Management (CCM) services furnished by RHCs and FQHCs, 
and established requirements and payment for general Behavioral Health 
Integration (BHI) and psychiatric Collaborative Care Management (CoCM) 
services furnished in RHCs and FQHCs, beginning on January 1, 2018.
    For CCM services furnished by RHCs or FQHCs between January 1, 
2016, and December 31, 2017, payment is at the PFS national average 
payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM 
services furnished by RHCs or FQHCs on or after January 1, 2018, we 
established 2 new HCPCS codes. The first HCPCS code, G0511, is a 
General Care Management code for use by RHCs or FQHCs when at least 20 
minutes of qualified CCM or general BHI services are furnished to a 
patient in a calendar month. The second HCPCS code, G0512, is a 
psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes 
of initial psychiatric CoCM services or 60 minutes of subsequent 
psychiatric CoCM services are furnished to a patient in a calendar 
month.
    The payment amount for HCPCS code G0511 is set at the average of 
the 3 national non-facility PFS payment rates for the CCM and general 
BHI codes and updated annually based on the PFS amounts. The 3 codes 
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60 
minutes or more of complex CCM services), and CPT 99484 (20 minutes or 
more of BHI services).
    The payment amount for HCPCS code G0512 is set at the average of 
the 2 national non-facility PFS payment rates for CoCM codes and 
updated annually based on the PFS amounts. The 2 codes are CPT 99492 
(70 minutes or more of initial psychiatric CoCM services) and CPT 99493 
(60 minutes or more of subsequent psychiatric CoCM services).
    For practitioners billing under the PFS, we are proposing for CY 
2019 a new CPT code, 994X7, which would correspond to 30 minutes or 
more of CCM furnished by a physician or other qualified health care 
professional and is similar to CPT codes 99490 and 99487. For RHCs and 
FQHCs, we are proposing to add CPT code 994X7 as a general care 
management service and to include it in the calculation of HCPCS code 
G0511. That is, we propose that starting on January 1, 2019, RHCs and 
FQHC would be paid for G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and 
994X7.
    We propose to revise Sec.  405.2464 to reflect the current payment 
methodology that was finalized in the CY 2018 PFS and incorporate the 
addition of new CPT codes to HCPCS G0511.
2. Communication Technology-Based Services and Remote Evaluations
    RHC and FQHC visits are face-to-face (in-person) encounters between 
a patient and an RHC or FQHC practitioner during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners, physician 
assistants, certified nurse midwives, clinical psychologists, and 
clinical social workers, and under certain conditions, a registered 
nurse or licensed practical nurse furnishing care to a homebound RHC or 
FQHC patient. A Transitional Care Management service can also be an RHC 
or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a 
Medical Nutrition Therapy (MNT)

[[Page 35864]]

service furnished by a certified DSMT or MNT provider may also be an 
FQHC visit.
    RHCs are paid an all-inclusive rate (AIR) for medically-necessary, 
face-to-face visits with an RHC practitioner. The rate is subject to a 
payment limit, except for those RHCs that have an exception to the 
payment limit for being ``provider-based'' (see Sec.  413.65). FQHCs 
are paid the lesser of their charges or the FQHC Prospective Payment 
System (PPS) rate for medically-necessary, face-to-face visits with an 
FQHC practitioner. Only medically-necessary medical, mental health, or 
qualified preventive health services that require the skill level of an 
RHC or FQHC practitioner can be RHC or FQHC billable visits.
    The RHC and FQHC payment rates reflect the cost of all services and 
supplies that an RHC or FQHC furnishes to a patient in a single day, 
and are not adjusted for the complexity of the patient health care 
needs, the length of the visit, or the number or type of practitioners 
involved in the patient's care.
    Services furnished by auxiliary personnel (such as nurses, medical 
assistants, or other clinical personnel acting under the supervision of 
the RHC or FQHC practitioner) are considered incident to the visit and 
are included in the per-visit payment. This may include services 
furnished prior to or after the billable visit that occur within a 
medically appropriate time period, which is usually 30 days or less.
    RHCS and FQHCs are also paid for care management services, 
including chronic care management services, general behavioral health 
integration services, and psychiatric Collaborative Care Model 
services. These are typically non-face-to-face services that do not 
require the skill level of an RHC or FQHC practitioner and are not 
included in the RHC or FQHC payment methodologies.
    For practitioners billing under the PFS, we are proposing for CY 
2019 separate payment for certain communication technology-based 
services. This includes what is referred to as ``Brief Communication 
Technology-based Service'' for a ``virtual check-in'' and separate 
payment for remote evaluation of recorded video and/or images. The 
``virtual check-in'' visit would be billable when a physician or non-
physician practitioner has a brief (5 to 10 minutes), non-face-to-face 
check in with a patient via communication technology to assess whether 
the patient's condition necessitates an office visit. This service 
could be billed only in situations where the medical discussion was for 
a condition not related to an E/M service provided within the previous 
7 days, and does not lead to an E/M service or procedure within the 
next 24 hours or at the soonest available appointment. We are also 
proposing payment for practitioners billing under the PFS for remote 
evaluation services. This payment would be for the remote evaluation of 
patient-transmitted information conducted via pre-recorded ``store and 
forward'' video or image technology, 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. Both of these services would be 
priced under the PFS at a rate that reflects the resource costs of 
these non-face-to-face services relative to other PFS services, 
including face-to-face and in-person visits.
    The RHC and FQHC payment models are distinct from the PFS model in 
that the payment is for a comprehensive set of services and supplies 
associated with an RHC or FQHC visit. A direct comparison between the 
payment for a specific service furnished in an RHC or FQHC and the same 
service furnished in a physician's office is not possible, because the 
payment for RHCs and FQHCs is a per diem payment that includes the cost 
for all services and supplies rendered during an encounter, and payment 
for a service furnished in a physician's office and billed under the 
PFS is only for that service.
    We recognize that there are occasions when it may be beneficial to 
both the patient and the RHC or FQHC to utilize communications-based 
technology to determine the course of action for a health issue. 
Currently under the RHC and FQHC payment systems, if the communication 
results in a face-to-face billable visit with an RHC or FQHC 
practitioner, the cost of the prior communication would be included in 
the RHC AIR or the FQHC PPS. However, if as a result of the 
communication it is determined that a visit is not necessary, there 
would not be a billable visit and there would be no payment.
    RHCs and FQHCs furnish services in rural and urban areas that have 
been determined to be medically underserved areas or health 
professional shortage areas. They are an integral component of the 
Nation's health care safety net, and we want to assure that Medicare 
patients who are served by RHCs and FQHCs are able to communicate with 
their RHC or FQHC practitioner in a manner that enhances access to 
care, consistent with evolving medical care. Particularly in rural 
areas where transportation is limited and distances may be far, we 
believe the use of communication technology may help some patients to 
determine if they need to schedule a visit at the RHC or FQHC. If it is 
determined that a visit is not necessary, the RHC or FQHC practitioner 
would be available for other patients who need their care.
    When communication-based technology services are furnished in 
association with an RHC or FQHC billable visit, the costs of these 
services are included in the RHC AIR or the FQHC PPS and are not 
separately billable. However, if there is no RHC or FQHC billable 
visit, these costs are not paid as part of an RHC AIR or FQHC PPS 
payment. We are therefore proposing that, effective January 1, 2019, 
RHCs and FQHCs receive an additional payment for the costs of 
communication technology-based services or remote evaluation services 
that are not already captured in the RHC AIR or the FQHC PPS payment 
when the requirements for these services are met.
    We propose that RHCs and FQHCs receive payment for communication 
technology-based services or remote evaluation services when at least 5 
minutes of communications-based technology or remote evaluation 
services are furnished by an RHC or FQHC practitioner to a patient that 
has been seen in the RHC or FQHC within the previous year. These 
services may only be billed when the medical discussion or remote 
evaluation is for a condition not related to an RHC or FQHC service 
provided within the previous 7 days, and does not lead to an RHC or 
FQHC service within the next 24 hours or at the soonest available 
appointment, since in those situation the services are already paid as 
part of the RHC or FQHC per-visit payment.
    We propose to create a new Virtual Communications G code for use by 
RHCs and FQHCs only, with a payment rate set at the average of the PFS 
national non-facility payment rates for HCPCS code GVCI1 for 
communication technology-based services, and HCPCS code GRAS1 for 
remote evaluation services. RHCs and FQHCs would be able to bill the 
Virtual Communications G-code either alone or with other payable 
services. The payment rate for the Virtual Communications G-code would 
be updated annually based on the PFS amounts.
    We also propose to waive the RHC and FQHC face-to-face requirements 
when these services are furnished to an

[[Page 35865]]

RHC or FQHC patient. Coinsurance would be applied to FQHC claims, and 
coinsurance and deductibles would apply to RHC claims for these 
services. Services that are currently being furnished and paid under 
the RHC AIR or FQHC PPS payment methodology will not be affected by the 
ability of the RHC or FQHC to receive payment for additional services 
that are not included in the RHC AIR or FQHC PPS.
3. Other Options Considered
    We considered other options for payment for these services. First, 
we considered adding communication technology-based and remote 
evaluation services as an RHC or FQHC stand-alone service. Under this 
option, payment for RHCs would be at the AIR, and payment for FQHCs 
would be the lesser of total charges or the PPS rate. We are not 
proposing this payment option because these services do not meet the 
requirements for an RHC or FQHC billable visit and payment at the RHC 
AIR or FQHC PPS would result in a payment rate incongruent with 
efficiencies inherent in the provision of the technology-based 
services.
    The second option we considered was to allow RHCs and FQHCs to bill 
HCPCS codes GVCI1 or GRAS1 separately on an RHC or FQHC claim. We are 
not proposing this payment option because we believe that a combined G 
code is less burdensome and will allow expansion of these services 
without adding additional codes on an RHC or FQHC claim.
    We invite comments on this proposal. In particular, we are 
interested in comments regarding the appropriateness of payment for 
communication technology-based and remote evaluation services in the 
absence of an RHC or FQHC visit, the burden associated with 
documentation for billing these codes (RHC or FQHC practitioner's time, 
medical records, etc.), and any potential impact on the per diem nature 
of RHC and FQHC billing and payment structure as a result of payment 
for these services. We are also seeking public comment on whether it 
would be clinically appropriate to apply a frequency limitation on the 
use of the new Virtual Communications G code by the same RHC or FQHC 
with the same patient, and on what would be a reasonable frequency 
limitation to ensure that this code is appropriately utilized.
4. Other Regulatory Updates
    In addition to the regulatory change described in this section of 
the rule, we propose the following for accuracy:
     Removal of the extra section mark in the definition of 
``Federally qualified health center (FQHC)'' in Sec.  405.2401.
     Replacing the word ``his'' with ``his or her'' in the 
definition of ``Secretary'' in Sec.  405.2401.

D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the Protecting Access to Medicare Act (PAMA) 
amended Title XVIII of the Act to add section 1834(q) of the Act 
directing us to establish a program to promote the use of appropriate 
use criteria (AUC) for advanced diagnostic imaging services. The CY 
2016 PFS final rule with comment period addressed the initial component 
of the new Medicare AUC program, specifying applicable AUC. In that 
rule (80 FR 70886), we established an evidence-based process and 
transparency requirements for the development of AUC, defined provider-
led entities (PLEs) and established the process by which PLEs may 
become qualified to develop, modify or endorse AUC. The first list of 
qualified PLEs was posted on the CMS website at the end of June 2016 at 
which time their AUC libraries became specified applicable AUC for 
purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final 
rule addressed the second component of this program, specification of 
qualified clinical decision support mechanisms (CDSMs). In the CY 2017 
PFS final rule (81 FR 80170), we defined CDSM, identified the 
requirements CDSMs must meet for qualification, including preliminary 
qualification for mechanisms documenting how and when each requirement 
is reasonably expected to be met, and established a process by which 
CDSMs may become qualified. We also defined applicable payment systems 
under this program, specified the first list of priority clinical 
areas, and identified exceptions to the requirement that ordering 
professionals consult specified applicable AUC when ordering applicable 
imaging services. The first list of qualified CDSMs was posted on the 
CMS website in July 2017.
    The CY 2018 PFS final rule addressed the third component of this 
program, the consultation and reporting requirements. In the CY 2018 
PFS final rule (82 FR 53190), we established the start date of January 
1, 2020 for the Medicare AUC program for advanced diagnostic imaging 
services. It is for services ordered on and after this date that 
ordering professionals must consult specified applicable AUC using a 
qualified CDSM when ordering applicable imaging services, and 
furnishing professionals must report AUC consultation information on 
the Medicare claim. We further specified that the AUC program will 
begin on January 1, 2020 with a year-long educational and operations 
testing period during which time claims will not be denied for failure 
to include proper AUC consultation information. We also established a 
voluntary period from July 2018 through the end of 2019 during which 
ordering professionals who are ready to participate in the AUC program 
may consult specified applicable AUC through qualified CDSMs and 
communicate the results to furnishing professionals, and furnishing 
professionals who are ready to do so may report AUC consultation 
information on the claim (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf). Additionally, to incentivize early use of qualified CDSMs 
to consult AUC, we established in the CY 2018 Updates to the Quality 
Payment Program; and Quality Payment Program: Extreme and 
Uncontrollable Circumstances Policy for the Transition Year final rule 
with comment period and interim final rule (hereinafter ``CY 2018 
Quality Payment Program final rule'') a high-weight improvement 
activity for ordering professionals who consult specified AUC using a 
qualified CDSM for the Merit-based Incentive Payment System (MIPS) 
performance period that began January 1, 2018 (82 FR 54193).
    This rule proposes additions to the definition of applicable 
setting, clarification around who may perform the required AUC 
consultation using a qualified CDSM under this program, clarification 
that reporting is required across claim types and by both the 
furnishing professional and furnishing facility, changes to the policy 
for significant hardship exceptions for ordering professionals under 
this program, mechanisms for claims-based reporting, and a solicitation 
of feedback regarding the methodology to identify outlier ordering 
professionals.
1. Background
    AUC present information in a manner that links: A specific clinical 
condition or presentation; one or more services; and an assessment of 
the appropriateness of the service(s). Evidence-based AUC for imaging 
can assist clinicians in selecting the imaging study that is most 
likely to improve health outcomes for patients based on their 
individual clinical presentation. For purposes of this program AUC is a 
set or library of individual appropriate use criteria. Each individual 
criterion is

[[Page 35866]]

an evidence-based guideline for a particular clinical scenario based on 
a patient's presenting symptoms or condition.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. CDSMs are the electronic portals through which 
clinicians access the AUC during the patient workup. They can be 
standalone applications that require direct entry of patient 
information, but may be more effective when they are integrated into 
Electronic Health Records (EHRs). Ideally, practitioners would interact 
directly with the CDSM through their primary user interface, thus 
minimizing interruption to the clinical workflow.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directs the Secretary to establish a new program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with specified applicable AUC through a 
qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system; and 
payment for such service may only be made if the claim for the service 
includes information about the ordering professional's consultation of 
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by January 1, 
2017 (section 1834(q)(4) of the Act); and (4) annual identification of 
outlier ordering professionals for services furnished after January 1, 
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms 
for consultation by April 1, 2016. Therefore, we did not require 
ordering professionals to consult CDSMs or furnishing professionals to 
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included defining 
the term PLE (provider-led entity) and finalizing requirements for the 
rigorous, evidence-based process by which a PLE would develop AUC, upon 
which qualification is based, as provided in section 1834(q)(2)(B) of 
the Act and in the CY 2016 PFS final rule with comment period. Using 
this process, once a PLE is qualified by CMS, the AUC that are 
developed, modified or endorsed by the qualified PLE are considered to 
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We 
defined PLE to include national professional medical societies, health 
systems, hospitals, clinical practices and collaborations of such 
entities such as the High Value Healthcare Collaborative or the 
National Comprehensive Cancer Network. Qualified PLEs may collaborate 
with third parties that they believe add value to their development of 
AUC, provided such collaboration is transparent. We expect qualified 
PLEs to have sufficient infrastructure, resources, and the relevant 
experience to develop and maintain AUC according to the rigorous, 
transparent, and evidence-based processes detailed in the CY 2016 PFS 
final rule with comment period.
    In the same rule we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Consistent with 
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB 
Control Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. CDSMs may receive full qualification or preliminary 
qualification if most, but not all, of the requirements are met at the 
time of application. The preliminary qualification period began June 
30, 2017 and ends when the AUC consulting and reporting requirements 
become effective on January 1, 2020. The preliminarily qualified CDSMs 
must meet all requirements by that date. We defined CDSM as an 
interactive, electronic tool for use by clinicians that communicates 
AUC information to the user and assists them in making the most 
appropriate treatment decision for a patient's specific clinical 
condition. Tools may be modules within or available through certified 
EHR technology (as defined in section 1848(o)(4) of the Act) or private 
sector mechanisms independent from certified EHR technology or a 
mechanism established by the Secretary.
    In the CY 2017 PFS final rule, we established a timeline and 
process in Sec.  414.94(g)(2) for CDSM developers to apply to have 
their CDSMs qualified. Consistent with this timeline, the first list of 
qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).
c. AUC Consultation and Reporting
    In the CY 2018 PFS final rule, we addressed the third major 
component of the Medicare AUC program--consultation with applicable AUC 
by the ordering professional and reporting of such consultations under 
section 1834(q)(4) of the Act. We established a January 1, 2020 
effective date for the AUC consultation and reporting requirements for 
this program. We also established a voluntary period during which early 
adopters can begin reporting limited consultation information on 
Medicare claims from July 2018 through December 2019. During the 
voluntary period there is no requirement for ordering professionals to 
consult AUC or furnishing professionals to report information related 
to the consultation. On January 1, 2020, the program will begin with an 
educational and operations testing period and during this time we will 
continue to pay claims whether or not they correctly include AUC 
consultation information. Ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2020; and furnishing 
professionals must report the AUC consultation information on the 
Medicare claim for these services ordered on or after January 1, 2020.
    Consistent with section 1834(q)(4)(B) of the Act, we also 
established that furnishing professionals must report the

[[Page 35867]]

following information on Medicare claims for advanced diagnostic 
imaging services as specified in section 1834(q)(1)(C) of the Act and 
defined in Sec.  414.94(b), furnished in an applicable setting as 
defined in section 1834(q)(1)(D) of the Act, paid for under an 
applicable payment system as defined in section 1834(q)(4)(D) of the 
Act, and ordered on or after January 1, 2020: (1) The qualified CDSM 
consulted by the ordering professional; (2) whether the service ordered 
would or would not adhere to specified applicable AUC, or whether the 
specified applicable AUC consulted was not applicable to the service 
ordered; and (3) the NPI of the ordering professional (if different 
from the furnishing professional). Proposed clarifying revisions to the 
reporting requirement are discussed later in this preamble.
    Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC 
consultation and reporting requirements in the case of: A service 
ordered for an individual with an emergency medical condition, a 
service ordered for an inpatient and for which payment is made under 
Medicare Part A, and a service ordered by an ordering professional for 
whom the Secretary determines that consultation with applicable AUC 
would result in a significant hardship. In the CY 2017 PFS final rule, 
we adopted a regulation at Sec.  414.94(h)(1)(i) to specify the 
circumstances under which AUC consultation and reporting requirements 
are not applicable. These include applicable imaging services ordered: 
(1) For an individual with an emergency medical condition (as defined 
in section 1867(e)(1) of the Act); (2) for an inpatient and for which 
payment is made under Medicare Part A; and (3) by an ordering 
professional who is granted a significant hardship exception to the 
Medicare EHR Incentive Program payment adjustment for that year under 
42 CFR 495.102(d)(4), except for those granted under Sec.  
495.102(d)(4)(iv)(C). We are proposing changes to the conditions for 
significant hardship exceptions, and our proposals are discussed later 
in this preamble. We remind readers that consistent with section 
1834(q)(4)(A) of the Act, ordering professionals must consult AUC for 
every applicable imaging service furnished in an applicable setting and 
paid under an applicable payment system unless a statutory exception 
applies.
    Section 1834(q)(4)(D) of the Act specifies the applicable payment 
systems for which AUC consultation and reporting requirements apply 
and, in the CY 2017 PFS final rule, consistent with the statute, we 
defined applicable payment system in our regulation at Sec.  414.94(b) 
as: (1) The PFS established under section 1848(b) of the Act; (2) the 
prospective payment system for hospital outpatient department services 
under section 1833(t) of the Act; and (3) the ambulatory surgical 
center payment system under section 1833(i) of the Act.
    Section 1834(q)(1)(D) of the Act specifies the applicable settings 
in which AUC consultation and reporting requirements apply: A 
physician's office, a hospital outpatient department (including an 
emergency department), an ambulatory surgical center, and any other 
``provider-led outpatient setting determined appropriate by the 
Secretary.'' In the CY 2017 PFS final rule, we added this definition to 
our regulation at Sec.  414.94(b). Proposed additional applicable 
settings are discussed later in this preamble.
d. Identification of Outliers
    The fourth component of the Medicare AUC program is specified in 
section 1834(q)(5) of the Act, Identification of Outlier Ordering 
Professionals. The identification of outlier ordering professionals 
under this paragraph facilitates a prior authorization requirement that 
applies for outlier professionals beginning January 1, 2020, as 
specified under section 1834(q)(6) of the Act. Because we established a 
start date of January 1, 2020 for AUC consultation and reporting 
requirements, we will not have identified any outlier ordering 
professionals by that date. As such, implementation of the prior 
authorization component is delayed. However, we did finalize in the CY 
2017 PFS final rule the first list of priority clinical areas to guide 
identification of outlier ordering professionals as follows:
     Coronary artery disease (suspected or diagnosed).
     Suspected pulmonary embolism.
     Headache (traumatic and non-traumatic).
     Hip pain.
     Low back pain.
     Shoulder pain (to include suspected rotator cuff injury).
     Cancer of the lung (primary or metastatic, suspected or 
diagnosed).
     Cervical or neck pain.
    We are not including proposals to expand or modify the list of 
priority clinical areas in this proposed rule.
4. Proposals for Continuing Implementation
    We propose to amend Sec.  414.94 of our regulations, ``Appropriate 
Use Criteria for Certain Imaging Services,'' to reflect the following 
proposals.
a. Expanding Applicable Settings
    Section 1834(q)(1)(D) of the Act specifies that the AUC 
consultation and reporting requirements apply only in an applicable 
setting, which means a physician's office, a hospital outpatient 
department (including an emergency department), an ambulatory surgical 
center, and any other provider-led outpatient setting determined 
appropriate by the Secretary. In the CY 2017 PFS final rule, we 
codified this definition in Sec.  414.94(b). We are proposing to revise 
the definition of applicable setting to add an independent diagnostic 
testing facility (IDTF).
    We believe the addition of IDTFs to the definition of applicable 
setting will ensure that the AUC program is in place across outpatient 
settings in which outpatient advanced diagnostic imaging services are 
furnished. IDTFs furnish services for a large number of Medicare 
beneficiaries; nearly $1 billion in claims for 2.4 million 
beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a 
hospital or physician's office and diagnostic tests furnished by an 
IDTF are performed by licensed, certified non-physician personnel under 
appropriate physician supervision (Sec.  410.33). Like other applicable 
settings, IDTFs must meet the requirements specified in Sec.  410.33 of 
our regulations to be enrolled to furnish and bill for advanced 
diagnostic imaging and other IDTF services. Services that may be 
provided by an IDTF include, but are not limited to, magnetic resonance 
imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a 
fixed location, a mobile entity, or an individual non-physician 
practitioner, and diagnostic procedures performed by an IDTF are paid 
under the PFS. IDTF services must be furnished under the appropriate 
level of physician supervision as specified in Sec.  410.33(b); and all 
procedures furnished by the IDTF must be ordered in writing by the 
patient's treating physician or non-physician practitioner. As such, we 
believe the IDTF setting is a provider-led outpatient setting 
appropriate for addition to the list of applicable settings under 
section 1834(q)(1)(D), and we propose to add IDTF to our definition of 
applicable setting under Sec.  414.94(b) of the regulations.
    We note that under the PFS, payment for many diagnostic tests 
including the advanced diagnostic imaging services to which the AUC 
program applies can be made either ``globally'' when the entire

[[Page 35868]]

service is furnished and billed by the same entity; or payment can be 
made separately for the technical component (TC) of the service and the 
professional component (PC) when those portions of the service are 
furnished and billed by different entities. In general, the TC for an 
advanced diagnostic imaging service is the portion of the test during 
which the patient is present and the image is captured. The PC is the 
portion of the test that involves a physician's interpretation and 
report on the captured image. For example, when a CT scan is ordered by 
a patient's treating physician, the entire test (TC and PC) could be 
furnished by a radiologist in their office and billed as a ``global'' 
service. Alternatively, the TC could be furnished and billed by an 
IDTF, and the PC could be furnished and billed by a radiologist in 
private practice. By adding IDTFs as an applicable setting, we believe 
we would appropriately and consistently apply the AUC program across 
the range of outpatient settings where applicable imaging services are 
furnished.
    We propose to revise the definition of applicable setting under 
Sec.  414.94(b) to include an IDTF. We invite comments on this proposal 
and on the possible inclusion of any other applicable setting. We 
remind commenters that application of the AUC program is not only 
limited to applicable settings, but also to services for which payment 
is made under applicable payment systems (the physician fee schedule, 
the OPPS, and the ASC payment system).
b. Consultations by Ordering Professionals
    Section 1834(q)(1)(E) of the Act defines the term ``ordering 
professional'' as a physician (as defined in section 1861(r)) or a 
practitioner described in section 1842(b)(18)(C) who orders an 
applicable imaging service. The AUC consultation requirement applies to 
these ordering professionals. We are proposing that the consultation 
with AUC through a qualified CDSM may be performed by clinical staff 
working under the direction of the ordering professional, subject to 
applicable State licensure and scope of practice law, when the 
consultation is not performed personally by the ordering professional 
whose NPI will be listed on the order for an advanced imaging service.
    In response to the CY 2018 PFS proposed rule, we received several 
public comments requesting clarification regarding who is required to 
perform the consultation of AUC through a qualified CDSM. Commenters 
not only sought clarification, but also provided recommendations for 
requirements around this topic. Some commenters recommended that CMS 
strictly interpret the statutory language and only allow the clinician 
placing the order to perform the consultation and others recommended 
that CMS allow others to perform the AUC consultation on behalf of the 
clinician.
    Section 1834(q)(4)(A)(i) of the Act requires an ordering 
professional to consult with a qualified CDSM, and this was codified in 
our regulations at Sec.  414.94(j). The statute does not explicitly 
provide for consultations under the AUC program to be fulfilled by 
other professionals, individuals or organizations on behalf of the 
ordering professional; however, we continue to seek ways to minimize 
the burden of this new Medicare program and understand that many 
practices currently use clinical staff, working under the direction of 
the ordering professional, to interact with the CDSM for AUC 
consultation and subsequent ordering of advanced diagnostic imaging. 
Therefore, we propose to modify paragraph Sec.  414.94(j) to specify 
that additional individuals may perform the required AUC consultation.
    When the AUC consultation is not performed personally by the 
ordering professional, we propose the consultation may be performed by 
auxiliary personnel incident to the ordering physician or non-physician 
practitioner's professional service. We believe this approach is 
appropriate under this program and still accomplishes the goal of 
promoting the use of AUC. This proposed policy would allow the ordering 
professional to exercise their discretion to delegate the performance 
of this consultation. It is important to note that the ordering 
professional is ultimately responsible for the consultation as their 
NPI is reported by the furnishing professional on the claim for the 
applicable imaging service; and that it is the ordering professional 
who could be identified as an outlier ordering professional and become 
subject to prior authorization based on their ordering pattern.
    We propose to revise the AUC consultation requirement specified at 
Sec.  414.94(j) to specify that the AUC consultation may be performed 
by auxiliary personnel under the direction of the ordering professional 
and incident to the ordering professional's services.
c. Reporting AUC Consultation Information
    Section 1834(q)(4)(B) of the Act requires that payment for an 
applicable imaging service furnished in an applicable setting and paid 
for under an applicable payment system may only be made if the claim 
for the service includes certain information about the AUC 
consultation. As such, the statute requires that AUC consultation 
information be included on any claim for an outpatient advanced 
diagnostic imaging service, including those billed and paid under any 
applicable payment system (the PFS, OPPS or ASC payment system). When 
we initially codified the AUC consultation reporting requirement in 
Sec.  414.94(k) through rulemaking in the CY 2018 PFS final rule, we 
specified only that ``furnishing professionals'' must report AUC 
consultation information on claims for applicable imaging services. 
This led some stakeholders to believe that AUC consultation information 
would be required only on practitioner claims. To better reflect the 
statutory requirements of section 1834(q)(4)(B) of the Act, we are 
proposing to revise our regulations to clarify that AUC consultation 
information must be reported on all claims for an applicable imaging 
service furnished in an applicable setting and paid for under an 
applicable payment system. The revised regulation would more clearly 
express the scope of advanced diagnostic imaging services that are 
subject to the AUC program, that is, those furnished in an applicable 
setting and paid under an applicable payment system.
    The language codified in Sec.  414.94(k) uses the term furnishing 
professional to describe who must report the information on the 
Medicare claims. We recognize that section 1834(q)(1)(F) of the Act 
specifies that a ``furnishing professional'' is a physician (as defined 
in section 1861(r)) or a practitioner described in section 
1842(b)(18)(C) who furnishes an applicable imaging service. However, 
because section 1834(q)(4)(B) of the Act, as described above, clearly 
includes all claims paid under applicable payment systems without 
exclusion, we believe that the claims from both furnishing 
professionals and facilities must include AUC consultation information. 
In other words, we would expect this information to be included on the 
practitioner's claim for the professional component of the applicable 
advanced diagnostic imaging service and on the provider's or supplier's 
claim for the facility portion or TC of the imaging service.
    As such, we propose to revise Sec.  414.94(k) to clearly reflect 
the scope of claims for which AUC consultation information must be 
reported, and to clarify that the requirement to report AUC 
consultation information is not limited to the furnishing professional.

[[Page 35869]]

d. Claims-Based Reporting
    In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a 
combination of G-codes and modifiers to report the AUC consultation 
information on the Medicare claim. We received numerous public comments 
objecting to this potential solution. In the 2018 PFS final rule, we 
agreed with many of the commenters that additional approaches to 
reporting AUC consultation information on Medicare claims should be 
considered, and we learned from many commenters that reporting a unique 
consultation identifier (UCI) would be a less burdensome and preferred 
approach. The UCI would include all the information required under 
section 1834(q)(4)(B) of the Act including an indication of AUC 
adherence, non-adherence and not applicable responses. Commenters noted 
that capturing a truly distinguishing UCI on the claim will allow for 
direct mapping from a single AUC consultation to embedded information 
within a CDSM. We indicated that we would work with stakeholders to 
further explore the concept of using a UCI to satisfy the requirements 
of section 1834(q)(4)(B) of the Act, which will be used for Medicare 
claims processing and, ultimately, for the identification of outlier 
ordering professionals, and consider developing a taxonomy for a UCI.
    We had the opportunity to engage with some stakeholders over the 
last 6 months and we understand that some commenters from the previous 
rule continue to be in favor of a UCI, while some may have changed 
their position upon further consideration.
    We provide the following information to summarize alternatives we 
considered. CMS had originally considered assigning a G-code for every 
qualified CDSM with a code descriptor containing the name of the 
qualified CDSM. The challenge to this approach arises when there is 
more than one advanced imaging service on a single claim. CMS could 
attribute a single G-code to all of the applicable imaging services for 
the patient's clinical condition on the claim, which might be 
appropriate if each AUC consultation for each service was through the 
same CDSM. If a different CDSM was used for each service (for example, 
when services on a single claim were ordered by more than one ordering 
professional and each ordering professional used a different CDSM) then 
multiple G-codes could be needed on the claim. Each G-code would appear 
on the claim individually as its own line item. As a potential 
solution, we considered the use of modifiers, which are appealing 
because they would appear on the same line as the CPT code that 
identifies the specific billed service. Therefore, information entered 
onto a claim would arrive into the claims processing system paired with 
the relevant AUC consultation information.
    When reporting the required AUC consultation information based on 
the response from a CDSM: (1) The imaging service would adhere to the 
applicable AUC; (2) the imaging service would not adhere to such 
criteria; or (3) such criteria were not applicable to the imaging 
service ordered, three modifiers could be developed. These modifiers, 
when placed on the same line with the CPT code for the advanced imaging 
service would allow this information to be easily accessed in the 
Medicare claims data and matched with the imaging service.
    Stakeholders have made various suggestions for a taxonomy that 
could be used to develop a UCI to report the required information. 
Stakeholders have also considered where to place the UCI on the claim. 
We understand the majority of solutions suggested by stakeholders 
involving a UCI are claim-level solutions and would not allow CMS to 
attribute the CDSM used or the AUC adherence status (adherent or not 
adherent, or not applicable) to a specific imaging service. As such, 
the approach of using a UCI would not identify whether an AUC 
consultation was performed for each applicable imaging service reported 
on a claim form, or be useful for purposes of identifying outlier 
ordering professionals in accordance with section 1834(q)(5) of the 
Act.
    We have received ideas from stakeholders that are both for and 
against the two approaches we have identified; and we appreciate the 
stakeholders that have provided additional information or engaged us in 
this discussion. Internally, we have explored the possibility of using 
and feasibility of developing a UCI, and concluded that, although we 
initiated this approach during the CY 2018 PFS final rule, it is not 
feasible to create a uniform UCI taxonomy, determine a location of the 
UCI on the claims forms, obtain the support and permission by national 
bodies to use claim fields for this purpose, and solve the underlying 
issue that the UCI seems limited to claim-level reporting. Using coding 
structures that are already in place (such as G-codes and modifiers) 
would allow CMS to establish reporting requirements prior to the start 
of the program (January 1, 2020).
    Since we did not finalize a proposal in the CY 2018 PFS final rule, 
we propose in this rule to use established coding methods, to include 
G-codes and modifiers, to report the required AUC information on 
Medicare claims. This will allow the program to be implemented by 
January 1, 2020. We will consider future opportunities to use a UCI and 
look forward to continued engagement with and feedback from 
stakeholders.
e. Significant Hardship Exception
    We are proposing to revise Sec.  414.94(i)(3) of our regulations to 
adjust the significant hardship exception requirements under the AUC 
program. We are proposing criteria specific to the AUC program and 
independent of other programs. An ordering professional experiencing 
any of the following when ordering an advanced diagnostic imaging 
service would not be required to consult AUC using a qualified CDSM, 
and the claim for the applicable imaging service would not be required 
to include AUC consultation information. The proposed criteria include:
     Insufficient internet access;
     EHR or CDSM vendor issues; or
     Extreme and uncontrollable circumstances.
    Insufficient internet access is specific to the location where an 
advanced diagnostic imaging service is ordered by the ordering 
professional. EHR or CDSM vendor issues may include situations where 
ordering professionals experience temporary technical problems, 
installation or upgrades that temporarily impede access to the CDSM, 
vendors cease operations, or CMS de-qualifies a CDSM. CMS expects these 
situations to generally be irregular and unusual. Extreme and 
uncontrollable circumstances include disasters, natural or man-made, 
that have a significant negative impact on healthcare operations, area 
infrastructure or communication systems. These could include areas 
where events occur that have been designated a Federal Emergency 
Management Agency (FEMA) major disaster or a public health emergency 
declared by the Secretary. Based on 2016 data from the Medicare EHR 
Incentive Program and the 2019 payment year MIPS eligibility and 
special status file, we estimate that 6,699 eligible clinicians could 
submit such a request due to extreme and uncontrollable circumstances 
or as a result of a decertification of an EHR, which represents less 
than 1-percent of available ordering professionals.
    In the CY 2017 PFS final rule, for purposes of the AUC program 
significant hardship exceptions, we

[[Page 35870]]

provided that those who received significant hardship exceptions in the 
following categories from Sec.  495.102(d)(4) would also qualify for 
significant hardship exceptions for the AUC program:
     Insufficient Internet Connectivity (as specified in Sec.  
495.102(d)(4)(i)).
     Practicing for less than 2 years (as specified in Sec.  
495.102(d)(4)(ii)).
     Extreme and Uncontrollable Circumstances (as specified in 
Sec.  495.102(d)(4)(iii)).
     Lack of Control over the Availability of CEHRT (as 
specified in Sec.  495.102(d)(4)(iv)(A)).
     Lack of Face-to-Face Patient Interaction (as specified in 
Sec.  495.102(d)(4)(iv)(B)).
    In the CY 2018 PFS proposed rule, we proposed to amend the AUC 
significant hardship exception regulation to specify that ordering 
professionals who are granted reweighting of the Advancing Care 
Information (ACI) performance category to zero percent of the final 
score for the year under MIPS per Sec.  414.1380(c)(2) due to 
circumstances that include the criteria listed in Sec.  
495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined 
in the bulleted list above) would be excepted from the AUC consultation 
requirement during the same year that the re-weighting applies for 
purposes of the MIPS payment adjustment. This proposal removed Sec.  
495.102(d)(4)(ii), practicing for less than 2 years, as a criterion 
since these clinicians are not MIPS eligible clinicians and thus would 
never meet the criteria for reweighting of their MIPS ACI performance 
category for the year.
    In response to public comments, we did not finalize the proposed 
changes to the significant hardship exceptions in the CY 2018 PFS final 
rule and instead decided further evaluation was needed before moving 
forward with any modifications. As we have continued to evaluate both 
policy options and operational considerations for the AUC significant 
hardship exception, we have concluded that the most appropriate 
approach, which we consider to be more straightforward and less 
burdensome than the current approach, involves establishing significant 
hardship criteria and a process that is independent from other Medicare 
programs. Our original intention was to design the AUC significant 
hardship exception process in alignment with the process for the 
Medicare EHR Incentive Program for eligible professionals, and then for 
the MIPS ACI (now Promoting Interoperability) performance category. 
Under section 1848(a)(7)(A) of the Act, the downward payment adjustment 
for eligible professionals under the Medicare EHR Incentive Program 
will end in 2018, and we are unable to continue making reference to a 
regulation relating to a program that is no longer in effect. We also 
note as we have in the past that the AUC program is a real-time program 
with a need for real-time significant hardship exceptions. This is in 
contrast to the way significant hardship exceptions are handled under 
MIPS where the hardship might impact some or all of a performance 
period, or might impact reporting, both of which occur well before the 
MIPS payment adjustment is applied in a subsequent year. We recognize 
that when a significant hardship arises, an application process to 
qualify for an exception becomes a time consuming hurdle for health 
care providers to navigate, and we believe that it is important to 
minimize the burden involved in seeking significant hardship 
exceptions. As such, we are proposing that ordering professionals would 
self-attest if they are experiencing a significant hardship at the time 
of placing an advanced diagnostic imaging order and such attestation be 
supported with documentation of significant hardship. Ordering 
professionals attesting to a significant hardship would communicate 
that information, along with the AUC consultation information, to the 
furnishing professional with the order and it would be reflected on the 
furnishing professional's and furnishing facility's claim by appending 
a HCPCS modifier. The modifier would indicate that the ordering 
professional has self-attested to experiencing a significant hardship 
and communicated this to the furnishing professional with the order. 
Claims for advanced diagnostic imaging services that include a 
significant hardship exception modifier would not be required to 
include AUC consultation information.
    In addition to the proposals above, we invite the public to comment 
on any additional circumstances that would cause the act of consulting 
AUC to be particularly difficult or challenging for the ordering 
professional, and for which it may be appropriate for an ordering 
professional to be granted a significant hardship exception under the 
AUC program. While we understand the desire by some for significant 
hardship categories unrelated to difficulty in consulting AUC through a 
CDSM, we remind readers that circumstances that are not specific to AUC 
consultation, such as the ordering professional being in clinical 
practice for a short period of time or having limited numbers of 
Medicare patients, would not impede clinicians from consulting AUC 
through a CDSM as required to meet the requirements of this program.
f. Identification of Outliers
    As previously mentioned, the fourth component of the AUC program 
specified in section 1834(q)(5) of the Act, is the identification of 
outlier ordering professionals. In our efforts to start a dialogue with 
stakeholders, we would like to invite the public to submit their ideas 
on a possible methodology for the identification of outlier ordering 
professionals who would eventually be subject to a prior authorization 
process when ordering advanced diagnostic imaging services. 
Specifically, we are soliciting comments on the data elements and 
thresholds that CMS should consider when identifying outliers. We also 
intend to perform and use analysis to assist us in developing the 
outlier methodology for the AUC program. Our existing prior 
authorization programs generally do not specifically focus on outliers. 
We are interested in hearing ideas from the public on how outliers 
could be determined for the AUC program. Because we would be concerned 
about data integrity and reliability, we do not intend to include data 
from the educational and operations testing period in CY 2020 in the 
analysis used to develop our outlier methodology. Since we intend to 
evaluate claims data to inform our methodology we expect to address 
outlier identification and prior authorization more fully in CY 2022 or 
2023 rulemaking. As noted above, we expect to solicit public comment to 
inform our methodology through rulemaking before finalizing our 
approach.
    We note that we may not provide comprehensive comment summaries and 
responses to comments submitted in response to this solicitation. 
Rather, we will actively consider all input as we develop the 
methodology for the identification of outliers.
5. Summary
    Section 1834(q) of the Act includes rapid timelines for 
establishing a Medicare AUC program for advanced diagnostic imaging 
services. The impact of this program is extensive as it will apply to 
every physician or other practitioner who orders or furnishes advanced 
diagnostic imaging services (for example, MRI, computed tomography (CT) 
or positron emission tomography (PET)). This crosses almost every 
medical specialty and could have a particular impact on primary care

[[Page 35871]]

physicians since their scope of practice can be quite broad.
    We continue to believe the best implementation approach is one that 
is diligent, maximizes the opportunity for public comment and 
stakeholder engagement, and allows for adequate advance notice to 
physicians and practitioners, beneficiaries, AUC developers, and CDSM 
developers. It is for these reasons we propose to continue a stepwise 
approach, adopted through notice and comment rulemaking.
    In summary, we are proposing policies to modify existing 
requirements and criteria and to provide further clarification on 
implementation of the AUC program. We include a proposal to add IDTFs 
to the definition of applicable settings under this program. We also 
include proposals regarding who beyond the ordering professional may 
consult AUC through a qualified CDSM to meet the statutory requirements 
for the AUC program, as well as a proposal to more clearly include all 
entities required to report AUC consultation information on the claim. 
Finally, we propose to modify the significant hardship exception 
criteria and process under Sec.  414.94(i)(3) to be specific to the AUC 
program and independent of other Medicare programs. We are also 
requesting public comment on other circumstances that could be 
considered significant hardships, posing particular real-time 
difficulty or challenge to the ordering professional in consulting AUC. 
We invite the public to submit comments on these proposals, as well as 
provide comment on potential methods for, and issues related to, 
mechanisms for claims-based reporting and identifying outlier ordering 
professionals.
    We will continue to post information on our website for this 
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.

E. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs)

1. Background
    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory 
basis for the incentive payments made to Medicaid EPs and eligible 
hospitals for the adoption, implementation, upgrade, and meaningful use 
of CEHRT. We have implemented these statutory provisions in prior 
rulemakings to establish the Medicaid Promoting Interoperability 
Programs.
    Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the 
Act, and the definition of ``meaningful EHR user'' in regulations at 
Sec.  495.4, one of the requirements of being a meaningful EHR user is 
to successfully report the clinical quality measures selected by CMS to 
CMS or a state, as applicable, in the form and manner specified by CMS 
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act 
requires that in selecting electronic clinical quality measures (eCQMs) 
for EPs to report under the Promoting Interoperability Program, and in 
establishing the form and manner of reporting, the Secretary shall seek 
to avoid redundant or duplicative reporting otherwise required. We have 
taken steps to align various quality reporting and payment programs 
that include the submission of eCQMs.
    In the ``Medicare Program; Hospital Inpatient Prospective Payment 
Systems for Acute Care Hospitals and the Long-Term Care Hospital 
Prospective Payment System and Policy Changes and Fiscal Year 2018 
Rates; Quality Reporting Requirements for Specific Providers; Medicare 
and Medicaid Electronic Health Record (EHR) Incentive Program 
Requirements for Eligible Hospitals, Critical Access Hospitals, and 
Eligible Professionals; Provider-Based Status of Indian Health Service 
and Tribal Facilities and Organizations; Costs Reporting and Provider 
Requirements; Agreement Termination Notices'' final rule (82 FR 37990, 
38487) (hereafter referred to as the ``FY 2018 IPPS/LTCH PPS final 
rule''), we established that, for 2017, Medicaid EPs would be required 
to report on any six eCQMs that are relevant to the EP's scope of 
practice. In proposing and finalizing that change, we indicated that it 
is our intention to align eCQM requirements for Medicaid EPs with the 
requirements of Medicare quality improvement programs, to the extent 
practicable.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting 
Interoperability Program for 2019
    CMS annually reviews and revises the list of eCQMs for each MIPS 
performance year to reflect updated clinical standards and guidelines. 
In section III.H.3.h.(2)(b)(i) of this proposed rule, we are proposing 
to amend the list of available eCQMs for the CY 2019 performance 
period. To keep eCQM specifications current and minimize complexity, we 
propose to align the eCQMs available for Medicaid EPs in 2019 with 
those available for MIPS eligible clinicians for the CY 2019 
performance period. Specifically, we propose that the eCQMs available 
for Medicaid EPs in 2019 would consist of the list of quality measures 
available under the eCQM collection type on the final list of quality 
measures established under MIPS for the CY 2019 performance period.
    We believe that this proposal would be responsive to stakeholder 
feedback supporting quality measure alignment between MIPS and the 
Medicaid Promoting Interoperability Program for EPs, and that it would 
encourage EP participation in the Medicaid Promoting Interoperability 
Program by allowing those that are also MIPS eligible clinicians the 
ability to report the same eCQMs as they report for MIPS in 2019. In 
addition, we believe that aligning the eCQMs available in each program 
would ensure the most uniform application of up-to-date clinical 
standards and guidelines possible.
    We anticipate that this proposal would reduce burden for Medicaid 
EPs by aligning the requirements for multiple reporting programs, and 
that the system changes required for EPs to implement this change would 
not be significant, particularly in light of our belief that many EPs 
will report eCQMs to meet the quality performance category of MIPS and 
therefore should be prepared to report on the available eCQMs for 2019. 
We expect that this proposal would have only a minimal impact on 
states, by requiring minor adjustments to state systems for 2019 to 
maintain current eCQM lists and specifications.
    We also request comments on whether in future years of the Medicaid 
Promoting Interoperability Program beyond 2019, we should include all 
e-specified measures from the core set of quality measures for Medicaid 
and the Children's Health Insurance Program (CHIP) (the Child Core Set) 
and the core set of health care quality measures for adults enrolled in 
Medicaid (Adult Core Set) (hereinafter together referred to as ``Core 
Sets'') as additional options for Medicaid EPs. Sections 1139A and 
1139B of the Act require the Secretary to identify and publish core 
sets of health care quality measures for child Medicaid and CHIP 
beneficiaries and adult Medicaid beneficiaries. These measure sets are 
required by statute to be updated annually and are voluntarily reported 
by states to CMS. These core sets comprise measures that specifically 
focus on populations served by the Medicaid and CHIP programs and are 
of particular importance to their care. Several of these Core Set 
measures are included in the MIPS eCQM list, but some are not. We 
believe that including as eCQM reporting options for Medicaid

[[Page 35872]]

EPs the e-specified measures from the Core Sets that are not also on 
the MIPS eCQM list would increase EP utilization of these measures and 
provide states with better data to report. At this time, the only 
measure within the Core Sets that would not be available as an option 
for Medicaid EPs in 2019 (because it is not on the MIPS eCQM list) is 
NQF-1360, ``Audiological Diagnosis No Later Than 3 Months of Age.'' 
However, as these Core Sets are updated annually, there may be other 
eCQMs that could be included in future years.
    For 2019, we propose that Medicaid EPs would report on any six 
eCQMs that are relevant to the EP's scope of practice, regardless of 
whether they report via attestation or electronically. After we removed 
the NQS domain requirements for EPs' 2017 eCQM submissions in the FY 
2018 IPPS/LTCH PPS final rule, we have found that allowing EPs to 
report on any six quality measures that are relevant to their practice 
has increased EPs' flexibility to report pertinent data. In addition, 
this policy would generally align with the MIPS data submission 
requirement for eligible clinicians using the eCQM collection type for 
the quality performance category, which is established at Sec.  
414.1335(a)(1). MIPS eligible clinicians who elect to submit eCQMs must 
submit data on at least six quality measures, including at least one 
outcome measure (or, if an applicable outcome measure is not available, 
one other high priority measure). We refer readers to Sec.  
414.1335(a)(2) and (3) for the data submission criteria that apply to 
individual MIPS eligible clinicians and groups who elect to submit data 
for other collection types.
    We also propose that for 2019 the Medicaid Promoting 
Interoperability Program would adopt the MIPS requirement that EPs 
report on at least one outcome measure (or, if an applicable outcome 
measure is not available or relevant, one other high priority measure). 
We also request comments on how high priority measures should be 
identified for Medicaid EPs. We propose to use all three of the 
following methods to identify which of the available measures are high 
priority measures, but invite comments on other possibilities.
    1. We would use the same set of high priority measures for EPs 
participating in the Medicaid Promoting Interoperability Program that 
the MIPS program has identified for eligible clinicians. We note that 
in section III.H., we are proposing to amend Sec.  414.1305 to revise 
the definition of high priority measure for purposes of MIPS to mean an 
outcome (including intermediate-outcome and patient-reported outcome), 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure, beginning with the 
2021 MIPS payment year.
    2. For 2019, we would also identify as high priority measures the 
available eCQMs that are included in the previous year's Core Sets and 
that are also included on the MIPS list of eCQMs. Because the Core Sets 
are released at the beginning of each year, it would not be possible to 
update the list of high-priority eCQMs with those added to the current 
year's Core Sets. CMS has already identified the measures included in 
the Core Sets as ones that specifically focus on populations served by 
the Medicaid and CHIP programs and are particularly important to their 
care. The eCQMs that would be available for EPs to report in 2019, that 
are both part of the Core Sets and on the MIPS list of eCQMs, and that 
would be considered high priority measures under our proposal are: 
CMS2, ``Preventive Care and Screening: Screening for Depression and 
Follow-Up Plan''; CMS4, ``Initiation and Engagement of Alcohol and 
Other Drug Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c 
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening''; 
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up 
Care for Children Prescribed ADHD Medication (ADD)''; CMS153, 
``Chlamydia Screening for Women''; CMS155, ``Weight Assessment and 
Counseling for Nutrition and Physical Activity for Children and 
Adolescents''; and CMS165, ``Controlling High Blood Pressure.''
    3. We would also give each state the flexibility to identify which 
of the available eCQMs selected by CMS are high priority measures for 
EPs in that state, with review and approval from CMS, through their 
State Medicaid HIT Plans (SMHP), similar to the flexibility granted 
states to modify the definition of Meaningful Use at Sec.  495.332(f). 
This would give states the ability to identify as high priority those 
measures that align with their state health goals or other programs 
within the state. We proposed to amend Sec.  495.332(f) to provide for 
this state flexibility to identify high priority measures.
    We propose that any eCQMs identified via any of these mechanisms be 
considered to be high priority measures for EPs participating in the 
Medicaid Promoting Interoperability Program for 2019. We invite 
comments on whether all three of these methods should be utilized (as 
proposed) or whether there are reasons to instead use a subset of these 
methods, or only one of them.
    We also propose that the eCQM reporting period for EPs in the 
Medicaid Promoting Interoperability Program would be a full CY in 2019 
for EPs who have demonstrated meaningful use in a prior year, in order 
to align with the corresponding performance period in MIPS for the 
quality performance category. We continue to align Medicaid Promoting 
Interoperability Program requirements with requirements for other CMS 
quality programs, such as MIPS, to the extent practicable, to reduce 
the burden of reporting different data for separate programs. In 
addition, we have found that clinical quality data from an entire year 
reporting period is significantly more useful than partial year data 
for quality measurement and improvement because it gives states a 
fuller picture of a health care provider's care and patient outcomes. 
The eCQM reporting period for EPs demonstrating meaningful use for the 
first time, which was established in the final rule entitled ``Medicare 
and Medicaid Programs; Electronic Health Record Incentive Program--
Stage 3 and Modifications to Meaningful Use in 2015 Through 2017'' (80 
FR 62762) (hereafter referred to as ``Stage 3 final rule''), would 
remain any continuous 90-day period (80 FR 62892).
    We will adjust future years' requirements for reporting eCQMs in 
the Medicaid Promoting Interoperability Program as necessary, through 
rulemaking, and will continue to align the quality reporting 
requirements, as logical and feasible, to minimize EP burden.
    We invite public comment on these proposals.
3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting 
Period in 2021 for EPs Participating in the Medicaid Promoting 
Interoperability Program
    In the July 28, 2010 final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program'' at 75 FR 44319, 
we established that, in accordance with section 1903(t)(4)(A)(iii) of 
the Act, in no case may any Medicaid EP receive an incentive after 2021 
(see Sec.  495.310(a)(2)(v)). Therefore, December 31, 2021 is the last 
date that states could make Medicaid Promoting Interoperability Program 
payments to Medicaid EPs (other than pursuant to a successful appeal 
related to 2021 or a prior year).
    For states to make payments by that deadline, there must be 
sufficient time after EHR and eCQM reporting periods

[[Page 35873]]

end for EPs to attest to states, for states to conduct their prepayment 
processes, and for states to issue payments. Therefore, we propose to 
amend Sec.  495.4 to provide that the EHR reporting period in 2021 for 
all EPs in the Medicaid Promoting Interoperability Program would be a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that the state can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021. Similarly, we propose 
to change the eCQM reporting period in 2021 for EPs in the Medicaid 
Promoting Interoperability Program to a minimum of any continuous 90-
day period within CY 2021, provided that the end date for this period 
falls before October 31, 2021, to help ensure that the state can issue 
all Medicaid Promoting Interoperability Program payments on or before 
December 31, 2021.
    We understand that the October 31, 2021 date might not provide some 
states with sufficient time to process payments by December 31, 2021. 
We believe that states are best positioned to determine the last 
possible date in CY 2021 by which the EHR or eCQM reporting periods for 
Medicaid EPs must end, and the deadline for receiving EP attestations, 
so that the state is able to issue all payments by December 31, 2021. 
Therefore, we propose to allow states the flexibility to set 
alternative, earlier final deadlines for EHR or eCQM reporting periods 
for Medicaid EPs in CY 2021, with prior approval from us, through their 
State Medicaid HIT Plan (SMHP). If a state establishes an alternative, 
earlier date within CY 2021 by which all EHR or eCQM reporting periods 
in CY 2021 must end, Medicaid EPs in that state would continue to have 
a reporting period of a minimum of any continuous 90-day period within 
CY 2021. The end date for the reporting period would have to occur 
before the day of attestation, which must occur prior to the final 
deadline for attestations established by their state. We proposed to 
amend Sec.  495.332(f) to provide for this state flexibility to 
identify an alternative date by which all EHR reporting periods or eCQM 
reporting periods for Medicaid EPs in CY 2021 must end.
    We believe there is no reason why a state would need to set a date 
by which EHR reporting periods and eCQM reporting periods must end for 
Medicaid EPs that is earlier than the day before that state's 
attestation deadline for EPs. Doing so would restrict EPs' ability to 
select EHR and eCQM reporting periods. Therefore, we propose that any 
alternative deadline for CY 2021 EHR and eCQM reporting periods set by 
a state may not be any earlier than the day prior to the attestation 
deadline for Medicaid EPs attesting to that state.
    We invite public comment on this proposal.
    While we are not making any proposals regarding eligible hospitals 
in this proposed rule, we acknowledge that there will be a similar 
issue if there are still hospitals eligible to receive Medicaid 
Promoting Interoperability Program payments in 2021, including 
Medicaid-only eligible hospitals as well as ``dually-eligible'' 
eligible hospitals and critical access hospitals (CAHs) (those that are 
eligible for an incentive payment under Medicare for meaningful use of 
CEHRT and/or subject to the Medicare payment reduction for failing to 
demonstrate meaningful use of CEHRT, and are also eligible to earn a 
Medicaid incentive payment for meaningful use of CEHRT). However, based 
on attestation data and information from states' SMHPs regarding the 
number of years states disburse Medicaid Promoting Interoperability 
Program payments to hospitals, we believe that there will be no 
hospitals eligible to receive Medicaid Promoting Interoperability 
Program payments in 2021 due to the requirement that, after 2016, 
eligible hospitals cannot receive a Medicaid Promoting Interoperability 
Program payment unless they have received such a payment in the prior 
fiscal year. At this time, we believe that there are no hospitals that 
will be able to receive incentive payments in 2020 or 2021. We invite 
comments and suggestions on whether this belief is accurate, and if 
not, how we could address the issue in a manner that limits the burden 
on hospitals and states. We are not proposing any specific policy in 
this rule, but, if necessary, we expect to address the issue in a 
future proposed rule that is more specifically related to hospital 
payment.
4. Proposed Revisions to Stage 3 Meaningful Use Measures for Medicaid 
EPs
a. Proposed Change to Objective 6 (Coordination of Care Through Patient 
Engagement)
    In the Stage 3 final rule, we adopted a phased approach under Stage 
3 for EP Objective 6 (Coordination of care through patient engagement), 
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging). This phased approach established a 5 percent 
threshold for both measures 1 and 2 of this objective for an EHR 
reporting period in 2017. (80 FR 62848 through 62849) In the same rule, 
we established that the threshold for Measure 1 would rise to 10 
percent, beginning with the EHR reporting period in 2018, and that the 
threshold for Measure 2 would rise to 25 percent, beginning with the 
EHR reporting period in 2018 We stated that we would continue to 
monitor performance on these measures to determine if any further 
adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 
38493), we established a policy allowing EPs, eligible hospitals, and 
CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination 
of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in 
CY 2018, and depending on which Edition(s) they use, to attest to the 
Modified Stage 2 objectives and measures or the Stage 3 objectives and 
measures. In doing so, we also delayed the rise of the Objective 6 
Measure 1 and Measure 2 thresholds until 2019.
    Based on feedback we have received, we understand that these two 
measures are the largest barrier to successfully demonstrating 
meaningful use, especially in rural areas and at safety net clinics. 
Stakeholders have reported a variety of causes that have resulted in 
lower patient participation than was anticipated when the Stage 3 final 
rule was issued. The data that we have collected via states for 
Medicaid EPs and at CMS from Medicare EPs for previous program years 
supports this feedback. The primary issue is that the view, download, 
transmit measure requires a positive action by patients, which cannot 
be controlled by an EP. Medicaid populations that are at the greatest 
risk have lower levels of internet access, internet literacy and health 
literacy than the general population. While the Secure Electronic 
Messaging measure does not require patient action, only that the EP 
send a secure message, we have received feedback that this 
functionality is not highly utilized by patients. While we encourage 
EPs to continue to reach out to patients via secure messaging to engage 
them in their health care between office visits, it is not productive 
for EPs to send messages to patients who are unlikely to see them or 
take action. Retaining the current threshold of 5 percent for both 
measures would continue to incentivize EPs to engage patients in their 
own care without raising the requirements to unattainable thresholds 
for EPs who serve vulnerable Medicaid patients. Therefore, we propose 
to amend Sec.  495.24(d)(6)(i) such that the thresholds

[[Page 35874]]

for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 
(Coordination of care through patient engagement) would remain 5 
percent for 2019 and subsequent years.
    We invite comments on this proposal.
b. Proposed Change to the Syndromic Surveillance Reporting Measure
    In the Stage 3 final rule, we established that the syndromic 
surveillance reporting measure for EPs was limited to those who 
practice in urgent care settings (80 FR 62866 through 62870). Since 
then, we have received feedback from states and public health agencies 
that while many are unable to accept non-emergency or non-urgent care 
ambulatory syndromic surveillance data electronically, some public 
health agencies can and do want to receive data from health care 
providers in non-urgent care settings. We believe that public health 
agencies that set the requirements for data submission to public health 
registries are in a better position to judge which health care 
providers can contribute useful data.
    Therefore, we propose to amend Sec.  495.24(d)(8)(i)(B)(2), EP 
Objective 8 (Public health and clinical data registry reporting), 
Measure 2 (Syndromic surveillance reporting measure), to amend the 
language restricting the use of syndromic surveillance reporting for 
meaningful use only to EPs practicing in an urgent care setting. We 
propose to include any EP defined by the state or local public health 
agency as a provider who can submit syndromic surveillance data. This 
change would not alter the exclusion for this measure at Sec.  
495.25(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health 
care providers from which ambulatory syndromic surveillance data is 
collected by their jurisdiction's syndromic surveillance system, as 
defined by the state or local public health agency. Furthermore, this 
does not create any requirements for syndromic surveillance registries 
to include all EPs. Additionally, under the specifications for the 2015 
Edition of CEHRT for syndromic surveillance, it is possible that an EP 
could own CEHRT and submit syndromic surveillance in a format that is 
not accepted by the local jurisdiction. In this case, the EP may take 
an exclusion for syndromic surveillance.
    We invite comments on this proposal.

F. Medicare Shared Savings Program

    As required under section 1899 of the Act, we established the 
Medicare Shared Savings Program (Shared Savings Program) to facilitate 
coordination and cooperation among health care providers to improve the 
quality of care for Medicare Fee-For-Service (FFS) beneficiaries and 
reduce the rate of growth in expenditures under Medicare Parts A and B. 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other health care providers, may participate in the 
Shared Savings Program by forming or participating in an Accountable 
Care Organization (ACO). The final rule establishing the Shared Savings 
Program appeared in the November 2, 2011 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the 
``November 2011 final rule''). A subsequent major update to the program 
rules appeared in the June 9, 2015 Federal Register (Medicare Program; 
Medicare Shared Savings Program: Accountable Care Organizations; Final 
Rule (80 FR 32692) (hereinafter referred to as the ``June 2015 final 
rule'')). The final rule entitled, ``Medicare Program; Medicare Shared 
Savings Program; Accountable Care Organizations--Revised Benchmark 
Rebasing Methodology, Facilitating Transition to Performance-Based 
Risk, and Administrative Finality of Financial Calculations,'' which 
addressed changes related to the program's financial benchmark 
methodology, appeared in the June 10, 2016 Federal Register (81 FR 
37950) (hereinafter referred to as the ``June 2016 final rule'').
    We have also made use of the annual calendar year (CY) Physician 
Fee Schedule (PFS) rules to address quality reporting for the Shared 
Savings Program and certain other issues. In the CY 2018 PFS final rule 
(82 FR 53209 through 53226), we finalized revisions to several 
different policies under the Shared Savings Program, including the 
assignment methodology, quality measure validation audit process, use 
of the skilled nursing facility (SNF) 3-day waiver, and handling of 
demonstration payments for purposes financial reconciliation and 
establishing historical benchmarks. In addition, in the CY 2017 Quality 
Payment Program final rule (81 FR 77255 through 77260) and the CY 2018 
Quality Payment Program final rule (82 FR 53688 through 53706), we 
finalized policies related to the Alternative Payment Model (APM) 
scoring standard under the Merit-Based Incentive Payment System (MIPS), 
which reduces the reporting burden for MIPS eligible clinicians who 
participate in MIPS APMs, such as the Shared Savings Program, by: (1) 
Using the CAHPS for ACOs survey and the ACO reported CMS Web Interface 
quality data for purposes of assessing quality performance in the 
Shared Savings Program and to score the MIPS quality performance 
category for these eligible clinicians; (2) automatically awarding MIPS 
eligible clinicians participating in Shared Savings Program ACOs a 
minimum of one-half of the total points in the MIPS improvement 
activities performance category; (3) requiring ACO participants to 
report Advancing Care Information (ACI) data at the group practice 
level or solo practitioner level; and (4) not assessing MIPS eligible 
clinicians on the MIPS cost performance category because, through their 
participation in the ACO, they are already being assessed on cost and 
utilization under the Shared Savings Program.
    As a general summary, we are proposing the following changes to the 
quality performance measures that will be used to assess quality 
performance under the Shared Savings Program for performance year 2019 
and subsequent years:
     Changes to Patient Experience of Care Survey measures.
     Changes to CMS Web Interface and Claims-Based measures.
1. Quality Measurement
a. Background
    Section 1899(b)(3)(C) of the Act states that the Secretary shall 
establish quality performance standards to assess the quality of care 
furnished by ACOs and seek to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both. 
In the November 2011 final rule, we established a quality performance 
standard consisting of 33 measures across four domains, including 
patient experience of care, care coordination/patient safety, 
preventive health, and at-risk population (76 FR 67872 through 67891). 
Since the Shared Savings Program was established, we have updated the 
measures that comprise the quality performance standard for the Shared 
Savings Program through the annual rulemaking in the CY 2015, 2016, and 
2017 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 
71268, and 81 FR 80484 through 80489, respectively).
    As we stated in the November 2011 final rule establishing the 
Shared Savings Program (76 FR 67872), our principal goal in selecting 
quality measures for ACOs has been to identify

[[Page 35875]]

measures of success in the delivery of high-quality health care at the 
individual and population levels, with a focus on outcomes.
    For performance year 2018, 31 quality measures are used to 
determine ACO quality performance (81 FR 80488 and 80489). Quality 
measures are submitted by the ACO through the CMS Web Interface, 
calculated by CMS from administrative and claims data, and collected 
via a patient experience of care survey referred to as the Consumer 
Assessment of Healthcare Provider and Systems (CAHPS) for ACOs Survey. 
The CAHPS for ACOs survey is based on the Clinician and Group Consumer 
Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey and 
includes additional, program specific questions that are not part of 
the CG-CAHPS. The CG-CAHPS survey is maintained, and periodically 
updated, by the Agency for Healthcare Research and Quality (AHRQ).
    The quality measures collected through the CMS Web Interface in 
2015 and 2016 were used to determine whether eligible professionals 
participating in an ACO would avoid the PQRS and automatic Physician 
Value-Based Payment Modifier (Value Modifier) downward payment 
adjustments for 2017 and 2018 and to determine if ACO participants were 
eligible for upward, neutral or downward adjustments based on quality 
measure performance under the Value Modifier. Beginning with the 2017 
performance period, which impacts payments in 2019, PQRS and the Value 
Modifier were replaced by the MIPS. Eligible clinicians who are 
participating in an ACO and subject to MIPS (MIPS eligible clinicians) 
will be scored under the alternative payment model (APM) scoring 
standard under MIPS (81 FR 77260). These MIPS eligible clinicians 
include any eligible clinicians who are participating in an ACO in a 
track of the Shared Savings Program that is an Advanced APM, but who do 
not become Qualifying APM Participants (QPs) as specified in Sec.  
414.1425, and are not otherwise excluded from MIPS. Beginning with the 
2017 reporting period, measures collected through the CMS Web Interface 
will be used to determine the MIPS quality performance category score 
for MIPS eligible clinicians participating in a Medicare Shared Savings 
Program ACO. Starting with the 2018 performance period, the quality 
performance category under the MIPS APM Scoring Standard for MIPS 
eligible clinicians participating in a Shared Savings Program ACO will 
include measures collected through the CMS Web Interface and the CAHPS 
for ACOs survey measures.
    The CAHPS for ACOs Survey includes the core questions contained in 
the CG-CAHPS, plus additional questions to measure access to and use of 
specialist care, experience with care coordination, patient involvement 
in decision-making, experiences with a health care team, health 
promotion and patient education, patient functional status, and general 
health. From 2014 through 2017, ACOs had the option to use a short 
version of the survey (8 Summary Survey Measures (SSMs) used in 
assessing quality performance, 1 SSM scored for informational purposes) 
or a longer version of the survey (8 SSMs used in determining quality 
performance and 4 SSMs scored for informational purposes). Although not 
all measures in the longer version of the survey were used in 
determining the ACO's quality score, the measure performance rate 
information could be used by the ACO in its quality improvement 
efforts. For 2018, CMS will only offer one version of the CAHPS for 
ACOs survey. Eight SSMs will be used in quality determination and two 
SSMs will be scored for informational purposes. There were no changes 
to the scored measure set between the 2017 and 2018 surveys: The 2018 
survey is a streamlined version of the survey that assesses the same 
content areas required in 2017, using fewer survey items.
    The 2018 CAHPS for ACOs survey incorporates updates made by AHRQ to 
the Clinician and Group (CG) CAHPS survey that were based on feedback 
from survey users and stakeholders as well as analyses of multiple data 
sets. In the ``Notice of Proposed Changes for the Consumer Assessment 
of Healthcare Providers and Systems (CAHPS) Clinician & Group Survey'' 
published in the January 21, 2015 Federal Register (80 FR 2938-2939), 
AHRQ solicited public comment on proposed updates to produce the CAHPS 
Clinician & Group Survey v. 3.0. Based on analyses of multiple data 
sets and comments received from the public, AHRQ, released the CAHPS 
Clinician & Group Survey v. 3.0. The 2018 CAHPS for ACOs survey 
includes language refinements and core SSM item changes that align with 
the CAHPS Clinician & Group Survey v. 3.0.
    Additional information on the CG-CAHPS survey update is available 
on the AHRQ website at https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/about/proposed-changes-cahps-c&g-survey2015.pdf.
    In addition to incorporating changes based on the AHRQ survey 
update, CMS removed all items included in the SSMs, Helping You to Take 
Medications as Directed and Between Visit Communication. These were 
optional SSMs that were not part of the scored measures. The update 
resulted in reducing the number of questions from 80 to 58 questions. 
Accordingly, the CAHPS for ACOs SSMs that contribute to the ACO 
performance score for performance year 2018, as finalized in the CY 
2017 PFS final rule (81 FR 80488) are: Getting Timely Care, 
Appointments & Information; How Well Your Providers Communicate; 
Patients' Rating of Provider; Access to Specialists; Health Promotion 
and Education; Shared Decision Making; Health Status & Functional 
Status; and Stewardship of Patient Resources. In addition, the core 
survey includes SSMs on Care Coordination and Courteous & Helpful 
Office Staff. However, because these measures are not included in the 
Shared Savings Program quality measure set for 2018, scores for these 
measures will be provided to ACOs for informational purposes only and 
will not be used in determining the ACOs' quality scores.
b. Proposals for Changes to the CAHPS Measure Set
    To enhance the Patient/Caregiver Experience domain and align with 
MIPS (82 FR 54163), we are proposing to begin scoring the 2 SSMs that 
are currently collected with the administration of the CAHPS for ACOs 
survey and shared with the ACOs for informational purposes only. Under 
this proposal, we would add the following CAHPS for ACOs SSMs that are 
already collected and provided to ACOs for informational purposes to 
the quality measure set for the Shared Savings Program as ACO-45, 
CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care 
Coordination. These measures would be scored and included in the ACO 
quality determination starting in 2019. Both of these SSMs are 
currently designated by AHRQ as CG CAHPS core measures.
    The Courteous and Helpful Office Staff SSM, which would be added as 
ACO-45, asks about the helpfulness, courtesy and respectfulness of 
office staff. This SSM has been a CG-CAHPS core measure in the previous 
two versions of the CG-CAHPS survey, but was previously provided for 
informational purposes only and not included in the ACO quality score 
determination. We are also proposing to add the SSM, CAHPS: Care 
Coordination to the CAHPS for ACOs

[[Page 35876]]

measures used in ACO quality score determination as ACO-46. The Care 
Coordination SSM asks questions about provider access to beneficiary 
information and provider follow-up. This SSM was designated a core 
measure in the most recent version of the CG-CAHPS survey.
    Inclusion of these measures in the quality measure set that is used 
to assess the quality performance of ACOs under the Shared Savings 
Program would place greater emphasis on outcome measures and the voice 
of the patient and provide ACOs with an additional incentive to act 
upon opportunities for improved care coordination and communication, 
and would align with the MIPS measure set finalized in the CY 2018 
Quality Payment Program final rule (82 FR 54163). Care Coordination and 
patient and caregiver engagement are goals of the Shared Savings 
Program. The Care Coordination SSM emphasizes the care coordination 
goal, while the Courteous and Helpful Office Staff SSM supports patient 
engagement as it addresses a topic that has been identified as 
important to beneficiaries in testing. For performance year 2016, the 
mean performance rates across all ACOs for these two measures, which 
were not included in the ACO quality score determination, were 87.18 
for the Care Coordination SSM and 92.12 for Courteous and Helpful 
Office Staff SSM.
    Consistent with Sec.  425.502(a)(4), regarding the scoring of newly 
introduced quality measures, we propose that these additional SSMs 
would be pay-for-reporting for all ACOs for 2 years (performance years 
2019 and 2020). The measures would then phase into pay-for-performance 
for ACOs in their first agreement period in the program according to 
the schedule in Table 25 beginning in performance year 2021. We seek 
comment on this proposed change to the quality measure set.
    Additionally, we seek comment on potentially converting the Health 
and Functional Status SSM (ACO-7) to pay-for-performance in the future. 
The Health and Functional Status SSM is currently pay-for-reporting for 
all years. We have not scored this measure because the scores on the 
Health and Functional Status SSM may reflect the underlying health of 
beneficiaries seen by ACO providers/suppliers as opposed to the quality 
of the care provided by the ACO. We are also considering possible 
options for enhancing collection of Health and Functional Status data. 
One option would be to change our data collection procedures to collect 
data from the same ACO assigned beneficiaries over time. This change 
could allow for measurement of changes that occurred while 
beneficiaries were receiving care from ACO providers/suppliers. We are 
seeking stakeholder feedback on this approach or other recommendations 
regarding the potential inclusion of a functional status measure in the 
assessment of ACO quality performance in the future.
c. Proposed Changes to the CMS Web Interface and Claims-Based Quality 
Measure Sets
    In developing these proposals, we considered the agency's efforts 
to streamline quality measures, reduce regulatory burden and promote 
innovation as part of the agency's Meaningful Measures initiative (See 
CMS Press Release, CMS Administrator Verma Announces New Meaningful 
Measures Initiative and Addresses Regulatory Reform; Promotes 
Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). Under the Meaningful Measures 
initiative, CMS has committed to assessing only those core issues that 
are most vital to providing high-quality care and improving patient 
outcomes, with the aim of focusing on outcome-based measures, reducing 
unnecessary burden on providers, and putting patients first. In 
considering the quality reporting requirements under the Shared Savings 
Program, we have also considered the quality reporting requirements 
under other initiatives, such as the MIPS and Million Hearts 
Initiative, and consulted with the measures community to ensure that 
the specifications for the measures used under the Shared Savings 
Program are up-to-date with current clinical guidelines, focus on 
outcomes over process, reflect agency and program priorities, and 
reduce reporting burden.
    Since the Shared Savings Program was first established in 2012, we 
have not only updated the quality measure set to reduce reporting 
burden, but also to focus on more meaningful, outcome-based measures. 
The most recent updates to the Shared Savings Program quality measure 
set were made in the CY 2017 PFS final rule (81 FR 80484 through 80489) 
to adopt the ACO measure recommendations made by the Core Quality 
Measures Collaborative, a multi-stakeholder group with the goal of 
aligning quality measures for reporting across public and private 
initiatives to reduce provider reporting burden. Currently, more than 
half of the 31 Shared Savings Program quality measures are outcome-
based, including:
     Patient-reported outcome measures collected through the 
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
     Outcome measures supporting effective communication and 
care coordination, such as unplanned admission and readmission 
measures.
     Intermediate outcome measures that address the effective 
treatment of chronic disease, such as hemoglobin A1c control for 
patients with diabetes.
    In this rule, we are proposing to reduce the total number of 
measures in the Shared Savings Program quality measure set. These 
proposals are intended to reduce the burden on ACOs and their 
participating providers and suppliers by lowering the number of 
measures they are required to report through the CMS Web Interface and 
on which they are assessed through the use of claims data. Reducing the 
number of measures on which ACOs are measured would reduce the number 
of performance metrics that they are required to track and eliminate 
redundancies between measures that target similar populations. The 
proposed reduction in the number of measures would enable ACOs to 
better utilize their resources toward improving patient care. These 
proposals further reduce burden by aligning with the proposed changes 
to the CMS Web Interface measures that are reported under MIPS as 
discussed in Tables A, C, and D of Appendix 1: Proposed MIPS Quality 
Measures of this proposed rule. We recognize that ACOs and their 
participating providers and suppliers dedicate resources to performing 
well on our quality metrics, and we believe that reducing the number of 
metrics and aligning them across programs would allow them to more 
effectively target those resources toward improving patient care. We 
are proposing to reduce the number of measures by minimizing measure 
overlap and eliminating several process measures. The proposal to 
remove process measures also aligns with our proposal to reduce the 
number of process measures within the MIPS measure set as discussed in 
section III.H.b.iii of this proposed rule and would support the CMS 
goal of moving toward outcome-based measurement.
    We are proposing to retire the following claims-based quality 
measures, which have a high degree of overlap with other measures that 
would remain in the measure set:
     ACO-35--Skilled Nursing Facility 30-Day All-Cause 
Readmission Measure (SNFRM).
     ACO-36--All-Cause Unplanned Admissions for Patients with 
Diabetes.

[[Page 35877]]

     ACO-37--All-Cause Unplanned Admission for Patients with 
Heart Failure.
    Within the claims-based quality measures, overlap exists between 
measures with respect to the population being measured (the 
denominator), because a single admission may be counted in the 
numerator for multiple measures. For example, ACO-35 addresses 
unplanned readmissions from a SNF, and the vast majority of these SNF 
readmissions are also captured in the numerator of ACO-8 Risk-
Standardized All Condition Readmission. Similarly, ACO-36 and ACO-37 
address unplanned admissions for patients with diabetes and heart 
failure and most of these admissions are captured in the numerator of 
ACO-38 Risk-Standardized Acute Admission Rates for Patients with 
Multiple Chronic Conditions (please note that the measure name has been 
updated to align with changes made by the measure steward). Therefore, 
to reduce redundancies within the Shared Savings Program measure set, 
we propose to remove ACO-35, ACO-36, and ACO-37 from the measure set. 
However, because these measures are claims-based measures and therefore 
do not impose any reporting burden on ACOs, we intend to continue to 
provide information to ACOs on their performance on these measures for 
use in their quality improvement activities through a new quarterly 
claims-based quality outcome report that ACOs will begin receiving in 
2018.
    Although we are proposing to retire ACO-35 (SNFRM) from the set of 
quality measures that are scored for the Shared Savings Program, we 
recognize the value of measuring the quality of care furnished to 
Medicare beneficiaries in SNFs. Therefore, we are seeking comment on 
the possibility of adding the Skilled Nursing Facility Quality 
Reporting Program (SNFQRP) measure ``Potentially Preventable 30-Day 
Post-Discharge Readmission Measure for Skilled Nursing Facilities'' to 
the Shared Savings Program quality measure set through future 
rulemaking. This measure differs from ACO-35 (Skilled Nursing Facility 
30-Day All-Cause Readmission Measure), which we are proposing to remove 
above, as the SNFQRP measure looks only at unplanned, potentially 
preventable readmissions for Medicare Fee-For-Service beneficiaries 
within 30 days of discharge to a lower level of care from a SNF, while 
ACO-35 assesses readmissions from a SNF, regardless of cause, that 
occur within 30 days following discharge from a hospital. As a result, 
the SNFQRP measure would have less overlap with ACO-8 (Risk-
Standardized All Cause Readmission measure) than does ACO-35 (SNFRM), 
because the two measures' readmission windows differ. Specifically, the 
readmission window for the SNFQRP measure is 30 days following 
discharge from a SNF, while the readmission window for ACO-8 is 30 days 
following discharge from a hospital.
    We are also proposing to retire claims-based measure ACO-44 (Use of 
Imaging Studies for Low Back Pain), as this measure is restricted to 
individuals 18-50 years of age, which results in low denominator rates 
under the Shared Savings Program, meaning that the measure is not a 
valuable reflection of the beneficiaries cared for by Shared Savings 
Program ACOs. As a result, although this measure was originally added 
to the Shared Savings Program quality measure set in order to align 
with the Core Quality Measures Collaborative, we no longer believe ACO-
44 is a meaningful measure that should be retained in the Shared 
Savings Program quality measure set. The deletion of this measure would 
also align ACO quality measurement with the MIPS requirements as this 
measure was removed for purposes of reporting under the MIPS program in 
the CY 2018 Quality Payment Program final rule (82 FR 54159). However, 
in recognition of the value in providing feedback to providers on 
potential overuse of diagnostic procedures, we intend to continue to 
provide ACOs feedback on performance on this measure as part of the new 
quarterly claims based quality report.
    We welcome public comment on our proposal to retire these 4 claims-
based measures from the quality measure set.
    Further, we seek to align with changes made to the CMS Web 
Interface measures under the Quality Payment Program. In the 2017 PFS 
final rule, we stated we do not believe it is beneficial to propose CMS 
Web interface measures for ACO quality reporting separately (81 FR 
80499). Therefore, in order to avoid confusion and duplicative 
rulemaking, we adopted a policy that any future changes to the CMS Web 
interface measures would be proposed and finalized through rulemaking 
for the Quality Payment Program, and that such changes would be 
applicable to ACO quality reporting under the Shared Savings Program. 
In accordance with the policy adopted in the CY 2017 PFS final rule (81 
FR 80501), we are not making any specific proposals related to changes 
in CMS Web Interface measures reported under the Shared Savings 
Program. Rather, we refer readers to Tables A, C, and D of Appendix 1: 
Proposed MIPS Quality Measures of this proposed rule for a complete 
discussion of the proposed changes to the CMS Web Interface measures. 
If the proposed changes are finalized, ACOs would no longer be 
responsible for reporting the following measures for purposes of the 
Shared Savings Program starting with reporting for performance year 
2019:
     ACO-12 (NQF #0097) Medication Reconciliation Post-
Discharge.
     ACO-13 (NQF #0101) Falls: Screening for Future Fall Risk.
     ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older 
Adults.
     ACO-16 (NQF #0421) Preventive Care and Screening: Body 
Mass Index (BMI) Screening and Follow Up.
     ACO-41 (NQF #0055) Diabetes: Eye Exam.
     ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of 
Aspirin or another Antithrombotic.
    We note that ACO-41 is one measure within a two-component diabetes 
composite that is currently scored as one measure. The proposed removal 
of ACO-41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor 
Control (>9%) would now be assessed as an individual measure. If the 
proposed changes are finalized as proposed, Table 26 shows the maximum 
possible points that may be earned by an ACO in each domain and overall 
in performance year 2019 and in subsequent performance years.
    Additionally, we note that we are proposing to add the following 
measure to the CMS Web Interface for purposes of the Quality Payment 
Program:
     ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and 
Plan of Care to Prevent Future Falls.
    If this proposal is finalized, consistent with our policy of 
adopting changes to the CMS Web Interface Measures through rulemaking 
for the Quality Payment Program, Shared Savings Program ACOs would be 
responsible for reporting this measure starting in performance year 
2019.
    Table 25 shows the proposed Shared Savings Program quality measure 
set for performance year 2019 and subsequent performance years.

[[Page 35878]]



   Table 25--Proposed Measure Set for Use in Establishing the Shared Savings Program Quality Performance Standard, Starting With Performance Year 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Pay for performance phase-
                                                                                                                                  in R--Reporting P--
             Domain               ACO  measure     Measure title     New measure   NQF #/measure steward     Method of data           Performance
                                      No.                                                                      submission     --------------------------
                                                                                                                                 PY1      PY2      PY3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            AIM: Better Care for Individuals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience...  ACO-1          CAHPS: Getting      ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Timely Care,
                                                 Appointments, and
                                                 Information.
                                 ACO-2          CAHPS: How Well     ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Your Providers
                                                 Communicate.
                                 ACO-3          CAHPS: Patients'    ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Rating of
                                                 Provider.
                                 ACO-4          CAHPS: Access to    ............  NQF #N/A CMS/AHRQ        Survey............       R        P        P
                                                 Specialists.
                                 ACO-5          CAHPS: Health       ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 Promotion and
                                                 Education.
                                 ACO-6          CAHPS: Shared       ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 Decision Making.
                                 ACO-7          CAHPS: Health       ............  NQF #N/A AHRQ            Survey............       R        R        R
                                                 Status/Functional
                                                 Status.
                                 ACO-34         CAHPS: Stewardship  ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 of Patient
                                                 Resources.
                                 ACO-45         CAHPS: Courteous          \1\ X   NQF #N/A AHRQ            Survey............       R        R        P
                                                 and Helpful
                                                 Office Staff.
                                 ACO-46         CAHPS: Care               \1\ X   NQF #N/A AHRQ            Survey............       R        R        P
                                                 Coordination.
Care Coordination/Patient        ACO-8          Risk-Standardized,  ............  Adapted NQF #1789 CMS    Claims............       R        R        P
 Safety.                                         All Condition
                                                 Readmission.
                                 ACO-38         Risk-Standardized   ............  NQF#2888 CMS             Claims............       R        R        P
                                                 Acute Admission
                                                 Rates for
                                                 Patients with
                                                 Multiple Chronic
                                                 Conditions.
                                 ACO-43         Ambulatory          ............  AHRQ                     Claims............       R        P        P
                                                 Sensitive
                                                 Condition Acute
                                                 Composite (AHRQ
                                                 Prevention
                                                 Quality Indicator
                                                 (PQI) #91)
                                                 (version with
                                                 additional Risk
                                                 Adjustment) \2\.
                                 ACO-47         Falls: Screening,   ............  NQF #0101 NCQA           CMS Web Interface.       R        R        P
                                                 Risk-Assessment,
                                                 and Plan of Care
                                                 to Prevent Future
                                                 Falls.
                                 ACO-11         Use of certified    ............  NQF #N/A CMS             Quality Payment          R        P        P
                                                 EHR technology.                                            Program Advancing
                                                                                                            Care Information.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           AIM: Better Health for Populations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preventive Health..............  ACO-14         Preventive Care     ............  NQF #0041 AMA-PCPI       CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Influenza
                                                 Immunization.
                                 ACO-17         Preventive Care     ............  NQF #0028 AMA-PCPI       CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Tobacco Use:
                                                 Screening and
                                                 Cessation
                                                 Intervention.
                                 ACO-18         Preventive Care     ............  NQF #0418 CMS            CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Screening for
                                                 Depression and
                                                 Follow-up Plan.
                                 ACO-19         Colorectal Cancer   ............  NQF #0034 NCQA           CMS Web Interface.       R        R        P
                                                 Screening.
                                 ACO-20         Breast Cancer       ............  NQF #2372 NCQA           CMS Web Interface.       R        R        P
                                                 Screening.
                                 ACO-42         Statin Therapy for  ............  NQF #N/A CMS             CMS Web Interface.       R        R        R
                                                 the Prevention
                                                 and Treatment of
                                                 Cardiovascular
                                                 Disease.
Clinical Care for At Risk        ACO-40         Depression          ............  NQF #0710 MNCM           CMS Web Interface.       R        R        R
 Population--Depression.                         Remission at
                                                 Twelve Months.
Clinical Care for At Risk        ACO-27         Diabetes            ............  NQF #0059 NCQA           CMS Web Interface.       R        P        P
 Population--Diabetes.                           Hemoglobin A1c
                                                 (HbA1c) Poor
                                                 Control (>9%).
Clinical Care for At Risk        ACO-28         Hypertension :      ............  NQF #0018 NCQA           CMS Web Interface.       R        P        P
 Population--Hypertension.                       Controlling High
                                                 Blood Pressure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Measures that are currently collected as part of the administration of the CAHPS for ACO survey, but will be considered new measures for purposes of
  the pay for performance phase-in.
\2\ The language in parentheses has been added for clarity and no changes have been made to the measure.

    We are proposing to eliminate 10 measures and to add one measure to 
the Shared Savings Program quality measure set. This would result in 24 
measures for which ACOs would be held accountable. With these proposed 
measure changes, the 4 domains would include the following numbers of 
quality measures (See Table 26):
     Patient/Caregiver Experience of Care--10 measures.
     Care Coordination/Patient Safety--5 measures, including 
the double-weighted EHR measure (ACO-11).
     Preventive Health--6 measures.
     At Risk Populations--3 measures.
    Table 26 provides a summary of the number of measures by domain and 
the total points and domain weights that would be used for scoring 
purposes under the changes to the quality measure set proposed in this 
proposed rule.

[[Page 35879]]



     Table 26--Number of Measures and Total Points for Each Domain Within the Shared Savings Program Quality
                            Performance Standard, Starting With Performance Year 2019
----------------------------------------------------------------------------------------------------------------
                                           Number of
                Domain                    individual       Total measures for     Total possible   Domain weight
                                           measures         scoring purposes          points            (%)
----------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience..........              10  10 individual survey                  20              25
                                                         module measures.
Care Coordination/Patient Safety......               5  5 measures, including                 12              25
                                                         double-weighted EHR
                                                         measure.
Preventive Health.....................               6  6 measures..............              12              25
At-Risk Population....................               3  3 individual measures...               6              25
                                       -------------------------------------------------------------------------
    Total in all Domains..............              24  24......................              50             100
----------------------------------------------------------------------------------------------------------------

G. Physician Self-Referral Law

1. Background
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services (DHS) payable by Medicare to an entity with 
which he or she (or an immediate family member) has a financial 
relationship (ownership or compensation), unless an exception applies; 
and (2) prohibits the entity from filing claims with Medicare (or 
billing another individual, entity, or third party payer) for those 
referred services. The statute establishes a number of specific 
exceptions, and grants the Secretary the authority to create regulatory 
exceptions for financial relationships that pose no risk of program or 
patient abuse. Additionally, the statute mandates refunding any amount 
collected under a bill for an item or service furnished under a 
prohibited referral. Finally, the statute imposes reporting 
requirements and provides for sanctions, including civil monetary 
penalty provisions.
    Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123, enacted February 9, 2018) added provisions to section 1877(h)(1) 
of the Act pertaining to the writing and signature requirements in 
certain compensation arrangement exceptions to the statute's referral 
and billing prohibitions. Although we believe that the newly enacted 
provisions in section 1877(h)(1) of the Act are principally intended 
merely to codify in statute existing CMS policy and regulations with 
respect to compliance with the writing and signature requirements, we 
are proposing revisions to our regulations to address any actual or 
perceived difference between the statutory and regulatory language, to 
codify in regulation our longstanding policy regarding satisfaction of 
the writing requirement found in many of the exceptions to the 
physician self-referral law, and to make the Bipartisan Budget Act of 
2018 policies applicable to compensation arrangement exceptions issued 
using the Secretary's authority in section 1877(b)(4) of the Act.
    In the CY 2016 PFS final rule with comment period (80 FR 70885), we 
revised Sec.  411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease 
arrangement or personal service arrangement to continue indefinitely 
beyond the stated expiration of the written documentation describing 
the arrangement under certain circumstances. Section 50404 of the 
Bipartisan Budget Act of 2018 added substantively identical holdover 
provisions to section 1877(e) of the Act. Because the new statutory 
holdover provisions effectively mirror the existing regulatory 
provisions, we do not believe it is necessary to revise Sec.  
411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory 
revisions.
2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(E) of 
the Act)
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangements are set out in writing and signed 
by the parties. (See Sec.  411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i), 
(e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained 
in Sec.  1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both 
incorporating the requirements contained in Sec.  411.357(e)(1)(i)), 
(v)(7), (w)(7), (x)(1)(i), and (y)(1).) \7\ As described above, section 
50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the 
Act with respect to the writing and signature requirements in the 
statutory compensation arrangement exceptions. As detailed below, we 
are proposing a new special rule on compensation arrangements at Sec.  
411.354(e) and proposing to amend existing Sec.  411.353(g) to codify 
the statutory provisions in our regulations.
---------------------------------------------------------------------------

    \7\ We note that, where the writing requirement appears in the 
statutory and regulatory exceptions, we interpret it uniformly, 
regardless of any minor differences in the language of the 
requirement. See 80 FR 71315. Similarly, we interpret the signature 
requirement uniformly where it appears, regardless of any minor 
differences in the language of the statutory and regulatory 
exceptions.
---------------------------------------------------------------------------

a. Writing Requirement (Sec.  411.354(e))
    In the CY 2016 PFS final rule with comment period, we stated CMS' 
longstanding policy that the writing requirement in various 
compensation arrangement exceptions in Sec.  411.357 can be satisfied 
by ``a collection of documents, including contemporaneous documents 
evidencing the course of conduct between the parties'' (80 FR 71315). 
Our guidance on the writing requirement appeared in the preamble of the 
CY 2016 PFS final rule with comment period but was not codified in 
regulations. Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph D, ``Written Requirement Clarified,'' to section 
1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that, 
in the case of any requirement in section 1877 of the Act for a 
compensation arrangement to be in writing, such requirement shall be 
satisfied by such means as determined by the Secretary, including by a 
collection of documents, including contemporaneous documents evidencing 
the course of conduct between the parties involved.
    In light of the recently added statutory provision at section 
1877(h)(1)(D) of the Act, we are proposing to add a special rule on 
compensation arrangements at Sec.  411.354(e). Proposed Sec.  
411.354(e) provides that, in the case of any requirement in 42 CFR part 
411, subpart J, for a compensation arrangement to be in writing, the 
writing requirement may be satisfied by a collection of documents, 
including contemporaneous documents evidencing the course of conduct 
between the parties. The special rule at Sec.  411.357(e) codifies our 
existing policy on the writing requirement, as previously articulated 
in the CY 2016 PFS final rule with comment period. (See 80 FR 71314 et 
seq.)

[[Page 35880]]

b. Special Rule for Certain Arrangements Involving Temporary 
Noncompliance With Signature Requirements (Sec.  411.353(g))
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangement (that is, the written 
documentation evidencing the arrangement) is signed by the parties to 
the arrangement. Under our existing special rule for certain 
arrangements involving temporary noncompliance with signature 
requirements at Sec.  411.353(g)(1), an entity that has a compensation 
arrangement with a physician that satisfies all the requirements of an 
applicable exception in Sec.  411.355, Sec.  411.356 or Sec.  411.357 
except the signature requirement may submit a claim and receive payment 
for a designated health service referred by the physician, provided 
that: (1) The parties obtain the required signature(s) within 90 
consecutive calendar days immediately following the date on which the 
compensation arrangement became noncompliant (without regard to whether 
any referrals occur or compensation is paid during such 90-day period); 
and (2) the compensation arrangement otherwise complies with all 
criteria of the applicable exception. Existing Sec.  411.353(g)(1) 
specifies the paragraphs where the applicable signature requirements 
are found and existing Sec.  411.353(g)(2) limits an entity's use of 
the special rule at Sec.  411.353(g)(1) to only once every 3 years with 
respect to the same referring physician.
    Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the 
Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any 
requirement in section 1877 of the Act for a compensation arrangement 
to be in writing and signed by the parties, the signature requirement 
is satisfied if: (1) Not later than 90 consecutive calendar days 
immediately following the date on which the compensation arrangement 
became noncompliant, the parties obtain the required signatures; and 
(2) the compensation arrangement otherwise complies with all criteria 
of the applicable exception. Notably, under the newly added section 
1877(h)(1)(E) of the Act, an applicable signature requirement is not 
limited to specific exceptions and entities are not limited in their 
use of the rule to only once every 3 years with respect to the same 
referring physician. In addition, section 1877(h)(1)(E) of the Act does 
not include a reference to the occurrence of referrals or the payment 
of compensation during the 90-day period when the signature requirement 
is not met.
    To conform the regulations with the recently added statutory 
provision at section 1877(h)(1)(E) of the Act, we are proposing to 
amend existing Sec.  411.353(g) by: (1) Revising the reference at Sec.  
411.353(g)(1) to specific exceptions and signature requirements; (2) 
deleting the reference at Sec.  411.353(g)(1) to the occurrence of 
referrals or the payment of compensation during the 90-day period when 
the signature requirement is not met; and (3) deleting the limitation 
at Sec.  411.353(g)(2). In the alternative, we are proposing to delete 
Sec.  411.353(g) in its entirety and codify in proposed Sec.  
411.354(e) the special rule for signature requirements in section 
1877(h)(1)(E). We seek comments regarding the best approach for 
codifying in regulation this provision of the Bipartisan Budget Act of 
2018.
    Finally, we note that the effective date of section 50404 of the 
Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9, 
2018, parties who meet the requirements of section 1877(h)(1)(E) of the 
Act, including parties who otherwise would have been barred from 
relying on the special rule for certain arrangements involving 
temporary noncompliance with signature requirements at Sec.  
411.353(g)(1) because of the 3-year limitation at Sec.  411.353(g)(2), 
may avail themselves of the new statutory provision at section 
1877(h)(1)(E) of the Act.

H. CY 2019 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This proposed rule would make payment and policy changes to the 
Quality Payment Program. The Medicare Access and CHIP Reauthorization 
Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) amended 
title XVIII of the Act to repeal the Medicare sustainable growth rate 
(SGR) formula, to reauthorize the Children's Health Insurance Program, 
and to strengthen Medicare access by improving physician and other 
clinician payments and making other improvements. The MACRA advances a 
forward-looking, coordinated framework for clinicians to successfully 
take part in the Quality Payment Program that rewards value in one of 
two ways:
     The Merit-based Incentive Payment System (MIPS).
     Advanced Alternative Payment Models (Advanced APMs).
    As we move into the third year of the Quality Payment Program, we 
have taken all stakeholder input into consideration including 
recommendations made by the Medicare Payment Advisory Commission 
(MedPAC), an independent congressional agency established by the 
Balanced Budget Act of 1997 (Pub. L. 105-33) to advise the U.S. 
Congress on issues affecting the Medicare program, including payment 
policies under Medicare, the factors affecting expenditures for the 
efficient provision of services, and the relationship of payment 
policies to access and quality of care for Medicare beneficiaries. We 
will continue to implement the Quality Payment Program as required, 
smoothing the transition where possible and offering targeted 
educational resources for program participants. A few examples of how 
we are working to address MedPAC's concerns are evident in our work 
around burden reduction and reshaping our focus of interoperability. 
Additionally, we heard the concern about process-based measures, and we 
are continuing to move towards the development and use of more outcome 
measures by way of removing process measures that are topped out and 
funding new quality measure development, as required by section 102 of 
MACRA. Additionally, we are also developing new episode-based cost 
measures, with stakeholder feedback, for potential inclusion in the 
cost performance category beginning in 2019. CMS acknowledges that the 
Quality Payment Program is a large shift for many clinicians and 
practices, and thus, we will continue to implement the program 
gradually with targeted educational resources, public trainings, and 
technical assistance for those who qualify. With MIPS, eligible 
clinicians now report under one program, which replaces three separate 
legacy programs. The Quality Payment Program takes a comprehensive 
approach to payment. Instead of basing payment only on a series of fee-
for-service billing codes, the Quality Payment Program adds 
consideration of quality through a set of evidence-based measures and 
clinical practice improvement activities that were primarily developed 
by clinicians.
    As a priority for Quality Payment Program Year 3, we are committed 
to reducing clinician burden, implementing the Meaningful Measures 
Initiative, promoting interoperability, continuing our support of small 
and rural practices, empowering patients through the Patients Over 
Paperwork initiative, and promoting price transparency.

[[Page 35881]]

Reducing Clinician Burden
    We are committed to reducing clinician burden by simplifying and 
reducing burden for participating clinicians. Examples include:
     Implementing the Meaningful Measures Initiative, which is 
a framework that applies a series of cross-cutting criteria to keep the 
most meaningful measures with the least amount of burden and greatest 
impact on patient outcomes;
     Promoting advances in interoperability; and
     Establishing an automatic extreme and uncontrollable 
circumstances policy for MIPS eligible clinicians.
Improving Patient Outcomes and Reducing Burden Through Meaningful 
Measures
    Regulatory reform and reducing regulatory burden are high 
priorities for us. To reduce the regulatory burden on the healthcare 
industry, lower health care costs, and enhance patient care, in October 
2017, we launched the Meaningful Measures Initiative.\8\ This 
initiative is one component of our agency-wide Patients Over Paperwork 
Initiative,\9\ which is aimed at evaluating and streamlining 
regulations with a goal to reduce unnecessary cost and burden, increase 
efficiencies, and improve beneficiary experience. The Meaningful 
Measures Initiative is aimed at identifying the highest priority areas 
for quality measurement and quality improvement to assess the core 
quality of care issues that are most vital to advancing our work to 
improve patient outcomes. The Meaningful Measures Initiative represents 
a new approach to quality measures that fosters operational 
efficiencies and will reduce costs, including the collection and 
reporting burden, while producing quality measurement that is more 
focused on meaningful outcomes.
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    \8\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \9\ See Remarks by Administrator Seema Verma at the Health Care 
Payment Learning and Action Network (LAN) Fall Summit, as prepared 
for delivery on October 30, 2017, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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    The Meaningful Measures Framework has the following objectives:
     Address high-impact measure areas that safeguard public 
health;
     Patient-centered and meaningful to patients;
     Outcome-based where possible;
     Fulfill each program's statutory requirements;
     Minimize the level of burden for health care providers 
(for example, through a preference for EHR-based measures where 
possible, such as electronic clinical quality measures);
     Significant opportunity for improvement;
     Address measure needs for population based payment through 
alternative payment models; and
     Align across programs and/or with other payers.
    To achieve these objectives, we have identified 19 Meaningful 
Measures areas and mapped them to six overarching quality priorities as 
shown in Table 27.

    Table 27--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
            Quality priority                 Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm       Healthcare-Associated
 Caused in the Delivery of Care.          Infections.
                                         Preventable Healthcare Harm.
Strengthen Person and Family Engagement  Care is Personalized and
 as Partners in Their Care.               Aligned with Patient's Goals.
                                         End of Life Care according to
                                          Preferences.
                                         Patient's Experience of Care.
                                         Patient Reported Functional
                                          Outcomes.
Promote Effective Communication and      Medication Management.
 Coordination of Care.                   Admissions and Readmissions to
                                          Hospitals.
                                         Transfer of Health Information
                                          and Interoperability.
Promote Effective Prevention and         Preventive Care.
 Treatment of Chronic Disease.           Management of Chronic
                                          Conditions.
                                         Prevention, Treatment, and
                                          Management of Mental Health.
                                         Prevention and Treatment of
                                          Opioid and Substance Use
                                          Disorders.
                                         Risk Adjusted Mortality.
Work with Communities to Promote Best    Equity of Care.
 Practices of Healthy Living.            Community Engagement.
Make Care Affordable...................  Appropriate Use of Healthcare.
                                         Patient-focused Episode of
                                          Care.
                                         Risk Adjusted Total Cost of
                                          Care.
------------------------------------------------------------------------

    By including Meaningful Measures in our programs, we believe that 
we can also address the following cross-cutting measure criteria:
     Eliminating disparities;
     Tracking measurable outcomes and impact;
     Safeguarding public health;
     Achieving cost savings;
     Improving access for rural communities; and
     Reducing burden.
    We believe that the Meaningful Measures Initiative will improve 
outcomes for patients, their families, and health care providers while 
reducing burden and costs for clinicians and providers and promoting 
operational efficiencies.
    In the quality performance category, clinicians have the 
flexibility to select and report the measures that matter most to their 
practice and patients. However, we have received feedback that some 
clinicians find the performance requirements confusing, and the program 
makes it difficult for them to choose measures that are meaningful to 
their practices and have more direct benefit to beneficiaries. For the 
2019 MIPS performance period, we are proposing the following updates: 
(1) Adding 10 new MIPS quality measures that include 4 patient reported 
outcome measures, 7 high priority measures, 1 measure that replaces an 
existing measure, and 2 other measures on important clinical topics in 
the Meaningful Measures framework; and (2) removing 34 quality 
measures.
    In addition to having the right measures, we want to ensure that 
the collection of information is valuable to clinicians and worth the 
cost and burden of collecting the information. In

[[Page 35882]]

section III.H.3.h.(2)(b)(iv) of this proposed rule, we are requesting 
comments on a tiered scoring system for quality measures where measures 
would be awarded points based on their value. We are also seeking 
comment on what patient reported outcome measures produce better 
outcomes and request accompanying supporting evidence that the measures 
do, in fact, improve outcomes.
Promoting Interoperability Performance Category
    As required by MACRA, the Quality Payment Program includes a MIPS 
performance category that focuses on meaningful use of certified EHR 
technology, referred to in the CY 2017 and CY 2018 Quality Payment 
Program rules as the ``advancing care information'' performance 
category. As part of our approach to promoting and prioritizing 
interoperability of healthcare data, in Quality Payment Program Year 2, 
we changed the name of the performance category to the Promoting 
Interoperability performance category.
    We have prioritized interoperability, which we define as health 
information technology that enables the secure exchange of electronic 
health information with, and use of electronic health information from, 
other health information technology without special effort on the part 
of the user; allows for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable law; and does not constitute information blocking as defined 
by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 
2016). We are committed to working with the Office of the National 
Coordinator for Health IT (ONC) on implementation of the 
interoperability provisions of the 21st Century Cures Act to have 
seamless but secure exchange of health information for clinicians and 
patients, ultimately enabling Medicare beneficiaries to get their 
claims information electronically. In addition, we are prioritizing 
quality measures and improvement activities that lead to 
interoperability.
    To further CMS' commitment to implementing interoperability, at the 
2018 Healthcare Information and Management Systems Society (HIMSS) 
conference, CMS Administrator Seema Verma announced the launching of 
the MyHealthEData initiative.\10\ This initiative aims to empower 
patients by ensuring that they control their healthcare data and can 
decide how their data is going to be used, all while keeping that 
information safe and secure. The overall government-wide initiative is 
led by the White House Office of American Innovation with participation 
from HHS--including its CMS, ONC, and the National Institutes of Health 
(NIH)--as well as the U.S. Department of Veterans Affairs (VA). 
MyHealthEData aims to break down the barriers that prevent patients 
from having electronic access and true control of their own health 
records from the device or application of their choice. This effort 
will approach the issue of healthcare data from the patient's 
perspective.
---------------------------------------------------------------------------

    \10\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-03-06.html.
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    For the Promoting Interoperability performance category, we require 
MIPS eligible clinicians to use 2015 Edition certified EHR technology 
beginning with the 2019 MIPS performance period to make it easier for:
     Patients to access their data.
     Patient information to be shared between doctors and other 
health care providers.
Continuing To Support Small and Rural Practices
    We understand that the Quality Payment Program is a big change for 
clinicians, especially for those in small and rural practices. We 
intend to continue to offer tailored flexibilities to help these 
clinicians to participate in the program. For example, we propose to 
retain a small practice bonus under MIPS by moving it to the quality 
performance category. We will also continue to support small and rural 
practices by offering free and customized resources available within 
local communities, including direct, one-on-one support from the Small, 
Underserved, and Rural Support Initiative along with our other no-cost 
technical assistance.
    Further, we note that we are proposing to amend our regulatory text 
to allow small practices to continue using the Medicare Part B claims 
collection type. We are also proposing to revise the regulatory text to 
allow a small practice to submit quality data for covered professional 
services through the Medicare Part B claims submission type for the 
quality performance category, as discussed further in section 
III.H.3.h. of this proposed rule. Finally, small practices may continue 
to choose to participate in MIPS as a virtual group, as discussed in 
section III.H.3. of this proposed rule.
Empowering Patients Through the Patients Over Paperwork Initiative
    Our Patients Over Paperwork initiative establishes an internal 
process to evaluate and streamline regulations with a goal to reduce 
unnecessary burden, to increase efficiencies, and to improve the 
beneficiary experience.\11\ This administration is dedicated to putting 
patients first, empowering consumers of healthcare to have the 
information they need to be engaged and active decision-makers in their 
care. As a result of this consumer empowerment, clinicians will gain 
competitive advantage by delivering coordinated, high-value quality 
care.
---------------------------------------------------------------------------

    \11\ Patients Over Paperwork web page available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.
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    The proposals for the Quality Payment Program in this proposed rule 
seek to promote competition and to empower patients. We are 
consistently listening, and we are committed to using data-driven 
insights, increasingly aligned and meaningful quality measures, and 
technology that empowers patients and clinicians to make decisions 
about their healthcare.
    In conjunction with development of the Patients Over Paperwork 
initiative, we are making progress toward developing a patient-centered 
portfolio of measures for the Quality Payment Program, including 7 new 
outcome measures included on the 2017 CMS Measures Under Consideration 
List,\12\ 5 of which are directly applicable to the prioritized 
specialties of general medicine/crosscutting and orthopedic surgery. 
Finally, on March 2, 2018, CMS announced a funding opportunity for $30 
million in grants to be awarded for quality measure development. The 
funding opportunity is aimed at external stakeholders with insight into 
clinician and patient perspectives on quality measurement and areas for 
improvement to advance quality measures for the Quality Payment 
Program.\13\
---------------------------------------------------------------------------

    \12\ Centers for Medicare & Medicaid Services. List of Measures 
Under Consideration for December 1, 2017. Baltimore, MD: US 
Department of Health and Human Services; 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/Measures-under-Consideration-Listfor2017.pdf. Accessed May 4, 2018.
    \13\ Centers for Medicare & Medicaid Services. Medicare Access 
and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: 
Measure Development for the Quality Payment Program. Baltimore, MD: 
US Department of Health and Human Services; 2018. https://blog.cms.gov/2018/03/02/medicare-access-and-chipreauthorization-act-of-2015-macra-funding-opportunity/. Accessed May 4, 2018.

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[[Page 35883]]

Promoting Price Transparency
    Through the Executive Order Promoting Healthcare Choice and 
Competition Across the United States (E.O. 13813, 82 FR 48385 (Oct. 12, 
2017)), the President prioritized changing the rate of growth of 
healthcare spending to foster competition in healthcare markets, 
resulting in the American people receiving better value for their 
investment in healthcare. To support these goals, we are helping 
patients control their health data and make it easier to take their 
data with them as they move in and out of the healthcare system. This 
will let patients make informed choices about their care, leading to 
more competition and lower costs.
b. Summary of the Major Provisions
(1) Quality Payment Program Year 3
    We believe the third year of the Quality Payment Program should 
build upon the foundation that has been established in the first 2 
years, which provides a trajectory for clinicians moving to a 
performance-based payment system. This trajectory provides clinicians 
the ability to participate in the program through two pathways: MIPS 
and Advanced APMs.
(2) Payment Adjustments
    As discussed in section VII.F.8. of this proposed rule, for the 
2021 MIPS payment year and based on Advanced APM participation during 
the 2019 MIPS performance period, we estimate that between 160,000 and 
215,000 clinicians will become Qualifying APM Participants (QP). As a 
QP, an eligible clinician is exempt from the MIPS reporting 
requirements and payment adjustment, and qualifies for a lump sum 
incentive payment based on 5 percent of their aggregate payment amounts 
for covered professional services for the prior year. We estimate that 
the total lump sum APM incentive payments will be approximately $600-
800 million for the 2021 Quality Payment Program payment year.
    For MIPS, we have posted a blog that provides preliminary 
participation information for the first year of MIPS.\14\ However, due 
to time constraints, we are unable to incorporate and analyze the 
performance and participation data from the first year of MIPS for the 
estimates in this proposed rule. Therefore, under the policies proposed 
in this proposed rule, we based our estimates for the 2019 MIPS 
performance period/2021 MIPS payment year on historical 2016 PQRS and 
Medicare and Medicaid EHR Incentive Program data. We estimate that 
approximately 650,000 clinicians would be MIPS eligible clinicians in 
the 2019 MIPS performance period. This number will depend on a number 
of factors, including the number of eligible clinicians excluded from 
MIPS based on their status as QPs or Partial QPs, the number that 
report as groups, and the number that elect to opt-in to MIPS. In the 
2021 MIPS payment year, MIPS payment adjustments, which only apply to 
covered professional services, will be applied based on MIPS eligible 
clinicians' performance on specified measures and activities within 
four integrated performance categories. We estimate that MIPS payment 
adjustments will be approximately equally distributed between negative 
MIPS payment adjustments ($372 million) and positive MIPS payment 
adjustments ($372 million) to MIPS eligible clinicians, as required by 
the statute to ensure budget neutrality. Positive MIPS payment 
adjustments will also include up to an additional $500 million for 
exceptional performance to MIPS eligible clinicians whose final score 
meets or exceeds the proposed additional performance threshold of 80 
points. However, the distribution will change based on the final 
population of MIPS eligible clinicians for the 2021 MIPS payment year 
and the distribution of final scores under the program. We anticipate 
that we will be able to update these estimates with the data from the 
first year of MIPS in the CY 2019 Quality Payment Program final rule.
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    \14\ https://blog.cms.gov/2018/05/31/quality-payment-program-exceeds-year-1-participation-goal/.
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2. Definitions
    At Sec.  414.1305, subpart O--
     We define the following terms:
    ++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
    ++ Collection type.
    ++ Health IT vendor.
    ++ MIPS determination period.
    ++ Submission type.
    ++ Submitter type.
    ++ Third party intermediary.
     We revise the definitions of the following terms:
    ++ High priority measure.
    ++ Hospital-based MIPS eligible clinician
    ++ Low-volume threshold.
    ++ MIPS eligible clinician.
    ++ Non-patient facing MIPS eligible clinician.
    ++ Qualified Clinical Data Registry (QCDR).
    ++ Qualifying APM Participant (QP).
    ++ Small practices.
    These terms and definitions are discussed in detail in relevant 
sections of this proposed rule.
3. MIPS Program Details
a. MIPS Eligible Clinicians
    Under Sec.  414.1305, a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, is 
defined as any of the following (excluding those identified at Sec.  
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a 
physician assistant, nurse practitioner, and clinical nurse specialist 
(as such terms are defined in section 1861(aa)(5) of the Act); a 
certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); and a group that includes such clinicians. 
Section 1848(q)(1)(C)(II) of the Act provides the Secretary with 
discretion, beginning with the 2021 MIPS payment year, to specify 
additional eligible clinicians (as defined in section 1848(k)(3)(B) of 
the Act) as MIPS eligible clinicians. Such clinicians may include 
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section 
1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in 
section 1861(gg)(2) of the Act); clinical social workers (as defined in 
section 1861(hh)(1) of the Act); clinical psychologists (as defined by 
the Secretary for purposes of section 1861(ii) of the Act); and 
registered dietitians or nutrition professionals.
    We received feedback from non-physician associations representing 
each type of additional eligible clinician through listening sessions 
and meetings with various stakeholder entities and through public 
comments discussed in the CY 2017 Quality Payment Program final rule 
(81 FR 77038). Commenters generally supported the specification of such 
clinicians as MIPS eligible clinicians beginning with the 2021 MIPS 
payment year.
    To assess whether these additional eligible clinicians could 
successfully participate in MIPS, we evaluated whether there would be 
sufficient measures and activities applicable and available for each of 
the additional eligible clinician types. We focused our analysis on the 
quality and improvement activities performance categories because these 
performance categories require submission of data. We did not focus on 
the Promoting Interoperability performance category because there is 
extensive analysis regarding who can participate under the current 
exclusion criteria. In addition,

[[Page 35884]]

in section III.H.3.i.(2)(b) of this proposed rule, we are proposing to 
automatically assign a zero percent weighting for the Promoting 
Interoperability performance category for these new types of MIPS 
eligible clinicians. In addition, we did not focus on the cost 
performance category because we are only able to assess cost 
performance for a subset of eligible clinicians--those who are 
currently eligible as a result of not meeting any of the current 
exclusion criteria. So the impact of the cost performance category for 
these additional eligible clinicians will continue to be considered but 
is currently not a decisive factor. From our analysis, we found that 
improvement activities would generally be applicable and available for 
each of the additional eligible clinician types. However, for the 
quality performance category, we found that not all of the additional 
eligible clinician types would have sufficient MIPS quality measures 
applicable and available. As discussed in section III.H.3.h.(2)(b)(iii) 
of this proposed rule, for the quality performance category, we are 
proposing to remove several MIPS quality measures. If those measures 
are finalized for removal, we anticipate that qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals would each have less 
than 6 MIPS quality measures applicable and available to them. However, 
if the quality measures are not finalized for removal, we will reassess 
whether these eligible clinicians would have an adequate amount of MIPS 
quality measures available to them. If we find that these additional 
clinicians do have at least 6 MIPS quality measures available to them, 
then we propose to include them in the MIPS eligible clinician 
definition. We are focusing on the quality performance category because 
as discussed above, the quality and improvement activities performance 
categories require submission of data. We believe there would generally 
be applicable and available improvement activities for each of the 
additional eligible clinician types, but that not all of the additional 
eligible clinician types would have sufficient MIPS quality measures 
applicable and available if the proposed MIPS quality measures are 
removed from the program. We did find QCDR measures approved for the CY 
2018 performance period that are either high priority and/or outcome 
measures that, if approved for the CY 2019 performance period, may be 
applicable to these additional eligible clinicians. However, this would 
necessitate that they utilize a QCDR in order to be successful in MIPS.
    Further, we have heard some concerns from the non-physician 
associations, through written correspondence, that since their 
clinicians would be joining the program 2 years after its inception, we 
should consider several ramp-up policies in order to facilitate an 
efficient integration of these clinicians into MIPS. We note that the 
MIPS program is still ramping up, and we will continue to increase the 
performance threshold to ensure a gradual and incremental transition to 
the performance threshold until Quality Payment Program Year 6. 
Therefore, if specified as MIPS eligible clinicians beginning with the 
2021 MIPS payment year, the additional eligible clinicians would have 4 
years in the program in order to ramp up. Conversely, if specified as 
MIPS eligible clinicians beginning in a future year, they would be 
afforded less time to ramp up the closer the program gets to Quality 
Payment Program Year 6.
    Therefore, we request comments on our proposal to amend Sec.  
414.1305 to modify the definition of a MIPS eligible clinician, as 
identified by a unique billing TIN and NPI combination used to assess 
performance, to mean any of the following (excluding those identified 
at Sec.  414.1310(b)): A physician (as defined in section 1861(r) of 
the Act); a physician assistant, nurse practitioner, and clinical nurse 
specialist (as such terms are defined in section 1861(aa)(5) of the 
Act); a certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a 
physical therapist, occupational therapist, clinical social worker (as 
defined in section 1861(hh)(1) of the Act), and clinical psychologist 
(as defined by the Secretary for purposes of section 1861(ii) of the 
Act); and a group that includes such clinicians. Alternatively, we 
propose that if the quality measures proposed for removal are not 
finalized, then we would include additional eligible clinician types in 
the definition of a MIPS eligible clinician beginning with the 2021 
MIPS payment year (specifically, qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals), provided that we 
determine that each applicable eligible clinician type would have at 
least 6 MIPS quality measures available to them. In addition, we are 
requesting comments on: (1) Specifying qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals as MIPS eligible 
clinicians beginning with the 2021 MIPS payment year; and (2) delaying 
the specification of one or more additional eligible clinician types as 
MIPS eligible clinicians until a future MIPS payment year.
b. MIPS Determination Period
    Currently, MIPS uses various determination periods to identify 
certain MIPS eligible clinicians for consideration for certain 
applicable policies. For example, the low-volume threshold, non-patient 
facing, small practice, hospital-based, and ambulatory surgical center 
(ASC)-based determinations are on the same timeline with slight 
differences in the claims run-out policies, whereas the facility-based 
determinations has a slightly different determination period. The 
virtual group eligibility determination requires a separate election 
process. We are proposing in this rule to add a virtual group 
eligibility determination period beginning in CY 2020 as discussed in 
section III.H.3.f.(2)(a) of this proposed rule. In addition, the rural 
and health professional shortage area (HPSA) determinations do not 
utilize a determination period.
    Under Sec.  414.1305, the low-volume threshold determination period 
is described as a 24-month assessment period consisting of an initial 
12-month segment that spans from the last 4 months of the calendar year 
2 years prior to the performance period through the first 8 months of 
the calendar year preceding the performance period, and a second 12-
month segment that spans from the last 4 months of the calendar year 1 
year prior to the performance period through the first 8 months of the 
calendar year performance period. An individual eligible clinician or 
group that is identified as not exceeding the low-volume threshold 
during the initial 12-month segment will continue to be excluded under 
Sec.  414.1310(b)(1)(iii) for the applicable year regardless of the 
results of the second 12-month segment analysis. For the 2020 MIPS 
payment year and future years, each segment of the low-volume threshold 
determination period includes a 30-day claims run out.
    Under Sec.  414.1305, the non-patient facing determination period 
is described as a 24-month assessment period consisting of an initial 
12-month segment that spans from the last 4 months of the calendar year 
2 years prior to the performance period through the first 8 months of 
the calendar year preceding the performance period and a second 12-
month segment that spans from the last 4 months of the calendar year 1 
year prior to the performance

[[Page 35885]]

period through the first 8 months of the calendar year performance 
period. An individual eligible MIPS clinician, group, or virtual group 
that is identified as non-patient facing during the initial 12-month 
segment will continue to be considered non-patient facing for the 
applicable year regardless of the results of the second 12-month 
segment analysis. For the 2020 MIPS payment year and future years, each 
segment of the non-patient facing determination period includes a 30-
day claims run out.
    In the CY 2018 Quality Payment Program final rule (82 FR 53581), we 
finalized that for the small practice size determination period, we 
would utilize a 12-month assessment period, which consists of an 
analysis of claims data that spans from the last 4 months of a calendar 
year 2 years prior to the performance period followed by the first 8 
months of the next calendar year and includes a 30-day claims run out.
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we finalized that to identify a MIPS eligible clinician 
as hospital-based we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53684 
through 53685), we finalized that to identify a MIPS eligible clinician 
as ASC-based, we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53760), we 
discussed, but did not finalize, our proposal or the alternative option 
for how an individual clinician or group would elect to use and be 
identified as using facility-based measurement for the MIPS program. 
Because we were not offering facility-based measurement until the 2019 
MIPS performance period, we did not need to finalize either of these 
for the 2018 MIPS performance period. However, in section 
III.H.3.i.(1)(d) of this proposed rule, we are proposing to amend Sec.  
414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be 
eligible for facility-based measurement. Specifically, that is, the 
clinician furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the place of 
service codes used in the HIPAA standard transaction as an inpatient 
hospital, on-campus outpatient hospital, or emergency room setting 
based on claims for a 12-month segment beginning on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
ending on September 30 of the calendar year preceding the applicable 
performance period with a 30-days claims run out. We are not proposing 
to utilize the MIPS determination period for purposes of the facility-
based determination because for the facility-based determination, we 
are only using the first segment of the MIPS determination period. We 
are using the first segment because the performance period for measures 
in the hospital value-based purchasing program overlapped in part with 
that determination period. If we were to use the second segment, we 
could not be assured that the clinician actually worked in the hospital 
on which their MIPS score would be based during that time. We believe 
this approach provides clarity and i