Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)

[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

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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

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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

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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

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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.

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(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

[[Page 35766]]

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,

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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

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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

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(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.

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(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]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.000

[[Page 35788]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.001

[[Page 35789]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.002

[[Page 35790]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.003

[[Page 35791]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.004

[[Page 35792]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.005

[[Page 35793]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.006

[[Page 35794]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.007

[[Page 35795]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.008

[[Page 35796]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.009

[[Page 35797]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.010

[[Page 35798]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.011

[[Page 35799]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.012

[[Page 35800]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.013

[[Page 35801]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.014

[[Page 35802]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.015

[[Page 35803]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.016

[[Page 35804]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.017

[[Page 35805]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.018

[[Page 35806]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.019

[[Page 35807]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.020

[[Page 35808]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.021

[[Page 35809]]

[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

[[Page 35814]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.027

[[Page 35815]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.028

[[Page 35816]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.029

[[Page 35817]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.030

[[Page 35818]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.031

[[Page 35819]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.032

[[Page 35820]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.033

[[Page 35821]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.034

[[Page 35822]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.035

[[Page 35823]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.036

[[Page 35824]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.037

[[Page 35825]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.038

[[Page 35826]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.039

[[Page 35827]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.040

[[Page 35828]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.041

[[Page 35829]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.042

[[Page 35830]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.043

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

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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.
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\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.
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\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 is a cleaner than providing a
special exception for the facility-based determination in the MIPS
determination period for the second segment. We refer readers to
section III.H.3.i.(1)(d) for further details on the facility-based
determinations and the time periods that are applicable to those
determinations.
In the CY 2018 Quality Payment Program final rule (82 FR 53602
through 53604), we finalized that for the virtual group eligibility
determination period, we would utilize an analysis of claims data
during an assessment period of up to 5 months that would begin on July
1 and end as late as November 30 of the calendar year prior to the
applicable performance period and include a 30-day claims run out. To
capture a real-time representation of TIN size, we finalized that we
would analyze up to 5 months of claims data on a rolling basis, in
which virtual group eligibility determinations for each TIN would be
updated and made available monthly. We noted that an eligibility
determination regarding TIN size is based on a relative point in time
within the 5-month virtual group eligibility determination period, and
not made at the end of such 5-month determination period. Beginning
with the 2019 performance period, we are proposing to amend Sec.
414.1315(c)(1) to establish a virtual group eligibility determination
period to align with the first segment of the MIPS determination
period, which includes an analysis of claims data during a 12-month
assessment period (fiscal year) that would begin on October 1 of the
calendar year 2 years prior to the applicable performance period and
end on September 30 of the calendar year preceding the applicable
performance period and include a 30-day claims run out. We refer
readers to section III.H.3.f.(2)(a) for further details on this
proposal.
In addition, we have established other special status
determinations, including rural area and HPSA. Rural area is defined at
Sec. 414.1305 as a ZIP code designated as rural, using the most recent
Health Resources and Services Administration (HRSA) Area Health
Resource File data set available. HPSAs are defined at Sec. 414.1305
as areas designated under section 332(a)(1)(A) of the Public Health
Service Act.
We understand that the current use of various MIPS determination
periods is complex and causes confusion. Therefore, beginning with the
2021 MIPS payment year, we propose to consolidate several of these
policies into a single MIPS determination period that would be used for
purposes of the low-volume threshold and to identify MIPS eligible
clinicians as non-patient facing, a small practice, hospital-based, and
ASC-based, as applicable. We are not proposing to include the facility-
based or virtual group eligibility determination periods or the rural
and HPSA determinations in the MIPS determination period, as they each
require a different process or timeline that does not align with the
other determination periods, or do not utilize determination periods.
We invite public comments on the possibility of incorporating these
determinations into the MIPS determination period in the future.
There are several reasons we believe a single MIPS determination
period for most of the eligibility criteria is the most appropriate.
First, it would simplify the program by aligning most of the MIPS
eligibility determination periods. Second, it would continue to allow
us to provide eligibility determinations as close to the beginning of
the performance period as feasible. Third, we believe a timeframe that
aligns with the fiscal year is easier to communicate and more
straightforward to understand compared to the current determination
periods. Finally, it would allow us to extend our data analysis an
additional 30 days.
It is important to note that during the final 3 months of the
calendar year in

[[Page 35886]]

which the performance period occurs, in general, we do not believe it
would be feasible for many MIPS eligible clinicians who join an
existing practice (existing TIN) or join a newly formed practice (new
TIN) to participate in MIPS as individuals. We refer readers to section
III.H.3.i.(2)(b) of this proposed rule for more information on the
proposed reweighting policies for MIPS eligible clinicians who join an
existing practice or who join a newly formed practice during this
timeframe.
We request comments on our proposal that beginning with the 2021
MIPS payment year, the MIPS determination period would be a 24-month
assessment period including a two-segment analysis of claims data
consisting of: (1) An initial 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; and (2) a second 12-month segment
beginning on October 1 of the calendar year preceding the applicable
performance period and ending on September 30 of the calendar year in
which the applicable performance period occurs. The first segment would
include a 30-day claims run out. The second segment would not include a
claims run out, but would include quarterly snapshots for informational
use only, if technically feasible. For example, a clinician could use
the quarterly snapshots to understand their eligibility status between
segments. Specifically, we believe the quarterly snapshots would be
helpful for new TIN/NPIs and TINs created between the first segment and
the second segment allowing them to see their preliminary eligibility
status sooner. Without the quarterly snapshots, these clinicians would
not have any indication of their eligibility status until just before
the submission period. An individual eligible clinician or group that
is identified as not exceeding the low-volume threshold, or a MIPS
eligible clinician that is identified as non-patient facing, a small
practice, hospital-based, or ASC-based, as applicable, during the first
segment would continue to be identified as such for the applicable MIPS
payment year regardless of the second segment. For example, for the
2021 MIPS payment year, the first segment would be October 1, 2017
through September 30, 2018, and the second segment would be October 1,
2018 through September 30, 2019. However, based on our experience with
the Quality Payment Program, we believe that some eligible clinicians,
whose TIN or TIN/NPIs are identified as eligible during the first
segment and do not exist in the second segment, are no longer utilizing
these same TIN or TIN/NPI combinations. Therefore, because those TIN or
TIN/NPIs would not exceed the low-volume threshold in the second
segment, they would no longer be eligible for MIPS. For example, in the
2019 performance period a clinician exceeded the low-volume threshold
during the first segment of the determination period (data from the end
of CY 2017 to early 2018) under one TIN; then in CY 2019 the clinician
switches practices under a new TIN and during segment two of the
determination period. Therefore, it is determined that the clinician is
not eligible (based on CY 2019 data) under either TIN. This clinician
would not be eligible to participate in MIPS based on either segment of
the determination period because the TIN that was assessed for the
first segment of the determination period no longer exists. So there
are no charges or services that would be available to assess in the
second segment for that TIN and the new TIN assessed during the second
segment was not eligible. In this scenario, though the clinician
exceeded the low-volume threshold criteria initially, the clinician is
not required to submit any data based on TIN eligibility
determinations. However, it is important to note that if a TIN or TIN/
NPI did not exist in the first segment but does exist in the second
segment, these eligible clinicians could be eligible for MIPS. For
example, the eligible clinician may not find their TIN or TIN/NPI in
the Quality Payment Program lookup tool but may still be eligible if
they exceed the low-volume threshold in the second segment. We proposed
to incorporate this policy into our proposed definition of MIPS
determination period at Sec. 414.1305. We also request comments on our
proposals to define MIPS determination period at Sec. 414.1305 and
modify the definitions of low-volume threshold, non-patient facing, a
small practice, hospital-based, and ASC-based at Sec. 414.1305 to
incorporate references to the MIPS determination period.
c. Low-Volume Threshold
(1) Overview
Section 1848(q)(1)(C)(iv) of the Act, as amended by section
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that,
for performance periods beginning on or after January 1, 2018, the low-
volume threshold selected by the Secretary may include one or more or a
combination of the following (as determined by the Secretary): (1) The
minimum number of part B-enrolled individuals who are furnished covered
professional services (as defined in section 1848(k)(3)(A) of the Act)
by the eligible clinician for the performance period involved; (2) the
minimum number of covered professional services furnished to part B-
enrolled individuals by such clinician for such performance period; and
(3) the minimum amount of allowed charges for covered professional
services billed by such clinician for such performance period.
Under Sec. 414.1310(b)(1)(iii), for a year, eligible clinicians
who do not exceed the low-volume threshold for the performance period
with respect to a year are excluded from MIPS. Under Sec. 414.1305,
the low-volume threshold is defined as, for the 2019 MIPS payment year,
the low-volume threshold that applies to an individual eligible
clinician or group that, during the low-volume threshold determination
period, has Medicare Part B allowed charges less than or equal to
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare
beneficiaries. In addition, for the 2020 MIPS payment year and future
years, the low-volume threshold is defined as the low-volume threshold
that applies to an individual eligible clinician or group that, during
the low-volume threshold determination period, has Medicare Part B
allowed charges less than or equal to $90,000 or provides care for 200
or fewer Part B-enrolled Medicare beneficiaries. The low-volume
threshold determination period is a 24-month assessment period
consisting of: (1) 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 (2) 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 2019 MIPS payment year, each segment of
the low-volume threshold determination period includes a 60-day claims
run out. For the 2020 MIPS payment year, each segment of the low-volume
threshold determination period includes a 30-day claims run out.

[[Page 35887]]

(2) Proposed Amendments To Comply With the Bipartisan Budget Act of
2018
In this proposed rule, we are proposing to amend Sec. 414.1305 to
modify the definition of low-volume threshold in accordance with
section 1848(q)(1)(C)(iv) of the Act, as amended by section
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018. Specifically,
we request comments on our proposals that for the 2020 MIPS payment
year, we will utilize the minimum number (200 patients) of Part B-
enrolled individuals who are furnished covered professional services by
the eligible clinician or group during the low-volume threshold
determination period or the minimum amount ($90,000) of allowed charges
for covered professional services to Part B-enrolled individuals by the
eligible clinician or group during the low-volume threshold
determination period.
(3) MIPS Program Details
We request comments on our proposal to modify Sec. 414.1310 to
specify in paragraph (a), Program Implementation, that except as
specified in paragraph (b), MIPS applies to payments for covered
professional services furnished by MIPS eligible clinicians on or after
January 1, 2019. We also request comments on our proposal to revise
Sec. 414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible
clinician does not include an eligible clinician that is a Partial
Qualifying APM Participant (as defined in Sec. 414.1305) and does not
elect, as discussed in section III.H.4.e. of this proposed rule, to
report on applicable measures and activities under MIPS. Finally, we
request comments on our proposal to revise Sec. 414.1310(d) to specify
that, in no case will a MIPS payment adjustment factor (or additional
MIPS payment adjustment factor) apply to payments for covered
professional services furnished during a year by eligible clinicians
(including those described in paragraphs (b) and (c) of this section)
who are not MIPS eligible clinicians, including those who voluntarily
report on applicable measures and activities under MIPS.
(4) Proposed Addition of Low-Volume Threshold Criterion Based on Number
of Covered Professional Services
In the CY 2018 Quality Payment Program final rule (82 FR 53591), we
received several comments in response to the proposed rule regarding
adding a third criterion of ``items and services'' for defining the
low-volume threshold. We refer readers to that rule for further
details.
For the 2021 MIPS payment year and future years, we are proposing
to add one additional criterion to the low-volume threshold
determination--the minimum number of covered professional services
furnished to Part B-enrolled individuals by the clinician.
Specifically, we request comments on our proposal, for the 2021 MIPS
payment year and future years, that eligible clinicians or groups who
meet at least one of the following three criteria during the MIPS
determination period would not exceed the low-volume threshold: (1)
Those who have allowed charges for covered professional services less
than or equal to $90,000; (2) those who provide covered professional
services to 200 or fewer Part B-enrolled individuals; or (3) those who
provide 200 or fewer covered professional services to Part B-enrolled
individuals.
For the third criterion, we are proposing to set the threshold at
200 or fewer covered professional services furnished to Part B-enrolled
individuals for several reasons. First, in the CY 2018 Quality Payment
Program final rule (82 FR 53589 through 53590), while we received
positive feedback from stakeholders on the increased low-volume
threshold, we also heard from some stakeholders that they would like to
participate in the program. Second, setting the third criterion at 200
or fewer covered professional services allows us to ensure that a
significant number of eligible clinicians have the ability to opt-in if
they wish to participate in MIPS. Finally, when we were considering
where to set the low-volume threshold for covered professional
services, we examined two options: 100 or 200 covered professional
services. For 100 covered professional services, there is some
historical precedent. In the CY 2017 Quality Payment Program final rule
(81 FR 77062), we finalized a low-volume threshold that excluded
individual eligible clinicians or groups that have Medicare Part B
allowed charges less than $30,000 or that provide care for 100 or fewer
Part B-enrolled Medicare beneficiaries; we believe the latter criterion
is comparable to 100 covered professional services. Conversely for 200
covered professional services, in the CY 2018 Quality Payment Program
final rule comment period (82 FR 53588), we discussed that based on our
data analysis, excluding individual eligible clinicians or groups that
have Medicare Part B allowed charges less than or equal to $90,000 or
that provide care for 200 or fewer Part B-enrolled Medicare
beneficiaries decreased the percentage of MIPS eligible clinicians that
come from small practices. In addition, in the CY 2018 Quality Payment
final rule (82 FR 53955), we codified at Sec. 414.1380(b)(1)(iv) a
minimum case requirements for quality measures are 20 cases which both
services threshold considerations (100 or 200) exceed and at Sec.
414.1380(b)(1)(v) a minimum case requirements for the all-cause
hospital readmission measure is 200 cases, which only the 200 services
threshold consideration exceeds. We believe that setting a threshold of
200 services for the third criterion strikes the appropriate balance
between allowing a significant number of eligible clinicians the
ability to opt-in (as described below) to MIPS and consistency with the
previously established low-volume threshold criteria. In section
VII.F.8.b. of this proposed rule, we estimate no additional clinicians
would be excluded if we add the third criterion because a clinician
that cares for at least 200 beneficiaries would have at least 100 or
200 services; however, we estimate 42,025 clinicians would opt-in with
the low-volume threshold at 200 services, as compared to 19,621
clinicians if we did not add the third criterion. If we set the third
criterion at 100 services, then we estimate 50,260 clinicians would
opt-in.
(5) Low-Volume Threshold Opt-In
In the CY 2018 Quality Payment Program final rule (82 FR 53589), we
proposed the option to opt-in to MIPS participation if clinicians might
otherwise be excluded under the low-volume threshold. We received
general support from comments received in the CY 2018 Quality Payment
Program final rule (82 FR 53589). However, we did not finalize the
proposal for the 2019 MIPS performance period. We were concerned that
we would not be able to operationalize this policy in a low-burden
manner to MIPS eligible clinicians as it was proposed.
After consideration of operational and user experience implications
of an opt-in policy, we are proposing an approach we believe can be
implemented in a way that provides the least burden to clinicians. We
are proposing to modify Sec. 414.1310(b)(1)(iii) to provide that
beginning with the 2021 MIPS payment year, if an eligible clinician or
group meets or exceeds at least one, but not all, of the low-volume
threshold determinations, including as defined by dollar amount (less
than or equal to $90,000) or number of beneficiaries (200 or fewer), or
number of covered professional services (200 or fewer), then such
eligible individual or group may choose to opt-in to MIPS.

[[Page 35888]]

This policy would apply to individual eligible clinicians and
groups who exceed at least one, but not all, of the low-volume
threshold criteria and would otherwise be excluded from MIPS
participation as a result of the low-volume threshold. We believe that
it would be beneficial to provide, to the extent feasible, such
individual eligible clinicians and groups with the ability to opt-in to
MIPS. Conversely, this policy would not apply to individual eligible
clinicians and groups who exceed all of the low-volume threshold
criteria, who unless otherwise excluded, are required to participate in
MIPS. In addition, this policy would not apply to individual eligible
clinicians and groups who do not exceed any of the low-volume threshold
criteria, who would be excluded from MIPS participation without the
ability to opt-in to MIPS. While we believe we are proposing the
appropriate balance for the low-volume threshold elements, we request
comments on other low-volume threshold criteria and supporting
justification for the recommended criteria.
Under the proposed policies, we estimate clinician eligibility
based on the following (we refer readers to the regulatory impact
analysis in section VII.F.8.b. of this proposed rule for further
details on our assumptions): (1) Eligible because they exceed all three
criteria of the low-volume threshold and are not otherwise excluded
(estimated 608,000 based on our assumptions of who did individual and
group reporting); (2) eligible because they exceed at least one, but
not all, of the low-volume threshold criteria and elect to opt-in
(estimated 42,000 for a total MIPS eligible clinician population of
approximately 650,000); (3) potentially eligible if they either did
group reporting or elected to opt-in \15\ (estimated 483,000); (4)
excluded because they do not exceed any of the low-volume threshold
criteria (estimated 88,000); and (5) excluded due to non-eligible
specialty, newly enrolled, or QP status (estimated 302,000).
---------------------------------------------------------------------------

\15\ A clinician may be in a group that we estimated would not
elect group reporting, however, the group would exceed the low-
volume threshold on all three criteria if the group elected group
reporting. Similarly, an individual or group may exceed at least one
but not all of the low-volume threshold criteria, but we estimated
the clinician or group would not elect to opt-in to MIPS. In both
cases, these clinicians could be eligible for MIPS if the group or
individual makes choices that differ from our assumptions.
---------------------------------------------------------------------------

We are proposing that applicable eligible clinicians who meet one
or two, but not all, of the criteria to opt-in and are interested in
participating in MIPS would be required to make a definitive choice to
either opt-in to participate in MIPS or choose to voluntarily report
before data submission. If they did not want to participate in MIPS,
they would not be required to do anything and would be excluded from
MIPS under the low-volume threshold. For those who did want to
participate in MIPS, we considered the option of allowing the
submission of data to signal that the clinician is choosing to
participate in MIPS. However, we anticipated that some clinicians who
utilize the quality data code (QDC) claims submission type may have
their systems coded to automatically append QDCs on claims for eligible
patients. We were concerned that they could submit a QDC code and
inadvertently opt-in when that was not their intention.
For individual eligible clinicians and groups to make an election
to opt-in or voluntarily report to MIPS, they would make an election
via the Quality Payment Program portal by logging into their account
and simply selecting either the option to opt-in (positive, neutral, or
negative MIPS adjustment) or to remain excluded and voluntarily report
(no MIPS adjustment). Once the eligible clinician has elected to
participate in MIPS, the decision to opt-in to MIPS would be
irrevocable and could not be changed for the applicable performance
period. Clinicians who opt-in would be subject to the MIPS payment
adjustment during the applicable MIPS payment year. Clinicians who do
not decide to opt-in to MIPS would remain excluded and may choose to
voluntarily report. Such clinicians would not receive a MIPS payment
adjustment factor. To assist commenters in providing pertinent
comments, we have developed a website that provides design examples of
the different approaches to MIPS participation in CY 2019. The website
uses wireframe (schematic) drawings to illustrate the three different
approaches to MIPS participation: Voluntary reporting to MIPS, opt-in
reporting to MIPS, and required to participate in MIPS. We refer
readers to the Quality Payment Program at qpp.cms.gov/design-examples
to review these wireframe drawings. The website will provide specific
matrices illustrating potential stakeholder experiences when opting-in
or voluntarily reporting.
It should be noted that the option to opt-in to participate in the
MIPS as a result of an individual eligible clinician or group exceeding
at least one, but not all, of the low-volume threshold elements differs
from the option to voluntarily report to the MIPS as established at
Sec. 414.1310(b)(2) and (d). Individual eligible clinicians and groups
opting-in to participate in MIPS would be considered MIPS eligible
clinicians, and therefore subject to the MIPS payment adjustment
factor; whereas, individual eligible clinicians and groups voluntarily
reporting measures and activities for the MIPS are not considered MIPS
eligible clinicians, and therefore not subject to the MIPS payment
adjustment factor. MIPS eligible clinicians and groups that made an
election to opt-in would be able to participate in MIPS at the
individual, group, or virtual group level for that performance period.
Eligible clinicians and groups that are excluded from MIPS, but
voluntarily report, are able to report measures and activities at the
individual or group level; however, such eligible clinicians and groups
are not able to voluntarily report for MIPS at the virtual group level.
In Table 28, we are providing possible scenarios regarding which
eligible clinicians may be able to opt-in to MIPS depending upon their
beneficiary count, dollars, and covered professional services if the
proposed opt-in policy was finalized.

Table 28--Low-Volume Threshold Determination Opt-In Scenarios
--------------------------------------------------------------------------------------------------------------------------------------------------------
Covered professional
Beneficiaries Dollars services Eligible for opt-in
--------------------------------------------------------------------------------------------------------------------------------------------------------
<=200................... <=90K................... <=200.................. Excluded not eligible to Opt-in.
<=200................... <=90K................... >200................... Eligible to Opt-in, Voluntarily Report, or Not Participate.
<=200................... >90K.................... <=200.................. Eligible to Opt-in, Voluntarily Report, or Not Participate.
>200.................... <=90K................... >200................... Eligible to Opt-in, Voluntarily Report, or Not Participate.
>200.................... >90K.................... >200................... Not eligible to Opt-in, Required to Participate.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 35889]]

We recognize that the low-volume threshold opt-in option may expand
MIPS participation at the individual, group, and virtual group levels.
For solo practitioners and groups with 10 or fewer eligible clinicians
(including at least one MIPS eligible clinician) that exceed at least
one, but not all, of the elements of the low-volume threshold and are
interested in participating in MIPS via the opt-in and doing so as part
of a virtual group, such solo practitioners and groups would need to
make an election to opt-in to participate in the MIPS. Therefore,
beginning with the 2021 MIPS payment year, we are proposing that a
virtual group election would constitute a low-volume threshold opt-in
for any prospective member of the virtual group (solo practitioner or
group) that exceeds at least one, but not all, of the low-volume
threshold criteria. As a result of the virtual group election, any such
solo practitioner or group would be treated as a MIPS eligible
clinician for the applicable MIPS payment year.
During the virtual group election process, the official virtual
group representative of a virtual group submits an election to
participate in the MIPS as a virtual group to CMS prior to the start of
a performance period (82 FR 53601 through 53604). The submission of a
virtual group election includes TIN and NPI information, which is the
identification of TINs composing the virtual group and each member of
the virtual group. As part of a virtual group election, the virtual
group representative is required to confirm through acknowledgement
that a formal written agreement is in place between each member of the
virtual group (82 FR 53604). A virtual group may not include a solo
practitioner or group as part of a virtual group unless an authorized
person of the TIN has executed a formal written agreement.
For a solo practitioner or group that exceeds only one or two
elements of the low-volume threshold, an election to opt-in to
participate in the MIPS as part of a virtual group would be represented
by being identified as a TIN that is included in the submission of a
virtual group election. Such solo practitioners and groups opting-in to
participate in the MIPS as part of a virtual group would not need to
independently make a separate election to opt-in to participate in the
MIPS. It should be noted that being identified as a TIN in a submitted
virtual group election, any such TIN (represented as a solo
practitioner or group) that exceeds at least one, but not all, of the
low-volume threshold elements during the MIPS determination period is
signifying an election to opt-in to participate in MIPS as part of a
virtual group and recognizing that a MIPS payment adjustment factor
would be applied to any such TIN based on the final score of the
virtual group. For a virtual group election that includes a TIN
determined to exceed at least one, but not all, of the low-volume
threshold elements during the MIPS determination period, such election
would have a precedence over the eligibility determination made during
the MIPS determination period pertaining to the low-volume threshold
and as a result, any such TIN would be considered MIPS eligible and
subject to a MIPS payment adjustment factor due the virtual group
election. Furthermore, we note that a virtual group election would
constitute an election to opt-in to participate in MIPS and any low-
volume threshold determinations that result from segment 2 data
analysis of the MIPS determination period would not have any bearing on
the virtual group election. Thus, a TIN included as part of a virtual
group election that submitted prior to the start of the applicable
performance period and does not exceed at least one element of the low-
volume threshold during segment 2 of the MIPS determination period,
such TIN would be considered MIPS eligible and a virtual group
participant by virtue of the virtual group's election to participate in
MIPS as a virtual group that was made prior to the applicable
performance period. For virtual groups with a composition that may only
consist of solo practitioners and groups that exceed at least one, but
not all of the low-volume threshold elements, such virtual groups are
encouraged to form a virtual group that would include a sufficient
number of TINs to ensure that such virtual groups are able to meet
program requirements such as case minimum criteria that would allow
measures to be scored. For example, if a virtual group does not have a
sufficient number of cases to report for quality measures (minimum of
20 cases per episode-based measures), a virtual group would not be
scored on such measures (81 FR 77175).
We further note that for APM Entities in MIPS APMs, which meet one
or two, but not all, of the low-volume threshold elements to opt-in and
are interested in participating in MIPS under the APM scoring standard,
would be required to make a definitive choice at the APM Entity level
to opt-in to participate in MIPS. For such APM Entities to make an
election to opt-in to MIPS, they would make an election via a similar
process that individual eligible clinicians and groups will use to make
an election to opt-in. Once the APM Entity has elected to participate
in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be
changed for the performance period in which the data was submitted.
Eligible clinicians in APM Entities in MIPS APMs that opt-in would be
subject to the MIPS payment adjustment factor. APM Entities in MIPS
APMs that do not decided to opt-in to MIPS cannot voluntarily report.
Additionally, we are proposing for applicable eligible clinicians
participating in a MIPS APM, whose APM Entity meets one or two, but not
all, of the low-volume threshold elements rendering the option to opt-
in and does not decide to opt-in to MIPS, that if their TIN or virtual
group does elect to opt-in, it does not mean that the eligible
clinician is opting-in on his/her own behalf, or on behalf of the APM
Entity, but that the eligible clinician is still excluded from MIPS
participation as part of the APM Entity even though such eligible
clinician is part of a TIN or virtual group. This is necessary because
low-volume threshold determinations are currently conducted at the APM
Entity level for all applicable eligible clinicians in MIPS APMs, and
therefore, the low-volume threshold opt-in option should similarly be
executed at the APM Entity level rather than at the individual eligible
clinician, TIN, or virtual group level. Thus, in order for an APM
Entity to opt-in to participate in MIPS at the APM Entity level and for
eligible clinicians within such APM Entity to be subject to the MIPS
payment adjustment factor, an election would need to be made at the APM
Entity level in a similar process that individual eligible clinicians
and groups would use to make an election to opt-in to participate in
MIPS.
We request comments on our proposals: (1) To modify Sec. 414.1305
for the low-volume threshold definition at (3) to specify that,
beginning with the 2021 MIPS payment year, the low-volume threshold
that applies to an individual eligible clinician or group that, during
the MIPS determination period, has allowed charges for covered
professional services less than or equal to $90,000, furnishes covered
professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals; (2) that a clinician who is
eligible to opt-in would be required to make an affirmative election to
opt-in to participate in MIPS, elect to be a voluntary reporter, or by
not submitting any data the clinician is choosing to not report; and
(3) to modify

[[Page 35890]]

Sec. 414.1310(b)(1)(iii) under Applicability to specify exclusions as
follows: Beginning with the 2021 MIPS payment year, if an individual
eligible clinician, group, or APM Entity group in a MIPS APM exceeds at
least one, but not all, of the low-volume threshold criteria and elects
to report on applicable measures and activities under MIPS, the
individual eligible clinician, group, or APM Entity group is treated as
a MIPS eligible clinician for the applicable MIPS payment year. For APM
Entity groups in MIPS APMs, only the APM Entity group election can
result in the APM Entity group being treated as MIPS eligible
clinicians for the applicable payment year.
(6) Part B Services Subject to MIPS Payment Adjustment
Section 1848(q)(6)(E) of the Act, as amended by section
51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the
MIPS adjustment factor and, as applicable, the additional MIPS
adjustment factor, apply to the amount otherwise paid under Part B with
respect to covered professional services (as defined in subsection
(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a
year (beginning with 2019) and with respect to the MIPS eligible
clinician for such year.
In this proposed rule, we are requesting comments on our proposal
to amend Sec. 414.1405(e) to modify the application of both the MIPS
adjustment factor and, if applicable, the additional MIPS adjustment
factor so that beginning with the 2019 MIPS payment year, these
adjustment factors will apply to Part B payments for covered
professional services (as defined in section 1848(k)(3)(A) of the Act)
furnished by the MIPS eligible clinician during the year. We are making
this change beginning with the first MIPS payment year and note that
these adjustment factors will not apply to Part B drugs and other items
furnished by a MIPS eligible clinician, but will apply to covered
professional services furnished by a MIPS eligible clinician. We refer
readers to section III.H.3.j. of this proposed rule for further details
on this modification.
d. Partial QPs
(1) Partial QP Elections Within Virtual Groups
In the CY 2017 Quality Payment Program final rule, we finalized
that following a determination that eligible clinicians in an APM
Entity group in an Advanced APM are Partial QPs for a year, the APM
Entity will make an election whether to report on applicable measures
and activities as required under MIPS. If the APM Entity elects to
report to MIPS, all eligible clinicians in the APM Entity would be
subject to the MIPS reporting requirements and payment adjustments for
the relevant year. If the APM Entity elects not to report, all eligible
clinicians in the APM Entity group will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year
(81 FR 77449).
We also finalized that in cases where the Partial QP determination
is made at the individual eligible clinician level, if the individual
eligible clinician is determined to be a Partial QP, the eligible
clinician will make the election whether to report on applicable
measures and activities as required under MIPS and, as a result, be
subject to the MIPS reporting requirements and payment adjustments (81
FR 77449). If the individual eligible clinician elects to report to
MIPS, he or she would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the individual eligible
elects not to report to MIPS, he or she will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year.
We also clarified how we consider the absence of an explicit election
to report to MIPS or to be excluded from MIPS. We finalized that for
situations in which the APM Entity is responsible for making the
decision on behalf of all eligible clinicians in the APM Entity group,
the group of Partial QPs will not be considered MIPS eligible
clinicians unless the APM Entity opts the group into MIPS
participation, so that no actions other than the APM Entity's election
for the group to participate in MIPS would result in MIPS participation
(81 FR 77449). For eligible clinicians who are determined to be Partial
QPs individually, we finalized that we will use the eligible
clinician's actual MIPS reporting activity to determine whether to
exclude the Partial QP from MIPS in the absence of an explicit
election. Therefore, if an eligible clinician who is individually
determined to be a Partial QP submits information to MIPS (not
including information automatically populated or calculated by CMS on
the Partial QP's behalf), we will consider the Partial QP to have
reported, and thus to be participating in MIPS. Likewise, if such an
individual does not take any action to submit information to MIPS, we
will consider the Partial QP to have elected to be excluded from MIPS
(81 FR 77449).
In the CY 2018 Quality Payment Program final rule, we clarified
that in the case of an eligible clinician participating in both a
virtual group and an Advanced APM who has achieved Partial QP status,
that the eligible clinician would be excluded from the MIPS payment
adjustment unless the eligible clinician elects to report under MIPS
(82 FR 53615). However, we incorrectly stated that affirmatively
agreeing to participate in MIPS as part of a virtual group prior to the
start of the applicable performance period would constitute an explicit
election to report under MIPS for all Partial QPs. As such, we also
incorrectly stated that all eligible clinicians who participate in a
virtual group and achieve Partial QP status would remain subject to the
MIPS payment adjustment due to their virtual group election to report
under MIPS, regardless of their Partial QP election. We note that an
election made prior to the start of an applicable performance period to
participate in MIPS as part of a virtual group is separate from an
election made during the performance period that is warranted as a
result of an individual eligible clinician or APM Entity achieving
Partial QP status during the applicable performance period. A virtual
group election does not equate to an individual eligible clinician or
APM Entity with a Partial QP status explicitly electing to participate
in MIPS. In order for an individual eligible clinician or APM Entity
with a Partial QP status to explicitly elect to participate in MIPS and
be subject to the MIPS payment adjustment factor, such individual
eligible clinician or APM Entity would make such election during the
applicable performance period as a Partial QP status becomes applicable
and such option for election is warranted. Thus, we are restating that
affirmatively agreeing to participate in MIPS as part of a virtual
group prior to the start of the applicable performance period does not
constitute an explicit election to report under MIPS as it pertains to
making an explicit election to either report to MIPS or be excluded
from MIPS for individual eligible clinicians or APM Entities that have
Partial QP status.
Related to this clarification, we have proposed in section
III.H.4.e.(3) of this proposed rule to clarify that beginning with the
2021 MIPS payment year, when an eligible clinician is determined to be
a Partial QP for a year at the individual eligible clinician level, the
individual eligible clinician will make an election whether to report
to MIPS. If the eligible clinician elects to report

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to MIPS, he or she will be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician elects to not report to
MIPS, he or she will not be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician does not make any
affirmatively election to report to MIPS, he or she will not be subject
to MIPS reporting requirements and payment adjustments. As a result,
beginning with the 2021 MIPS payment year, for eligible clinicians who
are determined to be Partial QPs individually, we will not use the
eligible clinician's actual MIPS reporting activity to determine
whether to exclude the Partial QP from MIPS in the absence of an
explicit election.
Therefore, the proposed policy in section III.H.4.e.(3) of this
proposed rule eliminates the scenario in which affirmatively agreeing
to participate in MIPS as part of a virtual group prior to the start of
the applicable performance period would constitute an explicit election
to report under MIPS for eligible clinicians who are determined to be
Partial QPs individually and make no explicit election to either report
to MIPS or be excluded from MIPS. We believe this change is necessary
because QP status and Partial QP status, achieved at the APM Entity
level or eligible clinician level, is applied to an individual and all
of his or her TIN/NPI combinations, whereas virtual group participation
is determined at the TIN level. Therefore, we do not believe that it is
appropriate that the actions of the TIN in joining the virtual group
should deprive the eligible clinician who is a Partial QP, whether that
status was achieved at APM Entity level or eligible clinician level, of
the opportunity to elect whether or not to opt-in to MIPS.
e. Group Reporting
We refer readers to Sec. 414.1310(e) and the CY 2018 Quality
Payment Program final rule (82 FR 53592 through 53593) for a
description of our previously established policies regarding group
reporting.
In the CY 2018 Quality Payment Program final rule (82 FR 53593), we
clarified that we consider a group to be either an entire single TIN or
portion of a TIN that: (1) Is participating in MIPS according to the
generally applicable scoring criteria while the remaining portion of
the TIN is participating in a MIPS APM or an Advanced APM according to
the MIPS APM scoring standard; and (2) chooses to participate in MIPS
at the group level. We would like to further clarify that we consider a
group to be an entire single TIN that chooses to participate in MIPS at
the group level. However, individual eligible clinicians (TIN/NPIs)
within that group may receive a MIPS payment adjustment based on the
APM scoring standard if they are on the participant list of a MIPS APM.
We are proposing to amend Sec. Sec. 414.1310(e) and 414.1370(f)(2) to
codify this policy and more fully reflect the scoring hierarchy as
discussed in section III.H.3.h.(6) of this proposed rule.
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53593), one of the overarching themes we have heard from
stakeholders is that we make an option available to groups that would
allow a portion of a group to report as a separate sub-group on
measures and activities that are more applicable to the sub-group and
be assessed and scored accordingly based on the performance of the sub-
group. We stated that in future rulemaking, we intend to explore the
feasibility of establishing group-related policies that would permit
participation in MIPS at a sub-group level and create such
functionality through a new identifier. In the CY 2018 Quality Payment
Program proposed rule (82 FR 30027), we solicited public comments on
the ways in which participation in MIPS at the sub-group level could be
established. In addition, in the CY 2018 Quality Payment Program final
rule (82 FR 53593), we sought comment on additional ways to define a
group, not solely based on a TIN. Because there are several operational
challenges with implementing a sub-group option, we are not proposing
any such changes to our established reporting policies in this proposed
rule. Rather, we are considering facilitating the use of a sub-group
identifier in the Quality Payment Program Year 4 through future
rulemaking, as necessary. In addition, it has come to our attention
that providing a sub-group option may provide potential gaming
opportunities. For example, a group could manipulate scoring by
creating sub-groups that are comprised of only the high performing
clinicians in the group. Therefore, we are requesting comment on
implementing sub-group level reporting through a separate sub-group
sub-identifier in the Quality Payment Program Year 4 and possibly
future years of the program. We are specifically requesting comments on
the following: (1) Whether and how a sub-group should be treated as a
separate group from the primary group: For example, if there is 1 sub-
group within a group, how would we assess eligibility, performance,
scoring, and application of the MIPS payment adjustment at the sub-
group level; (2) whether all of the sub-group's MIPS performance data
should be aggregated with that of the primary group or should be
treated as a distinct entity for determining the sub-group's final
score, MIPS payment adjustments, and public reporting, and eligibility
be determined at the whole group level; (3) possible low burden
solutions for identification of sub-groups: For example, whether we
should require registration similar to the CMS Web Interface or a
similar mechanism to the low-volume threshold opt-in that we are
proposing in section III.H.3.c.(5) of this proposed rule; and (4) and
potential issues or solutions needed for sub-groups utilizing
submission mechanisms, measures, or activities, such as APM
participation, that are different than the primary group. We also
welcome comments on other approaches for sub-group reporting that we
should consider.
f. Virtual Groups
(1) Background
We refer readers to Sec. 414.1315 and the CY 2018 Quality Payment
Program final rule (82 FR 53593 through 53617) for our previously
established policies regarding virtual groups.
(2) Virtual Group Election Process
We refer readers to Sec. 414.1315(c) and the CY 2018 Quality
Payment Program final rule (82 FR 53601 through 53604) for our
previously established policies regarding the virtual group election
process.
We are proposing to amend Sec. 414.1315(c) to continue to apply
the previously established policies regarding the virtual group
election process for the 2022 MIPS payment year and future years, with
the exception of the proposed policy modification discussed below.
Under Sec. 414.1315(c)(2)(ii), an official designated virtual
group representative must submit an election on behalf of the virtual
group by December 31 of the calendar year prior to the start of the
applicable performance period. In the CY 2018 Quality Payment Program
final rule (82 FR 53603), we stated that such election will occur via
email to the Quality Payment Program Service Center using the following
email address for the 2018 and 2019 performance periods:
MIPS_VirtualGroups@cms.hhs.gov. Beginning with the 2022 MIPS payment
year, we propose to amend Sec. 414.1315(c)(2)(ii) to provide that the
election would occur in a manner specified by CMS. We anticipate that a
virtual group representative would make an election

[[Page 35892]]

on behalf of a virtual group by registering to participate in MIPS as a
virtual group via a web-based system developed by CMS. We believe that
a web-based system would be less burdensome for virtual groups given
that the interactions stakeholders would have with the Quality Payment
Program are already conducted via the Quality Payment Program portal,
and would provide stakeholders with a seamless user experience.
Stakeholders would be able to make a virtual group election in a
similar manner to all other interactions with the Quality Payment
Program portal and would no longer need to separately identify the
appropriate email address to submit such an election and email an
election outside of the Quality Payment Program portal. The Quality
Payment Program portal is the gateway and source for interaction with
MIPS that contains a range of information on topics including
eligibility, data submission, and performance reports. We believe that
using the same web-based platform to make a virtual group election
would enhance the one-stop MIPS interactive experience and eliminate
the potential for stakeholders to be unable to identify or erroneously
enter the email address.
We solicit public comment on this proposal, which would provide for
an election to occur in a manner specified by CMS such as a web-based
system developed by CMS.
(a) Virtual Group Eligibility Determinations
For purposes of determining TIN size for virtual group
participation eligibility for the CY 2018 and 2019 performance periods,
we coined the term ``virtual group eligibility determination period''
and defined it to mean an analysis of claims data during an assessment
period of up to 5 months that would begin on July 1 and end as late as
November 30 of the calendar year prior to the applicable performance
period and includes a 30-day claims run out (82 FR 53602). We are
proposing to modify the virtual group eligibility determination period
beginning with the 2019 performance period. We propose to amend Sec.
414.1315(c)(1) to establish a virtual group eligibility determination
period to mean an analysis of claims data during a 12-month assessment
period (fiscal year) that would begin on October 1 of the calendar year
2 years prior to the applicable performance period and end on September
30 of the calendar year preceding the applicable performance period and
include a 30-day claims run out. The virtual group eligibility
determination period aligns with the first segment of data analysis
under the MIPS eligibility determination period. As part of the virtual
group eligibility determination period, TINs would be able to inquire
about their TIN size prior to making an election during a 5-month
timeframe, which would begin on August 1 and end on December 31 of a
calendar year prior to the applicable performance period. TIN size
inquiries would be made through the Quality Payment Program Service
Center. For TINs that inquire about their TIN size during such 5-month
timeframe, it should be noted that any TIN size information provided is
only for informational purposes and may be subject to change; official
eligibility regarding TIN size and all other eligibility pertaining to
virtual groups would be determined in accordance with the MIPS
determination period and other applicable special status eligibility
determination periods. The proposed modification would provide
stakeholders with real-time information regarding TIN size for
informational purposes instead of TIN size eligibility determinations
on an ongoing basis (between July 1 and November 30 of the calendar
year prior to the applicable performance period) due to technical
limitations.
For the 2018 and 2019 performance periods, TINs could determine
their status by contacting their designated TA representative as
provided at Sec. 414.1315(c)(1); otherwise, the TIN's status would be
determined at the time that the TIN's virtual group election is
submitted. We propose to amend Sec. 414.1315(c)(1) to remove this
provision since the inquiry about TIN size would be for informational
purposes only and may be subject to change.
We believe that the utilization of the Quality Payment Program
Service Center, versus the utilization of designated TA
representatives, as the means for stakeholders to obtain information
regarding TIN size provides continuity and a seamless experience for
stakeholders. We note that the TA resources already available to
stakeholders would continue to be available. The following describes
the experience a stakeholder would encounter when interacting with the
Quality Payment Program Service Center to obtain information pertaining
to TIN size. For example, the applicable performance period for the
2022 MIPS payment year would be CY 2020. If a group contacted the
Quality Payment Program Service Center on September 20, 2019, the
claims data analysis would include the months of October of 2018
through August of 2019. If another group contacted the Quality Payment
Program Service Center on November 20, 2019, the claims data analysis
would include the months of October of 2018 through September of 2019
with a 30-day claims run out.
We believe this virtual group eligibility determination period
provides a real-time representation of TIN size for purposes of
determining virtual group eligibility and allows solo practitioners and
groups to know their real-time virtual group eligibility status and
plan accordingly for virtual group implementation. Beginning with the
2022 MIPS payment year, it is anticipated that starting in August of
each calendar year prior to the applicable performance period, solo
practitioners and groups would be able to contact the Quality Payment
Program Service Center and inquire about their TIN size. TIN size
determinations would be based on the number of NPIs associated with a
TIN, which may include clinicians (NPIs) who do not meet the definition
of a MIPS eligible clinician at Sec. 414.1305 or who are excluded from
MIPS under Sec. 414.1310(b) or (c).
We are proposing to continue to apply the aforementioned previously
established virtual group policies for the 2022 MIPS payment year and
future years, with the exception of the following proposed policy
modifications:
The virtual group eligibility determination period would
align with the first segment of the MIPS determination period, which
includes an analysis of claims data during a 12-month assessment period
(fiscal year) that would begin on October 1 of the calendar year 2
years prior to the applicable performance period and end on September
30 of the calendar year preceding the applicable performance period and
include a 30-day claims run out. As part of the virtual group
eligibility determination period, TINs would be able to inquire about
their TIN size prior to making an election during a 5-month timeframe,
which would begin on August 1 and end on December 31 of a calendar year
prior to the applicable performance period.
MIPS eligible clinicians would be able to contact their
designated technical assistance representative or, beginning with the
2022 MIPS payment year, the Quality Payment Program Service Center, as
applicable, to inquire about their TIN size for informational purposes
in order to assist MIPS eligible clinicians in determining whether or
not to participate in MIPS as part of a virtual group. We anticipate
that starting in August of each calendar year prior to

[[Page 35893]]

the applicable performance period, solo practitioners and groups would
be able to contact the Quality Payment Program Service Center and
inquire about virtual group participation eligibility.
A virtual group representative would make an election on
behalf of a virtual group by registering to participate in MIPS as a
virtual group in a form and manner specified by CMS. We anticipate that
a virtual group representative would make the election via a web-based
system developed by CMS.
We are also proposing updates to Sec. 414.1315 in an effort to
more clearly and concisely capture previously established policies.
These proposed updates are not intended to be substantive in nature,
but rather to bring more clarity to the regulatory text.
g. MIPS Performance Period
In the CY 2018 Quality Payment Program final rule (82 FR 53617
through 53619), we finalized at Sec. 414.1320(c)(1) that for purposes
of the 2021 MIPS payment year, the performance period for the quality
and cost performance categories is CY 2019 (January 1, 2019 through
December 31, 2019). We did not finalize the performance period for the
quality and cost performance categories for purposes of the 2022 MIPS
payment year or future years. We also redesignated Sec. 414.1320(d)(1)
and finalized at Sec. 414.1320(c)(2) that for purposes of the 2021
MIPS payment year, the performance period for the Promoting
Interoperability and improvement activities performance categories is a
minimum of a continuous 90-day period within CY 2019, up to and
including the full CY 2019 (January 1, 2019 through December 31, 2019).
As noted in the CY 2018 Quality Payment Program final rule, we
received comments that were not supportive of a full calendar year
performance period for the quality and cost performance categories.
However, we continue to believe that a full calendar year performance
period for the quality and cost performance categories will be less
confusing for MIPS eligible clinicians. Further, a longer performance
period for the quality and cost performance categories will likely
include more patient encounters, which will increase the denominator of
the quality and cost measures. Statistically, larger sample sizes
provide more accurate and actionable information. Additionally, a full
calendar year performance period is consistent with how many of the
measures used in our program were designed to be performed and
reported. We also note that the Bipartisan Budget Act of 2018 (Pub. L.
115-119, enacted on February 9, 2018) has provided further flexibility
to the third, fourth, and fifth years to which MIPS applies to help
continue the gradual transition to MIPS.
Regarding the Promoting Interoperability performance category, we
have heard from stakeholders through public comments, letters, and
listening sessions that they oppose a full year performance period,
indicating that it is very challenging and may add administrative
burdens. Some stated that a 90-day performance period is necessary in
order to enable clinicians to have a greater focus on the objectives
and measures that promote patient safety, support clinical
effectiveness, and drive toward advanced use of health IT. They also
noted that as this category requires the use of CEHRT, a 90-day
performance period will help relieve pressure on clinicians to quickly
implement changes and updates from their CEHRT vendors and developers
so that patient care is not compromised. Others cited the challenges
associated with reporting on a full calendar year for clinicians newly
employed by a health system or practice during the course of a program
year, switching CEHRT, vendor issues, system downtime, cyber-attacks,
difficulty getting data from old places of employment, and office
relocation. Most stakeholders stated that the performance period should
be 90 days in perpetuity, as this would greatly reduce the reporting
burden.
In an effort to provide as much transparency as possible so that
MIPS eligible clinicians and groups can plan for participation in the
program, we request comments on our proposals at Sec. 414.1320(d)(1)
that for purposes of the 2022 MIPS payment year and future years, the
performance period for the quality and cost performance categories
would be the full calendar year (January 1 through December 31) that
occurs 2 years prior to the applicable MIPS payment year. For example,
for the 2022 MIPS payment year, the performance period would be 2020
(January 1, 2020 through December 31, 2020), and for the 2023 MIPS
payment year, the performance period would be CY 2021 (January 1, 2021
through December 31, 2021).
We request comments on our proposal at Sec. 414.1320(d)(2) that
for purposes of the 2022 MIPS payment year and future years, the
performance period for the improvement activities performance category
would be a minimum of a continuous 90-day period within the calendar
year that occurs 2 years prior to the applicable MIPS payment year, up
to and including the full calendar year. For example, for the 2022 MIPS
payment year, the performance period for the improvement activities
performance category would be a minimum of a continuous 90-day period
within CY 2020, up to and including the full CY 2020 (January 1, 2020
through December 31, 2020). For the 2023 MIPS payment year, the
performance period for the improvement activities performance category
would be a minimum of a continuous 90-day period within CY 2021, up to
and including the full CY 2021 (January 1, 2021 through December 31,
2021) that occurs 2 years before the MIPS payment year.
In addition, we request comments on our proposal to add Sec.
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the
performance period for the Promoting Interoperability performance
category would be a minimum of a continuous 90-day period within the
calendar year that occurs 2 years prior to the applicable MIPS payment
year, up to and including the full calendar year. Thus, for the 2022
MIPS payment year, the performance period for the Promoting
Interoperability performance category would be a minimum of a
continuous 90-day period within CY 2020, up to and including the full
CY 2020 (January 1, 2020 through December 31, 2020).
h. MIPS Performance Category Measures and Activities
(1) Performance Category Measures and Reporting
(a) Background
We refer readers to Sec. 414.1325 and the CY 2017 and CY 2018
Quality Payment Program final rules (81 FR 77087 through 77095, and 82
FR 53619 through 53626, respectively) for our previously established
policies regarding data submission requirements.
(b) Collection Types, Submission Types and Submitter Types
It has come to our attention that the way we have previously
described data submission by MIPS eligible clinicians, groups and third
party intermediaries does not precisely reflect the experience users
have when submitting data to us. To clarify, we have previously used
the term ``submission mechanisms'' to refer not only to the mechanism
by which data is submitted, but also to certain types of measures and
activities on which data are submitted (for example, electronic
clinical quality measures (eCQMs) reported via EHR) and to the entities
submitting such data (for example, third party intermediaries on behalf
of MIPS eligible clinicians and groups). To ensure clarity and
precision

[[Page 35894]]

for all users, we are proposing to revise existing and define
additional terminology to more precisely reflect the experience users
have when submitting data to the Quality Payment Program.
At Sec. 414.1305, we propose to define the following terms:
Collection type as a set of quality measures with
comparable specifications and data completeness criteria, including, as
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR
measures; Medicare Part B claims measures; CMS Web Interface measures;
the CAHPS for MIPS survey; and administrative claims measures. The term
MIPS CQMs would replace what was formerly referred to as registry
measures since entities other than registries may submit data on these
measures. These new terms are referenced in the collection type field
for the following measure tables of the appendices in this proposed
rule: Table Group A: Proposed New Quality Measures for Inclusion in
MIPS for the 2021 MIPS Payment Year and Future Years; Table Group B:
Proposed New and Modified MIPS Specialty Measure Sets for the 2021 MIPS
Payment Year and Future Years; Table C: Quality Measures Proposed for
Removal from the Merit-Based Incentive Payment System Program for the
2019 Performance Period and Future Years; and Table Group D: Measures
with Substantive Changes Proposed for the 2021 MIPS Payment Year and
Future Years.
Submitter type as the MIPS eligible clinician, group, or
third party intermediary acting on behalf of a MIPS eligible clinician
or group, as applicable, that submits data on measures and activities
under MIPS.
Submission type as the mechanism by which a submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface. The direct submission type allows users to transmit data
through a computer-to-computer interaction, such as an API. The log in
and upload submission type allows users to upload and submit data in
the form and manner specified by CMS with a set of authenticated
credentials. The log in and attest submission type allows users to
manually attest that certain measures and activities were performed in
the form and manner specified by CMS with a set of authenticated
credentials. We note that there is no submission type for the
administrative claims collection type because we calculate measures for
this collection type based on administrative claims data available to
us.
We solicit additional feedback and alternative suggestions on
terminology that appropriately reflects the concepts described in the
proposed definitions of collection type, submitter type and submission
type, as well as the term MIPS CQMs to replace the formerly used term
of registry measures.
We previously finalized at Sec. 414.1325(a) and (e), respectively,
that MIPS eligible clinicians and groups must submit measures,
objectives, and activities for the quality, improvement activities, and
advancing care information performance categories and that there are no
data submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category; CMS will calculate performance on these measures
using administrative claims data. We propose to amend Sec. 414.1325(a)
to incorporate Sec. 414.1325(e), as they both address which
performance categories require data submission; Sec. 414.1325(f) would
be redesignated as Sec. 414.1325(e). We also propose at Sec.
414.1325(a)(2)(ii) that there is no data submission requirement for the
quality or cost performance category, as applicable, for MIPS eligible
clinicians and groups that are scored under the facility-based
measurement scoring methodology described in Sec. 414.1380(e). We also
recognize the need to clarify to users how they submit data to us.
There are five basic submission types that we are proposing to define
in MIPS: Direct; log in and upload; login and attest; Medicare Part B
claims; and the CMS Web Interface. We are proposing to reorganize Sec.
414.1325(b) and (c) by performance category. We are proposing to
clarify at Sec. 414.1325(b)(1) that an individual MIPS eligible
clinician may submit their MIPS data for the quality performance
category using the direct, login and upload, and Medicare Part B claims
submission types. Similarly, we are proposing to clarify at Sec.
414.1325(b)(2) that an individual MIPS eligible clinician may submit
their MIPS data for the improvement activities or Promoting
Interoperability performance categories using the direct, login and
upload, or login and attest submission types. As for groups, we propose
to clarify at Sec. 414.1325(c)(1) that groups may submit their MIPS
data for the quality performance category using the direct, login and
upload, and CMS Web Interface (for groups consisting of 25 or more
eligible clinicians) submission types. Lastly, we propose to clarify at
Sec. 414.1325(c)(2) that groups may submit their MIPS data for the
improvement activities or Promoting Interoperability performance
categories using the direct, login and upload, or login and attest
submission types. We believe that these clarifications will enhance the
submission experience for clinicians and other stakeholders. As
technology continues to evolve, we will continue to look for new ways
that we can offer further technical flexibilities on submitting data to
the Quality Payment Program. We request comment on these proposals. To
assist commenters in providing pertinent comments, we have developed a
website that uses wireframe (schematic) drawings to illustrate a subset
of the different submission types available for MIPS participation.
Specifically, the wireframe drawings describe the direct, login and
attest, and login and upload submission types. We refer readers to the
Quality Payment Program at qpp.cms.gov/design-examples to review these
wireframe drawings. The website will provide specific matrices
illustrating potential stakeholder experiences when choosing to submit
data under MIPS.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. While we would like to move towards the utilization of
electronic reporting by all clinicians and groups, we realize that
small practices face additional challenges, and this requirement may
limit their ability to participate. For this reason, we believe that
Medicare Part B claims measures should be available to small practices,
regardless of whether they are reporting an individual MIPS eligible
clinicians or as groups. Therefore, we propose amending Sec.
414.1325(c)(1) to make the Medicare Part B claims collection type
available to MIPS eligible clinicians in small practices beginning with
the 2021 MIPS payment year. While this would limit the current
availability of Medicare Part B claims measures for individual MIPS
eligible clinicians, it would expand the availability of such measures
for groups, which currently do not have any claims-based reporting
option.
Under Sec. 414.1325(c)(4), we previously finalized that groups may
submit their MIPS data using the CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) for the quality,
improvement activities, and promoting interoperability performance
categories. We are proposing that the CMS Web Interface submission type
would no longer be available for groups to use to submit data for the
improvement activities and Promoting Interoperability

[[Page 35895]]

performance categories at Sec. 414.1325(c)(2). The CMS Web Interface
has been designed based on user feedback as a method for quality
submissions only; however, groups that elect to utilize the CMS Web
Interface can still submit improvement activities or promoting
interoperability data via direct, log in and attest or log in and
upload submission types. We also recognize that certain groups that
have elected to use the CMS Web Interface may prefer to have their data
submitted on their behalf by a third party intermediary described at
Sec. 414.1400(a). We recognize the benefit and burden reduction in
such a flexibility and therefore propose to allow third party
intermediaries to submit data to the CMS Web Interface in addition to
groups. Specifically, we propose to redesignate Sec. 414.1325(c)(4) as
Sec. 414.1325(c)(1) and amend Sec. 414.1325(c)(1) to allow third
party intermediaries to submit data using the CMS Web Interface on
behalf of groups. To further our efforts to provide flexibility in
reporting to the Quality Payment Program, we are soliciting comment on
expanding the CMS Web Interface submission type to groups consisting of
16 or more eligible clinicians to inform our future rulemaking.
We previously finalized at Sec. 414.1325(e) that there are no data
submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category and that CMS will calculate performance on these
measures using administrative claims data. We also finalized at Sec.
414.1325(f)(2), (which, as noted, we are proposing to redesignate as
Sec. 414.1325(e)(2)) that for Medicare Part B claims, data must be
submitted on claims with dates of service during the performance period
that must be processed no later than 60 days following the close of the
performance period. We neglected to codify this requirement at Sec.
414.1325(e) (which, as noted, we are proposing to consolidate with
Sec. 414.1325(a)) for administrative claims data used to assess
performance in the cost performance category and for administrative
claims-based quality measures. Therefore, we propose to amend Sec.
414.1325(a)(2)(i) to reflect that claims included in the measures are
those submitted with dates of service during the performance period
that are processed no later than 60 days following the close of the
performance period.
A summary of these proposed changes is included in Tables 29 and
30. For reference, Table 29 summarizes the data submission types for
individual MIPS eligible clinicians that we are proposing at Sec.
414.1325(b) and (e). Table 30 summarizes the data submission types for
groups that we are proposing at Sec. 414.1325(c) and (e). We request
comment on these proposals.

Table 29--Data Submission Types for MIPS Eligible Clinicians Reporting as Individuals
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission type Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Individual or Third eCQMs.
Log in and upload...... Party Intermediary \2\. MIPS CQMs.
QCDR measures.
Medicare Part B claims Individual............. Medicare Part B claims
(small practices) \1\. measures (small
practices).
Cost................................. No data submission Individual.............
required \2\.
Promoting Interoperability........... Direct................. Individual or Third
Log in and upload...... Party Intermediary.
Log in and attest......
Improvement Activities............... Direct................. Individual or Third
Log in and upload...... Party Intermediary.
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims.
Note: As used in this proposed rule, the term ``Medicare Part B claims'' differs from ``administrative claims''
in that ``Medicare Part B claims'' require MIPS eligible clinicians to append certain billing codes to
denominator-eligible claims to indicate the required quality action or exclusion occurred.

Table 30--Data Submission Types for MIPS Eligible Clinicians Reporting as Groups
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission types Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Group or Third Party eCQMs.
Log in and upload...... Intermediary. MIPS CQMs.
CMS Web Interface QCDR measures.
(groups of 25 or more CMS Web Interface
eligible clinicians). measures.
Medicare Part B claims Medicare Part B claims
(small practices) \1\. measures (small
practices).
CMS approved survey
vendor measure.
Administrative claims
measures.
Cost................................. No data submission Group..................
required 1 2.
Promoting Interoperability........... Direct................. Group or Third Party
Log in and upload...... Intermediary.
Log in and attest......

[[Page 35896]]

Improvement Activities............... Direct................. Group or Third Party
Log in and upload...... Intermediary.
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims. Note: As used in this proposed rule, the term ``Medicare
Part B claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS
eligible clinicians to append certain billing codes to denominator-eligible claims to indicate the required
quality action or exclusion occurred.

(c) Submission Deadlines
We previously finalized data submission deadlines in the CY 2017
Quality Payment Program final rule (81 FR 77095 through 77097) at Sec.
414.1325(f), which outlined data submission deadlines for all
submission mechanisms for individual eligible clinicians and groups for
all performance categories. As discussed in section III.H.3.h.(1) of
this proposed rule, the term submission mechanism, that includes
submission via the qualified registry, QCDR, EHR, Medicare Part B
claims, the CMS Web Interface and attestation, does not align with the
existing process of data submission to the Quality Payment Program. We
are proposing to revise regulatory text language at Sec. 414.1325(f),
which, as noted, we are proposing to redesignate as Sec. 414.1325(e),
to outline data submission deadlines for all submission types for
individual eligible clinicians and groups for all performance
categories. We also propose to revise Sec. 414.1325(e)(1) to allow
flexibility for CMS to alter submission deadlines for the direct, login
and upload, the CMS Web Interface, and login and attest submission
types. We anticipate that in scenarios where the March 31st deadline
falls on a weekend or holiday, we would extend the submission period to
the next business day (that is, Monday). There also may be instances
where due to unforeseen technical issues, the submission system may be
inaccessible for a period of time. If this scenario were to occur, we
anticipate that we would extend the submission period to account for
this lost time, to the extent feasible. We note that this revision
would also revise the previously finalized policy at Sec.
414.1325(e)(3) stating that data must be submitted during an 8-week
period following the close of the performance period, and that the
period must begin no earlier than January 2 and end no later than March
31 for the CMS Web Interface. We are proposing to align the deadline
for the CMS Web Interface submission type with all other submission
type deadlines at Sec. 414.1325(e)(1), while we are also proposing to
remove the previously finalized policy at Sec. 414.1325(e)(3) because
it is no longer needed to mandate a different submission deadline for
the CMS Web Interface submission type.
We are also proposing a number of other technical revisions to
Sec. 414.1325 to more clearly and concisely reflect previously
established policies.
(2) Quality Performance Category
(a) Background
We refer readers to Sec. Sec. 414.1330 through 414.1340 and the CY
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for
our previously established policies regarding the quality performance
category.
(i) Assessing Performance on the Quality Performance Category
Under Sec. 414.1330(a), for purposes of assessing performance of
MIPS eligible clinicians on the quality performance category, we will
use: Quality measures included in the MIPS final list of quality
measures and quality measures used by QCDRs. We are proposing to amend
Sec. 414.1330(a) to account for facility-based measurement and the APM
scoring standard. For that reason, we are proposing Sec. 414.1330(a)
to specify, for a MIPS payment year, we use the following quality
measures, as applicable, to assess performance in the quality
performance category: Measures included in the MIPS final list of
quality measures established by us through rulemaking; QCDR measures
approved by us under Sec. 414.1440; facility-based measures as
described under Sec. 414.1380; and MIPS APM measures as described at
Sec. 414.1370.
(ii) Contribution to Final Score
Under Sec. 414.1330(b)(2) and (3), performance in the quality
performance category will comprise 50 percent of a MIPS eligible
clinician's final score for the 2020 MIPS payment year and 30 percent
of a MIPS eligible clinician's final score for each MIPS payment year
thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by
section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018,
provides that 30 percent of the final score shall be based on
performance with respect to the quality performance category, but that
for each of the first through fifth years for which MIPS applies to
payments, the quality performance category performance percentage shall
be increased so that the total percentage points of the increase equals
the total number of percentage points by which the cost performance
category performance percentage is less than 30 percent for the
respective year. As discussed in section III.H.3.i.(c) of this proposed
rule, we are proposing to weight the cost performance category at 15
percent for the 2021 MIPS payment year. Accordingly, we are proposing
to amend Sec. 414.1330(b)(2) to provide that performance in the
quality performance category will comprise 50 percent of a MIPS
eligible clinician's final score for the 2020 MIPS payment year, and
propose at Sec. 414.1330(b)(3) that the quality performance category
comprises 45 percent of a MIPS eligible clinician's final score for the
2021 MIPS payment year.
(iii) Quality Data Submission Criteria
(A) Submission Criteria
(aa) Submission Criteria for Groups Reporting Quality Measures,
Excluding CMS Web Interface Measures and the CAHPS for MIPS Survey
Measure
We refer readers to Sec. 414.1335(a)(1) for our previously
established submission criteria for quality measures submitted via
claims, registry, QCDR, or EHR. In section III.H.3.h. of this proposed
rule, we propose revisions to existing and additional terminology to
clarify the data submission processes available for MIPS eligible
clinicians, groups and third party intermediaries, to align with the
way users actually submit data to the Quality Payment Program. For that
reason, we are proposing to revise Sec. 414.1335(a)(1) to

[[Page 35897]]

state that data would be collected for the following collection types:
Medicare Part B claims measures; MIPS CQMs; eCQMs, or QCDR measures.
Codified at Sec. 414.1335(a)(1)(i), MIPS eligible clinicians and
groups must submit data on at least six measures including at least one
outcome measure. If an applicable outcome measure is not available,
report one other high priority measure. If fewer than six measures
apply to the MIPS eligible clinician or group, report on each measure
that is applicable. Furthermore, we are proposing beginning with the
2021 MIPS payment year to revise Sec. 414.1335(a)(1)(ii) to indicate
that MIPS eligible clinicians and groups that report on a specialty or
subspecialty measure set, must submit data on at least six measures
within that set, provided the set contain at least six measures. If the
set contains fewer than six measures or if fewer than six measures
apply to the MIPS eligible clinician or group, report on each measure
that is applicable.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. As discussed in section III.H.3.h. of this proposed rule,
we are proposing to limit the Medicare Part B claims submission type,
and therefore, the Medicare Part B claims measures, to MIPS eligible
clinicians in small practices. We refer readers to section III.H.3.h of
this proposed rule for discussion of this proposal.
(bb) Submission Criteria for Groups Reporting CMS Web Interface
Measures
While we are not proposing any changes to the established
submission criteria for CMS Web Interface measures at Sec.
414.1335(a)(2), beginning with the 2021 MIPS payment year, we are
proposing to revise the terminology in which CMS Web Interface measures
are referenced-to align with the updated submission terminology as
discussed in section III.H.3.h of this proposed rule. Therefore, we
propose to revise Sec. 414.1335(a)(2) from via the CMS Web Interface-
for groups consisting of 25 or more eligible clinicians only, to for
CMS Web Interface measures.
In order to ensure that the collection of information is valuable
to clinicians and worth the cost and burden of collecting information,
and address the challenge of fragmented reporting for multiple measures
and submission options, we seek comment on expanding the CMS Web
Interface option to groups with 16 or more eligible clinicians.
Preliminary analysis has indicated that expanding the CMS Web Interface
option to groups of 16 or more eligible clinicians will likely result
in many of these new groups not being able fully satisfy measure case
minimums on multiple CMS Web Interface measures. However, we can
possibly mitigate this issue if we require smaller groups (with 16-24
eligible clinicians) to report on only a subset of the CMS Web
Interface measures, such as the preventive care measures. We are
interested in stakeholder feedback on the issue of expanding the CMS
Web interface to groups of 16 or more, as well as other factors we
should consider with such expansion.
As discussed in section III.F.1.c. of the Medicare Shared Savings
Program portion of this proposed rule, changes proposed and finalized
through rulemaking to the CMS Web Interface measures for MIPS would be
applicable to ACO quality reporting under the Shared Savings Program.
In Table Group D: Measures with Substantive Changes Proposed for the
2021 MIPS Payment Year and Future Years of the measures appendix, we
are proposing to remove 6 measures from the CMS Web Interface in MIPS.
If finalized, groups reporting CMS Web Interface measures for MIPS
would not be responsible for reporting those removed measures. We refer
readers to the quality measure appendix for additional details on the
proposals related to changes in CMS Web Interface measures.
As discussed in the CY 2017 Quality Payment Program final rule (81
FR 77116), the CMS Web Interface has a two-step attribution process
that associates beneficiaries with TINs during the period in which
performance is assessed (adopted from the Physician Value-based Payment
Modifier (VM) program). The CAHPS for MIPS survey utilizes the same
two-step attribution process as the CMS Web Interface. The CY 2017
Quality Payment Program final rule (81 FR 77116) noted that attribution
would be conducted using the different identifiers in MIPS. For
purposes of the CMS Web Interface and the CAHPS for MIPS survey, we
clarify that attribution would be conducted at the TIN level.
(cc) Submission Criteria for Groups Electing To Report Consumer
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
While we are not proposing any changes to the established
submission criteria for the CAHPS for MIPS Survey at Sec.
414.1335(a)(3), beginning with the 2021 MIPS payment year, we are
proposing to revise Sec. 414.1335(a)(3) to clarify that for the CAHPS
for MIPS survey, for the 12-month performance period, a group that
wishes to voluntarily elect to participate in the CAHPS for MIPS survey
measure must use a survey vendor that is approved by CMS for the
applicable performance period to transmit survey measure data to us.
(B) Summary of Data Submission Criteria
We are not proposing any changes to the quality data submission
criteria for the 2021 MIPS payment year in this proposed rule; however,
as discussed in section III.H.3.h. of this proposed rule, we are
proposing changes to existing and additional submission related
terminology. Similarly, while we are not proposing changes to the data
completeness criteria at Sec. 414.1340, we are proposing to changes to
existing and additional submission related terminology. For that
reason, we are proposing to revise Sec. 414.1340 to specify that MIPS
eligible clinicians and groups submitting quality measures data on QCDR
measures, MIPS CQMs, or the eCQMs must submit data on at least 60
percent of the MIPS eligible clinician or group's patients that meet
the measure's denominator criteria, regardless of payer for MIPS
payment year 2021; MIPS eligible clinicians and groups submitting
quality measure data on the Medicare Part B claims measures must submit
data on at least 60 percent of the applicable Medicare Part B patients
seen during the performance period to which the measure applies for the
2021 MIPS payment year; and groups submitting quality measures data on
CMS Web Interface measures or the CAHPS for MIPS survey measure, must
meet the data submission requirement on the sample of the Medicare Part
B patients CMS provides. Below, we have included Tables 31 and 32 to
clearly capture the data completeness requirements and submission
criteria by collection type for individual clinicians and groups.

[[Page 35898]]

Table 31--Summary of Data Completeness Requirements and Performance
Period by Collection Type for the 2020 and 2021 MIPS Payment Years
------------------------------------------------------------------------
Performance
Collection type period Data completeness
------------------------------------------------------------------------
Medicare Part B claims Jan 1-Dec 31 (or 60 percent of
measures. 90 days for individual MIPS
selected eligible
measures). clinician's, or
group's (beginning
with the 2021 MIPS
payment year)
Medicare Part B
patients for the
performance period.
Administrative claims measures Jan 1-Dec 31..... 100 percent of
individual MIPS
eligible clinician's
Medicare Part B
patients for the
performance period.
QCDR measures, MIPS CQMs, and Jan 1-Dec 31 (or 60 percent of
eCQMs. 90 days for individual MIPS
selected eligible
measures). clinician's, or
group's patients
across all payers
for the performance
period.
CMS Web Interface measures.... Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients: Populate
data fields for the
first 248
consecutively ranked
and assigned
Medicare
beneficiaries in the
order in which they
appear in the
group's sample for
each module/measure.
If the pool of
eligible assigned
beneficiaries is
less than 248, then
the group would
report on 100
percent of assigned
beneficiaries.
CAHPS for MIPS survey......... Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients.
------------------------------------------------------------------------

Table 32--Summary of Quality Data Submission Criteria for MIPS Payment
Year 2021 for Individual Clinicians and Groups
------------------------------------------------------------------------
Measure collection
Clinician type Submission criteria types (or measure
sets) available
------------------------------------------------------------------------
Individual Clinicians....... Report at least six Individual MIPS
measures including eligible clinicians
one outcome select their
measure, or if an measures from the
outcome measure is following
not available collection types:
report another high Medicare Part B
priority measure; claims measures
if less than six (individual
measures apply then clinicians in small
report on each practices only),
measure that is MIPS CQMs, QCDR
applicable. measures, eCQMs, or
Clinicians would reports on one of
need to meet the the specialty
applicable data measure sets if
completeness applicable.
standard for the
applicable
performance period
for each collection
type.
Groups (non-CMS Web Report at least six Groups select their
Interface). measures including measures from the
one outcome following
measure, or if an collection types:
outcome measure is Medicare Part B
not available claims measures
report another high (small practices
priority measure; only), MIPS CQMs,
if less than six QCDR measures,
measures apply then eCQMs, or the CAHPS
report on each for MIPS survey--or
measure that is reports on one of
applicable. the specialty
Clinicians would measure sets if
need to meet the applicable.
applicable data Groups of 16 or more
completeness clinicians who meet
standard for the the case minimum of
applicable 200 will also be
performance period automatically
for each collection scored on the
type. administrative
claims based all-
cause hospital
readmission
measure.
Groups (CMS Web Interface Report on all Groups report on all
for group of at least 25 measures includes measures included
clinicians). in the CMS Web in the CMS Web
Interface Interface measures
collection type and collection type and
optionally the optionally the
CAHPS for MIPS CAHPS for MIPS
survey. survey.
Clinicians would Groups of 16 or more
need to meet the clinicians who meet
applicable data the case minimum of
completeness 200 will also be
standard for the automatically
applicable scored on the
performance period administrative
for each collection claims based all-
type. cause hospital
readmission
measure.
------------------------------------------------------------------------

(iv) Application of Facility-Based Measures
According to section 1848(q)(2)(C)(ii) of the Act, the Secretary
may use measures for payment systems other than for physicians, such as
measures used for inpatient hospitals, for purposes of the quality and
cost performance categories. However, the Secretary may not use
measures for hospital outpatient departments, except in the case of
items and services furnished by emergency physicians, radiologists, and
anesthesiologists. We refer readers to section III.H.3.i.(1)(d) of this
proposed rule, Facility-Based Measures Scoring Option for the 2021 MIPS
Payment Year for the Quality and Cost Performance Categories, for full
discussion of facility-based measures and scoring for the 2021 MIPS
payment year.
(b) Selection of MIPS Quality Measures for Individual MIPS Eligible
Clinicians and Groups Under the Annual List of Quality Measures
Available for MIPS Assessment
(i) Background and Policies for the Call for Measures and Measure
Selection Process
In the CY 2017 Quality Payment Program final rule (81 FR 77153), we
established that we would categorize measures into the six NQS domains
(patient safety, person-and caregiver-centered experience and outcomes,
communication and care coordination, effective clinical care,
community/population health, and efficiency and cost reduction). To
streamline quality measures, reduce regulatory burden, and promote
innovation, we have developed and announced our Meaningful Measures
Initiative.\16\ By identifying the highest priority areas for quality
measurement and quality improvement, the Meaning Measures Initiative,
identifies the core quality of care issues that advances our work to
improve patient outcomes. Through subregulatory guidance, we will
categorize quality measures by the 19 Meaningful Measure areas as
identified on the Meaningful Measures Initiative website at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-

[[Page 35899]]

Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-
Page.html. The categorization of quality measures by Meaningful Measure
area would provide MIPS eligible clinicians and groups with guidance as
to how each measure fits into the framework of the Meaningful Measure
Initiative.
---------------------------------------------------------------------------

\16\ Link to Meaningful Measures web page on CMS site to be
provided at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
---------------------------------------------------------------------------

Furthermore, under Sec. 414.1305, a high priority measure is
defined as an outcome, appropriate use, patient safety, efficiency,
patient experience or care coordination quality measure. Due to the
immense impact of the opioid epidemic across the United States, we
believe it is imperative to promote the measurement of opioid use and
overuse, risks, monitoring, and education through quality reporting.
For that reason, beginning with the 2019 performance period, we are
proposing at Sec. 414.1305 to amend the definition of a high priority
measure, to include quality measures that relate to opioids and to
further clarify the types of outcome measures that are considered high
priority. Beginning with the 2021 MIPS payment year, we are proposing
to define at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Outcome measures would
include intermediate-outcome and patient-reported outcome measures. We
request comment on this proposal, specifically if stakeholders have
suggestions on what aspects of opioids should be measured. For example,
should we focus solely on opioid overuse?
Previously finalized MIPS quality measures can be found in the CY
2018 Quality Payment Program final rule (82 FR 53966 through 54174) and
in the CY 2017 Quality Payment Program final rule (81 FR 77558 through
77816). The new MIPS quality measures proposed for inclusion in MIPS
for the 2019 performance period and future years are found in Table A
of Appendix 1: Proposed MIPS Quality Measures of this proposed rule.
The current specialty measure sets can be found in the CY 2018 Quality
Payment Program final rule (82 FR 53976 through 54146). The proposed
new and modified quality measure specialty sets can be found in Table B
of Appendix 1: Proposed MIPS Quality Measures of this proposed rule,
and include new proposed measures, previously finalized measures with
proposed modifications, and previously finalized measures with no
proposed modifications.
We note that modifications made to the specialty sets may include
the removal of certain previously finalized quality measures. Certain
MIPS specialty sets have further defined subspecialty sets, each of
which constitutes a separate specialty set. In instances where an
individual MIPS eligible clinician or group reports on a specialty or
subspecialty set, if the set has less than six measures, that is all
the clinician is required to report. MIPS eligible clinicians are not
required to report on the specialty measure sets, but they are
suggested measures for specific specialties. Please note that the
proposed specialty and subspecialty sets are not inclusive of every
specialty or subspecialty.
On January 9, 2018,\17\ we announced that we would be accepting
recommendations for potential new specialty measure sets for Year 3 of
MIPS under the Quality Payment Program. These recommendations were
based on the MIPS quality measures finalized in the CY 2018 Quality
Payment Program final rule, and includes recommendations to add or
remove the current MIPS quality measures from the specialty measure
sets. All specialty measure set recommendations submitted for
consideration were assessed to ensure that they meet the needs of the
Quality Payment Program.
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\17\ Listserv messaging was distributed through the Quality
Payment Program listserv on January 9th, 2018, titled: ``CMS is
Soliciting Stakeholder Recommendations for Potential Consideration
of New Specialty Measure Sets and/or Revisions to the Existing
Specialty Measure Sets for the 2019 Program Year of Merit-based
Incentive Payment System (MIPS).''
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In the CY 2017 Quality Payment Program final rule (81 FR 77137), we
finalized that substantive changes to MIPS quality measures, to include
but are not limited to, measures that have had measure specification
changes, measure title changes, or domain changes. MIPS quality
measures with proposed substantive changes can be found in Table D of
Appendix 1: Proposed MIPS Quality Measures of this proposed rule.
With regards to eCQMs, in the 2015 EHR Incentive Program final
rule, CMS required eligible clinicians, eligible hospitals, and
critical access hospitals (CAHs) to use the most recent version of an
eCQM for electronic reporting beginning in 2017 (80 FR 62893). We are
proposing this policy for the end-to-end electronic reporting bonus
under MIPS and encourage MIPS eligible clinicians to work with their
EHR vendors to ensure they have the most recent version of the eCQM.
CMS will not accept an older version of an eCQM as a submission for the
MIPS program for the quality performance category or the end-to-end
electronic reporting bonus within that category. MIPS eligible
clinicians and groups reporting on the quality performance category are
required to use the most recent version of the eCQM specifications. The
annual updates to the eCQM specifications and any applicable addenda
are available on the electronic quality improvement (eCQI) Resource
Center website at https://ecqi.healthit.gov for the applicable
performance period. Furthermore, as discussed in section III.E. of this
proposed rule, the Medicaid Promoting Interoperability Program intends
to utilize eCQM measures as they are available in MIPS. We refer
readers to section III.E. of this proposed rule for additional details
and criteria on the Medicaid Promoting Interoperability Program.
In MIPS, there are a limited number of CMS Web Interface measures,
we seek comment on building upon the CMS Web Interface submission type
by expanding the core set of measures available for that submission
type to include other specialty specific measures (such as surgery).
To provide clinicians with a more cohesive reporting experience,
where they may focus on activities and measures that are meaningful to
their scope of practice, we discuss the development of public health
priority measurement sets that would include measures and activities
across the quality, Promoting Interoperability, and improvement
activities performance categories, focused on public health priorities
such as fighting the opioid epidemic, in section III.H.3.h.(5),
Promoting Interoperability. We refer readers to section III.H.3.h.(5)
of this proposed rule for additional details on this concept.
(ii) Topped Out Measures
In the CY 2018 Quality Payment Program final rule (82 FR 53637
through 53640), we finalized the 4-year timeline to identify topped out
measures, after which we may propose to remove the measures through
future rulemaking. After a measure has been identified as topped out
for 3 consecutive years through the benchmarks, we may propose to
remove the measure through notice and comment rulemaking. Therefore, in
the 4th year, if finalized through rulemaking, the measure would be
removed and would no longer be available for reporting during the
performance period. We refer readers to the 2018 MIPS Quality
Benchmarks' file, that is located on the Quality Payment Program
resource library (https://www.cms.gov/Medicare/

[[Page 35900]]

Quality-Payment-Program/Resource-Library/Resource-library.html) to
determine which measure benchmarks are topped out for 2018 and would be
subject to the cap if they are also topped out in the 2019 MIPS Quality
Benchmarks' file. It should be noted that the final determination of
which measure benchmarks are subject to the topped out cap would not be
available until the 2019 MIPS Quality Benchmarks' file is released in
late 2018.
We are proposing that once a measure has reached an extremely
topped out status (for example, a measure with an average mean
performance within the 98th to 100th percentile range), we may propose
the measure for removal in the next rulemaking cycle, regardless of
whether or not it is in the midst of the topped out measure lifecycle,
due to the extremely high and unvarying performance where meaningful
distinctions and improvement in performance can no longer be made,
after taking into account any other relevant factors. We are concerned
that topped out non-high priority process measures require data
collection burden without added value for eligible clinicians and
groups participating in MIPS. It is important to remove these types of
measures, so that available measures provide meaningful value to
clinicians collecting data, beneficiaries, and the program. However, we
would also consider retaining the measure if there are compelling
reasons as to why it should not be removed (for example, if the removal
would impact the number of measures available to a specialist type or
if the measure addressed an area of importance to the Agency).
Since QCDR measures are not approved or removed from MIPS through
the rulemaking timeline or cycle, we are proposing to exclude QCDR
measures from the topped out timeline that was finalized in the CY 2018
Quality Payment Program final rule (82 FR 53640). When a QCDR measure
reaches topped out status, as determined during the QCDR measure
approval process, it may not be approved as a QCDR measure for the
applicable performance period. Because QCDRs have more flexibility to
develop innovative measures, we believe there is limited value in
maintaining topped out QCDR measures in MIPS.
(iii) Removal of Quality Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77136
through 77137), we discussed removal criteria for quality measures,
including that a quality measure may be considered for removal if the
Secretary determines that the measure is no longer meaningful, such as
measures that are topped out. Furthermore, if a measure steward is no
longer able to maintain the quality measure, it would also be
considered for removal.
We have previously communicated to stakeholders our desire to
reduce the number of process measures within the MIPS quality measure
set. In the CY 2017 Quality Payment Program final rule (81 FR 77101),
we explained that we believe that outcome measures are more valuable
than clinical process measures and are instrumental to improving the
quality of care patients receive. In the CY 2018 Quality Payment
Program quality measure set, 102 of the 275 quality measures are
process measures that are not considered high priority. As discussed
above, beginning with the 2021 MIPS payment year, we are proposing to
define at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Because the removal of
all non-high priority process measures would impact most specialty
sets, nearly 94 percent, we believe incrementally removing non-high
priority process measures through notice and comment rulemaking is
appropriate.
Beginning with the 2019 performance period, we propose to implement
an approach to incrementally remove process measures where prior to
removal, considerations will be given to, but is not limited to:
Whether the removal of the process measure impacts the
number of measures available for a specific specialty.
Whether the measure addresses a priority area highlighted
in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
Whether the measure promotes positive outcomes in
patients.
Considerations and evaluation of the measure's performance
data.
Whether the measure is designated as high priority or not.
Whether the measure has reached a topped out status within
the 98th to 100th percentile range, due to the extremely high and
unvarying performance where meaningful distinctions and improvement in
performance can no longer be made, as described in the proposal in the
above topped out measures section.
(iv) Categorizing Measures by Value
In outlining the various types of MIPS quality and QCDR measures
available for reporting in the quality performance category, such as
outcome, high-priority, composite, and process measures, we acknowledge
that not all measures are created equal. For example, the value or
information gained by reporting on certain process measures does not
equate that which is collected on outcome measures. We seek to ensure
that the collection and submission of data is valuable to clinicians
and worth the cost and burden of collecting the information.
Based on this, we seek comment on implementing a system where
measures are classified as a particular value (gold, silver or bronze)
and points are awarded based on the value of the measure. For example,
higher value measures that are considered ``gold'' standard, which
could include outcome measures, composite measures, or measures that
address agency priorities (such as opioids). The CAHPS for MIPS survey,
which collects patient experience data, may also be considered a high
value measure. Measures that are considered second tier, or at a
``silver'' standard would be measures that are considered process
measures that are directly related to outcomes and have a good gap in
performance (there is no high, unwavering performance) and demonstrate
room for improvement; or topped out outcome measures. Lower value
measures, such as standard of care process measures or topped out
process measures would be considered ``bronze'' measures. We refer
readers to section III.H.3.i. (1)(b)(xi) of this proposed rule for
discussion on the assignment of value and scoring based on measure
value.
(3) Cost Performance Category
For a description of the statutory basis and our existing policies
for the cost performance category, we refer readers to the CY 2017 and
CY 2018 Quality Payment Program final rule (81 FR 77162 through 77177,
and 82 FR 53641 through 53648, respectively).
(a) Weight in the Final Score
In the CY 2018 Quality Payment Program final rule, we established
that the weight of the cost performance category would be 10 percent of
the final score for the 2020 MIPS payment year (82 FR 53643). We had
previously finalized in the CY 2017 Quality Payment Program final rule
at Sec. 414.1350(b)(3) that beginning with the 2021 MIPS payment year,
the cost performance category would be 30

[[Page 35901]]

percent of the final score, as required by section
1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR 77166). Section
51003(a)(1)(C) of the Bipartisan Budget Act of 2018, enacted on
February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb) of the Act
such that for each of the second, third, fourth, and fifth years for
which the MIPS applies to payments, not less than 10 percent and not
more than 30 percent of the MIPS final score shall be based on the cost
performance category score. Additionally, this provision shall not be
construed as preventing the Secretary from adopting a 30 percent weight
if the Secretary determines, based on information posted under section
1848(r)(2)(I) of the Act, that sufficient cost measures are ready for
adoption for use under the cost performance category for the relevant
performance period. Section 51003(a)(2) of the Bipartisan Budget Act of
2018 amended section 1848(r)(2) of the Act to add a new paragraph (I),
which we discuss in section III.H.3.h.(3)(b)(i) of this proposed rule.
In light of these amendments, we propose at Sec. 414.1350(d)(3)
the cost performance category would make up 15 percent of a MIPS
eligible clinician's final score for the 2021 MIPS payment year. As
discussed in section III.H.3.h.(3)(b)(iv) of this proposed rule, we are
proposing to codify the existing policies for the attribution of cost
measures, which would result in redesignating Sec. 414.1350(b) as
Sec. 414.1350(d). We propose to delete the existing text under Sec.
414.1350(b)(3) and address the weight of the cost performance category
for the MIPS payment years following 2021 in future rulemaking. We also
propose a technical change to the text at Sec. 414.1350(b)
(redesignated as Sec. 414.1350(d)) to state that the cost performance
category weight will be as specified under redesignated Sec.
414.1350(d), unless a different scoring weight is assigned by CMS under
section 1848(q)(5)(F) of the Act.
We believe that measuring cost is an integral part of measuring
value, and we believe that clinicians have a significant impact on the
costs of patient care. However, we are proposing to only modestly
increase the weight of the cost performance category for the 2021 MIPS
payment year from the 2020 MIPS payment year because we recognize that
cost measures are still relatively early in the process of development
and that clinicians do not have the level of familiarity or
understanding of cost measures that they do of comparable quality
measures. As described in section III.H.3.h.(3)(b)(ii) of this proposed
rule, we are proposing to add 8 episode-based measures to the cost
performance category beginning with the 2019 MIPS performance period.
This is a first step in developing a more robust and clinician-focused
measurement of cost performance. We will continue to work on developing
additional episode-based measures that we may consider proposing for
the cost performance category in future years. Introducing more
measures over time would allow for more clinicians to be measured in
this performance category. It would also allow time for more outreach
to clinicians to better educate them on the cost measures. We
considered maintaining the weight of the cost performance category at
10 percent for the 2021 MIPS payment year as we recognize that
clinicians are still learning about the cost performance category and
being introduced to new measures. We invite comment on whether we
should consider an alternative weight for the 2021 MIPS payment year.
In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we
will continue to evaluate whether sufficient cost measures are ready
for adoption under the cost performance category and move towards the
goal of increasing the weight to 30 percent of the final score. To
provide for a smooth transition, we anticipate that we would increase
the weight of the cost performance category by 5 percentage points each
year until we reach the required 30 percent weight for the 2024 MIPS
payment year. We invite comments on this approach to the weight of the
cost performance category for the 2022 and 2023 MIPS payment years,
considering our flexibility in setting the weight between 10 percent
and 30 percent of the final score, the availability of cost measures,
and our desire to ensure a smooth transition to a 30 percent weight for
the cost performance category.
(b) Cost Criteria
(i) Background
Under Sec. 414.1350(a), we specify cost measures for a performance
period to assess the performance of MIPS eligible clinicians on the
cost performance category. In the CY 2018 Quality Payment Program final
rule, we established two cost measures (total per capita cost measure
and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS
performance period and future performance periods (82 FR 53644). These
measures were previously established for the 2017 MIPS performance
period (81 FR 77168). We will continue to evaluate cost measures that
are included in MIPS on a regular basis and anticipate that measures
could be added or removed through rulemaking as measure development
continues. In general, we expect to evaluate cost measures according to
the measure reevaluation and maintenance processes outlined in the
``Blueprint for the CMS Measures Management System'' (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf). As described in section 2
of the Blueprint for the CMS Measures Management System Version 13.0,
we will conduct annual evaluations to review the continued accuracy of
the measure specifications. Annual updates ensure that the procedure,
diagnostic, and other codes used in the measure account for updates to
coding systems over time. To the extent that these updates would
constitute a substantive change to a measure, we would ensure the
changes are proposed for adoption through rulemaking. We will also
comprehensively reevaluate the measures every 3 years to ensure that
they continue to meet measure priorities. As a part of this
comprehensive reevaluation, we will gather information through
environmental scans and literature reviews of recent studies and new
clinical guidelines that may inform potential refinements. We will also
analyze measure performance rates and re-assess the reliability and
validity of the measures. Throughout these reevaluation efforts, we
will summarize and consider all stakeholder feedback received on the
measure specifications during the implementation process, and may seek
input through public comment periods. In addition, the measure
development contractor may acquire individual input on measures by
convening Technical Expert Panels (TEPs) and clinical subcommittees.
Aside from these regular measure reevaluations, there may be ad-hoc
reviews of the measures if new evidence comes to light which indicates
that significant revisions may be required.
We will also continue to update the specifications to address
changes in coding, risk adjustment, and other factors. The process for
updating measure specifications will take place through ongoing
maintenance and evaluation, during which we expect to continue seeking
stakeholder input. As we noted above, any substantive changes to a
measure would be proposed for adoption in future years through notice
and comment

[[Page 35902]]

rulemaking. We appreciate the feedback that we have received so far
throughout the measure development process and believe that
stakeholders will continue to provide feedback to the measure
development contractor on episode-based cost measures by submitting
written comments during public comment opportunities, by participating
in the clinical subcommittees convened by the measure development
contractor, or by attending education and outreach events. We will take
all comments and feedback into consideration as part of the ongoing
measure evaluation process.
As we noted in the CY 2017 Quality Payment Program final rule (81
FR 77137) regarding quality measures, which we believe would also apply
for cost measures, some updates may incorporate changes that would not
substantively change the intent of the measure. Examples of such
changes may include updated diagnosis or procedure codes or changes to
exclusions to the patient population or definitions. While we address
such changes on a case-by-case basis, we generally believe these types
of maintenance changes are distinct from substantive changes to
measures that result in what are considered new or different measures.
As described in section 3 of the Blueprint for the CMS Measures
Management System Version 13.0, if substantive changes to these
measures become necessary, we expect to follow the pre-rulemaking
process for new measures, including resubmission to the Measures Under
Consideration (MUC) list and consideration by the Measure Applications
Partnership (MAP). The MAP provides an additional opportunity for an
interdisciplinary group of stakeholders to provide feedback on whether
they believe the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. They also consider
whether the measures are scientifically acceptable, and reflect current
clinical guidelines.
Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended
section 1848(r)(2) of the Act to add a new paragraph (I) requiring the
Secretary to post on the CMS website information on cost measures in
use under MIPS, cost measures under development and the time-frame for
such development, potential future cost measure topics, a description
of stakeholder engagement, and the percent of expenditures under
Medicare Part A and Part B that are covered by cost measures. This
information shall be posted no later than December 31 of each year
beginning with 2018. We expect this posting will provide a list of the
cost measures established for the cost performance category for the
current performance period (for example, the posting in 2018 would
include a list of the measures for the 2018 MIPS performance period),
as well as a list of any cost measures that may be proposed for a
future performance period through rulemaking. We will provide
hyperlinks to the measure specifications documents, and include the
percent of Medicare Part A and Part B expenditures that are covered by
these cost measures. The posting will also include a list and
description of the measures under development at that time. We intend
to summarize the timeline for measure development, including the
stakeholder engagement activities undertaken, which may include a TEP,
clinical subcommittees, field testing, and education and outreach
activities, such as national provider calls and listening sessions.
Finally, the posting will provide an overview of potential future
topics in cost measure development, such as any clinical areas in which
measures may be developed in the future.
(ii) Episode-Based Measures Proposed for the 2019 and Future
Performance Periods
Episode-based measures differ from the total per capita cost
measure and MSPB measure because episode-based measure specifications
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given timeframe.
We discussed our progress in the development of episode-based
measures in the CY 2018 Quality Payment Program proposed rule (82 FR
30049 through 30050) and received significant positive feedback on the
process used to develop the measures as well as the measures' clinical
focus that was informed by expert opinion (82 FR 53644 through 53646).
The specific measures selected for the initial round of field testing
were included based on the volume of beneficiaries impacted by the
condition or procedure, the share of cost to Medicare impacted by the
condition or procedure, the number of clinicians/clinician groups
attributed, and the potential for alignment with existing quality
measures.
We have developed episode-based measures to represent the cost to
Medicare for the items and services furnished to a patient during an
episode of care (``episode''). Episode-based measures are developed to
let attributed clinicians know the cost of the care clinically related
to their initial treatment of a patient and provided during the
episode's timeframe. Specifically, we define cost based on the allowed
amounts on Medicare claims, which include both Medicare payments and
beneficiary deductible and coinsurance amounts. Episode-based measures
are calculated using Medicare Parts A and B fee-for-service claims data
and are based on episode groups. Episode groups:
Represent a clinically cohesive set of medical services
rendered to treat a given medical condition.
Aggregate all items and services provided for a defined
patient cohort to assess the total cost of care.
Are defined around treatment for a condition (acute or
chronic) or performance of a procedure.
Items and services in the episode group could be treatment
services, diagnostic services, and ancillary items and services
directly related to treatment (such as anesthesia for a surgical
procedure). They could also be items and services that occur after the
initial treatment period that may be furnished to patients as follow-up
care or to treat complications resulting from the treatment. An episode
is a specific instance of an episode group for a specific patient and
clinician. For example, in a given year, a clinician might be
attributed 20 episodes (instances of the episode group) from the
episode group for heart failure. In section III.H.3.h.(3)(b)(iv) of
this proposed rule, we discuss the attribution rules for cost measures.
After episodes are attributed to one or more clinicians, items and
services may be included in the episode costs if they are furnished
within a patient's episode window. Items and services will be included
if they are the trigger event for the episode or if a service
assignment rule identifies them as a clinically related item or service
during the episode. The detailed specifications for these measures,
which include information about the service assignment rule, can be
reviewed at qpp.cms.gov.
To ensure a more accurate comparison of cost across clinicians,
episode costs are payment standardized and risk adjusted. Payment
standardization adjusts the allowed amount for an item or service to
facilitate cost comparisons and limit observed differences in costs to
those that may result from health care delivery choices. Payment
standardized costs remove any Medicare payment differences due to
adjustments for

[[Page 35903]]

geographic differences in wage levels or policy-driven payment
adjustments such as those for teaching hospitals. Risk adjustment
accounts for patient characteristics that can influence spending and
are outside of clinician control. For example, for the elective
outpatient PCI episode-based measure, the risk adjustment model may
account for a patient's history of heart failure.
The measure development contractor has continued to seek extensive
stakeholder feedback on the development of episode-based measures,
building on the processes outlined in the CY 2018 Quality Payment
Program final rule (82 FR 53644). These processes included convening a
TEP and clinical subcommittees to solicit expert and clinical input for
measure development, conducting national field testing on the episode-
based cost measures developed, and seeking input from clinicians and
stakeholders through engagement activities. Seven clinical
subcommittees were convened through an open call for nominations
between March 17, 2017 and April 24, 2017, composed of nearly 150
clinicians affiliated with almost 100 specialty societies. These
subcommittees met at an in-person meeting and through webinars from May
2017 to January 2018 to select an episode group or groups to develop
and provide detailed clinical input on each component of episode-based
cost measures. These components included episode triggers and windows,
item and service assignment, exclusions, attribution methodology, and
risk adjustment variables.
As described in the CY 2018 Quality Payment Program final rule (82
FR 53645), we provided an initial opportunity for clinicians to review
their performance based on the new episode-based measures developed by
the clinical subcommittees in the fall of 2017 through national field
testing. During the period of October 16, 2017 to November 20, 2017,
solo practitioners and clinician groups were able to access field test
reports about their cost measure performance on the CMS Enterprise
Portal if they were attributed at least 10 episodes for at least one of
these eight measures during the measurement period of June 1, 2016 to
May 31, 2017. In addition to the field test reports, stakeholders could
review a range of materials about the new episode-based cost measures,
including a fact sheet, frequently asked questions (FAQ) document, a
mock field test report, and draft measure specifications for each of
the 8 new episode-based measures (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Episode-based-cost-measures-field-test-zip-files.zip).
During field testing, we sought feedback from stakeholders on the
draft measure specifications, feedback report format, and supplemental
documentation through an online form. We received over 200 responses,
including 53 comment letters, during the field test feedback period. We
shared the feedback on the draft measure specifications with the
clinical subcommittees who considered it in providing input on measure
refinements after the end of field testing. A field testing feedback
summary report is publicly available at qpp.cms.gov.
To engage clinicians and stakeholders, we conducted extensive
outreach activities including hosting National Provider Calls (NPCs) to
provide information about the measure development process and field
test reports, and to give stakeholders the opportunity to ask
questions.
The new episode-based measures developed by the clinical
subcommittees were considered by the NQF-convened MAP, and were all
conditionally supported by the MAP, with the recommendation of
obtaining NQF endorsement. We intend to submit these episode-based
measures to NQF for endorsement in the future. The MAP provides an
opportunity for an interdisciplinary group of stakeholders to provide
input on whether the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. Following the successful
field testing and review through the MAP process, we propose to add 8
episode-based measures listed in Table 33 as cost measures for the 2019
MIPS performance period and future performance periods.
The attribution methodology for these measures is discussed in
section III.H.3.h.(3)(b)(iv)(B) of this proposed rule. The detailed
specifications for these measures can be reviewed at qpp.cms.gov. These
specifications documents consist of (i) a methods document that
outlines the methodology for constructing the measures, and (ii) a
measure codes list file that contains the medical codes used in that
methodology. First, the methods document provides a high-level overview
of the measure development process, including discussion of the
detailed clinical input obtained at each step, and details about the
components of episode-based cost measures: Defining an episode group;
assigning costs to the episode group; attributing the episode group;
risk adjusting episode group costs; and aligning cost with quality. The
methods document also contains the detailed measure methodology that
describes each logic step involved in constructing the episode groups
and calculating the cost measure. Second, the measure codes list file
contains the codes used in the specifications, including the episode
triggers, exclusions, episode sub-groups, assigned items and services,
and risk adjustors.

Table 33--Episode-Based Measures Proposed for the 2019 MIPS Performance
Period and Future Performance Periods
------------------------------------------------------------------------
Measure topic Measure type
------------------------------------------------------------------------
Elective Outpatient Procedural.
Percutaneous Coronary
Intervention (PCI).
Knee Arthroplasty............ Procedural.
Revascularization for Lower Procedural.
Extremity Chronic Critical
Limb Ischemia.
Routine Cataract Removal with Procedural.
Intraocular Lens (IOL)
Implantation.
Screening/Surveillance Procedural.
Colonoscopy.
Intracranial Hemorrhage or Acute inpatient medical condition.
Cerebral Infarction.
Simple Pneumonia with Acute inpatient medical condition.
Hospitalization.
ST-Elevation Myocardial Acute inpatient medical condition.
Infarction (STEMI) with
Percutaneous Coronary
Intervention (PCI).
------------------------------------------------------------------------

[[Page 35904]]

(iii) Reliability
In the CY 2017 Quality Payment Program final rule (81 FR 77169
through 77170), we finalized a reliability threshold of 0.4 for
measures in the cost performance category. We seek to ensure that MIPS
eligible clinicians are measured reliably. In the CY 2017 Quality
Payment Program final rule, we finalized a case minimum of 20 for the
episode-based measures specified for the 2017 MIPS performance period
(81 FR 77175). We examined the reliability of the proposed 8 episode-
based measures listed in Table 33 at various case minimums and found
that all of these measures meet the reliability threshold of 0.4 for
the majority of clinicians and groups at a case minimum of 10 episodes
for procedural episode-based measures and 20 episodes for acute
inpatient medical condition episode-based measures. Furthermore, these
case minimums would balance the goal of increased reliability with the
goal of adopting cost measures that are applicable to a larger set of
clinicians and clinician groups. Our analysis indicated that the case
minimum for procedural episode-based measures could be lower than that
of acute inpatient medical condition episode-based measures while still
ensuring reliable measures.
Table 34 presents the percentage of TINs and TIN/NPIs with 0.4 or
higher reliability, as well as the mean reliability for the subset of
TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for
procedural episode-based measures and 20 episodes for acute inpatient
medical condition episode-based measures for each of the proposed
episode-based measures. Each row in this table provides the percentage
of TINs and TIN/NPIs who had reliability of 0.4 or higher among all the
TINs and TIN/NPIs who met the case minimum for that measure during the
study period (6/1/2016 to 5/31/2017).

Table 34--Percentage of TINs and TIN/NPIs With 0.4 or Higher Reliability From June 1, 2016 to May 31, 2017 at
Proposed Case Minimums
----------------------------------------------------------------------------------------------------------------
Percentage Percentage
TINs with 0.4 Mean TIN/NPIs with Mean
Measure name or higher reliability 0.4 or higher reliability
reliability for TINs reliability for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Elective Outpatient Percutaneous Coronary 100.0 0.73 84.1 0.53
Intervention (PCI).............................
Knee Arthroplasty............................... 100.0 0.87 100.0 0.81
Revascularization for Lower Extremity Chronic 100.0 0.74 100.0 0.64
Critical Limb Ischemia.........................
Routine Cataract Removal with Intraocular Lens 100.0 0.95 100.0 0.94
(IOL) Implantation.............................
Screening/Surveillance Colonoscopy.............. 100.0 0.96 100.0 0.93
Intracranial Hemorrhage or Cerebral Infarction.. 100.0 0.70 74.9 0.48
Simple Pneumonia with Hospitalization........... 100.0 0.64 31.8 0.40
ST-Elevation Myocardial Infarction (STEMI) with 100.0 0.59 100.0 0.59
PCI............................................
----------------------------------------------------------------------------------------------------------------

Based on this analysis, we propose at Sec. 414.1350(c)(4) and (5)
a case minimum of 10 episodes for the procedural episode-based measures
and 20 episodes for the acute inpatient medical condition episode-based
measures that we have proposed beginning with the 2019 MIPS performance
period. These case minimums would ensure that the measures meet the
reliability threshold for groups and individual clinicians. We believe
that the proposed case minimums for these procedural and acute
inpatient medical condition episode-based measures would achieve a
balance between several important considerations. In order to help
clinicians become familiar with the episode-based measures as a robust
and clinician-focused form of cost measurement, we want to provide as
many clinicians as possible the opportunity to receive information
about their performance on reliable measures. This is consistent with
the stakeholder feedback that we have received throughout the measure
development process. We believe that calculating episode-based measures
with these case minimums would accurately and reliably measure the
performance of a large number of clinicians and clinician group
practices.
We recognize that the percentage of TIN/NPIs with 0.4 or greater
reliability for the Simple Pneumonia with Hospitalization measure,
while still meeting our reliability threshold, is somewhat lower than
that of the other proposed acute inpatient medical condition episode-
based measures, as well as all of the proposed procedural episode-based
measures. For this reason, we considered an alternative case minimum of
30 for both TIN/NPIs and TINs for this measure. At this case minimum,
100 percent of TIN/NPIs would have 0.4 or greater reliability and the
mean reliability would increase to 0.49 for TIN/NPIs and 0.70 for TINs.
However, the number of TINs and TIN/NPIs that would meet the case
minimum for this important measure would decrease by 29 percent for
TINs and by 84 percent for TIN/NPIs. We invite comments on this
alternative case minimum for TIN/NPIs and TINs for the Simple Pneumonia
with Hospitalization episode-based measure.
We previously finalized a case minimum of 35 for the MSPB measure
(81 FR 77171), 20 for the total per capita cost measure (81 FR 77170),
and 20 for the episode-based measures specified for the 2017 MIPS
performance period (81 FR 77175). We propose to codify these final
policies under Sec. 414.1350(c).
In general, higher case minimums increase reliability, but also
decrease the number of clinicians who are measured. We aim to measure
as many clinicians as possible in the cost performance category. Some
clinicians or smaller groups may never see enough patients in a single
year to meet the case minimum for a specific episode-based measure. For
this reason, we seek comment on whether we should consider expanding
the performance period for the cost performance category measures from
a single year to 2 or more years in future rulemaking. We believe this
would allow us to more reliably measure a larger number of clinicians.
However, we are also concerned that expanding the performance period
would increase the time between the measurement of performance and the
application of the MIPS payment adjustment. In addition, it would take
a longer period of time for us to introduce new cost measures as we
would expect to adopt them through rulemaking prior to the beginning of
the performance period.

[[Page 35905]]

(iv) Attribution
(A) Attribution Methodology for Cost Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77168
through 77169; 77174 through 77176), we adopted final policies
concerning the attribution methodologies for the total per capita cost
measure, the MSPB measure, and the episode-based measures specified for
the 2017 MIPS performance period in addition to an attribution
methodology for individual clinicians and groups. We propose to codify
these final policies under Sec. 414.1350(b).
(B) Attribution Rules for the Proposed Episode-Based Measures
In section III.H.3.h.(3)(b)(ii) of this proposed rule, we propose
to add 8 episode-based measures as cost measures for the 2019 MIPS
performance period and future performance periods, which can be
categorized into two types of episode groups: Acute inpatient medical
condition episode groups, and procedural episode groups. These measures
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given period of time. The attribution
methodology would be the same for all of the measures within each type
of episode groups--acute inpatient medical condition episode groups and
procedural episode groups. Our proposed approach to attribution would
ensure that the episode-based measures reflect the roles of the
individuals and groups in providing care to patients.
For acute inpatient medical condition episode groups specified
beginning in the 2019 performance period, we propose at Sec.
414.1350(b)(6) to attribute episodes to each MIPS eligible clinician
who bills inpatient evaluation and management (E&M) claim lines during
a trigger inpatient hospitalization under a TIN that renders at least
30 percent of the inpatient E&M claim lines in that hospitalization. A
trigger inpatient hospitalization is a hospitalization with a
particular MS-DRG identifying the episode group. These MS-DRGs, and any
supplementary trigger rules, are identified in the measure
specifications posted at qpp.cms.gov. The measure score for an
individual clinician (TIN/NPI) is based on all of the episodes
attributed to the individual. The measure score for a group (TIN) is
based on all of the episodes attributed to a TIN/NPI in the given TIN.
If a single episode is attributed to multiple TIN/NPIs in a single TIN,
the episode is only counted once in the TIN's measure score. We believe
that establishing a 30 percent threshold for the TIN would ensure that
the clinician group is collectively measured across all of its
clinicians who are likely responsible for the oversight of care for the
patient during the trigger hospitalization.
This proposed attribution approach differs from the attribution
approach previously established for episode-based measures for acute
inpatient medical conditions specified for the 2017 performance period
in the CY 2017 Quality Payment Program final rule (81 FR 77174 through
77175). The previous approach attributed episodes to TIN/NPIs who
individually exceed the 30 percent E&M threshold, while excluding all
episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout
the measure development process, stakeholders have discussed the team-
based nature of acute care, in which multiple clinicians share
management of a patient during a hospital stay. The previous approach
outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174
through 77175) does not capture patients' episodes when a group
collaborates to manage a patient but no individual clinician exceeds
the 30 percent threshold. Based upon stakeholder feedback, our proposed
approach emphasizes team-based care and expands the measures' coverage
of clinicians, patients, and cost.
To illustrate the proposed attribution rules for acute inpatient
medical condition episode groups, we are providing an example where 3
MIPS eligible clinicians are part of the same TIN. The TIN bills 50
percent of total inpatient E&M claim lines during an inpatient
hospitalization. Clinician A and B each bill 3 inpatient E&M claim
lines under the TIN, and Clinician C bills none under the TIN. If MIPS
eligible clinicians under this TIN are scored as individual TIN/NPIs,
this episode would be attributed to Clinicians A and B, but not
Clinician C. The episode would be used to calculate Clinician A's
measure score and Clinician B's measure score, but not Clinician C's.
The episode would count towards the individual 20 episode case minimums
for both Clinicians A and B. If this TIN is instead scored as a group,
the episode would be included in the calculation of the TIN's measure
score because it has exceeded the 30 percent inpatient E&M threshold.
This episode would count towards the TIN's 20 episode case minimum. We
note that this episode would only be counted once towards the TIN's
score, even though 2 clinicians under the TIN exceeded the 30 percent
threshold. The previous attribution approach outlined in the CY 2017
Quality Payment Program final rule (81 FR 77174 through 77175) would
discard this episode altogether. Specifically, it would not attribute
this episode to Clinician A, B, or C, in the above example and the
episode would not be included in these clinicians' measures or their
TIN's measure.
For procedural episode groups specified beginning in the 2019 MIPS
performance period, we propose at Sec. 414.1350(b)(7) to attribute
episodes to each MIPS eligible clinician who renders a trigger service
as identified by HCPCS/CPT procedure codes. These trigger services are
identified in the measure specifications posted at qpp.cms.gov. The
measure score for an individual clinician (TIN/NPI) is based on all of
the episodes attributed to the individual. The measure score for a
group (TIN) is based on all of the episodes attributed to a TIN/NPI in
the given TIN. If a single episode is attributed to multiple TIN/NPIs
in a single TIN, the episode is only counted once in the TIN's measure
score. We believe this approach best identifies the clinician(s)
responsible for the patient's care. This attribution method is similar
to that used for procedural episode-based measures in the 2017 MIPS
performance period but more clearly defines that the services must be
provided during the episode and how we would address instances in which
two NPIs in the same TIN provided a trigger service.
(4) Improvement Activities Performance Category
(a) Background
In CY 2017 Quality Payment Program final rule (81 FR 77179 through
77180), we codified at Sec. 414.1355 that the improvement activities
performance category would account for 15 percent of the final score.
We refer readers to section III.H.3.i.(1)(e) of this proposed rule
where we are proposing to modify Sec. 414.1355 to provide further
technical clarifications. In addition, in the CY 2018 Quality Payment
Program final rule (82 FR 53649), we codified at Sec.
414.1380(b)(3)(iv) that the term ``recognized'' be accepted as
equivalent to the term ``certified'' when referring to the requirements
for a patient-centered medical home to receive full credit for the
improvement activities performance category for MIPS. We also finalized
at Sec. 414.1380(b)(3)(x) that for the 2020 MIPS payment year and
future years, to

[[Page 35906]]

receive full credit as a certified or recognized patient-centered
medical home or comparable specialty practice, at least 50 percent of
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
We refer readers to section III.H.3.i.(1)(e)(i)(E) of this proposed
rule for details on our proposals regarding patient-centered medical
homes.
In the CY 2017 Quality Payment Program final rule (81 FR 77539), we
codified the definition of improvement activities at Sec. 414.1305 to
mean an activity that relevant MIPS eligible clinicians, organizations,
and other relevant stakeholders identify as improving clinical practice
or care delivery and that the Secretary determines, when effectively
executed, is likely to result in improved outcomes. Further, in that
final rule (81 FR 77190), we codified at Sec. 414.1365 that the
improvement activities performance category would include the
subcategories of activities provided at section 1848(q)(2)(B)(iii) of
the Act. We also codified subcategories for improvement activities at
Sec. 414.1365 (81 FR 77190).
We also previously codified in the CY 2017 and CY 2018 Quality
Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively)
data submission criteria for the improvement activities performance
category at Sec. 414.1360(a)(1). In addition, we established
exceptions for: Small practices; practices located in rural areas;
practices located in geographic HPSAs; non-patient facing individual
MIPS eligible clinicians or groups; and individual MIPS eligible
clinicians and groups that participate in a MIPS APM or a patient-
centered medical home submitting in MIPS (81 FR 77185, 77188).
Specifically, we codified at Sec. 414.1380(b)(3)(vii) that non-patient
facing MIPS eligible clinicians and groups, small practices, and
practices located in rural areas and geographic HPSAs receive full
credit for the improvement activities performance category by selecting
one high-weighted improvement activity or two medium-weighted
improvement activities; such practices receive half credit for the
improvement activities performance category by selecting one medium-
weighted improvement activity (81 FR 77185). We refer readers to
section III.H.3.i.(1)(e)(i)(B) of this proposed rule for our proposals
related to that provision. In addition, we specified at Sec. 414.1305
that rural areas refers to ZIP codes designated as rural, using the
most recent HRSA Area Health Resource File data set available (81 FR
77188, 82 FR 53582). Lastly, we finalized the meaning of Health
Professional Shortage Areas (HPSA) at Sec. 414.1305 to mean areas as
designated under section 332(a)(1)(A) of the Public Health Service Act
(81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR
53581), we modified the definition of small practices at Sec. 414.1305
to mean practices consisting of 15 or fewer eligible clinicians.
In this proposed rule, we request comments on our proposals to: (1)
Revise Sec. 414.1360(a)(1) to more accurately describe the data
submission criteria; (2) delete Sec. 414.1365 and move improvement
activities subcategories to Sec. 414.1355(c); (3) update the criteria
considered for nominating new improvement activities; (4) modify the
Annual Call for Activities timeline for the CY 2019 performance period
and future years; (5) add 6 new improvement activities for the CY 2019
performance period and future years; (6) modify 5 existing improvement
activities for the CY 2019 performance period and future years; and (7)
remove 1 existing improvement activity for the CY 2019 performance
period and future years. In addition, we also request comments on our
proposals with respect to the CMS Study on Factors Associated with
Reporting Quality Measures for the CY 2019 performance period and
future years the following proposals: (1) Change the title of the study
to ``CMS Study on Factors Associated with Reporting Quality Measures;''
(2) increase the sample size to a minimum of 200 participants; (3)
limit the focus group requirement to a subset of the 200 participants;
and (4) require that at least one of the minimum of three required
measures be a high priority measure. We are also making clarifications
to: (1) Considerations for selecting improvement activities for the CY
2019 performance period and future years; and (2) the weighting of
improvement activities.
These topics are discussed in more detail below.
(b) Submission Criteria
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77181) for submission mechanism policies we finalized and
codified for the transition year of MIPS. In the CY 2018 Quality
Payment Program final rule (82 FR 53651), we continued these policies
for future years. Specifically, we finalized that for MIPS Year 2 and
future years, MIPS eligible clinicians or groups must submit data on
MIPS improvement activities in one of the following manners: Qualified
registries; EHR submission mechanisms; QCDR; CMS Web Interface; or
attestation. Additionally, we finalized that for activities that are
performed for at least a continuous 90-days during the performance
period, MIPS eligible clinicians must submit a yes response for
activities within the improvement activities inventory. In addition, in
the case where an individual MIPS eligible clinician or group is using
a health IT vendor, QCDR, or qualified registry for their data
submission, we finalized that the MIPS eligible clinician or group must
certify all improvement activities were performed and the health IT
vendor, QCDR, or qualified registry would submit on their behalf (82 FR
53650 through 53651). We also updated Sec. 414.1360 to reflect those
changes (82 FR 53651).
We refer readers to section III.H.3.h.(1) of this proposed rule,
MIPS Performance Category Measures and Activities, where we discuss our
proposals to update the data submission process for MIPS eligible
clinicians, groups and third party intermediaries, by updating our
terminology. We also refer readers to proposed changes to Sec.
414.1325 for Data submission requirements. We are proposing those
changes to more closely align with the actual submission experience
users have. In alignment with those proposals, we are requesting
comments on our proposal to revise Sec. 414.1360(a)(1) to more
accurately reflect the data submission process for the improvement
activities performance category. In particular, we are proposing that
instead of ``via qualified registries; EHR submission mechanisms; QCDR,
CMS Web Interface; or attestation,'' as currently stated, we are
revising the first sentence to state that data would be submitted ``via
direct, login and upload, and login and attest'' as discussed in
section III.H.3.h.(1)(b) of this proposed rule.
In addition, we are proposing to add further additions to Sec.
414.1360(a)(1) to include paragraph (i). In Sec. 414.1360(a)(1), we
are proposing to specify, submit a yes response for each improvement
activity that is performed for at least a continuous 90-day period
during the applicable performance period.
(c) Subcategories
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we
finalized at Sec. 414.1365 that the improvement activities performance
category includes the subcategories of activities provided at section
1848(q)(2)(B)(iii) of the Act. It has since come to our attention that
it is unnecessary to have a separate

[[Page 35907]]

regulation text included under Sec. 414.1365 since the subcategories
are not a component of the scoring calculations. Therefore, we are
proposing to delete Sec. 414.1365 and move the same improvement
activities subcategories to Sec. 414.1355(c). We reiterate that we are
not proposing any changes to the subcategories themselves. These
subcategories are:
Expanded practice access, such as same day appointments
for urgent needs and after-hours access to clinician advice.
Population management, such as monitoring health
conditions of individuals to provide timely health care interventions
or participation in a QCDR.
Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients or other
clinicians, and use of remote monitoring or telehealth.
Beneficiary engagement, such as the establishment of care
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision making
mechanisms.
Patient safety and practice assessment, such as through
the use of clinical or surgical checklists and practice assessments
related to maintaining certification.
Participation in an APM.
Achieving health equity, such as for MIPS eligible
clinicians that achieve high quality for underserved populations,
including persons with behavioral health conditions, racial and ethnic
minorities, sexual and gender minorities, people with disabilities,
people living in rural areas, and people in geographic HPSAs.
Emergency preparedness and response, such as measuring
MIPS eligible clinician participation in the Medical Reserve Corps,
measuring registration in the Emergency System for Advance Registration
of Volunteer Health Professionals, measuring relevant reserve and
active duty uniformed services MIPS eligible clinician activities, and
measuring MIPS eligible clinician volunteer participation in domestic
or international humanitarian medical relief work.
Integrated behavioral and mental health, such as measuring
or evaluating such practices as: Co-location of behavioral health and
primary care services; shared/integrated behavioral health and primary
care records; cross training of MIPS eligible clinicians, and
integrating behavioral health with primary care to address substance
use disorders or other behavioral health conditions, as well as
integrating mental health with primary care.
(d) Improvement Activities Inventory
In this section of this proposed rule, we are proposing to: (1)
Adopt one new criterion and remove one existing criterion for
nominating new improvement activities beginning with the CY 2019
performance period and future years; (2) modify the timeframe for the
Annual Call for Activities; (3) add 6 new improvement activities for
the CY 2019 performance period and future years; (4) modify 5 existing
improvement activities for the CY 2019 performance period and future
years; and (5) remove 1 existing improvement activity for the CY 2019
performance period and future years. We are also making clarifications
to: (1) Considerations for selecting improvement activities for the CY
2019 performance period and future years; and (2) the weighting of
improvement activities.
(i) Annual Call for Activities
In the CY 2017 Quality Payment Program final rule (81 FR 77190),
for the transition year of MIPS, we implemented the initial Improvement
Activities Inventory and took several steps to ensure it was inclusive
of activities in line with statutory and program requirements. For Year
2, we provided an informal process for submitting new improvement
activities or modifications for potential inclusion in the
comprehensive Improvement Activities Inventory for the Quality Payment
Program Year 2 and future years through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). In the CY 2018 Quality Payment Program
final rule (82 FR 53656 through 53659), for Year 3 and future years, we
finalized a formal Annual Call for Activities process for adding
possible new activities or providing modifications to the current
activities in the Improvement Activities Inventory, including
information required to submit a nomination form similar to the one we
utilized for Year 2 (82 FR 53656 through 53659). It is important to
note that in order to submit a request for a new activity or a
modification to an existing improvement activity the stakeholder must
submit a nomination form found at www.qpp.cms.gov during the Annual
Call for Improvement Activities.
(A) Criteria for Nominating New Improvement Activities
In this proposed rule, we are proposing to add one new criterion
and remove a previously adopted criterion from the improvement
activities nomination criteria. We are also clarifying our
considerations in selecting improvement activities.
(aa) Currently Adopted Criteria
In the CY 2017 Quality Payment final rule (81 FR 77190
through77195), we discussed guidelines for the selection of improvement
activities. In the CY 2018 Quality Payment Program final rule, we
formalized the Annual Call for Activities process for Year 3 and future
years and added additional criteria; stakeholders would apply one or
more of the below criteria when submitting nominations for improvement
activities (82 FR 53660):
Relevance to an existing improvement activities
subcategory (or a proposed new subcategory);
Importance of an activity toward achieving improved
beneficiary health outcome;
Importance of an activity that could lead to improvement
in practice to reduce health care disparities;
Aligned with patient-centered medical homes;
Focus on meaningful actions from the person and family's
point of view;
Support the patient's family or personal caregiver;
Activities that may be considered for an advancing care
information bonus;
Representative of activities that multiple individual MIPS
eligible clinicians or groups could perform (for example, primary care,
specialty care);
Feasible to implement, recognizing importance in
minimizing burden, especially for small practices, practices in rural
areas, or in areas designated as geographic HPSAs by HRSA;
Evidence supports that an activity has a high probability
of contributing to improved beneficiary health outcomes; or
CMS is able to validate the activity.
(bb) Proposed New Criteria
We believe it is important to place attention on public health
emergencies, such as the opioid epidemic, when considering improvement
activities for inclusion in the Inventory, because their inclusion
raises awareness for clinicians about the urgency of the situation and
to promote clinician adoption of best practices to combat those public
health emergencies. A list of the public health emergency declarations
is available at

[[Page 35908]]

https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx.
Therefore, in this proposed rule, we are proposing to adopt an
additional criterion entitled ``Include a public health emergency as
determined by the Secretary'' to the criteria for nominating new
improvement activities beginning with the CY 2019 performance period
and future years. We invite public comment on our proposal.
(cc) Proposed Removal of One Criteria
In the CY 2017 Quality Payment Program final rule (81 FR 77202
through 77209), we adopted a policy to award a bonus to the Promoting
Interoperability performance category score for MIPS eligible
clinicians who use CEHRT to complete certain activities in the
improvement activities performance category. We included a designation
column in the Improvement Activities Inventory at Table H in the
Appendix of the CY 2017 Quality Payment Program final rule (81 FR
77817) that indicated which activities qualified for the Promoting
Interoperability (formerly Advancing Care Information) bonus codified
at Sec. 414.1380(b)(4)(i)(D).
In section III.H.3.h.(5)(d)(ii) of this proposed rule, under the
Promoting Interoperability performance category, we are proposing a new
approach for scoring that moves away from the base, performance, and
bonus score methodology currently established. This new approach would
remove the availability of a bonus score for attesting to completing
one or more specified improvement activities using CEHRT beginning with
the CY 2019 performance period and future years. If this policy is
finalized, then we do not believe the criterion for selecting
improvement activities for inclusion in the program entitled
``Activities that may be considered for an advancing care information
bonus'' remains relevant. Therefore, we are proposing to remove the
criterion for selecting improvement activities for inclusion in the
program entitled ``Activities that may be considered for an advancing
care information bonus'' beginning with the CY 2019 performance period
and future years. We note that this proposal is being made in alignment
with and contingent upon those in section III.H.3.h.(5)(d)(ii) of the
proposed rule. If those proposals are not finalized, this proposal
would also not be finalized.
If our proposals to add one criterion and remove one criterion are
adopted as proposed, the new list of criteria for nominating new
improvement activities for the CY 2019 performance period and future
years would be as follows:
Relevance to an existing improvement activities
subcategory (or a proposed new subcategory);
Importance of an activity toward achieving improved
beneficiary health outcome;
Importance of an activity that could lead to improvement
in practice to reduce health care disparities;
Aligned with patient-centered medical homes;
Focus on meaningful actions from the person and family's
point of view;
Support the patient's family or personal caregiver;
Representative of activities that multiple individual MIPS
eligible clinicians or groups could perform (for example, primary care,
specialty care);
Feasible to implement, recognizing importance in
minimizing burden, especially for small practices, practices in rural
areas, or in areas designated as geographic HPSAs by HRSA;
Evidence supports that an activity has a high probability
of contributing to improved beneficiary health outcomes;
Include a public health emergency as determined by the
Secretary; or
CMS is able to validate the activity.
(B) Considerations in Selecting Improvement Activities
As noted in the CY 2017 Quality Payment final rule, we intend to
use the criteria for nominating new improvement activities in selecting
improvement activities for inclusion in the program (82 FR 53659).
However, we clarify here that those criteria are but one factor in
determining which improvement activities we ultimately propose. For
example, we also generally take into consideration other factors, such
as whether the nominated improvement activity uses publically available
products or techniques (that is, does not contain proprietary products
or information limiting an activity) or whether the nominated
improvement activity duplicates any currently adopted activity.
(C) Weighting of Improvement Activities
Given stakeholder feedback requesting additional transparency
regarding the weighting of improvement activities (82 FR 53657), in
this proposed rule, we are summarizing considerations we have
previously used to assign weights to improvement activities included in
the Improvement Activities Inventory (see Appendix 2: Improvement
Activities, Tables A and B). We are also making a few clarifications
and seeking comment for future weighting considerations. These topics
are discussed in more detail below.
(aa) Summary of Past Considerations
In the CY 2017 Quality Payment Program final rule (81 FR 77191), we
explained that to define the criteria and establish weighting for each
activity, we engage multiple stakeholder groups, including the Centers
for Disease Control, Health Resources and Services Administration,
Office of the National Coordinator for Health Information Technology,
SAMHSA, Agency for Healthcare Research and Quality, Food and Drug
Administration, the Department of Veterans Affairs, and several
clinical specialty groups, small and rural practices and non-patient
facing clinicians. Activities were proposed to be weighted as high
based on the extent to which they align with activities that support
the patient-centered medical home, since that is the standard under
section 1848(q)(5)(C)(i) of the Act for achieving the highest potential
score for the improvement activities performance category, as well as
with our priorities for transforming clinical practice (81 FR 77191).
Activities that require performance of multiple actions, such as
participation in the Transforming Clinical Practice Initiative (TCPI),
participation in a MIPS eligible clinician's state Medicaid program, or
an activity identified as a public health priority (such as emphasis on
anticoagulation management or utilization of prescription drug
monitoring programs) were also proposed to be weighted as high (81 FR
77191). We also stated that we believe that high weighting should be
used for activities that directly address areas with the greatest
impact on beneficiary care, safety, health, and well-being (81 FR
77194). In the past, we have given certain improvement activities high
weighting due to the intensity of the activity; for example, one
improvement activity was changed to high weighting because it often
involves travel and work under challenging physical and clinical
circumstances (81 FR 77194). Also, we note that successful
participation in the CMS Study on Factors Associated with Reporting
Quality Measures as discussed in section III.H.3.h.(4)(e) of this
proposed rule would result in full credit for the improvement
activities performance category of 40 points; if participants do not
meet the study guidelines, they will need to follow the current
improvement activities guidelines (81 FR 77197).
(bb) Clarifications
In this proposed rule, we are clarifying: (a) Our consideration of
giving high-weighting due to activity

[[Page 35909]]

intensity; and (b) differences between high- and medium-weighting.
(AA) High-Weighting Due to Activity Intensity
As stated above, we have given certain improvement activities high
weighting due to the intensity of the activity (81 FR 77194). To
elaborate, we believe that an activity that requires significant
investment of time and resources should be high-weighted. For example,
we finalized the CAHPS for MIPS survey as high-weighted (81 FR 77827),
because it requires a significant investment of time and resources. As
part of the requirements of this activity, MIPS eligible clinicians:
(1) Must register for the CAHPS for MIPS survey; (2) must select and
authorize a CMS-approved survey vendor to collect and report survey
data using the survey and specifications provided by us; and (3) are
responsible for vendor's costs to collect and report the survey (ranges
from approximately $4,000 to $7,000 depending on services requested).
In contrast, we believe medium-weighted improvement activities are
simpler to complete and require less time and resources as compared to
high-weighted improvement activities. For example, we finalized the
Cost Display for Laboratory and Radiographic Orders improvement
activity as medium-weighted (82 FR 54188), because the information
required to be used is readily available (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html) at no
cost through the Medicare clinical laboratory fee schedule and can be
distributed in a variety of manners with very little investment (for
example, it may be displayed in the clinic, provided to patients
through hardcopies, or incorporated in the electronic health record).
(BB) High- Versus Medium-Weighting
We recognize that we did not previously explicitly state separate
considerations for medium-weighted activities specifically. This is
because an improvement activity is only either high or medium-weighted.
In this proposed rule, we are clarifying that an improvement activity
is by default medium-weight unless it meets considerations for high-
weighting as discussed above.
(cc) Request for Comments
We intend to more thoroughly revisit our improvement activity
weighting policies in next year's rulemaking. We invite public comment
on the need for additional transparency and guidance on the weighting
of improvement activities as we work to refine the Annual Call for
Activities process for future years. Furthermore, in light of the
proposed policy to remove bonus points for improvement activities that
may be applicable to the Promoting Interoperability performance
category as discussed in sections III.H.3.h.(4)(d)(i)(A)(cc) and
III.H.3.h.(5)(d)(ii), we recognize the need to continue incentives for
CEHRT. Therefore, for future consideration, we are seeking comment on
potentially applying high-weighting for any improvement activity
employing CEHRT. We also invite public comment on any other additional
considerations for high- or medium-weighting.
(D) Timeframe for the Annual Call for Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we
finalized that we would accept submissions for prospective improvement
activities and modifications to existing improvement activities at any
time during the performance period to be added to the Improvement
Activities Under Review (IAUR) list, for the applicable performance
period, which would be displayed on a CMS website following the close
of the Call for Activities. In addition, we finalized that for the
Annual Call for Activities, only nominations and modifications
submitted by March 1st would be considered for inclusion in the IAUR
list and Improvement Activities Inventory for the performance period
occurring in the following calendar year (82 FR 53660). For example,
for the CY 2018 Call for Activities, we received nominations for new
and modified improvement activities from February 1st through March
1st. Currently, an improvement activity nomination submitted during the
CY 2018 Annual Call for Activities would be vetted in CY 2018, and
after review, if accepted by CMS, would be proposed during the CY 2018
rulemaking cycle for possible implementation in the CY 2019 performance
period and future years.
However, the previously established timeline, which includes
prospective new and modified improvement activities submission period,
review, and publication of proposed improvement activities for
implementation in the next performance period, has become operationally
challenging. Based on our experience over the past 2 years, we have
found that processing and reviewing the volume of improvement
activities nominations requires more time than originally thought. In
addition, preparations and drafting for annual rulemaking begin around
the time of the close date for the current Call for Activities (that
is, March 1st), leaving incorporation into the proposed rule
challenging. Therefore, in this proposed rule, beginning with the CY
2019 performance period and future years, we are proposing to: (1)
Delay the year for which nominations of prospective new and modified
improvement activities would apply; and (2) expand the submission
timeframe/due date for nominations.
Beginning with the CY 2019 performance period and for future years,
we are proposing to change the performance year for which the
nominations of prospective new and modified improvement activities
would apply, such that improvement activities nominations received in a
particular year will be vetted and considered for the next year's
rulemaking cycle for possible implementation in a future year. This
timeframe parallels the Promoting Interoperability performance category
Annual Call for EHR Measures timeframe found at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. For example, an improvement activity nomination
submitted during the CY 2020 Annual Call for Activities would be
vetted, and if accepted by CMS, would be proposed during the CY 2021
rulemaking cycle for possible implementation starting in CY 2022. We
believe this change will give us adequate time to thoroughly vet
improvement activity nominations prior to rulemaking.
Second, beginning with the CY 2019 performance period, we are
proposing to change the submission timeframe for the Call for
Activities from February 1st through March 1st to February 1st through
June 30th, providing approximately 4 additional months for stakeholders
to submit nominations. We believe this change will assist stakeholders
by providing additional time to submit improvement activities
nominations. Consistent with previous policy, nominations for
prospective new and modified improvement activities would be accepted
during the Call for Activities time period only and would be included
in the IAUR displayed on a CMS website following the close of the
Annual Call for Activities.

[[Page 35910]]

(ii) Proposed New Improvement Activities and Modifications to and
Removal of Existing Improvement Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we
finalized that we would add new improvement activities to the
Improvement Activities Inventory through notice-and-comment rulemaking.
We refer readers to Table H in the Appendix of the CY 2017 Quality
Payment Program final rule (81 FR 77177 through 77199) and Table F and
G in the Appendix of the CY 2018 Quality Payment Program final rule (82
FR 54175 through 54229) for our previously finalized Improvement
Activities Inventory. In this proposed rule, for CY 2019 performance
period and future years, we are proposing 6 new improvement activities;
we are also proposing to: (1) Modify 5 existing activities; and (2)
remove 1 existing activity. We refer readers to the Improvement
Activities Inventory in Tables A and B of Appendix 2 of this proposed
rule for further details. We are also proposing changes to our CMS
Study on Factors Associated with Reporting Quality Measures in section
III.H.3.h.(4)(e) of this proposed rule.
We invite public comments on the proposed new activities and
modifications to and removal of existing activities listed in the
Improvement Activities Inventory for the CY 2019 performance period and
future years.
(e) CMS Study on Factors Associated With Reporting Quality Measures
(i) Background
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we
created the Study on Improvement Activities and Measurement. In CMS'
quest to create a culture of improvement using evidence based medicine
on a consistent basis, fully understanding the strengths and
limitations of the current processes is crucial to better understand
the current processes. We proposed to conduct a study on clinical
improvement activities and measurement to examine clinical quality
workflows and data capture using a simpler approach to quality measures
(81 FR 77196). The lessons learned in this study on practice
improvement and measurement may influence changes to future MIPS data
submission requirements. The goals of the study are to see whether
there will be improved outcomes, reduced burden in reporting, and
enhancements in clinical care by selected MIPS eligible clinicians (81
FR 77196). This study shall inform us on the root causes of clinicians'
performance measure data collection and submission burdens, as well as
challenges that hinder accurate and timely quality measurement
activities. Our goals are to use high quality, low cost measures that
are meaningful, easy to understand, operable, reliable, and valid. As
discussed in the CY 2017 Quality Payment Program final rule (81 FR
77195) the CMS Study on Burden Associated with Quality Reporting goals
are to see whether there will be improved outcomes, reduced burden in
reporting, and enhancements in clinical care by selected MIPS eligible
clinicians desiring:
A more data driven approach to quality measurement.
Measure selection unconstrained by a CEHRT program or
system.
Improving data quality submitted to CMS.
Enabling CMS to get data more frequently and provide
feedback more often.
This study evolved into ``CMS Study on Burdens Associated with
Reporting Quality Measures'' in the CY 2018 Quality Payment Program
final rule (82 FR 53662).
This study is ongoing, participants are recruited on a yearly basis
for a minimum period of 3 years, and current participants can opt-in or
out when the study year ends (81 FR 77195). Successful participation in
the study would result in full credit for the improvement activities
performance category of 40 points; if participants do not meet the
study guidelines, they will need to follow the current improvement
activities requirements (81 FR 77197). To meet the study requirements,
study participants must partake in two web-based survey questionnaires,
submit data for at least three MIPS clinician quality measures to CMS
during the CY 2019 performance period, and be available for selection
and participation in at least one focus group meeting (82 FR 53662).
While we are not proposing any changes to the study purpose, aim,
eligibility, or credit, we are proposing, for the CY 2019 performance
period and future years, changes to the: (1) Title of the study; (2)
sample size to allow enough statistical power for rigorous analysis
within some categories, (3) focus group and survey requirements; and
(4) measure requirements. These proposals are discussed in more detail
below.
(ii) Title
Beginning with the CY 2019 performance period, we are proposing to
change the title of the study from ``CMS Study on Burdens Associated
with Reporting Quality Measures'' to ``CMS Study on Factors Associated
with Reporting Quality Measures'' to more accurately reflect the
study's intent and purpose. To assess the root causes of clinician
burden associated with the collection and submission of clinician
quality measures for MIPS, as depicted in CY 2017 Quality Payment
Program final rule (81 FR 77195), replacing ``Burden'' with ``Factors''
in the title will eliminate possible response or recall bias that may
occur with data collection. Having ``burden'' in the study title may
elicit the tendency of survey participants reporting more on their
perception of burden and challenges, and/or suppressing other factors
that are associated with their quality measure data collection and
submission, that may be relevant to examining the root cause of burden.
(iii) Sample Size
(A) Current Policy
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we
initially finalized a sample size of 42 participants (comprising of
groups and individual MIPS eligible facilities). In the CY 2018 Quality
Payment Program final rule (82 FR 53661), we increased that number and
finalized a sample size of a minimum of 102 individual and group
participants for performance periods occurring in CY 2018 for the
following categories:
20 urban individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
20 rural individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
10 groups of 3-8 eligible clinicians.
10 groups of 8-20 eligible clinicians.
10 groups of 20-100 eligible clinicians.
10 groups of 100 or greater eligible clinicians.
6 groups of >20 eligible clinicians reporting as
individuals--(broken down into 3 urban & 3 rural).
6 specialty groups--(broken down into 3 reporting
individually & 3 reporting as a group).
Up to 10 non-MIPS eligible clinicians reporting as a group
or individual (any number of individuals and any group size).
(B) Proposed New Sample Size
In this proposed rule, we are proposing to again increase the
sample size for the CY 2019 performance period and future years from a
minimum of 102 to a minimum of 200 MIPS eligible

[[Page 35911]]

clinicians, which will enable us to more rigorously analyze the
statistical difference between the burden and factors associated within
the categories listed above. This proposed increase in sample size
would provide the minimum sample needed to get a significant result
with adequate statistical power to determine whether there are any
statistically significant differences in quality measurement data
submission associated with: (1) The size of practice or facility; (2)
clinician specialty of practice; (3) region of practice; (4) individual
or group reporting; and (5) clinician quality measure type. This
rigorous statistical analysis is important, because it facilitates
tracing the root causes of measurement burdens and data submission
errors that may be associated with various sub-groups of clinician
practices using quantitative analytical methods. We believe that a
larger sample size would also account for any attrition (drop out of
study participants before the study ends). Therefore, we are proposing
that the new sample size distribution would be:
40 urban individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
40 rural individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
20 groups of 3-8 eligible clinicians.
20 groups of 8-20 eligible clinicians.
20 groups of 20-100 eligible clinicians.
20 groups of 100 or greater eligible clinicians.
Up to 6 groups of >20 eligible clinicians reporting as
individuals--(broken down into 3 urban & 3 rural).
Up to 6 specialty groups--(broken down into 3 reporting
individually & 3 reporting as a group).
Up to 10 non-MIPS eligible clinicians reporting as a group
or individual (any number of individuals and any group size).
(iv) Focus Group
(A) Current Policies
We previously finalized in the CY 2017 Quality Payment Program
final rule (81 FR 77195) that for the transition year of MIPS, study
participants were required to attend a monthly focus group to share
lessons learned in submitting quality data along with providing survey
feedback to monitor effectiveness. The focus group includes providing
visual displays of data, workflows, and best practices to share amongst
the participants to obtain feedback and make further improvements (81
FR 77196). The focus groups are used to learn from the practices about
how to be more agile as we test new ways of measure recording and
workflow (81 FR 77196). In the CY 2018 Quality Payment Program final
rule (82 FR 53662), for Year 2 and future years, we reduced that
requirement and finalized that study participants would be required to
complete at least two web-based survey questionnaire and attend up to 4
focus group sessions throughout the year, but certain study
participants would be able to attend less frequently. Each study
participant is required to complete a survey prior to submitting MIPS
data and another survey after submitting MIPS data (82 FR 53662). The
purpose of reducing focus group attendance and survey participation was
to ease requirements for MIPS eligible clinicians or group of
clinicians who may have nothing new to contribute, without compromising
the minimum sample needed for focus groups. For example, if a MIPS
eligible clinician submitted all 6 measures after collecting 90 days of
data and attended the first available focus group and/or survey, the
clinician may have nothing new or relevant to discuss with the research
team on subsequent focus groups and/or surveys.
(B) Proposed New Requirements for Focus Group and Survey Participation
Although we are proposing in the section above to increase the
sample size of the study to a minimum of 200 MIPS eligible clinicians,
we do not believe we need focus groups for the entirety of that
population. We believe that requiring focus groups for all proposed
minimum of 200 MIPS eligible clinicians would only result in bringing
the data to a saturation point, a situation whereby the same themes and
information are recurring, and no new insights are given by additional
sources of data from focus groups.
Instead, we believe that selecting a subset of clinicians,
purposively, to participate in focus groups would be a more appropriate
approach because that would allow us to understand the experience of
select clinicians without imposing undue burden on all. This study is
voluntary as clinicians nominate themselves to participate and we
select a cohort from among these volunteers. Therefore, we are
proposing to make the focus group participation a requirement only for
a selected subset of the study participants, using purposive sampling
and random sampling methods, beginning with the CY 2019 performance
period and future years. Those who are selected would be required to
participate, in at least one focus group meeting and complete survey
requirements, in addition to all the other study requirements. As
previously established, each study participant is required to complete
a survey prior to submitting MIPS data and another survey after
submitting MIPS data. This requirement would continue to apply for each
selected subset participating in a focus group.
(v) Measure Requirements
(A) Current Requirements
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we
finalized that for CY 2017, the participating MIPS eligible clinicians
or groups would submit their data and workflows for a minimum of three
MIPS clinician quality measures that are relevant and prioritized by
their practice. One of the measures must be an outcome measure, and one
must be a patient experience measure (81 FR 77196). We also finalized
that for future years, participating MIPS eligible clinicians or groups
would select three of the measures for which they have baseline data
from the 2017 performance period to compare against later performance
years. We note that participating MIPS eligible clinicians could elect
to report on more measures originally as this would provide more
options from which to select in subsequent years for purposes of
measuring improvement. In the CY 2018 Quality Payment Program final
rule, we finalized for the Quality Payment Program Year 2 and future
years, that study participants could submit all their quality measures
data at once, as it is done in the MIPS program, (qpp.cms.gov) (82 FR
53662).
(B) Proposed Measure Requirements
In this proposed rule, we are proposing to continue the previously
required minimum number of measures. That is, for the CY 2019
performance period and future years: Participants must submit data and
workflows for a minimum of three MIPS quality measures for which they
have baseline data. However, instead of requiring one outcome measure
and one patient experience measure as previously finalized, we are
proposing that, for the CY 2019 performance period and future years, at
least one of the minimum of three measures must be a high priority
measure as defined at Sec. 414.1305. As defined there and discussed in
section III.H.3.h.(2) of this proposed rule, a high priority measure
means an outcome, appropriate use, patient safety, efficiency, patient
experience, care coordination, or opioid-related quality

[[Page 35912]]

measure. Outcome measures includes intermediate-outcome and patient-
reported outcome measures. We believe that focusing on high priority
measures, rather than patient experience measures, is important at this
time, because it better aligns with the MIPS quality measures data
submission criteria. We invite public comment on our proposal.
We note that although the aforementioned activities (that is, the
CMS Study on Factors Associated with Reporting Quality Measures)
constitute an information collection request as defined in the
implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR
part 1320), the associated burden is exempt from application of the
Paperwork Reduction Act. Specifically, section 1848(s) (7) of the Act,
as added by section 102 of MACRA (Pub. L. 114-10) states that Chapter
35 of title 44, United States Code, shall not apply to the collection
of information for the development of quality measures.
(5) Promoting Interoperability (PI) (Previously Known as the Advancing
Care Information Performance Category)
(a) Background
Section 1848(q)(2)(A) of the Act includes the meaningful use of
CEHRT as a performance category under the MIPS. In prior rulemaking, we
referred to this performance category as the advancing care information
performance category, and it is reported by MIPS eligible clinicians as
part of the overall MIPS program. As required by sections 1848(q)(2)
and (5) of the Act, the four performance categories of the MIPS shall
be used in determining the MIPS final score for each MIPS eligible
clinician. In general, MIPS eligible clinicians will be evaluated under
all four of the MIPS performance categories, including the advancing
care information performance category.
(b) Renaming the Advancing Care Information Performance Category
In this proposed rule, we are proposing several scoring and
measurement policies that would bring the performance category to a new
phase of EHR measurement with an increased focus on interoperability
and improving patient access to health information. To better reflect
this focus, we renamed the advancing care information performance
category to the Promoting Interoperability (PI) performance category.
We believe this change will help highlight the enhanced goals of this
performance category. We are proposing revisions to the regulation text
under 42 CFR part 414, subpart O, to reflect the new name.
(c) Certification Requirements Beginning in 2019
Under the definition of CEHRT under Sec. 414.1305, for the
performance periods in 2017 and 2018, MIPS eligible clinicians had
flexibility to use EHR technology certified to either the 2014 or 2015
Edition certification criteria, or a combination of the two Editions,
to meet the objectives and measures specified for the Promoting
Interoperability performance category (82 FR 53671 through 53672).
However, beginning with the performance period in 2019, MIPS eligible
clinicians must use EHR technology certified to the 2015 Edition
certification criteria as specified at Sec. 414.1305. As discussed in
this section, we continue to believe it is appropriate to require the
use of 2015 Edition CEHRT beginning in CY 2019. In reviewing the state
of health information technology, it is clear the 2014 Edition
certification criterion are out of date and insufficient for clinician
needs in the evolving health information technology (IT) industry. It
would be beneficial to health IT developers and health care providers
to move to more up-to-date standards and functions that better support
interoperable exchange of health information and improve clinical
workflows.
The 2014 Edition certification criteria, which were first issued in
regulations in 2012, now includes standards that are significantly out
of date, which can impose limits on interoperability and the access,
exchange, and use of health information. Moving from certifying to the
2014 Edition to certifying to the 2015 Edition would also eliminate the
inconsistencies that are inherent with maintaining and implementing two
separate certification programs. In the last calendar year, the number
of new and unique 2014 Edition products have been declining, showing
that the market acknowledges the shift towards newer and more effective
technologies. The vast majority of 2014 Edition certifications are for
inherited certified status. The resulting legacy systems, while
certified to the 2014 Edition, are not the most up-to-date and detract
from health information technology's goal of increasing
interoperability and increasing the access, exchange, and use of health
data.
Prolonging backwards compatibility of newer products to legacy
systems causes market fragmentation. Health IT stakeholders noted the
impact of system fragmentation on the cost to develop and maintain
health IT connectivity to support data exchange, develop products to
support specialty clinical care, and integrate software supporting
administrative and clinical processes. As previously stated, a large
proportion of the sector is ready to use only the 2015 Edition of
CEHRT; allowing use of both certification editions contributes to
market fragmentation, which heightens implementation costs for health
IT developers, clinicians, and other health care providers. Developers
and consumers that maintain two different certification editions spend
large amounts of money on the recertification of older products, which
diverts resources from the development, maintenance, and implementation
of more advanced technologies, including 2015 Edition CEHRT.
In addition to the monetary savings resulting from a move to the
2015 Edition, there will also be reduced burden across many settings.
MIPS eligible clinicians will see a reduction in burden through the
relief from certifying to a legacy system and can use 2015 Edition
CEHRT to better streamline workflows and utilize more comprehensive
functions to meet patient safety goals and improve care coordination
across the continuum. Maintaining only one edition of certification
requirements would also reduce the burden for health IT developers, as
well as Office of the National Coordinator for Health Information
Technology (ONC)-Authorized Testing Laboratories and ONC-Authorized
Certification Bodies because they would no longer have to support two,
increasingly distant sets of requirements.
One of the major improvements of the 2015 Edition is the
Application Programming Interface (API) functionality. The API
functionality supports health care providers and patient electronic
access to health information. These functions allow for patient data to
move between systems and assist patients with making key decisions
about their health care. These functions also contribute to quality
improvement and greater interoperability between systems. The API has
the ability to complement a specific health care provider branded
patient portal or could also potentially make one unnecessary if
patients are able to use software applications designed to interact
with an API that could support their ability to view, download, and
transmit their health information to a third party (80 FR 62842).
Furthermore, the API allows for third-party application usage with more
flexibility and smoother workflow from various systems than what is
often found in many current patient portals.

[[Page 35913]]

The 2015 Edition also includes certification criterion specifying a
core set of data that health care providers have noted are critical to
interoperable exchange and can be exchanged across a wide variety of
other settings and use cases, known as the Common Clinical Data Set
(CCDS) (80 FR 62603). The US Core Data for Interoperability (USCDI)
builds off the CCDS definition adopted for the 2015 Edition of
certified health IT for instance as the data which must be included in
a summary care record. The USCDI aims to support the goals set forth in
the 21st Century Cures Act by specifying a common set of data classes
that are required for interoperable exchange and identifying a
predictable, transparent, and collaborative process for achieving those
goals. The USCDI is referenced by the Draft Trusted Exchange Framework
(https://www.healthit.gov/sites/default/files/draft-trusted-exchange-framework.pdf), which is intended to enable Healthcare Information
Networks (HINs) and Qualified HINs to securely exchange electronic
health information in support of a range permitted purposes, including
treatment, payment, operations, individual access, public health, and
benefits determination.
The 2015 Edition also includes a requirement that products must be
able to export data from one patient, a set of patients, or a subset of
patients, which is responsive to health care provider feedback that
their data is unable to carry over from a previous EHR. The 2014
Edition did not include a requirement that the vendor allow the MIPS
eligible clinician to export the data themselves. In the 2015 Edition,
the health care provider has the autonomy to export data themselves
without intervention by their vendor, resulting in increased
interoperability and data exchange in the 2015 Edition.
In efforts to track certification readiness for the 2015 Edition,
ONC considers the number of health care providers likely to be served
by the developers seeking certification under the ONC Health IT
Certification Program in real time as the testing and certification
process progresses. The ONC considers trends within the industry when
projecting for 2015 Edition readiness. In working with ONC, we are able
to identify the percentage of MIPS eligible clinicians that have a 2015
Edition of CEHRT available to them based on vendor readiness and
information. As of the beginning of the first quarter of CY 2018, ONC
confirmed that at least 66 percent of MIPS eligible clinicians have
2015 Edition CEHRT available based on previous Medicare and Medicaid
EHR Incentive Programs attestation data. Based on these data, and as
compared to the transition from 2011 Edition to 2014 Edition, it
appears that the transition from the 2014 Edition to the 2015 Edition
is on schedule for the performance period in CY 2019.
This information is current as of the beginning of CY 2018, and
based on historical data, we expect readiness to continue to improve as
developers and health care providers prepare for program participation
using the 2015 Edition in CY 2019.
We continue to recognize there is a burden associated with
development and deployment of new technology, but we believe requiring
use of the most recent version of CEHRT is important in ensuring health
care providers will use technology that has improved interoperability
features and up-to-date standards to collect and exchange relevant
patient health information. The 2015 Edition includes key updates to
functions and standards that support improved interoperability and
clinical effectiveness through the use of health IT.
(d) Scoring Methodology
(i) Scoring Methodology for 2017 and 2018 Performance Periods
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of
the MIPS final score shall be based on performance for the Promoting
Interoperability performance category. Accordingly, under Sec.
414.1375(a), the Promoting Interoperability performance category
comprises 25 percent of a MIPS eligible clinician's final score for the
2019 MIPS payment year and each MIPS payment year thereafter, unless we
assign a different scoring weight. We are proposing to revise Sec.
414.1375(a) to specify the various sections of the statute (sections
1848(o)(2)(D), 1848(q)(5)(E)(ii), and 1848(q)(5)(F) of the Act) under
which a different scoring weight may be assigned for the Promoting
Interoperability performance category. We established the reporting
criteria to earn a performance category score for the Promoting
Interoperability performance category under Sec. 414.1375(b). We are
proposing to revise Sec. 414.1375(b)(2)(i) to replace the reference to
``each required measure'' with ``each base score measure'' to improve
the precision of the text. Under Sec. 414.1380(b)(4), the Promoting
Interoperability performance category score is comprised of a score for
participation and reporting, known as the ``base score,'' and a score
for performance at varying levels above the base score requirements,
known as the ``performance score,'' as well as any applicable bonus
scores. We are proposing several editorial changes to Sec.
414.1380(b)(4) in an effort to more clearly and concisely capture the
previously established policies. For further explanation of our scoring
policies for performance periods in 2017 and 2018 for the Promoting
Interoperability performance category, we refer readers to 81 FR 77216
through 77227 and 82 FR 53663 through 53664.
A general summary overview of the scoring methodology for the
performance period in 2018 is provided in the Table 35.

Table 35--2018 Performance Period Promoting Interoperability Performance Category Scoring Methodology Promoting Interoperability Objectives and Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
2018 Promoting
2018 Promoting interoperability interoperability Required/not required for Performance score (up to 90%) Reporting requirement
objective measure base score (50%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protect Patient Health Security Risk Required.................. 0............................. Yes/No Statement.
Information. Analysis.
Electronic Prescribing........... e-Prescribing **..... Required.................. 0............................. Numerator/Denominator.
Patient Electronic Access........ Provide Patient Required.................. Up to 10...................... Numerator/Denominator.
Access.
Patient-Specific Not Required.............. Up to 10...................... Numerator/Denominator.
Education.
Coordination of Care Through View, Download, or Not Required.............. Up to 10...................... Numerator/Denominator.
Patient Engagement. Transmit (VDT). Not Required.............. Up to 10...................... Numerator/Denominator.
Secure Messaging.....
Patient-Generated Not Required.............. Up to 10...................... Numerator/Denominator.
Health Data.
Health Information Exchange...... Send a Summary of Required.................. Up to 10...................... Numerator/Denominator.
Care **.

[[Page 35914]]

Request/Accept Required.................. Up to 10...................... Numerator/Denominator.
Summary of Care **.
Clinical Information Not Required.............. Up to 10...................... Numerator/Denominator.
Reconciliation.
Public Health and Clinical Data Immunization Registry Not Required.............. 0 or 10 *..................... Yes/No Statement.
Registry Reporting. Reporting. Not Required.............. 0 or 10 *..................... Yes/No Statement
Syndromic
Surveillance
Reporting.
Electronic Case Not Required.............. 0 or 10 *..................... Yes/No Statement.
Reporting.
Public Health Not Required.............. 0 or 10 *..................... Yes/No Statement.
Registry Reporting.
Clinical Data Not Required.............. 0 or 10 *..................... Yes/No Statement.
Registry Reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bonus (up to 25%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Report to one or more additional public health agencies 5% bonus Yes/No Statement..............
or clinical data registries beyond the one identified
for the performance score.
----------------------------------------------------------------------------------------------------------------------
Report improvement activities using CEHRT.............. 10% bonus Yes/No Statement..............
----------------------------------------------------------------------------------------------------------------------
Report using only 2015 Edition CEHRT................... 10% bonus Based on measures submitted...
--------------------------------------------------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10 percent for each public health agency or clinical data registry to which the clinician reports, up to a maximum
of 10 percent under the performance score.
** Exclusions are available for these measures.

We heard from many stakeholders that the current scoring
methodology is complicated and difficult to understand. In fact, we
have received hundreds of questions requesting clarification of various
aspects of the scoring methodology. For example, many clinicians asked
how many performance score measures they should submit. By providing
flexibility and offering clinicians multiple measures to choose from
within the performance score, it appears some clinicians may have been
confused by the options. Other MIPS eligible clinicians have indicated
that they dislike the base score because it is a required set of
measures and provides no flexibility because the scoring is all or
nothing. If a MIPS eligible clinician cannot fulfill the base score,
they cannot earn a performance and/or bonus score. We have also
received feedback from clinicians and specialty societies that the
current requirements detract from their ability to provide care to
their patients. In addition, stakeholders have indicated that the
requirements of the Promoting Interoperability performance category for
clinicians do not align with the requirements of the Medicare Promoting
Interoperability Program for eligible hospitals and critical access
hospitals (CAHs) and that this creates a burden for the medical staff
who are tasked with overseeing the participation of both clinicians and
hospitals in these programs.
Based on the concerns expressed by stakeholders, we are proposing a
new scoring methodology and moving away from the base, performance and
bonus score methodology that we currently use. We believe this change
would provide a simpler, more flexible, less burdensome structure,
allowing MIPS eligible clinicians to put their focus back on patients.
The introduction of this new scoring methodology would continue to
encourage MIPS eligible clinicians to push themselves on measures that
are most applicable to how they deliver care to patients, instead of
focusing on measures that may not be as applicable to them. Our goal is
to provide increased flexibility to MIPS eligible clinicians and enable
them to focus more on patient care and health data exchange through
interoperability. Additionally, we want to align the requirements of
the Promoting Interoperability performance category with the
requirements of the Medicare Promoting Interoperability Program for
eligible hospitals and CAHs as we have proposed in the FY 2019 IPPS/
LTCH PPS proposed rule (83 FR 20518 through 20537). As the distinction
between ambulatory and inpatient CEHRT has diminished and more
clinicians are sharing hospitals' CEHRT, we believe that aligning the
requirements between programs would lessen the burden on health care
providers and facilitate their participation in both programs.
(ii) Proposed Scoring Methodology Beginning With the MIPS Performance
Period in 2019
We are proposing a new scoring methodology, beginning with the
performance period in 2019, to include a combination of new measures,
as well as the existing Promoting Interoperability performance category
measures, broken into a smaller set of four objectives and scored based
on performance. We believe this is an overhaul of the existing program
requirements as it eliminates the concept of base and performance
scores. The smaller set of objectives would include e-Prescribing,
Health Information Exchange, Provider to Patient Exchange, and Public
Health and Clinical Data Exchange. We are proposing these objectives to
promote specific HHS priorities and satisfy the requirements of section
1848(o)(2) of the Act. We include the e-Prescribing and Health
Information Exchange objectives in part to capture what we believe are
core goals for the 2015 Edition of CEHRT and also to satisfy the
statutory requirements. These core goals promote interoperability
between health care providers and health IT systems to support safer,
more coordinated care. The Provider to Patient Exchange objective
promotes patient awareness and involvement in their health care through
the use of APIs, and ensures patients have access to their medical
data. Finally, the Public Health and Clinical Data Exchange objective
supports the ongoing systematic

[[Page 35915]]

collection, analysis, and interpretation of data that may be used in
the prevention and controlling of disease through the estimation of
health status and behavior. The integration of health IT systems into
the national network of health data tracking and promotion improves the
efficiency, timeliness, and effectiveness of public health
surveillance. We believe it is important to keep these core goals,
primarily because these objectives promote interoperability between
health care providers and health IT systems to support safer, more
coordinated care while ensuring patients have access to their medical
data.
Under the proposed scoring methodology, MIPS eligible clinicians
would be required to report certain measures from each of the four
objectives, with performance-based scoring occurring at the individual
measure-level. Each measure would be scored based on the MIPS eligible
clinician's performance for that measure, based on the submission of a
numerator and denominator, except for the measures associated with the
Public Health and Clinical Data Exchange objective, which require ``yes
or no'' submissions. Each measure would contribute to the MIPS eligible
clinician's total Promoting Interoperability performance category
score. The scores for each of the individual measures would be added
together to calculate the Promoting Interoperability performance
category score of up to 100 possible points for each MIPS eligible
clinician. In general, the Promoting Interoperability performance
category score makes up 25 percent of the MIPS final score. If a MIPS
eligible clinician fails to report on a required measure or claim an
exclusion for a required measure if applicable, the clinician would
receive a total score of zero for the Promoting Interoperability
performance category.
We also considered an alternative approach in which scoring would
occur at the objective level, instead of the individual measure level,
and MIPS eligible clinicians would be required to report on only one
measure from each objective to earn a score for that objective. Under
this scoring methodology, instead of six required measures, the MIPS
eligible clinician total Promoting Interoperability performance
category score would be based on only four measures, one measure from
each objective. Each objective would be weighted similarly to how the
objectives are weighted in our proposed methodology, and bonus points
would be awarded for reporting any additional measures beyond the
required four. We are seeking public comment on this alternative
approach, and whether additional flexibilities should be considered,
such as allowing MIPS eligible clinicians to select which measures to
report on within an objective and how those objectives should be
weighted, as well as whether additional scoring approaches or
methodologies should be considered.
In our proposed scoring methodology, the e-Prescribing objective
would contain three measures each weighted differently to reflect their
potential availability and applicability to the clinician community. In
addition to the existing e-Prescribing measure, we are proposing to add
two new measures to the e-Prescribing objective: Query of Prescription
Drug Monitoring Program (PDMP); and Verify Opioid Treatment Agreement.
For more information about these two proposed measures, we refer
readers to section. III.H.3.h.(5)(f) of this proposed rule. The e-
Prescribing measure would be required for reporting and weighted at 10
points because we believe it would be applicable to most MIPS eligible
clinicians. In the event that a MIPS eligible clinician meets the
criteria and claims the exclusion for the e-Prescribing measure in
2019, the 10 points available for that measure would be redistributed
equally among the two measures under the Health Information Exchange
objective:
Support Electronic Referral Loops By Sending Health
Information Measure (25 points)
Support Electronic Referral Loops By Receiving and
Incorporating Health Information (25 points)
We are seeking public comment on whether this redistribution is
appropriate for 2019, or whether the points should be distributed
differently.
The Query of PDMP and Verify Opioid Treatment Agreement measures
would be optional for the MIPS performance period in 2019. These new
measures may not be available to all MIPS eligible clinicians for the
MIPS performance period in 2019 as they may not have been fully
developed by their health IT vendor, or not fully implemented in time
for data capture and reporting. Therefore, we are not proposing to
require these two new measures in 2019, although MIPS eligible
clinicians may choose to report them and earn up to 5 bonus points for
each measure. We are proposing to require these measures beginning with
the MIPS performance period in 2020, and we are seeking public comment
on this proposal. Due to varying State requirements, not all MIPS
eligible clinicians would be able to e-prescribe controlled substances,
and thus, these measures would not be available to them. For these
reasons, we are proposing an exclusion for these two measures beginning
with the MIPS performance period in 2020. The exclusion would provide
that any MIPS eligible clinician who is unable to report the measure in
accordance with applicable law would be excluded from reporting the
measure, and the 5 points assigned to that measure would be
redistributed to the e-Prescribing measure.
As the two new opioid measures become more broadly available in
CEHRT, we are proposing each of the three measures within the e-
Prescribing objective would be worth 5 points beginning with the MIPS
performance period in 2020. Requiring these two measures would add 10
points to the maximum total score for the Promoting Interoperability
performance category as these measures would no longer be eligible for
optional bonus points. To maintain a maximum total score of 100 points,
beginning with the MIPS performance period in 2020, we are proposing to
reweight the e-Prescribing measure from 10 points down to 5 points, and
reweight the Provide Patients Electronic Access to Their Health
Information measure from 40 points down to 35 points as illustrated in
Table 36. We are proposing that if the MIPS eligible clinician
qualifies for the e-Prescribing exclusion and is excluded from
reporting all three of the measures associated with the e-Prescribing
objective as described in section III.H.3.h.(5)(f) of this proposed
rule, the 15 points for the e-Prescribing objective would be
redistributed evenly among the two measures associated with the Health
Information Exchange objective and the Provide Patients Electronic
Access to their Health Information measure by adding 5 points to each
measure.
For the Health Information Exchange objective, we are proposing to
change the name of the existing Send a Summary of Care measure to
Support Electronic Referral Loops by Sending Health Information, and
proposing a new measure which combines the functionality of the
existing Request/Accept Summary of Care and Clinical Information
Reconciliation measures into a new measure, Support Electronic Referral
Loops by Receiving and Incorporating Health Information. For more
information about the proposed measure and measure changes, we refer
readers to section III.H.3.h.(5)(f) of this proposed rule. MIPS
eligible clinicians would be required to report both of these measures,
each worth 20 points toward their total Promoting

[[Page 35916]]

Interoperability performance category score. These measures are
weighted heavily to emphasize the importance of sharing health
information through interoperable exchange in an effort to promote care
coordination and better patient outcomes. Similar to the two new
measures in the e-Prescribing objective, the new Support Electronic
Referral Loops by Receiving and Incorporating Health Information
measure may not be available to all MIPS eligible clinicians as it may
not have been fully developed by their health IT vendor, or not fully
implemented in time for a MIPS performance period in 2019. For these
reasons, we are proposing an exclusion for the Support Electronic
Referral Loops by Receiving and Incorporating Health Information
measure: Any MIPS eligible clinician who is unable to implement the
measure for a MIPS performance period in 2019 would be excluded from
having to report this measure.
In the event that a MIPS eligible clinician claims an exclusion for
the Support Electronic Referral Loops by Receiving and Incorporating
Health Information measure, the 20 points would be redistributed to the
Support Electronic Referral Loops by Sending Health Information
measure, and that measure would then be worth 40 points. We are seeking
public comment on whether this redistribution is appropriate, or
whether the points should be redistributed to other measures instead.
We are proposing to weight the one measure in the Provider to
Patient Exchange objective, Provide Patients Electronic Access to Their
Health Information, at 40 points toward the total Promoting
Interoperability performance category score in 2019 and 35 points
beginning in 2020. We are proposing that this measure would be weighted
at 35 points beginning in 2020 to account for the two new opioid
measures, which would be worth 5 points each beginning in 2020 as
proposed above. We believe this objective and its associated measure
get to the core of improved access and exchange of patient data in
Promoting Interoperability and are the crux of the Promoting
Interoperability performance category. This exchange of data between
health care provider and patient is imperative in order to continue to
improve interoperability, data exchange and improved health outcomes.
We believe that it is important for patients to have control over their
own health information, and through this highly weighted objective we
are aiming to show our dedication to this effort.
The measures under the Public Health and Clinical Data Exchange
objective are reported using ``yes or no'' responses and thus we are
proposing to score those measures on a pass/fail basis in which the
MIPS eligible clinician would receive the full 10 points for reporting
two ``yes'' responses, or for submitting a ``yes'' for one measure and
claiming an exclusion for another. If there are no ``yes'' responses
and two exclusions are claimed, the 10 points would be redistributed to
the Provide Patients Electronic Access to Their Health Information
measure. A MIPS eligible clinician would receive zero points for
reporting ``no'' responses for the measures in this objective if they
do not submit a ``yes'' or claim an exclusion for at least two measures
under this objective. We are proposing that for this objective, the
MIPS eligible clinician would be required to report on two measures of
their choice from the following list of measures: Immunization Registry
Reporting, Electronic Case Reporting, Public Health Registry Reporting,
Clinical Data Registry Reporting, and Syndromic Surveillance Reporting.
To account for the possibility that not all of the measures under the
Public Health and Clinical Data Exchange objective may be applicable to
all MIPS eligible clinicians, we are proposing to establish exclusions
for these measures as described in section III.H.3.h.(5)(f) of this
proposed rule. If a MIPS eligible clinician claims two exclusions, the
10 points for this objective would be redistributed to the Provide
Patients Electronic Access to their Health Information measure under
the Provider to Patient Exchange objective, making that measure worth
50 points in 2019 and 45 points beginning in 2020. Reporting more than
two measures for this objective would not earn the MIPS eligible
clinician any additional points. We refer readers to section
III.H.3.h.(5)(f) of this proposed rule in regard to the proposals for
the Public Health and Clinical Data Exchange objective and its
associated measures.
We propose that the Protect Patient Health Information objective
and its associated measure, Security Risk Analysis, would remain part
of the requirements for the Promoting Interoperability performance
category, but would no longer be scored as a measure and would not
contribute to the MIPS eligible clinician's Promoting Interoperability
performance category score. To earn any score in the Promoting
Interoperability performance category, we are proposing a MIPS eligible
clinician would have to report that they completed the actions included
in the Security Risk Analysis measure at some point during the calendar
year in which the performance period occurs. We believe the Security
Risk Analysis measure involves critical tasks and note that the HIPAA
Security Rule requires covered entities to conduct a risk assessment of
their healthcare organization. This risk assessment will help MIPS
eligible clinicians comply with HIPAA's administrative, physical, and
technical safeguards. Therefore, we believe that every MIPS eligible
clinician should already be meeting the requirements for this objective
and measure as it is a requirement of HIPAA. We still believe this
objective and its associated measure are imperative in ensuring the
safe delivery of patient health data. As a result, we would maintain
the Security Risk Analysis measure as part of the Promoting
Interoperability performance category, but we would not score the
measure.
Similar to how MIPS eligible clinicians currently submit data, the
MIPS eligible clinician would submit their numerator and denominator
data for each measure, and a ``yes or no'' response for each of the two
reported measures under the Public Health and Clinical Data Exchange
objective. The numerator and denominator for each measure would then
translate to a performance rate for that measure and would be applied
to the total possible points for that measure. For example, the e-
Prescribing measure is worth 10 points. A numerator of 200 and
denominator of 250 would yield a performance rate of (200/250) = 80
percent. This 80 percent would be applied to the 10 total points
available for the e-Prescribing measure to determine the measure score.
A performance rate of 80 percent for the e-Prescribing measure would
equate to a measure score of 8 points (performance rate * total
possible measure points = points awarded toward the total Promoting
Interoperability performance category score; 80 percent * 10 = 8
points). To calculate the Promoting Interoperability performance
category score, the measure scores would be added together, and the
total sum would be divided by the total possible points (100). The
total sum cannot exceed the total possible points. This calculation
results in a fraction from zero to 1, which can be formatted as a
percent. For example, using the numerical values in Table 38, a total
score of 83 points would be converted to a performance category score
of 83 percent (total score/total possible score for the Promoting

[[Page 35917]]

Interoperability performance category = 83 points/100 points). The
Promoting Interoperability performance category score would be
multiplied by the performance category weight (which is ultimately
multiplied by 100) to get 20.75 points toward the final score ((83
percent * 25 percent * 100) = 20.75 points toward the final score.)
These calculations and application to the total Promoting
Interoperability performance category score, as well as an example of
how they would apply, are set out in Tables 36, 37, and 38.
When calculating the performance rates, measure and objective
scores, and Promoting Interoperability performance category score, we
would generally round to the nearest whole number. For example if a
MIPS eligible clinician received a score of 8.53 the nearest whole
number would be 9. Similarly, if the MIPS eligible clinician received a
score of 8.33 the nearest whole number would be 8. In the event that
the MIPS eligible clinician receives a performance rate or measure
score of less than 0.5, as long as the MIPS eligible clinician reported
on at least one patient for a given measure, a score of 1 would be
awarded for that measure. We believe this is the best method for the
issues that might arise with the decimal points and is the easiest for
computations.
In order to meet statutory requirements and HHS priorities, the
MIPS eligible clinician would need to report on all of the required
measures across all objectives in order to earn any score at all for
the Promoting Interoperability performance category. Failure to report
any required measure, or reporting a ``no'' response on a ``yes or no''
response measure, unless an exclusion applies would result in a score
of zero. We are seeking public comment on the proposed requirement to
report on all required measures, or whether reporting on a smaller
subset of optional measures would be appropriate.
Tables 36, 37, and 38 illustrate our proposal for the new scoring
methodology and an example of application of the proposed scoring
methodology.

Table 36--Proposed Scoring Methodology for the MIPS Performance Period in 2019
----------------------------------------------------------------------------------------------------------------
Objectives Measures Maximum points
----------------------------------------------------------------------------------------------------------------
e-Prescribing......................... e-Prescribing........................... 10 points.
Bonus: Query of Prescription Drug 5 points bonus.
Monitoring Program (PDMP).
Bonus: Verify Opioid Treatment Agreement 5 points bonus.
Health Information Exchange........... Support Electronic Referral Loops by 20 points.
Sending Health Information.
Support Electronic Referral Loops by 20 points.
Receiving and Incorporating Health
Information.
Provider to Patient Exchange.......... Provide Patients Electronic Access to 40 points.
Their Health Information.
Public Health and Clinical Data Choose two of the following:............ 10 points.
Exchange. Immunization Registry Reporting.........
Electronic Case Reporting...............
Public Health Registry Reporting........
Clinical Data Registry Reporting........
Syndromic Surveillance Reporting........
----------------------------------------------------------------------------------------------------------------

Table 37--Proposed Scoring Methodology Beginning With MIPS Performance Period in 2020
----------------------------------------------------------------------------------------------------------------
Objectives Measures Maximum points
----------------------------------------------------------------------------------------------------------------
e-Prescribing......................... e-Prescribing........................... 5 points.
Query of Prescription Drug Monitoring 5 points.
Program (PDMP).
Verify Opioid Treatment Agreement....... 5 points.
Health Information Exchange........... Support Electronic Referral Loops by 20 points.
Sending Health Information.
Support Electronic Referral Loops by 20 points.
Receiving and Incorporating Health
Information.
Provider to Patient Exchange.......... Provide Patients Electronic Access to 35 points.
Their Health Information.
Public Health and Clinical Data Choose two of the following:............ 10 points.
Exchange. Immunization Registry Reporting.........
Electronic Case Reporting...............
Public Health Registry Reporting........
Clinical Data Registry Reporting........
Syndromic Surveillance Reporting........
----------------------------------------------------------------------------------------------------------------

We are seeking public comment on whether these measures are
weighted appropriately, or whether a different weighting distribution,
such as equal distribution across all measures would be better suited
to this program and this proposed scoring methodology. We are also
seeking public comment on other scoring methodologies such as the
alternative we considered and outlined earlier in this section.

Table 38--Proposed Scoring Methodology for the MIPS Performance Period in 2019 Example
----------------------------------------------------------------------------------------------------------------
Maximum Numerator/ Performance
Objective Measures points denominator rate (%) Score
----------------------------------------------------------------------------------------------------------------
e-Prescribing................... e-Prescribing..... 10 200/250 80 10 * 0.8 = 8
points.
Query of 5 150/175 86 5 bonus points.
Prescription Drug
Monitoring
Program.
Verify Opioid 5 N/A N/A 0 points.
Treatment
Agreement.

[[Page 35918]]

Health Information Exchange..... Support Electronic 20 135/185 73 20 * 0.73 = 15
Referral Loops by points.
Sending Health
Information.
Support Electronic 20 145/175 83 20 * 0.83 = 17
Referral Loops by points.
Receiving and
Incorporating
Health
Information.
Provider to Patient Exchange.... Provide Patients 40 350/500 70 40 * 0.70 = 28
Electronic Access points.
to Their Health
Information.
Public Health and Clinical Data Immunization 10 Yes N/A 10 points.
Exchange. Registry
Reporting.
Public Health ........... Yes N/A 10 points.
Registry
Reporting.
-----------------------------------------------------------
Total Score................. .................. ........... ........... ............ 83 points.
----------------------------------------------------------------------------------------------------------------

If we do not finalize a new scoring methodology, we propose to
maintain for the performance period in 2019 the current Promoting
Interoperability performance category scoring methodology with the same
objectives, measures and requirements as established for the
performance period in 2018, except that we would discontinue the 2018
Promoting Interoperability Transition Objectives and Measures (82 FR
53677). We would discontinue the use of the transition measures because
they are associated with 2014 Edition CEHRT and we are requiring the
use of 2015 Edition CEHRT solely beginning with the performance period
in 2019. For more information, we refer readers to the CY 2018 Quality
Payment Program final rule (82 FR 53663 through 53680). In addition, we
propose to include the 2 new opioid measures, if finalized. We refer
readers to section III.H.3.h.(5)(f) of this proposed rule for a
discussion of the measure proposals.
We also are seeking public comment on the feasibility of the
proposed new scoring methodology in 2019 and whether MIPS eligible
clinicians would be able to implement the new measures and reporting
requirements under this scoring methodology. In addition, in section
III.H.3.h.(5) of this proposed rule, we are seeking public comment on
how the Promoting Interoperability performance category should evolve
in future years regarding the new scoring methodology and related
aspects of the program.
We are proposing to codify the proposed new scoring methodology in
new paragraphs (b)(4)(ii) and (iii) under Sec. 414.1380.
(e) Promoting Interoperability/Advancing Care Information Objectives
and Measures Specifications for the 2018 Performance Period
The Advancing Care Information (now Promoting Interoperability)
performance category Objectives and Measures for the 2018 performance
period are as follows. For more information, we refer readers to the CY
2017 and CY 2018 Quality Payment Program final rules (81 FR 77227
through 77229, and 82 FR 53674 through 53680, respectively).
Objective: Protect Patient Health Information.
Objective: Protect electronic protected health information (ePHI)
created or maintained by the CEHRT through the implementation of
appropriate technical, administrative, and physical safeguards.
Security Risk Analysis Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1),
including addressing the security (to include encryption) of ePHI data
created or maintained by CEHRT in accordance with requirements in 45
CFR 164.312(a)(2)(iv) and 164.306(d)(3), implement security updates as
necessary, and correct identified security deficiencies as part of the
MIPS eligible clinician's risk management process.
Objective: Electronic Prescribing.
Objective: Generate and transmit permissible prescriptions
electronically.
e-Prescribing Measure: At least one permissible prescription
written by the MIPS eligible clinician is queried for a drug formulary
and transmitted electronically using CEHRT.
Denominator: Number of prescriptions written for drugs requiring a
prescription in order to be dispensed other than controlled substances
during the performance period; or number of prescriptions written for
drugs requiring a prescription in order to be dispensed during the
performance period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary, and transmitted electronically
using CEHRT.
Exclusion: Any MIPS eligible clinician who writes fewer than 100
permissible prescriptions during the performance period.
Objective: Patient Electronic Access.
Objective: The MIPS eligible clinician provides patients (or
patient-authorized representative) with timely electronic access to
their health information and patient-specific education.
Patient Access Measure: For at least one unique patient seen by the
MIPS eligible clinician: (1) The patient (or the patient-authorized
representative) is provided timely access to view online, download, and
transmit his or her health information; and (2) The MIPS eligible
clinician ensures the patient's health information is available for the
patient (or patient-authorized representative) to access using any
application of their choice that is configured to meet the technical
specifications of the Application Programing Interface (API) in the
MIPS eligible clinician's CEHRT.
Denominator: The number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator (or patient
authorized representative) who are provided timely access to health
information to view online, download, and transmit to a third party and
to access using an application of their choice that is configured meet
the technical specifications of the API in the MIPS eligible
clinician's CEHRT.
Patient-Specific Education Measure: The MIPS eligible clinician
must use clinically relevant information from CEHRT to identify
patient-specific educational resources and provide electronic access to
those materials to at least one unique patient seen by the MIPS
eligible clinician.
Denominator: The number of unique patients seen by the MIPS
eligible

[[Page 35919]]

clinician during the performance period.
Numerator: The number of patients in the denominator who were
provided electronic access to patient-specific educational resources
using clinically relevant information identified from CEHRT during the
performance period.
Objective: Coordination of Care Through Patient Engagement.
Objective: Use CEHRT to engage with patients or their authorized
representatives about the patient's care.
View, Download, Transmit (VDT) Measure: During the performance
period, at least one unique patient (or patient-authorized
representatives) seen by the MIPS eligible clinician actively engages
with the EHR made accessible by the MIPS eligible clinician by either:
(1) Viewing, downloading or transmitting to a third party their health
information; or (2) accessing their health information through the use
of an API that can be used by applications chosen by the patient and
configured to the API in the MIPS eligible clinician's CEHRT; or (3) a
combination of (1) and (2).
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of unique patients (or their authorized
representatives) in the denominator who have viewed online, downloaded,
or transmitted to a third party the patient's health information during
the performance period and the number of unique patients (or their
authorized representatives) in the denominator who have accessed their
health information through the use of an API during the performance
period.
Secure Messaging Measure: For at least one unique patient seen by
the MIPS eligible clinician during the performance period, a secure
message was sent using the electronic messaging function of CEHRT to
the patient (or the patient-authorized representative), or in response
to a secure message sent by the patient (or the patient-authorized
representative).
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of patients in the denominator for whom a
secure electronic message is sent to the patient (or patient-authorized
representative) or in response to a secure message sent by the patient
(or patient-authorized representative), during the performance period.
Patient-Generated Health Data Measure: Patient-generated health
data or data from a non-clinical setting is incorporated into the CEHRT
for at least one unique patient seen by the MIPS eligible clinician
during the performance period.
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of patients in the denominator for whom data
from non-clinical settings, which may include patient-generated health
data, is captured through the CEHRT into the patient record during the
performance period.
Objective: Health Information Exchange.
Objective: The MIPS eligible clinician provides a summary of care
record when transitioning or referring their patient to another setting
of care, receives or retrieves a summary of care record upon the
receipt of a transition or referral or upon the first patient encounter
with a new patient, and incorporates summary of care information from
other health care providers into their EHR using the functions of
CEHRT.
Send a Summary of Care Measure: For at least one transition of care
or referral, the MIPS eligible clinician that transitions or refers
their patient to another setting of care or health care provider (1)
creates a summary of care record using CEHRT; and (2) electronically
exchanges the summary of care record.
Denominator: Number of transitions of care and referrals during the
performance period for which the MIPS eligible clinician was the
transferring or referring clinician.
Numerator: The number of transitions of care and referrals in the
denominator where a summary of care record was created using CEHRT and
exchanged electronically.
Exclusion: Any MIPS eligible clinician who transfers a patient to
another setting or refers a patient is fewer than 100 times during the
performance period.
Request/Accept Summary of Care Measure: For at least one transition
of care or referral received or patient encounter in which the MIPS
eligible clinician has never before encountered the patient, the MIPS
eligible clinician receives or retrieves and incorporates into the
patient's record an electronic summary of care document.
Denominator: Number of patient encounters during the performance
period for which a MIPS eligible clinician was the receiving party of a
transition or referral or has never before encountered the patient and
for which an electronic summary of care record is available.
Numerator: Number of patient encounters in the denominator where an
electronic summary of care record received is incorporated by the
clinician into the CEHRT.
Exclusion: Any MIPS eligible clinician who receives transitions of
care or referrals or has patient encounters in which the MIPS eligible
clinician has never before encountered the patient fewer than 100 times
during the performance period.
Clinical Information Reconciliation Measure: For at least one
transition of care or referral received or patient encounter in which
the MIPS eligible clinician has never before encountered the patient,
the MIPS eligible clinician performs clinical information
reconciliation. The MIPS eligible clinician must implement clinical
information reconciliation for the following three clinical information
sets: (1) Medication. Review of the patient's medication, including the
name, dosage, frequency, and route of each medication; (2) Medication
allergy. Review of the patient's known medication allergies; and (3)
Current Problem list. Review of the patient's current and active
diagnoses.
Denominator: Number of transitions of care or referrals during the
performance period for which the MIPS eligible clinician was the
recipient of the transition or referral or has never before encountered
the patient.
Numerator: The number of transitions of care or referrals in the
denominator where the following three clinical information
reconciliations were performed: Medication list; medication allergy
list; and current problem list.
Objective: Public Health and Clinical Data Registry Reporting.
Objective: The MIPS eligible clinician is in active engagement with
a public health agency or clinical data registry to submit electronic
public health data in a meaningful way using CEHRT, except where
prohibited, and in accordance with applicable law and practice.
Immunization Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
immunization data and receive immunization forecasts and histories from
the public health immunization registry/immunization information system
(IIS).
Syndromic Surveillance Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
syndromic surveillance data from an urgent care setting.

[[Page 35920]]

Electronic Case Reporting Measure: The MIPS eligible clinician is
in active engagement with a public health agency to electronically
submit case reporting of reportable conditions.
Public Health Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
data to public health registries.
Clinical Data Registry Reporting Measure: The MIPS eligible
clinician is in active engagement to submit data to a clinical data
registry.
(f) Promoting Interoperability Performance Category Measure Proposals
for MIPS Eligible Clinicians
(i) Measure Proposal Summary Overview
We are proposing to adopt beginning with the performance period in
2019 the existing Promoting Interoperability objectives and measures as
finalized in the CY 2018 Quality Payment Program final rule (82 FR
53674 through 53680) with several proposed changes as discussed herein,
including the addition of new measures, removal of some of the existing
measures, and modifications to the specifications of some of the
existing measures. We are not proposing to continue the Promoting
Interoperability transition objectives and measures (see 82 FR 53674
through 53676) beyond the 2018 MIPS performance period because the 2015
Edition of CEHRT will be required beginning with the MIPS performance
period in 2019. Our intent for these proposed changes is to ensure the
measures better focus on the effective use of health IT, particularly
for interoperability, and to address concerns stakeholders have raised
through public forums and in public comments related to the perceived
burden associated with the current measures in the program. As stated
in the CY 2017 Quality Payment Program final rule (81 FR 77216) our
priority is to finalize reporting requirements for the Promoting
Interoperability performance category that incentivizes performance and
reporting with minimal complexity and reporting burden. In addition, we
acknowledged that while we believe all of the measures of the Promoting
Interoperability performance category are important, we must also
balance the need for these data with data collection and reporting
burden (81 FR 77221).
In CY 2017, we initiated an informal process outside of rulemaking
for submission of new Promoting Interoperability performance category
measures for potential inclusion in the Year 3 Quality Payment Program
proposed rule. We prioritized measures that build on interoperability
and health information exchange, the advanced use of CEHRT using 2015
Edition Standards and Certification Criteria, improve program
efficiency and flexibility, measure patient outcomes, emphasize patient
safety, and support improvement activities and quality performance
categories of MIPS. In addition, and as we indicated in the CY 2018
Quality Payment Program proposed rule (82 FR 30079), we sought new
measures that may be more broadly applicable to MIPS eligible
clinicians who are Nurse Practitioners (NPs), Physician Assistants
(PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical
Nurse Specialists (CNSs).
During this initial submission period, various MIPS eligible
clinicians, stakeholders and health IT developers submitted new
measures for consideration via an application posted on the CMS
website, now hosted at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. Through our
review process, which included representation from the ONC, as well as
various stakeholder listening sessions, we identified measure
submissions that met our criteria and aligned with the Promoting
Interoperability performance category goals and priorities, as well as
broader HHS initiatives related to the opioid crisis.\18\ As a result
of this process, we are proposing two measures, Query of PDMP and
Verify Opioid Treatment Agreement.
---------------------------------------------------------------------------

\18\ https://www.hhs.gov/opioids/about-the-epidemic/index.html;
https://www.healthit.gov/opioids.
---------------------------------------------------------------------------

We are proposing to remove six measures from the Promoting
Interoperability objectives and measures beginning with the performance
period in 2019. Two of the measures we are proposing to remove--
Request/Accept Summary of Care and Clinical Information
Reconciliation--would be replaced by the Support Electronic Referral
Loops by Receiving and Incorporating Health Information measure, which
combines the functionalities and goals of the two measures it is
replacing. Four of the measures--Patient-Specific Education; Secure
Messaging; View, Download, or Transmit; and Patient-Generated Health
Data--would be removed because they have proven burdensome to MIPS
eligible clinicians in ways that were unintended and may detract from
clinicians' progress on current program priorities. While the measures
proposed for removal would no longer need to be submitted if we
finalize the proposal to remove them, MIPS eligible clinicians may
still continue to use the standards and functions of those measures
based on the preferences of their patients and their practice needs. We
believe that this burden reduction would enable MIPS eligible
clinicians to focus on new measures that further interoperability,
advances of innovation in the use of CEHRT and the exchange of health
care information.
As discussed in the proposed scoring methodology in section
III.H.3.h.(5)(f) of this proposed rule, we are proposing to add three
new measures to the Promoting Interoperability objectives and measures
beginning with the performance period in 2019. For the e-Prescribing
objective, we are proposing the two new measures referenced above,
Query of PDMP and Verify Opioid Treatment Agreement, both of which
support HHS initiatives related to the treatment of opioid and
substance use disorders by helping health care providers avoid
inappropriate prescriptions, improving coordination of prescribing
amongst health care providers and focusing on the advanced use of
CEHRT. For the Health Information Exchange objective, we are proposing
a new measure, Support Electronic Referral Loops by Receiving and
Incorporating Health Information, which builds upon and replaces the
existing Request/Accept Summary of Care and Clinical Information
Reconciliation measures, while furthering interoperability and the
exchange of health information.
We are also proposing to modify some of the existing Promoting
Interoperability objectives and measures beginning with the performance
period in 2019. We are proposing to rename the Send a Summary of Care
measure to Support Electronic Referral Loops by Sending Health
Information. In addition, we are proposing to rename the Patient
Electronic Access objective to Provider to Patient Exchange, and
proposing to rename the remaining measure, Provide Patient Access to
Provide Patients Electronic Access to Their Health Information. We are
proposing to eliminate the Coordination of Care Through Patient
Engagement objective and all of its associated measures as described
above. Finally, we are proposing to rename the Public Health and
Clinical Data Registry Reporting objective to Public Health and
Clinical Data Exchange and require reporting on at least two measures
of the MIPS eligible clinician's choice from the following:
Immunization Registry Reporting; Syndromic Surveillance Reporting,
Electronic Case Reporting;

[[Page 35921]]

Public Health Registry Reporting; and Clinical Data Registry Reporting.
In addition, we are proposing exclusion criteria for each of these
measures.
Finally, we are seeking comment on a potential new measure Health
Information Exchange Across the Care Continuum under the Health
Information Exchange objective in which a MIPS eligible clinician would
send an electronic summary of care record, or receive and incorporate
an electronic summary of care record, for transitions of care and
referrals with a health care provider other than a MIPS eligible
clinician. The measure would include health care providers in care
settings including but not limited to long term care facilities and
post-acute care providers such as skilled nursing facilities, home
health, and behavioral health settings.
Table 39 provides a summary of these measures proposals.

Table 39--Summary of Proposals for the Promoting Interoperability
Performance Category Objectives and Measures for the MIPS Performance
Period in 2019
------------------------------------------------------------------------
Measure status Measure
------------------------------------------------------------------------
Measures retained--no e-Prescribing.
modifications *.
Measures retained with Send a Summary of Care
modifications. (name proposal--Support Electronic
Referral Loops by Sending Health
Information).
Provide Patient Access
(name proposal--Provide Patients
Electronic Access to Their Health
Information).
Immunization Registry
Reporting.
Syndromic Surveillance
Reporting.
Electronic Case Reporting.
Public Health Registry
Reporting.
Clinical Data Registry
Reporting.
Removed measures.................. Request/Accept Summary of
Care.
Clinical Information
Reconciliation.
Patient-Specific Education.
Secure Messaging.
View, Download or Transmit.
Patient-Generated Health
Data.
New measures...................... Query of Prescription Drug
Monitoring Program (PDMP).
Verify Opioid Treatment
Agreement.
Support Electronic Referral
Loops--Receiving and Incorporating
Health Information.
------------------------------------------------------------------------
* Security Risk Analysis is retained, but not included as a measure
under the proposed scoring methodology.

We understand from previous listening sessions that EHR vendors and
developers would need time to develop, test and implement new measures,
and MIPS eligible clinicians would need time to implement as well as
establish and test their processes and workflows. As indicated above
and in the discussion of the proposed scoring methodology in section
III.H.3.h.(5)(d) of this proposed rule, we are proposing three new
measures (Query of PDMP, Verify Opioid Treatment Agreement, and Support
Electronic Referral Loops by Receiving and Incorporating Health
Information). We are proposing that the Query of PDMP and Verify Opioid
Treatment Agreement measures would be optional for the performance
period in 2019 and bonus points may be earned for reporting on them. We
are proposing that the Support Electronic Referral Loops by Receiving
and Incorporating Health Information would be required beginning with
the performance period in 2019 with an exclusion available. We are
proposing to require the Query of PDMP and Verify Opioid Treatment
Agreement measures beginning with the performance period in 2020, and
we are seeking public comment on this proposal. The proposals under the
Health Information Exchange objective require only consolidation of
existing workflows and actions, while certification criteria and
standards remain the same as in the CY 2018 Quality Payment Program
final rule (82 FR 53677 through 53678). Therefore, we believe MIPS
eligible clinicians could potentially implement this new measure for
the performance period in 2019.
(ii) Measure Proposals for the e-Prescribing Objective
Based on our review of the submissions we received through the
informal measure submission process described in the preceding section,
and considerations of overall agency priorities as discussed below, we
are proposing two new measures under the e-Prescribing objective. In
the CY 2017 Quality Payment Program final rule, we stated that MIPS
eligible clinicians would have the option to include or not include
controlled substances in the definition of ``permissible
prescriptions'' at their discretion where feasible and allowable by law
in the jurisdiction where they provide care (81 FR 77227). We believe
it is important to consider other requirements specific to electronic
prescribing of controlled substances for health care providers to take
into account and how this may interact with the proposals under this
rulemaking. CMS is committed to combatting the opioid epidemic by
making it a top priority for the agency and aligning its efforts with
the HHS opioid initiative to combat misuse and promote programs that
support treatment and recovery support services. The HHS five-point
Opioid Strategy aims to:
Improve access to prevention, treatment, and recovery
support services to prevent the health, social, and economic
consequences associated with opioid addiction and to enable individuals
to achieve long-term recovery;
Target the availability and distribution of overdose-
reversing drugs to ensure the provision of these drugs to people likely
to experience or respond to an overdose, with a particular focus on
targeting high-risk populations;
Strengthen public health data reporting and collection to
improve the timeliness and specificity of data and to inform a real-
time public health response;
Support cutting-edge research that advances our
understanding of pain and addiction, leads to the development of new
treatments, and identifies effective

[[Page 35922]]

public health interventions to reduce opioid-related health harms; and
Advance the practice of pain management to enable access
to high-quality, evidence-based pain care that reduces the burden of
pain for individuals, families, and society while also reducing the
inappropriate use of opioids and opioid-related harms.
CMS' strategy includes reducing the risk of opioid use disorders,
overdoses, inappropriate prescribing practices and drug diversion. We
have identified two new measures which align with the broader HHS
efforts to increase the use of PDMPs to reduce inappropriate
prescriptions, improve patient outcomes and promote more informed
prescribing practices.
We are proposing to add two new measures to the e-Prescribing
objective that are based on electronic prescriptions for controlled
substances (EPCS): Query of PDMP; and Verify Opioid Treatment
Agreement. These measures build upon the meaningful use of CEHRT as
well as the security of electronic prescribing of Schedule II
controlled substances while preventing diversion. For both measures, we
are proposing to define opioids as Schedule II controlled substances
under 21 CFR 1308.12, as they are recognized as having a high potential
for abuse with potential for severe psychological or physical
dependence. We are also proposing to apply the same policies for the
existing e-Prescribing measure to both the Query of PDMP and Verify
Opioid Treatment Agreement measures, including the requirement to use
CEHRT as the sole means of creating the prescription and for
transmission to the pharmacy. MIPS eligible clinicians have the option
to include or exclude controlled substances in the e-Prescribing
measure denominator as long as they are treated uniformly across
patients and all available schedules and in accordance with applicable
law (81 FR 77227). However, because the intent of these two new
measures is to improve prescribing practices for controlled substances,
MIPS eligible clinicians would have to include Schedule II opioid
prescriptions in the numerator and denominator or claim the applicable
exclusion. Additionally, the intent of the proposed measures is not to
dissuade the prescribing or use of opioids for patients with medical
diagnoses or conditions that benefit from their use, such as patients
diagnosed with cancer or those receiving hospice. We seek comment on
the impact that implementing this measure could have on patients who
receive opioids due to medical diagnoses such as cancer or receiving
hospice care as well as treatment of patients under a program involving
substance abuse education, treatment, or prevention under 42 CFR part
2. Additionally, we seek comment on the federal and state statutory and
regulatory requirements that may impact implementation of the Query of
PDMP and Verify Opioid Treatment Agreement measures.
In the event we finalize the new scoring methodology that we are
proposing in section III.H.3.h.(5)(d) of this proposed rule, MIPS
eligible clinicians who claim the exclusion under the existing e-
Prescribing measure would automatically receive an exclusion for all
three of the measures under the e-Prescribing objective; they would not
have to also claim exclusions for the other two measures, Query of PDMP
and Verify Opioid Treatment Agreement.
In the event we do not finalize the new scoring methodology
proposed in section III.H.3.h(5)(d) of this proposed rule, but we do
finalize the proposed measures of Query of PDMP and Verify Opioid
Treatment Agreement under the e-Prescribing objective, we propose to
include them under the bonus score with each measure being worth 5
percentage points, but we would not include exclusion criteria as
reporting would be optional under the scoring methodology finalized in
previous rulemaking (81 FR 77216 through 77227 and 82 FR 53663 through
53664). We believe these measures should be part of the bonus score
because not all MIPS eligible clinicians are able to prescribe
controlled substances, and therefore these measures may not be
applicable to them. Additionally, in the event we do not finalize the
proposed scoring methodology, we would retain the existing e-
Prescribing measure (with its exclusion) as a base score requirement.
(A) Proposed Measure: Query of Prescription Drug Monitoring Program
(PDMP)
A PDMP is an electronic database that tracks prescriptions of
controlled substances at the State level. PDMPs play an important role
in patient safety by assisting in the identification of patients who
have multiple prescriptions for controlled substances or may be
misusing or overusing them. Querying the PDMP is important for tracking
the prescribed controlled substances and improving prescribing
practices. The ONC, Centers for Disease Control and Prevention (CDC),
Department of Justice (DOJ) and Substance Abuse and Mental Health
Services Administration (SAMHSA) have had integral roles in the
integration and expansion of PMDPs with health information technology
systems. For example, the ONC and SAMHSA collaboratively led the
``Enhancing Access'' project to improve health care provider access to
PDMP data utilizing health IT.\19\ Likewise, the CDC conducted a
process and outcome evaluation of the PDMP EHR Integration and
Interoperability Expansion (PEHRIIE) program funded by SAMHSA for nine
states between FY 2012 and 2016. The PEHRIIE program goals were to
integrate PDMPs into health IT and improve the comprehensiveness of
PDMPs through initiating and/or improving interstate data exchange.\20\
In addition, the Bureau of Justice Assistance's Harold Rogers
Prescription Monitoring Program supports Prescription Drug Monitoring
Program Information Exchange (PMIX) through funding, the goal of PMIX
is to help states implement a cost-effective solution to facilitate
interstate data sharing among PDMPs.\21\ Integration of the PDMP with
health information technology systems supports improves access to PDMP
data, minimizes changes to current workflow and overall burden and
optimizes prescribing practices. The intent of the Query of the PDMP
measure is to build upon the current PDMP initiatives from Federal
partners focusing on prescriptions generated and dispensing of opioids.
---------------------------------------------------------------------------

\19\ https://www.healthit.gov/PDMP and https://www.healthit.gov/sites/default/files/work_group_document_integrated_paper_final_0.pdf.
\20\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
\21\ https://www.bja.gov/funding/Category-5-awards.pdf.
---------------------------------------------------------------------------

Proposed Measure Description: For at least one Schedule II opioid
electronically prescribed using CEHRT during the performance period,
the MIPS eligible clinician uses data from CEHRT to conduct a query of
a Prescription Drug Monitoring Program (PDMP) for prescription drug
history, except where prohibited and in accordance with applicable law.
CMS recognizes both the utility and value of addressing PDMP EHR
integration and further recognizes the majority of states mandate use
of State prescription monitoring programs (PMPs) requiring prescribers/
dispensers to access PMP.\22\ According to the CDC, State-level
policies that enhance PDMPs or regulate pain clinics helped several
states drive down opioid prescriptions and overdose deaths.\23\ We are
also further aware of the varying integration

[[Page 35923]]

approaches underway including efforts to integrate a state PDMP into a
health information exchange or EHR or other efforts to enhance a user
interface of some type, such as risk assessment tools or red flags. We
note federal evaluation resources available to inform integration
efforts \24\ and believe integration is critical for enhancing health
care provider workflow, access to critical PDMP data, and improving
clinical care including prescription management.
---------------------------------------------------------------------------

\22\ http://www.namsdl.org/library/14D3122C-96F5-F53E-E8F23E906B4DE09D/.
\23\ https://www.cdc.gov/drugoverdose/policy/successes.html.
\24\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
---------------------------------------------------------------------------

We are proposing that the query of the PDMP for prescription drug
history must be conducted prior to the electronic transmission of the
Schedule II opioid prescription. MIPS eligible clinicians would have
flexibility to query the PDMP using CEHRT in any manner allowed under
their State law.
Although the query of the PDMP may currently be burdensome for some
MIPS eligible clinicians as part of their current workflow practice, we
believe querying the PDMP is beneficial to optimal prescribing
practices and foresee progression toward fully automated queries of the
PDMP building upon the current initiatives at the State level.
We are proposing to include in this measure all permissible
prescriptions and dispensing of Schedule II opioids regardless of the
amount prescribed during an encounter in order for MIPS eligible
clinicians to identify multiple health care provider episodes
(physician shopping), prescriptions of dangerous combinations of drugs,
prescribing rates and controlled substances prescribed in high
quantities. We request comment on these policy proposals, including
whether additional queries should be performed and under which
circumstances. In addition we seek comment on whether the query should
have additional constraints concerning when it should be performed.
Denominator: Number of Schedule II opioids electronically
prescribed using CEHRT by the MIPS eligible clinician during the
performance period.
Numerator: The number of Schedule II opioid prescriptions in the
denominator for which data from CEHRT is used to conduct a query of a
PDMP for prescription drug history except where prohibited and in
accordance with applicable law. A numerator of at least one is required
to fulfill this measure.
Exclusion (beginning in 2020): Any MIPS eligible clinician who is
unable to electronically prescribe Schedule II opioids in accordance
with applicable law during the performance period. We propose that the
exclusion criteria would be limited to prescriptions of Schedule II
opioids as the measure action is limited to prescriptions of Schedule
II opioids only and does not include any other types of electronic
prescriptions. We are also requesting comment on the proposed exclusion
criteria and whether there are circumstances which may justify other
exclusions for the Query of PDMP measure and what those circumstances
might be including medical diagnoses such as cancer or patients under
care of hospice.
We also understand that PDMP integration is not currently in
widespread use for CEHRT, and many MIPS eligible clinicians may require
additional time and workflow changes at the point of care before they
can meet this measure without experiencing significant burden. For
instance, many MIPS eligible clinicians will likely need to manually
enter the data into CEHRT to document the completion of the query of
the PDMP action. In addition, some MIPS eligible clinicians may also
need to conduct manual calculation of the measure. Even for those MIPS
eligible clinicians that have achieved successful integration of a PDMP
with their EHR, this measure may not be machine calculable, for
instance, in cases where the MIPS eligible clinician follows a link
within the EHR to a separate PDMP system. For the purposes of meeting
this measure, we also understand that there is no existing
certification criteria for the query of a PDMP. However, we believe
that the use of structured data captured in the CEHRT can support
querying a PDMP through the broader use of health IT. We seek public
comment on whether ONC should consider adopting standards and
certification criteria to support the query of a PDMP, and if such
criteria were to be adopted, on what timeline should CMS require their
use to meet this measure.
The NCPDP SCRIPT 2017071 standard for e-prescribing is now
available and can help to support PDMP and EHR integration. We are
seeking public comment, especially from health care providers and
health IT developers on whether they believe use of this standard can
support MIPS eligible clinicians seeking to report on this measure, and
whether HHS should encourage use of this standard through separate
rulemaking.
We seek comment on the challenges associated with querying the PDMP
with and without CEHRT integration and whether this proposed measure
should require certain standards, methods or functionalities to
minimize burden.
In including EPCS as a component of the measure as proposed, we
acknowledge and seek input on perceived and real technological barriers
as part of its effective implementation including but not limited to
input on two-factor authentication and on the effective and appropriate
uses of technology, including the use of telehealth modalities to
support established patient and health care provider relationships
subsequent to in-person visit(s) and for prescribing purposes.
In the event we do not finalize the proposed scoring methodology,
we are proposing MIPS eligible clinicians must report at least one
prescription in the numerator to report on this new measure and earn
points towards the bonus score. We believe a threshold of at least one
prescription is appropriate because varying State laws related to
integration of the PDMP into CEHRT can lead to differing standards for
querying.
We are also proposing that in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at 45 CFR 170.315(a)(10)(ii) and (b)(3).
(B) Proposed Measure: Verify Opioid Treatment Agreement
The intent of this measure is for MIPS eligible clinicians to
identify whether there is an existing opioid treatment agreement when
they electronically prescribe a Schedule II opioid using CEHRT if the
total duration of the patient's Schedule II opioid prescriptions is at
least 30 cumulative days. We believe seeking to identify an opioid
treatment agreement will further efforts to coordinate care between
health care providers and foster a more informed review of patient
therapy. The intent of the treatment agreement is to clearly outline
the responsibilities of both patient and MIPS eligible clinician in the
treatment plan. Such a treatment plan can be integrated into care
coordination and care plan activities and documents as discussed and
agreed upon by the patient and MIPS eligible clinician. An opioid
treatment agreement is intended to support and to enable further
coordination and the sharing of substance use disorder (SUD) data with
consent, as may be required of the individual.
According to the American Journal of Psychiatry article
Prescription Opioid Misuse, Abuse, and Treatment in the

[[Page 35924]]

United States: An Update,\25\ patient and health care provider
treatment agreements are part of the recommendations to enhance efforts
to prevent opioid abuse per the Office of the National Drug Control
Policy's National Drug Control Strategy.\26\ The article further
indicates that the treatment agreement can be beneficial as it provides
clear information for the agreed upon pain management plan, preventing
misconceptions.
---------------------------------------------------------------------------

\25\ Brady, K.T., McCauley, J,L,, Back, S.E. Prescription Opioid
Misuse, Abuse, and Treatment in the United States: An Update,
American Journal of Psychiatry, Volume 173, Issue 1, January 01,
2016, pp. 18-26. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782928/.
\26\ https://obamawhitehouse.archives.gov/ondcp/policy-and-research/ndcs.
---------------------------------------------------------------------------

An article in Pain Medicine, Universal Precautions in Pain
Medicine: A Rational Approach to the Treatment of Chronic Pain also
includes treatment agreements as part of the ``Ten Steps of Universal
Precautions in Pain Medicine'' which are stated to be recommended
starting points for discussion in the treatment of chronic pain.\27\
---------------------------------------------------------------------------

\27\ Gourlay, D.L., Heit, H.A., Almahrezi, A. ``Universal
Precautions in Pain Medicine: A Rational Approach to the Treatment
of Chronic Pain.'' Pain Medicine, Volume 6, Issue 2, 1 March 2005,
pp. 107-112. Available at https://academic.oup.com/painmedicine/article/6/2/107/1819946.
---------------------------------------------------------------------------

We also understand from stakeholder feedback during listening
sessions that there are varied opinions regarding opioid treatment
agreements amongst health care providers. Some are supportive of their
use, indicating that treatment agreements are an important part of the
prescription of opioids for pain management, and help patients
understand their role and responsibilities for maintaining compliance
with terms of the treatment. Other health care providers object to
their use citing ethical concerns, and creation of division and trust
issues in the health care provider-patient relationship. Other concerns
stem from possible disconnect between the language and terminology used
in the agreement and the level of comprehension on the part of the
patient. Because of the debate among practitioners, we request comment
on the challenges this proposed measure may create for MIPS eligible
clinicians, how those challenges might be mitigated, and whether this
measure should be included as part of the Promoting Interoperability
performance category. We also acknowledge challenges related to
prescribing practices and multiple State laws which may present
barriers to the uniform implementation of this proposed measure. We are
seeking public comment on the challenges and concerns associated with
opioid treatment agreements and how they could impact the feasibility
of the proposal.
Proposed Measure Description: For at least one unique patient for
whom a Schedule II opioid was electronically prescribed by the MIPS
eligible clinician using CEHRT during the performance period, if the
total duration of the patient's Schedule II opioid prescriptions is at
least 30 cumulative days within a 6-month look-back period, the MIPS
eligible clinician seeks to identify the existence of a signed opioid
treatment agreement and incorporates it into the patient's electronic
health record using CEHRT.
We are proposing this measure would include all Schedule II opioids
prescribed for a patient electronically using CEHRT by the MIPS
eligible clinician during the performance period, as well as any
Schedule II opioid prescriptions identified in the patient's medication
history request and response transactions during a 6-month look-back
period, where the total number of days for which a Schedule II opioid
was prescribed for the patient is at least 30 days.
There also may be MIPS eligible clinician burdens specific to
identifying the existence of a treatment agreement which could require
additional time and changes to existing workflows, determining what
constitutes a treatment agreement due to a lack of a definition,
standard or electronic format and manual calculation of the measure. In
addition, limitations in the completeness of care team information may
limit the ability of a MIPS eligible clinician to identify all
potential sources for querying and obtaining information on a treatment
agreement for a specific patient. There are currently pilots in
development focused on increasing connectivity and data exchange among
health care providers to better integrate behavioral health
information, for instance, pilots taking place as part of the federal
Demonstration Program for Certified Community Behavioral Health Clinics
(CCBHC) \28\ includes criteria on how CCBHCs should use health IT to
coordinate services and track data on quality measures. Participants in
such pilots would potentially have the means necessary to leverage
health IT connectivity to query behavioral health data resources and
health providers within their region to identify the existence of an
opioid treatment agreement and to successfully integrate patient
information from the hospital stay into the care plan for the patient.
We seek comment on other similar pathways to facilitate the
identification and exchange of treatment agreements and opioid abuse
treatment planning.
---------------------------------------------------------------------------

\28\ https://www.samhsa.gov/section-223.
---------------------------------------------------------------------------

We are proposing the 6-month look-back period would begin on the
date on which the MIPS eligible clinician electronically transmits
their Schedule II opioid prescription using CEHRT. For example, all of
the following prescriptions would be counted for this measure: A
Schedule II opioid electronically prescribed for a patient for a
duration of five days by the MIPS eligible clinician using CEHRT during
the performance period, and four prior prescriptions for any Schedule
II opioid prescribed by another health care provider (each for a
duration of seven days) as identified in the patient's medication
history request and response transactions during the 6-month period
preceding the date on which the MIPS eligible clinician electronically
transmits their Schedule II opioid prescription using CEHRT. In this
example, the total number of days for which a Schedule II opioid was
prescribed for the patient would equal 33 cumulative days.
We are proposing a 6-month look-back period to identify more
egregious cases of potential overutilization of opioids and to cover
timeframes for use outside the performance period. In addition, we are
proposing that the 6-month look-back period would utilize at a minimum
the industry standard NCDCP SCRIPT v10.6 medication history request and
response transactions codified at Sec. 170.205(b)(2)). As ONC has
stated (80 FR 62642), adoption of the requirements for NCDCP SCRIPT
v10.6 does not preclude developers from incorporating and using
technology standards or services not required by regulation in their
health IT products.
We are not proposing to define an opioid treatment agreement as a
standardized electronic document; nor are we proposing to define the
data elements, content structure, or clinical purpose for a specific
document to be considered a ``treatment agreement.'' For this measure,
we are seeking comment on what characteristics should be part of an
opioid treatment agreement including data, content and clinical purpose
into CEHRT, including which functionalities could be utilized to
accomplish this. We note that a variety of standards available in CEHRT
might support the electronic exchange of opioid abuse related treatment
data, such as use of the Consolidated Clinical

[[Page 35925]]

Document Architecture (CCDA) care plan template that is currently
optional in CEHRT. We are also seeking comment on methods or processes
for incorporation of the treatment agreement into CEHRT, including
which functionalities could be utilized to accomplish this task. We
seek comment on whether there are specific data elements that are
currently standardized that should be incorporated via reconciliation
and if the ``patient health data capture'' functionality (45 CFR
170.315(e)(3)) could be used to incorporate a treatment plan that is
not a structured document with structured data elements.
Denominator: Number of unique patients for whom a Schedule II
opioid was electronically prescribed by the MIPS eligible clinician
using CEHRT during the performance period and the total duration of
Schedule II opioid prescriptions is at least 30 cumulative days as
identified in the patient's medication history request and response
transactions during a 6-month look-back period.
Numerator: The number of unique patients in the denominator for
whom the MIPS eligible clinician seeks to identify a signed opioid
treatment agreement and, if identified, incorporates the agreement in
CEHRT. A numerator of at least one is required to fulfill this measure.
Exclusion (beginning in 2020): Any MIPS eligible clinician who is
unable to electronically prescribe Schedule II opioids in accordance
with applicable law during the performance period.
We propose that the exclusion criteria would be limited to
prescriptions of Schedule II opioids as the measure action is limited
to electronic prescriptions of Schedule II opioids only and does not
include any other types of electronic prescriptions.
We are requesting comment on the proposed exclusion criteria and
whether there are additional circumstances that should be added to the
exclusion criteria and what those circumstances might be including
medical diagnoses such as cancer or patients under care of hospice.
We are seeking comment on whether these types of agreements could
create a burden on clinicians and patients, particularly clinicians who
serve patients with cancer or those practicing in hospice, as well as
the patients they serve.
In the event we do not finalize the proposed scoring methodology,
we are proposing MIPS eligible clinicians must report at least one
unique patient in the numerator to report on this new measure and earn
points towards the bonus score. We believe a threshold of at least one
unique patient is appropriate to account for the varying support for
the use of opioid treatment agreements and acknowledging that not all
patients who receive at least 30 cumulative days of Schedule II opioids
would have a treatment agreement in place. We also note there are
medical diagnoses and conditions that could necessitate prescribing
Schedule II opioids for a cumulative period of more than 30 days
including medical diagnoses such as cancer or care under hospice.
We also are proposing that, in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at Sec. Sec. 170.315(a)(10) and (b)(3) and 170.205(b)(2).
As discussed above, we recognize that many health care providers
are only beginning to adopt electronic prescriptions for controlled
substances (EPCS) at this time. While we have proposed two new measures
which combine EPCS with other actions, we request comment on whether
stakeholders would be interested in a measure focused only on the
number of Schedule II opioids prescribed and the successful use of EPCS
for permissible prescriptions electronically prescribed. We seek
comment about the feasibility of such a measure, and whether
stakeholders believe this would help to encourage broader adoption of
EPCS.
(iii) Measure Proposals for the Health Information Exchange Objective
The Health Information Exchange measures for MIPS eligible
clinicians hold particular importance because of the role they play
within the care continuum. In addition, these measures encourage and
leverage interoperability on a broader scale and promote health IT-
based care coordination. However, through our review of the existing
measures, we determined that we could potentially improve the measures
to further reduce burden and better focus the measures on
interoperability in health care provider to health care provider
exchange. Such modifications would address a number of concerns raised
by stakeholders including:
Supporting the implementation of effective health IT
supported workflows based on a specific organization's needs;
Reducing complexity and burden associated with the manual
tracking of workflows to support health IT measures; and
Emphasizing within these measures the importance of using
health IT to support closing the referral loop to improve care
coordination.
We believe we can potentially improve the existing Health
Information Exchange measures to streamline measurement, remove
redundancy, reduce complexity and burden, and address stakeholders'
concerns about the focus and impact of the measures on the
interoperable use of health IT.
We are proposing several changes to the current measures under the
Health Information Exchange objective. First, we propose to change the
name of the Send a Summary of Care measure to Support Electronic
Referral Loops by Sending Health Information. We also propose to remove
the Clinical Information Reconciliation measure and combine it with the
Request/Accept Summary of Care measure to create a new measure, Support
Electronic Referral Loops by Receiving and Incorporating Health
Information. This proposed new measure would include actions from both
the Request/Accept Summary of Care measure and Clinical Information
Reconciliation measure.
In the event we do not finalize a new scoring methodology as
proposed in section III.H.3. h.(5)(d) of this proposed rule, we would
maintain the existing Health Information Exchange objective, measures
and reporting requirements as finalized in the CY 2018 Quality Payment
Program final rule at 82 FR 53674 through 53680.
(A) Proposed Modifications to the Send a Summary of Care Measure
We are proposing to change the name of the Send a Summary of Care
measure to Support Electronic Referral Loops by Sending Health
Information measure, to better reflect the emphasis on completing the
referral loop and improving care coordination.
Through public comment and stakeholder correspondence, we have
become aware that in the health care industry there is some
misunderstanding of the scope of transitions and referrals which must
be included in the denominator of this measure. In the event that a
MIPS eligible clinician is the recipient of a transition of care or
referral, and subsequent to providing care the MIPS eligible clinician
transitions or refers the patient back to the referring provider of
care, this transition of care should be included in the denominator of
the measure for the MIPS eligible clinician. We expect this will help
build upon the current provider to provider communication via
electronic exchange of summary of care records created by CEHRT
required under this measure, further promote interoperability and care
coordination with additional health

[[Page 35926]]

care providers, and prevent redundancy in creation of a separate
measure.
In the past, stakeholders have raised concerns that the summary
care records shared according to the CCDA standard included excessive
information not relevant to immediate care needs, which increased
burden on health care providers. Under the ONC Health IT Certification
Program 2015 Edition, CEHRT must have the capability to exchange all of
the information in the CCDS as part of a summary care record structured
according to the CCDA standard. We previously finalized in the final
rule titled ``Medicare and Medicaid Programs Electronic Health Record
Incentive Program--Stage 2: Health Information Technology, Standards
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology''
(hereafter referred to as the ``Stage 2 final rule'') (77 FR 53991
through 53993) that health care providers must transmit all of the CCDS
information as part of this summary care record, if known, and that
health care providers must always transmit information about the
problem list, medications, and medication allergies, or validate that
this information is not known.
As finalized in the ``Medicare and Medicaid Programs; Electronic
Health Record Incentive Program--Stage 3 and Modifications to
Meaningful Use in 2015 Through 2017; Final Rule'' (hereafter referred
to as the ``2015 EHR Incentive Programs final rule'' (80 FR 62852
through 62861), our policy allows health care providers to constrain
the information in the summary care record to support transitions of
care. For instance, we encouraged health care providers to send a list
of items that he or she believes to be pertinent and relevant to the
patient's care, rather than a list of all problems, whether active or
resolved, that have ever populated the problem list. While a current
problem list must always be included, the health care provider can use
his or her judgment in deciding which items historically present on the
problem list, medical history list (if it exists in CEHRT), or surgical
history list are relevant given the clinical circumstances.
We also wish to encourage MIPS eligible clinicians to use the
document template available within the CCDA which contains the most
clinically relevant information required by the receiver. Accordingly,
we are proposing that MIPS eligible clinicians may use any document
template within the CCDA standard for purposes of the measures under
the Health Information Exchange objective. While a MIPS eligible
clinician's CEHRT must be capable of sending the full CCDA upon
request, we believe this additional flexibility will help support
clinicians' efforts to ensure the information supporting a transition
is relevant.
For instance, when the MIPS eligible clinician is referring to
another health care provider the recommended document is the ``Referral
Note'' which is designed to communicate pertinent information from a
MIPS eligible clinician who is requesting services of another health
care provider of clinical or non-clinical services. When the receiving
health care provider sends back the information, the most relevant CCDA
document template may be the ``Consultation Note,'' which is generated
by a request from a clinician for an opinion or advice from another
clinician. While the 2015 Edition transition of care certification
criterion only requires testing to the Continuity of Care Document and
Referral Note document templates, we are proposing to allow MIPS
eligible clinicians the flexibility to use additional CCDA templates
most appropriate to their clinical workflows. Clinicians would need to
work with their health IT developer to determine appropriate technical
workflows and implementation. For more information about the CCDA and
associated templates, see http://www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG_CCDA_CLINNOTES_R1_DSTUR2.1_2015AUG.zip.
In the event we do not finalize a new scoring methodology as
proposed in section III.H.3.h.(5)(d), we would maintain the current
Promoting Interoperability performance category objectives, measures
and reporting requirements as finalized in previous rulemaking. MIPS
eligible clinicians would be required to report the Send a Summary of
Care measure as part of the base score as finalized in previous
rulemaking (82 FR 53674 through 53680).
(B) Proposed Removal of the Request/Accept Summary of Care Measure
We are proposing to remove the Request/Accept Summary of Care
measure based on our analysis of the existing measure and in response
to stakeholder input.
Through review of implementation practices based on stakeholder
feedback, we believe that the existing Request/Accept Summary of Care
measure is not feasible for machine calculation in the majority of
cases. The intent of the measure is to identify when MIPS eligible
clinicians are engaging with other providers of care or care team
members to obtain up-to-date patient health information and to
subsequently incorporate relevant data into the patient record.
However, stakeholders have noted the measure specification does not
effectively further this purpose. Specifically, the existing measure
specification results in unintended consequences where health care
providers implement either:
(1) A burdensome workflow to document the manual action to request
or obtain an electronic record, for example, clicking a check box to
document each phone call or similar manual administrative task, or
(2) A workflow which is limited to only querying internal resources
for the existence of an electronic document.
Neither of these two implementation options is desirable when the
intent of the measure is to incentivize and encourage health care
providers to implement effective workflows to identify, receive, and
incorporate patient health information from other health care providers
into the patient record.
In addition, our analysis identified that the definition of
incorporate within the Request/Accept Summary of Care measure is
insufficient to ensure an interoperable result. When this measure was
initially finalized in the 2015 EHR Incentive Programs final rule at 80
FR 62860, we did not define ``incorporate'' as we believed it would
vary amongst health care provider's workflows, patient population and
the referring health care provider. In addition, we noted that the
information could be included as an attachment, as a link within the
EHR, as imported structured data or reconciled within the record and
not exclusively performed through use of CEHRT. Further, stakeholder
feedback highlights the fact that the requirement to incorporate data
is insufficiently clear regarding what data must be incorporated.
Our intention was that ``incorporate'' would relate to the
workflows undertaken in the process of clinical information
reconciliation further defined in the Clinical Information
Reconciliation measure (80 FR 62852 through 62862). Taken together, the
three measures under the Health Information Exchange objective were
intended to support the referral loop through sending, receiving, and
incorporating patient health data into the patient record. However,
stakeholder feedback on the measures suggests that the separation
between receiving and reconciling patient health

[[Page 35927]]

information is not reflective of clinical and care coordination
workflows. Further, stakeholders noted, that when approached
separately, the incorporate portion of the Request/Accept Summary of
Care measure is both inconsistent with and redundant to the Clinical
Information Reconciliation measure which causes unnecessary burden and
duplicative measure calculation.
(C) Proposed Removal of the Clinical Information Reconciliation Measure
We are proposing to remove the Clinical Information Reconciliation
measure to reduce redundancy, complexity, and MIPS eligible clinician
burden.
We believe the Clinical Information Reconciliation measure is
redundant in regard to the requirement to ``incorporate'' electronic
summaries of care in light of the requirements of the Request/Accept
Summary of Care measure. In addition, the measure is not fully health
IT based as the exchange of health care information is not required to
complete the measure action and the measure specification is not
limited to only the reconciliation of electronic information in health
IT supported workflows. We stated in the 2015 EHR Incentive Programs
final rule at 80 FR 62861 that the clinical information reconciliation
process could involve both automated and manual reconciliation to allow
the receiving health care provider to work with both electronic data
received as well as the patient to reconcile their health information.
Further, stakeholder feedback from hospitals, clinicians, and health IT
developers indicates that because the measure is not fully based on the
use of health IT to meet the measurement requirements, health care
providers must engage in burdensome tracking of manual workflows. While
the overall activity of clinical information reconciliation supports
quality patient care and should be a part of effective clinical
workflows, the process to record and track each individual action
places unnecessary burden on MIPS eligible clinicians.
(D) Proposed New Measure: Support Electronic Referral Loops by
Receiving and Incorporating Health Information
We are proposing to add the following new measure for inclusion in
the Health Information Exchange objective: Support Electronic Referral
Loops by Receiving and Incorporating Health Information. This measure
would build upon and replace the existing Request/Accept Summary of
Care and Clinical Information Reconciliation measures.
Proposed name of measure and description: Support Electronic
Referral Loops by Receiving and Incorporating Health Information: For
at least one electronic summary of care record received for patient
encounters during the performance period for which a MIPS eligible
clinician was the receiving party of a transition of care or referral,
or for patient encounters during the performance period in which the
MIPS eligible clinician has never before encountered the patient, the
MIPS eligible clinician conducts clinical information reconciliation
for medication, medication allergy, and current problem list.
We are proposing to combine two existing measures, the Request/
Accept Summary of Care measure and the Clinical Information
Reconciliation measure, in this new Support Electronic Referral Loops
by Receiving and Incorporating Health Information measure to focus on
the exchange of health care information as the current Clinical
Information Reconciliation measure is not reliant on the exchange of
health care information to complete the measure action. We are not
proposing to change the actions associated with the existing measures;
rather, we are proposing to combine the two measures to focus on the
exchange of the health care information, reduce administrative burden,
and streamline and simplify reporting.
CMS and ONC worked together to define the following for this
measure:
Denominator: Number of electronic summary of care records received
using CEHRT for patient encounters during the performance period for
which a MIPS eligible clinician was the receiving party of a transition
of care or referral, and for patient encounters during the performance
period in which the MIPS eligible clinician has never before
encountered the patient.
Numerator: The number of electronic summary of care records in the
denominator for which clinical information reconciliation is completed
using CEHRT for the following three clinical information sets: (1)
Medication--Review of the patient's medication, including the name,
dosage, frequency, and route of each medication; (2) Medication
allergy--Review of the patient's known medication allergies; and (3)
Current Problem List--Review of the patient's current and active
diagnoses.
Exclusion: Any MIPS eligible clinician who receives fewer than 100
transitions of care or referrals or has fewer than 100 encounters with
patients never before encountered during the performance period.
We are requesting comment on the proposed exclusion criteria and
whether there are additional circumstances that should be added to the
exclusion criteria and what those circumstances might be.
For the proposed measure, the denominator would increment on the
receipt of an electronic summary of care record after the MIPS eligible
clinician engages in workflows to obtain an electronic summary of care
record for a transition, referral or patient encounter in which the
MIPS eligible clinician has never before encountered the patient. The
numerator would increment upon completion of clinical information
reconciliation of the electronic summary of care record for
medications, medication allergies, and current problems. The MIPS
eligible clinician would no longer be required to manually count each
individual non-health-IT-related action taken to engage with other
providers of care and care team members to identify and obtain the
electronic summary of care record. Instead, the proposed measure would
focus on the result of these actions when an electronic summary of care
record is successfully identified, received, and reconciled with the
patient record. We believe this approach would allow MIPS eligible
clinicians to determine and implement appropriate workflows supporting
efforts to receive the electronic summary of care record consistent
with the implementation of effective health IT information exchange at
an organizational level.
Finally, we are proposing to apply our existing policy for cases in
which the MIPS eligible clinician determines no update or modification
is necessary within the patient record based on the electronic clinical
information received, and the MIPS eligible clinician may count the
reconciliation in the numerator without completing a redundant or
duplicate update to the record. We welcome public comment on methods by
which this specific action could potentially be electronically measured
by the MIPS eligible clinician's health IT system--such as incrementing
on electronic signature or approval by an authorized health care
provider--to mitigate the risk of burden associated with manual
tracking of the action, such as having to click check boxes.
We welcome public comment on these proposals. We are seeking
comment on methods and approaches to quantify the reduction in burden
for MIPS eligible clinicians implementing streamlined workflows for
this proposed health IT-based measure. We also are seeking comment on
the impact these

[[Page 35928]]

proposed modifications may have for health IT developers in updating,
testing, and implementing new measure calculations related to these
proposed changes. Specifically, we seek comment on whether ONC should
require developers to recertify their EHR technology as a result of the
changes proposed, or whether they should be able to make the changes
and engage in testing without recertification, and on the appropriate
timeline for such requirements factoring in the proposed continuous 90
day performance period within the calendar year for clinicians.
Finally, we are seeking comment on whether this proposed new measure
that combines the Request/Accept Summary of Care and Clinical
Information Reconciliation measures should be adopted, or whether
either or both of the existing Request/Accept Summary of Care and
Clinical Information Reconciliation measures should be retained in lieu
of this proposed new measure.
In the event we finalize the new scoring methodology we are
proposing in section III.H.3.h.(5)(d) of this proposed rule, an
exclusion would be available for MIPS eligible clinicians who could not
implement the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure for a performance period in CY
2019.
In the event we do not finalize the proposed scoring methodology,
we would maintain the current Promoting Interoperability performance
category objectives, measures and reporting requirements as finalized
in previous rulemaking. MIPS eligible clinicians would be required to
report the Request/Accept Summary of Care measure as part of the base
score and the Clinical Information Reconciliation measure would remain
as part of the performance score as finalized in previous rulemaking
(82 FR 53674 through 53680).
We also are proposing that, in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at Sec. 170.315(b)(1) and (2).
(iv) Measure Proposals for the Provider to Patient Exchange Objective
The Provider to Patient Exchange objective for MIPS eligible
clinicians builds upon the goal of improved access and exchange of
patient data, patient centered communication and coordination of care
using CEHRT. We are proposing a new scoring methodology in section
III.H.3.h.(5)(d) of this proposed rule, under which we are proposing to
rename the Patient Electronic Access objective to Provider to Patient
Exchange, remove the Patient-Specific Education measure and rename the
Provide Patient Access measure to Provide Patients Electronic Access to
Their Health Information. In addition, we are proposing to remove the
Coordination of Care through Patient Engagement objective and all
associated measures. The existing Promoting Interoperability
performance category Patient Electronic Access objective includes two
measures and the existing Coordination of Care through Patient
Engagement objective includes three measures.
We reviewed the Promoting Interoperability performance category
requirements and determined that these proposals could reduce program
complexity and burden and better focus on leveraging the most current
health IT functions and standards for patient flexibility of access and
exchange of information.
We are proposing the Provider to Patient Exchange objective would
include one measure, the existing Provide Patient Access measure, which
are proposing to rename to Provide Patients Electronic Access to Their
Health Information.
In the event we do not finalize the proposed scoring methodology in
III.H.3.(5)(c), we would maintain the current Promoting
Interoperability performance category objectives, measures and
reporting requirements as finalized in previous rulemaking. MIPS
eligible clinicians would be required to report the Provide Patient
Access measure as part of the base score under the Patient Electronic
Access objective, and the Patient-Specific Education measure would
remain as part of the performance score as finalized in previous
rulemaking (82 FR 53674 through 53680). The Coordination of Care
Through Patient Engagement objective and its associated measures (VDT,
Secure Messaging, and Patient-Generated Health Data) would remain as
part of the performance score as finalized in previous rulemaking (82
FR 53674 through 53680).
(A) Proposed Modification To Provide Patient Access Measure
We are proposing to change the name of the Provide Patient Access
measure to Provide Patients Electronic Access to Their Health
Information measure to better reflect the emphasis on patient
engagement in their health care and patient's electronic access of
their health information through use of APIs.
We propose to change the measure name to emphasize electronic
access of patient health information as opposed to use of paper based
actions and limit the focus to only health IT solutions to encourage
adoption and innovation in use of CEHRT (80 FR 62783 through 62784). In
addition, we are committed to promoting patient engagement with their
healthcare information and ensuring access in an electronic format.
(B) Proposed Removal of the Patient-Generated Health Data Measure
We are proposing to remove the Patient-Generated Health Data (PGHD)
measure to reduce complexity and focus on the goal of using advanced
EHR technology and functionalities to advance interoperability and
health information exchange.
As finalized in the 2015 EHR Incentive Programs final rule at 80 FR
62851, the measure is not fully health IT based as we did not specify
the manner in which health care providers would incorporate the data
received. Instead, we finalized that health care providers could work
with their EHR developers to establish the methods and processes that
work best for their practice and needs. We indicated that this could
include incorporation of the information using a structured format
(such as an existing field in the EHR or maintaining an isolation
between the data and the patient record such as incorporation as an
attachment, link or text reference which would not require the advanced
use of CEHRT). While we continue to believe that incorporating this
data is valuable, we are prioritizing only those actions which are
completed electronically using certified health IT.
(C) Proposed Removal of the Patient-Specific Education Measure
We are proposing to remove the Patient-Specific Education measure
as it has proven burdensome to MIPS eligible clinicians in ways that
were unintended and detracts from their progress on current program
priorities.
The Patient-Specific Education measure was finalized as a
performance score measure for MIPS eligible clinicians in the CY 2017
Quality Payment Program final rule with the intent of improving patient
health, increasing transparency and engaging patients in their care (81
FR 77228 through 77237).
We believe that the Patient-Specific Education measure does not
align with the current emphasis of the Promoting Interoperability
performance category to increase interoperability, or reduce burden for
MIPS eligible clinicians. In addition to not including interoperability
as a core focus, stakeholders have indicated that this measure does not
capture many of the

[[Page 35929]]

innovative activities around providing patient education, for instance
new approaches to integrating patient education within clinical
decision support modules. As a result of this lack of alignment, this
measure could potentially increase clinician burden.
(D) Proposed Removal of the Secure Messaging Measure
We are proposing to remove the Secure Messaging measure as it has
proven burdensome to MIPS eligible clinicians in ways that were
unintended and detracts from MIPS eligible clinicians' progress on
current program priorities.
The Secure Messaging measure was finalized in the CY 2017 Quality
Payment Program final rule with the intent to build upon the policy
goals of Stage 2 under the EHR Incentive Programs of using CEHRT for
health care provider-patient communication (81 FR 77227 through 77236).
As outlined above, we believe that the Secure Messaging measure does
not align with the current emphasis of the Promoting Interoperability
performance category to increase interoperability or reduce burden for
MIPS eligible clinicians. In addition, we believe there is burden
associated with tracking secure messages, including the unintended
consequences of workflows designed for the measure rather than for
clinical and administrative effectiveness.
(E) Proposed Removal of the View, Download or Transmit Measure
We are proposing to remove the View, Download or Transmit measure
as it has proven burdensome to MIPS eligible clinicians in ways that
were unintended and detracts from their progress on current program
priorities.
We received MIPS eligible clinician and stakeholder feedback
through correspondence, public forums, and listening sessions
indicating there is ongoing concern with measures which require patient
action for successful submission. We have noted that data analysis on
the patient action measures supports stakeholder concerns that barriers
exist which impact a clinician's ability to meet them. Stakeholders
have indicated that successful submission of the measure is reliant
upon the patient, who may face barriers to access which are outside a
clinician's control.
After additional review, we note that successful performance
predicated solely on a patient's action has inadvertently created
burdens to MIPS eligible clinicians and detracts from progress on
Promoting Interoperability measure goals of focusing on patient care,
interoperability and leveraging advanced used of health IT. Therefore,
we propose to remove the View, Download or Transmit measure.
(v) Proposed Modifications to the Public Health and Clinical Data
Registry Reporting Objective and Measures
In connection with the scoring methodology proposed in section
III.H.3.h.(5)(d) of this proposed rule, we are proposing changes to the
Public Health and Clinical Data Registry Reporting objective and five
associated measures.
We believe that public health reporting through EHRs will extend
the use of electronic reporting solutions to additional events and care
processes, increase timeliness and efficiency of reporting and replace
manual data entry.
We are proposing to change the name of the objective to Public
Health and Clinical Data Exchange and are proposing exclusions for each
of the associated measures.
Under the new scoring methodology proposed in section
III.H.3.h.(5)(d) of this proposed rule, we are proposing that a MIPS
eligible clinician would be required to submit two of the measures of
the clinician's choice from the five measures associated with the
objective: Immunization Registry Reporting, Syndromic Surveillance
Reporting, Electronic Case Reporting, Public Health Registry Reporting,
and Clinical Data Registry Reporting.
In prior rulemaking, we recognized the goal of increasing
interoperability through public health registry exchange of data (80 FR
62771). We continue to believe that public health reporting is valuable
in terms of health information exchange between MIPS eligible
clinicians and public health and clinical data registries. For example,
when immunization information is directly exchanged between EHRs and
registries, patient information may be accessed by all of a patient's
health care providers for improved continuity of care and reduced
health care provider burden, as well as supporting population health
monitoring.
We are also proposing exclusion criteria for each of the Public
Health and Clinical Data Exchange measures beginning with the
performance period in 2019. Under the scoring methodology for the
Promoting Interoperability performance category for the performance
period in 2018 (82 FR 53676 through 53677), the measures associated
with the Public Health and Clinical Data Registry Reporting objective
are not required for the base score, and thus we did not establish
exclusion criteria for them. However, we understand that some MIPS
eligible clinicians may not be able to report to public health agencies
or clinical data registries due to their scope of practice. For
example, we noted in the CY 2018 Quality Payment Program final rule (82
FR 53663) that there are MIPS eligible clinicians who lack access to
immunization registries or do not administer immunizations. Also, we
noted in the 2017 Quality Payment Program final rule (81 FR 77236) few
jurisdictions accept syndromic surveillance from non-urgent care EPs.
Therefore, we are proposing the following measure exclusions based on
the exclusions finalized in previous rulemaking under the EHR Incentive
Programs (80 FR 62862 through 62871).
Measure: Immunization Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Immunization
Registry Reporting measure if the MIPS eligible clinician:
1. Does not administer any immunizations to any of the populations
for which data is collected by its jurisdiction's immunization registry
or immunization information system during the performance period.
2. Operates in a jurisdiction for which no immunization registry or
immunization information system is capable of accepting the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data as of 6 months prior to the start of the performance
period.
Measure: Syndromic Surveillance Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Syndromic
Surveillance Reporting measure if the MIPS eligible clinician:
1. Is not in a category of health care providers from which
ambulatory syndromic surveillance data is collected by their
jurisdiction's syndromic surveillance system.
2. Operates in a jurisdiction for which no public health agency is
capable of receiving electronic syndromic surveillance data in the
specific standards required to meet the CEHRT definition at the start
of the performance period.
3. Operates in a jurisdiction where no public health agency has
declared

[[Page 35930]]

readiness to receive syndromic surveillance data from MIPS eligible
clinicians as of 6 months prior to the start of the performance period.
Measure: Electronic Case Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Electronic Case
Reporting measure if the MIPS eligible clinician:
1. Does not treat or diagnose any reportable diseases for which
data is collected by their jurisdiction's reportable disease system
during the performance period.
2. Operates in a jurisdiction for which no public health agency is
capable of receiving electronic case reporting data in the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic case reporting data as of 6
months prior to the start of the performance period.
Measure: Public Health Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Public Health
Reporting measure if the MIPS eligible clinician;
1. Does not diagnose or directly treat any disease or condition
associated with a public health registry in the MIPS eligible
clinician's jurisdiction during the performance period.
2. Operates in a jurisdiction for which no public health agency is
capable of accepting electronic registry transactions in the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no public health registry for
which the MIPS eligible clinician is eligible has declared readiness to
receive electronic registry transactions as of 6 months prior to the
start of the performance period.
Measure: Clinical Data Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Clinical Data
Registry Reporting measure if the MIPS eligible clinician;
1. Does not diagnose or directly treat any disease or condition
associated with a clinical data registry in their jurisdiction during
the performance period.
2. Operates in a jurisdiction for which no clinical data registry
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the performance period.
3. Operates in a jurisdiction where no clinical data registry for
which the MIPS eligible clinician is eligible has declared readiness to
receive electronic registry transactions as of 6 months prior to the
start of the performance period.
We seek comment on the proposed exclusions and whether there are
circumstances that would require additional exclusion criteria for the
measures.
In addition, we intend to propose in future rulemaking to remove
the Public Health and Clinical Data Exchange objective and measures no
later than CY 2022, and are seeking public comment on whether MIPS
eligible clinicians will continue to share such data with public health
entities once the Public Health and Clinical Data Exchange objective is
removed, as well as other policy levers outside of the Promoting
Interoperability performance category that could be adopted for
continued reporting to public health and clinical data registries, if
necessary. As noted above, while we believe that these registries
provide the necessary monitoring of public health nationally and
contribute to the overall health of the nation, we are also focusing on
reducing burden and identifying other appropriate venues in which
reporting to public health and clinical data registries could be
reported. We are seeking public comment on the role that each of the
public health and clinical data registries should have in the future of
the Promoting Interoperability performance category and whether the
submission of this data should still be required.
Lastly, we are seeking public comment on whether the Promoting
Interoperability performance category is the best means for promoting
sharing of clinical data with public health entities.
In the event we do not finalize the new scoring methodology we are
proposing in section III.H.3.h.(5)(d) of this proposed rule, current
Promoting Interoperability performance category objectives, measures
and reporting requirements would be maintained as finalized in previous
rulemaking. Therefore, all Public Health and Clinical Data Registry
Reporting measures would be part of the performance and bonus score as
finalized in previous rulemaking (82 FR 53674 through 53680).
To assist readers in identifying the requirements of CEHRT for the
Promoting Interoperability Objectives and Measures under the scoring
methodology proposed in section III.H.3.h.(5)(d) of this proposed rule,
we are including Table 40, which includes the 2015 Edition
certification criteria required to meet the objectives and measures.

Table 40--Promoting Interoperability Objectives and Measures and
Certification Criteria for the 2015 Edition
------------------------------------------------------------------------
Objective Measure 2015 Edition
------------------------------------------------------------------------
Protect Patient Health Security Risk The requirements are
Information. Analysis. a part of CEHRT
specific to each
certification
criterion.
e-Prescribing................. e-Prescribing.... Sec. 170.315(b)(3)
(Electronic
Prescribing).
Sec. 170.315(a)(10)
(Drug-Formulary and
Preferred Drug List
checks).
Query of PDMP.... Sec. 170.315(a)(10)
(Drug-Formulary and
Preferred Drug List
checks) and (b)(3)
(Electronic
Prescribing).
Verify Opioid Sec. 170.315(a)(10)
Treatment (Drug-Formulary and
Agreement. Preferred Drug List
checks) (b)(3)
(Electronic
Prescribing), and
Sec. 170.205(b)(2)
(Electronic
Prescribing
Standard).
Health Information Exchange... Support Sec. 170.315(b)(1)
Electronic (Transitions of
Referral Loops Care).
by Sending
Health
Information.
Support Sec. 170.315(b)(1)
Electronic (Transitions of
Referral Loops Care).
by Receiving and Sec. 170.315(b)(2)
Incorporating (Clinical
Health Information
Information. Reconciliation and
Incorporation).

[[Page 35931]]

Provider to Patient Exchange.. Provide Patients Sec. 170.315(e)(1)
Electronic (View, Download, and
Access to Their Transmit to 3rd
Health Party).
Information. Sec. 170.315(g)(7)
(Application Access--
Patient Selection).
Sec. 170.315(g)(8)
(Application Access--
Data Category
Request).
Sec. 170.315(g)(9)
(Application Access--
All Data Request).
The three criteria
combined are the
``API''
certification
criteria.
Public Health and Clinical Immunization Sec. 170.315(f)(1)
Data Exchange. Registry (Transmission to
Reporting. Immunization
Syndromic Registries).
Surveillance Sec. 170.315(f)(2)
Reporting. (Transmission to
Public Health
Agencies--Syndromic
Surveillance) Urgent
Care Setting Only.
Electronic Case Sec. 170.315(f)(5)
Reporting. (Transmission to
Public Health
Agencies--Electronic
Case Reporting).
Public Health EPs may choose one or
Registry more of the
Reporting. following: Sec.
170.315(f)(4)
(Transmission to
Cancer Registries).
Sec. 170.315(f)(7)
(Transmission to
Public Health
Agencies--Health
Care Surveys).
Clinical Data No 2015 Edition
Registry health IT
Reporting. certification
criteria at this
time.
------------------------------------------------------------------------

(vi) Request for Comment--Potential New Measures Health Information
Exchange Across the Care Continuum
We are working to introduce additional flexibility to allow MIPS
eligible clinicians a wider range of options in selecting measures that
are most appropriate to their setting, patient population, and clinical
practice improvement goals. For this reason, we are seeking comment on
a potential concept for future rulemaking to add two additional measure
options related to health information exchange for MIPS eligible
clinicians.
The Promoting Interoperability performance category requirements
for health information exchange primarily focused on the exchange
between and among health care providers. While these use cases
represent a significant portion of the health care industry, the care
continuum is much broader and includes a wide range of health care
providers and settings of care that have adopted and implemented health
IT systems to support patient care and electronic information exchange.
Specifically, health care providers in long-term care and post-acute
care settings, skilled nursing facilities, and behavioral health
settings have made significant advancements in the adoption and use of
health IT. Many MIPS eligible clinicians are now engaged in bi-
directional exchange of patient health information with these health
care providers and settings of care and many more are seeking to
incorporate these workflows as part of efforts to improve care team
coordination or to support alternative payment models.
For these reasons, we are seeking comment on two potential new
measures for inclusion in the program to enable MIPS eligible
clinicians to exchange health information through health IT supported
care coordination across a wide range of settings.
New Measure Description for Support Electronic Referral Loops by
Sending Health Information Across the Care Continuum: For at least one
transition of care or referral to a provider of care other than a MIPS
eligible clinician, the MIPS eligible clinician creates a summary of
care record using CEHRT; and electronically exchanges the summary of
care record.
New Measure Denominator: Number of transitions of care and
referrals during the performance period for which the MIPS eligible
clinician was the transitioning or referring health care provider to a
provider of care other than a MIPS eligible clinician.
New Measure Numerator: The number of transitions of care and
referrals in the denominator where a summary of care record was created
and exchanged electronically using CEHRT.
New Measure Description for Support Electronic Referral Loops by
Receiving and Incorporating Health Information Across the Care
Continuum: For at least one electronic summary of care record received
by a MIPS eligible clinician from a transition of care or referral from
a provider of care other than a MIPS eligible clinician, the MIPS
eligible clinician conducts clinical information reconciliation for
medications, medication allergies, and problem list.
New Measure Denominator: The number of electronic summary of care
records received for a patient encounter during the performance period
for which a MIPS eligible clinician was the recipient of a transition
of care or referral from a provider of care other than a MIPS eligible
clinician.
New Measure Numerator: The number of electronic summary of care
records received for which clinical information reconciliation was
completed using CEHRT for the following three clinical information
sets: (1) Medication--Review of the patient's medication, including the
name, dosage, frequency, and route of each medication; (2) Medication
allergy--Review of the patient's known medication allergies; and (3)
Current Problem List--Review of the patient's current and active
diagnoses.
We are seeking comment on whether these two measures should be
combined into one measure so that a MIPS eligible clinician who is
engaged in exchanging health information across the care continuum may
include any such exchange in a single measure. We seek comment on
whether the denominators should be combined to a single measure
including both transitions of care to and from a MIPS eligible
clinician. We further seek comment on whether the numerators should be
combined to a single measure including both the sending and receiving
of electronic patient health information. We are seeking comment on
whether the potential new measures should be considered for inclusion
in a future program year or whether stakeholders believe there is
sufficient readiness and interest in the measures to implement them as
early as CY 2019.
For the purposes of focusing the denominator, we are seeking
comment regarding whether the potential new measures should be limited
to transitions of care to and/or from referrals involving long-term and
post-acute care, skilled nursing care, and behavioral health care. We
also are seeking comment on whether additional settings of care should
be considered for

[[Page 35932]]

inclusion in the denominators and whether a MIPS eligible clinician
should be allowed to limit the denominators to a specific type of care
setting based on their organizational needs, clinical improvement
goals, or participation in an alternative payment model. We also are
interested in comments regarding the feasibility of these measures in
instances where a MIPS eligible clinician receives information from a
non-MIPS eligible clinician that is not using CEHRT. Finally, we are
seeking comment on the impact the potential new measures may have for
health IT developers to develop, test, and implement a new measure
calculation for a future program year.
(g) Improvement Activities Bonus Score Under the Promoting
Interoperability Performance Category and Future Reporting
Considerations
In the CY 2017 Quality Payment Program final rule (81 FR 77202), we
discussed our approach to the measurement of the use of CEHRT to allow
MIPS eligible clinicians and groups the flexibility to implement CEHRT
in a way that supports their clinical needs. Toward that end, we
adopted a policy for the 2017 and 2018 performance periods (81 FR
77202-77209 and 82 FR 53664-53670) and codified it at Sec.
414.1380(b)(4)(i)(C)(2) to award a bonus score to MIPS eligible
clinicians who use CEHRT to complete certain activities in the
improvement activities performance category based on our belief that
the use of CEHRT in carrying out these activities could further the
outcomes of clinical practice improvement.
In section III,H.3.h.(5)(d) of this proposed rule, we have proposed
significant changes to the scoring methodology and measures beginning
with the performance period in 2019. In connection with these changes,
we are not proposing to continue the bonus for completing certain
improvement activities using CEHRT for the performance period in 2019
and subsequent performance periods. As discussed in section
III.H.3.h.(5)(b) of this proposed rule, we are shifting the focus of
this performance category to put a greater emphasis on interoperability
and patient access to health information, and we do not believe
awarding a bonus for performing an improvement activity using CEHRT
would directly support those goals. While we continue to believe that
the use of CEHRT in completing improvement activities is extremely
valuable and vital to the role of CEHRT in practice improvement, we do
not believe that awarding a bonus in the Promoting Interoperability
performance category would be appropriate in light of the new direction
we want to take, and we seek comment on other ways to promote the use
of CEHRT.
We invite comments on our decision not to propose to continue the
bonus for completing certain improvement activities using CEHRT for the
performance period in 2019 and subsequent performance periods.
We acknowledge that the omission of this bonus could be viewed as
increasing burden, and seek to counteract that concern by evaluating
other methods to reduce burden to offset this potential increase. We
have also considered various ways to align and streamline the different
performance categories under the MIPS. In lieu of the improvement
activities bonus score, we have looked extensively at ways to link
three of the performance categories--quality, improvement activities
and Promoting Interoperability--to reduce burden and create a more
cohesive and closely linked MIPS program. One possibility we have
identified is to establish several sets of new multi-category measures
that would cut across the different performance categories and allow
MIPS eligible clinicians to report once for credit in all three
performance categories. For example, one possible combined measure
would bring together the elements of the proposed Promoting
Interoperability measure, Support Electronic Referral Loops by Sending
Health Information, the improvement activity, implementation of use of
specialist reports back to referring clinician or group to close
referral loop, and the quality measure, Closing the Referral Loop:
Receipt of Specialist Report. Our goal would be to establish several of
these combined measures so MIPS eligible clinicians could report once
for credit across all three performance categories. At the present
time, we are only seeking comment on this concept, as we are still
evaluating the appropriate measure combinations and feasibility of a
multi-category model. We believe that as we further develop the new
focus and goals of the Promoting Interoperability performance category,
we may be able to identify additional measure links that could make
this concept a reality and overcome some of the challenges we currently
face in implementing this concept. For example, one challenge we have
identified is the lack of measures and activities that share identical
and aligned requirements across the three performance categories. We
seek comment on this reporting model, as well as measure and activity
suggestions to enhance the link between the three performance
categories.
Furthermore, to promote measurement that provides clinicians with
measures that are meaningful to their practices, we intend to consider
proposing in future rulemaking MIPS public health priority sets across
the four performance categories (quality, improvement activities,
Promoting Interoperability, and cost). We believe that adopting such
sets would provide clinicians with a cohesive reporting experience, by
allowing them to focus on activities and measures that fit within their
workflow, address their patient population needs, and encourage
increased participation in MIPS. Furthermore, it would drive
participation and continued improvement across performance categories.
Consistent with the goals of the Meaningful Measures Initiative, the
public health priority sets would seek to provide clinicians with sets
of measures and activities that are most meaningful to them, with an
emphasis on improving quality of life and outcomes for patients. The
construction of public health priority sets could also identify where
there are measurement gaps, and what areas measure development should
focus on, such as the lack of sufficient measures for certain
specialists.
The public health priority sets would be built across performance
categories and decrease the burden of having to report for separate
performance categories as relevant measures and activities are bundled.
In developing the first few public health priority sets, we intend to
focus on areas that address the opioid epidemic impacting the nation,
as well as other patient wellness priorities that are attributable to
more complex diseases or clinical conditions. We intend to develop the
first few public health priority sets around: Opioids; blood pressure;
diabetes; and general health (healthy habits). In this proposed rule,
we are seeking comments on additional public health priority areas that
should be considered, and whether these public health priority sets
should be more specialty focused versus condition specific. We are also
seeking comment on how CMS could implement public health priority sets
in ways that further minimize burden for health care providers, for
instance, by offering sets which emphasize use of common health IT
functionalities. Finally, we are seeking comment on how CMS could
encourage or incentivize health care providers to consider using these
public health priority sets.

[[Page 35933]]

(h) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse
Specialists, and Certified Registered Nurse Anesthetists
In prior rulemaking (82 FR 30079), we discussed our belief that
certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs)
may lack experience with the adoption and use of CEHRT. Because many of
these non-physician clinicians were or are not eligible to participate
in the Medicare or Medicaid Promoting Interoperability Program, we
stated that we have little evidence as to whether there are sufficient
measures applicable and available to these types of MIPS eligible
clinicians under the advancing care information performance category.
We established a policy for the performance periods in 2017 and 2018
under section 1848(q)(5)(F) of the Act to assign a weight of zero to
the advancing care information performance category in the MIPS final
score if there are not sufficient measures applicable and available to
NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the
event that an NP, PA, CRNA, or CNS does not submit any data for any of
the measures specified for the advancing care information performance
category, but if they choose to report, they will be scored on the
advancing care information performance category like all other MIPS
eligible clinicians and the performance category will be given the
weighting prescribed by section 1848(q)(5)(E) of the Act. We stated our
intention to use data from the first performance period (2017) to
further evaluate the participation of these MIPS eligible clinicians in
the advancing care information performance category and consider for
subsequent years whether the measures specified for this category are
applicable and available to these MIPS eligible clinicians. As we have
not yet analyzed the data for the first MIPS performance period, it
would be premature to propose to alter our treatment of these MIPS
eligible clinicians in year 3.
We are proposing to continue this policy for the performance period
in 2019 and to codify the policy at Sec. 414.1380(c)(2)(i)(A)(5). We
request public comments on this proposal.
(ii) Physical Therapists, Occupational Therapists, Clinical Social
Workers, and Clinical Psychologists
As discussed in section III.H.3.a. of this proposed rule, in
accordance with section 1848(q)(1)(C)(i)(II) of the Act, we are
proposing to add the following clinician types to the definition of a
MIPS eligible clinician, beginning with the performance period in 2019:
Physical therapists, occupational therapists, clinical social workers,
and clinical psychologists. For the reasons discussed in prior
rulemaking and in the preceding section III.H.3.h.(5)(f), we are
proposing to apply the same policy we adopted for NPs, PAs, CNSs, and
CRNAs for the performance periods in 2017 and 2018 to these new types
of MIPS eligible clinicians for the performance period in 2019. Because
many of these clinician types were or are not eligible to participate
in the Medicare or Medicaid Promoting Interoperability Program, we have
little evidence as to whether there are sufficient measures applicable
and available to them under the Promoting Interoperability performance
category. Thus, we are proposing to rely on section 1848(q)(5)(F) of
the Act to assign a weight of zero to the Promoting Interoperability
performance category if there are not sufficient measures applicable
and available to these new types of MIPS eligible clinicians (physical
therapists, occupational therapists, clinical social workers, and
clinical psychologists). We encourage all of these new types of MIPS
eligible clinicians to report on these measures to the extent they are
applicable and available; however, we understand that some of them may
choose to accept a weight of zero for this performance category if they
are unable to fully report the Promoting Interoperability measures. We
believe this approach is appropriate for their first performance period
(in 2019) based on the payment consequences associated with reporting,
the fact that many of these types of MIPS eligible clinicians may lack
experience with EHR use, and our current uncertainty as to whether we
have proposed sufficient measures that are applicable and available to
these types of MIPS eligible clinicians. We would use their first
performance period to further evaluate the participation of these MIPS
eligible clinicians in the Promoting Interoperability performance
category and would consider for subsequent years whether the measures
specified for this category are applicable and available to these MIPS
eligible clinicians.
These MIPS eligible clinicians may choose to submit Promoting
Interoperability measures if they determine that these measures are
applicable and available to them; however, if they choose to report,
they would be scored on the Promoting Interoperability performance
category like all other MIPS eligible clinicians and the performance
category would be given the weighting prescribed by section
1848(q)(5)(E) of the Act regardless of their Promoting Interoperability
performance category score.
We are proposing to codify this policy at Sec.
414.1380(c)(2)(i)(A)(4).
(6) APM Scoring Standard for MIPS Eligible Clinicians Participating in
MIPS APMs
(a) Overview
As codified at Sec. 414.1370, MIPS eligible clinicians, including
those participating in MIPS APMs, are subject to MIPS reporting
requirements and payment adjustments, unless excluded on another basis.
In the CY 2017 Quality Payment Program rule, we finalized the APM
scoring standard, which is designed to reduce reporting burden for
participants in certain APMs by reducing the need for duplicative data
submission to MIPS and their respective APMs, and to avoid potentially
conflicting incentives between those APMs and the MIPS.
We established at Sec. 414.1370(c) that the MIPS performance
period under Sec. 414.1320 applies for the APM scoring standard. We
finalized under Sec. 414.1370(f) that, under the APM scoring standard,
MIPS eligible clinicians will be scored at the APM entity group level
and each MIPS eligible clinician will receive the APM Entity's final
MIPS score. We propose to amend Sec. 414.1370(f)(2) to state that if
the APM Entity group is excluded from MIPS, all eligible clinicians
within that APM Entity group are also excluded from MIPS.
The MIPS final score under the APM scoring standard is comprised of
the four MIPS performance categories as finalized at Sec. 414.1370(g):
Quality; cost; improvement activities; and advancing care information.
In 2018, these performance categories are scored at 50 percent, 0
percent, 30 percent, and 20 percent, respectively.
In this proposed rule for the APM scoring standard, we propose to:
(1) Revise Sec. 414.1370(b)(3) to clarify the requirement for MIPS
APMs to assess performance on quality measures and cost/utilization,
modify the Shared Savings Program quality reporting requirements by
extending the reporting exception to solo practitioners; (2) remove the
Promoting Interoperability (formerly advancing care information) full-
TIN reporting requirement for participants in the Shared Savings
Program to allow individual TIN/NPIs to report for the Promoting
Interoperability performance category; and (3) update the MIPS APM
measure

[[Page 35934]]

sets that apply for purposes of the APM scoring standard. In addition,
we explain how performance feedback may be accessed by ACO participant
TINs in the Shared Savings Program.
(b) MIPS APM Criteria
In the CY 2017 Quality Payment Program final rule, we established
at Sec. 414.1370(b) that for an APM to be considered a MIPS APM, it
must satisfy the following criteria: (1) APM Entities participate in
the APM under an agreement with CMS or by law or regulation; (2) the
APM requires that APM Entities include at least one MIPS eligible
clinician on a participation list; (3) the APM bases payment incentives
on performance (either at the APM entity or eligible clinician level)
on cost/utilization and quality measures; and (4) the APM is neither a
new APM for which the first performance period begins after the first
day of the MIPS performance year, nor an APM in the final year of
operation for which the APM scoring standard is impracticable.
It has come to our attention that there may be some ambiguity in
the third criterion at Sec. 414.1370(b)(3). We have received questions
as to whether the criterion requires MIPS APMs to base payment
incentives on performance on cost/utilization ``measures,'' or whether
it requires more generally that MIPS APMs base payment incentives on
``cost/utilization.'' Because we did not address this exact point in
prior rulemaking and our intended policy is not strictly clear from the
regulation text, we are clarifying here that we intended the word
``measures'' at Sec. 414.1370(b)(3) to modify only ``quality'' and not
``cost/utilization.'' To make this criterion clearer, we are proposing
to modify the regulation to specify that a MIPS APM must be designed in
such a way that participating APM Entities are incented to reduce costs
of care or utilization of services, or both. This proposed change to
Sec. 414.1370(b)(3) would make it clear that a MIPS APM could take
into account performance in terms of cost/utilization using model
design features other than the direct use of cost/utilization measures.
Specifically, we are proposing to change the order in which the
requirements in the third criterion are listed to state that the APM
bases payment incentives on performance (either at the APM entity or
eligible clinician level) on quality measures and cost/utilization.
We further would like to clarify that we will consider each
distinct track of an APM and whether it meets the above criteria in
order to be a MIPS APM, and that it is possible for an APM to have
tracks that are MIPS APMs and tracks that are not MIPS APMs. We would
not, however, further consider whether the individual APM Entities or
MIPS eligible clinicians participating within a given track each
satisfy all of the above MIPS APM criteria.
For purposes of this proposal, we understand the term ``track'' to
refer to a distinct arrangement through which an APM Entity
participates in the APM, and that such participation is mutually
exclusive of the APM Entity's participation in another ``track'' within
the same APM. For example, we would consider the two risk arrangements
under OCM to be two separate ``tracks.''
We also would like to clarify our interpretation of the rule at
Sec. 414.1370(b)(4)(i) for APMs that begin after the first day of the
MIPS performance period for the year (currently January 1), but require
participants to report quality data for quality measures tied to
payment for the full MIPS performance period, beginning January 1.
Under these circumstances where quality measures tied to payment must
be reported for purposes of the APM from the first day of the MIPS
performance period, we believe it would be counter to the purpose of
the APM scoring standard to require duplicative reporting of quality
measures for both the APM and MIPS, and to create potentially
conflicting incentives between the quality scoring requirements and
payment incentive structures under the APM and MIPS. Therefore, for the
purposes of MIPS APM determinations, we consider the first performance
year for an APM to begin as of the first date for which eligible
clinicians and APM entities participating in the model must report on
quality measures under the terms of the APM.
Based on the MIPS APM criteria, for the 2019 MIPS performance year,
we expect that ten APMs likely will satisfy the requirements to be MIPS
APMs: Comprehensive ESRD Care Model (all Tracks), Comprehensive Primary
Care Plus Model (all Tracks), Next Generation ACO Model, Oncology Care
Model (all Tracks), Medicare Shared Savings Program (all Tracks),
Medicare ACO Track 1+ Model, Bundled Payments for Care Improvement,
Advanced, Independence at Home Demonstration (if extended), Maryland
Total Cost of Care Model (Maryland Primary Care Program), and Vermont
Medicare ACO Initiative.
(c) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
For the quality performance category, MIPS eligible clinicians in
APM Entities will continue to be scored only on the quality measures
that are required under the terms of their respective APMs, and
available for scoring as specified in Sec. 414.1370(g)(1) and
explained in the CY 2017 Quality Payment Program final rule (82 FR
53698, 53692).
(A) Web Interface Reporters
In the CY 2018 Quality Payment Program final, we discussed, the
requirements for MIPS eligible clinicians participating in a MIPS APM
that requires use of the CMS Web Interface for quality reporting,
subsequently referred to as ``Web Interface Reporters'' (82 FR 53954).
In that rule we finalized a policy to use quality measure data that
participating APM Entities submit using the CMS Web Interface and CAHPS
surveys as required under the terms of the APM, and to use MIPS
benchmarks for these measures when APM benchmarks are not available, in
order to score quality for MIPS eligible clinicians at the APM Entity
level under the APM scoring standard (82 FR 53568, 53692). We also
codified at Sec. 414.1370(f)(1) a policy under which, in the event a
Shared Savings Program ACO does not report quality measures as required
by the Shared Savings Program under Sec. 425.508, each ACO participant
TIN will be treated as a unique APM entity for purposes of the APM
scoring standard, and may report data for the MIPS quality performance
category according to the MIPS submission and reporting requirements.
For the 2019 MIPS performance year, we anticipate that there will
be four Web Interface Reporter APMs: The Shared Savings Program; the
Track 1+ Model; Next Generation ACO Model; and the Vermont ACO Medicare
Initiative.
(aa) Complete Reporting Requirement
Under Sec. 414.1370(f)(1), if a Shared Savings Program ACO does
not report data on quality measures as required by the Shared Savings
Program under Sec. 425.508, each ACO participant TIN will be treated
as a unique APM Entity for purposes of the APM scoring standard and the
ACO participant TINs may report data for the MIPS quality performance
category according to the MIPS submission and reporting requirements.
We would like to clarify that any ``partial'' reporting through the CMS
Web Interface that does not satisfy

[[Page 35935]]

the requirements of the Shared Savings Program will be considered a
failure to report. Should a Shared Savings Program ACO fail to report,
the exception under Sec. 414.1370(f)(1) is triggered. In this
scenario, each ACO participant TIN has the opportunity to report
quality data to MIPS according to MIPS group reporting requirements in
order to avoid a score of zero for the quality performance category (81
FR 77256).
We recognize that, under this policy, successfully reporting to
MIPS according to group reporting requirements may be difficult for
solo practitioners, for whom case thresholds and other requirements may
make many group reporting measures unavailable. Therefore, we are
modifying the exception such that beginning in 2019, in the case of a
Shared Savings Program ACO's failure to report quality measures as
required by the Shared Saving Program we would also allow a solo
practitioner (a MIPS eligible clinician who has only one NPI billing
through their TIN), to report on any available MIPS measures, including
individual measures, in the event that their ACO fails to complete
reporting for all Web Interface measures.
We are also proposing that, beginning with the 2019 performance
period, the complete reporting requirement for Web Interface reporters
be modified to specify that if an APM Entity (in this case, an ACO)
fails to complete reporting for Web Interface measures but successfully
reports the CAHPS for ACOs survey, we will score the CAHPS for ACOs
survey and apply it towards the APM Entity's quality performance
category score. In this scenario the Shared Savings Program TIN-level
reporting exception would not be triggered and all MIPS eligible
clinicians within the ACO would receive the APM Entity score.
We seek comment on this proposal.
(B) Other MIPS APMs
Under Sec. 414.1370(g)(1)(ii), the MIPS quality performance
category score for a MIPS performance period is calculated for the APM
Entity using the data submitted by the APM Entity based on measures
specified by us through notice and comment rulemaking and available for
scoring for each Other MIPS APM from among those used under the terms
of the Other MIPS APM.
In the 2019 MIPS performance year, we anticipate that there will be
up to six Other MIPS APMs for which we will use this scoring
methodology, based on their respective measure sets and reporting
requirements: The Oncology Care Model; Comprehensive ESRD Care Model;
Comprehensive Primary Care Plus Model; the Bundled Payments for Care
Improvement Advanced; Maryland Primary Care Program; and Independence
at Home Demonstration (in the event of an extension).
(ii) Promoting Interoperability Performance Category
In the CY 2017 Quality Payment Program final rule (81 FR 77262
through 77264; 81 FR 77266 through 77269), we established a policy at
Sec. 414.1370(g)(4)(ii) for MIPS APMs other than the Shared Savings
Program, under which we attribute one Promoting Interoperability
performance category score to each MIPS eligible clinician in an APM
Entity group based on either individual or group-level data submitted
for the MIPS eligible clinician and using the highest available score.
We will then use these scores to create an APM Entity group score equal
to the average of the highest scores available for each MIPS eligible
clinician in the APM Entity group.
For the Shared Savings Program, we also finalized at Sec.
414.1370(g)(4)(i) that ACO participant TINs are required to report on
the Promoting Interoperability performance category, and we will weight
and aggregate the ACO participant TIN scores to determine an APM Entity
group score (81 FR 77258 through 77260). This policy was meant to align
requirements between the MIPS Promoting Interoperability measures and
the Shared Savings Program ACO-11 measure, which is used to assess
Shared Savings Program ACOs based on the MIPS Promoting
Interoperability measures. However, we have found that limiting
reporting to the ACO participant TIN creates unnecessary confusion, and
restricts Promoting Interoperability reporting options for MIPS
eligible clinicians who participate in the Shared Savings Program.
Therefore, beginning in the 2019 MIPS performance period, we are
proposing to no longer apply the requirement as finalized at Sec.
414.1370(g)(4)(i) and instead to apply the existing policy at Sec.
414.1370(g)(4)(ii) to MIPS eligible clinicians who participate in the
Shared Savings Program so that they may report on the Promoting
Interoperability performance category at either the individual or group
level like all other MIPS eligible clinicians under the APM scoring
standard.
We seek comment on this proposal.
(d) MIPS APM Performance Feedback
As we discussed in the CY 2017 and 2018 Quality Payment Program
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively),
MIPS eligible clinicians who are scored under the APM scoring standard
will receive performance feedback under section 1848(q)(12) of the Act.
Regarding access to performance feedback, we should note that
whereas split-TIN APM Entities and their participants can only access
their performance feedback at the APM Entity or individual MIPS
eligible clinician level, MIPS eligible clinicians participating in the
Shared Savings Program, which only includes full-TIN ACOs, will be able
to access their performance feedback at the ACO participant TIN level.
(e) Measure Sets

Table 41--MIPS APM Measure List--Comprehensive ESRD Care
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measure
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
Diabetes Care: Eye Exam........ 0055............. Effective Percentage of patients NCQA.
Clinical Care. 18-75 years of age
with diabetes who had
a retinal or dilated
eye exam by an eye
care professional
during the
measurement period or
a negative retinal
exam (no evidence of
retinopathy) in the
12 months prior to
the measurement
period.

[[Page 35936]]

Diabetes Care: Foot Exam....... 0056............. Effective Percentage of patients NCQA.
Clinical Care. 18-75 years of age
with diabetes (type 1
and type 2) who
received a foot exam
(visual inspection
and sensory exam with
mono filament and a
pulse exam) during
the previous
measurement year.
Advance Care Plan.............. 0326............. Communication and Percentage of patients NCQA.
Care aged 65 years and
Coordination. older who have an
advance care plan or
surrogate decision
maker documented in
the medical record or
documentation in the
medical record that
an advance care plan
was discussed but the
patient did not wish
or was not able to
name a surrogate
decision maker or
provide an advance
care plan.
Medication Reconciliation Post- 0554............. Communication and The percentage of NCQA.
Discharge. Care discharges from any
Coordination. inpatient facility
(e.g., hospital,
skilled nursing
facility, or
rehabilitation
facility) for
patients 18 years of
age and older seen
within 30 days
following the
discharge in the
office by the
physicians,
prescribing
practitioner,
registered nurse, or
clinical pharmacist
providing on-going
care for whom the
discharge medication
list was reconciled
with the current
medication list in
the outpatient
medical record.
National Committee
for Quality
Assurance. This
measure is reported
as three rates
stratified by age
group:
Reporting
Criteria 1: 18-64
years of age.
Reporting
Criteria 2: 65 years
and older.
Total Rate:
All patients 18 years
of age and Older.
Influenza Immunization for the Not Endorsed..... N/A.............. Percentage of patients KCQA.
ESRD Population. aged 6 months and
older seen for a
visit between July 1
and March 31 who
received an influenza
immunization OR who
reported previous
receipt of an
influenza
immunization.
Pneumococcal Vaccination Status 0043............. Community/ Percentage of patients NCQA.
Population 65 years of age and
Health. older who have ever
received a
pneumococcal vaccine.
Screening for Clinical 0418............. Community/ Percentage of patients CMS.
Depression and Follow-Up Plan. Population aged 12 and older
Health. screened for
depression on the
date of the encounter
and using an age
appropriate
standardized
depression screening
tool AND if positive,
a follow-up plan is
documented on the
date of the positive
screen.
Tobacco Use: Screening and 0028............. Community/ Percentage of patients PCPI Foundation.
Cessation Intervention. Population aged 18 years and
Health. older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
Falls: Screening, Risk 0101............. Patient Safety... (A) Screening for NCQA.
Assessment, and Plan of Care Future Fall Risk:
to Prevent Future Falls. Patients who were
screened for future
fall risk at last
once within 12
months. (B)
Multifactorial Falls
Risk Assessment:
Patients at risk of
future fall who had a
multifactorial risk
assessment for falls
completed within 12
months. (C) Plan of
Care to Prevent
Future Falls:
Patients at risk of
future fall with a
plan of care or falls
prevention documented
within 12 months.
ICH CAHPS: Nephrologists' 0258............. N/A.............. Summary/Survey CMS.
Communication and Caring. Measures may include:
Getting
timely care,
appointments, and
information..
How well
providers
communicate..
Patients'
rating of provider..
Access to
specialists.
Health
promotion and
education.
Shared
Decision-making.

[[Page 35937]]

Health status
and functional
status.
Courteous and
helpful office staff.
Care
coordination.
Between visit
communication.
Helping you
to take medications
as directed, and
Stewardship
of patient resources.
ICH CAHPS: Quality of Dialysis 0258............. N/A.............. Comparison of services CMS.
Center Care and Operations. and quality of care
that dialysis
facilities provide
from the perspective
of ESRD patients
receiving in-center
hemodialysis care.
Patients will assess
their dialysis
providers, including
nephrologists and
medical and non-
medical staff, the
quality of dialysis
care they receive,
and information
sharing about their
disease.
ICH CAHPS: Providing 0258............. N/A.............. Comparison of services CMS.
Information to Patients. and quality of care
that dialysis
facilities provide
from the perspective
of ESRD patients
receiving in-center
hemodialysis care.
Patients will assess
their dialysis
providers, including
nephrologists and
medical and non-
medical staff, the
quality of dialysis
care they receive,
and information
sharing about their
disease.
ICH CAHPS: Rating of the 0258............. N/A.............. Comparison of services CMS.
Nephrologist. and quality of care
that dialysis
facilities provide
from the perspective
of ESRD patients
receiving in-center
hemodialysis care.
Patients will assess
their dialysis
providers, including
nephrologists and
medical and non-
medical staff, the
quality of dialysis
care they receive,
and information
sharing about their
disease.
ICH CAHPS: Rating of Dialysis 0258............. N/A.............. Comparison of services CMS.
Center Staff. and quality of care
that dialysis
facilities provide
from the perspective
of ESRD patients
receiving in-center
hemodialysis care.
Patients will assess
their dialysis
providers, including
nephrologists and
medical and non-
medical staff, the
quality of dialysis
care they receive,
and information
sharing about their
disease.
ICH CAHPS: Rating of the 0258............. N/A.............. Comparison of services CMS.
Dialysis Facility. and quality of care
that dialysis
facilities provide
from the perspective
of ESRD patients
receiving in-center
hemodialysis care.
Patients will assess
their dialysis
providers, including
nephrologists and
medical and non-
medical staff, the
quality of dialysis
care they receive,
and information
sharing about their
disease.
Standardized Mortality Ratio... 0369............. N/A.............. This measure is CMS.
calculated as a ratio
but expressed as a
rate.
Standardized First Kidney Not Endorsed..... N/A.............. The standardized ratio CMS.
Transplant Waitlist Ratio for of the observed to
Incident Dialysis Patients expected number of
(SWR). incident patients
under age 75 listed
on the kidney or
kidney-pancreas
transplant waitlist
or who received a
living donor
transplant within the
first year of
initiating dialysis
based on the national
rate.
Percentage of Prevalent Not Endorsed..... N/A.............. The percentage of CMS.
Patients Waitlisted (PPPW). patients who were on
the kidney or kidney-
pancreas transplant
waitlist.
----------------------------------------------------------------------------------------------------------------

[[Page 35938]]

Table 42--MIPS APM Measure List--Comprehensive Primary Care Plus (CPC+) Model
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measures
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
Controlling High Blood Pressure 0018............. Effective Percentage of patients National
Treatment/ 18-85 years of age Committee for
Clinical Care. who had a diagnosis Quality
of hypertension and Assurance.
whose blood pressure
was adequately
controlled (<140/90
mmHg) during the
measurement period.
Diabetes: Hemoglobin A1c 0059............. Effective Percentage of patients National
(HbA1c) Poor Control (>9%). Treatment/ 18-75 years of age Committee for
Clinical Care. with diabetes who had Quality
hemoglobin A1c >9.0% Assurance.
during the
measurement period.
Dementia: Cognitive Assessment. 2872............. Effective Percentage of PCPI Foundation.
Treatment/ patients, regardless
Clinical Care. of age, with a
diagnosis of dementia
for whom an
assessment of
cognition is
performed and the
results reviewed at
least once within a
12-month period.
Falls: Screening for Future 0101............. Patient Safety... Percentage of patients National
Fall Risk. 65 years of age and Committee for
older who were Quality
screened for future Assurance.
fall risk during the
measurement period.
Initiation and Engagement of 0004............. Effective Percentage of patients National
Alcohol and Other Drug Treatment/ 13 years of age and Committee for
Dependence Treatment. Clinical Care. older with a new Quality
episode of alcohol Assurance.
and other drug (AOD)
dependence who
received the
following. Two rates
are reported.
a. Percentage of
patients who
initiated treatment
within 14 days of the
diagnosis..
b. Percentage of
patients who
initiated treatment
and who had two or
more additional
services with an AOD
diagnosis within 30
days of the
initiation visit.
Closing the Referral Loop: Not Endorsed..... Communication and Percentage of patients CMS.
Receipt of Specialist Report. Care with referrals,
Coordination. regardless of age,
for which the
referring provider
receives a report
from the provider to
whom the patient was
referred.
Cervical Cancer Screening...... 0032............. Effective Percentage of women 21- National
Treatment/ 64 years of age, who Committee for
Clinical Care. were screened for Quality
cervical cancer using Assurance.
either of the
following criteria.
Women age 21-
64 who had cervical
cytology performed
every 3 years..
Women age 30-
64 who had cervical
cytology/human
papillomavirus (HPV)
co-testing performed
every 5 years.
Colorectal Cancer Screening.... 0034............. Effective Percentage of National
Treatment/ patients, 50-75 years Committee for
Clinical Care. of age who had Quality
appropriate screening Assurance.
for colorectal cancer.
Diabetes: Eye Exam............. 0055............. Effective Percentage of patients National
Treatment/ 18-75 years of age Committee for
Clinical Care. with diabetes who had Quality
a retinal or dilated Assurance.
eye exam by an eye
care professional
during the
measurement period or
a negative retinal
exam (no evidence of
retinopathy) in the
12 months prior to
the measurement
period.
Preventive Care and Screening: 0028............. Community/ Percentage of patients PCPI Foundation.
Tobacco Use: Screening and Population aged 18 years and
Cessation Intervention. Health. older who were
screened for tobacco
use one or more times
within 24 months and
who received
cessation counseling
intervention if
identified as a
tobacco user.
Breast Cancer Screening........ 2372............. Effective Percentage of women 50- National
Treatment/ 74 years of age who Committee for
Clinical Care. had a mammogram to Quality
screen for breast Assurance.
cancer.
CG-CAPHS Survey 3.0--modified Not Endorsed..... Person and CG-CAHPS Survey 3.0... AHRQ.
for CPC+. Caregiver-
Centered
Experience and
Outcomes.
Inpatient Hospital Utilization. Not Endorsed..... Communication and For members 18 years National
Care of age and older, the Committee for
Coordination. risk-adjusted ratio Quality
of observed to Assurance.
expected acute
inpatient discharges
during the
measurement year
reported by Surgery,
Medicine, and Total.
Emergency Department Not Endorsed..... Communication and For members 18 years National
Utilization. Care of age and older, the Committee for
Coordination. risk-adjusted ratio Quality
of observed to Assurance.
expected emergency
department (ED)
visits during the
measurement year.

[[Page 35939]]

Diabetes: Medical Attention for 0062............. Effective The percentage of National
Nephropathy. Treatment/ patients 18-75 years Committee for
Clinical Care. of age with diabetes Quality
who had a nephropathy Assurance.
screening test or
evidence of
nephropathy during
the measurement
period.
Preventive Care and Screening: 0418............. Community/ Percentage of patients PCPI Foundation.
Depression and Follow-Up Plan. Population aged 12 years and
Health. older screened for
depression on the
date of the encounter
using an age
appropriate
standardized
depression screening
tool AND if positive,
a follow-up plan is
documented on the
date of the positive
screen.
Depression Utilization of the 0712............. Effective The percentage of MN Community
PHQ-9 Tool. Treatment/ patients age 18 and Measurement.
Clinical Care. older with the
diagnosis of major
depression or
dysthymia who have a
completed PHQ-9
during each
applicable 4 month
period in which there
was a qualifying
visit.
Preventive Care and Screening: 0041............. Community/ Percentage of patients American Medical
Influenza Immunization. Population aged 6 months and Association-
Health. older seen for a convened
visit between October Physician
1 and March 31 who Consortium for
received an influenza Performance
immunization OR who Improvement(R)
reported previous (AMA-PCPI).
receipt of an
influenza
immunization.
Pneumococcal Vaccination Status Not Endorsed..... Community/ Percentage of patients National
for Older Adults. Population 65 years of age and Committee for
Health. older who have ever Quality
received a Assurance.
pneumococcal vaccine.
Ischemic Vascular Disease 0068............. Effective Percentage of patients National
(IVD): Use of Aspirin or Treatment/ 18 years of age and Committee for
Another Antiplatelet. Clinical Care. older who were Quality
diagnosed with acute Assurance.
myocardial infarction
(AMI), coronary
artery bypass graft
(CABG) or
percutaneous coronary
interventions (PCI)
in the 12 months
prior to the
measurement period,
or who had an active
diagnosis of ischemic
vascular disease
(IVD) during the
measurement period,
and who had
documentation of use
of aspirin or another
antiplatelet during
the measurement
period.
Statin Therapy for the Not Endorsed..... Effective Percentage of the CMS.
Prevention and Treatment of Treatment/ following patients--
Cardiovascular Disease. Clinical Care. all considered at
high risk of
cardiovascular
events--who were
prescribed or were on
statin therapy during
the measurement
period:
Adults aged
>=21 years who were
previously diagnosed
with or currently
have an active
diagnosis of clinical
atherosclerotic
cardiovascular
disease (ASCVD); OR.
Adults aged
>=21 years who have
ever had a fasting or
direct low-density
lipoprotein
cholesterol (LDL-C)
level >=190 mg/dL or
were previously
diagnosed with or
currently have an
active diagnosis of
familial or pure
hypercholesterolemia;
OR
Adults aged
40-75 years with a
diagnosis of diabetes
with a fasting or
direct LDL-C level of
70-189 mg/dL.
Use of High-Risk Medications in 0022............. Patient Safety... Percentage of patients National
the Elderly. 65 years of age and Committee for
older who were Quality
ordered high-risk Assurance.
medications.
Preventive Care and Screening: Not Endorsed..... Community/ Percentage of patients CMS.
Screening for High Blood Population aged 18 years and
Pressure and Follow-Up Health. older seen during the
Documented. reporting period who
were screened for
high blood pressure
AND a recommended
follow-up plan is
documented based on
the current blood
pressure (BP) reading
as indicated.
Documentation of Current 0419............. Patient Safety... Percentage of visits CMS.
Medications in the Medical for patients aged 18
Record. years and older for
which the eligible
professional attests
to documenting a list
of current
medications using all
immediate resources
available on the date
of the encounter.

[[Page 35940]]

Preventive Care and Screening: 0421............. Community/ Percentage of patients CMS.
Body Mass Index (BMI) Population aged 18 years and
Screening and Follow-Up Plan. Health. older with a BMI
documented during the
current encounter or
during the previous
twelve months AND
with a BMI outside of
normal parameters, a
follow-up plan is
documented during the
encounter or during
the previous twelve
months of the current
encounter.
Diabetes: Foot Exam............ 0056............. Effective Percentage of patients National
Treatment/ 18-75 years of age Committee for
Clinical Care. with diabetes (type 1 Quality
and type 2) who Assurance.
received a foot exam
(visual inspection
and sensory exam with
mono filament and a
pulse exam) during
the previous
measurement year.
Heart Failure (HF): Angiotensin- 0081............. Effective Percentage of patients PCPI Foundation.
Converting Enzyme (ACE) Treatment/ aged 18 years and
Inhibitor or Angiotensin Clinical Care. older with a
Receptor Blocker (ARB) Therapy diagnosis of heart
for Left Ventricular Systolic failure (HF) with a
Dysfunction (LVSD). current or prior left
ventricular ejection
fraction (LVEF) <40%
who were prescribed
ACE inhibitor or ARB
therapy either within
a 12 month period
when seen in the
outpatient setting OR
at each hospital
discharge.
Heart Failure (HF): Beta- 0083............. Effective Percentage of patients PCPI Foundation.
Blocker Therapy for Left Treatment/ aged 18 years and
Ventricular Systolic Clinical Care. older with a
Dysfunction (LVSD). diagnosis of heart
failure (HF) with a
current or prior left
ventricular ejection
fraction (LVEF) <40%
who were prescribed
beta-blocker therapy
either within a 12
month period when
seen in the
outpatient setting OR
at each hospital
discharge.
Coronary Artery Disease (CAD): 0070............. Effective Percentage of patients PCPI Foundation.
Beta-Blocker Therapy-Prior Treatment/ aged 18 years and
Myocardial Infarction (MI) or Clinical Care. older with a
Left Ventricular Systolic diagnosis of coronary
Dysfunction (LVEF <40%). artery disease seen
within a 12 month
period who also have
a prior MI or a
current or prior LVEF
<40% who were
prescribed beta-
blocker therapy.
Appropriate Use of DXA Scans in Not Endorsed..... Effective Percentage of female CMS.
Women Under 65 Years Who Do Treatment/ patients aged 50 to
Not Meet the Risk Factor Clinical Care. 64 without select
Profile for Osteoporotic risk factors for
Fracture. osteoporotic fracture
who received an order
for a dual-energy x-
ray absorptiometry
(DXA) scan during the
measurement period.
HIV Screening.................. Not Endorsed..... Community/ Percentage of patients Centers for
Population 15-65 years of age Disease Control
Health. who have ever been and Prevention
tested for human (CDC).
immunodeficiency
virus (HIV).
Total Resource Use Population- 1598............. N/A.............. This measure is used Minneapolis (MN):
based PMPM Index (RUI). to assess the total Health Partners.
resource use index
population-based per
member per month
(PMPM). The Resource
Use Index (RUI) is a
risk adjusted measure
of the frequency and
intensity of services
utilized to manage a
provider group's
patients. Resource
use includes all
resources associated
with treating members
including
professional,
facility inpatient
and outpatient,
pharmacy, lab,
radiology, ancillary
and behavioral health
services.
----------------------------------------------------------------------------------------------------------------

[[Page 35941]]

Table 43--MIPS APM Measure List--Oncology Care Model
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measure
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
Adjuvant chemotherapy is 0223............. Communication and Percentage of patients Commission on
recommended or administered Care under the age of 80 Cancer, American
within 4 months (120 days) of Coordination. with AJCC III (lymph College of
diagnosis to patients under node positive) colon Surgeons.
the age of 80 with AJCC III cancer for whom
(lymph node positive) colon adjuvant chemotherapy
cancer. is recommended and
not received or
administered within 4
months (120 days) of
diagnosis.
Breast Cancer: Hormonal Therapy 0387............. Communication and Percentage of female AMA-convened
for Stage I (T1b)-IIIC Care patients aged 18 Physician
Estrogen Receptor/Progesterone Coordination. years and older with Consortium for
Receptor (ER/PR) Positive Stage I (T1b) through Performance
Breast Cancer. IIIC, ER or PR Improvement.
positive breast
cancer who were
prescribed tamoxifen
or aromatase
inhibitor (AI) during
the 12-month
reporting period.
Oncology: Medical and 0384............. Person and Percentage of visits American Society
Radiation--Plan of Care for Caregiver- for patients, of Clinical
Pain. Centered regardless of age, Oncology.
Experience and with a diagnosis of
Outcomes. cancer currently
receiving
chemotherapy or
radiation therapy who
report having pain
with a documented
plan of care to
address pain.
Combination chemotherapy is 0559............. Communication and Percentage of female Commission on
recommended or administered Care patients, age >18 at Cancer, American
within 4 months (120 days) of Coordination. diagnosis, who have College of
diagnosis for women under 70 their first diagnosis Surgeons.
with AJCC T1cN0M0, or Stage IB- of breast cancer
III hormone receptor negative (epithelial
breast cancer. malignancy), at AJCC
stage T1cN0M0 (tumor
greater than 1 cm),
or Stage IB-III,
whose primary tumor
is progesterone and
estrogen receptor
negative recommended
for multiagent
chemotherapy
(recommended or
administered) within
4 months (120 days)
of diagnosis.
Documentation of Current 0419............. Patient Safety... Percentage of visits CMS.
Medications in the Medical for patients aged 18
Record. years and older for
which the eligible
clinician attests to
documenting a list of
current medications
using all immediate
resources available
on the date of the
encounter. This list
must include ALL
known prescriptions,
over the counters,
herbals, and vitamin/
mineral/dietary AND
must contain the
medications' name,
dosage, frequency and
route of
administration.
Oncology: Medical and 0383............. Person and Percentage of patient Physician
Radiation--Pain Intensity Caregiver visits, regardless of Consortium for
Quantified. Centered patient age, with a Performance
Experience. diagnosis of cancer Improvement
currently receiving Foundation.
chemotherapy or
radiation therapy in
which pain intensity
is quantified.
Patient-Reported Experience of N/A.............. Person and Summary/Survey CMS.
Care. Caregiver- Measures may include:
Centered Overall
Experience and measure of patient
Outcomes. experience..
Exchanging
Information with
Patients..
Access.......
Shared
Decision Making..
Enabling Self-
Management..
Affective
Communication..
Preventive Care and Screening: 0418............. Community/ Percentage of patients CMS.
Screening for Depression and Population aged 12 and older
Follow-Up Plan. Health. screened for
depression on the
date of the encounter
using an age
appropriate
standardized
depression screening
tool and if positive,
a follow-up plan is
documented on the
date of the positive
screen.
Proportion of patients who died N/A.............. N/A.............. Percentage of OCM- CMS.
who were admitted to hospice attributed FFS
for 3 days or more. beneficiaries who
died and spent at
least 3 days in
hospice during the
measurement time
period.
Risk-adjusted proportion of N/A.............. N/A.............. Percentage of OCM- CMS.
patients with all-cause ED attributed FFS
visits that did not result in beneficiaries who had
a hospital admission within an ER visit that did
the 6-month episode. not result in a
hospital stay during
the measurement
period.

[[Page 35942]]

Risk-adjusted proportion of N/A.............. N/A.............. Percentage of OCM- CMS.
patients with all-cause attributed FFS
hospital admissions within the beneficiaries who
6-month episode. were had an acute-
care hospital stay
during the
measurement period.
Trastuzumab administered to 1858............. Efficiency and Proportion of female American Society
patients with AJCC stage I Cost reduction. patients (aged 18 of Clinical
(T1c)-III and human epidermal years and older) with Oncology.
growth factor receptor 2 AJCC stage I (T1c)-
(HER2) positive breast cancer Ill, human epidermal
who receive adjuvant growth factor
chemotherapy. receptor 2 (HER2)
positive breast
cancer receiving
adjuvant Chemotherapy.
----------------------------------------------------------------------------------------------------------------

Table 44--MIPS APM Measure List--Bundled Payments for Care Improvement Advanced
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measure
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
All-Cause Hospital Readmission. 1789............. Communication and This measure estimates CMS.
Care a hospital-level risk-
Coordination. standardized
readmission rate
(RSRR) of unplanned,
all cause readmission
after admission for
any eligible
condition within 30
days of hospital
discharge.
Advanced Care Plan............. 0326............. Communication and Percentage of patients NCQA.
Care aged 65 years and
Coordination. older who have an
advance care plan or
surrogate decision
maker documented in
the medical record or
documentation in the
medical record that
an advance care plan
was discussed but the
patient did not wish
or was not able to
name a surrogate
decision maker or
provide an advance
care plan.
Perioperative Care: Selection 0268............. Patient Safety... Percentage of surgical American Society
of Prophylactic Antibiotic: patients aged 18 of Plastic
First or Second Generation years and older Surgeons.
Cephalosporin. undergoing procedures
with the indications
for a first OR second
generation
cephalosporin
prophylactic
antibiotic who had an
order for first OR
second generation
cephalosporin for
antimicrobial
prophylaxis.
Hospital-Level Risk- 2558............. Patient Safety... The measure estimates CMS.
Standardized Mortality Rate a hospital-level,
Following Elective Coronary risk-standardized
Artery Bypass Graft Surgery. mortality rate (RSMR)
for patients 18 years
and older discharged
from the hospital
following a
qualifying isolated
CABG procedure.
Mortality is defined
as death from any
cause within 30 days
of the procedure date
of an index CABG
admission. The
measure was developed
using Medicare Fee-
for-Service (FFS)
patients 65 years and
older and was tested
in all-payer patients
18 years and older.
An index admission is
the hospitalization
for a qualifying
isolated CABG
procedure considered
for the mortality
outcome.

[[Page 35943]]

Excess Days in Acute Care After 2881............. Patient Safety... This measure assesses CMS.
Hospitalization for Acute days spent in acute
Myocardial Infarction. care within 30 days
of discharge from an
inpatient
hospitalization for
acute myocardial
infarction (AMI) to
provide a patient-
centered assessment
of the post-discharge
period. This measure
is intended to
capture the quality
of care transitions
provided to
discharged patients
hospitalized with AMI
by collectively
measuring a set of
adverse acute care
outcomes that can
occur post-discharge:
Emergency department
(ED) visits,
observation stays,
and unplanned
readmissions at any
time during the 30
days post-discharge.
In order to aggregate
all three events, we
measure each in terms
of days. In 2016, CMS
will begin annual
reporting of the
measure for patients
who are 65 years or
older, are enrolled
in fee-for-service
(FFS) Medicare, and
are hospitalized in
non-federal hospitals.
AHRQ Patient Safety Measures... 0531............. Patient Safety... The modified PSI-90 AHRQ.
Composite measure
(name changed to
Patient Safety and
Adverse Events
Composite) consists
of ten component
indicators: PSI-3
Pressure ulcer rate;
PSI-6 Iatrogenic
pneumothorax rate;
PSI-8 Postoperative
hip fracture rate;
PSI-09 Perioperative
hemorrage or hematoma
rate; PSI-10
hysiologic and
metabolic derangement
rate; PSI-11
postoperative
respiratory failure
rate; PSI-12
Perioperative
pulmonary embolism or
Deep vein thrombosis
rate; PSI-13
Postoperative sepsis
rate; PSI-14
Postoperative wound
dehiscence rate; and
PSI-15 Accidental
puncture or
laceration rate.
Hospital-Level Risk- 1550............. Patient Safety... The measure estimates CMS.
Standardized Complication Rate a hospital-level risk-
Following Elective Primary standardized
Total Hip Arthroplasty and/or complication rate
Total Knee Arthroplasty. (RSCR) associated
with elective primary
THA and TKA in
Medicare Fee-For-
Service beneficiaries
who are 65 years and
older. The outcome
(complication) is
defined as any one of
the specified
complications
occurring from the
date of index
admission to 90 days
post date of the
index admission (the
admission included in
the measure cohort).
----------------------------------------------------------------------------------------------------------------

Table 45--MIPS APM Measure List--Maryland Total Cost of Care Model
[Maryland Primary Care Program]
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measure
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
Controlling High Blood Pressure 0018............. Effective Percentage of patients National
Treatment/ 18-85 years of age Committee for
Clinical Care. who had a diagnosis Quality
of hypertension and Assurance.
whose blood pressure
was adequately
controlled (<140/90
mmHg) during the
measurement period.
Diabetes: Hemoglobin A1c 0059............. Effective Percentage of patients National
(HbA1c) Poor Control (>9%). Treatment/ 18-75 years of age Committee for
Clinical Care. with diabetes who had Quality
hemoglobin A1c >9.0% Assurance.
during the
measurement period.
Dementia: Cognitive Assessment. 2872............. Effective Percentage of American Medical
Treatment/ patients, regardless Association-
Clinical Care. of age, with a convened
diagnosis of dementia Physician
for whom an Consortium for
assessment of Performance
cognition is Improvement(R)
performed and the (AMA-PCPI).
results reviewed at
least once within a
12-month period.

[[Page 35944]]

Falls: Screening for Future 0101............. Patient Safety/ Percentage of patients National
Fall Risk. Safety. 65 years of age and Committee for
older who were Quality
screened for future Assurance.
fall risk during the
measurement period.
Initiation and Engagement of 004.............. Effective Percentage of patients National
Alcohol and Other Drug Treatment/ 13 years of age and Committee for
Dependence Treatment. Clinical Care. older with a new Quality
episode of alcohol Assurance.
and other drug (AOD)
dependence who
received the
following. Two rates
are reported.
a. Percentage of
patients who
initiated treatment
within 14 days of the
diagnosis..
b. Percentage of
patients who
initiated treatment
and who had two or
more additional
services with an AOD
diagnosis within 30
days of the
initiation visit..
Closing the Referral Loop: N/A.............. Communication and Percentage of patients CMS.
Receipt of Specialist Report. Coordination/ with referrals,
Care regardless of age,
Coordination. for which the
referring provider
receives a report
from the provider to
whom the patient was
referred.
Cervical Cancer Screening...... 0032............. Effective Percentage of women 21- National
Treatment/ 64 years of age, who Committee for
Clinical Care. were screened for Quality
cervical cancer using Assurance.
either of the
following criteria.
Women age 21-
64 who had cervical
cytology performed
every 3 years..
Women age 30-
64 who had cervical
cytology/human
papillomavirus (HPV)
co-testing performed
every.
Colorectal Cancer Screening.... 0034............. Effective Percentage of National
Treatment/ patients, 50-75 years Committee for
Clinical Care. of age who had Quality
appropriate screening Assurance.
for colorectal cancer.
Diabetes: Eye Exam............. 0055............. Effective Percentage of patients National
Treatment/ 18-75 years of age Committee for
Clinical Care. with diabetes who had Quality
a retinal or dilated Assurance.
eye exam by an eye
care professional
during the
measurement period or
a negative retinal
exam (no evidence of
retinopathy) in the
12 months prior to
the measurement
period.
Preventive Care and Screening: 0028............. Healthy Living/ Percentage of patients American Medical
Tobacco Use: Screening and Population aged 18 years and Association-
Cessation Intervention. Health and older who were convened
Prevention. screened for tobacco Physician
use one or more times Consortium for
within 24 months and Performance
who received Improvement(R)
cessation counseling (AMA-PCPI).
intervention if
identified as a
tobacco user.
Breast Cancer Screening........ 2372............. Effective Percentage of women 50- National
Treatment/ 74 years of age who Committee for
Clinical Care. had a mammogram to Quality
screen for breast Assurance.
cancer.
CG-CAHPS Survey 3.0--modified Not Endorsed..... Person and Family CG-CAHPS Survey 3.0... AHRQ.
for CPC+. Engagement/
Patient and
Caregiver
Experience.
Inpatient Hospital Utilization. Not Endorsed..... Communication and For members 18 years National
Care of age and older, the Committee for
Coordination. risk-adjusted ratio Quality
of observed to Assurance.
expected acute
inpatient discharges
during the
measurement year
reported by Surgery,
Medicine, and Total.
Emergency Department Not Endorsed..... Communication and For members 18 years National
Utilization. Care of age and older, the Committee for
Coordination. risk-adjusted ratio Quality
of observed to Assurance.
expected emergency
department (ED)
visits during the
measurement year.
Diabetes: Medical Attention for 0062............. Effective The percentage of National
Nephropathy. Treatment/ patients 18-75 years Committee for
Clinical Care. of age with diabetes Quality
who had a nephropathy Assurance.
screening test or
evidence of
nephropathy during
the measurement
period.
Preventive Care and Screening: 0418............. Community/ Percentage of patients CMS.
Depression and Follow-Up Plan. Population aged 12 years and
Health. older screened for
depression on the
date of the encounter
using an age
appropriate
standardized
depression screening
tool AND if positive,
a follow-up plan is
documented on the
date of the positive
screen.

[[Page 35945]]

Depression Utilization of the 0712............. Effective The percentage of MN Community
PHQ-9 Tool. Treatment/ patients age 18 and Measurement.
Clinical Care. older with the
diagnosis of major
depression or
dysthymia who have a
completed PHQ-9
during each
applicable 4 month
period in which there
was a qualifying
visit.
Preventive Care and Screening: 0041............. Healthy Living/ Percentage of patients American Medical
Influenza Immunization. Population aged 6 months and Association-
Health and older seen for a convened
Prevention. visit between October Physician
1 and March 31 who Consortium for
received an influenza Performance
immunization OR who Improvement(R)
reported previous (AMA-PCPI).
receipt of an
influenza
immunization.
Pneumococcal Vaccination Status 0043............. Healthy Living/ Percentage of patients National
for Older Adults. Population 65 years of age and Committee for
Health and older who have ever Quality
Prevention. received a Assurance.
pneumococcal vaccine.
Ischemic Vascular Disease 0068............. Effective Percentage of patients National
(IVD): Use of Aspirin or Treatment/ 18 years of age and Committee for
Another Antiplatelet. Clinical Care. older who were Quality
diagnosed with acute Assurance.
myocardial infarction
(AMI), coronary
artery bypass graft
(CABG) or
percutaneous coronary
interventions (PCI)
in the 12 months
prior to the
measurement period,
or who had an active
diagnosis of ischemic
vascular disease
(IVD) during the
measurement period,
and who had
documentation of use
of aspirin or another
antiplatelet during
the measurement
period.
Statin Therapy for the Not Endorsed..... Effective Percentage of the CMS.
Prevention and Treatment of Treatment/ following patients--
Cardiovascular Disease. Clinical Care. all considered at
high risk of
cardiovascular
events--who were
prescribed or were on
statin therapy during
the measurement
period:
Adults aged
>=21 years who were
previously diagnosed
with or currently
have an active
diagnosis of clinical
atherosclerotic
cardiovascular
disease (ASCVD); OR.
Adults aged
>=21 years who have
ever had a fasting or
direct low-density
lipoprotein
cholesterol (LDL-C)
level >=190 mg/dL or
were previously
diagnosed with or
currently have an
active diagnosis of
familial or pure
hypercholesterolemia;
OR.
Adults aged
40-75 years with a
diagnosis of diabetes
with a fasting or
direct LDL-C level of
70-189 mg/dL.
Use of High-Risk Medications in 0022............. Patient Safety/ Percentage of patients National
the Elderly. Safety. 65 years of age and Committee for
older who were Quality
ordered high-risk Assurance.
medications.
----------------------------------------------------------------------------------------------------------------

Table 46--MIPS APM Measure List--Independence at Home Demonstration
----------------------------------------------------------------------------------------------------------------
NQF/Quality ID National quality Primary measure
Measure name No. strategy domain Measure description steward
----------------------------------------------------------------------------------------------------------------
Number of inpatient admissions Not Endorsed..... N/A.............. Number of inpatient CMS.
for ambulatory-care sensitive admissions for
conditions per 100 patient ambulatory-care
enrollment months. sensitive conditions
per 100 patient
enrollment months.
Number of readmissions within Not Endorsed..... N/A.............. Risk adjusted CMS.
30 days per 100 inpatient readmissions to a
discharges. hospital within 30
days following
discharge from the
hospital for an index
admission.
Emergency Department Visits for Not Endorsed..... N/A.............. Risk adjusted CMS.
Ambulatory Care Sensitive emergency department
Conditions. visits for three
ambulatory care
sensitive conditions:
diabetes, congestive
heart failure (CHF),
and chronic
obstructive pulmonary
disease (COPD).

[[Page 35946]]

Contact with beneficiaries Not Endorsed..... N/A.............. Percent of hospital CMS.
within 48 hours upon admission admissions, hospital
to the hospital and discharge discharges, and
from the hospital and/or ED. emergency department
(ED) visits for
beneficiaries
enrolled in IAH with
a follow-up contact
within 48 hours.
Medication reconciliation in Not Endorsed..... N/A.............. Percent of hospital CMS.
the home. discharges and
emergency department
(ED) visits for
beneficiaries
enrolled in IAH with
medication
reconciliation in the
home within 48 hours.
Percentage with Documented Not Endorsed..... N/A.............. Percent of CMS.
Patient Preferences. beneficiaries
enrolled in IAH with
patient preferences
documented in the
medical record for a
demonstration year.
----------------------------------------------------------------------------------------------------------------

i. MIPS Final Score Methodology
(1) Converting Measures and Activities Into Performance Category Scores
(a) Background
For the 2021 MIPS payment year, we intend to build on the scoring
methodology we finalized for the transition years, which allows for
accountability and alignment across the performance categories and
minimizes burden on MIPS eligible clinicians. The rationale for our
scoring methodology continues to be grounded in the understanding that
the MIPS scoring system has many components and various moving parts.
As we continue to move forward in implementing the MIPS program, we
strive to balance the statutory requirements and programmatic goals
with the ease of use, stability, and meaningfulness for MIPS eligible
clinicians. We do so while also emphasizing simplicity and the
continued development of a scoring methodology that is understandable
for MIPS eligible clinicians.
In the CY 2017 Quality Payment Program final rule, we finalized a
unified scoring system to determine a final score across the 4
performance categories (81 FR 77273 through 77276). For the 2019 MIPS
performance period, we propose to build on the scoring methodology we
previously finalized, focusing on encouraging MIPS eligible clinicians
to meet data completeness requirements. For the quality performance
category scoring, we propose to extend some of the transition year
policies to the 2019 MIPS performance period, and we are also proposing
several modifications to existing policies. In the CY 2018 Quality
Payment Program final rule (82 FR 53712 through 53714), we established
a methodology for scoring improvement in the cost performance category.
However, as required by section 51003(a)(1)(B) of the Bipartisan Budget
Act of 2018, we propose that the cost performance category score would
not take into account improvement until the 2024 MIPS payment year. In
the CY 2018 Quality Payment Program final rule (82 FR53753 through
53767), we finalized the availability of a facility-based measurement
option for clinicians who met certain requirements, beginning with the
2019 MIPS performance period; in section III.H.3.i.(1)(d) of this
proposed rule, we propose to change the determination of facility-based
measurement to include consideration of presence in the on-campus
outpatient hospital. The policies for scoring the 4 performance
categories are described in detail in section III.H.3.i.(1) of this
proposed rule.
These sets of proposed policies will help eligible clinicians as
they participate in the 2019 MIPS performance period/2021 MIPS payment
year, and as we move beyond the transition years of the program.
Section 51003 of the Bipartisan Budget Act of 2018 provides flexibility
to continue the gradual ramp up of the Quality Payment Program and
enables us to extend some of the transition year policies to the 2019
performance period.
Unless otherwise noted, for purposes of this section III.H.3.i. of
this proposed rule on scoring, the term ``MIPS eligible clinician''
will refer to MIPS eligible clinicians who collect and submit data and
are scored at either the individual or group level, including virtual
groups; it will not refer to MIPS eligible clinicians who are scored by
facility-based measurement, as discussed in section III.H.3.i.(1)(d) of
this proposed rule. We also note that the APM scoring standard applies
to MIPS eligible clinicians in APM Entities in MIPS APMs, and those
policies take precedence where applicable. Where those policies do not
apply, scoring for MIPS eligible clinicians as described in section
III.H.3.h.(6) of this proposed rule will apply. We refer readers to
section III.H.4. of this proposed rule for additional information about
the APM scoring standard.
(b) Scoring the Quality Performance Category for the Following
Collection Types: Part B Claims Measures, eCQMs, MIPS CQMs, QCDR
Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure
and Administrative Claims Measures
Although we do not propose changing the basic scoring system that
we finalized in the CY 2018 Quality Payment Program final rule for the
2021 MIPS payment year (82 FR 53712 through 53748), we are proposing
several modifications to scoring the quality performance category,
including removing high-priority measure bonus points for CMS Web
Interface measures and extending the bonus point caps, and adding a
small practice bonus to the quality performance category score. The
following section describes these previously finalized policies and our
new proposals.
We are also proposing updates to Sec. 414.1380(b)(1) in an effort
to more clearly and concisely capture previously established policies.
These proposed updates are not intended to be substantive in nature,
but rather to bring more clarity to the regulatory text. We will make
note of the updated regulatory citations in their relevant sections
below.
(i) Scoring Terminology
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77008 through 77831, and 82 FR 53568 through 54229, respectively),
we used the term ``submission mechanisms'' in reference to the various
ways in which a MIPS eligible clinician or group can submit data to
CMS. As discussed in section III.H.3.h.(1)(b) of this proposed

[[Page 35947]]

rule, it has come to our attention that the way we have described the
various ways in which MIPS eligible clinicians, groups and third-party
intermediaries can submit data to our systems does not accurately
reflect the experience users have when submitting data to us. We refer
readers to section III.H.3.h.(1)(b) of this proposed rule for further
discussion on our proposed changes to the scoring terminology related
to measure specification and data collection and submission. For
additional discussion on the impact of the proposed terminology change
on our benchmarking methodology, validation process, and end-to-end
reporting bonus, we refer readers to sections III.H.3.i.(1)(b)(ii),
(v), and (x) of this proposed rule.
(ii) Quality Measure Benchmarks
We refer readers to the CY 2017 and CY 2018 Quality Payment Program
final rules (81 FR 77282, and 82 FR 53718, respectively) for our
previously established benchmarking policies. As part of our proposed
technical updates to Sec. 414.1380(b)(1) discussed in section
III.H.3.i.(1)(a)(i) of this proposed rule, our previously established
benchmarking policies at Sec. 414.1380(b)(1)(i) through (iii) would
now be referenced at Sec. 414.1380(b)(1)(i) through (ii).
In the CY 2018 Quality Payment Program final rule, we solicited
comments on how we could improve our method of benchmarking quality
measures (82 FR 53718 through 53719). Several commenters provided
suggestions on improving our benchmarking methodology including
reconciling the differences between the MIPS and Physician Compare
benchmarking methodologies. Several other commenters expressed concerns
that the methodology may not reflect performance because, among other
reasons, commenters believed that the benchmarks use data from a small
number of clinicians, are based on various legacy programs, and create
ranging point variances based on collection type.
When we developed the quality measure benchmarks, we sought to
develop a system that enables MIPS eligible clinicians, beneficiaries,
and other stakeholders to understand what is required for a strong
performance in MIPS while being consistent with statutory requirements
(81 FR 28249 through 28250). The feedback we have received thus far
from stakeholders on our benchmarks is helping to inform our approach
to the benchmarking methodology, especially as we look for possible
ways of aligning with Physician Compare benchmarks. As described in
section III.H.3.i.(1)(b)(xii) of this proposed rule, we are seeking
comment on potential future approaches to scoring the quality
performance category to continue to promote value and improved
outcomes. We anticipate changes in scoring would be paired with
potential modifications to measure selection and criteria discussed in
section III.H.3.h.(2)(b) of this proposed rule. We are looking for
opportunities to further reduce confusion about our benchmarking
methodology described in the CY 2017 Quality Payment Program final rule
(81 FR 77277 through 77278), which includes further clarification of
our benchmarking process and potential areas of alignment between the
MIPS and Physician Compare benchmarking methodologies. We will take
commenters' suggestions into consideration in future rulemaking.
(A) Revised Terminology for MIPS Benchmarks
We previously established at Sec. 414.1380(b)(1)(iii) separate
benchmarks for the following submission mechanisms: EHR; QCDR/registry,
claims; CMS Web Interface; CMS-approved survey vendor; and
administrative claims. We are not proposing to change our basic
approach to our benchmarking methodology; however, we are proposing to
amend Sec. 414.1380(b)(1)(ii) consistent with the proposed data
submission terminology changes discussed in section III.H.3.h.(1)(b) of
this proposed rule. Specifically, beginning with the 2021 MIPS payment
year, we propose to establish separate benchmarks for the following
collection types: eCQMs; QCDR measures (as described at Sec.
414.1400(e)); MIPS CQMs; Medicare Part B claims measures; CMS Web
Interface measures; the CAHPS for MIPS survey; and administrative
claims measures. We would apply benchmarks based on collection type
rather than submission mechanism. For example, for an eCQM, we would
apply the eCQM benchmark regardless of submitter type (MIPS eligible
clinician, group, third party intermediary). In addition, we would
establish separate benchmarks for QCDR measures and MIPS CQMs since
these measures do not have comparable specifications. In addition, we
note that our proposed benchmarking policy allows for the addition of
future collection types as the universe of measures continues to evolve
and as new technology is introduced. Specifically, we propose to amend
Sec. 414.1380(b)(1)(ii) to remove the mention of each individual
benchmark and instead state that benchmarks will be based on collection
type, from all available sources, including MIPS eligible clinicians
and APMs, to the extent feasible, during the applicable baseline or
performance period.
(iii) Assigning Points Based on Achievement
In the CY 2017 Quality Payment Program final rule, we established
the policies for scoring quality measures performance (81 FR 77286). We
refer readers to Sec. 414.1380(b)(1) for more on these policies.
(A) Floor for Scored Quality Measures
For the 2019 and 2020 MIPS payment years, we finalized at Sec.
414.1380(b)(1)(i) a global 3-point floor for each scored quality
measure, as well as for the hospital readmission measure (if
applicable). In this way, MIPS eligible clinicians would receive
between 3 and 10 measure achievement points for each submitted measure
that can be reliably scored against a benchmark, which requires meeting
the case minimum and data completeness requirements (81 FR 77286
through 77287; 82 FR 53719). For measures with a benchmark based on the
performance period (rather than on the baseline period), we stated that
we would continue to assign between 3 and 10 measure achievement points
for performance periods after the first transition year (81 FR 77282,
77287; 82 FR 53719). For measures with benchmarks based on the baseline
period, we stated that the 3-point floor was for the transition year
and that we would revisit the 3-point floor in future years (81 FR
77286 through 77287; 82 FR 53719).
For the 2021 MIPS payment year, we propose to again apply a 3-point
floor for each measure that can be reliably scored against a benchmark
based on the baseline period, and to amend Sec. 414.1380(b)(1)(i)
accordingly. We will revisit the 3-point floor for such measures again
in future rulemaking.
(B) Additional Policies for the CAHPS for MIPS Measure Score
While participating in the CAHPS for MIPS survey is optional for
all groups, some groups will be unable to participate in the CAHPS for
MIPS survey because they do not meet the minimum beneficiary sampling
requirements. CMS has sampling requirements for groups of 100 or more
eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible
clinicians to ensure an adequate number of survey responses and the
ability to reliably report data. Our sampling timeframes (82 FR 53630
through 53632) necessitate notifying groups of their inability to

[[Page 35948]]

meet the sampling requirements late in the performance period (see 82
FR 53630 through 53632). As a result, we are concerned that some groups
that expect and plan to meet the quality performance category
requirements using the CAHPS for MIPS survey may find out late in the
performance period that they are unable to meet the sampling
requirements and, therefore, are unable to have their performance
assessed on this measure. These groups may need to report on another
measure to meet the requirements of the quality performance category.
We want to encourage the reporting of the CAHPS for MIPS survey and
do not want the uncertainty regarding sampling requirements to be a
barrier to selecting the CAHPS for MIPS survey. To mitigate this
concern, beginning with the 2021 MIPS payment year, we are proposing to
reduce the denominator (that is, the total available measure
achievement points) for the quality performance category by 10 points
for groups that register for the CAHPS for MIPS survey but do not meet
the minimum beneficiary sampling requirements. By reducing the
denominator instead of only assigning the group a score of zero measure
achievement points (because the group would be unable to submit any
CAHPS for MIPS survey data), we are effectively removing the impact of
the group's inability to submit the CAHPS for MIPS survey. We believe
this reduction in denominator would remove any need for groups to find
another measure if they are unable to submit the CAHPS for MIPS survey.
Therefore, we propose to amend Sec. 414.1380 to add paragraph
(b)(1)(vii)(B) to state that we will reduce the total available measure
achievement points for the quality performance category by 10 points
for groups that registered for the CAHPS for MIPS survey but do not
meet the minimum beneficiary sampling requirements.
We do not want groups to register for the CAHPS for MIPS survey if
they know in advance that they are unlikely to be able to meet the
sampling requirement, so we seek comment on whether we should limit
this proposed policy to groups for only one MIPS performance period.
For example, for the performance period following the application of
this proposed policy, a notice could be provided to groups during
registration indicating that if the sampling requirement is not met for
a second consecutive performance period, the proposed policy will not
be applied. This would provide notice to the group that they may not
meet the sampling requirement needed for the CAHPS for MIPS survey and
may need to look for alternate measures, but does not preclude the
group from registering for the CAHPS for MIPS survey if they expect to
meet the minimum beneficiary sampling requirements in the second MIPS
performance period.
(iv) Assigning Measure Achievement Points for Topped Out Measures
We refer readers to CY 2017 Quality Payment Program final rule (82
FR 53721 through 53727) for our established policies for scoring topped
out measures.
Under Sec. 414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment
year, six measures will receive a maximum of 7 measure achievement
points, provided that the applicable measure benchmarks are identified
as topped out again in the benchmarks published for the 2018 MIPS
performance period. Under Sec. 414.1380(b)(1)(xiii)(B), beginning with
the 2021 MIPS payment year, measure benchmarks (except for measures in
the CMS Web Interface) that are identified as topped out for 2 or more
consecutive years will receive a maximum of 7 measure achievement
points beginning in the second year the measure is identified as topped
out (82 FR 53726 through 53727). As part of our technical updates to
Sec. 414.1380(b)(1) outlined in section III.H.3.i.(1)(b) of this
proposed rule, our finalized topped out scoring policies are now
referenced at Sec. 414.1380(b)(1)(iv).
We refer readers to the 2018 MIPS Quality Benchmarks' file, that is
located on the Quality Payment Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure benchmarks are topped out for
2018 and would be subject to the cap if they are also topped out in the
2019 MIPS Quality Benchmarks' file. We note that the final
determination of which measure benchmarks are subject to the topped out
cap will not be available until the 2019 MIPS Quality Benchmarks' file
is released in late 2018.
We did not propose to apply our previously finalized topped out
scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the
CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have
historical benchmarks for the 2018 performance period, so the topped
out policy would not be applied for the 2019 performance period. Last
year, we received limited feedback when we sought comment on how the
topped out scoring policy should be applied to CAHPS for MIPS survey.
In this proposed rule, we are seeking feedback on potential ways we can
score CAHPS for MIPS Summary Survey Measures (SSM). For example, we
could score all SSMs, which means there would effectively be no topped
out scoring for CAHPS for MIPS SSMs, or we could cap the SSMs that are
topped out and score all other SSMs. We seek comment on these
approaches and additional approaches to the topped out scoring policy
for CAHPS for MIPS SSMs. We note that we would like to encourage groups
to report the CAHPS for MIPS survey as it incorporates beneficiary
feedback.
(v) Scoring Measures That Do Not Meet Case Minimum, Data Completeness,
and Benchmarks Requirements
In the CY 2017 Quality Payment Program final rule (81 FR 77288
through 77289), we established scoring policies for a measure that is
submitted but is unable to be scored because it does not meet the
required case minimum, does not have a benchmark, or does not meet the
data completeness requirement. As part of our proposed technical
updates to Sec. 414.1380(b)(1) discussed in section III.H.3.i.(1)(b)
of this proposed rule, our previous scoring policies are now referenced
at Sec. 414.1380(b)(1)(i)(A) and (B).
A summary of the current and proposed policies is provided in Table
47. For more of the statutory background and details on current
policies, we refer readers to the CY 2017 and CY 2018 Quality Payment
Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through
53730, respectively).

Table 47--Quality Performance Category: Scoring Measures
------------------------------------------------------------------------
Measure type Description Scoring rules
------------------------------------------------------------------------
Class 1............... For the 2018 and 2019 For the 2018 and 2019
MIPS performance MIPS performance
period: period:
Measures that can be 3 to 10 points based
scored based on on performance
performance. compared to the
Measures that were benchmark.
submitted or
calculated that met
the following
criteria:.

[[Page 35949]]

(1) Has a benchmark;
(2) Has at least 20
cases; and.
(3) Meets the data
completeness
standard (generally
60 percent)..
Class 2............... For the 2018 and 2019 For the 2018 and 2019
MIPS performance MIPS performance
period: period:
Measures that were 3 points.
submitted and meet * This Class 2 measure
data completeness, policy does not apply
but do not have to CMS Web Interface
both of the measures and
following:. administrative claims
(1) a benchmark........ based measures.
(2) at least 20 cases..
Class 3 **............ For the 2018 and 2019 For the 2018 and 2019
MIPS performance MIPS performance
period: period:
Measures that were 1 point except for
submitted, but do small practices,
not meet data which would receive
completeness 3 measure
criteria, achievement points.
regardless of Beginning with the 2020
whether they have a MIPS performance
benchmark or meet period:
the case minimum.. MIPS eligible
clinicians other than
small practices will
receive zero measure
achievement points.
Small practices will
continue to receive 3
points.
* This Class 3 measure
policy would not apply
to CMS Web Interface
measures and
administrative claims
based measures.
------------------------------------------------------------------------

As the MIPS program continues to mature, we are looking to find
ways to improve our policies, including what to do with measures that
do not meet the case minimum. While many MIPS eligible clinicians can
meet the 20-case minimum requirement, we recognize that small practices
and individual MIPS eligible clinicians may have difficulty meeting
this standard. While we process data from the CY 2017 MIPS performance
period to determine how often submitted measures do not meet case
minimums, we invite public comment on ways we can improve our case-
minimum policy. In determining future improvements to our case minimum
policy, our goal is to balance the concerns of MIPS eligible clinicians
who are unable to meet the case minimum requirement and for whom we
cannot capture enough data to reliably measure performance, while not
creating incentives for MIPS eligible clinicians to choose measures
that do not meet case minimum even though other more relevant measures
are available.
We propose to maintain the policies finalized for the CY 2018 MIPS
performance period regarding measures that do not meet the case-minimum
requirement, do not have a benchmark, or do not meet the data-
completeness criteria for the CY 2019 MIPS performance period, and to
amend Sec. 414.1380(b)(1)(i) accordingly.
We also propose to assign zero points for measures that do not meet
data completeness starting with the CY 2020 MIPS performance period and
to amend Sec. 414.1380(b)(1)(i)(B)(1) accordingly. This policy is part
of our effort to move toward complete and accurate reporting that
reflects meaningful effort to improve the quality of care that patients
receive. Measures submitted by small practices would continue to
receive 3 points for all future CY MIPS performance periods, although
we may revisit this policy through future rulemaking.
(vi) Scoring Flexibility for Measures With Clinical Guideline Changes
During the Performance Period
In the CY 2018 Quality Payment Program final rule (82 FR 53714
through 53716), we finalized that, beginning with the 2018 MIPS
performance period, we will assess performance on measures considered
significantly impacted by ICD-10 updates based only on the first 9
months of the 12-month performance period (for example, January 1,
2018, through September 30, 2018, for the 2018 MIPS performance
period). We noted that performance on measures that are not
significantly impacted by changes to ICD-10 codes would continue to be
assessed on the full 12-month performance period (January 1 through
December 31). Lastly, we finalized that we will publish the list of
measures requiring a 9-month assessment process on the CMS website by
October 1st of the performance period if technically feasible, but by
no later than the beginning of the data submission period (for example,
January 2, 2019, for the 2018 MIPS performance period). As part of our
technical updates to Sec. 414.1380(b)(1) outlined in section
III.H.3.i.(1)(b) of this proposed rule, these policies are now
referenced at Sec. 414.1380(b)(1)(viii).
We remain concerned about instances where clinical guideline
changes or other changes to evidence supporting a measure occur during
the performance period that may significantly impact a measure.
Clinical guidelines and protocols developed by clinical experts and
specialty medical societies often underpin quality measures. At times,
measure stewards must amend quality measures to reflect new research
and changed clinical guidelines, and sometimes, as a result of the
change in these guidelines, adherence to guidelines in the existing
measures could result in patient harm or otherwise provide misleading
results as to good quality care. We sought comment in the CY 2018
Quality Payment Program final rule regarding whether we should apply
scoring flexibility to measures significantly impacted by clinical
guideline changes (82 FR 53716).
A few commenters made suggestions. One commenter supported using an
approach similar to the one used for measures impacted by ICD-10
changes. One commenter also recommended that the process be evaluated
periodically. A few commenters did not support CMS scoring measures
with less than 12 months of data because the commenters believed this
may result in unsuccessful reporting and could affect the measure
logic. One commenter recommended engaging measure developers and/or
stewards and measure implementers who may have novel approaches for
accounting for ICD-10 and other significant changes, such as releasing
new measure guidance or suspending updates to the measure until the
following performance period. The commenter also recommended that, for
each measure with a significant change, CMS post the proposed approach
for scoring the measure on the Quality

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Payment Program website for a 30-day public comment period.
We remain concerned that findings of evidence-based research,
providing the basis for sound clinical practice guidelines and
recommendations that are the foundation of a quality measure, may
change outside of the rulemaking cycle. As the clinical evidence and
guidelines change, approved measures may no longer reflect the most up-
to-date clinical evidence and could be contrary to patient well-being.
There may be instances in which changes to clinical guidelines are so
significant, that an expedited review is needed outside of the
rulemaking cycle because measures may result in a practice that is
harmful to patients. To further align with policies adopted within
other value based programs such as the Hospital VBP Program (83 FR
20409), we are proposing to suppress a measure without rulemaking, if
during the performance period a measure is significantly impacted by
clinical guideline changes or other changes that CMS believes may pose
patient safety concerns. CMS would rely on measure stewards for
notification in changes to clinical guidelines. We will publish on the
CMS website suppressed measures whenever technically feasible, but by
no later than the beginning of the data submission period.
We propose policies to provide scoring flexibility in the event
that we need to suppress a measure during a performance period. Scoring
for a suppressed measure would result in a zero achievement points for
the measure and a reduction of the total available measure achievement
points by 10 points. We believe that this approach effectively removes
the impact of the eligible clinician's inability to receive measure
achievement points for the measure, if a submitted measure is later
suppressed.
We propose to add a new paragraph at Sec. 414.1380(b)(1)(vii) that
beginning with the 2019 MIPS performance period, CMS will reduce the
total available measure achievement points for the quality performance
category by 10 points for MIPS eligible clinicians that submit a
measure significantly impacted by clinical guideline changes or other
changes that CMS believes may pose patient safety concerns.
(vii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality
Performance Category Criteria
In the CY 2018 Quality Payment Program final rule (82 FR 53732), we
finalized that, beginning with the 2021 MIPS payment year, we will
validate the availability and applicability of quality measures only
with respect to the collection type that a MIPS eligible clinician
utilizes for the quality performance category for a performance period,
and only if a MIPS eligible clinician collects via claims only, MIPS
CQMs only, or a combination of MIPS CQMs and claims collection types.
We will not apply the validation process to any data collection type
that the MIPS eligible clinician does not utilize for the quality
performance category for the performance period. We sought comment on
how to modify the validation process for the 2021 MIPS payment year
when clinicians may submit measures collected via multiple collection
types.
As discussed in section III.H.3.h.(1)(b) of this proposed rule, we
are proposing to revise our terminology regarding data submission. This
updated terminology will more accurately reflect our current
submissions and validation policies. We propose to modify our
validation process to provide that it only applies to MIPS CQMs and the
claims collection type, regardless of the submitter type chosen. For
example, this policy would not apply to eCQMs even if they are
submitted by a registry.
We note that a MIPS eligible clinician may not have available and
applicable quality measures. If we are unable to score the quality
performance category, then we may reweight the clinician's score
according to the reweighting policies described in sections
III.H.3.i.(2)(b)(ii) and III.H.3.i.(2)(b)(iii) of this proposed rule.
(viii) Small Practice Bonus
In the CY 2018 Quality Payment Program final rule, we finalized at
Sec. 414.1380(c)(4) to add a small practice bonus of 5 points to the
final score for the 2020 MIPS payment year for MIPS eligible
clinicians, groups, APM Entities, and virtual groups that meet the
definition of a small practice as defined at Sec. 414.1305 and submit
data on at least one performance category in the 2018 MIPS performance
period.
We continue to believe an adjustment for small practices is
generally appropriate due to the unique challenges small practices
experience related to financial and other resources, as well as the
performance gap we have observed (based on historical PQRS data) for
small practices in comparison to larger practices. We believe a small
practice bonus specific to the quality performance category is
preferable for the 2021 MIPS payment year and future years. We believe
it is appropriate to apply a small practice bonus points to the quality
performance category based on observations using historical data, which
indicates that small practices are less likely to submit quality
performance data, less likely to report as a group and use the CMS Web
Interface, and more likely to have lower performance rates in the
quality performance category than other practices. We want the final
score to reflect performance, rather than the ability and
infrastructure to support submitting quality performance category data.
We considered whether we should continue to apply the small
practice bonus through bonus points in all four performance categories,
but believe the need for doing so is less compelling. The improvement
activities performance category already includes special scoring for
small practices (please refer to Sec. 414.1380(b)(3) and see section
III.H.3.i.(1)(e) of this proposed rule for more information). In
addition, for the Promoting Interoperability performance category,
small practices can apply for a significant hardship exception if they
have issues acquiring an EHR (see section III.H.3.h.(5) of this
proposed rule). Finally, the cost performance category does not require
submission of any data; therefore, there is less concern about a small
practice being burdened by those requirements. For these reasons, we
are proposing to transition the small practice bonus to the quality
performance category.
Starting with the 2021 MIPS payment year, we propose at Sec.
414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the
numerator of the quality performance category for MIPS eligible
clinicians in small practices if the MIPS eligible clinician submits
data to MIPS on at least 1 quality measure. Because MIPS eligible
clinicians in small practices are not measured on the readmission
measure and are not able to participate in the CMS Web Interface, they
generally have a quality performance category denominator of 60 total
possible measure achievement points. Thus, our proposal of 3 measure
bonus points generally represents 5 percent of the quality performance
category score. As described in section III.H.3.i.(2)(b)(iii) of this
proposed rule, for clinicians in many small practices, the quality
performance category weight may be up to 85 percent of the final score.
(For example, if a small practice applies for the Promoting
Interoperability significant hardship application and does not meet the
sufficient case minimum for cost measures then the weights of Promoting
Interoperability and cost performance categories are redistributed to
quality

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and the quality performance category weight would be 85 percent.)
With a weight of 85 percent, a small practice bonus of 3 points
added to the quality performance category will result in 4.25 bonus
points added to the final score for clinicians in small practices.\29\
We believe this is appropriate because it is similar to the impact of
the small practice bonus we finalized for the 2020 MIPS payment year (5
points added to the final score). While we recognize that the impact of
the small practice bonus for MIPS eligible clinicians in small
practices who do not receive reweighting for the cost and/or Promoting
Interoperability performance categories will be less than 4.25 points
added to the final score, we believe a consistent approach is
preferable for simplicity, and we do not believe that a larger bonus is
appropriate as that could potentially inflate the quality performance
category score and the final score and mask poor performance.
---------------------------------------------------------------------------

\29\ We get 4.25 points using the following calculation: (3
measure bonus point/60 total measure points) * 85 percent * 100 =
4.25.
---------------------------------------------------------------------------

(ix) Incentives To Report High-Priority Measures
In the CY 2017 Quality Payment Program final rule, we established a
cap on high-priority measure bonus points for the first 2 years of MIPS
at 10 percent of the denominator (total possible measure achievement
points the MIPS eligible clinician could receive in the quality
performance category) of the quality performance category (81 FR
77294). As part of our proposed technical updates to Sec.
414.1380(b)(1) discussed in section III.H.3.i.(1)(b) of this proposed
rule, our previously established policy on incentives to report high-
priority measures is now referenced at Sec. 414.1380(b)(1)(v)(A). We
are proposing to maintain the cap on measure bonus points for reporting
high-priority measures for the 2021 MIPS payment year, and to amend
Sec. 414.1380(b)(1)(v)(A)(1)(ii), accordingly.
We established the scoring policies for high-priority measure bonus
points in the CY 2017 Quality Payment Program final rule (81 FR 77293).
We noted that, in addition to the required measures, CMS Web Interface
reporters may also report the CAHPS for MIPS survey and receive measure
bonus points for submitting that measure (81 FR 77293). We refer
readers to Sec. 414.1380(b)(1)(v)(A) for more details on the high-
priority measure bonus points scoring policies.
For the 2021 MIPS payment year, we propose to modify the policies
finalized in the CY 2017 Quality Payment Program final rule (and amend
Sec. 414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure
bonus points to CMS Web Interface reporters for reporting high-priority
measures. As we continue to move forward in implementing the MIPS
program, we no longer believe that it is appropriate to award CMS Web
Interface reporters measure bonus points to be consistent with other
policies regarding selection of measures. Based on additional data
analyses since the first-year policy was implemented, we have found
that practices that elect to report via CMS Web Interface generally
perform better than other practices that select other collection types.
Therefore, the benefit of the bonus points is limited and instead we
believe will create higher than normal scores. Bonus points were
created as transition policies which were not meant to continue through
the life of the program. Measure bonus points are also used to
encourage the selection of additional high-priority measures. As the
program matures, we have established other policies related to measures
selection, such as applying a cap of 7 measure achievement points if a
clinician selects and submits a measure that has been topped out for 2
or more years; however, we have excluded CMS Web Interface reporters
from the topped out policies because reporters have no choice in
measures. By the same logic, since CMS Web Interface reporters have no
choice in measures, we do not believe it is appropriate to continue to
provide additional high-priority measure bonuses for reporting CMS Web
Interface measures. We note the CMS Web Interface users may still elect
to report the CAHPS for MIPS survey in addition to the CMS Web
Interface, and if they do, they would receive the high priority bonus
points for reporting the survey.
As part of our move towards fully implementing the high value
measures as discussed in section III.H.3.h.(2)(b)(iv) of this proposed
rule, we believe that bonus points for high priority measures for all
collection types may no longer be needed, and as a result, we intend to
consider in future rulemaking whether to modify our scoring policy to
no longer offer high priority bonus points after the 2021 MIPS payment
year.
(x) Incentives To Use CEHRT To Support Quality Performance Category
Submissions
Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to
encourage MIPS eligible clinicians to report on applicable quality
measures through the use of CEHRT. Under Sec. 414.1380(b)(1)(xv), 1
bonus point is available for each quality measure submitted with end-
to-end electronic reporting, under certain criteria. As part of our
proposed technical updates to Sec. 414.1380(b)(1) discussed in section
III.H.3.i.(1)(b) of this proposed rule, our previously established
electronic end-to-end reporting bonus point scoring policy is now
referenced at Sec. 414.1380(b)(1)(v)(B).
We are proposing to maintain the cap on measure bonus points for
reporting high-priority measures for the 2021 MIPS payment year. We
also propose to continue to assign bonus points for end-to-end
electronic reporting for the 2021 MIPS payment year, as we have seen
that this policy encourages electronic reporting. We propose to amend
Sec. 414.1380(b)(1)(v)(B) accordingly.
We also are proposing to modify our end-to-end reporting bonus
point scoring policy based on the proposed changes to the submission
terminology discussed in section III.H.3.h.(1)(b) of this proposed
rule. We propose that the end-to-end reporting bonus can only apply to
the subset of data submitted by direct, log in and upload, and CMS Web
Interface that meet the criteria finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77297 through 77298). However, the
end-to-end reporting bonus would not be applied to the claims
submission type because it does not meet the criteria discussed above.
This is not a policy change but rather a clarification of our current
process in light of the proposed terminology changes.
As discussed in section III.H.3.i.(1)(b)(x) of this proposed rule,
we believe that in the future bonus points for end-to-end reporting for
all submission types will no longer be needed as we move towards fully
implementing the program, and as a result we intend to consider in
future rulemaking modifying our scoring policy to no longer offer end-
to-end reporting bonus points after the 2021 MIPS payment year.
Consistent with the section 1848(q)(5)(B)(ii) of the Act, which
requires the Secretary to encourage the use of CEHRT for quality
reporting, we will continue to be committed to ways that we can
incentivize and encourage these reporting methods. We invite comment on
other ways that we can encourage the use of CEHRT for quality
reporting.

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(xi) Calculating Total Measure Achievement and Measure Bonus Points
(A) Calculating Total Measure Achievement and Measure Bonus Points for
Non-CMS Web Interface Reporters
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR
77300, and 82 FR 53733 through 53736, respectively), we established the
policy for calculating total measure achievement and measure bonus
points for Non-CMS Web Interface reporters. We refer readers to Sec.
414.1380(b)(1) for more details on these policies.
We are not proposing any changes to the policy for scoring
submitted measures collected across multiple collection types; however,
we provide a summary of how this policy will be scored using our new
terminology. We note that CMS Web Interface and facility-based
measurement each have a comprehensive set of measures that meet the
proposed MIPS category requirements. As a result, we did not combine
CMS Web Interface measures or facility-based measurement with other
ways groups can be scored for data submitted for MIPS (other than CAHPS
for MIPS, which can be submitted in conjunction with the CMS Web
Interface). We refer readers to section III.H.3.i.(1)(d) of this
proposed rule for a description of our policies on facility-based
measurement.
Although we have established a policy to account for scoring in
circumstances when the same measure is collected via multiple
collection types, we anticipate that this will be a rare circumstance
and do not encourage clinicians to submit the same measure collected
via multiple collection types. Table 48 is included in this proposed
rule for illustrative purposes and clarity due to the changes in
terminology discussed in section III.H.3.h.(1)(b) of this proposed
rule. For further discussion of this example, we refer readers to the
CY 2018 Quality Payment Program final rule (82 FR 53734).
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We do not propose any changes to our policy regarding scoring
measure achievement points and bonus points when using multiple
collection types for non-Web Interface MIPS eligible clinicians in the
quality performance category for the 2019 MIPS performance period.
(B) Calculating Total Measure Achievement and Measure Bonus Points for
CMS Web Interface Reporters
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR
77302 through 77306, and 82 FR 53736 through 82 FR 53737,
respectively), we finalized the scoring policies for CMS Web Interface
reporters. As part of our proposed technical updates to Sec.
414.1380(b)(1) discussed in section III.H.3.i.(1)(b) of this proposed
rule, our previously established policies for CMS Web Interface
reporters are now referenced at Sec. 414.1380(b)(1)(i)(A)(2)(i) and
(b)(1)(v)(A).
(xii) Future Approaches to Scoring the Quality Performance Category
As we discuss in section III.H.3.h.(2)(b)(iv) of this proposed
rule, we anticipate making changes to the quality performance category
to reduce burden and increase the value of the measures we are
collecting. We discussed that existing measures have differing levels
of value and our approaches for implementing a system where points are
awarded based on the value of the measure. Should we adopt these
approaches, we anticipate needing to modify our scoring approaches
accordingly. In addition, we have received stakeholder feedback asking
us to simplify scoring for the quality performance category. Therefore,
we are seeking comment on the following approaches to scoring that we
may consider in future rulemaking and whether these approaches move the
clinicians towards reporting high value measures and more accurate
performance measurement.
One option for simplification is restructuring the quality
requirements with a pre-determined denominator, for example, 50 points,
but no specific requirements regarding the number of measures that must
be submitted. Further, we would categorize MIPS and QCDR measures by
value, because we recognize that not all measures are created equal. We
seek to ensure that the collection and submission of data is valuable
to clinicians and worth the cost and burden of collection of
information. A system to classify measures as a particular value (for
example, gold, silver, or bronze) is discussed in section
III.H.3.h.(2)(b)(iv) of this proposed rule. In this approach, the
highest tier would include measures that are considered ``gold''
standard, such as outcome measures, composite measure, or measures that
address agency priorities (such as opioids). The CAHPS for MIPS survey,
which collects patient experience data, may also be considered a high-
value measure. Measures considered in the second tier, or at a
``silver'' standard, would be process measures that are directly
related to outcomes and have a good gap in performance (there is no
high, unwavering performance) and demonstrate room for improvement, or
topped out outcome measures. Lower value measures, such as standard of
care process measures or topped out process measures, would have
scoring caps in place that would reflect the measure's status as a
``bronze measure.'' In this scenario, we could envision awarding points
for achievement as follows: up to 15 to 20 points in the top tier; up
to 10 points in the next tier; and up to 5 points in the lowest tier.
Similar to the structure of the improvement activities performance
category, a clinician that chooses a top-tier measure would not have to
submit as many measures to MIPS. We would still want to ensure the
submission of high value measures and might include requirements that
restrict the number of lower tier measures that could be submitted;
alternatively, we could add a requirement that a certain number of
higher tier measures would need to be submitted. With this approach, we
could still incentivize reporting on high-priority measures by
classifying them as ``gold'' standard measures which would be eligible
for up to 15 to 20 achievement points.
Alternatively, we could keep our current approach for the quality
performance category requiring 6 measures including one outcome
measure, with every measure worth up to 10 measure achievement points
in the denominator, but change the minimum number of measure
achievement points available to vary by the measure tier. For example,
high-tier measures could qualify for high priority bonus and/or have a
higher potential floor (for example, 5 measure achievement points
instead of the floor of 3 measure achievement points for ``gold''
standard measures, which would be eligible for up to 10 measure
achievement points.); whereas low-tier measures could have a lower
floor (for example, 1 measure achievement point instead of the floor of
3 measure achievement points for ``bronze standard' measures).
Taking into consideration the potential future quality performance
category change, we also believe that removing the validation process
to determine whether the eligible clinician has measures that are
available and applicable would simplify the quality performance
category significantly.

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Several stakeholders expressed their confusion with the validation
process. A move to sets of measures in the quality performance
category, potentially with some criteria to define the clinicians for
whom these measures are applicable, would eliminate the need for a
validation process for measures that are available and applicable.
Moving to sets of measures would also enable us to develop more robust
benchmarks. We also believe that in the next few years, we could remove
the validation process for measures that are available and applicable
if we set the denominator at a pre-determined level (as outlined in the
example above at 50 points) and let clinicians determine the best
method to achieve 50 points.
For the 2019 and 2020 MIPS payment years, MIPS eligible clinicians
and groups who report on QCDR measures that do not have an available
benchmark based on the baseline or performance period but meet data
completeness are assigned a score of 3 measure achievement points
(small practices receive 3 points regardless of whether they meet data
completeness). Through stakeholder engagement, particularly feedback
provided by QCDRs who have developed their own measures, we have heard
that MIPS eligible clinicians are hesitant to report QCDR measures
without established benchmarks. Eligible clinicians have voiced concern
on reporting on QCDR measures without benchmarks because they are not
certain that a benchmark could be calculated and established for the
MIPS performance period, and they would therefore be limited to a 3-
point score for that QCDR measure. In addition, QCDRs have inquired
about the possibility of creating QCDR benchmarks. To encourage
reporting of QCDR measures, we seek comment on an approach to develop
QCDR measure benchmarks based off historical measure data. This may
require QDCRs to submit historical data in a form and manner that meets
benchmarking needs as required by CMS. We anticipate that the
historical QCDR measure data would need to be submitted at the time of
self-nomination of the QCDR measure, during the self-nomination period.
Detailed discussion of the self-nomination period timeline and
requirements can be found in section III.H.3.k of this proposed rule.
Our concern with utilizing historical data provided by QCDRs to develop
benchmarks is whether QCDRs have the capability to filter through their
historical measure data to extract only data from MIPS eligible
clinicians and groups prior to submitting the historical data to CMS
for QCDR measure benchmarking consideration. Furthermore, once the
historical data is submitted by the QCDR, CMS would analyze the data to
ensure that it met benchmarking standards prior to it being accepted to
form a benchmark. However, to perform this analysis CMS may need
additional data elements such as the sources of the data, data
completeness, and the collection period. In addition to seeking comment
on developing QCDR measure benchmarks from historical data, we also
seek comment as to how our aforementioned concerns may be addressed for
future rulemaking.
We also recognize that improving the electronic capture,
calculation, and reporting of quality measures is also an important
component of reducing provider burden. We invite comment on how we can
incorporate incentives for the use of electronic clinical quality
measurement into the future approaches described under this section, as
well as other ways to encourage more efficient technology-enabled
measurement approaches.
We seek comment on these approaches and other approaches to
simplify scoring, provide incentives to submit more impactful measures
that assess outcomes rather than processes, and develop data that can
show differences in performance and determine clinicians that provide
high value care.
(xiii) Improvement Scoring for the MIPS Quality Performance Category
Percent Score
Section 1848(q)(5)(D)(i) of the Act stipulates that, beginning with
the second year to which the MIPS applies, if data sufficient to
measure improvement is available, the improvement of the quality
performance category score for eligible clinicians should be measured.
To measure improvement we require a direct comparison of data from one
Quality Payment Program year to another (82 FR 52740). For more
descriptions of our current policies, we refer readers to the CY 2018
Quality Payment Program proposed and final rule (82 FR 53737 to 53747).
As part of our proposed technical updates to Sec. 414.1380(b)(1)
discussed in section III.H.3.i.(1)(b) of this proposed rule, our
previously established improvement scoring policies are now referenced
at Sec. 414.1380(b)(1)(vi).
In the CY 2018 Quality Payment Program final rule, we adopted a
policy that MIPS eligible clinicians must fully participate to receive
a quality performance category improvement percent score greater than
zero (82 FR 53743 through 53745). In Sec. 414.1380(b)(1)(vi)(F), we
determined ``participation'' to mean compliance with Sec. 414.1330 and
Sec. 414.1340 in the current performance period. We issued a technical
correction for the CY 2018 Quality Payment Year final rule, replacing
Sec. 414.1330 with Sec. 414.1335 since Sec. 414.1335 is more
specific because it discusses the quality performance category
requirements.
We finalized at Sec. 414.1380(b)(1)(vi)(C)(4) that we would
compare the 2018 performance to an assumed 2017 quality performance
category achievement percent score of 30 percent if a MIPS eligible
clinician earned a quality performance category score less than or
equal to 30 percent in the previous year (82 FR 53744 through 53745).
We propose to continue this policy for the 2019 MIPS performance period
and amend Sec. 414.1380(b)(1)(vi)(C)(4), accordingly. We propose to
compare the 2019 performance to an assumed 2018 quality performance
category achievement percent score of 30 percent.
(xiv) Calculating the Quality Performance Category Percent Score
Including Achievement and Improvement Points
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the
policies on incorporating the improvement percent score into the
quality performance category percent score. As part of our proposed
technical updates to Sec. 414.1380(b)(1) discussed in section
III.H.3.i.(1)(b) of this proposed rule, our previously established
policies are now referenced at Sec. 414.1380(b)(1)(vii).
(c) Scoring the Cost Performance Category
(i) Scoring Achievement in the Cost Performance Category
For a description of the statutory basis and our existing policies
for scoring achievement in the cost performance category, we refer
readers to the CY 2017 Quality Payment Program final rule (81 FR 77308
through 77311) and the CY 2018 Quality Payment Program final rule (82
FR 53748 through 53749). In the CY 2017 Quality Payment Program final
rule (81 FR 77308 through 77309), we established that we will determine
cost measure benchmarks based on cost measure performance during the
performance period. We also established that at least 20 MIPS eligible
clinicians or groups must meet the minimum case volume that we specify

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for a cost measure in order for a benchmark to be determined for the
measure, and that if a benchmark is not determined for a cost measure,
the measure will not be scored. We propose to codify these final
policies at Sec. 414.1380(b)(2)(i).
(ii) Scoring Improvement in the Cost Performance Category
For a description of the statutory basis and our existing policies
for scoring improvement in the cost performance category, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR 53749
through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of
2018 modified section 1848(q)(5)(D) of the Act such that the cost
performance category score shall not take into account the improvement
of the MIPS eligible clinician for each of the second, third, fourth,
and fifth years for which the MIPS applies to payments. We do not
believe this change requires us to remove our existing methodology for
scoring improvement in the cost performance category (see 82 FR 53749
through 53752), but it does prohibit us from including an improvement
component in the cost performance category percent score for each of
the 2020 through 2023 MIPS payment years. Therefore, we propose to
revise Sec. 414.1380(b)(2)(iv)(E) to provide that the maximum cost
improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years
is zero percentage points. Under our existing policy (82 FR 53751
through 53752), the maximum cost improvement score for the 2020 MIPS
payment year is 1 percentage point, but due to the statutory changes
and under our proposal, the maximum cost improvement score for the 2020
MIPS payment year would be zero percentage points. We are also
proposing at Sec. 414.1380(a)(1)(ii) to modify the performance
standards to reflect that the cost performance category percent score
will not take into account improvement until the 2024 MIPS payment
year.
(d) Facility-Based Measures Scoring Option for the 2021 MIPS Payment
Year for the Quality and Cost Performance Categories
(i) Background
In the CY 2018 Quality Payment Program final rule, we established a
facility-based measurement scoring option for clinicians that meet
certain criteria beginning with the 2019 MIPS performance period/2021
MIPS payment year (82 FR 53752 through 53767). We originally proposed a
facility-based measurement scoring option for the 2018 MIPS performance
period. We did not finalize the policy because we were concerned that
we would not have the operational ability to inform clinicians early
enough in the 2018 MIPS performance period to allow them to consider
the consequences and benefits of participation (82 FR 53755).
(ii) Facility-Based Measurement Applicability
(A) General
In the CY 2018 Quality Payment Program final rule, we limited
facility-based reporting to the inpatient hospital in the first year
for several reasons, including that a more diverse group of clinicians
(and specialty types) provide services in an inpatient setting than in
other settings, and that the Hospital Value-Based Purchasing (VBP)
Program adjusts payment to hospitals in connection with both increases
and decreases in performance (82 FR 53753 through 53755). We also
limited measures applicable for facility-based measurement to those
used in the Hospital VBP Program because the Hospital VBP Program
compares hospitals on a series of different measures intended to
capture the breadth of inpatient care in the facility (82 FR 53753). We
noted that we were open to the consideration of additional facility
types in the future but recognized that adding a facility type would be
dependent upon the status of the VBP program applicable to that
facility, the applicability of measures, and the ability to
appropriately attribute a clinician to a facility (82 FR 53754). We do
not propose to add additional facility types for facility-based
measurement in this proposed rule, but we are interested in potentially
expanding to other settings in future rulemaking. Therefore, in section
III.H.3.i.(1)(d)(vii), we outline several issues that would need to be
resolved in order to expand this option to a wider group of facility-
based clinicians.
(B) Facility-Based Measurement by Individual Clinicians
In the CY 2018 Quality Payment Program final rule, we established
individual eligibility criteria for facility-based measurement at Sec.
414.1380(e)(2)(i). We established that a MIPS eligible clinician who
furnishes 75 percent or more of his or her covered professional
services in sites of service identified by the POS codes used in the
HIPAA standard transaction as an inpatient hospital or emergency room
based on claims for a period prior to the performance period as
specified by CMS (82 FR 53756 through 53757) is eligible as an
individual for facility-based measurement. We had noted, as a part of
our proposal summary, that we would use the definition of professional
services in section 1848(k)(3)(A) of the Act in applying this standard
(82 FR 53756). For purposes of determining eligibility for facility-
based measurement, we discussed CMS using data from the period between
September 1 of the calendar year, 2 years preceding the MIPS
performance period, through August 31 of the calendar year preceding
the MIPS performance period, with a 30-day claims run out but did not
finalize that as part of the applicable regulation (82 FR 53756 through
53757). Because we are using the quality measures associated with the
inpatient hospital to determine the MIPS quality and cost performance
category score, we wanted to ensure that eligible clinicians
contributed to care in that setting during that time period.
We indicated that CMS will use POS code 21 (inpatient) and POS code
23 (emergency department) for this purpose (82 FR 53756). Commenters on
our proposal (as summarized in the CY 2018 Quality Payment Program
final rule (82 FR 53756 through 53757)) expressed concern that adopting
the definition that we did for facility-based clinicians would limit
the number of clinicians who would be eligible. In particular,
commenters were concerned about the omission of the on-campus
outpatient hospital POS code (POS code 22) for observation services,
which are similar to and often take place in the same physical location
as inpatient services. In the CY 2018 Quality Payment Program final
rule, we sought comment on ways to identify clinicians who have a
significant presence within the inpatient setting, and how to address
concerns about including POS code 22 in this definition (82 FR 57357).
A few commenters that responded again suggested that CMS add POS code
22. In addition, a few commenters suggested that several other POS can
be included, including ambulatory surgical centers, IRFs, and SNFs.
We are proposing to modify our determination of a facility-based
individual at Sec. 414.1380(e)(2)(i) in four ways. First, we propose
to add on-campus outpatient hospital (as identified in the POS code in
the HIPAA standard transaction, that is, POS code 22) to the settings
that determine whether a clinician is facility-based. Second, we
propose that a clinician must have at least a single service billed
with the POS code used for the inpatient hospital or emergency room.
Third, we propose that, if we are unable to identify a facility with a
VBP score

[[Page 35957]]

to attribute a clinician's performance, that clinician is not eligible
for facility-based measurement. Fourth, we propose to align the time
period for determining eligibility for facility-based measurement with
changes to the dates used to determine MIPS eligibility and special
status detailed in section III.H.3.b. of this rule. We explain these
four proposals below. We believe that these proposals will further
expand the opportunity for facility-based measurement and eliminate
issues associated with the provision of observation services while
still restricting eligibility to those who work in an inpatient
setting.
First, we propose to add the on-campus outpatient hospital (POS
code 22) to the list of sites of service used to determine eligibility
for facility-based measurement. We agree with commenters that limiting
the eligibility to our current definition may prevent some clinicians
who are largely hospital-based from being eligible. However, expanding
eligibility without taking into account the relationship between the
clinician and the facility and facility's performance could result in
unfairly attributing to a clinician performance for which the clinician
is not responsible or has little to no role in improving. We do believe
that a significant provision of services in the on-campus outpatient
hospital are reflected in the quality captured by the Hospital VBP
Program. For example, patients in observation status are typically
treated by the same staff and clinicians as those who meet the
requirements for inpatient status. While there are some clinical
differences that may result in a patient having observation status, we
believe that the quality of care provided to these patients in this
same setting would be comparable, reflecting the overall healthcare
system at that particular location. Therefore, we are convinced that a
sufficient nexus exists for attributing the hospital's VBP performance
to clinicians that provide services in on-campus outpatient hospital
settings.
Second, we propose to require that clinicians bill at least a
single service with the POS codes for inpatient hospital or the
emergency room in order to be eligible for facility-based measurement.
While we generally believe that clinicians who provide services in the
outpatient hospital can affect the quality of care for inpatients, we
believe that a clinician who is to be measured according to the
performance of a hospital should at least have a minimal presence in
the inpatient or emergency room setting. We remain concerned about
including clinicians who provide at least 75 percent of their services
at on-campus outpatient hospitals (with POS code 22) when such
clinicians exclusively provide outpatient services that are unrelated
to inpatient hospital service. For example, a dermatologist who
provides office-based services in a hospital-owned clinic but who never
admits or treats patient within the inpatient or emergency room setting
does not meaningfully contribute to the quality of care for patients
measured under the Hospital VBP Program.
We considered different ways to best identify those who contribute
to the quality of care in the inpatient setting while keeping the
facility-based scoring option as simple as possible. We considered
separately measuring the HCPCS codes for observation services, but
believe that such a measurement may not fairly consider services
provided by clinicians for whom observations services may be embedded
in a global code for a procedure rather than billed as a separate
observation service. We also considered requiring a clinician to
provide a certain percentage of services with the inpatient hospital
POS. However, we have not identified a threshold (other the one claim
threshold we proposed here) that would more meaningfully differentiate
clinicians who provide services with the outpatient hospital POS code
but do not contribute to the services that would be measured under the
Hospital VBP Program. We believe it is important to ensure that the
program rules are clear and easily applied to clinicians, so as to both
avoid confusion on program participation requirements and to meet
overall agency goals to increase transparency in the agency's
activities. We believe that using a single service as the threshold
provides a simple, bright-line to differentiate those who never provide
inpatient services from clinicians that do provide inpatient services,
as well as outpatient services. We also believe this will limit the
opportunity for clinicians who exclusively practice in the outpatient
setting to be measured on the VBP performance of an unrelated hospital.
We recognize this requirement of one service with the inpatient or
emergency department POS may not demonstrate a significant presence in
a particular facility, and we seek comment on whether a better
threshold could be used to identify those who are contributing to the
quality of care for patients in the inpatient setting without creating
barriers to eligibility for facility-based measurement.
Our rationale and reasoning for these first two proposals is based
in large part on our analysis of the previously finalized policy for
eligibility for the facility-based measurement scoring option. Using
claims data, we identified all clinicians that would be MIPS eligible
as either an individual or group, and identified the POS codes
submitted for physician fee schedule services provided by those
clinicians. We then modeled the existing final policy based on
inpatient and ER services. We determined that while almost all ER
physicians would be scored under facility-based measurement, a
relatively small percentage of clinicians in other specialties, even
those which we would expect to have significant presence in the
hospital, would be eligible for the facility-based measurement scoring
option. For example, only 13.45 percent of anesthesiologists would be
eligible for the facility-based measurement scoring option under our
existing policy. Adding the on-campus outpatient hospital POS code
substantially increases eligibility for the facility-based measurement
scoring option, even after we adjust for requiring one service with the
inpatient or emergency department POS. By adopting our newly proposed
policy, 72.55 percent of anesthesiologists would be eligible. However,
this proposed new policy would not substantially increase the number of
clinicians eligible for the facility-based measurement scoring option
who, based on specialty identification, may not have a significant
presence in the hospital. For example, our newly proposed policy would
increase the percentage of family physicians eligible for the facility-
based measurement scoring option from 11.34 percent to 13.86 percent,
which is still a very small percentage of those clinicians.
Our third proposal is to add a new criterion (To be codified at
Sec. 414.1380(e)(2)(i)(C)): To be eligible for facility-based
measurement, we must be able to attribute a clinician to a particular
facility that has a VBP score. For facility-based measurement to be
applicable, we must be able to attribute a clinician to a facility with
a VBP score. Based on our definition of facility-based measurement,
this means a clinician must be associated with a hospital with a
Hospital VBP Program Total Performance Score. We are concerned that our
proposed expansion of eligibility for facility-based measurement could
increase the number of clinicians who are eligible for facility-based
measurement but whom we are unable to attribute to a particular
facility

[[Page 35958]]

that has a VBP score. In the CY 2018 Quality Payment Program final
rule, we noted that some hospitals do not have a Hospital VBP Program
Total Performance Score that could be used to determine a MIPS quality
and cost performance category score, such as hospitals in the state of
Maryland (82 FR 53766). Hence, clinicians associated with those
hospitals would not be able to use facility-based measurement but could
report quality measures through another method and have cost measures
calculated if applicable. We believe a similar result should apply if
we cannot attribute a clinician identified as facility-based to a
specific facility. We believe that such a situation would be relatively
rare. Those clinicians who are identified as facility-based but for
whom we are unable to attribute to a hospital must participate in MIPS
quality reporting through another method, or they will receive a score
of zero in the quality performance category. We therefore propose to
add the requirement to Sec. 414.1380(e)(2)(i) that a clinician must be
able to be attributed to a particular facility with a VBP score under
the methodology specified in Sec. 414.1380(e)(5) to meet eligibility
for facility-based measurement. The cross-reference to paragraph (e)(5)
is to the methodology for determining the applicable facility score
that would be used. Our proposed new regulatory text at Sec.
414.1380(e)(2)(i)(C) addresses both attribution to a facility and the
need for that facility to have a VBP score by conditioning eligibility
for facility-based scoring for an individual clinician on the clinician
being attributed under the methodology in paragraph (e)(5) to a
facility with a VBP score.
Fourth, we propose to change the dates of determining eligibility
for facility-based measurement. In section III.M.3.b. of this rule, we
propose to modify the dates of the MIPS determination period that would
provide eligibility determination for small practice size, non-patient
facing, low-volume threshold, ASC, hospital-based, and facility-based
determination periods. To align this regulation with these other
determination periods, we propose that CMS will use data from the
initial 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-day claims run out in determining eligibility for
facility-based measurement.
(C) Facility-Based Measurement by Group
In the CY 2018 Quality Payment Program final rule, we finalized at
Sec. 414.1380(e)(2)(ii) that a MIPS eligible clinician is eligible for
facility-based measurement under MIPS if they are determined to be
facility-based as part of a group (82 FR 53757). We established at
Sec. 414.1380(e)(2)(ii) that a facility-based group is a group in
which 75 percent or more of its eligible clinician NPIs billing under
the group's TIN meet the requirements at Sec. 414.1380(e)(2)(i) (82 FR
53758). We do not propose any changes to the determination of a
facility-based group but acknowledge that our proposal to change how
individual clinicians are determined to be eligible for facility-based
measurement will necessarily have a practical impact for practice
groups. For more of the statutory background and descriptions of our
current policies on determining a facility-based group, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR 53757
through 53758).
(iii) Facility Attribution for Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we finalized at
Sec. 414.1380(e)(5) a method to identify the hospital whose scores
would be associated with a MIPS eligible clinician or group that elects
facility-based measurement scoring (82 FR 53759). Although we did not
specifically address the issue of how facility-based groups would be
assigned to a facility (for purposes of attributing facility
performance to the group) in the preamble of the CY 2018 Quality
Payment Program proposed rule, our proposed regulation at Sec.
414.380(e)(5) did apply the same standard to individuals and groups. We
believe that this provided sufficient notice of the policy;
nevertheless, we indicated we would address this issue as part of the
next Quality Payment Program rulemaking cycle (82 FR 53759). Therefore,
we are revisiting facility-based attribution for individuals and groups
in this proposed rule.
Under the current regulation text Sec. 414.1380(e)(5), a facility-
based clinician or group receives a score under the facility-based
measurement scoring standard derived from the VBP score for the
facility at which the clinician or group provided services to the most
Medicare beneficiaries during the year claims are drawn (that is, the
12-month period described in paragraph (e)(2)). If an equal number of
Medicare beneficiaries are treated at more than one facility, then we
will use the VBP score for the highest-scoring facility (82 FR 53759
through 53760). For more of the statutory background and descriptions
of our current policies for attributing a facility to a MIPS eligible
clinician, we refer readers to the CY 2018 Quality Payment Program
final (82 FR 53759 through 53760).
In considering the issue of facility attribution for a facility-
based group, we believe that a change to facility-based attribution is
appropriate to better align the policy with the determination of a
facility-based group at Sec. 414.1380(e)(2)(ii). A facility-based
group is one in which 75 percent or more of the eligible clinician NPIs
billing under the group's TIN are eligible for facility-based
measurement as individuals. Additionally, under the current regulation,
the VBP score for the highest scoring facility would be used in the
case of a tie among the number of facilities at which the group
provided services to Medicare beneficiaries. We propose to revise Sec.
414.1380(e)(5) to differentiate how a facility-based clinician or group
receives a score based on whether they participate as a clinician or a
group.
We propose to remove ``or group'' from Sec. 414.1380(e)(5) and
redesignate that paragraph as (e)(5)(i) so that it only applies to
individual MIPS eligible clinicians. Under our proposal, newly
redesignated paragraph (e)(5)(i) retains the rule for facility
attribution for an individual MIPS eligible clinician as finalized in
the CY 2018 Quality Payment Program final rule; we are also proposing a
few minor edits to the paragraph for grammar and to improve the
sentence flow. We also propose to add a new paragraph (e)(5)(ii) to
provide that a facility-based group receives a score under the
facility-based measurement scoring standard derived from the VBP score
for the facility at which the plurality of clinicians identified as
facility-based would have had their score determined under the
methodology described in Sec. 414.1380(e)(5)(i) if the clinicians had
been scored under facility-based measurement as individuals. We make
this proposal because we wish to emphasize the connection between an
individual clinician and a facility. We believe that using the
plurality of clinicians reinforces the connection between an individual
clinician and facility and is more easily understandable for larger
groups.
(iv) No Election of Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we did not
finalize

[[Page 35959]]

our proposal for how individual MIPS eligible clinicians or groups who
wish to have their quality and cost performance category scores
determined based on a facility's performance would elect to do so
through an attestation (82 FR 53760). We did finalize, and reflect in
the introductory text at Sec. 414.1380(e), that an individual
clinician or group would elect to use a facility-based score. The
proposal had specified that such clinicians or groups would be required
to submit their election during the data submission period through the
attestation submission mechanism established for the improvement
activities and the Promoting Interoperability performance categories
(82 FR 53760). An alternative approach, which likewise was not
finalized, did not require an election process, but instead would have
automatically applied a facility-based measurement to MIPS eligible
clinicians and groups who are eligible for facility-based measurement,
if such an application were technically feasible (82 FR 53760). We
noted in the CY 2018 Quality Payment Program final rule that we would
examine both the attestation process we proposed and the alternative
opt-out process, and work with stakeholders to identify a new proposal
in future rulemaking (82 FR 53760). We indicated our interest in a
process that would impose less burden on clinicians than an attestation
requirement.
In the CY 2018 Quality Payment Program final rule, we requested
further comment on the propriety of automatically assigning a clinician
or group a score under facility-based measurement, but where CMS would
notify and give the clinician the opportunity to opt-out of facility-
based measurement (82 FR 53760). We subsequently received comments both
in favor of and opposed to an opt-out approach. A few commenters
supported the opt-out approach because it would reduce administrative
burden on behalf of the clinician. A few commenters expressed concern
that an opt-out process could result in clinicians unintentionally
being measured on the basis of a facility. A few commenters expressed
concern that an automatic assignment of a score would provide an unfair
advantage for facility-based clinicians.
After further considering the advantages and disadvantages of an
opt-in or an opt-out process, we are proposing a modified policy that
does not require an election process. Instead, we propose to
automatically apply facility-based measurement to MIPS eligible
clinicians and groups who are eligible for facility-based measurement
and who would benefit by having a higher combined quality and cost
performance category score. That is, if the MIPS eligible clinician or
group is eligible for facility-based measurement, we would calculate a
combined quality and cost performance category score. We propose to use
the facility-based score to determine the MIPS quality and cost
performance category scores, unless we receive another submission of
quality data for or on behalf of that clinician or group and the
combined quality and cost performance category score for the other
submission results in a higher combined quality and cost performance
score. If the other submission has a higher combined quality and cost
performance score, then we would not apply the facility-based
performance scores for either the quality or cost performance
categories. Under our proposal, the combined score for the quality and
cost performance categories would determine the scores to be used for
both the quality and cost performance categories, for both individual
clinicians and for groups that meet the requirements of paragraph
(e)(2). We do not propose to adopt a formal opt-out process because,
under our proposal, the higher of the quality and cost performance
scores available or possible for the clinician or clinician group would
be used, which would only benefit the clinician or group. We have a
strong commitment to reducing burden as part of the Quality Payment
Program, and we believe that requiring a clinician or group to elect a
measurement process (or to opt-out of a measurement process) based on
facility performance would add unnecessary burden.
In MIPS, we score clinicians as individuals unless they submit data
as a group. We believe that same policy should apply to facility-based
measurement, even though there are no submission requirements for the
quality performance category for individuals under facility-based
measurement. Therefore, we propose to revise Sec. 414.1380(e)(4) to
state that there are no submission requirements for individual
clinicians in facility-based measurement but a group must submit data
in the improvement activities or Promoting Interoperability performance
categories in order to be measured as a group under facility-based
measurement. If a group does not submit improvement activities or
Promoting Interoperability measures, then we would apply facility-based
measurement to the individual clinicians and such clinicians would not
be scored as a group. In the case of virtual groups, MIPS eligible
clinicians would have formed virtual groups prior to the MIPS
performance period; as a result, virtual groups eligible for facility-
based measurement would always be measured as a virtual group. While we
could calculate a score for a TIN without the submission of data by the
TIN, we would be uncertain if the clinicians within that group wished
to be measured as a group without an active submission (in other words,
if the group did not submit data as a group). Submission of data on the
improvement activities or Promoting Interoperability measures indicates
an intent and desire to be scored as a group. Hence, we believe that
using the choice to submit data as a group to identify a group in the
context of facility-based scoring will preserve choices made by
clinicians and groups while avoiding the burden of an election process
to be scored as a group solely for the purpose of facility-based
scoring. We solicit comment specifically on this proposal and other
means to achieve the same ends.
In the CY 2018 Quality Payment Program final rule, we established
that if a clinician or group elects facility-based measurement but also
submits MIPS quality data, then the clinician or group would be
measured on the method that results in the higher quality score (82 FR
53767). We propose to adopt this same scoring principle in conjunction
with our proposal not to use (or require) an election process.
Therefore, we propose at Sec. 414.1380(e)(6)(vi) that the MIPS quality
and cost score for clinicians and groups eligible for facility-based
measurement will be based on the facility-based measurement scoring
methodology described in Sec. 414.1380(e)(6) unless the clinician or
group receives a higher combined score for the MIPS quality and cost
performance categories through data submitted to CMS for MIPS. Because
Sec. 414.1380(d) states that MIPS eligible clinicians in MIPS APMs are
scored under the MIPS APM scoring standard described at Sec. 414.1370,
those clinicians would not be scored using facility-based measurement.
We also propose conforming changes in two other sections of
regulatory text. We propose to revise the introductory text at Sec.
414.1380(e) to remove ``elect to,'' and therefore, reflect that
clinicians and groups who are determined to be facility-based will
receive MIPS quality and cost performance categories under the
methodology in paragraph (e). We note that because we do not require
clinicians to opt-in into facility-based measurement, there may be
clinicians that will continue to submit data via other methods. Hence,
these clinicians

[[Page 35960]]

and groups are not prohibited from submitting quality measures to CMS
for purposes of MIPS; if higher combined quality and cost scores are
achieved using data submitted to CMS for purposes of MIPS, then we will
use that result. We also propose to revise Sec. 414.1380(e)(4) and
(e)(6)(v)(A) to reflect that facility-based measurement does not
require election and to replace the phrase ``clinicians that elect
facility-based measurement'' with ``clinicians and groups scored under
facility-based measurement.''
(v) Facility-Based Measures
(A) Background
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary
may use measures used for payment systems other than for physicians,
such as measures for inpatient hospitals, for purposes of the quality
and cost performance categories. However, the Secretary may not use
measures for hospital outpatient departments, except in the case of
items and services furnished by emergency physicians, radiologists, and
anesthesiologists. In the CY 2018 Quality Payment Program proposed
rule, we proposed to include for the 2020 MIPS payment year all the
measures adopted for the FY 2019 Hospital VBP Program on the MIPS list
of quality measures and cost measures for purposes of facility based
measurement (82 FR 30125). We noted how these measures meet the
definition of additional system-based measures provided in section
1848(q)(2)(C)(ii) of the Act (82 FR 30125). In the CY 2018 Quality
Payment Program final rule, we did not finalize our proposal that the
facility-based measures available for the 2018 MIPS performance period
would be the measures adopted for the FY 2019 Hospital VBP Program; nor
did we finalize our proposal that, for the 2020 MIPS payment year,
facility-based individual MIPS eligible clinicians or groups that were
attributed to a facility would be scored on all measures on which the
facility is scored via the Hospital VBP Program's Total Performance
Score methodology (82 FR 53762).
We did finalize a facility-based measurement scoring standard but
not the specific instance of using the FY 2019 Hospital VBP Program
Total Performance Score methodology (82 FR 53755). We expressed our
belief that the policy approach of using all measures from the Hospital
VBP program is appropriate; nevertheless, because we did not finalize
the facility-based measurement scoring option for the 2018 MIPS
performance period/2021 MIPS payment year, it was not appropriate to
adopt these policies at that time (82 FR 53762 through 53763). We noted
that we intended to propose measures that would be available for
facility-based measurement for the 2019 MIPS performance period/2021
MIPS payment year in future rulemaking (82 FR 53763).
For a detailed description of the policies proposed and finalized,
we refer readers to the CY 2018 Quality Payment Program final rule (82
FR 53761 through 53763).
(B) Measures in Facility-Based Scoring
We continue to believe it is appropriate to adopt all the measures
for the Hospital VBP Program into MIPS for purposes of facility-based
scoring; these Hospital VBP Program measures meet the definition of
additional system-based measures provided in section 1848(q)(2)(C)(ii)
of the Act. We also believe it is appropriate to adopt the performance
periods for the measures, which generally are consistent with the dates
that we use to determine eligibility for facility-based measurement.
Therefore, beginning with the 2019 MIPS performance period, we
propose at Sec. 414.1380(e)(1)(i) to adopt for facility-based
measurement, the measure set that we finalize for the fiscal year
Hospital VBP program for which payment begins during the applicable
MIPS performance period. For example, for the 2019 MIPS performance
period, which runs on the 2019 calendar year, we propose to adopt the
FY 2020 Hospital VBP Program measure set, for which payment begins on
October 1, 2019. The performance period for these measures varies but
performance ends in 2018 for all measures.
We also propose at Sec. 414.1380(e)(1)(ii) that, starting with the
2021 MIPS payment year, the scoring methodology applicable for MIPS
eligible clinicians scored with facility-based measurement is the Total
Performance Score methodology adopted for the Hospital VBP Program, for
the fiscal year for which payment begins during the applicable MIPS
performance period. Therefore, for the 2021 MIPS payment year, the
Total Performance Score methodology for 2019 would apply for facility-
based scoring. We note that this approach of adopting all the measures
in the Hospital VBP program can be applied to other VBP programs in the
future, should we decide to expand facility-based measurement to
settings other than hospitals in the future.
In the CY 2018 Quality Payment Program final rule we also
established at Sec. 414.1380(e)(6)(i) that the available quality and
cost measures for facility-based measurement are those adopted under
the VBP program of the facility for the year specified. We established
at Sec. 414.1380(e)(6)(ii) that we will use the benchmarks adopted
under the VBP program of the facility program for the year specified
(82 FR 53763 through 53764). We noted that we would determine the
particular VBP program to be used for facility-based measurement in
future rulemaking but would routinely use the benchmarks associated
with that program (82 FR 53764). Likewise, at Sec.
414.1380(e)(6)(iii), we established that the performance period for
facility-based measurement is the performance period for the measures
adopted under the VBP program of the facility program for the year
specified (82 FR 53755). We noted that these provisions referred to the
general parameters of our method of facility-based measurement and that
we would address specific programs and years in future rulemaking (82
FR 53763). We now propose regulation for these three provisions to
specify that the measures, performance period, and benchmark period for
facility-based measurement are the measures, performance period, and
benchmark period established for the VBP program used to determine the
score as described in Sec. 414.1380(e)(1). As an example, for the 2019
MIPS performance period and 2021 MIPS payment year, the measures used
would be those for the FY 2019 Hospital VBP program along with the
associated benchmarks and performance periods.
(C) Measures for MIPS 2019 Performance Period/2021 MIPS Payment Year
For informational purposes, we are providing a list of measures
included in the FY 2020 Hospital VBP Program measures in determining
the quality and cost performance category scores for the 2019 MIPS
performance period/2021 MIPS payment year. The FY 2020 Hospital VBP
Program has adopted 12 measures covering 4 domains (83 FR 20412 through
13). The performance period for measures in the Hospital VBP Program
varies depending on the measure, and some measures include multi-year
performance periods. We include the FY 2020 Hospital VBP Program
measures in Table 49. We note that these measures are determined
through separate rulemaking (82 FR 38244). As noted in section
III.H.3.i.(1)(d)(v) of this proposed rule, we would adopt these
measures, benchmarks, and performance periods for the purposes of
facility-based measurement.

[[Page 35961]]

Table 49--FY 2020 Hospital VBP Program Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short name Domain/measure name NQF No. Performance period
--------------------------------------------------------------------------------------------------------------------------------------------------------
Person and Community Engagement Domain
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCAHPS................................... Hospital Consumer Assessment of 0166 (0228) January 1, 2018-December 31, 2018.
Healthcare Providers and Systems
(HCAHPS) (including Care
Transition Measure).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Outcomes Domain *
--------------------------------------------------------------------------------------------------------------------------------------------------------
MORT-30-AMI.............................. Hospital 30-Day, All-Cause, Risk- 0230 July 1, 2015-June 30, 2018.
Standardized Mortality Rate
(RSMR) Following Acute
Myocardial Infarction (AMI)
Hospitalization.
MORT-30-HF............................... Hospital 30-Day, All-Cause, Risk- 0229 July 1, 2015-June 30, 2018.
Standardized Mortality Rate
(RSMR) Following Heart Failure
(HF) Hospitalization.
MORT-30-PN............................... Hospital 30-Day, All-Cause, Risk- 0468 July 1, 2015-June 30, 2018.
Standardized Mortality Rate
(RSMR) Following Pneumonia
Hospitalization.
THA/TKA.................................. Hospital-Level Risk-Standardized 1550 July 1, 2015-June 30, 2018.
Complication Rate (RSCR)
Following Elective Primary Total
Hip Arthroplasty (THA) and/or
Total Knee Arthroplasty (TKA).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Safety Domain **
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAUTI.................................... National Healthcare Safety 0138 January 1, 2018-December 31, 2018.
Network (NHSN) Catheter-
Associated Urinary Tract
Infection (CAUTI) Outcome
Measure.
CLABSI................................... National Healthcare Safety 0139 January 1, 2018-December 31, 2018.
Network (NHSN) Central Line-
Associated Bloodstream Infection
(CLABSI) Outcome Measure.
Colon and Abdominal Hysterectomy SSI..... American College of Surgeons-- 0753 January 1, 2018-December 31, 2018.
Centers for Disease Control and
Prevention (ACS-CDC) Harmonized
Procedure Specific Surgical Site
Infection (SSI) Outcome Measure.
MRSA Bacteremia.......................... National Healthcare Safety 1716 January 1, 2018-December 31, 2018.
Network (NHSN) Facility-wide
Inpatient Hospital-onset
Methicillin-resistant
Staphylococcus aureus (MRSA)
Bacteremia Outcome Measure.
CDI...................................... National Healthcare Safety 1717 January 1, 2018-December 31, 2018.
Network (NHSN) Facility-wide
Inpatient Hospital-onset
Clostridium difficile Infection
(CDI) Outcome Measure.
PC-01.................................... Elective Delivery................ 0469 January 1, 2018-December 31, 2018.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficiency and Cost Reduction Domain
--------------------------------------------------------------------------------------------------------------------------------------------------------
MSPB..................................... Payment-Standardized Medicare 2158 January 1, 2018-December 31, 2018.
Spending Per Beneficiary (MSPB).
--------------------------------------------------------------------------------------------------------------------------------------------------------

(vi) Scoring Facility-Based Measurement
(A) Scoring Achievement in Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we adopted
certain scoring policies for clinicians and groups in facility-based
measurement. We established at Sec. 414.1380(e)(6)(iv) and (v) that
the quality and cost performance category percent scores would be
established by determining the percentile performance of the facility
in the VBP purchasing program for the specified year, then awarding
scores associated with that same percentile performance in the MIPS
quality and cost performance categories for those MIPS eligible
clinicians who are not scored using facility-based measurement for the
MIPS payment year (82 FR 53764). We also finalized at Sec.
414.1380(e)(6)(v)(A) that clinicians scored under facility-based
measurement would not be scored on other cost measures (82 FR 53767).
For detailed descriptions of the current policies related to
scoring achievement in facility-based measurement, we refer readers to
the CY 2018 Quality Payment Program final rule (82 FR 53763). Because
we propose in section III.H.3.i.(1)(d)(iv) of this rule to not require
or allow an opt-in process for facility-based measurement, we propose a
change to the determination of the quality and cost performance
category scores. We propose that the quality and cost performance
category percent scores would be established by determining the
percentile performance of the facility in the Hospital VBP Program for
the specified year, then awarding a score associated with that same
percentile performance in the MIPS quality and cost performance
categories for those MIPS eligible clinicians who are not eligible to
be scored under facility-based measurement for the MIPS payment year.
This proposed change allows for the determination of percentile
performance independent of those clinicians who would not have their
quality or cost scores determined until we made the determination of
their status under facility-based measurement.
(B) Scoring Improvement in Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we finalized
that we would not give a clinician or group participating in facility-
based measurement the opportunity to earn improvement points based on
prior performance in the MIPS quality and cost performance categories;
we noted that the Hospital VBP Program already takes improvement into
account in determining the score (82 FR 53764 through 53765). We
propose to add this

[[Page 35962]]

previously finalized policy to regulatory text at Sec.
414.1380(e)(6)(iv) and (v).
However, we did not address a policy for a clinician or group who
participates in facility-based measurement for one performance period,
and then does not participate in facility-based measurement in a
subsequent performance period (for example, a clinician who is scored
using facility-based measurement in the 2019 MIPS performance period
and is not eligible for facility-based measurement in the 2020 MIPS
performance period).
After further considering the issue, we do not believe it is
possible to assess improvement in the quality performance category for
those who are measured under facility-based measurement in 1 year and
then through another method in the following year. Our method of
assessing and rewarding improvement in the MIPS quality performance
category separates points awarded for measure performance from those
received for bonus points (82 FR 53745). Our method of determining the
quality performance category score using facility-based measurement
does not allow for the separation of achievement from bonus points. For
this reason, we propose at Sec. 414.1380(b)(1)(xi)(A)(4) to not assess
improvement for MIPS-eligible clinicians who are scored in MIPS through
facility-based measurement in 1 year but through another method in the
following year.
(vii) Expansion of Facility-Based Measurement To Use in Other Settings
We initiated the process of facility-based measurement focusing on
the inpatient hospital setting but noted that we wished to consider
opportunities to expand the concept into other facilities and programs
and future years (82 FR 53754). We are particularly interested in the
opportunity to expand facility-based measurement into post-acute care
(PAC) and the end-stage renal disease (ESRD) settings and seek comment
on how we may do so.
PAC is a significant sector in the spectrum of healthcare services,
providing services to over 6.9 million Medicare beneficiaries annually
through Long-Term Care Hospitals (LTCHs), Inpatient Rehabilitation
Facilities (IRFs), Skilled Nursing Facilities (SNFs), Home Health
Agencies (HHAs), and Hospice.\30\ Recent legislative efforts have
focused on improving patient outcomes for PAC through the use of
standardized patient assessment data to enable information sharing and
cross-setting quality assessment intended to improve outcomes in
specified clinical domains. For example, section 2(a) of the Improving
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act, Pub.
L. 113-185 enacted on October 6, 2014) added a new section 1899B to the
Act, which requires, among other things, that LTCHs, IRFs, SNFs, and
HHAs submit standardized patient assessment data on the quality
measures specified under section 1899B(c) of the Act. These cross-
setting quality measures, which must be calculated, at least in part,
using these standardized patient assessment data, allow for the
comparability of patient outcomes across PAC settings. Section 1899B(i)
of the Act requires the Secretary to promulgate regulations and
interpretive guidelines applicable to LTCHs, HHAs, SNFs and IRFs,
hospitals and critical access hospitals that require those providers to
take into account data on measures submitted by LTCHs, HHAs, SNFs and
IRFs in the discharge planning process.
---------------------------------------------------------------------------

\30\ MedPAC. Report to the Congress: Medicare Payment Policy.
2018, Report to the Congress: Medicare Payment Policy,
www.medpac.gov/docs/default-source/reports/mar18_medpac_entirereport_sec.pdf?sfvrsn=0.
---------------------------------------------------------------------------

In response to previous rulemakings, commenters have requested the
opportunity for clinicians who furnish care in PAC settings and bill
Medicare Part B to be measured similarly to hospital-based clinicians.
Commenters suggested that this would limit administrative burden on
clinicians by avoiding clinician reporting of measures which may be
similar or duplicative to those already reported for facility-based
programs such as QRPs for certain PAC settings (82 FR 53754).
In light of the importance of PAC services, PAC legislative
changes, and the interest of the stakeholder community, we wish to
explore the opportunity to further align quality and cost measurement
from the PAC QRPs with the clinicians who provide care in those
settings. We need to consider alternative ways in which we may use
measures from the PAC QRPs to measure clinicians in MIPS through
facility-based measurement.
Therefore, we are seeking comment on how we may attribute the
quality and cost of care for patients in PAC settings to clinicians.
For the facility-based measurement for MIPS program, clinicians receive
a score that is based on the VBP score of a particular hospital at
which the clinician or group provides services to patients. We
specifically solicit comment on whether a similar approach could work
for PAC given the number and variation of PAC settings and clinicians.
We are particularly interested to learn what level of influence MIPS-
eligible clinicians have in determining performance on quality measures
for individual settings and programs in the PAC setting.
In addition, we invite comments on which PAC QRP measures may be
best utilized to measure clinician performance. Under our current
approach for facility-based measurement (that is, the regulations
finalized previously and the proposals in this rule), all measures in
the Hospital VBP Program are used to determine the MIPS score. The
measures used in determining the VBP score reflect the breadth of
performance in the hospital program and as such would reflect the
quality of care provided by a clinician.
We also request comments on methods to identify the appropriate
measures for scoring, and what measures would be most influenced by
clinicians. Specifically, we solicit comment on whether all measures
that are reported as part of the PAC QRPs should be included or whether
we should identify a subset of measures. The 2020 LTCH QRP includes 19
measures, of which 3 are proposed to be removed as explained in the FY
2019 IPPS/LTCH proposed rule (83 FR 20512 through 20515). The 2020 IRF
QRP includes 18 measures, of which 1 is proposed for removal beginning
FY 2020 and 1 is proposed for removal beginning FY 2021, as explained
in the FY 2019 IRF proposed rule (83 FR 21001 through 21002). The
measures adopted for the 2020 SNF QRP can be found at 82 FR 36570
through 36594, and none are currently proposed for removal. The
measures adopted for the 2020 HH QRP can be found at 82 FR 51717
through 51730. The measures used in the FY 2019 Hospice program can be
found at 82 FR 36655 through 36656; no measures have been proposed for
removal for FY 2020 in the FY 2019 Hospice Wage Index proposed rule (83
FR 20956 through 20957).
Finally, considering the attribution challenges of using measures
reported by a facility to measure clinicians, we solicit comment on
whether we should limit facility-based measurement to specific PAC
settings and programs such as the IRF QRP or LTCH QRP, or whether we
should consider all PAC settings in the facility-based measurement
discussion.
In addition to our consideration of PAC settings, we also solicit
comment on opportunities to consider facility-based measurement for
patients with ESRD. Dialysis facilities treat patients with ESRD and
acute kidney injury. The ESRD Quality Incentive Program (QIP) was the
first VBP program that tied Medicare payment to a facility's
performance on quality measures, and

[[Page 35963]]

payment reductions under that program began with renal dialysis
services furnished on or after January 1, 2012. Like the Hospital VBP
program and MIPS, this program determines scores and rewards
performance based on a set of measures. However, this program only
allows ESRD facilities that meet a certain threshold to avoid a
negative payment adjustment and does not allow for a positive payment
adjustment. We generally believe the scoring methodology associated
with the ESRD QIP could be integrated into our current approach but
recognize that the structure is different from the Hospital VBP
Program. The Payment Year 2020 ESRD QIP measures along with a
description of our scoring methodology for that payment year can be
reviewed at 81 FR 77896 through 77931 and 82 FR 50760 through 50767.
Additionally, we believe MIPS eligible clinicians' roles in
dialysis centers differ from their roles in hospitals. However, we
believe that these clinicians have a significant impact on the quality
of care for patients, even if they cannot control all aspects of their
care. We seek comment on the extent to which the quality measures of
dialysis centers reflect clinician performance. Additionally, we seek
comments on whether we might be able to attribute the performance of a
specific facility to an individual clinician. We reviewed the
attribution methodology utilized for the Comprehensive ESRD Care (CEC)
Model. CMS currently uses the ``first touch'' approach--where the
beneficiary's first visit to a CEC Model participating dialysis center
will prospectively match the beneficiary to the dialysis facility.
While this approach ties a patient to an ESRD facility, it does not tie
a clinician to an ESRD facility. We also seek comment on whether
another approach, similar to our consideration of the PAC measures,
might be more appropriate in this setting.
(e) Scoring the Improvement Activities Performance Category
For our previously established policies regarding scoring the
improvement activities performance category, we refer readers to Sec.
414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82
FR 53767 through 53769). We also refer readers to Sec. 414.1355 and
the CY 2018 Quality Payment Program final rule (82 FR 53648 through
53662) and CY 2017 Quality Payment Program final rule (81 FR 77177
through 77199) for previously established policies regarding the
improvement activities performance category generally.
(i) Regulatory Text Updates
In this proposed rule, we are proposing updates to both Sec. Sec.
414.1380(b)(3) and 414.1355 to more clearly and concisely capture
previously established policies. We are also proposing one substantive
change with respect to Patient Centered Medical Homes and comparable
specialty practices. These are discussed in more detail below.
(A) Improvement Activities Performance Category Score and Total
Required Points
In an effort to more clearly and concisely capture previously
established policies, we are proposing updates to Sec. 414.1380(b)(3)
and refer readers to section VIII for more details.
We also are clarifying here that the improvement activities
performance category score cannot exceed 100 percent.
(B) Weighting of Improvement Activities
In an effort to more clearly and concisely capture previously
established policies, we are proposing updates to Sec. 414.1380(b)(3)
and refer readers to section VIII for more details.
(C) APM Improvement Activities Performance Category Score
In an effort to more clearly and concisely capture previously
established policies, we are proposing updates to Sec.
414.1380(b)(3)(i) and refer readers to section VIII for more details.
(D) Patient-Centered Medical Homes and Comparable Specialty Practices
In this proposed rule, we are proposing to modify our regulations
at Sec. 414.1380(b)(3)(ii) to more clearly and concisely capture our
previously established policies for patient-centered medical homes and
comparable specialty practices and refer readers to section VIII for
more details.
In addition, it has come to our attention that in the preamble of
the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179),
the terminology ``automatic'' was used in reference to patient-centered
medical home or comparable specialty practice improvement activities
scoring credit. In that rule, in response to one comment, we stated,
``. . . any MIPS eligible clinician or group that does not qualify by
October 1st of the performance year as a certified patient-centered
medical home or comparable specialty practice cannot receive automatic
credit as such for the improvement activities performance category.''
(81 FR 77186). In response to another comment in that rule, we stated,
``Other certifications that are not for patient-centered medical homes
or comparable specialty practices would also not qualify automatically
for the highest score.'' (81 FR 77179).
While we used the term ``automatic'' then, we have since come to
believe it is inaccurate because an eligible clinician or group must
attest to their status as a patient-centered medical home or comparable
specialty practice in order to receive full credit for the improvement
activities performance category. In the CY 2018 Quality Performance
Payment final rule (82 FR 53649) in response to comments we received
regarding patient-centered medical homes or comparable specialty
practices receiving full credit for the improvement activities
performance category for MIPS; we stated that we would like to make
clear that credit is not automatically granted; MIPS eligible
clinicians and groups must attest in order to receive the credit.
Therefore, in this proposed rule, we are codifying at Sec.
414.1380(b)(3)(ii) to require that an eligible clinician or group must
attest to their status as a patient-centered medical home or comparable
specialty practice in order to receive this credit. Specifically, MIPS
eligible clinicians who wish to claim this status for purposes of
receiving full credit in the improvement activities performance
category must attest to their status as a patient-centered medical home
or comparable specialty practice for a continuous 90-day minimum during
the performance period.
(E) Improvement Activities Performance Category Weighting for Final
Scoring
In this proposed rule, in an effort to more clearly and concisely
capture previously established policies, we are proposing to make
technical changes to Sec. 414.1355(b) to state that unless a different
scoring weight is assigned by CMS under section 1848(q)(5)(F) of the
Act, performance in the improvement activities performance category
comprises 15 percent of a MIPS eligible clinician's final score for the
2019 MIPS payment year and for each MIPS payment year thereafter. We
believe these changes would better align the regulation text with the
text of the statute.
(ii) CEHRT Bonus
In the CY 2017 Quality Payment Program final rule (81 FR 77202
through 77209) and the CY 2018 Quality Payment Program final rule (82
FR 53664 through 53670), we established

[[Page 35964]]

that certain activities in the improvement activities performance
category will qualify for a bonus under the Promoting Interoperability
performance category if they are completed using CEHRT. This bonus is
applied under the Promoting Interoperability performance category and
not under the improvement activities performance category. In section
III.H.3.h.(5) of this proposed rule, we are proposing a new approach
for scoring the Promoting Interoperability performance category that is
aligned with our MIPS program goals of flexibility and simplicity. We
refer readers to section III.H.3.h.(5)(g) of this proposed rule for
more details on this proposal.
We invite public comment on these proposals.
(f) Scoring the Promoting Interoperability Performance Category
We refer readers to section III.H.3.h.(5) of this proposed rule,
where we discuss our proposals for scoring the Promoting
Interoperability performance category.
(2) Calculating the Final Score
For a description of the statutory basis and our policies for
calculating the final score for MIPS eligible clinicians, we refer
readers to Sec. 414.1380(c), the discussion in the CY 2017 Quality
Payment Program final rule (81 FR 77319 through 77329), and the
discussion in the CY 2018 Quality Payment Program final rule (82 FR
53769 through 53785). In this proposed rule, we propose to continue the
complex patient bonus for the 2021 MIPS payment year, propose a
modification to the final score calculation for the 2021 MIPS payment
year, and propose refinements to reweighting policies.
(a) Accounting for Risk Factors
Section 1848(q)(1)(G) of the Act requires us to consider risk
factors in our scoring methodology. Specifically, it provides that the
Secretary, on an ongoing basis, shall, as the Secretary determines
appropriate and based on individuals' health status and other risk
factors, assess appropriate adjustments to quality measures, cost
measures, and other measures used under MIPS and assess and implement
appropriate adjustments to payment adjustments, final scores, scores
for performance categories, or scores for measures or activities under
MIPS. In doing so, the Secretary is required to take into account the
relevant studies conducted under section 2(d) of the Improving Medicare
Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as
appropriate, other information, including information collected before
completion of such studies and recommendations.
In this section, we summarize our efforts related to social risk
and the relevant studies conducted under section 2(d) of the IMPACT
Act. We also propose to adjust the final score by continuing a bonus to
address patient complexity for the 2021 MIPS payment year.
(i) Considerations for Social Risk
In the CY 2018 Quality Payment Program final rule (82 FR 53770), we
discussed the importance of improving beneficiary outcomes including
reducing health disparities. We also discussed our commitment to
ensuring that medically complex patients, as well as those with social
risk factors, receive excellent care. We discussed how studies show
that social risk factors, such as being near or below the poverty level
as determined by HHS, belonging to a racial or ethnic minority group,
or living with a disability, can be associated with poor health
outcomes, and how some of this disparity is related to the quality of
health care.\31\ Among our core objectives, we aim to improve health
outcomes, attain health equity for all beneficiaries, and ensure that
complex patients as well as those with social risk factors receive
excellent care. Within this context, reports by the Office of the
Assistant Secretary for Planning and Evaluation (ASPE) and the National
Academy of Medicine have examined the influence of social risk factors
in our value-based purchasing programs.\32\ As we noted in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38428 through 38429), ASPE's Report to
Congress, found that, in the context of value-based purchasing
programs, dual eligibility was the most powerful predictor of poor
health care outcomes among those social risk factors that they examined
and tested. In addition, as noted in the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38428), the National Quality Forum (NQF) undertook a 2-year
trial period in which certain new measures and measures undergoing
maintenance review have been assessed to determine if risk adjustment
for social risk factors is appropriate for these measures.\33\ The
trial period ended in April 2017 and a final report is available at
http://www.qualityforum.org/SES_Trial_Period.aspx. The trial concluded
that ``measures with a conceptual basis for adjustment generally did
not demonstrate an empirical relationship'' between social risk factors
and the outcomes measured. This discrepancy may be explained in part by
the methods used for adjustment and the limited availability of robust
data on social risk factors. NQF has extended the socioeconomic status
(SES) trial,\34\ allowing further examination of social risk factors in
outcome measures.
---------------------------------------------------------------------------

\31\ See, for example, United States Department of Health and
Human Services. ``Healthy People 2020: Disparities. 2014,'' http://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities or National Academies of Sciences, Engineering, and
Medicine. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: National Academies
of Sciences, Engineering, and Medicine 2016.
\32\ Department of Health and Human Services Office of the
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Purchasing Programs.'' December 2016. Available at
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
\33\ Available at http://www.qualityforum.org/SES_Trial_Period.aspx.
\34\ Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
---------------------------------------------------------------------------

In the CY 2018 Quality Payment Program proposed rule, we solicited
feedback on which social risk factors provide the most valuable
information to stakeholders and the methodology for illuminating
differences in outcomes rates among patient groups seen by a MIPS
eligible clinician that would also allow for a comparison of those
differences, or disparities, across MIPS eligible clinicians (82 FR
30134). We received feedback encouraging CMS to explore whether
additional factors should be used to stratify or risk adjust the
individual quality and cost measures and to consider any additional
factors that might be appropriate. We intend to explore options for
adjustment of individual quality measures used in MIPS in future years.
We also intend to explore additional approaches to account for patient
risk factors through adjustments to the performance category scores or
the final score. However, as described in section III.H.3.i.(2)(a)(ii),
we believe it is appropriate to maintain the complex patient bonus for
the 2021 MIPS payment year.
We plan to continue working with ASPE, the public, and other key
stakeholders on this important issue to identify policy solutions that
achieve the goals of attaining health equity for all beneficiaries and
minimizing unintended consequences.
(ii) Complex Patient Bonus for the 2021 MIPS Payment Year
In the CY 2018 Quality Payment Program final rule, under the
authority in section 1848(q)(1)(G) of the Act, we

[[Page 35965]]

finalized at Sec. 414.1380(c)(3) a complex patient bonus of up to 5
points to be added to the final score for the 2020 MIPS payment year
(82 FR 53771 through 53776). We intended for this bonus to serve as a
short-term strategy to address the impact patient complexity may have
on MIPS scoring while we continue to work with stakeholders on methods
to account for patient risk factors. Our overall goal for the complex
patient bonus was two-fold: (1) To protect access to care for complex
patients and provide them with excellent care; and (2) to avoid placing
MIPS eligible clinicians who care for complex patients at a potential
disadvantage while we review the completed studies and research to
address the underlying issues. We noted that we would assess on an
annual basis whether to continue the bonus and how the bonus should be
structured (82 FR 53771). For a detailed description of the complex
patient bonus finalized for the 2020 MIPS payment year, please refer to
the CY 2018 Quality Payment Program final rule (82 FR 53771 through
53776).
For the 2019 MIPS performance period/2021 MIPS payment year, we
propose to continue the complex patient bonus as finalized for the 2018
MIPS performance period/2020 MIPS payment year and to revise Sec.
414.1380(c)(3) to reflect this policy. Although we intend to maintain
the complex patient bonus as a short-term solution, we do not believe
we have sufficient information available at this time to develop a
long-term solution to account for patient risk factors in MIPS such
that we would be able to include a different approach in this proposed
rule. An updated ASPE report is expected in October 2019 which will
build on the analyses included in the initial reports and may provide
additional input for a long-term solution to addressing risk factors in
MIPS. At this time, we do not believe additional data sources are
available that would be feasible to use as the basis for a different
approach to account for patient risk factors in MIPS. We intend to
analyze data when feasible from the 2017 MIPS performance period which
will be available following the data submission deadline on March 31,
2018 to identify differences in performance that are consistent across
performance categories and may, in the future, shift the complex
patient bonus to specific performance categories. However, in the
absence of data analysis from the first year of MIPS, we do not believe
that this change is appropriate at this time. Therefore, while we work
with stakeholders to identify a long-term approach to account for
patient risk factors in MIPS, we believe it would be appropriate to
continue the complex patient bonus for another year to support MIPS
eligible clinicians who treat patients with risk factors, as well as to
maintain consistency with the 2020 MIPS payment year and minimize
confusion. We have received significant feedback from MIPS eligible
clinicians that consistency in the MIPS program over time is valued
when possible in order to minimize confusion and to help MIPS eligible
clinicians predict how they will be scored under MIPS. Therefore, we
believe it is appropriate to maintain consistent policies for the
complex patient bonus in the 2021 MIPS payment year until we have
sufficient evidence and new data sources that support an updated
approach to account for patient risk factors.
Although we are not proposing changes to the complex patient bonus
for the 2021 MIPS payment year, the dates used in the calculation of
the complex patient bonus may change as a result of other proposals we
are making in this proposed rule. For the 2020 MIPS payment year, we
finalized that we would use the second 12-month segment of the
eligibility determination period to calculate average HCC risk scores
and the proportion of full benefit or partial benefit dual eligible
beneficiaries for MIPS eligible clinicians (82 FR 53771 through 53772).
As discussed in section III.H.3.a. of this proposed rule, we are
proposing to change the dates of the eligibility determination period
(now referred to as the MIPS determination period) beginning with the
2021 MIPS payment year. Specifically, the second 12-month segment would
begin on October 1 of the calendar year preceding the applicable
performance period and end on September 30 of the calendar year in
which the applicable performance period occurs. If this proposed change
to the MIPS determination period is finalized, then beginning with the
2021 MIPS payment year, the second 12-month segment of the MIPS
determination period (beginning on October 1 of the calendar year
preceding the applicable performance period and ending on September 30
of the calendar year in which the applicable performance period occurs)
would be used when calculating average HCC risk scores and proportion
of full benefit or partial benefit dual eligible beneficiaries for MIPS
eligible clinicians.
(b) Final Score Performance Category Weights
(i) General Weights
Section 1848(q)(5)(E)(i) of the Act specifies weights for the
performance categories included in the MIPS final score: In general, 30
percent for the quality performance category; 30 percent for the cost
performance category; 25 percent for the Promoting Interoperability
performance category (formerly the advancing care information
performance category); and 15 percent for the improvement activities
performance category. For more of the statutory background and
descriptions of our current policies, we refer readers to the CY 2017
and CY 2018 Quality Payment Program final rules (81 FR 77320 and 82 FR
53779, respectively). Under the proposals we are making in sections
III.H.3.h.(3)(a) and III.H.3.h.(2)(a) of this proposed rule, for the
2021 MIPS payment year, the cost performance category would make up 15
percent and the quality performance category would make up 45 percent
of a MIPS eligible clinician's final score. Table 50 summarizes the
weights specified for each performance category.

Table 50--Finalized and Proposed Weights by MIPS Performance Category and MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
Transition 2020 MIPS
year payment year 2021 MIPS
Performance category (previously (previously payment year
finalized) finalized) (proposed)
(percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
Quality......................................................... 60 50 45
Cost............................................................ 0 10 15
Improvement Activities.......................................... 15 15 15
Promoting Interoperability...................................... 25 25 25
----------------------------------------------------------------------------------------------------------------

[[Page 35966]]

(ii) Flexibility for Weighting Performance Categories
Under section 1848(q)(5)(F) of the Act, if there are not sufficient
measures and activities applicable and available to each type of MIPS
eligible clinician involved, the Secretary shall assign different
scoring weights (including a weight of zero) for each performance
category based on the extent to which the category is applicable to the
type of MIPS eligible clinician involved and for each measure and
activity with respect to each performance category based on the extent
to which the measure or activity is applicable and available to the
type of MIPS eligible clinician involved. Under section
1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician
who fails to report on an applicable measure or activity that is
required to be reported by the clinician, the clinician must be treated
as achieving the lowest potential score applicable to such measure or
activity. In this scenario of failing to report, the MIPS eligible
clinician would receive a score of zero for the measure or activity,
which would contribute to the final score for that MIPS eligible
clinician. Assigning a scoring weight of zero percent and
redistributing the weight to the other performance categories differs
from the scenario of a MIPS eligible clinician failing to report on an
applicable measure or activity that is required to be reported.
(A) Scenarios Where the Quality, Cost, Improvement Activities, and
Promoting Interoperability Performance Categories Would Be Reweighted
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we
explained our interpretation of what it means for there to be
sufficient measures applicable and available for the quality and cost
performance categories, and we finalized policies for the 2019 and 2020
MIPS payment years under which we would assign a scoring weight of zero
percent to the quality or cost performance category and redistribute
its weight to the other performance categories in the event there are
not sufficient measures applicable and available, as authorized by
section 1848(q)(5)(F) of the Act. For the quality performance category,
we stated that having sufficient measures applicable and available
means that we can calculate a quality performance category percent
score for the MIPS eligible clinician because at least one quality
measure is applicable and available to the clinician (82 FR 53780). For
the cost performance category, we stated that having sufficient
measures applicable and available means that we can reliably calculate
a score for the cost measures that adequately captures and reflects the
performance of a MIPS eligible clinician (82 FR 53780). We established
that if a MIPS eligible clinician is not attributed enough cases for a
measure (in other words, has not met the required case minimum for the
measure), or if a measure does not have a benchmark, then the measure
will not be scored for that clinician (81 FR 77323). We stated that if
we do not score any cost measures for a MIPS eligible clinician in
accordance with this policy, then the clinician would not receive a
cost performance category percent score (82 FR 53780).
We are proposing to codify these policies for the quality and cost
performance categories at Sec. 414.1380(c)(2)(i)(A)(1) and (2),
respectively, and to continue them for the 2021 MIPS payment year and
each subsequent MIPS payment year.
For the Promoting Interoperability performance category, in the CY
2017 Quality Payment Program final rule (81 FR 77238 through 77245) and
the CY 2018 Quality Payment Program final rule (82 FR 53680 through
53687), we established policies for assigning a scoring weight of zero
percent to the Promoting Interoperability performance category and
redistributing its weight to the other performance categories in the
final score. We are proposing to codify those policies under Sec.
414.1380(c)(2)(i) and (iii).
For the improvement activities performance category, we continue to
believe that all MIPS eligible clinicians will have sufficient
activities applicable and available, except for limited extreme and
uncontrollable circumstances, such as natural disasters, where a
clinician is unable to report improvement activities, and circumstances
where a MIPS eligible clinician joins a practice in the final 3 months
of the performance period as discussed in section
III.H.3.i.(2)(b)(ii)(C) of this proposed rule. Barring these
circumstances, we believe that all MIPS eligible clinicians will have
sufficient improvement activities applicable and available (82 FR
53780).
(B) Reweighting the Quality, Cost, and Improvement Activities
Performance Categories for Extreme and Uncontrollable Circumstances
For a summary of the final policy we adopted beginning with the
2018 MIPS performance period/2020 MIPS payment year to reweight the
quality, cost, and improvement activities performance categories based
on a request submitted by a MIPS eligible clinician, group, or virtual
group that was subject to extreme and uncontrollable circumstances, we
refer readers to the CY 2018 Quality Payment Program final rule (82 FR
53780 through 53783). We are proposing to codify this policy at Sec.
414.1380(c)(2)(i)(A)(5).
We sought comment in the CY 2018 Quality Payment Program final rule
on two topics related to our extreme and uncontrollable policies (82 FR
53782 through 52783). First, in response to a public comment on the CY
2018 Quality Payment Program proposed rule in which the commenter
requested that we include improvement scoring for those who are
affected by extreme and uncontrollable circumstances, we sought comment
on ways we could modify our improvement scoring policies to account for
clinicians who have been affected by extreme and uncontrollable
circumstances. In response, we received one comment expressing support
for an improvement score without providing any additional details. At
this time, we are not proposing modifications to our improvement
scoring; therefore, MIPS eligible clinicians who receive a zero percent
weighting for the quality or cost performance categories due to extreme
and uncontrollable circumstances would not be eligible for improvement
scoring because data sufficient to measure improvement would not be
available from the performance period in which the quality or cost
performance categories are weighted at zero percent.
We also sought comment on alternatives to the finalized policies,
such as using a shortened performance period, which may allow us to
measure performance, rather than reweighting the performance categories
to zero percent. Many commenters generally supported the extreme and
uncontrollable circumstances policy as finalized. One commenter
requested that we reconsider our policy to not include issues third
party intermediaries might have submitting information to CMS on behalf
of a MIPS eligible clinician. We considered updating our policy to
include third party intermediaries; however, we continue to believe
that inclusion of third party intermediaries is not necessary because
MIPS eligible clinicians may identify multiple ways to submit data and
participate in MIPS. We seek comments on the specific circumstances
under which the extreme and uncontrollable circumstances policy should
be made applicable to third party intermediary issues. One

[[Page 35967]]

commenter recommended that CMS require MIPS eligible clinicians to
submit data before an extreme and uncontrollable event and within a
reasonable timeframe after the event to incentivize quality improvement
while allowing for flexibility. Although we considered this alternative
approach, in order to provide maximum flexibility, we continue to
believe that MIPS eligible clinicians who demonstrate (through a
reweighting application) that an extreme and uncontrollable event
impacted their ability to report for a given performance category
should have reweighting for that performance category for the
performance period. However, we may consider modifying our policies in
future years which we would propose through future rulemaking.
We are proposing a few minor modifications to our extreme and
uncontrollable circumstances policy. First, beginning with the 2019
MIPS performance period/2021 MIPS payment year, we are proposing at
Sec. 414.1380(c)(2)(i)(A)(5) that, if a MIPS eligible clinician
submits an application for reweighting based on extreme and
uncontrollable circumstances, but also submits data on the measures or
activities specified for the quality or improvement activities
performance categories in accordance with Sec. 414.1325, he or she
would be scored on the submitted data like all other MIPS eligible
clinicians, and the categories would not be reweighted. We are
proposing this modification to align with a similar policy for the
Promoting Interoperability performance category (82 FR 53680 through
53682). If a MIPS eligible clinician reports on measures or activities
specified for the quality or improvement activities performance
categories, then we assume the clinician believes there are sufficient
measures or activities applicable and available to the clinician.
For most quality measures and improvement activities, the data
submission occurs after the end of the MIPS performance period, so
clinicians would know about the extreme and uncontrollable circumstance
prior to submission. However, for the quality performance category,
measures submitted via the Part B claims submission type are submitted
by adding quality data codes to a claim. As a result, it is possible
that a MIPS eligible clinician could have submitted some Part B claims
data prior to the submission of a reweighting application for extreme
and uncontrollable events. Under our proposal, we would score the
quality performance category because we have received data. However, we
previously finalized at Sec. 414.1380(c) that if a MIPS eligible
clinician is scored on fewer than two performance categories, he or she
will receive a final score equal to the performance threshold (81 FR
77320 through 77321 and 82 FR 53778 through 53779). If a clinician
experiences an extreme and uncontrollable event that affects all of the
performance categories, then under our proposal the clinician would
only be scored on the quality performance category if they submit data
for only that category. The clinician would also have to submit data
for the improvement activities or the Promoting Interoperability
performance categories in order to be scored on two or more performance
categories and receive a final score different than the performance
threshold.
This proposal does not include administrative claims data that we
receive through the claims submission process and use to calculate the
cost measures and certain quality measures. As we propose to codify
under Sec. 414.1325(a)(2)(i), there are no data submission
requirements for the cost performance category and for certain quality
measures used to assess performance in the quality performance
category. We calculate performance on these measures using
administrative claims data, and clinicians are not required to submit
any additional data for these measures. Therefore, we do not believe
that it would be appropriate to void a reweighting application based on
administrative claims data we receive for measures that do not require
data submission for purposes of MIPS.
We also propose to apply the policy we finalized for virtual groups
in the CY 2018 Quality Payment Program final rule (82 FR 53782 through
53783) to groups submitting reweighting applications for the quality,
cost, or improvement activities performance categories based on extreme
and uncontrollable circumstances. For groups, we would evaluate whether
sufficient measures and activities are applicable and available to MIPS
eligible clinicians in the group on a case-by-case basis and determine
whether to reweight a performance category based on the information
provided for the individual clinicians and practice location(s)
affected by extreme and uncontrollable circumstances and the nature of
those circumstances. While we did not specifically propose to apply
this policy to groups in the CY 2018 Quality Payment Program proposed
rule, our intention was to apply the same policy for groups and virtual
groups, and thus if we adopt this proposal, we would apply the policy
to groups beginning with the 2018 performance period/2020 MIPS payment
year.
(C) Reweighting the Quality, Cost, Improvement Activities, and
Promoting Interoperability Performance Categories for MIPS Eligible
Clinicians Who Join a Practice in the Final 3 Months of the Performance
Period Year
Beginning with the 2019 MIPS performance period, we are proposing
that a MIPS eligible clinician who joins an existing practice (existing
TIN) during the final 3 months of the calendar year in which the MIPS
performance period occurs (the performance period year) that is not
participating in MIPS as a group would not have sufficient measures
applicable and available. We are also proposing that a MIPS eligible
clinician who joins a practice that is newly formed (new TIN) during
the final 3 months of the performance period year would not have
sufficient measures applicable and available, regardless of whether the
clinicians in the practice report for purposes of MIPS as individuals
or as a group. In each of these scenarios, we are proposing to reweight
all four of the performance categories to zero percent for the MIPS
eligible clinician and, because he or she would be scored on fewer than
two performance categories, the MIPS eligible clinician would receive a
final score equal to the performance threshold and a neutral MIPS
payment adjustment under the policy at Sec. 414.1380(c). We propose to
codify these policies at Sec. 414.1380(c)(2)(i)(A)(3).
We are proposing this policy because we are not currently able to
identify these MIPS eligible clinicians (or groups if the group is
formed in the final 3 months of the performance period year) at the
start of the MIPS submission period. When we designed our systems, we
incorporated user feedback that requested eligibility information be
connected to the submission process. In order to submit data, an
individual TIN/NPI or the group TIN must be in the files generated from
the MIPS eligibility determination periods. As discussed in section
III.H.3.a., we have two 12-month determination periods for eligibility.
We are proposing that the second 12-month segment of the MIPS
eligibility determination period would end on September 30 of the
calendar year in which the applicable MIPS performance period occurs;
therefore, we would have no eligibility information about clinicians
who join a practice after September 30 of the performance period year.
MIPS eligible clinicians who join an existing practice (existing TIN)
in the

[[Page 35968]]

final 3 months of the performance period year that is not participating
in MIPS as a group would not be identified by our systems, and we would
not have the ability to inform them that they are eligible or to
receive MIPS data from them. Similarly, practices that form (new TIN)
in the final 3 months of the performance period year would not be in
the MIPS determination files. Accordingly, the measures and activities
would not be available because any data from these MIPS eligible
clinicians would not be accessible to us.
If a MIPS eligible clinician joins a practice (existing TIN) in the
final 3 months of the performance period year, and the practice is not
newly formed and is reporting as a group for the performance period,
the MIPS eligible clinician would be able to report as part of that
group. In this case, we are able to accept data for the group because
the TIN would be in our MIPS eligibility determination files.
Therefore, we believe the measures and activities would be available in
this scenario, and reweighting would not be necessary for the MIPS
eligible clinician. We note that, if a MIPS eligible clinician's TIN/
NPI combination was not part of the group practice during the MIPS
determination period, the TIN/NPI combination would not be identified
in our system at the start of the MIPS data submission period; however,
if the MIPS eligible clinician qualifies to receive the group final
score under our proposal, we would apply the group final score to the
MIPS eligible clinician's TIN/NPI combination as soon as the
information becomes available. Please see section III.H.3.j.(1) of this
proposed rule for more information about assigning group scores to MIPS
eligible clinicians.
(D) Proposed Automatic Extreme and Uncontrollable Circumstances Policy
Beginning With the 2020 MIPS Payment Year
In conjunction with the CY 2018 Quality Payment Program final rule,
and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued
an interim final rule with comment period (IFC) in which we adopted on
an interim final basis a policy for automatically reweighting the
quality, improvement activities, and advancing care information (now
referred to as Promoting Interoperability) performance categories for
the transition year of MIPS (the 2017 performance period/2019 MIPS
payment year) for MIPS eligible clinicians who are affected by extreme
and uncontrollable circumstances affecting entire regions or locales
(82 FR 53895 through 53900). We propose to codify this policy for the
quality and improvement activities performance categories at Sec.
414.1380(c)(2)(i)(A)(6) and for the advancing care information (now
Promoting Interoperability) performance category at Sec.
414.1380(c)(2)(i)(C)(3).
We believe that a similar automatic extreme and uncontrollable
circumstances policy would be appropriate for any year of the MIPS
program to account for natural disasters and other extreme and
uncontrollable circumstances that impact an entire region or locale. As
we discussed in the interim final rule (82 FR 53897), we believe such a
policy would reduce burden on clinicians who have been affected by
widespread catastrophes and would align with existing policies for
other Medicare programs. We propose at Sec. 414.1380(c)(2)(i)(A)(7)
and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable
circumstances policy we adopted for the transition year to subsequent
years of the MIPS program, beginning with the 2018 MIPS performance
period and the 2020 MIPS payment year, with a few additions to address
the cost performance category. For a description of the policy we
adopted for the MIPS transition year, we refer readers to the
discussion in the interim final rule (82 FR 53895 through 53900).
In the interim final rule (82 FR 53897), we stated that we were not
including the cost performance category in the automatic extreme and
uncontrollable circumstances policy for the transition year because the
cost performance category is weighted at zero percent in the final
score for the 2017 MIPS performance period/2019 MIPS payment year. We
finalized a 10 percent weight for the cost performance category for the
2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and
are proposing a 15 percent weight for the 2019 performance period/2021
MIPS payment year (see section III.H.3.h.(3)(a) of this proposed rule).
For the reasons discussed in the CY 2018 Quality Payment Program final
rule (82 FR 53781), we believe a MIPS eligible clinician's performance
on measures calculated based on administrative claims data, such as the
measures specified for the cost performance category, could be
adversely affected by a natural disaster or other extreme and
uncontrollable circumstance, and that the cost measures may not be
applicable to that MIPS eligible clinician. Therefore, we are proposing
to include the cost performance category in the automatic extreme and
uncontrollable circumstances policy beginning with the 2018 MIPS
performance period/2020 MIPS payment year. Under our policy for the
transition year, if a MIPS eligible clinician in an affected area
submits data for any of the MIPS performance categories by the
applicable submission deadline for the 2017 MIPS performance period, he
or she will be scored on each performance category for which he or she
submits data, and the performance category will not be reweighted to
zero percent in the final score (82 FR 53898). Our policy for the
transition year did not include measures that are calculated based on
administrative claims data (82 FR 53898). As discussed in the preceding
section III.H.3.h.(3)(b), under Sec. 414.1325(e), there are no data
submission requirements for the cost performance category, and we will
calculate performance on the measures specified for the cost
performance category using administrative claims data. We are proposing
for the cost performance category, if a MIPS eligible clinician is
located in an affected area, we would assume the clinician does not
have sufficient cost measures applicable to him or her and assign a
weight of zero percent to that category in the final score, even if we
receive administrative claims data that would enable us to calculate
the cost measures for that clinician.
In the interim final rule (82 FR 53897), we did not include an
automatic extreme and uncontrollable circumstances policy for groups or
virtual groups, and we continue to believe such a policy is not
necessary. Unless we receive data from a TIN indicating that the TIN
would like to be scored as a group for MIPS, performance by default is
assessed at the individual MIPS eligible clinician level. Similarly,
performance is not assessed at the virtual group level unless the
member TINs submit an application in accordance with Sec. 414.1315. If
we receive data from a group or virtual group, we would score that
data, even if individual MIPS eligible clinicians within the group or
virtual group are impacted by an event that would be included in our
automatic extreme and uncontrollable circumstances policy. Regardless
of whether we receive data from a group or virtual group, we would have
no mechanism to determine whether the group or virtual group did not
submit data, or submitted data and performed poorly, because it had
been affected by an extreme and uncontrollable event unless the group
notifies us of its circumstances. Instead of establishing a threshold
for groups or virtual groups to receive automatic reweighting based on
the number of

[[Page 35969]]

clinicians in the group or virtual group impacted by extreme and
uncontrollable events, we believe it is preferable that these groups
and virtual groups submit an application for reweighting based on
extreme and uncontrollable circumstances under our existing policy (82
FR 53780 through 53783) where they may be eligible for reweighting if
they establish that the group or virtual group was sufficiently
impacted by the extreme and uncontrollable event. For example, if less
than 100 percent of the clinicians in the group or virtual group were
impacted, but the practice location that was responsible for data
submission was among those impacted and thus impeded successful
reporting for all clinicians in the group or virtual group, we believe
reweighting may be appropriate.
(iii) Redistributing Performance Category Weights
In the CY 2017 and CY 2018 Quality Payment Program final rules, we
established policies for redistributing the weights of performance
categories for the 2019 and 2020 MIPS payment years in the event that a
scoring weight different from the generally applicable weight is
assigned to a category or categories (81 FR 77325 through 77329; 82 FR
53783 through 53785, 53895 through 53900). We are proposing to codify
these policies under Sec. 414.1380(c)(2)(ii).
For the 2021 MIPS payment year, we propose at Sec.
414.1380(c)(2)(ii)(B) to apply similar reweighting policies as
finalized for the 2020 MIPS payment year (82 FR 53783 through 53785).
In general, we would redistribute the weight of a performance category
or categories to the quality performance category. We continue to
believe redistributing weight to the quality performance category is
appropriate because of the experience MIPS eligible clinicians have had
reporting on quality measures under other CMS programs. We propose to
continue to redistribute the weight of the quality performance category
to the improvement activities and Promoting Interoperability
performance categories. However, for the 2021 MIPS payment year, with
our proposal to weight cost at 15 percent, we propose to reweight the
Promoting Interoperability performance category to 45 percent and the
improvement activities performance category to 40 percent when the
quality performance category is weighted at zero percent. We chose to
weight Promoting Interoperability higher in order to align with goals
of interoperability and for simplicity because we generally have
avoided assigning partial percentage points to performance category
weights. Reweighting scenarios under this proposal are presented in
Table 51.

Table 51--Performance Category Redistribution Policies Proposed for the 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
Improvement Promoting
Reweighting scenario Quality Cost activities Interoperability
(percent) (percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 45 15 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 60 0 15 25
--No Promoting Interoperability........... 70 15 15 0
--No Quality.............................. 0 15 40 45
--No Improvement Activities............... 60 15 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 15 85 0
Quality..................................
--No Promoting Interoperability and no 85 15 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 15 0 85
----------------------------------------------------------------------------------------------------------------

We have heard from stakeholders in previous years that our
reweighting policies place undue weight on the quality performance
category, and, although we continue to believe the policies are
appropriate, we seek comment on alternative redistribution policies in
which we would also redistribute weight to the improvement activities
performance category (see Table 52). Under the alternative
redistribution policy we considered, we would redistribute the weight
of the Promoting Interoperability performance category to the quality
and improvement activities performance categories. We would
redistribute 15 percent of the Promoting Interoperability performance
category weight to the quality performance category, and 10 percent to
the improvement activities performance category. We believe
redistributing more of the weight of the Promoting Interoperability
performance category to the quality performance category is appropriate
because MIPS eligible clinicians have had more experience reporting on
quality measures under other CMS programs than reporting on improvement
activities. We would redistribute the cost performance category weight
equally to the quality and improvement activities performance
categories (5 percent to each) under this alternative policy.

[[Page 35970]]

Table 52--Alternative Performance Category Redistribution Policies Considered for the 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
Alternative redistribution policy: Reweight promoting
interoperability and cost to quality and improvement activities
Reweighting scenario -----------------------------------------------------------------
Improvement Promoting
Quality Cost activities interoperability
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 45 15 15 25
categories...............................
Reweight One Performance Category:
--No Promoting Interoperability........... 60 15 25 0
--No Cost................................. 55 0 20 25
--No Quality.............................. 0 15 40 45
--No Improvement Activities............... 60 15 0 25
Reweight Two Performance Categories:
--No Cost and No Promoting 70 0 30 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 15 85 0
Quality..................................
--No Promoting Interoperability and no 85 15 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 15 0 85
----------------------------------------------------------------------------------------------------------------

Because the cost performance category was zero percent of a MIPS
eligible clinician's final score for the 2017 MIPS performance period,
we did not believe it is appropriate to redistribute weight to the cost
performance category for the 2019 MIPS performance period because MIPS
eligible clinicians have limited experience being scored on cost
measures for purposes of MIPS. In addition, we are concerned that there
would be limited measures in the cost performance category under our
proposal for the 2019 MIPS performance period discussed in section
III.H.3.h.(3)(b) of this proposed rule, and believe it may be
appropriate to delay shifting additional weight to the cost performance
category until additional measures are developed. However, we also
believe that cost is a critical component of the Quality Payment
Program and believe placing additional emphasis on the cost performance
category in future years may be appropriate. Therefore, we seek comment
on redistributing weight to the cost performance category in future
years.
(c) Final Score Calculation
We are proposing to revise the formula at Sec. 414.1380(c) for
calculating the final score. As discussed in section
III.H.3.i.(1)(b)(vii), we are not proposing to continue to add the
small practice bonus to the final score for the 2021 MIPS payment year
and are proposing to add a small practice bonus to the quality
performance category score instead starting with the 2021 MIPS payment
year. Therefore, we are proposing to revise the formula to omit the
small practice bonus from the final score calculation beginning with
the 2021 MIPS payment year. We request public comments on this
proposal.
In the CY 2018 Quality Payment Program final rule (82 FR 53779), we
requested public comment on approaches to display scores and provide
feedback to MIPS eligible clinicians in a way that MIPS eligible
clinicians can easily understand how their scores are calculated,
including how performance category scores are translated to a final
score. We also sought comment on how to simplify the scoring system
while still recognizing differences in clinician practices.
A few commenters suggested that we make performance category scores
equal to the number of points they will represent in the final score to
minimize confusion. For example, the quality performance category score
would be out of 50 total possible points, when the quality performance
category weight is 50 percent. A few commenters provided suggestions
for tools that may help MIPS eligible clinicians to understand scoring
better. For example, a few commenters suggested that we create an
interactive online tool for clinicians to calculate their own scores. A
few commenters suggested that we should not compare MIPS eligible
clinicians to benchmarks because they do not believe the benchmarks
actually represent high quality care. One commenter suggested that we
could simplify scoring by awarding points for multiple performance
categories for performance on one measure or activity. Another
commenter requested that we simplify scoring because the commenter
believes that clinicians may view the program as unfair and be subject
to negative payment adjustments due to confusion rather than
performance.
We thank the commenters for their suggestions, and we will take
them into consideration in future rulemaking.
In response to commenters requesting that the total number of
points available for a performance category should be equivalent to the
performance category's weight in the final score, we note that various
reweighting scenarios could mean that the weight of the performance
categories for each MIPS eligible clinician may vary (for example, if
the weight of one or more performance categories is redistributed to
other performance categories), which makes it impossible for all MIPS
eligible clinicians to have the same total number of points available
for a performance category. In addition, the total points possible for
the quality and cost performance categories may vary--for example, if a
group is scored on the readmission measure they will have a maximum of
70 points for the 6 measures they are required to submit and the
readmission measure instead of 60 points for 6 measures for individuals
and groups who are not scored via Web Interface and who do not have the
readmission measure. However, we continue to value simplicity in our
scoring for MIPS and intend to explore approaches to simplify our
scoring whenever possible in future years. We seek comments on
approaches to simplify calculation of the final score that take into
consideration these limitations described above.

[[Page 35971]]

j. MIPS Payment Adjustments
(1) Final Score Used in Payment Adjustment Calculation
For our previously established policies regarding the final score
used in payment adjustment calculation, we refer readers to the CY 2017
Quality Payment Program final rule (81 FR 77330 through 77332) and the
CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787).
Under our policies, for groups submitting data using the TIN
identifier, we will apply the group final score to all the TIN/NPI
combinations that bill under that TIN during the performance period (82
FR 53785). We are proposing to modify this policy for the application
of the group final score, beginning with the 2019 performance period/
2021 MIPS payment year. We are proposing a 15-month window that starts
with the second 12-month determination period (October 1 prior to the
MIPS performance period through September of the MIPS performance
period) and also includes the final 3 months of the performance period
year (October 1 through December 31 of the performance period year). We
are proposing for groups submitting data using the TIN identifier, we
would apply the group final score to all of the TIN/NPI combinations
that bill under that TIN during the proposed 15-month window. We
believe that partially aligning with the second 12-month determination
period creates consistency with our eligibility policies that informs a
group or eligible clinician of who is eligible. We refer readers to
section III.H.3.b. of this proposed rule where we discuss our proposals
related to MIPS determination periods.
We note that, if a MIPS eligible clinician's TIN/NPI combination
was not part of the group practice during the MIPS determination
period, the TIN/NPI combination would not be identified in our system
at the start of the MIPS data submission period; however, if the MIPS
eligible clinician qualifies to receive the group final score under our
proposal, we would apply the group final score to the MIPS eligible
clinician's TIN/NPI combination as soon as the information becomes
available.
(2) Establishing the Performance Threshold
Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS,
the Secretary shall compute a performance threshold with respect to
which the final scores of MIPS eligible clinicians are compared for
purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act for a year. The performance threshold
for a year must be either the mean or median (as selected by the
Secretary, and which may be reassessed every 3 years) of the final
scores for all MIPS eligible clinicians for a prior period specified by
the Secretary.
Section 1848(q)(6)(D)(iii) of the Act included a special rule for
the initial 2 years of MIPS, which requires the Secretary, prior to the
performance period for such years, to establish a performance threshold
for purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act and an additional performance
threshold for purposes of determining the additional MIPS payment
adjustment factors under section 1848(q)(6)(C) of the Act, each of
which shall be based on a period prior to the performance period and
take into account data available for performance on measures and
activities that may be used under the performance categories and other
factors determined appropriate by the Secretary. Section 51003(a)(1)(D)
of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii)
of the Act to extend the special rule to apply for the initial 5 years
of MIPS instead of only the initial 2 years of MIPS.
In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which
includes an additional special rule for the third, fourth, and fifth
years of MIPS (the 2021 through 2023 MIPS payment years). This
additional special rule provides, for purposes of determining the MIPS
payment adjustment factors under section 1848(q)(6)(A) of the Act, in
addition to the requirements specified in section 1848(q)(6)(D)(iii) of
the Act, the Secretary shall increase the performance threshold for
each of the third, fourth, and fifth years to ensure a gradual and
incremental transition to the performance threshold described in
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary)
with respect to the sixth year (the 2024 MIPS payment year) to which
the MIPS applies.
To determine a performance threshold to propose for the third year
of MIPS (2021 MIPS payment year), we again relied upon the special rule
in section 1848(q)(6)(D)(iii) of the Act, as amended by 51003(a)(1)(D)
of the Bipartisan Budget Act of 2018. As required by section
1848(q)(6)(D)(iii) of the Act, we considered data available from a
prior period with respect to performance on measures and activities
that may be used under the MIPS performance categories. In accordance
with newly added clause (iv) of section 1848(q)(6)(D) of the Act, we
also considered which data could be used to estimate the performance
threshold for the 2024 MIPS payment year to ensure a gradual and
incremental transition from the performance threshold we would
establish for the 2021 MIPS payment year. We considered using the final
scores for the 2017 MIPS performance period/2019 MIPS payment year;
however, the data used to calculate the final scores was submitted
through the first quarter of 2018, and final scores for MIPS eligible
clinicians were not available in time for us to use in our analyses for
purposes of this proposed rule. If technically feasible, we would
consider using the actual data used to determine the final scores for
the 2019 MIPS payment year to estimate a performance threshold for the
2024 MIPS payment year in the final rule.
Because the final scores for MIPS eligible clinicians are not yet
available to us, we reviewed the data relied upon for the CY 2017
Quality Payment Program final rule regulatory impact analysis (81 FR
77514 through 77536) and believe it is the best data currently
available to us to estimate the actual data for the 2017 MIPS
performance period/2019 MIPS payment year.
Specifically, we used data from claims, MIPS eligibility data, 2015
PQRS data, 2014 PQRS Experience Report, 2014 VM data, National Plan and
Provider Enumeration System Data, APM participation lists, and initial
analyses for QP determination to model the estimated MIPS eligible
clinicians, final scores, and the economic impact of MIPS final score.
In these models, we assumed that historic PQRS participation
assumptions would significantly overestimate the impact on clinicians,
particularly on clinicians in practices with 1 to 15 clinicians, which
have traditionally had lower participation rates. To assess the
sensitivity of the impact to the participation rate, we prepared two
sets of analyses. The first analysis relies on the assumption that a
minimum 90 percent of MIPS eligible clinicians will participate in
submitting quality performance category data to MIPS, regardless of
practice size. The second analysis relies on the assumption that a
minimum 80 percent of MIPS eligible clinicians will participate in
submitting quality performance category data to MIPS, regardless of
practice size (81 FR 77522 through 77523). We also reviewed the
available data based on actual participation in PQRS (81 FR 77522
through 77523) without applying any participation assumptions.

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In accordance with section 1848(q)(6)(D)(i) of the Act, the
performance threshold for the 2024 MIPS payment year would be either
the mean or median of the final scores for all MIPS eligible clinicians
for a prior period specified by the Secretary. When we analyzed the
estimated final scores for the 2019 MIPS payment year, the mean final
score was between 63.50 and 68.98 points and the median was between
77.83 and 82.5 points based on the different participation assumptions.
For purposes of estimating the performance threshold for the 2024 MIPS
payment year, we are using the mean final score based on data used for
the CY 2017 Quality Payment Program final rule regulatory impact
analysis (81 FR 77514 through 77536), which would result in an
estimated performance threshold between 63.50 and 68.98 points for the
2024 MIPS payment year. We note that this is only an estimation we are
providing in accordance with section 1848(q)(6)(D)(iv) of the Act, and
we will propose the actual performance threshold for the 2024 MIPS
payment year in future rulemaking.
We propose a performance threshold of 30 points for the 2021 MIPS
payment year to be codified at Sec. 414.1405(b)(6). A performance
threshold of 30 points would be a modest increase over the performance
threshold for the 2020 MIPS payment year (15 points), and we believe it
would provide a gradual and incremental transition to the performance
threshold we would establish for the 2024 MIPS payment year, which we
have estimated would be between 63.50 and 68.98 points.
We want to encourage continued participation and the collection of
meaningful data by MIPS eligible clinicians. A higher performance
threshold would help MIPS eligible clinicians strive to achieve more
complete reporting and better performance and prepare MIPS eligible
clinicians for the 2024 MIPS payment year. However, a performance
threshold set too high could also create a performance barrier,
particularly for MIPS eligible clinicians who did not previously
participate in PQRS or the EHR Incentive Programs. Additionally, we
believe a modest increase from the performance threshold for the 2020
MIPS payment year would be particularly important to reduce the burden
for MIPS eligible clinicians in small or solo practices. We believe
that active participation of MIPS eligible clinicians in MIPS will
improve the overall quality, cost, and care coordination of services
provided to Medicare beneficiaries.
We have heard from stakeholders requesting that we continue a low
performance threshold and from stakeholders requesting that we ramp up
the performance threshold to help MIPS eligible clinicians prepare for
a future performance threshold of the mean or median of final scores
and to meaningfully incentivize higher performance. We have also heard
from stakeholders who believe a higher performance threshold may
incentivize higher performance by MIPS eligible clinicians through
higher positive MIPS payment adjustments for those who exceed the
performance threshold. We believe that a performance threshold of 30
points for the 2021 MIPS payment year would provide a gradual and
incremental increase from the performance threshold of 15 points for
the 2020 MIPS payment year and could incentivize higher performance by
MIPS eligible clinicians.
We also believe that a performance threshold of 30 points
represents a meaningful increase compared to 15 points, while
maintaining flexibility for MIPS eligible clinicians in the pathways
available to achieve this performance threshold. For example, generally
a MIPS eligible clinician that is reporting individually and is not in
a small practice could meet the performance threshold of 30 points by
earning 40 measure achievement points out of 60 total possible measure
achievement points that could be achieved through performing at the
highest level of performance for 2 measures and earning 5 measure
achievement points for each of the 4 other measures submitted for a
total of 6 required measures submitted in the quality performance
category (assuming an outcome measure is submitted).\35\ Alternatively,
a performance threshold of 30 points could be met by performance at 50
percent for the Promoting Interoperability performance category
(receiving a 50 percent performance category score with a performance
category weight of 25 percent of the final score is 12.5 points),
receiving a 50 percent performance category score for the cost
performance category (receiving a 50 percent performance category score
with a performance category weight of 15 percent of the final score is
7.5 points), and also earning the maximum number of points for the
improvement activities performance category (which is worth 15 points
towards the final score), which collectively would produce a final
score of at least 35 points (15 points for improvement activities + 7.5
points for cost + 12.5 points for Promoting Interoperability.
---------------------------------------------------------------------------

\35\ The score for the quality performance category would be (10
measure achievement points x 2 measures plus 5 measure achievement
points x 4 measures)/60 total possible achievement points or 66.67
percent. That score could be higher if the clinician qualifies for
bonuses in the quality performance category. The 66.67 percent
quality performance category percent score is weighted at 45 percent
of the final score which is multiplied by 100 and equals 30 points
towards the final score.
---------------------------------------------------------------------------

We refer readers to section III.H.3.j.(4)(e) of this proposed rule
for additional examples of how a MIPS eligible clinician can meet or
exceed the performance threshold. We invite public comment on the
proposal to set the performance threshold for the 2021 MIPS payment
year at 30 points. Alternatively, we considered whether the performance
threshold should be set at a higher or lower number, for example, 25
points or 35 points, and also seek comment on alternative numerical
values for the performance threshold for the 2021 MIPS payment year.
We also seek comment on our approach to estimating the performance
threshold for the 2024 MIPS payment year, which above we based on the
estimated mean final score for the 2019 MIPS payment year. We are
particularly interested in whether we should use the median, instead of
the mean, and whether in the future we should estimate the mean or
median based on the final scores for another MIPS payment year. In our
model estimates, we have seen that the mean scores are lower than the
median and would expect a larger proportion of clinicians estimated to
have final scores above the mean, rather than the median, because the
mean is lower than the median with those who do not submit the required
data getting the lowest possible score. That in turn could lower the
scaling factor compared to a performance threshold based on the median.
We also seek comment on whether establishing a path forward to a
performance threshold for the 2024 MIPS payment year that provides
certainty to clinicians and ensures a gradual and incremental increase
from the performance threshold for the 2021 MIPS payment year to the
estimated performance threshold for the 2024 MIPS payment year would be
beneficial. For example, we could consider setting a performance
threshold of 30 points for the 2021 MIPS payment year, 50 points for
the 2022 MIPS payment year, and 70 points for the 2023 MIPS payment
year as gradual and incremental increases toward the estimated
performance threshold for the 2024 MIPS payment year based on our
estimated median final scores discussed above; or we could have
slightly lower values if we were to continue to

[[Page 35973]]

estimate the performance threshold for the 2024 MIPS payment year based
on our estimated mean final scores. We believe there may be value to
MIPS eligible clinicians in knowing in advance the performance
threshold for the 2022 and 2023 MIPS payment years to encourage and
facilitate increased clinician engagement and prepare clinicians for
meeting the performance threshold for the 2024 MIPS payment year.
Alternatively, we also believe that our estimates for the 2024 MIPS
payment year performance threshold may change as we analyze actual MIPS
data and, therefore, it may be appropriate to propose the performance
threshold annually as we better understand the mean and median final
scores.
(3) Additional Performance Threshold for Exceptional Performance
Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to
compute, for each year of the MIPS, an additional performance threshold
for purposes of determining the additional MIPS payment adjustment
factors for exceptional performance under section 1848(q)(6)(C) of the
Act. For each such year, the Secretary shall apply either of the
following methods for computing the additional performance threshold:
(1) The threshold shall be the score that is equal to the 25th
percentile of the range of possible final scores above the performance
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2)
the threshold shall be the score that is equal to the 25th percentile
of the actual final scores for MIPS eligible clinicians with final
scores at or above the performance threshold for the prior period
described in section 1848(q)(6)(D)(i) of the Act.
Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician
with a final score at or above the additional performance threshold
will receive an additional MIPS payment adjustment factor and may share
in the $500,000,000 of funding available for the year under section
1848(q)(6)(F)(iv) of the Act.
As we discussed in section III.H.3.j.(2) of this proposed rule, we
are relying on the special rule under section 1848(q)(6)(D)(iii) of the
Act, as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act
of 2018, to propose a performance threshold of 30 points for the 2021
MIPS payment year. The special rule under section 1848(q)(6)(D)(iii) of
the Act also applies for purposes of establishing an additional
performance threshold for a year. For the 2021 MIPS payment year, we
are proposing to again decouple the additional performance threshold
from the performance threshold.
Because we do not have actual MIPS final scores for a prior
performance period, if we do not decouple the additional performance
threshold from the performance threshold, then we would have to set the
additional performance threshold at the 25th percentile of possible
final scores above the performance threshold. With a performance
threshold set at 30 points, the range of total possible points above
the performance threshold is 30.01 to 100 points and the 25th
percentile of that range is 47.5, which is less than one-half of the
possible 100 points in the MIPS final score. We do not believe it would
be appropriate to lower the additional performance threshold to 47.5
points because we do not believe a final score of 47.5 points
demonstrates exceptional performance by a MIPS eligible clinician. We
believe these additional incentives should only be available to those
clinicians with very high performance on the MIPS measures and
activities. Therefore, we are relying on the special rule under section
1848(q)(6)(D)(iii) of the Act and propose at Sec. 414.1405(d)(5) to
set the additional performance threshold at 80 points for the 2021 MIPS
payment year, which is higher than the 25th percentile of the range of
the possible final scores above the performance threshold.
As required by section 1848(q)(6)(D)(iii) of the Act, we took into
account the data available and the modeling described in section VII.
of this proposed rule to estimate final scores for the 2021 MIPS
payment year. We believe 80 points is appropriate because it is vital
to incentivize clinicians who have made greater strides to meaningfully
participate in the MIPS program to perform at even higher levels. An
additional performance threshold of 80 points requires a MIPS eligible
clinician to perform well on at least two performance categories.
Generally, a MIPS eligible clinician could receive a maximum score of
45 points for the quality performance category, which is below the 80-
point additional performance threshold. In addition, 80 points is at a
high enough level that MIPS eligible clinicians must submit data for
the quality performance category to achieve this target. For example,
if a MIPS eligible clinician gets a perfect score for the improvement
activities, the cost, and Promoting Interoperability performance
categories, but does not submit quality measures data, then the MIPS
eligible clinician would only receive 55 points (0 points for quality +
15 points for the cost performance category + 15 points for improvement
activities + 25 points for Promoting Interoperability performance
category), which is below the additional performance threshold. We
believe the additional performance threshold at 80 points increases the
incentive for excellent performance while keeping the focus on quality
performance.
We also believe this increase would encourage increased engagement
and further incentivize clinicians whose performance meets or exceeds
the additional performance threshold, recognizing that a fixed amount
is available for a year under section 1848(q)(6)(F)(iv) of the Act to
fund the additional MIPS payment adjustments and that the more
clinicians who receive an additional MIPS payment adjustment, the lower
the average clinician's additional MIPS payment adjustment will be.
For future years, we may consider additional increases to the
additional performance threshold.
(4) Application of the MIPS Payment Adjustment Factors
(a) Application to the Medicare Paid Amount for Covered Professional
Services
In the CY 2018 Quality Payment Program final rule, we finalized the
application of the MIPS payment adjustment factor, and if applicable,
the additional MIPS payment adjustment factor, to the Medicare paid
amount for items and services paid under Part B and furnished by the
MIPS eligible clinician during the year (82 FR 53795). Sections
51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of
2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act,
respectively, by replacing the references to ``items and services''
with ``covered professional services'' (as defined in section
1848(k)(3)(A) of the Act). Covered professional services as defined in
section 1848(k)(3)(A) of the Act are those services for which payment
is made under, or is based on, the Medicare Physician Fee Schedule and
which are furnished by an eligible professional. As a result of these
changes, the MIPS payment adjustment factor determined under section
1848(q)(6)(A), and as applicable, the additional MIPS payment
adjustment factor determined under section 1848(q)(6)(C) of the Act,
will be applied to Part B payments for covered professional services
furnished by a MIPS eligible clinician during a year beginning with the
2019 MIPS payment year and not to Part B payments for other items and
services.

[[Page 35974]]

To conform with these amendments to the statute, we are proposing
to revise Sec. 414.1405(e) to apply the MIPS payment adjustment factor
and, if applicable, the additional MIPS payment adjustment factor, to
the Medicare Part B paid amount for covered professional services
furnished by a MIPS eligible clinician during a MIPS payment year
(beginning with 2019). We are also proposing to revise Sec.
414.1405(e) to specify the formula for applying these adjustment
factors in a manner that more closely tracks the statutory formula
under section 1848(q)(6)(E) of the Act. Specifically, we are proposing
the following formula: In the case of covered professional services (as
defined in section 1848(k)(3)(A) of the Act) furnished by a MIPS
eligible clinician during a MIPS payment year beginning with 2019, the
amount otherwise paid under Part B with respect to such covered
professional services and MIPS eligible clinician for such year, is
multiplied by 1, plus the sum of: The MIPS payment adjustment factor
divided by 100, and as applicable, the additional MIPS payment
adjustment factor divided by 100. We also refer readers to section
III.H.3.a. of this proposed rule where we discuss the covered
professional services to which the MIPS payment adjustment could be
applied.
(b) Application for Non-Assigned Claims for Non-Participating
Clinicians
In the CY 2018 Quality Payment Program final rule, we did not
address the application of the MIPS payment adjustment for non-assigned
claims for non-participating clinicians. In the CY 2018 Quality Payment
Program final rule, we responded to a comment requesting guidance on
how the MIPS payment adjustment and the calculation of the Medicare
limiting charge amount would be applied for non-participating
clinicians, and we stated our intention to address these issues in
future rulemaking (82 FR 53795). Beginning with the 2019 MIPS payment
year, we are proposing that the MIPS payment adjustment does not apply
for non-assigned claims for non-participating clinicians. This approach
is consistent with the policy for application of the value modifier
that was finalized in the CY 2015 Physician Fee Schedule final rule (79
FR 67950 through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of
the Act require that we specify a MIPS payment adjustment factor, and
if applicable, an additional MIPS payment adjustment factor for each
MIPS eligible clinician, and section 1848(q)(6)(E) of the Act (as
amended by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018)
requires that these payment adjustment factor(s) be applied to adjust
the amount otherwise paid under Part B for covered professional
services furnished by the MIPS eligible clinician during the MIPS
payment year. When non-participating clinicians choose not to accept
assignment for a claim, Medicare makes payment directly to the
beneficiary, and the physician collects payment from the beneficiary.
This is referred to as a non-assigned claim. Application of the MIPS
payment adjustment to these non-assigned claims would not affect
payment to the MIPS eligible clinician. Rather, it would only affect
Medicare payment to the beneficiary. If the MIPS payment adjustment
were to be applied to non-assigned services, then the Medicare payment
to a beneficiary would be increased when the MIPS payment adjustment is
positive and decreased when the MIPS payment adjustment is negative.
Although the statute does not directly address this situation, it does
suggest that the MIPS payment adjustment is directed toward payment to
the MIPS eligible clinician and the covered professional services they
furnish. We continue to believe that it is important that beneficiary
liability not be affected by the MIPS payment adjustment and that the
MIPS payment adjustment should be applied to the amount that Medicare
pays to MIPS eligible clinicians.
On that basis, we propose to apply the MIPS payment adjustment to
claims that are billed and paid on an assignment-related basis, and not
to any non-assigned claims, beginning with the 2019 MIPS payment year.
We do not expect this proposal, that the MIPS payment adjustment would
not apply to non-assigned claims, would be likely to affect a
clinician's decision to participate in Medicare or to otherwise accept
assignment for a particular claim, but we seek comment on whether
stakeholders and others believe clinician behavior would change as a
result of this policy.
(c) Waiver of the Requirement To Apply the MIPS Payment Adjustment
Factors to Certain Payments in Models Tested Under Section 1115A of the
Social Security Act
CMS tests models under section 1115A of the Act that may include
model-specific payments made only to model participants under the terms
of the model and not to any other providers of services or suppliers.
Some of these model-specific payments may be considered payments for
covered professional services furnished by a MIPS eligible clinician,
meaning that the MIPS payment adjustment factor, and, as applicable,
the additional MIPS payment adjustment factor (collectively referred to
as the MIPS payment adjustment factors) applied under Sec. 414.1405(e)
of our regulations would normally apply to those payments. Section
1115A(d)(1) of the Act authorizes the Secretary to waive requirements
of Title XVIII of the Act (and certain other requirements) as may be
necessary solely for the purposes of testing models under section
1115A. We believe it is necessary to waive the requirement to apply the
MIPS payment adjustment factors to a model-specific payment or payments
(to the extent such a payment or payments are subject to the
requirement to apply the MIPS payment adjustment factors) for purposes
of testing a section 1115A model under which such model-specific
payment or payments are made in a specified payment amount (for
example, $160 per-beneficiary, per-month); or paid according to a
methodology for calculating a model-specific payment that is applied in
a consistent manner to all model participants. In both cases, applying
the MIPS payment adjustment factors to these model-specific payments
would introduce variation in the amounts of model-specific payments
paid across model participants, which could compromise the model test
and the evaluation thereof.
We propose to amend Sec. 414.1405 to add a new paragraph (f) to
specify that the MIPS payment adjustment factors applied under Sec.
414.1405(e) would not apply to certain model-specific payments as
described above for the duration of a section 1115A model's testing,
beginning in the 2019 MIPS payment year. We are proposing to use the
authority under section 1115A(d)(1) of the Act to waive the requirement
to apply the MIPS payment adjustment factors under section
1848(q)(6)(E) of the Act and Sec. 414.1405(e) specifically for these
types of payments because the waiver is necessary solely for purposes
of testing models that involve such payments.
We believe this policy is appropriate because it would enable us to
effectively test and evaluate the payment and savings impacts of such
model-specific payments made under section 1115A models during model
testing, which may not be possible if the requirement to apply the MIPS
payment adjustment factors was not waived. This waiver would not apply
to payments made outside of a section 1115A model with respect to both
MIPS eligible clinicians that are participating in and MIPS eligible
clinicians that are not participating in a section 1115A model.

[[Page 35975]]

To illustrate how this waiver would apply, one model-specific
payment to which this proposed rule would apply is the Monthly Enhanced
Oncology Services (MEOS) payment in the Oncology Care Model (OCM). The
duration of this waiver would begin with the 2019 MIPS payment year and
continue for the duration of OCM. Application of our proposed
regulation to the MEOS payment illustrates why the waiver is necessary
for some payments under section 1115A models. OCM incorporates two
model-specific payments for participating practices, creating
incentives to improve the quality of care at a lower cost and furnish
enhanced services for beneficiaries who undergo chemotherapy treatment
for a cancer diagnosis. There is a per-beneficiary per-month MEOS
payment for the duration of each 6-month episode of chemotherapy care
attributed to the practice, and there is the potential for a
performance-based payment for such episodes.
MEOS payments are for Enhanced Services furnished to the OCM
practices' beneficiary population for attributed episodes of care (that
is, 24/7 access, patient navigation, care planning, and using therapies
consistent with nationally recognized clinical guidelines); while some
beneficiaries attributed to an OCM Practice will require more support
than others, all beneficiaries in episodes of care attributed to an OCM
practice have access to the OCM Enhanced Services throughout their 6-
month episode. The MEOS payment is set at $160 per beneficiary per
month for all OCM Practitioners. Because the MEOS payments are made for
services for which payment is made under, or based on the PFS and which
are furnished by an eligible clinician, they are considered covered
professional services as defined in section 1848(k)(3)(A) of the Act.
Accordingly, beginning in 2019 (the first MIPS payment year), the MEOS
payments would be subject to the MIPS payment adjustments (positive,
neutral, or negative) that are applicable for each OCM Practitioner who
is a MIPS eligible clinician (at the TIN/NPI level) unless the
requirement to apply the MIPS payment adjustment factors to the MEOS
payments is waived pursuant to section 1115A(d)(1) of the Act.
We believe it is necessary to waive the requirement to apply the
MIPS payment adjustment factors to the MEOS payments solely for
purposes of testing OCM because we established the $160 per beneficiary
per month MEOS payment rate after careful study and consideration, and
we are specifically testing the impact and appropriateness of $160 as
the per beneficiary per month MEOS payment amount to OCM Practitioners.
Though some payment adjustments such as sequestration apply to MEOS
payments, we do not apply others that would result in differential
payments across OCM Practitioners, such as the Geographic Pricing Cost
Index adjustment and Value-Based Payment Modifier for CY 2018. If the
MEOS payments were subject to the MIPS payment adjustment, the MEOS
payment amount would not be consistent for all OCM Practitioners across
the OCM. We are concerned that the resulting differential MEOS payment
amounts would increase the complexity of the model evaluation.
Specifically, if OCM practices receive differential MEOS payment
amounts, they would therefore receive different levels of payment from
OCM per attributed beneficiary, which could provide differential
incentives for OCM practices to invest in care coordination and other
practice transformation activities. This would substantially increase
the complexity of evaluating the impact of the model, as it would be
challenging to evaluate how these differential payment amounts
influence outcomes, potentially lessening our ability to accurately
discern whether $160 per beneficiary per month is the appropriate
payment amount. These differential payment amounts may also potentially
distort CMS's intent to incentivize the provision of enhanced oncology
care by OCM Practitioners via a standardized per-beneficiary per-month
payment for such services.
We propose to provide the public with notice that this proposed new
regulation applies to model-specific payments that the Innovation
Center elects to test in the future in two ways: First, we will update
the Quality Payment Program website (www.qpp.cms.gov) when new model-
specific payments subject to this proposed waiver are announced, and
second, we will provide a notice in the Federal Register to update the
public on any new model-specific payments to which this waiver will
apply.
(d) CY 2018 Exclusion of MIPS Eligible Clinicians Participating in the
Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI)
Demonstration
In conjunction with releasing this proposed rule, CMS is announcing
the MAQI Demonstration, authorized under section 402 of the Social
Security Amendments of 1968 (as amended). The MAQI Demonstration is
designed to test whether excluding MIPS eligible clinicians who
participate to a sufficient degree in certain payment arrangements with
Medicare Advantage Organizations (MAOs) from the MIPS reporting
requirements and payment adjustment will increase or maintain
participation in payment arrangements similar to Advanced APMs with
MAOs and change the manner in which clinicians deliver care.
If the waivers proposed below are finalized, the MAQI Demonstration
will allow certain participating clinicians to be excluded from the
MIPS reporting requirements and payment adjustment (if the clinicians
participate to a sufficient degree in a combination of Qualifying
Payment Arrangements with MAOs and Advanced APMs with Medicare FFS
during the performance period for that year) without meeting the
criteria to be QPs or otherwise meeting a MIPS exclusion criterion
under the Quality Payment Program. For example, eligible clinicians
that did not meet the criteria to be a QP for a given year, or were not
otherwise eligible to be excluded from MIPS (that is, were not newly
enrolled in Medicare or did not fall below the low volume threshold for
Medicare FFS patients or payments) could be excluded from the MIPS
reporting requirements and payment adjustment through the
Demonstration. For purposes of the MAQI Demonstration, we would apply
requirements for Qualifying Payment Arrangements that are consistent
with the criteria for Other Payer Advanced APMs under the Quality
Payment Program as set forth in Sec. 414.1420. In addition, we are
proposing that the combined thresholds for Medicare payments or
patients through Qualifying Payment Arrangements with MAOs and Advanced
APMs that a participating clinician must meet in order to attain
waivers of the MIPS reporting requirements and payment adjustment
through the MAQI Demonstration matches the thresholds for participation
in Advanced APMs under the Medicare Option of the Quality Payment
Program. In 2018, those thresholds are 25 percent for the payment
amount threshold and 20 percent for the patient count threshold. Under
the MAQI Demonstration, aggregate participation in Advanced APMs and
Qualifying Payment Arrangements will be used, without applying a
specific minimum threshold to participation in either type of payment
arrangement.
Section 402(b) of the Social Security Amendments of 1968 (as
amended) authorizes the Secretary to waive requirements of Title XVIII
that relate to payment and reimbursement in order to carry out
demonstrations under section

[[Page 35976]]

402(a). We propose to use the authority in section 402(b) of the Social
Security Amendments of 1968 (as amended) to waive requirements of
section 1848(q)(6)(E) of the Act and the regulations implementing it,
to waive the payment consequences (positive, negative or neutral
adjustments) of the MIPS and to waive the associated MIPS reporting
requirements in 42 CFR part 414 adopted to implement the payment
consequences, subject to conditions outlined in the Demonstration. As a
practical matter, the waiver would have the effect of acting as another
exclusion from MIPS for eligible clinicians who participate in the MAQI
Demonstration and meet the performance thresholds set in the
demonstration. To qualify for these waivers, a participating clinician
must participate to a sufficient degree in Qualifying Payment
Arrangements with MAOs and Advanced APMs in FFS Medicare during the
performance period for that year, without meeting the criteria to be
QPs or Partial QPs, or otherwise meeting the MIPS exclusion criteria of
the Quality Payment Program. The threshold to qualify for the waivers
using participation in these specific payment arrangements could be met
in one of two ways: A certain percentage of payments or patients is
tied to participation in a combination of Advanced APMs and Qualifying
Payment Arrangements. These thresholds will match the thresholds under
the Medicare Option of the Quality Payment Program. We propose to begin
the MAQI Demonstration in Calendar 2018, with the 2018 Performance
Period, and operate the project for a total of 5 years.
The Demonstration will also waive the provision in section
1848(q)(1)(A) of the Act that the Secretary shall permit any eligible
clinician to report on applicable measures and activities, so that the
Demonstration will prohibit reporting under the MIPS by eligible
clinicians who participate in the Demonstration and meet the thresholds
to receive the waivers from the MIPS reporting requirements and payment
adjustment for a given year. This waiver is necessary to prevent the
potential gaming opportunity wherein participating clinicians could
intentionally report artificially poor performance under the MIPS for
years in which they receive waivers from MIPS payment consequences,
then receive artificially inflated quality improvement points under
MIPS in later years when they do not receive waivers from MIPS payment
consequences. We believe this waiver is necessary under the
Demonstration because the Demonstration creates a scenario in which
participating clinicians could report to MIPS, not be subject to the
MIPS payment adjustment for that year, but have that year's data used
in the calculation of quality improvement points in future years.
Clinicians who are excluded from the MIPS reporting requirements and
payment adjustment through participation in the Demonstration would not
be permitted to report to MIPS. Clinicians who participate in the
Demonstration but are not excluded from MIPS (whether through
participation in the Demonstration or otherwise) would continue to be
MIPS eligible clinicians who are subject to the MIPS reporting
requirements and payment adjustment as usual.
Because of the requirement to ensure budget neutrality with regard
to the MIPS payment adjustments under section 1848(q)(6)(F)(ii) of the
Act, removing MIPS eligible clinicians from the population across which
positive and negative payment adjustments are calculated under MIPS may
affect the payment adjustments for other MIPS eligible clinicians.
Specifically, the Demonstration would exclude certain clinicians from
the pool of MIPS eligible clinicians for which the MIPS payment
adjustments are calculated, thereby decreasing the aggregate allowed
charges resulting from the application of MIPS adjustment factors
included in the budget neutrality determination. The application of
waivers to MIPS eligible clinicians participating to a sufficient
degree in the MAQI Demonstration may have the effect of changing the
aggregate amount of MIPS payment adjustments received by MIPS eligible
clinicians to whom the waivers do not apply. The Demonstration is
contingent on the finalization of these waivers through rulemaking due
to its effect on MIPS payment adjustments for other clinicians.
We invite comment on this proposal.
(e) Example of Adjustment Factors
We provide a figure and several tables as illustrative examples of
how various final scores would be converted to a MIPS payment
adjustment factor, and potentially an additional MIPS payment
adjustment factor, using the statutory formula and based on our
proposed policies for the 2021 MIPS payment year.
Figure A (below) provides an example of how various final scores
would be converted to a MIPS payment adjustment factor, and potentially
an additional MIPS payment adjustment factor, using the statutory
formula and based on proposed policies for the 2021 MIPS payment year.
In Figure A, the performance threshold is 30 points. The applicable
percentage is 7 percent for the 2021 MIPS payment year. The MIPS
payment adjustment factor is determined on a linear sliding scale from
zero to 100, with zero being the lowest possible score which receives
the negative applicable percentage (negative 7 percent for the 2021
MIPS payment year) and resulting in the lowest payment adjustment, and
100 being the highest possible score which receives the highest
positive applicable percentage and resulting in the highest payment
adjustment. However, there are two modifications to this linear sliding
scale. First, there is an exception for a final score between zero and
one-fourth of the performance threshold (zero and 7.5 points based on
the performance threshold of 30 points for the 2021 MIPS payment year).
All MIPS eligible clinicians with a final score in this range would
receive the lowest negative applicable percentage (negative 7 percent
for the 2021 MIPS payment year). Second, the linear sliding scale line
for the positive MIPS payment adjustment factor is adjusted by the
scaling factor, which cannot be higher than 3.0.
If the scaling factor is greater than zero and less than or equal
to 1.0, then the MIPS payment adjustment factor for a final score of
100 would be less than or equal to 7 percent. If the scaling factor is
above 1.0, but less than or equal to 3.0, then the MIPS payment
adjustment factor for a final score of 100 would be higher than 7
percent.
Only those MIPS eligible clinicians with a final score equal to 30
points (which is the performance threshold in this example) would
receive a neutral MIPS payment adjustment. Because the performance
threshold is 30 points, we anticipate that more clinicians will receive
a positive adjustment than a negative adjustment and that the scaling
factor would be less than 1 and the MIPS payment adjustment factor for
each MIPS eligible clinician with a final score of 100 points would be
less than 7 percent.
Figure A illustrates an example of the slope of the line for the
linear adjustments and has been updated from prior rules, but it could
change considerably as new information becomes available. In this
example, the scaling factor for the MIPS payment adjustment factor is
0.229. In this example, MIPS eligible clinicians with a final score
equal to 100 would have a MIPS payment adjustment factor of 1.60
percent (7 percent x 0.229).
The additional performance threshold is 80 points. An additional
MIPS payment adjustment factor of 0.5

[[Page 35977]]

percent starts at the additional performance threshold and increases on
a linear sliding scale up to 10 percent. This linear sliding scale line
is also multiplied by a scaling factor that is greater than zero and
less than or equal to 1.0. The scaling factor will be determined so
that the estimated aggregate increase in payments associated with the
application of the additional MIPS payment adjustment factors is equal
to $500,000,000. In Figure A, the example scaling factor for the
additional MIPS payment adjustment factor is 0.407. Therefore, MIPS
eligible clinicians with a final score of 100 would have an additional
MIPS payment adjustment factor of 4.07 percent (10 percent x 0.407).
The total adjustment for a MIPS eligible clinician with a final score
equal to 100 would be 1 + 0.0106 + 0.0407 = 1.0567, for a total
positive MIPS payment adjustment of 5.67 percent.

BILLING CODE 4120-01-P

[[Page 35978]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.044

BILLING CODE 4120-01-C

The final MIPS payment adjustments will be determined by the
distribution of final scores across MIPS eligible clinicians and the
performance threshold. More MIPS eligible clinicians above the
performance threshold means the scaling factors would decrease because
more MIPS eligible clinicians receive a positive MIPS payment
adjustment factor. More MIPS eligible clinicians below the performance
threshold means the scaling factors would increase because more MIPS
eligible clinicians would receive a negative MIPS payment adjustment
factor and relatively fewer MIPS eligible

[[Page 35979]]

clinicians would receive a positive MIPS payment adjustment factor.
Table 53 illustrates the changes in payment adjustments based on
the final policies from the 2019 MIPS payment year and the 2020 MIPS
payment year, and on the proposed policies for the 2021 MIPS payment
year, as well as the statutorily required increase in the applicable
percent as required by section 1848(q)(6)(B) of the Act.

Table 53--Illustration of Point System and Associated Adjustments Comparison Between Transition Year and the
2020 MIPS Payment Year and 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
Transition year 2020 MIPS payment year 2021 MIPS payment year
----------------------------------------------------------------------------------------------------------------
Final score
Final score points MIPS adjustment Final score points MIPS adjustment points MIPS adjustment
----------------------------------------------------------------------------------------------------------------
0.0-0.75........... Negative 4%..... 0.0-3.75........... Negative 5%.... 0.0-7.5........... Negative 7%.
0.76-2.99.......... Negative MIPS 3.76-14.99......... Negative MIPS 7.51-29.99........ Negative MIPS
payment payment payment
adjustment adjustment adjustment
greater than greater than greater than
negative 4% and negative 5% negative 7%
less than 0% on and less than and less than
a linear 0% on a linear 0% on a linear
sliding scale. sliding scale. sliding scale.
3.00............... 0% adjustment... 15.0............... 0% adjustment.. 30.0.............. 0% adjustment.
3.01-69.99......... Positive MIPS 15.01-69.99........ Positive MIPS 30.01-79.99....... Positive MIPS
payment payment payment
adjustment adjustment adjustment
greater than 0% greater than greater than
on a linear 0% on a linear 0% on a linear
sliding scale. sliding scale. sliding scale.
The linear The linear The linear
sliding scale sliding scale sliding scale
ranges from 0 ranges from 0 ranges from 0
to 4% for to 5% for to 7% for
scores from scores from scores from
3.00 to 100.00. 15.00 to 30.00 to
100.00. 100.00.
This sliding This sliding This sliding
scale is scale is scale is
multiplied by a multiplied by multiplied by
scaling factor a scaling a scaling
greater than factor greater factor greater
zero but not than zero but than zero but
exceeding 3.0 not exceeding not exceeding
to preserve 3.0 to 3.0 to
budget preserve preserve
neutrality. budget budget
neutrality. neutrality.
70.0-100........... Positive MIPS 70.0-100........... Positive MIPS 80.0-100.......... Positive MIPS
payment payment payment
adjustment adjustment adjustment
greater than 0% greater than greater than
on a linear 0% on a linear 0% on a linear
sliding scale. sliding scale. sliding scale.
The linear The linear The linear
sliding scale sliding scale sliding scale
ranges from 0 ranges from 0 ranges from 0
to 4% for to 5% for to 7% for
scores from scores from scores from
3.00 to 100.00. 15.00 to 30.00 to
100.00. 100.00.
This sliding This sliding This sliding
scale is scale is scale is
multiplied by a multiplied by multiplied by
scaling factor a scaling a scaling
greater than factor greater factor greater
zero but not than zero but than zero but
exceeding 3.0 not exceeding not exceeding
to preserve 3.0 to 3.0 to
budget preserve preserve
neutrality. budget budget
PLUS. neutrality. neutrality.
PLUS. PLUS.
An additional An additional An additional
MIPS payment MIPS payment MIPS payment
adjustment for adjustment for adjustment for
exceptional exceptional exceptional
performance. performance. performance.
The additional The additional The additional
MIPS payment MIPS payment MIPS payment
adjustment adjustment adjustment
starts at 0.5% starts at 0.5% starts at 0.5%
and increases and increases and increases
on a linear on a linear on a linear
sliding scale. sliding scale. sliding scale.
The linear The linear The linear
sliding scale sliding scale sliding scale
ranges from 0.5 ranges from ranges from
to 10% for 0.5 to 10% for 0.5 to 10% for
scores from scores from scores from
70.00 to 100.00. 70.00 to 80.00 to
100.00. 100.00.
This sliding This sliding This sliding
scale is scale is scale is
multiplied by a multiplied by multiplied by
scaling factor a scaling a scaling
not greater factor not factor not
than 1.0 in greater than greater than
order to 1.0 in order 1.0 in order
proportionately to to
distribute the proportionatel proportionatel
available funds y distribute y distribute
for exceptional the available the available
performance. funds for funds for
exceptional exceptional
performance. performance.
----------------------------------------------------------------------------------------------------------------

We have provided updated examples below for the 2021 MIPS payment
year to demonstrate scenarios in which MIPS eligible clinicians can
achieve a final score at or above the performance threshold of 30
points for the 2021 MIPS payment year.
Example 1: MIPS Eligible Clinician in Small Practice Submits 1 Quality
Measure and 1 Improvement Activity
In the example illustrated in Table 54, a MIPS eligible clinician
in a small practice reporting individually exceeds the performance
threshold by reporting 1 quality measure via claims and performing at
the highest level on the measure, for which the MIPS eligible clinician
receives 10 measure achievement points, and reporting one medium-weight
improvement activity. The practice does not submit data for the
Promoting Interoperability performance category but does submit a
significant hardship exception application which is approved;
therefore, the weight for the Promoting Interoperability performance
category is

[[Page 35980]]

redistributed to the quality performance category under the reweighting
policies discussed in this proposed rule at section III.H.3.i.(2)(b).
We note that this example is only intended to illustrate that small
practices may be later adopters of CEHRT and that during the transition
period there are opportunities to succeed while practices work towards
CEHRT adoption and interoperability. We also assumed the small practice
has a cost performance category percent score of 50 percent. Finally,
we assumed a complex patient bonus of 3 points. There are several
special scoring rules which affect MIPS eligible clinicians in a small
practice:
10 measure achievement points for the 1 quality measure
submitted at the highest level of performance. We refer readers to this
policy at Sec. 414.1380(b)(1). Because the measure is submitted via
claims, it does not qualify for the end-to-end electronic reporting
bonus, nor would it qualify for the high-priority bonus because it is
the only measure submitted. Because the MIPS eligible clinician does
not meet full participation requirements, the MIPS eligible clinician
does not qualify for improvement scoring. However, because the
clinician did submit a measure, the clinician is able to receive 3
measure bonus points for the small practice bonus. Therefore, the
quality performance category is (10 measure achievement points + 3
measure bonus points)/60 total available measure points + zero
improvement percent score which is 21.67 percent.
The Promoting Interoperability performance category weight
is redistributed to the quality performance category so that the
quality performance category score is worth 70 percent of the final
score. We refer readers to section III.H.3.i.(2)(b) of this proposed
rule for a discussion of reweighting policies.
MIPS eligible clinicians in small practices qualify for
special scoring for improvement activities so a medium weighted
activity is worth 20 points (instead of 10 points for MIPS eligible
clinicians generally) out of a total of 40 possible points for the
improvement activities performance category. We refer readers to Sec.
414.1380(b)(3) for this policy.
This MIPS eligible clinician exceeds the performance
threshold of 30 points (but does not exceed the additional performance
threshold). This score is summarized in Table 54.

Table 54--Scoring Example 1, MIPS Eligible Clinician in a Small Practice
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score......... Category weight.......... Earned points
([B] * [C] *
100)
----------------------------------------------------------------------------------------------------------------
Quality................................ 21.67%.................... 70%...................... 15.17
Cost................................... 50%....................... 15%...................... 7.5
Improvement Activities................. 20 out of 40 points--50%.. 15%...................... 7.5
Promoting Interoperability............. N/A....................... 0% (reweighted to 0
quality).
-----------------
Subtotal (Before Bonus)............ .......................... ......................... 30.17
Complex Patient Bonus.............. .......................... ......................... 3
-----------------
Final Score (not to exceed 100) .......................... ......................... 33.17
----------------------------------------------------------------------------------------------------------------

Example 2: Group Submission Not in a Small Practice
In the example illustrated in Table 55, a MIPS eligible clinician
in a medium size practice participating in MIPS as a group receives
performance category scores of 85 percent for the quality performance
category, 50 percent for the cost performance category, 75 percent for
the Promoting Interoperability, and 100 percent for the improvement
activities performance categories. There are many paths for a practice
to receive an 85 percent score in the quality performance category, so
for simplicity we are assuming the score has been calculated at this
amount. The final score is calculated to be 82.5, and both the
performance threshold of 30 and the additional performance threshold of
80 are exceeded. Again, for simplicity, we assume a complex patient
bonus of 3 points. In this example, the group practice does not qualify
for any special scoring, yet is able to exceed the additional
performance threshold and will receive the additional MIPS payment
adjustment factor.

Table 55--Scoring Example 2, MIPS Eligible Clinician in a Medium Practice
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score............. Category weight Earned points
([B] * [C] *
100)
----------------------------------------------------------------------------------------------------------------
Quality..................................... 85%........................... 45% 38.25
Cost........................................ 50%........................... 15% 7.5
Improvement Activities...................... 40 out of 40 points--100%..... 15% 15
Promoting Interoperability.................. 75%........................... 25% 18.75
-----------------------------------
Subtotal (Before Bonus)................. .............................. ................ 79.5
Complex Patient Bonus................... .............................. ................ 3
-----------------------------------
Final Score (not to exceed 100)..... .............................. ................ 82.5
----------------------------------------------------------------------------------------------------------------

[[Page 35981]]

Example 3: Non-Patient Facing MIPS Eligible Clinician
In the example illustrated in Table 56, an individual MIPS eligible
clinician that is non-patient facing and not in a small practice
receives performance category scores of 50 percent for the quality
performance category, 50 percent for the cost performance category, and
50 percent for 1 medium-weighted improvement activity. Again, there are
many paths for a practice to receive a 50 percent score in the quality
performance category, so for simplicity we are assuming the score has
been calculated. Because the MIPS eligible clinician is non-patient
facing, they qualify for special scoring for improvement activities and
receive 20 points (out of 40 possible points) for each medium weighted
activity Also, this individual did not submit Promoting
Interoperability performance category measures and qualifies for the
automatic redistribution of the Promoting Interoperability performance
category weight to the quality performance category. Again, for
simplicity, we assume a complex patient bonus of 3 points.
In this example, the final score is 53 and the performance
threshold of 30 is exceeded while the additional performance threshold
of 80 is not.

Table 56--Scoring Example 3, Non-Patient Facing MIPS Eligible Clinician
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score......... Category weight.......... Earned points
([B] * [C] *
100)
----------------------------------------------------------------------------------------------------------------
Quality................................ 50%....................... 70%...................... 35
Cost................................... 50%....................... 15%...................... 7.5
Improvement Activities................. 20 out of 40 points for 1 15%...................... 7.5
medium weight activity--
50%.
Promoting Interoperability............. 0%........................ 0% (reweighted to 0
quality).
-----------------
Subtotal (Before Bonus)............ .......................... ......................... 50
Complex Patient Bonus.............. .......................... ......................... 3
-----------------
Final Score (not to exceed 100) .......................... ......................... 53
----------------------------------------------------------------------------------------------------------------

We note that these examples are not intended to be exhaustive of
the types of participants nor the opportunities for reaching and
exceeding the performance threshold.
k. Third Party Intermediaries
We refer readers to Sec. 414.1400 and the CY 2018 Quality Payment
Program final rule (82 FR 53806 through 53819) for our previously
established policies regarding third party intermediaries.
In this proposed rule, we are proposing to: (1) Define third party
intermediary and require third party intermediaries to be based in the
U.S.; (2) update certification requirements for data submission; (3)
update the definition of Qualified Clinical Data Registry (QCDR);
revise the self-nomination period for QCDRs; update of information
required for QCDRs at the time of self-nomination; update consideration
criteria for approval of QCDR measures; define the topped out timeline
for QCDR measures; (4) revise the self-nomination period for qualified
registries; (5) define health IT vendor; (6) update the definition,
criteria, and requirements for CMS-approved survey vendor; auditing
criteria; and (7) revising probation and disqualification criteria. As
we continue our efforts to provide flexible and meaningful reporting
options for MIPS eligible clinicians and groups, we will expound on the
requirements and functions of a third party intermediary.
(1) Third Party Intermediaries Definition
At Sec. 414.1305, we are proposing a new definition to define a
third party intermediary as an entity that has been approved under
Sec. 414.1400 to submit data on behalf of a MIPS eligible clinician,
group, or virtual group for one or more of the quality, improvement
activities, and Promoting Interoperability performance categories. A
QCDR, qualified registry, health IT vendor, or CMS-approved survey
vendor are considered third party intermediaries. We are also proposing
to change the section heading at Sec. 414.1400 from ``Third party data
submissions'' to ``Third party intermediaries'' to elucidate the
definition and function of a third party intermediary.
We have received inquiries from stakeholders regarding the ability
of a non-U.S. based third party intermediary to participate in MIPS.
CMS IT systems are required to adhere to multiple agency and federal
security standards and policy. CMS policy prohibits non-U.S. citizens
from accessing CMS IT systems, and also requires all CMS program data
to be retained in accordance with U.S. Federal policy, specifically
National Institute of Standards and Technology (NIST) Special
Publication (SP) 800-63, which outlines enrollment and identity
proofing requirements (levels of assurance) for federal IT system
access. Access to the Quality Payment Program would necessitate passing
a remote or in-person Federated Identity Proofing process (that is,
Equifax or equivalent). A non-U.S. based third party intermediary's
potential lack of a SSN, TIN, U.S. based address, and other elements
required for identity proofing and identity verification would impact
their ability to pass the necessary background checks. An inability to
pass identity proofing may limit or fully deny access to the Quality
Payment Program if the intent is to interact with the Quality Payment
Program outside of the U.S. for the purposes of reporting and storing
data.
We would like to emphasize that these requirements are all tied to
existing federal policy which is applicable to all HHS/CMS FISMA
systems and assets and are not Quality Payment Program specific. More
information on these policies is available here: HHS Information
Security and Privacy Policy (IS2P) (https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/index.html); CMS Information Systems Security
and Privacy Policy (IS2P2) (https://www.cms.gov/Research-Statistics-
Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-
Security-Library-Items/CMS-

[[Page 35982]]

Information-Systems-Security-and-Privacy-Policy-IS2P2.html); OMB
Memorandum 04-04, E-Authentication Guidance for Federal Agencies
(https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy04/m04-04.pdf); and NIST SP 800-63 Digital Identity Guidelines (https://pages.nist.gov/800-63-3/). Therefore, we propose to amend previously
finalized policies at Sec. 414.1400(a)(4) to indicate that a third
party intermediary's principle place of business and retention of
associated CMS data must be within the U.S.
We would like to note that third party intermediaries that are
authorized by us to submit data on behalf of MIPS eligible clinicians,
groups or virtual groups have not otherwise been evaluated for the
capabilities, quality, or any other features or its products. The
United States Government and CMS do not endorse or recommend any third
party intermediary or its products. Prior to selecting or using any
third party intermediary or its products, MIPS eligible clinicians,
groups or virtual groups should perform their own due diligence on the
entity and its products, including contacting the entity directly to
learn more about its products.
(2) Certification
We previously finalized in the CY 2018 Quality Payment Program
final rule (82 FR 53807) at Sec. 414.1400(a)(5), that all data
submitted to us by a third party intermediary on behalf of a MIPS
eligible clinician, group or virtual group must be certified by the
third party intermediary to the best of its knowledge as true,
accurate, and complete; and that this certification must occur at the
time of the submission and accompany the submission. We have discovered
it is not operationally feasible to require certification at the time
of submission, or to require that the certification accompany the
submission, for submission types by third party intermediaries,
including data via direct, login and upload, login and attest, CMS Web
Interface or Medicare Part B claims. We refer readers to section
III.H.3.h of this proposed rule for our proposed modifications to the
previously established data submission terminology. In order to address
these various submission types that are currently available, we are
proposing to amend Sec. 414.1400(a)(5) to state that all data
submitted to CMS by a third party intermediary must be certified as
true, accurate, and complete to the best of its knowledge and that such
certification must be made in a form and manner and at such time as
specified by CMS.
(3) Qualified Clinical Data Registries (QCDRs)
We refer readers to Sec. 414.1400 and the CY 2018 Quality Payment
Program final rule (82 FR 53807 through 53815) for our previously
finalized policies regarding QCDRs. In this proposed rule, we are
proposing to update: The definition of QCDR, the self-nomination period
for QCDRs, information required for QCDRs at the time of self-
nomination, and consideration of criteria for approval of QCDR
measures.
(a) Proposed Update to the Definition of a QCDR
At Sec. 414.1305 and in the CY 2017 Quality Payment Program final
rule (81 FR 77363 through 77364), we finalized the definition of a QCDR
to be a CMS-approved entity that has self-nominated and successfully
completed a qualification process to determine whether the entity may
collect medical or clinical data for the purpose of patient and disease
tracking to foster improvement in the quality of care provided to
patients.
We want to ensure that QCDRs that participate in MIPS have access
to clinical expertise in quality measurement and are able to provide
and demonstrate an understanding of the clinical medicine, evidence-
based gaps in care, and opportunities for improvement in the quality of
care delivered to patients and priorities that are important to MIPS
eligible clinicians. From our experiences with QCDRs to date, we have
discovered that certain entities that have a predominantly technical
background with limited understanding of medical quality metrics or the
process for developing quality measures are seeking approval as a QCDR.
We recognize the importance of these organizations' expertise within
the Quality Payment Program; however, we do not believe that these
types of entities, in the absence of clinical expertise in quality
measurement, meet the intent of QCDRs. Specifically, we are concerned
that the QCDR measures submitted by such entities for approval have not
undergone the same consensus development, scientific rigor, and
clinical assessment that is needed for developing measures, compared to
those QCDR measures that are developed by specialty societies and other
entities with clinical expertise.
We refer readers to the CMS Quality Measure Development Plan at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf for
more information regarding the measure development process. While we
have encouraged the participation of entities as QCDRs, during the past
two iterations of the self-nomination period, a large number of
entities that do not have the necessary clinical expertise to foster
quality improvement have self-nominated or indicated their interest in
becoming QCDRs. In reviewing previous QCDR measure submissions during
the self-nomination and QCDR measure review and approval cycles in
MIPS, we have observed that some entities were developing QCDR measures
without a complete understanding of measure constructs (such as what is
required of a composite measure or what it means to risk-adjust), and
in some instances, QCDRs were developing QCDR measures in clinical
areas in which they did not have expertise. We believe that with the
increasing interest in QCDR development, it is important to ensure that
QCDRs that participate in MIPS are first and foremost in business to
improve the quality of care clinicians provide to their patients
through quality measurement and/or disease tracking. An added benefit
for QCDR participants is providing reliable quality reporting options
for quality reporting programs for clinicians and specialists.
Therefore, beginning with the 2022 MIPS payment year, we propose to
amend Sec. 414.1305 to modify the definition of a QCDR to state that
the approved entity must have clinical expertise in medicine and
quality measure development. As a part of the self-nomination process,
we would look for entities that have quality improvement expertise and
a clinical background. We would also follow up with the entity via, for
example, email or teleconference, should we question whether or not our
standards are met. Specifically, a QCDR would be defined as an entity
with clinical expertise in medicine and in quality measurement
development that collects medical or clinical data on behalf of a MIPS
eligible clinician for the purpose of patient and disease tracking to
foster improvement in the quality of care provided to patients. In
addition, under Sec. 414.1400(b)(2)(ii), an entity that uses an
external organization for purposes of data collection, calculation, or
transmission may meet the definition of a QCDR as long as the entity
has a signed, written agreement that specifically details the
relationship and responsibilities of the entity with the external
organization effective as of September 1 the year prior to the year for
which the entity seeks to become a QCDR. Thus, we expect entities
without clinical expertise in medicine and

[[Page 35983]]

quality measure development that want to become QCDRs would collaborate
or align with entities with such expertise in accordance with Sec.
414.1400(b)(2)(ii). However, such entities may seek to qualify as
another type of third party intermediary, such as a qualified registry.
Becoming a registry does not require the level of measure development
expertise that is needed to be a QCDR that develops measures.
(b) Establishment of an Entity Seeking To Qualify as a QCDR
In the CY 2017 Quality Payment Program final rule (81 FR 77364), we
require at Sec. 414.1400 (c)(2) that the QCDR must have at least 25
participants by January 1 of the performance period. These participants
do not need to use the QCDR to report MIPS data to us; rather, they
need to submit data to the QCDR for quality improvement. We realize
that a QCDR's lack of preparedness to accept data from MIPS eligible
clinicians and groups beginning on January 1 of the performance period
may negatively impact a clinician's ability to use a QCDR to report,
monitor the quality of care they provide to their patients (and act on
these results) and may inadvertently increase clinician burden. For
these reasons, we are proposing to redesignate Sec. 414.1400 (c)(2) as
Sec. 414.1400(b)(2)(i) to state that beginning with the 2022 MIPS
Payment Year, the QCDR must have at least 25 participants by January 1
of the year prior to the performance period. These participants do not
need to use the QCDR to report MIPS data to us; rather, they need to
submit data to the QCDR for quality improvement.
(c) Self-Nomination Process
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53808 through 53813) for our previously established policies
regarding the simplified self-nomination process for existing QCDRs in
MIPS that are in good standing and web-based submission of self-
nomination forms. We are not proposing any changes to those policies in
this proposed rule; however, we are proposing to update: (1) The self-
nomination period; and (2) information required at the time of self-
nomination.
(i) Self-Nomination Period
Under Sec. 414.1400(b), QCDRs must self-nominate from September 1
of the year prior to the applicable performance period until November 1
of the same year and must, among other things, provide all information
requested by us at the time of self-nomination. As indicated in the CY
2017 Quality Payment Program final rule (81 FR 77366), our goal has
been to publish the list of approved QCDRs along with their approved
QCDR measures prior to the beginning of the applicable performance
period.
We have received feedback from entities that have self-nominated to
be a QCDR about the need for additional time to respond to requests for
information during the review process, particularly with respect to
QCDR measures that the entity intends to submit to us for the
applicable performance period. In addition, based on our observations
of the previous two self-nomination cycles, we anticipate an increase
in the number of QCDR measure submissions for our review and
consideration. For the transition year of MIPS, we received over 1,000
QCDR measure submissions for review, and for the CY 2018 performance
period, we received over 1,400 QCDR measure submissions. In order for
us to process, review, and approve the QCDR measure submissions and
provide QCDRs with sufficient time to respond to requests for
information during the review process, while still meeting our goal to
publish the list of approved QCDRs along with their approved QCDR
measures prior to the start of the applicable performance period, we
believe that an earlier self-nomination period is needed.
Therefore, we are proposing to update the self-nomination period
from September 1 of the year prior to the applicable performance period
until November 1 to July 1 of the calendar year prior to the applicable
performance period until September 1. Therefore, we are also proposing
to amend Sec. 414.1400(b)(1) to provide that, beginning with the 2022
MIPS payment year, entities seeking to qualify as QCDRs must self-
nominate during a 60-day period beginning on July 1 of the calendar
year prior to the applicable performance period and ending on September
1 of the same year; must provide all information required by us at the
time of self-nomination; and must provide any additional information
requested by us during the review process. For example, for the 2022
MIPS payment year, the applicable performance period would be CY 2020,
as discussed in section III.H.3.g. of this proposed rule. Therefore for
the CY 2020 performance period, the self-nomination period would begin
on July 1st, 2019 and end on September 1st, 2019, and we will make
QCDRs aware of this through our normal communication channels. We
believe that updating the self-nomination period would allow for
additional review time and measure discussions with QCDRs.
(ii) Information Required at the Time of Self-Nomination
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53814), where we finalized that as a part of the self-nomination
review and approval process for the CY 2018 performance period and
future years, we will assign QCDR measure IDs to approved QCDR
measures, and the same measure ID must be used by any other QCDRs that
have received permission to also report the measure. We have received
some questions from stakeholders as to whether the QCDR measure ID must
be utilized or whether it is optional. As stated in the CY 2018 Quality
Payment Program final rule, QCDRs, including any other QCDRs that have
received permission to also report the measure, must use the CMS-
assigned QDCR measure ID. It is important that the CMS-assigned QCDR
measure ID is posted and used accordingly, because without this ID we
are not able to accurately identify and calculate the QCDR measures
according to their specifications. Therefore, we propose to update
Sec. 414.1400(b)(3)(iii) to state that QCDRs must include their CMS-
assigned QCDR measure ID number when posting their approved QCDR
measure specifications, and also when submitting data on the QCDR
measures to us.
(d) QCDR Measure Requirements
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77374 through 77375) for where we previously finalized standards
and criteria used for selecting and approving QCDR measures. We
finalized that QCDR measures must: Provide specifications for each
measure, activity, or objective the QCDR intends to submit to CMS; and
provide CMS descriptions and narrative specifications for each measure,
activity, or objective no later than November 1 of the applicable
performance period for which the QCDR wishes to submit quality measures
or other performance category (improvement activities and Promoting
Interoperability) data starting with the 2018 performance period and in
future program years. We are proposing to consolidate our previously
finalized standards and criteria used for selecting and approving QCDR
measures at Sec. 414.1400(e) and (f) at Sec. 414.1400(b)(3). In this
proposed rule, we are proposing to apply certain criteria used under
the Call for Quality Measures Process when considering QCDR measures
for possible

[[Page 35984]]

inclusion in MIPS beginning with the MIPS 2021 payment year.
In the CY 2018 Quality Payment Program final rule (82 FR 53814), we
noted our interest in elevating the standards for which QCDR measures
are selected and approved for use and sought comment on whether the
standards and criteria used for selecting and approving QCDR measures
should be more closely aligned with those used for the Call for Quality
Measures process described in the CY 2017 Quality Payment Program final
rule (81 FR 77151). Some commenters expressed concern with this
alignment, stating that the Call for Measures process is cumbersome,
and would increase burden. Other commenters expressed the belief that
the Call for Measures process does not recognize the uniqueness of
QCDRs, and is not agile. We would like to clarify that our intention
with any future alignment is to work towards consistent standards and
evaluation criteria that would be applicable to all MIPS quality
measures, including QCDR measures. We understand that some of the
criteria under the Call for Measures process may be difficult for QCDRs
to meet prior to submitting a particular measure for approval; however,
we believe that the criteria under the Call for Measures process helps
ensure that any new measures are reliable and valid for use in the
program. Having a greater alignment in measure standards helps ensure
that MIPS eligible clinicians and groups are able to select from an
array of measures that are considered to be higher quality and provide
meaningful measurement. As such, we believe that as we gain additional
experience with QCDRs in MIPS, it would be appropriate to further align
these criteria for QCDR measures with those of MIPS quality measures in
future program years.
Therefore, in addition to the QCDR measure criteria previously
finalized at Sec. 414.1400(f), we are proposing to apply select
criteria used under the Call for Measures Process, as described in the
CY 2018 Quality Payment Program final rule (82 FR 53636). Specifically,
in addition to the QCDR measure criteria at proposed Sec.
414.1400(b)(3), we propose to apply the following criteria beginning
with the 2021 MIPS payment year when considering QCDR measures for
possible inclusion in MIPS:
Measures that are beyond the measure concept phase of
development.
Preference given to measures that are outcome-based rather
than clinical process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain for care coordination.
Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost and resource use.
Measures that address significant variation in
performance.
We believe that as we gain additional experience with QCDRs in
MIPS, it would be appropriate to further align these criteria for QCDR
measures with those of MIPS quality measures in future program years.
(e) QCDRs Seeking Permission From Another QCDR To Use an Existing,
Approved QCDR Measure
In the CY 2018 Quality Payment Program final rule (82 FR 53813), we
finalized that beginning with the 2018 performance period and for
future program years, QCDR vendors may seek permission from another
QCDR to use an existing measure that is owned by the other QCDR. We
intended for this policy to help reduce the number of QCDR measures
that are similar in concept or clinical topic, or duplicative of other
QCDR measures that are being approved. Furthermore, having multiple
QCDRs report on the same QCDR measure allows for a larger cohort of
clinicians to report on the measure, which helps establish more
reliable benchmarks and may give some eligible clinicians or group a
better chance of obtaining a higher score on a particular measure.
However, we have experienced that this policy has created unintended
financial burden for QCDRs requesting permission from other QCDRs who
own QCDR measures, as some QCDRs charge a fee for the use of their QCDR
measures. MIPS quality measures, while stewarded by specific specialty
societies or organizations, are generally available for third party
intermediaries, MIPS eligible clinicians, and groups to report on for
purposes of MIPS without a fee for use. Similarly, we believe, that
once a QCDR measure is approved for reporting in MIPS, it should be
generally available for other QCDRs to report on for purposes of MIPS
without a fee for use. We propose at Sec. 414.1400 (b)(3)(ii)(C) that
beginning with the 2021 MIPS payment year, as a condition of a QCDR
measure's approval for purposes of MIPS, the QCDR measure owner would
be required to agree to enter into a license agreement with CMS
permitting any approved QCDR to submit data on the QCDR measure
(without modification) for purposes of MIPS and each applicable MIPS
payment year. We also propose at Sec. 414.1400(b)(3)(iii) that other
QCDRs would be required to use the same CMS-assigned QCDR measure ID.
If a QCDR refuses to enter into such a license agreement, the QCDR
measure would be rejected and another QCDR measure of similar clinical
concept or topic may be approved in its place.
(4) Qualified Registries
We refer readers to Sec. 414.1400 and the CY 2018 Quality Payment
Program final rule (82 FR 53815 through 53818) for our previously
finalized policies regarding qualified registries. In this rule, we are
proposing to update: Information required for qualified registries at
the time of self-nomination and the self-nomination period for
qualified registries. This is discussed in more detail below.
(a) Establishment of an Entity Seeking To Qualify as a Qualified
Registry
In the CY 2017 Quality Payment Program final rule (81 FR 77383), we
state at Sec. 414.1400(h)(2) that the qualified registry must have at
least 25 participants by January 1 of the performance period. These
participants do not need to use the qualified registry to report MIPS
data to us; rather, they need to submit data to the qualified registry
for quality improvement. We realize that a qualified registry's lack of
preparedness to accept data from MIPS eligible clinicians and groups
beginning on January 1 of the performance period may negatively impact
a clinician's ability to use a Qualified Registry to report, monitor
the quality of care they provide to their patients (and act on these
results) and may inadvertently increase clinician burden. For these
reasons, we are proposing to redesignate Sec. 414.1400(h)(2) as Sec.
414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year,
the qualified registry must have at least 25 participants by January 1
of the year prior to the applicable performance period. These
participants do not need to use the qualified registry to report MIPS
data to us; rather, they need to submit data to the qualified registry
for quality improvement.
(b) Self-Nomination Process
We refer readers to Sec. 414.1400(g), the CY 2017 and CY 2018
Quality Payment Program final rules (81 FR 77383 and 82 FR 53815,
respectively) for our previously established policies regarding the
self-nomination process for qualified registries. We are not proposing
any changes to this policy.

[[Page 35985]]

(c) Self-Nomination Period
Under the previously finalized policy at Sec. 414.1400(g),
qualified registries must self-nominate from September 1 of the year
prior to the applicable performance period until November 1 of the same
year and must, among other things, provide all information requested by
us at the time of self-nomination. To maintain alignment with the
timelines proposed for QCDR self-nomination, as discussed in section
III.H.3.k.(3)(c) above, we are also proposing to update the self-
nomination period from September 1 of the year prior to the applicable
performance period until November 1 to July 1 of the calendar year
prior to the applicable performance period until September 1.
Specifically, we are proposing at Sec. 414.1400(c)(1) that, beginning
with the 2022 MIPS payment year, entities seeking to qualify as
qualified registries must self-nominate during a 60-day period
beginning on July 1 of the calendar year prior to the applicable
performance period and ending on September 1 of the same year; must
provide all information required by us at the time of self-nomination;
and must provide any additional information requested by us during the
review process. For example, for the 2022 MIPS payment year, the
applicable performance period would be CY 2020, as discussed in section
III.H.3.g. of this proposed rule. Therefore, the self-nomination period
for qualified registries would begin on July 1, 2019 and end on
September 1, 2019.
(5) Health IT Vendors or Other Authorized Third Parties That Obtain
Data From MIPS Eligible Clinicians' Certified EHR Technology (CEHRT)
We refer readers to Sec. 414.1400 and the CY 2017 Quality Payment
Program final rule (81 FR 77377 through 77382) for our previously
finalized policies regarding health IT vendors or other authorized
third parties that obtain data from MIPS eligible clinicians. We
finalized that health IT vendors that obtain data from a MIPS eligible
clinician, like other third party intermediaries, would have to meet
all criteria designated by us as a condition of their qualification or
approval to participate in MIPS as a third party intermediary. This
includes submitting data in the form and manner specified by us. We
propose to codify these policies at Sec. 414.1400(d). Although we
specified criteria for a health IT vendor in the CY 2017 Quality
Payment Program final rule, we failed to codify the definition of a
health IT vendor. Therefore, in this proposed rule, we are proposing to
define at Sec. 414.1305, that health IT vendor means an entity that
supports the health IT requirements on behalf of a MIPS eligible
clinician (including obtaining data from a MIPS eligible clinician's
CEHRT).
As indicated in footnote 1 of the CY 2017 Quality Payment Program
final rule (81 FR 77014 through 77015), the term ``health IT vendor''
encompasses many types of entities that support the health IT
requirements on behalf of a MIPS eligible clinician. A ``health IT
vendor'' may or may not also be a ``health IT developer'' for the
purposes of the ONC Health IT Certification Program (Program), and, in
some cases, the developer and the vendor of a single product may be
different entities. Under the Program, a health IT developer
constitutes a vendor, self-developer, or other entity that presents
health IT for certification or has health IT certified under the
Program. Other health IT vendors may maintain a range of data
transmission, aggregation, and calculation services or functions, such
as organizations which facilitate health information exchange.
(6) CMS-Approved Survey Vendors
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we
finalized the criteria, required forms, and vendor business
requirements needed to participate in MIPS as a CMS-approved survey
vendor. In this proposed rule, we are proposing at Sec. 414.1400(e) to
codify these previously finalized criteria and requirements.
Accordingly, we propose that Sec. 414.1400(e) would state that
entities seeking to be a CMS-approved survey vendor for any MIPS
performance period must submit a survey vendor application to CMS in a
form and manner specified by CMS for each MIPS performance period for
which it wishes to transmit such data. The application and any
supplemental information requested by CMS must be submitted by
deadlines specified by CMS. We propose that a CMS-approved survey
vendor must meet several criteria. First, an entity must have
sufficient experience, capability, and capacity to accurately report
CAHPS data, including:
At least 3 years of experience administering mixed-mode
surveys (surveys that employ multiple modes to collect data) that
include mail survey administration followed by survey administration
via Computer Assisted Telephone Interview (CATI);
At least 3 years of experience administering surveys to a
Medicare population;
At least 3 years of experience administering CAHPS surveys
within the past 5 years;
Experience administering surveys in English and one of the
following languages: Cantonese, Korean, Mandarin, Russian, or
Vietnamese;
Use of equipment, software, computer programs, systems,
and facilities that can verify addresses and phone numbers of sampled
beneficiaries, monitor interviewers, collect data via CATI,
electronically administer the survey and schedule call-backs to
beneficiaries at varying times of the day and week, track fielded
surveys, assign final disposition codes to reflect the outcome of data
collection of each sampled case, and track cases from mail surveys
through telephone follow-up activities; and
Employ a program manager, information systems specialist,
call center supervisor and mail center supervisor to administer the
survey.
Furthermore, we propose that to be a CMS-approved survey vendor,
the entity must also meet the following criteria: It must have
certified that it has the ability to maintain and transmit quality data
in a manner that preserves the security and integrity of the data; the
entity must have successfully completed, and required its
subcontractors to successfully complete, vendor training(s)
administered by CMS or its contractors; the entity must have submitted
a quality assurance plan and other materials relevant to survey
administration, as determined by CMS, including cover letters,
questionnaires and telephone scripts; the entity must have agreed to
participate and cooperate, and have required its subcontractors to
participate and cooperate, in all oversight activities related to
survey administration conducted by CMS or its contractors; and the
entity must have sent an interim survey data file to CMS that
establishes the entity's ability to accurately report CAHPS data.
We also refer readers to the CY 2018 Quality Payment Program final
rule (82 FR 53818 through 53819) for our previously established
policies regarding the updated survey vendor application deadline.
(7) Auditing of Third Party Intermediaries Submitting MIPS Data
In the CY 2018 Quality Payment Program final rule (82 FR 53819), we
established policies regarding auditing of third party intermediaries
submitting MIPS data. In this proposed rule, we are not proposing any
changes to these policies.

[[Page 35986]]

(8) Remedial Action and Termination of Third Party Intermediaries
In the CY 2017 Quality Payment Program final rule (81 FR 77548), we
finalized the criteria for probation and disqualification for third
party intermediaries at Sec. 414.1400(k). In this proposed rule, we
are proposing to revise the numbering of this section and the title to
more accurately describe the policies in this section. Thus, we propose
to renumber this section as Sec. 414.1400(f) and to rename it as
``remedial action and termination of third party intermediaries.''
Additionally, we are proposing changes to Sec. 414.1400(f) to amend,
clarify, and streamline our policies related to remedial action and
termination.
Our intent with these policies is to identify noncompliance with
the applicable third party intermediary criteria, as well as identify
issues that may impact the accuracy of or our ability to use the data
submitted by third party intermediaries. Accordingly, we propose to
amend Sec. 414.1400(f)(1) to state that we may take remedial action
for noncompliance with applicable third party intermediary criteria for
approval (a deficiency) or for the submission of inaccurate, unusable,
or otherwise compromised data. In the CY 2017 Quality Payment Program
final rule, we finalized our policy regarding data inaccuracies at
Sec. 414.1400(k)(4). We are proposing at Sec. 414.1400(f)(3) to
expand data inaccuracies to include a determination by us that data is
inaccurate, unusable, or otherwise compromised. However, we are not
proposing to change the factors we may consider to make such a
determination. We also propose to move the notification requirement at
Sec. 414.1400(k)(6) to Sec. 414.1400(f)(1) and to apply the
requirement to all deficiencies and data errors.
Based on our early experience with third party intermediaries under
MIPS and the challenges for both third party intermediaries and us in
regards to timing and trying to resolve deficiencies and data errors
within the various reporting and performance periods, we propose to
amend the timeframes by which a third party intermediary must submit a
Corrective Action Plan (CAP) to us or come into compliance.
Specifically, we propose Sec. 414.1400(f)(2), which requires third
party intermediaries to submit a CAP or correct the deficiencies or
data errors by the date specified by us.
Additionally, we propose to consolidate the grounds by which we can
take remedial action against a third party intermediary found at Sec.
414.1400(k)(1) and (4) into Sec. 414.1400(f)(1), as well as the
grounds by which we can terminate a third party intermediary found at
Sec. 414.1400(k)(3), (5) and (7) into Sec. 414.1400(f)(2). Therefore,
we propose at Sec. 414.1400(f)(1) that if at any time we determine
that a third party intermediary has ceased to meet one or more of the
applicable criteria for approval, or has submitted data that is
inaccurate, unusable, or otherwise compromised, we may take certain
remedial actions (for example, request a Corrective Action Plan (CAP)).
In addition, we propose at Sec. 414.1400(f)(2) that we may terminate,
immediately or with advance notice, the ability of a third party
intermediary to submit MIPS data on behalf of a MIPS eligible
clinician, group, or virtual group for one or more of the following
reasons: We have grounds to impose remedial action, we have not
received a CAP within the specified time period or the CAP is not
accepted by us, or the third party intermediary fails to correct the
deficiencies or data errors by the data specified by us.
Finally, we propose to consolidate the actions we may take if we
identify a deficiency or data error that are set forth at Sec.
414.1400(k)(3) and (7) into Sec. 414.1400(f)(1). Thus, we propose at
Sec. 414.1400(f)(1) that if we determine a third party intermediary
has ceased to meet one or more of the applicable criteria for approval,
or has submitted data that is inaccurate, unusable, or otherwise
compromised, we may require the third party intermediary to submit a
CAP to us to address the identified deficiencies or data issue,
including the actions it will take to prevent the deficiencies or data
issues from recurring. The CAP must be submitted to CMS by a date
specified by CMS. We propose that CMS may determine that submitted data
is inaccurate, unusable, or otherwise compromised if the submitted
data: (1) Includes, without limitation, TIN/NPI mismatches, formatting
issues, calculation errors, or data audit discrepancies; and (2)
affects more than three percent (but less than 5 percent) of the total
number of MIPS eligible clinicians or group for which data was
submitted by the third party intermediary. In addition, we propose that
if the third party intermediary has a data error rate of 3 percent or
more, we will publicly disclose the entity's data error rate on the CMS
website until the data error rate falls below 3 percent.
We also propose to amend Sec. 414.1400(k) by removing our
probation policy. Therefore, we propose to remove the definition of
probation at Sec. 414.1400(k)(2) and references to probation in Sec.
414.1400(k)(1), (3) and (5).
1. Public Reporting on Physician Compare
This section contains our proposed policies for public reporting on
Physician Compare for year 3 of the Quality Payment Program (2019 data
available for public reporting in late 2020) and future years,
including MIPS, APMs, and other information as required by the MACRA
and building on our previously finalized public reporting policies (see
82 FR 53819 through 53832).
Physician Compare (http://www.medicare.gov/physiciancompare) draws
its operating authority from section 10331(a)(1) of the Affordable Care
Act. Consistent with section 10331(a)(2) of the Affordable Care Act,
Physician Compare initiated a phased approach to publicly reporting
performance scores that provide comparable information on quality and
patient experience measures. A complete history of public reporting on
Physician Compare is detailed in the CY 2016 PFS final rule (80 FR
71117 through 71122). More information about Physician Compare,
including the history of public reporting and regular updates about
what information is currently available, can also be accessed on the
Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53820), Physician Compare has continued to pursue a phased approach
to public reporting under the MACRA in accordance with section
1848(q)(9) of the Act. Generally, all data available for public
reporting on Physician Compare must meet our established public
reporting standards under Sec. 414.1395(b). In addition, for each
program year, CMS provides a 30-day preview period for any clinician or
group with Quality Payment Program data before the data are publicly
reported on Physician Compare under Sec. 414.1395(d). All data
available for public reporting--measure rates, scores, and
attestations, objectives, etc.--are available for review and correction
during the targeted review process. See the CY 2018 Quality Payment
Program final rule for details on this process (82 FR 53820).
Lastly, section 104(e) of the MACRA requires the Secretary to make
publicly available, on an annual basis, in an easily understandable
format, information for physicians and, as

[[Page 35987]]

appropriate, other eligible clinicians related to items and services
furnished to Medicare beneficiaries under Title XVIII of the Act. In
accordance with section 104(e) of the MACRA, we finalized a policy in
the CY 2016 PFS final rule (80 FR 71131) to add utilization data to the
Physician Compare downloadable database.
We believe section 10331 of the Affordable Care Act supports the
overarching goals of the MACRA by providing the public with performance
information that will help them make informed decisions about their
health care, while encouraging clinicians to improve the quality of
care they provide to their patients. In accordance with section 10331
of the Affordable Care Act, section 1848(q)(9) of the Act, and section
104(e) of the MACRA, we plan to continue to publicly report performance
information on Physician Compare. As such, the following sections
discuss the information previously finalized for inclusion on Physician
Compare for all program years, as well as our proposed policies for
public reporting on Physician Compare for year 3 of the Quality Payment
Program (2019 data available for public reporting in late 2020) and
future years.
(1) Final Score, Performance Categories, and Aggregate Information
In the CY 2018 Quality Payment Program final rule (82 FR 53823), we
finalized a policy to publicly report on Physician Compare, either on
profile pages or in the downloadable database, the final score for each
MIPS eligible clinician and the performance of each MIPS eligible
clinician for each performance category, and to periodically post
aggregate information on the MIPS, including the range of final scores
for all MIPS eligible clinicians and the range of performance of all
the MIPS eligible clinicians for each performance category, as
technically feasible, for all future years. We will use statistical
testing and user testing, as well as consultation with the Physician
Compare Technical Expert Panel convened by our contractor, to determine
how and where these data are best reported on Physician Compare.
A summary of the previously finalized policies related to each
performance category of MIPS data, as well as proposed policies for
year 3 and future years, follows. It is important to note just because
performance information is available for public reporting, it does not
mean all data under all performance categories will be included on
either public-facing profile pages or the downloadable database. These
data must meet the public reporting standards, first. And, second, we
are careful to ensure that we do not include too much information on
public-facing profile pages in an effort not to overwhelm website
users. Although all information submitted under MIPS is technically
available for public reporting, we will continue our phased approach to
making this information public.
(2) Quality
In the CY 2018 Quality Payment Program final rule (82 FR 53824), we
finalized a policy to make all measures under the MIPS quality
performance category available for public reporting on Physician
Compare, either on profile pages or in the downloadable database, as
technically feasible. This includes all available measures across all
collection types for both MIPS eligible clinicians and groups, for all
future years. We will use statistical testing and website user testing
to determine how and where measures are reported on Physician Compare.
We will not publicly report first year quality measures, meaning any
measure in its first year of use in the quality performance category,
under Sec. 414.1395(c). We will also include the total number of
patients reported on for each measure included in the downloadable
database (82 FR 53824).
We propose to modify Sec. 414.1395(b) to reference ``collection
types'' instead of ``submission mechanisms'' to accurately update the
terminology. We also propose to revise Sec. 414.1395(c) to indicate
that we will not publicly report first year quality measures for the
first 2 years a measure is in use in the quality performance category.
We propose this change to encourage clinicians and groups to report new
measures, get feedback on those measures, and learn from the early
years of reporting measures before measure are made public. We request
comment on these proposals.
(3) Cost
In the CY 2018 Quality Payment Program final rule (82 FR 53825), we
finalized a policy to include on Physician Compare a subset of cost
measures that meet the public reporting standards at Sec. 414.1395(b),
either on profile pages or in the downloadable database, if technically
feasible, for all future years. This includes all available cost
measures, and applies to both MIPS eligible clinicians and groups. We
will use statistical testing and website user testing to determine how
and where measures are reported on Physician Compare. We previously
finalized that we will not publicly report first year cost measures,
meaning any measure in its first year of use in the cost performance
category, under Sec. 414.1395(c). Consistent with our proposal for
first year quality measures, we propose to revise Sec. 414.1395(c) to
indicate that we will not publicly report first year cost measures for
the first 2 years a measure is in use in the cost performance category.
We propose this change to help clinicians and groups get feedback on
these measures and learn from the early years of these new measures
being calculated before measure are made public. We request comment on
this proposal.
(4) Improvement Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53826), we
finalized a policy to include a subset of improvement activities
information on Physician Compare, either on the profile pages or in the
downloadable database, if technically feasible, for all future years.
This includes all available activities reported via all available
collection types, and applies to both MIPS eligible clinicians and
groups. For those eligible clinicians and groups that successfully meet
the improvement activities performance category requirements, this
information will be posted on Physician Compare as an indicator. We
also finalized for all future years to publicly report first year
activities if all other public reporting criteria are satisfied.
(5) Promoting Interoperability (PI)
In the CY 2018 Quality Payment Program final rule (82 FR 53827), we
finalized a policy to include an indicator on Physician Compare for any
eligible clinician or group who successfully meets the Promoting
Interoperability performance category, as technically feasible, for all
future years. ``Successful'' performance is defined as obtaining the
base score of 50 percent (82 FR 53826). We also finalized a policy to
include on Physician Compare, either on the profile pages or in the
downloadable database, as technically feasible, additional information,
including, but not limited to, objectives, activities, or measures
specified in the CY 2018 Quality Payment Program final rule (82 FR
53827; see 82 FR 53663 through 53688). This includes all available
objectives, activities, or measures reported via all available
collection types, and applies to both MIPS eligible clinicians and
groups (82 FR 53827). We will use statistical testing and website user
testing to determine how and where objectives, activities, and measures
are reported on Physician Compare. We also

[[Page 35988]]

finalized for all future years to publicly report first year Promoting
Interoperability objectives, activities, and measures if all other
public reporting criteria are satisfied.
In addition, we finalized that we will indicate ``high''
performance, as technically feasible and appropriate, in year 2 of the
Quality Payment Program (2018 data available for public reporting in
late 2019). ``High'' performance is defined as obtaining a score of 100
percent (82 FR 53826 through 53827).
As the Quality Payment Program progresses into year 3, and
consistent with our work to simplify the requirements under the
Promoting Interoperability performance category of MIPS, we are
proposing not to include the indicator of ``high'' performance and to
maintain only an indicator for ``successful'' performance in the
Promoting Interoperability performance category beginning with year 2
of the Quality Payment Program (2018 data available for public
reporting in late 2019). Not including the ``high'' performance
indicator while maintaining the ``successful'' performance indicator
continues to provide useful information to patients and caregivers
without burdening website users with the additional complexity of
accurately differentiating between ``successful'' and ``high''
performance, as this proved difficult for users in testing. User
testing to date shows that website users value this information
overall, however, as they appreciate knowing clinicians and groups are
effectively using EHR technology to improve care quality.
We request comment on our proposal not to include the indicator for
``high'' performance in the Promoting Interoperability performance
category beginning with year 2 of the Quality Payment Program (2018
data available for public reporting in late 2019).
We are also seeking comment only on the type of EHR utilization
performance information stakeholders would like CMS to consider adding
to Physician Compare. This information would be considered for possible
future inclusion on the website.
(6) Achievable Benchmark of Care (ABC^TM)
Benchmarks are important to ensuring that the quality data
published on Physician Compare are accurately understood. A benchmark
allows website users to more easily evaluate the information published
by providing a point of comparison between groups and between
clinicians. In the CY 2018 Quality Payment Program final rule (82 FR
53829), we finalized a policy to use the Achievable Benchmark of Care
(ABC^TM) methodology to determine a benchmark for the
quality, cost, improvement activities, and Promoting Interoperability
data, as feasible and appropriate, by measure and collection type for
each year of the Quality Payment Program based on the most recently
available data each year. We also finalized a policy to use this
benchmark as the basis of a 5-star rating for each available measure,
as feasible and appropriate. For a detailed discussion of the
ABC^TM methodology, and more information about how this
benchmark together with the equal ranges method is currently used to
determine the 5-star rating system for Physician Compare, see the CY
2018 Quality Payment Program final rule (82 FR 53827 through 53829).
Additional information, including the Benchmark and Star Rating Fact
Sheet, can be found on the Physician Compare Initiative website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/index.html).
(a) Historical Data-Based Benchmarks
Benchmarks, and the resulting star rating, are valuable tools for
patients and caregivers to use to best understand the performance
information included on Physician Compare. Benchmarks can also help the
clinicians and groups reporting performance information understand
their performance relative to their peers, and therefore, help foster
continuous quality improvement. In the initial years of the Quality
Payment Program, we anticipated year-to-year changes in the measures
available. As noted, we previously finalized a policy to determine the
benchmark using the most recently available data (82 FR 53829). This
ensured that a benchmark could be calculated despite potential year-to-
year measure changes, but it also meant that the benchmark was not
known to clinicians and groups prior to the performance period.
By year 3 of the Quality Payment Program (2019 data available for
public reporting in late 2020), we expect enough year-to-year stability
in the measures available for reporting across all MIPS performance
categories to use historical data to produce a reliable and
statistically sound benchmark for most measures, by measure and
collection type. Therefore, we are proposing to modify our existing
policy to use the ABC^TM methodology to determine benchmarks
for the quality, cost, improvement activities, and Promoting
Interoperability performance categories based on historical data, as
feasible and appropriate, by measure and collection type beginning with
year 3 of the Quality Payment Program (2019 data available for public
reporting in late 2020). Specifically, benchmarks would be based on
performance data from a baseline period or, if such data is not
available, performance data from the performance period. The baseline
period would be the 12-month calendar year that is 2 years prior to the
applicable performance period. The benchmarks would be published prior
to the start of the performance period, as technically feasible. For
example, for the CY 2019 performance period, the benchmark developed
using the ABC^TM methodology would be calculated using CY
2017 performance period data and would be published by the start of CY
2019, as feasible and appropriate. If historical data is not available
for a particular measure, we would indicate that and calculate the
benchmark using performance data from the performance period. In this
example, we would use CY 2019 performance period data to calculate the
benchmark for CY 2019 performance period measures, as needed. This
approach of utilizing historical data would be consistent with how the
MIPS benchmarks are calculated for purposes of scoring the quality
performance category. But, most importantly, this approach would
provide eligible clinicians and groups with valuable information about
the benchmark to meet to receive a 5-star rating on Physician Compare
before data collection starts for the performance period. We request
comment on this proposal.
(b) QCDR Measure Benchmarks
Currently, only MIPS measures are star rated on Physician Compare.
QCDR measures, as that term is used in Sec. 414.1400(e), are publicly
reported as percent performance rates. As more QCDR measure data is
available for public reporting, and appreciating the value of star
rating the measures presented to website users, we believe star rating
the QCDR measures will greatly benefit patients and caregivers as they
work to make informed health care decisions. Particularly in the
quality performance category, we believe that reporting all measure
data in the same way will ease the burden of interpretation placed on
site users and make the data more useful to them. Therefore, we are
proposing to further modify our existing policy to extend the use of
the ABC^TM methodology and equal ranges method to determine,
by measure and collection type, a benchmark and 5-star rating for QCDR
measures, as that term is used in proposed Sec. 414.1400(b)(3), as
feasible

[[Page 35989]]

and appropriate, using current performance period data in year 2 of the
Quality Payment Program (2018 data available for public reporting in
late 2019), and using historical benchmark data when possible as
proposed above, beginning with year 3 of the Quality Payment Program
(2019 data available for public reporting in late 2020). We request
comment on this proposal.
(7) Voluntary Reporting
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we
finalized a policy to make available for public reporting all data
submitted voluntarily across all MIPS performance categories,
regardless of collection type, by eligible clinicians and groups that
are not subject to the MIPS payment adjustments, as technically
feasible, for all future years. If an eligible clinician or group that
is not subject to the MIPS payment adjustment chooses to submit data on
quality, cost (if applicable), improvement activities, or Promoting
Interoperability, these data are available for public reporting. We
also finalized that during the 30-day preview period, these eligible
clinicians and groups may opt out of having their data publicly
reported on Physician Compare (82 FR 53830). If these eligible
clinicians and groups do not opt out during the 30-day preview period,
their data will be available for inclusion on Physician Compare if the
data meet all public reporting standards at Sec. 414.1395(b).
(8) APM Data
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we
finalized a policy to publicly report the names of eligible clinicians
in Advanced APMs and the names and performance of Advanced APMs and
APMs that are not considered Advanced APMs related to the Quality
Payment Program, such as Track 1 Shared Savings Program Accountable
Care Organizations (ACOs), as technically feasible, for all future
years. We also finalized a policy to link clinicians and groups and the
APMs they participate in on Physician Compare, as technically feasible.
4. Overview of the APM Incentive
a. Overview
Section 1833(z) of the Act requires that an incentive payment be
made to QPs for achieving threshold levels of participation in Advanced
APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399
through 77491), we finalized the following policies:
Beginning in 2019, if an eligible clinician participated
sufficiently in an Advanced APM during the QP Performance Period, that
eligible clinician may become a QP for the year. Eligible clinicians
who are QPs are excluded from the MIPS reporting requirements for the
performance year and payment adjustment for the payment year.
For years from 2019 through 2024, QPs receive a lump sum
incentive payment equal to 5 percent of their prior year's estimated
aggregate payments for Part B covered professional services. Beginning
in 2026, QPs receive a higher update under the PFS for the year than
non-QPs.
For payment years 2019 and 2020, eligible clinicians may
become QPs only through participation in Advanced APMs.
For payment years 2021 and later, eligible clinicians may
become QPs through a combination of participation in Advanced APMs and
Other Payer Advanced APMs (which we refer to as the All-Payer
Combination Option).
In this proposed rule, we discuss proposals for clarifications and
modifications to some of the policies that we previously finalized
pertaining to Advanced APMs and the All-Payer Combination Option.
b. Terms and Definitions
As we continue to develop the Quality Payment Program, we have
identified the need to propose changes to some of the previously
finalized definitions. A complete list of the original definitions is
available in the CY 2017 Quality Payment Program final rule (81 FR
77537 through 77540).
In the CY 2018 Quality Payment Program final rule, in order to
consolidate our regulations and avoid unnecessarily defining a term, we
finalized removal of the defined term for ``Advanced APM Entity'' in
Sec. 414.1305 and replaced instances of that term throughout the
regulation with ``APM Entity.'' Similarly, we finalized replacing
``Advanced APM Entity group'' with ``APM Entity group'' where it
appears throughout our regulations (82 FR 53833). We noted that these
changes were technical and had no substantive effect on our policies.
To further consolidate our regulations and to clarify any potential
ambiguity, we propose to modify the definition of Qualifying APM
Participant (QP) at Sec. 414.1305 to provide that a QP is an eligible
clinician determined by CMS to have met or exceeded the relevant QP
payment amount or QP patient count threshold for the year based on
participation in or with an APM Entity that is participating in an
Advanced APM. The current definition of QP is based on an eligible
clinician's participation in an Advanced APM Entity, which no longer is
a defined term. Simply replacing the term ``Advanced APM Entity'' with
the term ``APM Entity'' as finalized in the CY 2018 Quality Payment
Program final rule does not fully convey the definition of QP because,
as previously noted at 82 FR 53833, an APM Entity can participate in an
APM that is, or is not, an Advanced APM; and QP status is attainable
only through participation in an Advanced APM. Again we note that this
proposed change is technical and would not have a substantive effect on
our policies.
d. Advanced APMs
(1) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77408), we
finalized the criteria that define an Advanced APM based on the
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An
Advanced APM is an APM that:
Requires its participants to use certified EHR technology
(CEHRT) (81 FR 77409 through 77414);
Provides for payment for covered professional services
based on quality measures comparable to measures under the quality
performance category under MIPS (81 FR 77414 through 77418); and
Either requires its participating APM Entities to bear
financial risk for monetary losses that are in excess of a nominal
amount, or is a Medical Home Model expanded under section 1115A(c) of
the Act (81 FR 77418 through 77431). We refer to this criterion as the
financial risk criterion.
(2) Use of CEHRT
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized
that an Advanced APM must require at least 50 percent of eligible
clinicians in each APM Entity to use CEHRT as defined at Sec. 414.1305
to document and communicate clinical care with patients and other
health care professionals. Further, we proposed but did not finalize an
increase to the requirement wherein Advanced APMs must require 75
percent CEHRT use in the subsequent year. Instead we maintained the 50
percent CEHRT use requirement for the second performance year and
beyond and indicated that we would consider making any potential
changes through future rulemaking (81 FR 77412).
As we move into the third year of the Quality Payment Program, we
have prioritized interoperability which we consider to be health
information

[[Page 35990]]

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 also
defined by the 21st Century Cures Act. As such, we are committed to
working with the ONC on implementation of the interoperability
provisions of the 21st Century Cures Act. We also are exploring
opportunities to incorporate these goals into the design of alternative
payment models, wherever feasible and appropriate, to further promote
the seamless and secure exchange of health information for clinicians
and patients.
(b) Increasing the CEHRT Use Criterion for Advanced APMs
We are now proposing that, beginning for CY 2019, in order to be an
Advanced APM, the APM must require at least 75 percent of eligible
clinicians in each APM Entity use CEHRT as defined at Sec. 414.1305 to
document and communicate clinical care with patients and other health
care professionals.
According to data collected by ONC, since the CY 2017 Quality
Payment Program final rule was published, EHR adoption has been
widespread and we want to encourage continued adoption. Additionally,
in response to the CY 2017 Quality Payment Program proposed rule
stakeholders encouraged us to raise the CEHRT use criterion to 75
percent (see 81 FR 77411). We believe that this proposed change aligns
with the increased adoption of CEHRT among providers and suppliers that
is already happening, and will encourage further CEHRT adoption. We
further believe that most existing Advanced APMs already include
provisions that would require participants to adhere to the level of
CEHRT use specified in our regulations, and therefore this increase
will not negatively impact the Advanced APM status of those APMs.
We seek comment on this proposal.
(3) MIPS Comparable Quality Measures
(a) Overview
In the CY 2017 Quality Payment Program final rule, we explained
that one of the criteria for an APM to be an Advanced APM is that it
must provide for payment for covered professional services based on
quality measures comparable to measures under the performance category
described in section 1848(q)(2)(A) of the Act, which is the MIPS
quality performance category. We generally refer to these measures in
the remainder of this discussion as ``MIPS-comparable quality
measures.'' We also explained that we interpret this criterion to
require the APM to incorporate quality measure results as a factor when
determining payment to participants under the terms of the APM (81 FR
77414).
In the CY 2017 Quality Payment Program proposed rule, we proposed
that to be an Advanced APM, an APM must base payment on quality
measures that are evidence-based, reliable, and valid; and that at
least one measure must be an outcome measure unless there is not an
applicable outcome measure on the MIPS quality list at the time the APM
is developed. The required outcome measure does not have to be one of
those on the MIPS quality measure list. We did not specify that the
outcome measure is required to be evidence-based, reliable, and valid.
(81 FR 28302). We finalized these policies in the CY 2017 Quality
Payment Program final rule and codified at Sec. 414.1415(b).
(b) General Quality Measures: Evidence-Based, Reliable, and Valid
We considered a number of ways to implement the Advanced APM
criterion that payment must be based on MIPS-comparable quality
measures, as well as how to define which measures would reflect the
statutory requirements to be ``comparable'' to MIPS quality measures.
We explored options for defining MIPS-comparable quality measures,
including: (1) Limiting comparable measures to those from the annual
MIPS list of measures; and (2) including measures that have an
evidence-based focus and are found to reliable and valid through
measure testing. We concluded that while these potential approaches
have merit, they may be overly restrictive for the variety of APMs,
which are intended to have the flexibility to test new ways of paying
for and delivering care (81 FR 28301 through 28302).
In light of this, we finalized a framework for identifying MIPS-
comparable quality measures that was intended to reflect a few key
principles: Specifically, that the measure framework would require
measures with an evidence-based focus that are reliable and valid,
while not being so restrictive as to limit the APMs from using new or
innovative measures (81 FR 28302).
Specifically, in the CY 2017 Quality Payment Program final rule, we
codified at Sec. 414.1415(b)(2) that at least one of the quality
measures upon which an Advanced APM bases the payment must have an
evidence-based focus, be reliable, and valid, and meet at least one of
the following criteria: Used in the MIPS quality performance category
as described in Sec. 414.1330; endorsed by a consensus-based entity;
developed under section 1848(s) of the Act; Submitted in response to
the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of
the Act; or any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid.
It has come to our attention that some have interpreted Sec.
414.1415(b)(2) to mean that measures on the MIPS final list or
submitted in response to the MIPS Call for Quality Measures necessarily
are MIPS-comparable quality measures, even if they are not evidence-
based, reliable, and valid. We did not intend to imply that any measure
that was merely submitted in response to the annual call for quality
measures or developed using Quality Payment Program funding would
automatically qualify as MIPS-comparable even if the measure was never
endorsed by a consensus-based entity, adopted under MIPS, or otherwise
determined to be evidence-based, reliable, and valid. While we believe
such measures may be evidence-based, reliable, and valid, we did not
intend to consider them so for purposes of Sec. 414.1415(b)(2) without
independent verification by a consensus-based entity, or based on our
own assessment and determination, that they are evidence-based,
reliable, and valid. We further believe the same principle applies to
Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are
endorsed by a consensus-based entity they are presumptively considered
MIPS-comparable quality measures for purposes of Sec. 414.1415(b)(2);
otherwise we would have needed independent verification, or to make our
own assessment and determination, that the measures are evidence-based,
reliable, and valid before considering them to be MIPS-comparable
quality measures (see 81 FR 77415 through 77417).
Because of the potential ambiguity in the existing definition and
out of an abundance of caution in order to avoid any adverse impact on
APM entities, eligible clinicians, or other stakeholders, we have used
the more permissive interpretation of the regulation text, wherein
measures developed under section 1848(s) of the Act and submitted in
response to the MIPS Call for Quality Measures will meet the quality
criterion in implementing the program thus far, and intend to use this
interpretation for the 2019 QP Performance Period until our new
proposal described below is

[[Page 35991]]

effective on January 1, 2020. Recognizing that APMs and other payer
payment arrangements that we might consider for Advanced APM and Other
Payer Advanced APM determinations are well into development for 2019,
we are proposing to amend our regulation at Sec. 414.1415(b)(2) to be
effective as of January 1, 2020. Specifically, we propose that at least
one of the quality measures upon which an Advanced APM bases the
payment in paragraph (b)(1) of this section must be finalized on the
MIPS final list of measures, as described in Sec. 414.1330; be
endorsed by a consensus-based entity; or otherwise determined by CMS to
be evidenced-based, reliable, and valid.
That is, for QP Performance Period 2020 and all future QP
Performance Periods, we will treat any measure that is either included
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All
other measures would need to be independently determined by CMS to be
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
We believe this revised regulation would better articulate our
interpretation of the statute and reflect the MIPS-comparable quality
measure standards that are currently met by all Advanced APMs in
operation, and that we anticipate would be met by those under
development. Additionally, this clarification is intended to align with
our parallel proposal for the Other Payer Advanced APM criteria, and
maintain consistency between the Advanced APM and Other Payer Advanced
APM criteria. We believe this proposal will better align our
regulations and inform stakeholders, particularly eligible clinicians
or APM Entities who may be participating in both Advanced APMs and
Other Payer Advanced APMs in CY 2019, of the applicable quality measure
requirements, while also helping non-Medicare payers to continue
developing payment arrangements that meet the quality measure criterion
to be an Other Payer Advanced APM as discussed at 82 FR 53847.
We seek comment on this proposal.
(c) Outcome Measures: Evidence-Based, Reliable, and Valid
In Sec. 414.1415(b)(3), we generally require that the measures
upon which an Advanced APM bases payment must include at least one
outcome measure, but specify that this requirement does not apply if
CMS determines that there are no available or applicable outcome
measures in the MIPS quality measure lists for the Advanced APM's first
QP Performance Period. We note that the current regulation does not
require that the outcome measure be evidence-based, reliable, and
valid. While it was our general expectation when crafting the CY 2017
Quality Payment Program final rule that outcome measures would meet
this standard, we did not explicitly include this requirement.
We are proposing to modify Sec. 414.1415(b)(3) to explicitly
require that an outcome measure must be evidence-based, reliable, and
valid (unless, as specified in the current regulation, there is no
available or applicable outcome measure). This proposal would have an
effective date of January 1, 2020, and would specifically require that
at least one outcome measure for which measure results are included as
a factor when determining payment to participants under the terms of
the APM for purposes of paragraph (b)(1) must also be a MIPS-comparable
quality measure. This is intended to align with our parallel proposal
for the Other Payer Advanced APM criteria. We believe this proposal
will better align our regulations and inform stakeholders, particularly
eligible clinicians or APM Entities who may be participating in both
Advanced APMs and Other Payer Advanced APMs in CY 2019, of the
originally intended applicable outcomes measure requirements for APMs
to be deemed Advanced APMs and for payment arrangements to be deemed
Other Payer Advanced APMs, while also helping non-Medicare payers to
continue developing payment arrangements that meet the outcomes measure
requirement to be an Other Payer Advanced APM.
As such, we propose to modify Sec. 414.1415(b)(3) (as similarly
proposed in the General Quality Measures: Evidence-Based, Reliable, and
Valid section III.H.4.d.(3)(b) of this proposed rule), so that at least
one outcome measure used for purposes of Sec. 414.1415(b)(1) must also
be:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Determined by CMS to be evidence-based, reliable, and
valid.
As for the proposed requirement for an evidence-based, reliable,
and valid quality measure, as we discuss in section III.H.4.d.(3)(b) of
this proposed rule, we propose to treat any measure that is either
included in the MIPS final list of measures or has been endorsed by a
consensus-based entity as presumptively evidence-based, reliable, and
valid. All other measures would need to be determined by CMS to be
evidence-based, reliable, and valid.
We believe this modification to our regulation would increase the
likelihood that the inclusion of quality measures in Advanced APMs will
lead to improvements in the quality of care and resulting patient
outcomes. Because an Advanced APM is required to base payment on an
outcome measure, (unless an applicable outcome measure is not
available), participants in Advanced APMs may have powerful financial
incentives to modify their behaviors to improve their performance on
this measure. Outcome measures that are not evidence-based, reliable,
and valid may encourage adverse patient selection, or create other
unintended or perverse incentives for model participants. As such, we
believe it is important that the outcome measures on which results are
included as a factor when determining payment under the APM must be
evidence-based, reliable, and valid. We note that these proposed
changes would not change the status of any APMs in our current
portfolio of Advanced APMs.
We seek comment on this proposal.
(4) Bearing Financial Risk for Monetary Losses
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized the
amount of the generally applicable revenue-based nominal amount
standard at 8 percent for the first two QP Performance Periods only,
and we sought comment on what the revenue-based nominal amount standard
should be for the third and subsequent QP Performance Periods.
Specifically, we sought comment on: (1) Setting the revenue-based
standard for 2019 and later at up to 15 percent of revenue; or (2)
setting the revenue-based standard at 10 percent so long as risk is at
least equal to 1.5 percent of expected expenditures for which an APM
Entity is responsible under an APM (81 FR 77427).
In the CY 2018 Quality Payment Program final rule, we finalized our
proposal to maintain the generally applicable revenue-based nominal
amount standard at 8 percent for the 2019 and 2020 QP Performance
Periods at Sec. 414.1415(c)(3)(i)(A). We also specified that the
standard is based on the average estimated total Medicare Parts A and B
revenue of all providers and suppliers in participating APM Entities.
We stated that we would address the nominal amount standard for QP
Performance Periods after 2020 in future rulemaking (82 FR 53838).

[[Page 35992]]

(b) Generally Applicable Nominal Amount Standard
We propose to amend our regulation at Sec. 414.1415(c)(3)(i)(A) to
maintain the generally applicable revenue-based nominal amount standard
at 8 percent of the average estimated total Medicare Parts A and B
revenue of all providers and suppliers in participating APM Entities
for QP Performance Periods 2021 through 2024.
We continue to believe that 8 percent of Medicare Parts A and B
revenues of all providers and suppliers in participating APM Entities
generally represents an appropriate standard for more than a nominal
amount of financial risk at this time. We also believe that maintaining
a consistent standard for several more years will help APM Entities to
plan for multi-year Advanced APM participation. We further believe that
maintaining a consistent standard will allow us to evaluate how APM
Entities succeed within these parameters over the applicable timeframe.
We seek comment on the proposal to maintain the 8 percent nominal
amount standard for QP Performance Periods through 2024.
We also seek comment on whether, as APM entities and participating
eligible clinicians grow more comfortable with assuming risk, we should
consider increasing the nominal amount standard. Specifically, we
request comments on whether we should consider raising the revenue-
based nominal amount standard to 10 percent, and the expenditure-based
nominal amount standard to 4 percent starting for QP Performance
Periods in 2025 and later.
(5) Summary of Proposals
In this section, we are proposing the following policies:
Use of CEHRT:
++ We are proposing to revise our regulation at Sec.
414.1415(a)(i) to specify that an Advanced APM must require at least 75
percent of eligible clinicians in each APM Entity use CEHRT as defined
at Sec. 414.1305 to document and communicate clinical care with
patients and other health care professionals.
MIPS-Comparable Quality Measures
++ We are proposing to revise our regulation to clarify at Sec.
414.1415(b)(2), effective January 1, 2020, that at least one of the
quality measures upon which an Advanced APM bases the payment in
paragraph (b)(1) of this section must either be finalized on the MIPS
final list of measures, as described in Sec. 414.1330; endorsed by a
consensus-based entity; or determined by CMS to be evidenced-based,
reliable, and valid.
++ We are also proposing to revise our regulation at Sec.
414.1415(b)(3), effective January 1, 2020, to provide that at least one
outcome measure, for which measure results are included as a factor
when determining payment to participants under the terms of the APM
must either be finalized on the MIPS final list of measures as
described in Sec. 414.1330, endorsed by a consensus-based entity; or
determined by CMS to be evidence-based, reliable, and valid.
Bearing Financial Risk for Monetary Losses: We propose to
amend our regulation at Sec. 414.1415(c)(3)(i)(A) to maintain the
generally applicable revenue-based nominal amount standard at 8 percent
of the average estimated total Medicare Parts A and B revenue of all
providers and suppliers in participating APM Entities for QP
Performance Periods 2021 through 2024.
e. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
We finalized policies relating to QP and Partial QP determinations
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through
77450).
(2) QP Performance Period
In the CY 2017 Quality Payment Program final rule, we finalized for
the timing of QP determinations that a QP Performance Period runs from
January 1 through August 31 of the calendar year that is 2 years prior
to the payment year (81 FR 77446-77447). During that QP Performance
Period, we will make QP determinations at three separate snapshot dates
(March 31, June 30, and August 31), each of which would be a final
determination for the eligible clinicians who are determined to be QPs.
The QP Performance Period and the three separate QP determinations
apply similarly for both the group of eligible clinicians on a
Participation List and the individual eligible clinicians on an
Affiliated Practitioner List.
We also finalized that for each of the three QP determinations, we
will allow for claims run-out for 3 months, or 90 days, before
calculating the Threshold Scores so that QP determinations will be
completed approximately 4 months after each snapshot date. As a result,
the last of these three QP determinations is complete on or around
January 1 of the subsequent calendar year, which is the year
immediately prior to the MIPS payment year. For most MIPS data
submission types, January 1 of the subsequent calendar year is also the
beginning of the MIPS data submission period. This way, eligible
clinicians know of their QP status prior to or near the beginning of
the MIPS data submission period and know whether they should report any
performance period data to MIPS for the applicable MIPS payment year.
Upon further consideration and based on our experience implementing
the program to date, we believe providing eligible clinicians
notification of their QP status more quickly after each of the three QP
determination snapshot dates, and prior to the beginning of the MIPS
data submission period after the last determination, will potentially
reduce burden for eligible clinicians and APM Entities while improving
their overall experience participating in the program.
Therefore, we propose that for each of the three QP determination
dates, we will allow for claims run-out for 60 days (approximately 2
months), before calculating the Threshold Scores so that the three QP
determinations will be completed approximately 3 months after the end
of that determination time period. We note that this proposal does not
affect the QP Performance Period per se, but rather the date by which
claims for services furnished during the QP Performance Period would
need to be processed in order for those services to be included in
calculating the Threshold Scores. To the extent that claims are used
for calculating the Threshold Scores, such claims would have to be
processed by no later than 60 days after each of the three QP
determination dates, in order for information on the claims to be
included in our calculations. Based on our analysis of Medicare Part B
claims for 2014, we found that there is only a 0.5 percent difference
in claims processing completeness when using 60 days rather than 90
days.
We seek comment on this proposal.
(3) Partial QP Election To Report to MIPS
(a) Overview
Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the
definition of MIPS eligible clinician an eligible clinician who is a
Partial QP for a year and who does not report on applicable measures
and activities as required under MIPS for the year. However, under
section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a
Partial QP for a year and reports on applicable measures and activities
as required under the MIPS is considered to be a MIPS eligible
clinician for the year.
In the CY 2017 Quality Payment Program final rule, we finalized
that following a determination that eligible

[[Page 35993]]

clinicians in an APM Entity group in an Advanced APM are Partial QPs
for a year, the APM Entity will make an election whether to report on
applicable measures and activities as required under MIPS. If the APM
Entity elects to report to MIPS, all eligible clinicians in the APM
Entity would be subject to the MIPS reporting requirements and payment
adjustments for the relevant year. If the APM Entity elects not to
report, all eligible clinicians in the APM Entity group will be
excluded from the MIPS reporting requirements and payment adjustments
for the relevant year (81 FR 77449).
We also finalized that in cases where the Partial QP determination
is made at the individual eligible clinician level, if the individual
eligible clinician is determined to be a Partial QP, the eligible
clinician will make the election whether to report on applicable
measures and activities as required under MIPS and, as a result, be
subject to the MIPS reporting requirements and payment adjustment (81
FR 77449). If the individual eligible clinician elects to report to
MIPS, he or she would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the individual eligible
elects not to report to MIPS, he or she will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year.
We note that QP determinations are made at the individual eligible
clinician level when the clinician is identified as participating in an
Advanced APM on an Affiliated Practitioner List rather than a
Participation List, or when an eligible clinician is in more than one
APM Entity group in one or more Advanced APMs, and does not achieve QP
status as part of any single APM Entity group (see Sec. 414.1425(b)(2)
and (c)(4) our regulations).
We also clarified how we consider the absence of an explicit
election to report to MIPS or to be excluded from MIPS. We finalized
that for situations in which the APM Entity is responsible for making
the decision on behalf of all eligible clinicians in the APM Entity
group, the group of Partial QPs will not be considered MIPS eligible
clinicians unless the APM Entity opts the group into MIPS
participation, so that no actions other than the APM Entity's election
for the group to participate in MIPS would result in MIPS participation
(81 FR 77449).
For eligible clinicians who are determined to be Partial QPs
individually, we finalized that we will use the eligible clinician's
actual MIPS reporting activity to determine whether to exclude the
Partial QP from MIPS in the absence of an explicit election. Therefore,
if an eligible clinician who is individually determined to be a Partial
QP submits information to MIPS (not including information automatically
populated or calculated by CMS on the Partial QP's behalf), we will
consider the Partial QP to have reported, and thus to be participating
in MIPS. Likewise, if such an individual does not take any action to
submit information to MIPS, we will consider the Partial QP to have
elected to be excluded from MIPS (81 FR 77449).
(b) Alignment of Partial QP Election Policies
Upon further consideration and based on our experience implementing
the program to date, we believe there is value in aligning our Partial
QP election policies across all eligible clinicians, whether they
achieved Partial QP status as a part of an APM Entity or as an
individual. We believe this approach will allow for greater simplicity
and clarity for stakeholders.
Therefore, we propose that when an eligible clinician is determined
to be a Partial QP for a year at the individual eligible clinician
level, the individual eligible clinician will make an election whether
to report to MIPS. If the eligible clinician elects to report to MIPS,
they will be subject to MIPS reporting requirements and payment
adjustments. If the eligible clinician elects to not report to MIPS,
they will not be subject to the MIPS reporting requirements and payment
adjustment. If the eligible clinician does not make any election, they
will not be subject to the MIPS reporting requirements and payment
adjustment.
We believe that this default minimizes the possibility of
unexpected participation in MIPS. Currently, eligible clinicians who
are determined to be Partial QPs individually could inadvertently be
subject to the MIPS reporting requirements and payment adjustment based
on reporting behavior that is not fully within their control. We also
believe this approach will minimize the risk that an individual
eligible clinician, particularly one whose NPI is associated with
multiple billing TINs, inadvertently will be subject to MIPS when that
was not that clinician's preference or expectation. We believe it is
important that we act in accordance with the preference of an eligible
clinician who is individually determined to be a Partial QP with
regards to whether they wish to be excluded from MIPS based on the QP
status they were able to achieve, regardless of the MIPS reporting
election decisions of other TINs with which that Partial QP's NPI is
associated.
Furthermore, this proposal creates alignment in the implementation
of our Partial QP election policy for eligible clinicians who are
determined to be Partial QPs individually and for eligible clinicians
who are determined to be Partial QPs at the APM Entity level.
Currently, for eligible clinicians who are determined to be Partial QPs
at the APM Entity level, that group of Partial QPs will not be
considered MIPS eligible clinicians in the absence of an explicit
election to report to MIPS or to be excluded from MIPS by their APM
Entity (81 FR 77449). This proposal would establish the same default in
the absence of an explicit election to report to MIPS or to be excluded
from MIPS for eligible clinicians who are determined to be Partial QPs
individually, so that no actions other than the individual Partial QP's
affirmative election to participate in MIPS would result in MIPS
participation.
We note that this policy change would only affect situations where
the Partial QP makes no election to either report to MIPS or to be
excluded from the MIPS reporting requirements and payment adjustment.
Under our proposed policy, all Partial QPs retain the full right to
affirmatively decide through the election process whether or not to be
subject to the MIPS reporting requirements and payment adjustment;
whereas, if the Partial QP does not make any election, they will not be
subject to the MIPS reporting requirements and payment adjustment.
We seek comment on this proposal.
(4) Summary of Proposals
In this section, we are proposing the following policies:
We propose that for each of the three QP determinations, we will
allow for claims run-out for 60 days (approximately 2 months), before
calculating the Threshold Scores so that the three QP determinations
will be completed approximately 3 months after the end of that
determination time period.
We also propose that when an eligible clinician is determined to be
a Partial QP for a year at the individual eligible clinician level, the
individual eligible clinician will make an election whether to report
to MIPS. If the eligible clinician elects to report to MIPS, they will
be subject to the MIPS reporting requirements and payment adjustment.
If the eligible clinician elects not to report, they will be excluded
from the MIPS reporting requirements and payment adjustment. In the
absence of an explicit election to report to MIPS,

[[Page 35994]]

the eligible clinician will be excluded from the MIPS reporting
requirements and payment adjustment. This means that no actions other
than the eligible clinician's affirmative election to participate in
MIPS would result in that eligible clinician becoming subject to the
MIPS reporting requirements and payment adjustment.
g. All-Payer Combination Option
(1) Overview
Section 1833(z)(2)(B)(ii) of the Act requires that beginning in
payment year 2021, in addition to the Medicare Option, eligible
clinicians may become QPs through the Combination All-Payer and
Medicare Payment Threshold Option, which we refer to as the All-Payer
Combination Option. In the CY 2017 Quality Payment Program final rule,
we finalized our overall approach to the All-Payer Combination Option
(81 FR 77459). The Medicare Option focuses on participation in Advanced
APMs, and we make QP determinations under this option based on Medicare
Part B covered professional services attributable to services furnished
through an APM Entity. The All-Payer Combination Option does not
replace or supersede the Medicare Option; instead, it will allow
eligible clinicians to become QPs by meeting the QP thresholds through
a pair of calculations that assess a combination of both Medicare Part
B covered professional services furnished through Advanced APMs and
services furnished through Other Payer Advanced APMs. We finalized that
beginning in payment year 2021, we will conduct QP determinations
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77438). The All-Payer Combination
Option encourages eligible clinicians to participate in payment
arrangements with payers other than Medicare that have payment designs
that satisfy the Other Payer Advanced APM criteria. It also encourages
sustained participation in Advanced APMs across multiple payers.
We finalized that the QP determinations under the All-Payer
Combination Option are based on payment amounts or patient counts as
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017
Quality Payment Program final rule (81 FR 77460 through 77461). We also
finalized that, in making QP determinations with respect to an eligible
clinician, we will use the Threshold Score that is most advantageous to
the eligible clinician toward achieving QP status, or if QP status is
not achieved, Partial QP status, for the year (81 FR 77475).

Table 57--QP Payment Amount Thresholds--All-Payer Combination Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023 and later
Payment year 2019 2020 2021 (%) 2022 (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Payment Amount Threshold:
Medicare Minimum.................... N/A........................... N/A........................... 25 25 25
Total............................... .............................. .............................. 50 50 75
Partial QP Payment Amount Threshold:
Medicare Minimum.................... N/A........................... N/A........................... 20 20 20
Total............................... .............................. .............................. 40 40 50
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 58--QP Patient Count Thresholds--All-Payer Combination Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023 and later
Payment year 2019 2020 2021 (%) 2022 (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Patient Count Threshold:
Medicare Minimum.................... N/A........................... N/A........................... 20 20 20
Total............................... .............................. .............................. 35 35 50
Partial QP Patient Count Threshold:
Medicare Minimum.................... N/A........................... N/A........................... 10 10 10
Total............................... .............................. .............................. 25 25 35
--------------------------------------------------------------------------------------------------------------------------------------------------------

BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP27JY18.045

BILLING CODE 4120-01-C
Unlike the Medicare Option, where we have access to all of the
information necessary to determine whether an APM meets the criteria to
be an Advanced APM, we cannot determine whether an other payer
arrangement meets the criteria to be an Other Payer Advanced APM
without receiving information about the payment arrangement from an
external source. Similarly, we do not have the necessary payment amount
and patient count information to determine under the All-Payer
Combination Option whether an eligible clinician meets the payment
amount or patient count threshold to be a QP without receiving certain
information from an external source.
In the CY 2018 Quality Payment Program final rule, we established
additional policies to implement the All-Payer Combination Option and
finalized certain modifications to our previously finalized policies
(82 FR 53844 through 53890). A detailed summary of those policies can
be found at 82 FR 53874 through 53876 and 53890 through 53891. In
relevant part, we finalized the following:
Payer Initiated Process
We finalized at Sec. 414.1445(a) and (b)(1) that certain
other payers, including payers with payment arrangements authorized
under Title XIX (the Medicaid statute), Medicare Health Plan payment
arrangements, and payers with payment arrangements aligned with a CMS
Multi-Payer Model, can request that we determine whether their other
payer arrangements are Other Payer Advanced APMs starting prior to the
2019 QP Performance Period and each year thereafter. We finalized that
remaining other payers, including

[[Page 35996]]

commercial and other private payers, could request that we determine
whether other payer arrangements are Other Payer Advanced APMs starting
in 2019 prior to the 2020 QP Performance Period, and annually each year
thereafter. We generally refer to this process as the Payer Initiated
Other Payer Advanced APM Determination Process (Payer Initiated
Process), and we finalized that the Payer Initiated Process would
generally involve the same steps for each payer type for each QP
Performance Period. If a payer uses the same other payer arrangement in
other commercial lines of business, we finalized our proposal to allow
the payer to concurrently request that we determine whether those other
payer arrangements are Other Payer Advanced APMs as well. This policy
is relevant only to the initial year of Payer Initiated Other Payer
Advanced APM determinations for which these submissions can be made
only by payers with arrangements under Title XIX, Medicare Health
Plans, or arrangements aligned with CMS multi-payer models.
Eligible Clinician Initiated Process
We finalized at Sec. 414.1445(a) and (b)(2) that, through
the Eligible Clinician Initiated Process, APM Entities and eligible
clinicians participating in other payer arrangements would have an
opportunity to request that we determine for the year whether those
other payer arrangements are Other Payer Advanced APMs. The Eligible
Clinician Initiated Process can be used to submit requests for
determinations before the beginning of a QP Performance Period for
other payer arrangements authorized under Title XIX. The Eligible
Clinician Initiated Process is available for the 2019 QP Performance
Period and each year thereafter.
Submission of Information for Other Payer Advanced APM Determinations
We finalized that, for each other payer arrangement for
which a payer requests us to make an Other Payer Advanced APM
determination, the payer must complete and submit the Payer Initiated
Submission Form by the relevant Submission Deadline.
We finalized that, for each other payer arrangement for
which an APM Entity or eligible clinician requests us to make an Other
Payer Advanced APM determination, the APM Entity or eligible clinician
must complete and submit the Eligible Clinician Initiated Submission
Form by the relevant Submission Deadline.
We removed the requirement, previously established at
Sec. 414.1445(b)(3), that payers must attest to the accuracy of
information submitted by eligible clinicians, and we also removed the
related attestation requirement at Sec. 414.1460(c). Instead, we
finalized an additional requirement at Sec. 414.1445(d) that an APM
Entity or eligible clinician that submits information under Sec.
414.1445(c) must certify that, to the best of its knowledge, the
information it submits to us is true, accurate, and complete.
QP Determinations Under the All-Payer Combination Option
We finalized at Sec. 414.1440(e) that eligible clinicians
may request that we make QP determinations at the individual eligible
clinician level and that APM Entities may request that we make QP
determinations at the APM Entity level.
We finalized at Sec. 414.1440(d)(1) that we will make QP
determinations under the All-Payer Combination Option based on eligible
clinicians' participation in Advanced APMs and Other Payer Advanced
APMs for three time periods of the QP Performance Period: January 1
through March 31; January 1 through June 30; and January 1 through
August 31. We finalized that we will use patient or payment data for
the same time periods to calculate both the Medicare and the other
payer portion of the Threshold Score calculation under the All-Payer
Cominbation Option.
We finalized at Sec. 414.1440(e)(4) that, to request a QP
determination under the All-Payer Combination Option, APM Entities or
eligible clinicians must submit all of the payment amount and patient
count information sufficient for us to make QP determinations by
December 1 of the calendar year that is 2 years to prior to the payment
year, which we refer to as the QP Determination Submission Deadline.
In this section of the proposed rule, we address policies within
the following topics: Other Payer Advanced APM Criteria; Other Payer
Advanced APM determinations; and Calculation of the All-Payer
Combination Option Threshold Scores and QP Determinations.
(2) Other Payer Advanced APM Criteria
(a) Overview
In general, our goal is to align the Advanced APM criteria under
the Medicare Option and the Other Payer Advanced APM criteria under the
All-Payer Combination Option as permitted by statute and as feasible
and appropriate. We believe this alignment would help simplify the
Quality Payment Program and encourage participation in Other Payer
Advanced APMs (82 FR 53847).
(b) Investment Payments
Some stakeholders have requested that we take into account
``business risk'' costs such as IT, personnel, and other administrative
costs associated with APM Entities' participation in Other Payer
Advanced APMs when implementing the financial risk standard. We are not
proposing to modify our financial risk standard in response to this
suggestion, and note that financial risk in the context of Other Payer
Advanced APMs is defined both in the Act (at section
1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section
1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at
Sec. 414.1420(d) so as to require that APM Entities in the payment
arrangement must assume financial risk when actual expenditures exceed
expected expenditures. However, we note that a payment arrangement with
an other payer, like some APMs, can be structured so that the APM
provides an investment payment to the participating APM Entities to
assist with the practice transformation that may be required for
participation in the payment arrangement. This investment payment could
be structured in various ways; for example, it could be structured
similarly to the Medicare ACO Investment model under, which expected
shared savings payment were pre-paid to encourage new ACOs to form in
rural and underserved areas and to assist existing ACOs in meeting
certain criteria; or it could be structured so that the payment is made
specifically to encourage participating APM Entities to continue to
make staffing, infrastructure, and operations investments as a means of
practice transformation; or it could have a different structure
entirely.
(c) Use of CEHRT
(i) Overview
In the CY 2017 Quality Payment Program final rule, we finalized
that to be an Other Payer Advanced APM, the other payer arrangement
must require at least 50 percent of participating eligible clinicians
in each APM Entity, or each hospital if hospitals are the APM Entities,
to use CEHRT to document and communicate clinical care (81 FR 77465).
This CEHRT use criterion directly paralleled the criterion established
for Advanced APMs in Sec. 414.1415(a)(1)(i).

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In the CY 2018 Quality Payment Program final rule, we finalized
that we would presume that an other payer arrangement meets the 50
percent CEHRT use criterion if we receive information and documentation
from the eligible clinician through the Eligible Clinician Initiated
Process showing that the other payer arrangement requires the
requesting eligible clinician to use CEHRT to document and communicate
clinical care (see Sec. 414.1445(c)(2)). We sought comment on whether
we should consider revising the 50 percent CEHRT use requirement in
future years, and if so what standard we should use in its place (82 FR
53874).
(ii) Increasing the CEHRT Use Criterion for Other Payer Advanced APMs
We are proposing to change the current CEHRT use criterion for
Other Payer Advanced APMs so that in order to qualify as an Other Payer
Advanced APM as of January 1, 2020, the other payer arrangement must
require at least 75 percent of participating eligible clinicians in
each APM Entity to use CEHRT.
According to data collected by ONC, since the CY 2017 Quality
Payment Program final rule was published, EHR adoption has been
widespread, and we want to encourage continued adoption. Additionally,
in response to the CY 2017 Quality Payment Program proposed rule
stakeholders encouraged us to raise the CEHRT threshold to 75 percent
in previous comment solicitations (see 81 FR 77411). We believe that
this proposed change aligns with our proposed change in the Advanced
APM section, wherein we also propose raising the CEHRT use criterion to
75 percent. We believe that this proposed change aligns with the
increased adoption of CEHRT among providers and suppliers that is
already happening, and would encourage further CEHRT adoption. Further,
we believe the January 1, 2020, adoption date would give stakeholders
sufficient time to make the necessary changes for the adoption of this
requirement; specifically, this will allow other payers additional time
to address the proposed increase to the CEHRT use criterion.
We seek comment on this proposal.
(iii) Evidence of CEHRT Use
In the CY 2017 Quality Payment Program final rule, we adopted a
CEHRT use criterion for Other Payer Advanced APMs that directly
paralleled the CEHRT use criterion for Advanced APMs wherein Other
Payer Advanced APMs must require at least 50 percent of eligible
clinicians in each participating APM Entity, or each hospital if
hospitals are the APM Entities, to use CEHRT to document and
communicate clinical care.
We have since heard from payers and other stakeholders that CEHRT
is often used under other payer arrangements even if it is not
expressly required under the payment arrangement. Because CEHRT use is
increasingly common among eligible clinicians, payers may not believe
it is necessary to specifically require the use of CEHRT under the
terms of an Other Payer payment arrangement.
We also note that the statutory CEHRT use requirement for Other
Payer Advanced APMs differs from the comparable standard for Advanced
APMs. The statutory CEHRT use criterion for Advanced APMs under section
1833(z)(3)(D)(i)(I) of the Act specifies that the APM must require
participants in such model to use CEHRT. This differs from section
1833(z)(2)(B)(iii)(II)(bb) of the Act (for payment years 2021 and 2022)
and section 1833(z)(2)(C)(iii)(II)(bb) of the Act (for payment years
beginning in 2023), which specify that Other Payer Advanced APMs are
payment arrangements in which ``CEHRT is used.''
Given this, we believe our current policy may needlessly exclude
certain existing payment arrangements that could meet the statutory
requirements for Other Payer Advanced APMs--including some where the
majority of eligible clinicians use CEHRT, even if they are not
explicitly required to do so under the terms of their payment
arrangements. Accordingly, we are proposing to modify our current
policy to offer additional flexibility that we believe would match more
closely with both the statute and current practices among other payers.
We are proposing that a payer or eligible clinician must provide
documentation to CMS that CEHRT is used to document and communicate
clinical care under the payment arrangement by at least 50 percent of
eligible clinicians in 2019, and 75 percent of the eligible clinicians
in 2020 and beyond, whether or not such CEHRT use is explicitly
required under the terms of the payment arrangement. We are
specifically proposing to modify the regulation at Sec. 414.1420(b) to
specify that to be an Other Payer Advanced APM, CEHRT must be used by
at least 50 percent of eligible clinicians participating in the
arrangement in 2019 (or, beginning in 2020, 75 percent) of such
eligible clinicians).
While a payer that requests an Other Payer Advanced APM
determination for a payment arrangement could continue to meet the
proposed CEHRT use requirement by demonstrating that CEHRT use is
required of at least 50 percent of eligible clinicians in 2019, (or,
beginning in 2020, of at least 75 percent of eligible clinicians),
under the terms of the payment arrangement, the payer and eligible
clinicians also could meet the criterion by documenting CEHRT use among
participating APM entities. Documentation could come from a variety of
sources. For example, the level of CEHRT use in a particular State
Medicaid program could be demonstrated by presenting data from the ONC
showing the CEHRT adoption rate for all physicians in that state along
with state data on the percentage of physicians that participate in the
State Medicaid program. Similarly, commercial payers could document
that CEHRT adoption rates within their networks meet or exceed the
relevant CEHRT use percentage for the year. This is not an exhaustive
list of ways that other payers could document CEHRT use under their
payment arrangements, but suggests some of the possible ways to do so.
With regard to submissions from eligible clinicians, similar sources of
information on CEHRT adoption could be used, such as data from the
State Medicaid Agency or the local health information exchange. To
determine whether the CEHRT use criterion is met, we are willing to
consider data from a payer or eligible clinician. Based on our
conversations with other payers regarding their payment arrangements,
including States with regard to their Medicaid payer arrangements,
Medicare Advantage Organizations with regard to their Medicare
Advantage arrangements, and commercial payers, we believe this
modification would offer additional flexibility and potentially match
more closely with the current commercial payer landscape, as CEHRT is
likely often used under other payer arrangements even if it is not
expressly required in the agreement.
We seek comment on this proposal.
(d) MIPS Comparable Quality Measures
(i) Overview
In the CY 2017 Quality Payment Program final rule, we explained
that one of the criteria for a payment arrangement to be an Other Payer
Advanced APM is that it must apply quality measures comparable to those
under the MIPS quality performance category (81 FR 77465).
In the CY 2017 Quality Payment Program proposed rule, we proposed
that to be an Other Payer Advanced

[[Page 35998]]

APM, a payment arrangement must have quality measures that are
evidence-based, reliable, and valid; and that at least one measure must
be an outcome measure if there is an applicable outcome measure on the
MIPS quality measure list. We generally refer to these measures in the
remainder of this discussion as ``MIPS-comparable quality measures.''
We did not specify that the outcome measure is required to be evidence-
based, reliable, and valid (81 FR 77466). We finalized these policies
in the CY 2017 Quality Payment Program final rule and codified them in
the regulation at Sec. 414.1420(c).
(ii) General Quality Measures: Evidence-Based, Reliable, and Valid
In the CY 2017 Quality Payment Program final rule, we codified at
Sec. 414.1420(c)(2) that at least one of the quality measures used in
the payment arrangement with an APM Entity must have an evidence-based
focus, be reliable, and valid, and meet at least one of the following
criteria:
Used in the MIPS quality performance category as described
in Sec. 414.1330;
Endorsed by a consensus-based entity;
Developed under section 1848(s) of the Act;
Submitted in response to the MIPS Call for Quality
Measures under section 1848(q)(2)(D)(ii) of the Act; or
Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid.
It has come to our attention that, as with the comparable policy
for Advanced APMs as discussed at 81 FR 28302, some have read the
regulation at Sec. 414.1420(c)(2) to mean that measures on the MIPS
final list or submitted in response to the MIPS Call for Quality
Measures necessarily are MIPS-comparable quality measures, even if they
have not been determined to be evidence-based, reliable, and valid. We
did not intend to imply that any measure that was merely submitted in
response to the annual call for quality measures or developed using
Quality Payment Program funding would automatically qualify as MIPS-
comparable even if the measure was never endorsed by a consensus-based
entity, adopted under MIPS, or otherwise determined to be evidence-
based, reliable, and valid. While we believe such measures may be
evidence-based, reliable, and valid, we did not intend consider them so
for purposes of Sec. 414.1420(c)(2) without independent verification
by a consensus-based entity, or based on our own assessment and
determination, that they are evidence-based, reliable, and valid. We
further believe the same principle applies to QCDR measures. If QCDR
measures are endorsed by a consensus-based entity they are
presumptively considered MIPS-comparable quality measures for purposes
of Sec. 414.1420(c)(2); otherwise we would have needed independent
verification, or to make our own assessment and determination, that the
measures are evidence-based, reliable, and valid before considering
them to be MIPS-comparable (see 81 FR 77415 through 77417).
Because of the potential ambiguity in the existing definition and
out of an abundance of caution in order to avoid any adverse impact on
APM entities, eligible clinicians or other stakeholders, we have used
the more permissive interpretation of the text, wherein measures
developed under section 1848(s) of the Act and submitted in response to
the MIPS Call for Quality Measures will meet the quality criterion in
implementing the program thus far, and intend to use this
interpretation for the 2019 QP Performance Period. Recognizing that
APMs and other payer arrangements that we might consider for Advanced
APM and Other Payer Advanced APM determinations are well into
development for 2019, we would use this interpretation until our new
proposal described below is effective on January 1, 2020.
Therefore, at Sec. 414.1420(c)(2), we are proposing, effective as
of January 1, 2020, that at least one of the quality measures used in
the payment arrangement with an APM Entity must meet at least one of
the following criteria:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Otherwise determined by CMS to be evidenced-based,
reliable, and valid.
That is, for QP Performance Period 2020 and all future QP
Performance Periods, we would treat any measure that is either included
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All
other measures would need to be independently determined by CMS to be
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
We believe this revised regulation would better articulate our
interpretation of the statute and reflect the MIPS-comparable quality
measure standards that are currently met by all Advanced APMs in
operation and that we anticipate would be met by those under
development. Additionally, this clarification is intended to align with
our parallel proposal for the Advanced APM criteria, and maintain
consistency between the Advanced APM and Other Payer Advanced APM
criteria. We believe this clarification will better align our
regulations and inform stakeholders, particularly eligible clinicians
or APM Entities who may be participating in both Advanced APMs and
Other Payer Advanced APMs in CY 2019, of the applicable quality measure
requirements, while also helping non-Medicare payers to continue
developing payment arrangements that meet the quality measure criterion
to be an Other Payer Advanced APM as discussed at 82 FR 53847.
(iii) Outcome Measures: Evidence-Based, Reliable, and Valid
In Sec. 414.1420(c)(3), we generally require that, to be an Other
Payer Advanced APM, the payment arrangement must use an outcome measure
if there is an applicable outcome measure on the MIPS quality measure
list. We note that the current regulation does not require that the
outcome measure be evidence-based, reliable, and valid.
We are proposing to revise Sec. 414.1420(c)(3), to explicitly
require that, unless there is no applicable outcome measure on the MIPS
quality measure list, at least one outcome measure that applies in the
payment arrangement must be evidence-based, reliable, and valid. This
proposal would have an effective date of January 1, 2020, and would
specifically require that an outcome measure must also be MIPS-
comparable. This proposal aligns with the similar proposal for Other
Payer Advanced APMs discussed at section III.H.4.d.(2)(d)(ii) of this
proposed rule, so that an outcome measure used in the payment
arrangement must also be:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Determined by CMS to be evidence-based, reliable, and
valid.
As with the general requirement for an evidence-based, reliable,
and valid quality measure, as we propose to clarify at section
III.H.4.d.(2)(d)(ii) of this proposed rule, we would treat any measure
that is either included in the MIPS final list of measures or has been
endorsed by a consensus-based entity as presumptively evidence-based,
reliable, and valid. All other measures would need to be determined by
CMS to be evidence-based, reliable, and valid.
We believe this modification to our regulation would increase the
likelihood

[[Page 35999]]

that Other Payer Advanced APMs use quality measures that will lead to
improvements in the quality of care and resulting patient outcomes.
Because an Other Payer Advanced APM is required to use an outcome
measure unless no one is available, participants in Other Payer
Advanced APMs may have powerful financial incentives to modify their
behaviors to improve their performance on this measure. Outcome
measures that are not evidence-based, reliable, and valid may encourage
adverse patient selection, or create other unintended and perverse
incentives for model participants. As such, we believe it is important
that the outcome measure be evidence-based, reliable, and valid.
We propose to make this change to our regulation effective January
1, 2020. This proposed effective date is intended to provide
stakeholders sufficient notice of, and opportunity to respond to, this
change in our regulation because the current regulation does not
explicitly require that an outcomes measures must be evidence-based,
reliable, and valid and, as a result some Other Payer Advanced APMs
that were submitted for determination in CY 2018 for the CY 2019
performance year may not include outcomes measures that are evidence-
based, reliable, and valid.
We also propose that, for such payment arrangements that are
determined to be Other Payer Advanced APMs for the 2019 performance
year and did not include an outcome measure that is evidence-based,
reliable, and valid, and that are resubmitted for an Other Payer
Advanced APM determination for the 2020 performance year (whether for a
single year, or for a multi-year determination as proposed in section
III.H.4.g.(3)(b) of this proposed rule), we would continue to apply the
current regulation for purposes of those determinations. Additionally,
payment arrangements in existence prior to the 2020 performance year
that are submitted for determination to be Other Payer Advanced APMs
for the 2020 performance year and later, will be assessed under the
rules of the current regulation meaning they do not need to include an
outcome measure that is evidence-based, reliable, and valid to be an
Other Payer Advanced APM. For all other payment arrangements the
proposed revised regulation would apply beginning in CY 2020.
We believe this is necessary because there may be some Other Payer
Advanced APMs that currently do not include outcomes measures that are
evidence-based, reliable, and valid because the current regulation does
not explicitly require it. In order to provide for an even application
of our current policy and an even transition to the proposed policy,
and to avoid any adverse impact on APM entities, eligible clinicians or
other stakeholders, we believe it is appropriate to apply the revision
to Sec. 414.1420(c)(3) beginning with determinations that occur after
2020 with respect to those payment arrangements noted above. We also
note that this exception would apply for only one year for single-year
determinations, and only through the earlier of the end of the payment
arrangement or 5 years for determinations under multi-year
determination process proposed in section III.H.4.g.(3)(b) of this
proposed rule. For all payment arrangements starting in 2020, or those
initially submitted for Other Payer Advanced APM determinations for the
2021 performance year and later, the payment arrangement would need to
use an outcome measure that is evidence-based, reliable, and valid
unless there is no applicable outcome measure on the MIPS final quality
measure list.
We note that these proposed changes to our regulations would not
change the status of any payment arrangements that we have determined
to be Other Payer Advanced APMs for 2019, or for the basis for our
determinations of Other Payer Advanced APMs in 2019 for 2020.
We believe a January 1, 2020, effective date would give
stakeholders sufficient notice of, and opportunity to respond to, this
change in our regulation.
(e) Financial Risk for Monetary Losses
(i) Overview
In the CY 2018 Quality Payment Program final rule, we finalized our
proposal to add a revenue-based nominal amount standard to the
generally applicable nominal amount standard for Other Payer Advanced
APMs that is parallel to the generally applicable revenue-based nominal
amount standard for Advanced APMs. Specifically, we finalized that an
other payer arrangement would meet the total risk component of the
proposed nominal risk standard if, under the terms of the other payer
arrangement, the total amount that an APM Entity potentially owes the
payer or foregoes is equal to at least: For the 2019 and 2020 QP
Performance Periods, 8 percent of the total combined revenues from the
payer of providers and suppliers in participating APM Entities. This
standard is in addition to the previously finalized expenditure-based
standard. We explained that a payment arrangement would only need to
meet one of the two standards. We would use this standard only for
other payer arrangements where financial risk is expressly defined in
terms of revenue in the payment arrangement.
(ii) Generally Applicable Nominal Amount Standard
We propose to amend our regulation at Sec. 414.1420(d)(3)(i) to
maintain the generally applicable revenue-based nominal amount standard
at 8 percent of the total combined revenues from the payer of providers
and suppliers in participating APM Entities for QP Performance Periods
2019 through 2024.
We continue to believe that 8 percent the total combined revenues
from the payer of providers and suppliers in participating APM Entities
generally represents an appropriate standard for more than a nominal
amount of financial risk at this time. We further believe that
maintaining a consistent standard between Advanced APMs and Other Payer
Advanced APMs will allow us to evaluate how APM Entities succeed within
these parameters across payers over the applicable timeframe.
We seek comment on the proposal to maintain the 8 percent nominal
amount standard for Other Payer Advanced APMs for QP Performance
Periods through 2024.
(3) Determination of Other Payer Advanced APMs
(a) Overview
In the CY 2017 Quality Payment Program final rule, we specified
that an APM Entity or eligible clinician must submit, by a date and in
a manner determined by us, information necessary to identify whether a
given payment arrangement satisfies the Other Payer Advanced APM
criteria (81 FR 77480).
In the CY 2018 Quality Payment Program final rule, we codified at
Sec. 414.1445 the Payer Initiated Other Payer Advanced APM
Determination Process and the Eligible Clinician Initiated Other Payer
Advanced APM Determination Process pertaining to the determination of
Other Payer Advanced APMs, as well as specifying the information
required for Other Payer Advanced APM determinations (82 FR 53814
through 53873).
(b) Multi-Year Other Payer Advanced APM Determinations
In the CY 2018 Quality Payment Program final rule, we finalized
that Other Payer Advanced APM determinations made in response to
requests submitted either through the Payer Initiated Other Payer
Advanced APM Determination Process (Payer Initiated Process) or the
Eligible Clinician Initiated Other Payer Advanced APM Determination
Process

[[Page 36000]]

(Eligible Clinician Initiated Process) would be in effect for only one
year at a time. We sought additional comment regarding the current
duration of payment arrangements and whether creating a multi-year
determination process would encourage the creation of more multi-year
payment arrangements as opposed to payment arrangements that are for
one year only. We also sought comment on what kind of information
should be submitted annually after the first year to update an Other
Payer Advanced APM determination (82 FR 53869 through 53870).
In response to our request for comments, we received several
comments asking that we allow Other Payer Advanced APM determinations
to be in effect for more than one year at a time. These commenters
suggested that requiring annual determinations is burdensome,
particularly because payment arrangements for other payers are often
implemented through multi-year contracts.
After consideration of this feedback, we are proposing to maintain
the annual submission process with the modifications outlined below for
both the Payer Initiated Process and the Eligible Clinician Initiated
Process. We propose that beginning with the 2019 and 2020 submission
periods for Other Payer Advanced APM determinations for performance
year 2020, after the first year that a payer, APM Entity, or eligible
clinician (which we refer to as the ``requester'' in the remainder of
this discussion) submits a multi-year payment arrangement that we
determine to be an Other Payer Advanced APM for that year, the
requester would need to submit information only on any changes to the
payment arrangement that are relevant to the Other Payer Advanced APM
criteria for each successive year for the remaining duration of the
payment arrangement. In the initial submission, the requester would
certify as usual that the information provided about the payment
arrangement using the Payer Initiated Process or Eligible Clinician
Initiated Process, as applicable, is true, accurate, and complete;
would authorize CMS to verify the information; and would certify that
they would submit revised information in the event of a material change
to the payment arrangement. For multi-year payment arrangements, we
propose to require as part of the submission that the certifying
official for the requester must agree to review the submission at least
once annually, to assess whether there have been any changes to the
information since it was submitted, and to submit updated information
notifying us of any changes to the payment arrangement that would be
relevant to the Other Payer Advanced APM criteria and, thus, to our
determination of the arrangement to be an Other Payer Advanced APM, for
each successive year of the arrangement. Absent the submission by the
requester of updated information to reflect changes to the payment
arrangement, we would continue to apply the original Other Payer
Advanced APM determination for each successive year through the earlier
of the end of that multi-year payment arrangement or 5 years.
We believe this proposal aligns with the multi-year payment
arrangements between other payers and eligible clinicians. In many
cases, details of the payment arrangements may not change over the full
duration of the payment arrangement. In other multi-year arrangements,
we understand based on public comments that only certain aspects of the
arrangement may change over the multi-year agreement, while most
elements of the arrangement remain in place throughout the multi-year
term of the agreement. However, because we understand that payment
arrangements between payers and eligible clinicians can be renewed for
multiple multi-year periods, we propose that the multi-year Other Payer
Advanced APM determination would remain in effect until the arrangement
is terminated or expires, but in no event longer than 5 years. Although
we believe multi-year determinations would appropriately take into
account multi-year payment arrangements, thereby reducing burden for
requesters, we also believe that requiring a periodic full submission
of information about a payment arrangement would be prudent, and that a
5-year interval is a reasonable time frame to require such a full
submission using the Payer Initiated Process or Eligible Clinician
Initiated Process (or other equivalent submission process that is in
place at that time).
We believe that our proposal will more accurately reflect the
manner and timeline on which payers make changes to payment
arrangements. The current policy requiring payers and eligible
clinicians to resubmit a comprehensive description of payment
arrangements each year even after an Other Payer Advanced APM
determination has been made in the previous year, and when the payment
arrangements have a term of multiple years and do not change
significantly from year to year, may be overly burdensome and
unnecessary as it may require the duplicative resubmission of a
substantial amount of information each year. Our proposal would
require, for the shorter of the term of the payment arrangement or five
years, the submission of information only in the event there are
changes in the information the requestor has submitted, and only when
those changes are relevant to the Other Payer Advanced APM criteria and
our Other Payer Advanced APM determination. We believe that while this
would allow us to continue to conduct regular reviews of the payment
arrangements to ensure the criteria for Other Payer Advanced APMs are
being met, it would greatly reduce the burden on the payers, APM
Entities, and eligible clinicians that submit requests for Other Payer
Advanced APM determinations for multi-year payment arrangements.
Further, we believe this proposal would simplify the Other Payer
Advanced APM determination process and would likely result in more
Other Payer Advanced APMs in general, specifically more Other Payer
Advanced APMs that are identified for multiple successive years. This,
in turn, would make the Quality Payment Program simpler, as well as
increase year-to-year consistency, and reliability for clinicians.
We seek comment on this proposal.
(c) Payer Initiated Other Payer Advanced APM Determination Process
(Payer Initiated Process)--Remaining Other Payers
In the CY 2018 Quality Payment Program final rule, we finalized
that we will allow certain other payers, including payers with payment
arrangements authorized under Title XIX, Medicare Health Plan payment
arrangements, and payers with payment arrangements aligned with a CMS
Multi-Payer Model to use the Payer Initiated Process to request that we
determine whether their other payer arrangements are Other Payer
Advanced APMs starting prior to the 2019 QP Performance Period and each
year thereafter (82 FR 53854). We codified this policy at Sec.
414.1445(b)(1).
We also finalized that the remaining other payers, including
commercial and other private payers, may request that we determine
whether other payer arrangements are Other Payer Advanced APMs starting
prior to the 2020 QP Performance Period and each year thereafter (82 FR
53867).
In this section, we are proposing details regarding the Payer
Initiated Process for the remaining other payers that were not among
those other payers permitted to use the Payer Initiated Process to
submit their arrangements for Other Payer Advanced APM Determinations
in 2018 (Remaining

[[Page 36001]]

Other Payers). To the extent possible, we are aligning the Payer
Initiated Process for remaining other payers with the previously
finalized Payer Initiated Process for Medicaid, Medicare Health Plans,
and CMS Multi-Payer Models.
In the CY 2018 Quality Payment Program final rule, we finalized
that the Payer Initiated Process will be voluntary for all payers (82
FR 53855). We note that the Payer Initiated Process will be similarly
voluntary for payers that were permitted to submit payment arrangements
in 2018 and for remaining other payers starting in 2019.
Guidance and Submission Form: As we have for the other payers
included in the Payer Initiated Process (82 FR 53874), we intend to
make guidance available regarding the Payer Initiated Process for
Remaining Other Payers prior to their first Submission Period, which
would occur during 2019. We intend to modify the submission form (which
we refer to as the Payer Initiated Submission Form) for use by
remaining other payers to request Other Payer Advanced APM
determinations, and to make this Payer Initiated Submission Form
available to remaining other payers prior to the first Submission
Period. We propose that a Remaining Other Payer would be required to
use the Payer Initiated Submission Form to request that we make an
Other Payer Advanced APM determination. We intend for the Payer
Initiated Submission Form to include questions that are applicable to
all payment arrangements and some questions that are specific to a
particular type of payment arrangement, and we intend for it to include
a way for payers to attach supporting documentation. We propose that
remaining other payers may submit requests for review of multiple other
payer arrangements through the Payer Initiated Process, though we would
make separate determinations as to each other payer arrangement and a
payer would be required to use a separate Payer Initiated Submission
Form for each other payer arrangement. Remaining other payers may
submit other payer arrangements with different tracks within that
arrangement as one request along with information specific to each
track.
Submission Period: We propose that the Submission Period for the
Payer Initiated Process for use by remaining other payers to request
Other Payer Advanced APM determinations would open on January 1 of the
calendar year prior to the relevant QP Performance Period for which we
would make Other Payer Advanced APM determinations. We proposed that
the Submission Deadline is June 1 of the year prior to the QP
Performance Period for which we would make the determination.
The proposed timeline for the Payer Initiated Process for Remaining
Other Payers as well as the finalized timeline for the Payer Initiated
Process for Medicaid and Medicare Health Plans, is summarized in Table
59 alongside the final timeline for the Eligible Clinician Initiated
Process.

Table 59--Proposed Other Payer Advanced APM Determination Process for Medicaid, Medicare Health Plans, and Remaining Other Payers for QP Performance
Period 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eligible clinician
Payer initiated Date (EC) initiated Date
process process *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid............................... Guidance sent to January 2019........................... Guidance made September 2019.
states, then available to ECs,
Submission Period then Submission
Opens. Period Opens.
Submission Period April 2019............................. Submission Period November 2019.
Closes. Closes.
CMS contacts states September 2019......................... CMS contacts ECs and December 2019.
and posts Other states and posts
Payer Advanced APM Other Payer
List. Advanced APM List.
Medicare Health Plans.................. Guidance made April 2019............................. Guidance made September 2020.
available to available to ECs,
Medicare Health then Submission
Plans, then Period Opens.
Submission Period
Opens.
Submission Period June 2019.............................. Submission Period November 2020.
Closes. Closes.
CMS contacts Medicare September 2019......................... CMS contacts ECs and December 2020.
Health Plans and Medicare Health
posts Other Payer Plans and posts
Advanced APM List. Other Payer
Advanced APM List.
Remaining Other Payers................. Guidance made January 2019........................... Guidance made September 2020.
available to available to ECs,
Remaining Other then Submission
Payers, then Period Opens.
Submission Period
Opens.
Submission Period June 2019.............................. Submission Period November 2020.
Closes. Closes.
CMS contacts September 2019......................... CMS contacts ECs and December 2020.
Remaining Other Remaining Other
Payers and posts Payers and posts
Other Payer Advanced Other Payer
APM List. Advanced APM List.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible Clinician Initiated Process.

CMS Determination: Upon the timely receipt of a Payer Initiated
Submission Form, we would use the information submitted to determine
whether the other payer arrangement meets the Other Payer Advanced APM
criteria. We propose that if we find that the Remaining Other Payer has
submitted incomplete or inadequate information, we would inform the
payer and allow them to submit additional information no later than 15
business days from the date we inform the payer of the need for
additional information. For each other payer arrangement for which the
Remaining Other Payer does not submit sufficient information in a
timely fashion, we would not make a determination in response to that
request submitted via the Payer Initiated Submission Form. As a result,
the other payer arrangement would not be considered an Other Payer
Advanced APM for the year. These determinations are final and not
subject to reconsideration.
CMS Notification: We intend to notify Remaining Other Payers of our
determination for each request as soon as practicable after the
relevant

[[Page 36002]]

Submission Deadline. We note that Remaining Other Payers may submit
information regarding an other payer arrangement for a subsequent QP
Performance Period even if we have determined that the other payer
arrangement is not an Other Payer Advanced APM for a prior year.
CMS Posting of Other Payer Advanced APMs: We intend to post on the
CMS website a list (which we refer to as the Other Payer Advanced APM
List) of all other payer arrangements that we determine to be Other
Payer Advanced APMs. Prior to the start of the relevant QP Performance
Period, we intend to post the Other Payer Advanced APMs that we
determine through the Payer Initiated Process and Other Payer Advanced
APMs under Title XIX that we determine through the Eligible Clinician
Initiated Process. After the QP Performance Period, we would update
this list to include Other Payer Advanced APMs that we determine based
on other requests through the Eligible Clinician Initiated Process. We
intend to post the list of other payer arrangements that we determine
to be Other Payer Advanced APMs through the Payer Initiated Process
prior to the start of the relevant QP Performance Period, and then to
update the list to include Other Payer Advanced APMs that we determine
based on requests received through the Eligible Clinician Initiated
Process.
(d) Payer Initiated Process--CMS Multi-Payer Models
In the CY 2018 Quality Payment Program final rule, we finalized
that beginning for the first QP Performance Period under the All-Payer
Combination Option, payers with a payment arrangement aligned with a
CMS Multi-Payer Model may request that we determine whether that
aligned payment arrangement is an Other Payer Advanced APM.
We are proposing to eliminate the Payer Initiated Process and
submission form that are specifically for CMS Multi-Payer Models. We
believe that payers aligned with CMS Multi-Payer Models can submit
their arrangements through the Payer Initiated Process for Remaining
Other Payers we have proposed in section III.H.4.g.(3)(c) of this
proposed rule, or through the existing Medicaid or Medicare Health Plan
payment arrangement submission process, as applicable.
In the first year of implementing the Payer Initiated Process, we
intentionally limited the types of payers that could use the process to
Medicaid, Medicare Health Plans, and CMS Multi-Payer Models. We limited
the types of other payers that could use the Payer Initiated Process so
as to limit the volume of submissions in our first year of
implementation, and chose to include payers that already have a
programmatic or contractual relationship with CMS. Payers in the
category of CMS Multi-Payer Models may be Medicaid, Medicare Health
Plans, or commercial payers who have partnered with CMS in the
development of some of our Advanced APMs.
In eliminating the Payer Initiated Process and submission form
specifically for CMS Multi-Payer Models, we are not prohibiting any of
these payers from submitting payment arrangements to request that CMS
make Other Payer Advanced APM determinations. Rather, we are providing
a process for them within larger categories of the Payer Initiated
Process, whether as commercial payers, or as arrangements under
Medicaid or Medicare Health Plans. We note that the policies proposed
for the Payer Initiated Process for Remaining Other Payers, including
the timeframe, deadlines, and submission form are substantially similar
or identical to those policies finalized for Payer Initiated Process
for payment arrangements under Medicaid and Medicare Health Plans.
(4) Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized our
overall approach to the All-Payer Combination Option (81 FR 77463).
Beginning in 2021, in addition to the Medicare Option, an eligible
clinician may alternatively become a QP through the All-Payer
Combination Option, and an eligible clinician need only meet the QP
threshold under one of the two options to be a QP for the payment year
(81 FR 77459). We finalized that we will conduct the QP determination
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77459).
In the CY 2017 Quality Payment Program final rule, we finalized
that we will calculate Threshold Scores under the Medicare Option
through both the payment amount and the patient count methods, compare
each Threshold Score to the relevant QP and Partial QP Thresholds, and
use the most advantageous scores to make QP determinations (81 FR
77457). We finalized the same approach for the All-Payer Combination
Option wherein we will use the most advantageous method for QP
determinations with the data that has been provided (81 FR 77475).
(b) QP Determinations Under the All-Payer Combination Option
In the CY 2018 Quality Payment Program final rule, we finalized
that an eligible clinician may request a QP determination at the
eligible clinician level, and that an APM Entity may request a QP
determination at the APM Entity Level (82 FR 53880 through 53881). In
the event that we receive a request for QP determination from an
individual eligible clinician and also separately from that individual
eligible clinician's APM Entity, we would make a determination at both
levels. The eligible clinician could become a QP on the basis of either
of the two determinations (82 FR 53881).
We sought comment on whether in future rulemaking we should add a
third alternative to allow QP determinations at the TIN level when all
clinicians who have reassigned billing rights to the TIN are included
in a single APM Entity. In particular, we sought comment on whether
submitting information to request QP determinations under the All-Payer
Combination Option at the TIN level would more closely align with
eligible clinicians' existing billing and recordkeeping practices, and
thereby be less burdensome (82 FR 53881).
We received several comments asking that we add a third alternative
to allow requests for QP determinations at the TIN level. These
commenters remarked that TIN-level requests and determinations would
align with how payers often contract with practices (that is, at the
TIN level), as well as encourage alignment between TIN-level Medicare
and Other Payer Advanced APMs, minimize data reporting burden, and
promote team-based care.
After considering these comments, and in the interest of increasing
flexibility under the All-Payer Combination Option, we are proposing to
add a third alternative to allow requests for QP determinations at the
TIN level in instances where all clinicians who have reassigned billing
rights under the TIN participate in a single APM Entity. This option
would therefore be available to all TINs participating in Full TIN
APMs, such as the Medicare Shared Savings Program. It would also be
available to any other TIN for which all clinicians who have reassigned
their billing rights to the TIN are participating in a single APM
Entity.
We are proposing that, similar to our existing policies for
individual and APM Entity requests for QP determinations under the All-
Payer Combination Option, we would assess

[[Page 36003]]

QP status based on the most advantageous result for each individual
eligible clinician. That is, if we receive any combination of QP
determination requests (at the TIN-level, APM Entity level, or
individual level) we would make QP assessments at all requested levels
and determine QP status on the basis of the QP assessment that is most
advantageous to the eligible clinician.
We are proposing to revise our regulations at Sec. 414.1440(d), to
add this third alternative to allow QP determinations at the TIN level
in instances where all clinicians who have reassigned billing rights to
the TIN participate in a single APM Entity, and to assess QP status
based on the most advantageous result for each eligible clinician.
We are further proposing to allow TIN level requests for QP
determinations only in instances where the entire TIN has met the
Medicare threshold for the All-Payer Combination Option based on their
participation in Advanced APMs, by virtue of their participation in a
single Advanced APM entity. This is by definition not the case in
scenarios where an eligible clinician meets the Medicare threshold for
the All-Payer Combination Option individually, and therefore we would
not allow TIN level request for QP determinations in such scenarios.
We believe that adding the third alternative as proposed would
provide more flexibility for eligible clinicians to attain QP status
and go further toward reflecting the way that payers typically contract
with eligible clinicians. We believe that having three possible levels
for QP determinations would likely increase the opportunities of
eligible clinicians to attain QP status. Further, we believe this
proposal would reduce burdens on eligible clinicians who frequently
contract, bill, and report data at the TIN level. This reduction in
burden may encourage increased participation in Other Payer Advanced
APMs.
(c) Use of Individual or APM Entity Group Information for Medicare
Payment Amount and Patient Count Calculation Under the All-Payer
Combination Option
(i) Flexibility in the Medicare Option and All-Payer Combination Option
Threshold Methods
In the CY 2018 Quality Payment Program final rule, we finalized
that when we make QP determinations at the individual eligible
clinician level, we would use the individual eligible clinician payment
amounts and patient counts for the Medicare calculations in the All-
Payer Combination Option. When we make QP determinations at the APM
Entity level, we will use APM Entity level payment amounts and patient
counts for the Medicare calculations in QP determinations under the
All-Payer Combination Option. Eligible clinicians assessed at the
individual eligible clinician level under the Medicare Option at Sec.
414.1425(b)(2) will be assessed at the individual eligible clinician
level only under the All-Payer Combination Option. We codified these
policies at Sec. 414.1440(d)(2) (82 FR 53881).
Based on comments from stakeholders, we believe there may be some
remaining confusion on the relationship between the payment amount and
patient count thresholds in the context of the All Payer Combination
Option. Therefore, we are reiterating our policy that the minimum
Medicare threshold needed to qualify for a QP determination for the
All-Payer Combination Option may be calculated based on either payment
amounts or patient counts (whichever is more favorable to the
clinician); and that the All-Payer threshold, which includes Medicare
data, may then be calculated based on either payment amounts or patient
counts, regardless of which method was used for the initial Medicare
threshold calculation and that we would similarly use whichever is more
favorable to the clinician. Some have read our regulation at Sec.
414.1440(d)(2) to suggest that consistency is required across the two
thresholds requiring eligible clinicians or APM Entities to meet the
minimum Medicare threshold needed to qualify for the All-Payer
Combination Option and the All-Payer threshold using the same method--
either payment amounts or patient counts. Although we did not directly
address this specific question in our current regulation or in prior
rulemaking, we are clarifying that eligible clinicians or APM Entities
can meet the minimum Medicare threshold for the All-Payer Combination
Option using one method (whichever is most favorable), and the All-
Payer threshold for the All-Payer Combination Option using either the
same, or the other method. All data submitted to us for Other Payer
Advanced APM determinations and, when applicable, QP determinations
using the All-Payer Combination Option will be considered and
evaluated; and eligible clinicians (or APM Entities or TINs, as
appropriate) may submit all data relating to both the payment amount
and patient count methods.
To avoid any potential ambiguity for the future, we are proposing a
change to our regulation at Sec. 414.1440(d) to codify this
clarification. We propose to add a new Sec. 414.1440(d)(4) to
expressly allow eligible clinicians or APM Entities to meet the minimum
Medicare threshold using the most favorable of the payment amount or
patient count method, and then to meet the All-Payer threshold using
either the same method or the other method.
We believe this clarification will encourage the submission of more
complete data with All-Payer Combination Option QP determination
requests, maximize the number of QPs, and thereby encourage
participation by eligible clinicians in Advanced APMs and Other Payer
Advanced APMs by always using the calculation method most favorable to
the clinician. Further, we believe the codification of this
clarification in our regulation would maximize flexibility while
reducing potential uncertainty.
(ii) Extending the Medicare Threshold Score Weighting Methodology to
TIN Level All-Payer Combination Option Threshold Score Calculations
In the CY 2018 Quality Payment Program final rule, we explained
that we recognize that in many cases an individual eligible clinician's
Medicare Threshold Scores would likely differ from the corresponding
Threshold Scores calculated at the APM Entity group level, which would
benefit those eligible clinicians whose individual Threshold Scores
would be higher than the group Threshold Scores and disadvantage those
eligible clinicians whose individual Threshold Scores are equal to or
lower than the group Threshold Scores (82 FR 53881-53882). In
situations where eligible clinicians are assessed under the Medicare
Option as an APM Entity group, and receive a Medicare Threshold Score
at the APM Entity group level, we believe that the Medicare portion of
their All-Payer calculation under the All-Payer Combination Option
should not be lower than the Medicare Threshold Score that they
received by participating in an APM Entity group.
To accomplish this outcome, we finalized a modified weighting
methodology. We finalized that when the eligible clinician's Medicare
Threshold Score calculated at the individual level would be lower than
the one calculated at the APM Entity group level, we would apply a
weighting methodology to calculate the Threshold Score for the eligible
clinician. This methodology allows us to apply the APM Entity group
level Medicare Threshold Score (if higher than the individual eligible
clinician

[[Page 36004]]

level Medicare Threshold Score), to the eligible clinician, under
either the payment amount or patient count method, but weighted to
reflect the individual eligible clinician's Medicare volume. We
multiply the eligible clinician's APM Entity group Medicare Threshold
Score by the total Medicare payments or patients made to that eligible
clinician as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.046

We propose to extend the same weighting methodology to TIN level
Medicare Threshold Scores in situations where a TIN is assessed under
the Medicare Option as part of an APM Entity group, and receives a
Medicare Threshold Score at the APM Entity group level. In this
scenario, we believe that the Medicare portion of the TIN's All-Payer
Combination Option Threshold Score should not be lower than the
Medicare Threshold Score that they received by participating in an APM
Entity group (82 FR 53881-53882). We note this extension of the
weighting methodology would only apply to a TIN when that TIN
represents a subset of the eligible clinicians in the APM Entity,
because when the TIN and the APM Entity are the same there is no need
for this weighted methodology. We would multiply the TIN's APM Entity
group Medicare Threshold Score by the total Medicare payments or
patients for that TIN as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.047

As an example of how this weighting methodology would apply under the
payment amount method for payment year 2021, consider the following APM
Entity group with two TINs, one of which participates in Other Payer
Advanced APMs and one which does not.

Table 60--Weighting Methodology Example--Payment Amount Method
----------------------------------------------------------------------------------------------------------------
Medicare-- Other payer--
advanced APM Medicare-- total Advanced APM Other payer--
payments payments payments total payments
----------------------------------------------------------------------------------------------------------------
TIN A................................... $150 $200 $0 $500
TIN B................................... 150 800 760 1,200
APM Entity.............................. 300 1,000
----------------------------------------------------------------------------------------------------------------

In this example, the APM Entity group Medicare Threshold Score is
$300/$1,000, or 30 percent. Eligible Clinicians in TIN A and B would
not be QPs under the Medicare Option, but TIN B could request that we
make a QP determination under the All-Payer Combination Option since
the APM Entity group exceeded the 25 percent minimum Medicare payment
amount threshold under that option.
If we calculate the TIN's payments on its own without the proposed
weighting policy, we would calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.048

Because TIN B's Threshold Score is less than the 50 percent QP Payment
Amount Threshold, TIN B would not meet the QP Threshold based on this
result. However, if we apply the weighting methodology, we would
calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.049

Based upon this Threshold Score, TIN B would meet the QP Threshold
under the All-Payer Combination Option.
We propose to calculate the TIN's Threshold Scores both on its own
and with this weighted methodology, and then use the most advantageous
score when making a QP determination. We believe that, as it does for
QP determinations made at the APM Entity level, this approach promotes
consistency between the Medicare Option and the All-Payer Combination
Option to the extent possible. Additionally, the proposed application
of this weighting approach in the case of a TIN level QP determination
would

[[Page 36005]]

be consistent with our established policy.
(5) Summary of Proposals
In this section, we propose the following policies:
Other Payer Advanced APM Criteria
We are proposing to change the CEHRT use criterion so that
in order to qualify as an Other Payer Advanced APM as of January 1,
2020, the percentage of eligible clinicians participating in the other
payer arrangement who are using CEHRT must be 75 percent.
We are proposing to allow payers and eligible clinicians
to submit evidence as part of their request for an Other Payer Advanced
APM determination that CEHRT is used by the requisite percentage of
eligible clinicians participating in the payment arrangement (50
percent for 2019, and 75 percent for 2020 and beyond) to document and
communicate clinical care, whether or not CEHRT use is explicitly
required under the terms of the payment arrangement.
We are proposing the following clarification to Sec.
414.1420(c)(2), effective January 1, 2020, to provide that at least one
of the quality measures used in the payment arrangement in paragraph
(c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We are proposing to revise Sec. 414.1420(c)(3) to require
that, effective January 1, 2020, unless there is no applicable outcome
measure on the MIPS quality measure list, an Other Payer Advanced APM
must use an outcome measure, that meets the proposed criteria in
paragraph (c)(2) of this regulation.
We are also proposing at Sec. 414.1420(c)(3)(i) that, for
payment arrangements determined to be Other Payer Advanced APMs for the
2019 performance year which did not include an outcome measure that is
evidence-based, reliable, and valid, that are resubmitted for an Other
Payer Advanced APM determination for the 2020 performance year (whether
for a single year, or for a multi-year determination as proposed in
section III.H.4.g.(3)(b) of this proposed rule), we would continue to
apply the current regulation for purposes of those determinations. This
proposed revision also applies to payment arrangements in existence
prior to the 2020 performance year that are submitted for determination
to be Other Payer Advanced APMs for the 2020 performance year and
later.
Determination of Other Payer Advanced APMs
We are proposing details regarding the Payer Initiated
Process for remaining other payers. To the extent possible, we are
aligning the Payer Initiated Process for remaining other payers with
the previously finalized Payer Initiated Process for Medicaid, Medicare
Health Plans, and CMS Multi-Payer Models.
We are proposing to eliminate the Payer Initiated Process
that is specifically for CMS Multi-Payer Models. We believe that payers
aligned with CMS Multi-Payer Models can submit their arrangements
through the Payer Initiated Process for Remaining Other Payers proposed
in section III.H.4.g.(3)(c) of this proposed rule, or through the
Medicaid or Medicare Health Plan payment arrangement submission
processes.
Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations
We propose to add a third alternative to allow requests
for QP determinations at the TIN level in instances where all
clinicians who reassigned billing rights under the TIN participate in a
single APM Entity. We propose to modify our regulation at Sec.
414.1440(d), by adding this third alternative to allow QP
determinations at the TIN level in instances where all clinicians who
have reassigned billing under the TIN participate in a single APM
Entity, as well as to assess QP status at the most advantageous level
for each eligible clinician.
We are also clarifying that, in making QP determinations
using the All-Payer Combination Option, eligible clinicians may meet
the minimum Medicare threshold using one method, and the All-Payer
threshold using the same or a different method. We are proposing to
codify this clarification by adding Sec. 414.1440(d)(4).
We propose to extend the weighting methodology that is
used to ensure that an eligible clinician does not receive a lower
score on the Medicare portion of their all-payer calculation under the
All-Payer Combination Option than the Medicare Threshold Score they
received at the APM Entity level in order to apply a similar policy to
the proposed TIN level Medicare Threshold Scores. We would use this
methodology only in situations where a TIN is assessed under the
Medicare Option as part of an APM Entity group, and receives a Medicare
Threshold Score at the APM Entity group level.
5. Quality Payment Program Technical Correction: Regulation Text
Changes
We are proposing certain technical revisions to our regulations in
order to correct several technical errors and to reconcile the text of
several of our regulations with the final policies we adopted through
notice and comment rulemaking.
We are proposing a technical revision to Sec. 414.1415(b)(1) of
our regulations to specify that an Advanced APM must require quality
measure performance as a factor when determining payment to
participants for covered professional services under the terms of the
APM. The addition of the word ``quality'' better aligns with section
1833(z)(3)(D) of the Act and with the policy that was finalized in the
CY 2017 Quality Payment Program final rule (81 FR 77406), and corrects
a clerical error we made in the course of revising the text of Sec.
414.1415(b)(1) for inclusion in the CY 2017 QPP final rule. This
proposed revision would not change our current policy for this Advanced
APM criterion.
We are also proposing technical revisions to the regulation at
Sec. 414.1420(d)(3)(ii)(B). These changes align with the generally
applicable nominal amount standard for Other Payer Advanced APMs that
was finalized in the CY 2017 Quality Payment Program final rule, and
the change to the generally applicable nominal amount standard in the
CY 2018 Quality Payment Program final rule where we established a
revenue-based nominal amount standard as part of the Other Payer
Advanced APM criteria (82 FR 53849-53850). We finalized that a payment
arrangement must require APM Entities to bear financial risk for at
least 3 percent of the expected expenditures for which an APM Entity is
responsible under the payment arrangement, and that a payment
arrangement's level of marginal risk must be at least 30 percent of
losses in excess of the expected expenditures, and the maximum
allowable minimum loss rate must be 4 percent (81 FR 77471). Due to a
clerical oversight, we inadvertently published two conflicting
provisions in regulation text; at Sec. 414.1420(d)(3)(i), we correctly
finalized that a payment arrangement must require APM Entities to bear
financial risk for at least 3 percent of the expected expenditures for
which an APM Entity is responsible under the payment arrangement, and
at Sec. 414.1420(d)(3)(ii)(B) we incorrectly finalized that the risk
arrangement must have a total potential risk of at least 4

[[Page 36006]]

percent of expected expenditures. We are effectuating this change by
removing the Other Payer Advanced APM Criteria, Financial Risk,
Generally Applicable Nominal Amount Standard provision at Sec.
414.1420(d)(3)(ii)(B) and consolidating Sec. 414.1420(d)(3)(ii)(A)
into Sec. 414.1420(d)(3)(ii).
We are proposing to revise the regulations at Sec. Sec.
414.1415(c) and 414.1420(d). In the CY 2017 Quality Payment Program
final rule, we finalized a capitation standard for the financial risk
criterion under the Advanced APM Criteria and the Other Payer Advanced
APM Criteria, respectively. We finalized that full capitation
arrangements would meet the Advanced APM financial risk criterion and
Other Payer Advanced APM financial risk criterion, and would not
separately need to meet the generally applicable financial risk
standard and generally applicable nominal amount standard in order to
satisfy the financial risk criterion for Advanced APMs and Other Payer
Advanced APMs (81 FR 77431; 77472). We believe the application of the
capitation standard as described by this regulation could be made
clearer by revising Sec. Sec. 414.1415(c) and 414.1420(d) to refer to
the full capitation exception that is expressed in paragraphs (c)(6)
and (d)(7), respectively.
We are also proposing to revise Sec. Sec. 414.1415(c)(6) and
414.1420(d)(7). In finalizing Sec. Sec. 414.1415(c)(6) and
414.1420(d)(7), we specified that a capitation arrangement means a
payment arrangement in which a per capita or otherwise predetermined
payment is made under the APM for all items and services for which
payment is made through the APM furnished to a population of
beneficiaries, and no settlement is performed to reconcile or share
losses incurred or savings earned by the APM Entity. This language does
not completely reflect our definition of capitation risk arrangements
as discussed in preamble at 81 FR 77430 where we state that,
``capitation risk arrangements, as defined here, involve full risk for
the population of beneficiaries covered by the arrangement, recognizing
that it might require no services whatsoever or could require
exponentially more services than were expected in calculating the
capitation rate. . . . [a] capitation risk arrangement adheres to the
idea of a global budget for all items and services to a population of
beneficiaries during a fixed period of time.'' We propose to revise
these regulations to align the Advanced APM Criteria, Financial Risk,
Capitation provision at Sec. 414.1415(c)(6), and the Other Payer
Advanced APM Criteria, Financial Risk, Capitation provision at Sec.
414.1420(d)(7) with the definition of capitation risk arrangements that
we expressed in the preamble of the CY 2017 Quality Payment Program
final rule at 81 FR 77430-77431.
We are also proposing a technical correction to remove the ``; or''
and replace it with a ``.'' at Sec. 414.1420(d)(3)(i) because the
paragraph that follows that section does not specify a standard that is
necessarily an alternative to the standard under Sec.
414.1420(d)(3)(i), but rather expresses a standard that is independent
of the standard under Sec. 414.1420(d)(3)(i). As indicated in the CY
2018 Quality Payment Program final rule at 82 FR 53849-53850, where we
established a revenue-based nominal amount standard for Other Payer
Advanced APMs, in order to meet the generally applicable nominal amount
standard under the Other Payer Advanced APM criteria, the total amount
that an APM Entity potentially owes the payer or foregoes under a
payment arrangement must be equal to at least: for the 2019 and 2020 QP
Performance Periods, 8 percent of the total combined revenues from the
payer to providers and other entities under the payment arrangement;
or, 3 percent of the expected expenditures for which an APM Entity is
responsible under the payment arrangement.
We are also proposing to amend the regulation at Sec.
414.1440(d)(3) to correct a typographical error by replacing the
``are'' with ``is'' in the third clause of the second sentence.

IV. Requests for Information

This section addresses two requests for information (RFIs). Upon
reviewing the RFIs, respondents are encouraged to provide complete but
concise responses. These RFIs are issued solely for information and
planning purposes; neither RFI constitutes a Request for Proposal
(RFP), application, proposal abstract, or quotation. The RFIs do not
commit the U.S. Government to contract for any supplies or services or
make a grant award. Further, CMS is not seeking proposals through these
RFIs and will not accept unsolicited proposals. Responders are advised
that the U.S. Government will not pay for any information or
administrative costs incurred in response to these RFIs; all costs
associated with responding to these RFIs will be solely at the
interested party's expense. Failing to respond to either RFI will not
preclude participation in any future procurement, if conducted. It is
the responsibility of the potential responders to monitor each RFI
announcement for additional information pertaining to the request.
Please note that CMS will not respond to questions about the policy
issues raised in these RFIs. CMS may or may not choose to contact
individual responders. Such communications would only serve to further
clarify written responses. Contractor support personnel may be used to
review RFI responses. Responses to these RFIs are not offers and cannot
be accepted by the U.S. Government to form a binding contract or issue
a grant. Information obtained as a result of these RFIs may be used by
the U.S. Government for program planning on a non-attribution basis.
Respondents should not include any information that might be considered
proprietary or confidential. These RFIs should not be construed as a
commitment or authorization to incur cost for which reimbursement would
be required or sought. All submissions become U.S. Government property
and will not be returned. CMS may publically post the comments
received, or a summary thereof.

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

Currently, Medicare- and Medicaid-participating providers and
suppliers are at varying stages of adoption of health information
technology (health IT). Many hospitals have adopted electronic health
records (EHRs), and CMS has provided incentive payments to eligible
hospitals, critical access hospitals (CAHs), and eligible professionals
who have demonstrated meaningful use of certified EHR technology
(CEHRT) under the Medicare EHR Incentive Program. As of 2015, 96
percent of Medicare- and Medicaid-participating non-Federal acute care
hospitals had adopted certified EHRs with the capability to
electronically export a summary of clinical care.\36\ While both
adoption of EHRs and electronic exchange of information have grown
substantially among hospitals, significant obstacles to exchanging
electronic health information across the continuum of care persist.
Routine electronic transfer of information post-discharge has not been
achieved by providers and suppliers in many

[[Page 36007]]

localities and regions throughout the Nation.
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\36\ These statistics can be accessed at https://dashboard.healthit.gov/quickstats/pages/FIG-Hospital-EHR-Adoption.php.
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CMS is firmly committed to the use of certified health IT and
interoperable EHR systems for electronic healthcare information
exchange to effectively help hospitals and other Medicare- and
Medicaid-participating providers and suppliers improve internal care
delivery practices, support the exchange of important information
across care team members during transitions of care, and enable
reporting of electronically specified clinical quality measures
(eCQMs). The Office of the National Coordinator for Health Information
Technology (ONC) acts as the principal Federal entity charged with
coordination of nationwide efforts to implement and use health
information technology and the electronic exchange of health
information on behalf of the Department of Health and Human Services.
In 2015, ONC finalized the 2015 Edition health IT certification
criteria (2015 Edition), the most recent criteria for health IT to be
certified to under the ONC Health IT Certification Program. The 2015
Edition facilitates greater interoperability for several clinical
health information purposes and enables health information exchange
through new and enhanced certification criteria, standards, and
implementation specifications. CMS requires eligible hospitals and CAHs
in the Medicare and Medicaid EHR Incentive Programs and eligible
clinicians in the Quality Payment Program (QPP) to use EHR technology
certified to the 2015 Edition beginning in CY 2019.
In addition, several important initiatives will be implemented over
the next several years to provide hospitals and other participating
providers and suppliers with access to robust infrastructure that will
enable routine electronic exchange of health information. Section 4003
of the 21st Century Cures Act (Pub. L. 114-255), enacted in 2016, and
amending section 3000 of the Public Health Service Act (42 U.S.C.
300jj), requires HHS to take steps to advance the electronic exchange
of health information and interoperability for participating providers
and suppliers in various settings across the care continuum.
Specifically, Congress directed that ONC ``. . . for the purpose of
ensuring full network-to-network exchange of health information,
convene public-private and public-public partnerships to build
consensus and develop or support a trusted exchange framework,
including a common agreement among health information networks
nationally.'' In January 2018, ONC released a draft version of its
proposal for the Trusted Exchange Framework and Common Agreement,\37\
which outlines principles and minimum terms and conditions for trusted
exchange to enable interoperability across disparate health information
networks (HINs). The Trusted Exchange Framework (TEF) is focused on
achieving the following four important outcomes in the long-term:
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\37\ The draft version of the trusted Exchange Framework may be
accessed at https://beta.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement.
---------------------------------------------------------------------------

Professional care providers, who deliver care across the
continuum, can access health information about their patients,
regardless of where the patient received care.
Patients can find all of their health information from
across the care continuum, even if they do not remember the name of the
professional care provider they saw.
Professional care providers and health systems, as well as
public and private health care organizations and public and private
payer organizations accountable for managing benefits and the health of
populations, can receive necessary and appropriate information on
groups of individuals without having to access one record at a time,
allowing them to analyze population health trends, outcomes, and costs;
identify at-risk populations; and track progress on quality improvement
initiatives.
The health IT community has open and accessible
application programming interfaces (APIs) to encourage entrepreneurial,
user-focused innovation that will make health information more
accessible and improve EHR usability.
ONC will revise the draft TEF based on public comment and
ultimately release a final version of the TEF that will subsequently be
available for adoption by HINs and their participants seeking to
participate in nationwide health information exchange. The goal for
stakeholders that participate in, or serve as, a HIN is to ensure that
participants will have the ability to seamlessly share and receive a
core set of data from other network participants in accordance with a
set of permitted purposes and applicable privacy and security
requirements. Broad adoption of this framework and its associated
exchange standards is intended to both achieve the outcomes described
above while creating an environment more conducive to innovation.
In light of the widespread adoption of EHRs along with the
increasing availability of health information exchange infrastructure
predominantly among hospitals, we are interested in hearing from
stakeholders on how we could use the CMS health and safety standards
that are required for providers and suppliers participating in the
Medicare and Medicaid programs (that is, the Conditions of
Participation (CoPs), Conditions for Coverage (CfCs), and Requirements
for Participation (RfPs) for Long-Term Care (LTC) Facilities) to
further advance electronic exchange of information that supports safe,
effective transitions of care between hospitals and community
providers. Specifically, CMS might consider revisions to the current
CMS CoPs for hospitals, such as: Requiring that hospitals transferring
medically necessary information to another facility upon a patient
transfer or discharge do so electronically; requiring that hospitals
electronically send required discharge information to a community
provider via electronic means if possible and if a community provider
can be identified; and requiring that hospitals make certain
information available to patients or a specified third-party
application (for example, required discharge instructions) via
electronic means if requested.
On November 3, 2015, we published a proposed rule (80 FR 68126) to
implement the provisions of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (the IMPACT Act) (Pub. L. 113-185) and to
revise the discharge planning CoP requirements that hospitals
(including short-term acute care hospitals, long-term care hospitals
(LTCHs), rehabilitation hospitals, psychiatric hospitals, children's
hospitals, and cancer hospitals), critical access hospitals (CAHs), and
home health agencies (HHAs) would need to meet in order to participate
in the Medicare and Medicaid programs. This proposed rule has not been
finalized yet. However, several of the proposed requirements directly
address the issue of communication between providers and between
providers and patients, as well as the issue of interoperability:
Hospitals and CAHs would be required to transfer certain
necessary medical information and a copy of the discharge instructions
and discharge summary to the patient's practitioner, if the
practitioner is known and has been clearly identified;
Hospitals and CAHs would be required to send certain
necessary medical information to the receiving facility/post-acute care
providers, at the time of discharge; and
Hospitals, CAHs, and HHAs would need to comply with the
IMPACT Act

[[Page 36008]]

requirements that would require hospitals, CAHs, and certain post-acute
care providers to use data on quality measures and data on resource use
measures to assist patients during the discharge planning process,
while taking into account the patient's goals of care and treatment
preferences.
We published another proposed rule (81 FR 39448) on June 16, 2016,
that updated a number of CoP requirements that hospitals and CAHs would
need to meet in order to participate in the Medicare and Medicaid
programs. This proposed rule has not been finalized yet. One of the
proposed hospital CoP revisions in that rule directly addresses the
issues of communication between providers and patients, patient access
to their medical records, and interoperability. We proposed that
patients have the right to access their medical records, upon an oral
or written request, in the form and format requested by such patients,
if it is readily producible in such form and format (including in an
electronic form or format when such medical records are maintained
electronically); or, if not, in a readable hard copy form or such other
form and format as agreed to by the facility and the individual,
including current medical records, within a reasonable timeframe. The
hospital must not frustrate the legitimate efforts of individuals to
gain access to their own medical records and must actively seek to meet
these requests as quickly as its recordkeeping system permits.
We also published a final rule (81 FR 68688) on October 4, 2016,
that revised the requirements that LTC facilities must meet to
participate in the Medicare and Medicaid programs. In this rule, we
made a number of revisions based on the importance of effective
communication between providers during transitions of care, such as
transfers and discharges of residents to other facilities or providers,
or to home. Among these revisions was a requirement that the
transferring LTC facility must provide all necessary information to the
resident's receiving provider, whether it is an acute care hospital, an
LTCH, a psychiatric facility, another LTC facility, a hospice, a home
health agency, or another community-based provider or practitioner (42
CFR 483.15(c)(2)(iii)). We specified that necessary information must
include the following:
Contact information of the practitioner responsible for
the care of the resident;
Resident representative information including contact
information;
Advance directive information;
Special instructions or precautions for ongoing care;
The resident's comprehensive care plan goals; and
All other necessary information, including a copy of the
resident's discharge or transfer summary and any other documentation to
ensure a safe and effective transition of care.
We note that the discharge summary mentioned above must include
reconciliation of the resident's medications, as well as a
recapitulation of the resident's stay, a final summary of the
resident's status, and the post-discharge plan of care. In addition, in
the preamble to the rule, we encouraged LTC facilities to
electronically exchange this information if possible and to identify
opportunities to streamline the collection and exchange of resident
information by using information that the facility is already capturing
electronically.
Additionally, we specifically invite stakeholder feedback on the
following questions regarding possible new or revised CoPs/CfCs/RfPs
for interoperability and electronic exchange of health information:
If CMS were to propose a new CoP/CfC/RfP standard to
require electronic exchange of medically necessary information, would
this help to reduce information blocking as defined in section 4004 of
the 21st Century Cures Act?
Should CMS propose new CoPs/CfCs/RfPs for hospitals and
other participating providers and suppliers to ensure a patient's or
resident's (or his or her caregiver's or representative's) right and
ability to electronically access his or her health information without
undue burden? Would existing portals or other electronic means
currently in use by many hospitals satisfy such a requirement regarding
patient/resident access as well as interoperability?
Are new or revised CMS CoPs/CfCs/RfPs for interoperability
and electronic exchange of health information necessary to ensure
patients/residents and their treating providers routinely receive
relevant electronic health information from hospitals on a timely basis
or will this be achieved in the next few years through existing
Medicare and Medicaid policies, the implementing regulations related to
the privacy and security standards of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) (Pub. L. 104-91), and
implementation of relevant policies in the 21st Century Cures Act?
What would be a reasonable implementation timeframe for
compliance with new or revised CMS CoPs/CfCs/RfPs for interoperability
and electronic exchange of health information if CMS were to propose
and finalize such requirements? Should these requirements have delayed
implementation dates for specific participating providers and
suppliers, or types of participating providers and suppliers (for
example, participating providers and suppliers that are not eligible
for the Medicare and Medicaid EHR Incentive Programs)?
Do stakeholders believe that new or revised CMS CoPs/CfCs/
RfPs for interoperability and electronic exchange of health information
would help improve routine electronic transfer of health information as
well as overall patient/resident care and safety?
Under new or revised CoPs/CfCs/RfPs, should non-electronic
forms of sharing medically necessary information (for example, printed
copies of patient/resident discharge/transfer summaries shared directly
with the patient/resident or with the receiving provider or supplier,
either directly transferred with the patient/resident or by mail or fax
to the receiving provider or supplier) be permitted to continue if the
receiving provider, supplier, or patient/resident cannot receive the
information electronically?
Are there any other operational or legal considerations
(for example, implementing regulations related to the HIPAA privacy and
security standards), obstacles, or barriers that hospitals and other
providers and suppliers would face in implementing changes to meet new
or revised interoperability and health information exchange
requirements under new or revised CMS CoPs/CfCs/RfPs if they are
proposed and finalized in the future?
What types of exceptions, if any, to meeting new or
revised interoperability and health information exchange requirements
should be allowed under new or revised CMS CoPs/CfCs/RfPs if they are
proposed and finalized in the future? Should exceptions under the QPP,
including CEHRT hardship or small practices, be extended to new
requirements? Would extending such exceptions impact the effectiveness
of these requirements?
We would also like to directly address the issue of communication
between hospitals (as well as the other providers and suppliers across
the continuum of patient care) and their patients and caregivers.
MyHealthEData is a government-wide initiative aimed at breaking down
barriers that contribute to preventing patients from being able to
access and control their medical records. Privacy and security of
patient data will be at the center of all CMS

[[Page 36009]]

efforts in this area. CMS must protect the confidentiality of patient
data, and CMS is completely aligned with the Department of Veterans
Affairs (VA), the National Institutes of Health (NIH), ONC, and the
rest of the Federal Government, on this objective.
While some Medicare beneficiaries have had, for quite some time,
the ability to download their Medicare claims information, in pdf or
Excel formats, through the CMS Blue Button platform, the information
was provided without any context or other information that would help
beneficiaries understand what the data were really telling them. For
beneficiaries, their claims information is useless if it is either too
hard to obtain or, as was the case with the information provided
through previous versions of Blue Button, hard to understand. In an
effort to fully contribute to the Federal Government's MyHealthEData
initiative, CMS developed and launched the new Blue Button 2.0, which
represents a major step toward giving patients meaningful control of
their health information in an easy-to-access and understandable way.
Blue Button 2.0 is a developer-friendly, standards-based application
programming interface (API) that enables Medicare beneficiaries to
connect their claims data to secure applications, services, and
research programs they trust. The possibilities for better care through
Blue Button 2.0 data are exciting, and might include enabling the
creation of health dashboards for Medicare beneficiaries to view their
health information in a single portal, or allowing beneficiaries to
share complete medication lists with their doctors to prevent dangerous
drug interactions.
To fully understand all of these health IT interoperability issues,
initiatives, and innovations through the lens of its regulatory
authority, CMS invites members of the public to submit their ideas on
how best to accomplish the goal of fully interoperable health IT and
EHR systems for Medicare- and Medicaid-participating providers and
suppliers, as well as how best to further contribute to and advance the
MyHealthEData initiative for patients. We are particularly interested
in identifying fundamental barriers to interoperability and health
information exchange, including those specific barriers that prevent
patients from being able to access and control their medical records.
We also welcome the public's ideas and innovative thoughts on
addressing these barriers and ultimately removing or reducing them in
an effective way, specifically through revisions to the current CMS
CoPs, CfCs, and RfPs for hospitals and other participating providers
and suppliers. We have received stakeholder input through recent CMS
Listening Sessions on the need to address health IT adoption and
interoperability among providers that were not eligible for the
Medicare and Medicaid EHR Incentives program, including long-term and
post-acute care providers, behavioral health providers, clinical
laboratories and social service providers, and we would also welcome
specific input on how to encourage adoption of certified health IT and
interoperability among these types of providers and suppliers as well.

B. Request for Information on Price Transparency: Improving Beneficiary
Access to Provider and Supplier Charge Information

In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20548 and 20549)
and the FY 2015 IPPS/LTCH PPS proposed and final rules (79 FR 28169 and
79 FR 50146, respectively), we stated that we intend to continue to
review and post relevant charge data in a consumer-friendly way, as we
previously have done by posting hospital and physician charge
information on the CMS website.\38\ In the FY 2019 IPPS/LTCH PPS
proposed rule, we also continued our discussion of the implementation
of section 2718(e) of the Public Health Service Act, which aims to
improve the transparency of hospital charges. This discussion in the FY
2019 IPPS/LTCH PPS proposed rule continued a discussion we began in the
FY 2015 IPPS/LTCH PPS proposed rule and final rule (79 FR 28169 and 79
FR 50146, respectively). In all of these rules, we noted that section
2718(e) of the Public Health Service Act requires that each hospital
operating within the United States, for each year, establish (and
update) and make public (in accordance with guidelines developed by the
Secretary) a list of the hospital's standard charges for items and
services provided by the hospital, including for diagnosis-related
groups (DRGs) established under section 1886(d)(4) of the Act. In the
FY 2015 IPPS/LTCH PPS proposed and final rules, we reminded hospitals
of their obligation to comply with the provisions of section 2718(e) of
the Public Health Service Act and provided guidelines for its
implementation. We stated that hospitals are required to either make
public a list of their standard charges (whether that be the
chargemaster itself or in another form of their choice) or their
policies for allowing the public to view a list of those charges in
response to an inquiry. In the FY 2019 IPPS/LTCH PPS proposed rule, we
took one step to further improve the public accessibility of charge
information. Specifically, effective January 1, 2019, we are updating
our guidelines to require hospitals to make available a list of their
current standard charges via the internet in a machine readable format
and to update this information at least annually, or more often as
appropriate.
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\38\ See, for example, Medicare Provider Utilization and Payment
Data, available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/index.html.
---------------------------------------------------------------------------

In general, we encourage all providers and suppliers to undertake
efforts to engage in consumer-friendly communication of their charges
to help patients understand what their potential financial liability
might be for services they obtain, and to enable patients to compare
charges for similar services. We encourage providers and suppliers to
update this information at least annually, or more often as
appropriate, to reflect current charges.
We are concerned that challenges continue to exist for patients due
to insufficient price transparency. Such challenges include patients
being surprised by out-of-network bills for physicians, such as
anesthesiologists and radiologists, who provide services at in-network
hospitals and in other settings, and patients being surprised by
facility fees, physician fees for emergency department visits, or by
fees for providers and suppliers that are part of an episode of care
but that were not furnished by the hospital. We also are concerned
that, for providers and suppliers that maintain a list of standard
charges, the charge data may not be helpful to patients for determining
what they are likely to pay for a particular service or facility
encounter. In order to promote greater price transparency for patients,
we are considering ways to improve the accessibility and usability of
current charge information.
We also are considering potential actions that would be appropriate
to further our objective of having providers and suppliers undertake
efforts to engage in consumer-friendly communication of their charges
to help patients understand what their potential financial liability
might be for services they obtain from the provider or supplier, and to
enable patients to compare charges for similar services across
providers and suppliers, including services that could be offered in
more than one setting. Therefore, we are seeking public comment from
all providers and suppliers on the following:
How should we define ``standard charges'' in various
provider and supplier settings? Is there one definition

[[Page 36010]]

for those settings that maintain chargemasters, and potentially a
different definition for those settings that do not maintain
chargemasters? Should ``standard charges'' be defined to mean: Average
or median rates for the items on a chargemaster or other price list or
charge list; average or median rates for groups of items and/or
services commonly billed together, as determined by the provider or
supplier based on its billing patterns; or the average discount off the
chargemaster, price list or charge list amount across all payers,
either for each separately enumerated item or for groups of services
commonly billed together? Should ``standard charges'' be defined and
reported for both some measure of the average contracted rate and the
chargemaster, price list or charge list? Or is the best measure of a
provider's or supplier's standard charges its chargemaster, price list
or charge list?
What types of information would be most beneficial to
patients, how can providers and suppliers best enable patients to use
charge and cost information in their decision-making, and how can CMS
and providers and suppliers help third parties create patient-friendly
interfaces with these data?
Should providers and suppliers be required to inform
patients how much their out-of-pocket costs for a service will be
before those patients are furnished that service? How can information
on out-of-pocket costs be provided to better support patients' choice
and decision-making? What changes would be needed to support greater
transparency around patient obligations for their out-of-pocket costs?
How can CMS help beneficiaries to better understand how co-pays and co-
insurance are applied to each service covered by Medicare? What can be
done to better inform patients of their financial obligations? Should
providers and suppliers of healthcare services play any role in helping
to inform patients of what their out-of-pocket obligations will be?
Can we require providers and suppliers to provide patients
with information on what Medicare pays for a particular service
performed by that provider or supplier? If so, what changes would need
to be made by providers and suppliers? What burden would be added as a
result of such a requirement?
In addition, we are seeking public comment on improving a Medigap
patient's understanding of his or her out-of-pocket costs prior to
receiving services, especially with respect to the following particular
questions:
How does Medigap coverage affect patients' understanding
of their out-of-pocket costs before they receive care? What challenges
do providers and suppliers face in providing information about out-of-
pocket costs to patients with Medigap? What changes can Medicare make
to support providers and suppliers that share out-of-pocket cost
information with patients that reflects the patient's Medigap coverage?
Who is best situated to provide patients with clear Medigap coverage
information on their out-of-pocket costs prior to receipt of care? What
role can Medigap plans play in providing information to patients on
their expected out-of-pocket costs for a service? What state-specific
requirements or programs help educate Medigap patients about their out-
of-pocket costs prior to receipt of care?

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter
35), we are required to publish a 60-day notice in the Federal Register
and solicit public comment before a collection of information
requirement is submitted to the Office of Management and Budget (OMB)
for review and approval.
To fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our burden estimates.
The quality, utility, and clarity of the information to be
collected.
Our effort to minimize the information collection burden
on the affected public, including the use of automated collection
techniques.
We are soliciting public comment on each of the section
3506(c)(2)(A) required issues for the following information collection
requirements (ICRs).

A. Wages

To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 61 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
salary), and the adjusted hourly wage.
Private Sector Wages: The adjusted hourly wage is used to calculate
the labor costs associated with our proposed requirements.

Table 61--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) overhead costs hourly wage ($/
($/hr) hr)
----------------------------------------------------------------------------------------------------------------
All Occupations (for Individuals' Wages)........ 00-0000 $24.34 n/a n/a
Billing and Posting Clerks...................... 43-3021 18.49 $18.49 $36.98
Computer Systems Analysts....................... 15-1121 44.59 44.59 89.18
Family and General Practitioner................. 29-1062 100.27 100.27 200.54
Legal Support Workers, All Other................ 23-2099 32.67 32.67 65.34
Licensed Practical Nurse (LPN).................. 29-2061 21.98 21.98 43.96
Medical Secretary............................... 43-6013 17.25 17.25 34.50
Physicians...................................... 29-1060 103.22 103.22 206.44
Practice Administrator (Medical and Health 11-9111 53.69 53.69 107.38
Services Managers).............................
Registered Nurse................................ 29-1141 35.36 35.36 70.72
----------------------------------------------------------------------------------------------------------------

As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to

[[Page 36011]]

employer, and because methods of estimating these costs vary widely
from study to study. Nonetheless, there is no practical alternative and
we believe that doubling the hourly wage to estimate total cost is a
reasonably accurate estimation method.
Wages for Individuals: For beneficiaries who elect to complete the
CAHPS for MIPS survey, we believe that the burden will be addressed
under All Occupations (BLS occupation code 00-0000) at $24.34/hr since
the group of individual respondents varies widely from working and
nonworking individuals and by respondent age, location, years of
employment, and educational attainment, etc. Unlike our private sector
adjustment to the respondent hourly wage, we are not adjusting this
figure for fringe benefits and overhead since the individuals'
activities would occur outside the scope of their employment.

B. Proposed Information Collection Requirements (ICRs)

1. ICRs Regarding the Clinical Laboratory Fee Schedule (CLFS) (Section
III.A. of This Proposed Rule)
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 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 payor data) collected during a ``data collection
period'' for their component ``applicable laboratories.'' In general,
the payment amount for each clinical diagnostic laboratory test (CDLT)
on the CLFS furnished beginning January 1, 2018, is based on the
applicable information collected during the 6-month data collection
period and reported to us during 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 Physician Fee Schedule. 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 during a data collection period for its
CDLTs that are not advanced diagnostic laboratory tests (ADLTs).
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. 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 to revise the majority of Medicare revenues threshold
component of the definition of applicable laboratory at Sec.
414.502(3) to exclude Medicare Advantage (MA) payments under Medicare
Part C from the definition of total Medicare revenues (that is, the
denominator of the majority of Medicare threshold equation).
Specifically, the proposed change could allow additional laboratories
of all types serving a significant population of beneficiaries enrolled
in Medicare Part C to meet the majority of Medicare revenues threshold
and potentially qualify as applicable laboratories (if they also meet
the low expenditure threshold) and report data to us.
As such, we believe this proposal may result in more data being
reported, which we would use to set CLFS payment rates. However, with
regard to the CLFS-related requirements and burden, we note that
section 1834A(h)(2) of the Act provides that the Paperwork Reduction
Act in chapter 35 of title 44 of the U.S.C. shall not apply to
information collected under section 1834A of the Act (which is the new
private payor rate-based CLFS).
For a complete discussion of our proposal to revise the majority of
Medicare revenues threshold component of the definition of applicable
laboratory under the Medicare CLFS, we refer readers to section III.A
of this proposed rule.
2. ICRs Regarding Appropriate Use Criteria (AUC) for Advanced
Diagnostic Imaging Services (Sec. 414.94 and Section III.D. of This
Proposed Rule)
Consultations: In this rule we propose to revise the regulation at
Sec. 414.94(j) to allow the AUC consultation, when not performed
personally by the ordering professional, to be performed by auxiliary
personnel (as defined in Sec. 410.26(a)(1)) under the direction of,
and incident to, the ordering professional's services. The consultation
requirements and burden will be submitted to OMB for approval under
control number 0938-1345 (CMS-10654).
General practitioners make up a large group of practitioners who
order applicable imaging services and would be required to consult AUC
under this program so we use ``family and general practitioner'' from
the list of BLS occupation titles (see Table O1) to calculate the
following cost estimates. As our proposal would modify the AUC
consultation requirement to allow auxiliary personnel, working under
the direction of the ordering professional, to interact with the CDSM
for AUC consultation, we also use the ``registered nurse'' occupation
to calculate our revised cost estimates.
To derive the burden associated with the proposed provision in
Sec. 414.94(j) that would take effect January 1, 2020, we estimate it
would take 2 minutes (0.033 hr) at $70.72/hr for auxiliary personnel in
the form of a registered nurse to consult with a qualified CDSM. The
Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 60.2
IOM 100-02, Chapter 15, Section 60.2 requires that an incidental
service performed by the nonphysician practitioner must have followed
from a direct, personal, professional service furnished by the
physician. Therefore, to estimate the percentage of consultations
available to be performed incident to, we analyzed 2014 Medicare Part B
claims comparing evaluation and management visits for new (CPT codes
99201, 99202, 99203, 99204, and 99205) relative to established (CPT
codes 99211, 99212, 99213, 99214, 99215) patients with place of service
codes 11 (physician's office). We found that approximately 10 percent
of all claims incurred were for new patients. Therefore, we also
estimate that 90-percent or 38,863,636 of the total consultations
(43,181,818 total consultations x 0.90) could be performed by such
auxiliary personnel, with the remaining 10 percent

[[Page 36012]]

(43,181,818 x 0.10) performed by the ordering professional. In
aggregate, we estimate an annual burden of 1,282,500 hours
(38,863,636.2 consultations x 0.033 hr/consultation) at a cost of
$90,698,400 (1,282,500 hr x $70.72/hr) or $2.33 per consultation. If
this provision is finalized, we would continue to monitor our burden
estimates and, if necessary, adjust those estimates for more precision
once the program begins.
Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR
52976) explicitly discussed and provided a voluntary period for
ordering professionals to begin to familiarize themselves with
qualified CDSMs. During the current 18-month voluntary participation
period, we estimated there would be 10,230,000 consultations based on
market research from current applicants for the qualification of their
CDSMs for advanced diagnostic imaging services. Based on feedback from
CDSMs with experience in AUC consultation, as well as standards
recommended by the Office of the National Coordinator (ONC) \39\ and
the Healthcare Information Management Systems Society (HIMSS) \40\, we
estimated it would take 2 minutes (0.033 hr) at $200.54/hr for a family
and general practitioner or 2 minutes at $70.72/hr for a registered
nurse to use a qualified CDSM to consult specified applicable AUC. As
mentioned above, we estimate that as many as 90-percent of practices
would use auxiliary personnel working under the direction of the
ordering professional to interact with the CDSM for AUC consultation.
Consequently, we estimate a total burden of 337,590 hours (10,230,000
consultations x 0.033 hr) at a cost of $28,256,958 ([337,590 hr x 0.10
x $200.54/hr] + [337,590 hr x 0.90 x $70.72/hr]). Annually, we estimate
112,530 hours (337,590 hr/3 yr) at a cost of $9,418,986 ($28,256,958/3
yr). We are annualizing the one-time burden (by dividing our estimates
by OMB's 3-year approval period) since we do not anticipate any
additional burden after the 18-month voluntary participation period
ends.
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\39\ https://ecqi.healthit.gov/cds#quicktabs-tabs_cds3.
\40\ http://www.himss.org/improving-outcomes-cds-practical-pearls-new-himss-guidebook.
---------------------------------------------------------------------------

Beginning January 1, 2020, we anticipate 43,181,818 responses in
the form of consultations based on the aforementioned market research,
as well as Medicare claims data for advanced diagnostic imaging
services. As noted above, we estimate it would take 2 minutes (0.033
hr) at $200.54/hr for a family and general practitioner or 2 minutes at
$70.72/hr for a registered nurse to use a qualified CDSM to consult
specified applicable AUC. In aggregate, we estimate an annual burden of
1,425,000 hours (43,181,818 consultations x 0.033 hr/consultation) at a
cost of $119,275,350 ([0.1 x 1,425,000 hr x $200.54/hr] + [0.9 x
1,425,000 hr x $70.72/hr]).
Annual Reporting: Consistent with section 1834(q)(4)(B) of the Act,
in the CY 2018 PFS final rule (82 FR 52976) we estimated the burden of
implementing the one-time voluntary reporting period beginning in July
2018, and will be implementing the mandatory annual reporting
requirement beginning January 1, 2020. Specifically, the regulation at
Sec. [thinsp]414.94(k) requires that Medicare claims for advanced
diagnostic imaging services, paid for under an applicable payment
system (as defined in Sec. 414.94(b)) and ordered on or after January
1, 2020, report the following information: (1) Identify which qualified
CDSM was consulted by the ordering professional; (2) identify whether
the service ordered would adhere to specified applicable AUC, would not
adhere to specified applicable AUC, or whether specified applicable AUC
was not applicable to the service ordered; and (3) identify the NPI of
the ordering professional (if different from the furnishing
professional). The reporting requirement will not have any impact on
any Medicare claim forms because the forms' currently approved data
fields, instructions, and burden are not expected to change.
Consequently, there is no need for review by OMB under the authority of
the PRA, however, we have assessed the impact and include an analysis
to this effect in the regulatory impact section of this proposed rule.
Significant Hardship Exception: We propose to revise the regulation
at Sec. 414.94(i)(3) that provides for a significant hardship
exception for ordering professionals who experience a significant
hardship affecting their consultation of AUC when ordering an advanced
diagnostic imaging service. The proposed revision would establish a
process whereby all ordering professionals can self-attest that they
are experiencing a significant hardship at the time of placing an
advanced diagnostic imaging order. While this is not a certification
being used as a substitute for a collection of AUC consultation
information because no consultation is required by statute to take
place, the significant hardship exception process would involve
appending to the order for an applicable imaging service the
significant hardship information for inclusion on the Medicare claim in
lieu of the AUC consultation information. This imposes no burden beyond
the provision of identifying information and attesting to the
applicable information. In this regard, the use of this process is not
``information'' as defined under 5 CFR 1320.3(h), and therefore, is
exempt from requirements of the PRA.
Recordkeeping: Section 1834(q)(4)(C) of the Act provides for
certain exceptions to these reporting requirements, therefore we
believe that some claims for advanced diagnostic imaging services will
not contain AUC consultation information, such as in the case of an
ordering professional with a significant hardship. However, ordering
professionals would store documentation supporting the self-attestation
of a significant hardship. Storage of this information could involve
the use of automated, electronic, or other forms of information
technology at the discretion of the ordering professional. CMS
estimates that the average time for office clerical activities
associated with this storage of information to be 10 minutes (0.167 hr)
at $17.25/hr for a medical secretary to perform 6,699 recordkeeping
actions, since consultation will not take place in the year when a
hardship is incurred and 2016 data from the Medicare EHR Incentive
Program and the first 2019 payment year MIPS eligibility and special
status file suggests this estimate of those seeking hardship (control
number 0938-1314). In aggregate we estimate an annual burden of 1,119
hours (6,699 recordkeeping activities x 0.167 hr) at a cost of $19,303
(1,119 hr x $17.25/hr). We seek comments to inform these burden
estimates.
3. ICRs Regarding the Medicare Shared Savings Program (Part 425 and
Section III.F. of This Proposed Rule)
Section 1899(e) of the Act provides that chapter 35 of title 44 of
the U.S. Code, which includes such provisions as the PRA, shall not
apply to the Shared Savings Program.
4. ICRs Regarding the Physician Self-Referral Law (42 CFR Part 411 and
Section III.G. of This Proposed Rule)
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

[[Page 36013]]

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.
As discussed in section III.G. of this rule, we are proposing
regulatory updates to implement section 50404 of the Bipartisan Budget
Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), which added
provisions to section 1877(h)(1) of the Act pertaining to the writing
and signature requirements in certain compensation arrangement
exceptions to the physician self-referral law'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 at 42 CFR 411.354(e) and
411.353(g) 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. The burden associated with
the writing and signature requirements would be the time and effort
necessary to prepare written documents and obtain signatures of the
parties.
While the writing and signature requirements are subject to the
PRA, we believe the associated burden is exempt under 5 CFR
1320.3(b)(2). We believe that the time, effort, and financial resources
necessary to comply with the writing and signature requirements would
be incurred by persons without federal regulation during the normal
course of their activities. Specifically, we believe that, for normal
business operations purposes, health care providers and suppliers
document their financial arrangements with physicians and others in
order to identify and be able to enforce the legal obligations of the
parties. Therefore, we believe that the writing and signature
requirements should be considered usual and customary business
practices.
5. The Quality Payment Program (QPP) (Part 414 and Section III.H. of
This Proposed Rule)
Summary: With respect to the PRA, the Quality Payment Program is
comprised of a series of ICRs associated with MIPS and Advanced APMs.
The MIPS ICRs consist of registration for virtual groups; qualified
registry and QCDR self-nomination; CAHPS survey vendor application;
Quality Payment Program Identity Management Application Process;
quality performance category data submission by claims collection type,
QCDR and MIPS CQM collection type, eCQM collection type, and CMS web
interface submission type; CAHPS for MIPS survey beneficiary
participation; group registration for CMS web interface; group
registration for CAHPS for MIPS survey; call for quality measures;
Promoting Interoperability reweighting applications; Promoting
Interoperability performance category data submission; call for
Promoting Interoperability measures; improvement activities performance
category data submission; nomination of improvement activities; and
opt-out of Physician Compare for voluntary participants. ICRs for
Advanced APMs consist of partial qualifying APM participant (QP)
election; other payer Advanced APM identification: Payer Initiated and
Eligible Clinician Initiated Processes; and submission of data for All-
Payer QP determinations under the All-Payer combination option.
The following ICRs reflect this proposed rule's policies, as well
as policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568)
Quality Payment Program final. In discussing each ICR, we reference the
specific policies and whether they are proposed in this CY 2019
proposed rule or finalized in the CY 2017 or CY 2018 Quality Payment
Program final rules. As described below in more detail, two ICRs
(Quality: CMS Web Interface Submission Type, and Promoting
Interoperability Performance Category: Data Submission) show a
reduction in burden due to proposed changes in policies. Most burden
estimates are adjustments to reflect data available at the time of
publication of this proposed rule. Finally, we added one ICR to
incorporate a collection previously mentioned in the CY 2018 Quality
Payment Program final rule for which collection had not yet started:
Submission of Data for All-Payer QP Determinations (82 FR 53886). See
section V.B.4. of this proposed rule for a summary of the ICRs, the
overall burden estimates, changes in burden due to policies in this
proposed rule, and a summary of the policy and data changes affecting
each ICR.
The revised requirements and burden estimates for all Quality
Payment Program ICRs (except for CAHPS for MIPS and virtual groups
election) will be submitted to OMB for approval under control number
0938-1314 (CMS-10621). The proposed CAHPS for MIPS ICRs will be
submitted to OMB for approval under control number 0938-1222 (CMS-
10450). The Virtual Groups Election is approved by OMB control number
0938-1343 (CMS-10652).
With regard to Quality Payment Program respondents, we selected BLS
occupations Billing and Postal Clerks, Computer Systems Analysts,
Physicians, Practice Administrator, and Licensed Practical Nurse (see
Wage Estimates in section V.A. of this proposed rule) based on a study
(Casalino et al., 2016) that collected data on the staff in physician's
practices involved in the quality data submission process.\41\ To
calculate the cost for virtual groups to prepare their written formal
agreements, we used wage estimates for Legal Support Workers, All
Others.
---------------------------------------------------------------------------

\41\ Lawrence P. Casalino et al., ``US Physician Practices Spend
More than $15.4 Billion Annually to Report Quality Measures,''
Health Affairs, 35, no. 3 (2016): 401-406.
---------------------------------------------------------------------------

Respondent estimates are modeled using similar methodology to the
CY 2017 and CY 2018 Quality Payment Program final rules. For instance,
we are using the eligibility file generated for the MIPS program based
on the first 12-month determination period for the first year; the APM
Participation List for the third snapshot date of the 2017 QP
performance period to identify QP clinicians excluded from MIPS, and to
identify clinicians and groups eligible for MIPS but who are not
required to submit data for the Promoting Interoperability performance
category; and the 2016 PQRS data and 2016 Medicare and Medicaid EHR
Incentive Program data to estimate the number of respondents for the
improvement activities performance category. Although the submission
period for the 2017 MIPS performance period ended in April 2018, the
participation and performance data were not available at the time of
writing this proposed rule, with the sole exception of 286 CMS Web
Interface respondents, which is based on the number of groups who
submitted MIPS data via the CMS Web Interface during the 2018 MIPS
performance period. We intend to update our burden

[[Page 36014]]

estimates in the final rule using actual MIPS data if technically
feasible.
Our estimates assume clinicians who participated in 2016 PQRS and
who are not determined to be QPs based on their participation in
Advanced APMs in the 2017 performance period will continue to submit
quality data in the 2019 MIPS performance period. This assumption is
consistent with the CY 2017 and CY 2018 Quality Payment Program final
rules where we assumed that clinicians would continue to participate as
either MIPS eligible clinicians or voluntary reporters (81 FR 77501 and
82 FR 53908). As discussed in section III.H.3.a. of this proposed rule,
we are proposing to revise the eligibility criteria to expand MIPS to
additional clinician types. In addition, we are proposing in section
III.H.3.c. of this proposed rule to revise the low-volume threshold in
the following manner: If a MIPS eligible clinician meets or exceeds
one, but not all, of the low-volume threshold criterion, including as
defined by dollar amount ($90,000), beneficiary count (200), or covered
professional services to Part-B enrolled individuals (minimum threshold
of 200) then they may elect to submit data and opt-in to MIPS. If a
MIPS eligible clinician does not meet at least one of these low-volume
determinations or does not elect to opt-in, they are not eligible and
are excluded from MIPS. If they are excluded and submit data, they
would be voluntary reporters. If these policies are finalized, it would
expand the number of potential MIPS eligible clinicians, but we do not
anticipate an incremental increase in the burden because the affected
clinicians were assumed to be voluntary reporters in prior rules. In
the CY 2018 Quality Payment Program final rule, clinicians who
participated in 2016 PQRS, and who were not determined to be QPs based
on their participation in Advanced APMs during CY 2017 and were not
MIPS eligible, were assumed to be voluntary reporters in MIPS (82 FR
53908). Therefore, the proposed expansion in MIPS eligibility does not
change the total number of respondents, but instead shifts a certain
number of assumed voluntary reporters to MIPS eligible clinicians.
Additionally, we expect the act of electing to be a single click
once a clinician or group has submitted data; therefore, we do not
anticipate that proposal would revise the burden hours for any of our
burden estimates.
Our participation estimates are reflected in Tables 65, 66, and 67
for the quality performance category, Table 78 for the Promoting
Interoperability performance category, and Table 81 for the improvement
activities performance category. We also assume that previous PQRS
participants who are not QPs will submit data for the improvement
activities performance category, and will submit data for the Promoting
Interoperability performance category unless they receive a significant
hardship or other type of exception or are automatically assigned a
weighting of zero percent for the Promoting Interoperability
performance category.
Due to data limitations, our burden estimates may overstate the
total burden for data submission under the quality, Promoting
Interoperability, and improvement activities performance categories.
This is due to two primary reasons. First, we anticipate the number of
QPs to increase because of total expected growth in Advanced APM
participation. The additional QPs would be excluded from MIPS and
likely not report. Second, we anticipate that some portion of the
clinicians that opted to participate in PQRS may elect to not
participate in MIPS, and, therefore, the actual number of participants
may be lower than our estimates. However, we believe our estimates are
the most appropriate given the available data.
Framework for Understanding the Burden of MIPS Data Submission:
Because of the wide range of information collection requirements under
MIPS, Table 62 presents a framework for understanding how the
organizations permitted or required to submit data on behalf of
clinicians varies across the types of data, and whether the clinician
is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM
participant. As shown in the first row of Table 62, MIPS eligible
clinicians that are not in MIPS APMs and other clinicians voluntarily
submitting data will submit data either as individuals, groups, or
virtual groups for the quality, Promoting Interoperability, and
improvement activities performance categories. Note that virtual groups
are subject to the same requirements as groups, therefore we will refer
only to groups for the remainder of this section unless otherwise
noted. Because MIPS eligible clinicians are not required to provide any
additional information for assessment under the cost performance
category, the administrative claims data used for the cost performance
category is not represented in Table 62.
For MIPS eligible clinicians participating in MIPS APMs, the
organizations submitting data on behalf of MIPS eligible clinicians
will vary between performance categories and, in some instances,
between MIPS APMs. For the 2019 MIPS performance period, the quality
data submitted by Shared Savings Program ACOs, Next Generation ACOs,
and other APM Entities on behalf of their participant MIPS eligible
clinicians will fulfill any MIPS submission requirements for the
quality performance category.
For the Promoting Interoperability performance category, group TINs
may submit data on behalf of eligible clinicians in MIPS APMs, or
eligible clinicians in MIPS APMs may submit Promoting Interoperability
performance category data individually. For the improvement activities
performance category, we will assume no reporting burden for MIPS APM
participants. In the CY 2017 Quality Payment Program final rule, we
describe that for MIPS APMs, we compare the requirements of the
specific MIPS APM with the list of activities in the Improvement
Activities Inventory and score those activities in the same manner that
they are otherwise scored for MIPS eligible clinicians (81 FR 77185).
Although the policy allows for the submission of additional improvement
activities if a MIPS APM receives less than the maximum improvement
activities performance category score, to date all MIPS APM have
qualified for the maximum improvement activities score. Therefore, we
assume that no additional submission will be needed.
Advanced APM participants who are determined to be Partial QPs may
incur additional burden if they elect to participate in MIPS, which is
discussed in more detail in the CY 2018 Quality Payment Program final
rule (82 FR 53841 through 53844), but other than the election to
participate in MIPS, we do not have data to estimate that burden.

[[Page 36015]]

Table 62--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
of Clinician *
----------------------------------------------------------------------------------------------------------------
Type of data submitted
--------------------------------------------------------------------------------
Other data
Category of clinician Quality Promoting Improvement submitted on
performance interoperability activities behalf of MIPS
category performance performance eligible
category category clinicians
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not As group or As group or As group or Groups electing to
in MIPS APMs) and Other individual individual individual use a CMS-
Eligible Clinicians clinicians. clinicians. clinicians. approved survey
Voluntarily Submitting Data Clinicians who are vendor to
\a\. hospital-based, administer CAHPS
ambulatory must register.
surgical center- Groups electing
based, non-patient to submit via CMS
facing, physician Web Interface for
assistants, nurse the first time
practitioners, must register.
clinician nurse Virtual groups
specialists, must register via
certified email.
registered nurse
anesthetists,
physical
therapists,
occupational
therapists,
clinical social
workers, and
clinical
psychologists are
automatically
eligible for a
zero percent
weighting for the
Promoting
Interoperability
performance
category.
Clinicians
approved for
significant
hardship or other
exceptions are
also eligible for
a zero percent
weighting.
Eligible Clinicians ACOs submit to the Each MIPS eligible CMS will assign Advanced APM
participating in the Shared CMS Web Interface clinician in the the improvement Entities will
Savings Program or Next and CAHPS for APM Entity reports activities make election for
Generation ACO Model (both ACOs on behalf of data for the performance participating
MIPS APMs). their Promoting category score to MIPS eligible
participating Interoperability each APM Entity clinicians.
MIPS eligible performance group based on
clinicians. category through the activities
[These either group TIN involved in
submissions are or individual participation in
not included in reporting. [Burden the Shared
burden estimates estimates for this Savings
for this proposed proposed rule Program.\d\ [The
rule because assume group TIN- burden estimates
quality data level reporting.] for this proposed
submission to \c\ rule assume no
fulfill improvement
requirements of activity
the Shared reporting burden
Savings Program for APM
and for purposes participants
of testing and because we assume
evaluating the the MIPS APM
Next Generation model provides a
ACO Model are not maximum
subject to the improvement
PRA.] \b\ activity
performance
category score.]
Eligible Clinicians APM Entities Each MIPS eligible CMS will assign Advanced APM
participating in Other MIPS submit to MIPS on clinician in the the same Entities will
APMs. behalf of their APM Entity reports improvement make election for
participating data for the activities participating
MIPS eligible Promoting performance eligible
clinicians. Interoperability category score to clinicians.
[These performance each APM Entity
submissions are category through based on the
not included in either group TIN activities
burden estimates or individual involved in
for this proposed reporting. [The participation in
rule because burden estimates the MIPS APM.
quality data for this proposed [The burden
submission for rule assume group estimates for
purposes of TIN-level this proposed
testing and reporting.] rule assume no
evaluating improvement
Innovation Center activities
models tested performance
under Section category
1115A of the reporting burden
Social Security for APM
Act (or Section participants
3021 of the because we assume
Affordable Care the MIPS APM
Act) are not model provides a
subject to the maximum
PRA.] improvement
activity score.]
----------------------------------------------------------------------------------------------------------------
* Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not
required to provide any additional information, and therefore, the cost performance category is not
represented in this table.
\a\ Virtual group participation is limited to MIPS eligible clinicians, specifically, solo practitioners and
groups consisting of 10 eligible clinicians or fewer.

[[Page 36016]]

\b\ Sections 1899 and 1115A of the Act state the Shared Savings Program and testing, evaluation, and expansion
of Innovation Center models are not subject to the PRA (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively).
\c\ Both group TIN and individual clinician Promoting Interoperability data will be accepted. If both group TIN
and individual scores are submitted for the same APM Entity, CMS would take the higher score for each TIN/NPI.
The TIN/NPI scores are then aggregated for the APM Entity score.
\d\ APM Entities participating in MIPS APMs do not need to submit improvement activities data unless the CMS-
assigned improvement activities scores are below the maximum improvement activities score.

The policies finalized in the CY 2017 and CY 2018 Quality Payment
Program final rules and proposed in this CY 2019 rule create some
additional data collection requirements not listed in Table 62. These
additional data collections, some of which were previously approved by
OMB under the control numbers 0938-1314 (Quality Payment Program) and
0938-1222 (CAHPS for MIPS), are as follows:
Additional approved ICRs related to MIPS third-party vendors
Self-nomination of new and returning QCDRs (81 FR 77507
through 77508 and 82 FR 53906 through 53908) (0938-1314).
Self-nomination of new and returning registries (81 FR
77507 through 77508 and 82 FR 53906 through 53908) (0938-1314).
Approval process for new and returning CAHPS for MIPS
survey vendors (82 FR 53908) (0938-1222).
Additional ICRs related to the data submission and the quality
performance category
CAHPS for MIPS survey completion by beneficiaries (81 FR
77509 and 82 FR 53916 through 53917) (0938-1222).
Quality Payment Program Identity Management Application
Process (82 FR 53914).
Additional ICRs related to the Promoting Interoperability
performance category
Application for Promoting Interoperability Reweighting (82
FR 53918) (0938-1314).
Additional ICRs related to call for new MIPS measures and
activities
Nomination of improvement activities (82 FR 53922) (0938-
1314).
Call for new Promoting Interoperability measures (0938-
1314).
Call for new quality measures (0938-1314).
Additional ICRs related to MIPS
Opt out of performance data display on Physician Compare
for voluntary reporters under MIPS (82 FR 53924 through 53925) (0938-
1314).
Additional ICRs related to APMs
Partial QP Election (81 FR 77512 through 77513 and 82 FR
53922 through 53923) (0938-1314).
Other Payer Advanced APM determinations: Payer Initiated
Process (82 FR 53923 through 53924) (0938-1314).
Other Payer Advanced APM determinations: Eligible
Clinician Initiated Process (82 FR 53924) (0938-1314).
Submission of Data for All-Payer QP Determinations (New
data collection for the 2019 performance period).
6. Quality Payment Program ICRs Regarding the Virtual Group Election
(Sec. 414.1315)
This rule does not propose any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
virtual group election. The virtual group election requirements and
burden are currently approved by OMB under control number 0938-1343
(CMS-10652). Consequently, we are not making any virtual group election
changes under that control number.
7. Quality Payment Program ICRs Regarding Third-Party Reporting (Sec.
414.1400)
Under MIPS, quality, Promoting Interoperability, and improvement
activities performance category data may be submitted via relevant
third-party intermediaries, such as qualified registries, QCDRs, and
health IT vendors. Data on the CAHPS for MIPS survey, which counts as
one quality performance category measure, can be submitted via CMS-
approved survey vendors. In the CY 2018 Quality Payment Program final
rule, we combined the burden for self-nomination of qualified
registries and QCDRs (82 FR 53906). For this proposed rule, we
determined that requirements for self-nomination for qualified
registries were sufficiently different from QCDRs that it is necessary
to estimate the two independently. The change would align the burden
more closely to the requirements for QCDRs and qualified registries to
self-nominate, not because of any change in policy in this proposed
rule. Specifically, while the processes for self-nomination are
similar, QCDRs have the option to submit QCDR measures for the quality
performance category. Therefore, differences between QCDRs and
registries self-nomination are associated with the preparation of QCDR
measures for approval. The burden associated with qualified registry
self-nomination, QCDR self-nomination, and the CAHPS for MIPS survey
vendor applications follow:
Qualified Registry Self-Nomination: The proposed requirements and
burden associated with qualified registry self-nomination will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
Qualified registries interested in submitting MIPS data to us on
their participants' behalf need to complete a self-nomination process
to be considered qualified to submit on behalf of MIPS eligible
clinicians or groups (82 FR 53815).
In the CY 2018 Quality Payment Program final rule, previously
approved qualified registries in good standing (that are not on
probation or disqualified) that wish to self-nominate using the
simplified process can attest, in whole or in part, that their
previously approved form is still accurate and applicable (82 FR
53815). In the same rule, qualified registries in good standing that
would like to make minimal changes to their previously approved self-
nomination application from the previous year, may submit these
changes, and attest to no other changes from their previously approved
qualified registry application, for CMS review during the self-
nomination period, from September 1 to November 1 (82 FR 53815). This
simplified self-nomination process will begin for the 2019 MIPS
performance period.
The CY 2017 Quality Payment Program final rule provided the
definition of a qualified registry to be a medical registry, a
maintenance of certification program operated by a specialty body of
the American Board of Medical Specialties or other data intermediary
that, with respect to a particular performance period, has self-
nominated and successfully completed a vetting process (as specified by
CMS) to demonstrate its compliance with the MIPS qualification criteria
specified by CMS for that performance period (81 FR 77382).
For this CY 2019 Quality Payment Program rule, we are proposing
adjustments to the number of respondents (from 120 to 150) based on
more recent data and a revised definition of ``respondent'' to account
for self-nomination applications received but not approved. We are also
proposing adjustments to our per respondent time estimate (from 10
hours to 3 hours) based on our review of the current burden estimates
against the existing policy. Additionally, we are proposing a range of
time estimates

[[Page 36017]]

(from 10 hours to 0.5 hours) which reflect the availability of a
simplified self-nomination process for previously approved qualified
registries.
For the 2017 MIPS performance period, we received 138 applications
for nomination to be a qualified registry and 145 applications for the
2018 MIPS performance period. In continuance of this trend for the 2019
MIPS performance period, we estimate 150 nomination applications will
be received from qualified registries desiring approval to report MIPS
data, an increase of 30 respondents.
For this proposed rule, the burden associated with qualified
registry self-nomination will vary depending on the number of existing
qualified registries that will elect to use the simplified self-
nomination process in lieu of the full self-nomination process as
described in the CY 2018 Quality Payment Program final rule (82 FR
53815). The self-nomination form is submitted electronically using the
web-based tool JIRA. For the CY 2018 performance period, 141 qualified
registries were approved to submit MIPS data.
In the CY 2018 Quality Payment Program final rule, we estimated the
burden associated with self-nomination of a qualified registry to be 10
hours, similar to PQRS (82 FR 53907). For this proposed rule, we reduce
our estimate to 3 hours because registries no longer provide an XML
submission, calculated measure, or measure flow as part of the self-
nomination process and are not subject to a mandatory interview, which
were done previously as part of the PQRS qualified registry self-
nomination process, upon which the previous assumption of 10 hours was
based. As described in the CY 2017 Quality Payment Program final rule,
the full self-nomination process requires the submission of basic
information, a description of the process the qualified registry will
use for completion of a randomized audit of a subset of data prior to
submission, and the provision of a data validation plan along with the
results of the executed data validation plan by May 31 of the year
following the performance period (81 FR 77383 through 77384).
For the simplified self-nomination process, we estimate 0.5 hours
per qualified registry to submit a nomination, a reduction of 9.5 hours
from currently approved estimates.
As shown in Table 63, we estimate that the staff involved in the
qualified registry self-nomination process will be mainly computer
systems analysts or their equivalent, who have an adjusted labor cost
of $89.18/hour. Assuming that the time associated with the self-
nomination process ranges from a minimum of 0.5 hours (for the
simplified self-nomination process) to 3 hours (for the full self-
nomination process) per qualified registry, we estimate that the annual
burden will range from 97.5 hours ([141 qualified registries x 0.5 hr]
+ [9 qualified registries x 3 hr]) to 450 hours (150 qualified
registries x 3 hr) at a cost ranging from $8,695 (97.5 hr x $89.18/hr)
to $40,131 (450 hr x $89.18/hr), respectively (see Table 63).
Independent of the change to our per response time estimate, the
increase in the number of respondents results in an adjustment of 300
hours and $26,754 (30 registries x 10 hr x $89.18/hr). Accounting for
the change in the number of qualified registries, the change in time
per qualified registry to self-nominate results in an adjustment of
between -1,402.5 hours and -125,075 ([(141 registries x-9.5 hr)] + [(9
registries x-7 hr)] at $89.18/hr) and -1,050 hours and -$93,639 (150
registries x-7 hr x $89.18/hr). When these two adjustments are
combined, the net impact ranges between -1,102.5 (-1,402.5 + 300) and -
750 (-1,050 + 300) hours and -$98,321 (-$125,075 + $26,754) and -
$66,885 (-$93,639 + $26,754).
Qualified registries must comply with requirements on the
submission of MIPS data to CMS. The burden associated with the
qualified registry submission requirements will be the time and effort
associated with calculating quality measure results from the data
submitted to the qualified registry by its participants and submitting
these results, the numerator and denominator data on quality measures,
the Promoting Interoperability performance category, and improvement
activities data to us on behalf of their participants. These
requirements are currently approved by OMB under control number 0938-
1314 (CMS-10621) with no changes being proposed.
We expect that the time needed for a qualified registry to
accomplish these tasks will vary along with the number of MIPS eligible
clinicians submitting data to the qualified registry and the number of
applicable measures. However, we believe that qualified registries
already perform many of these activities for their participants. We
believe the estimates discussed above and shown in Table 63 represents
the upper bound of registry burden, with the potential for less
additional MIPS burden if the registry already provides similar data
submission services.
Based on the assumptions previously discussed, we provide an
estimate of the total annual burden associated with a qualified
registry self-nominating to be considered ``qualified'' to submit
quality measures results and numerator and denominator data on MIPS
eligible clinicians.

Table 63--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Number of Qualified Registry Simplified 141 0
Self-Nomination Applications submitted
(a)....................................
Number of Qualified Registry Full Self- 9 150
Nomination Applications submitted (b)..
Total Annual Hours Per Qualified 0.5 0.5
Registry for Simplified Process (c)....
Total Annual Hours Per Qualified 3 3
Registry for Full Process (d)..........
-------------------------------
Total Annual Hours for Qualified 97.5 450
Registries (e) = (a) * (c) + (b) *
(d)................................
------------------------------------------------------------------------
Cost Per Simplified Process Per Registry $44.59 $44.59
(@computer systems analyst's labor rate
of $89.18/hr.) (f).....................
Cost Per Full Process Per Registry $267.54 $267.54
(@computer systems analyst's labor rate
of $89.18/hr.) (g).....................
-------------------------------
Total Annual Cost for Qualified $8,695 $40,131
Registries (h) = (a) * (f) + (b) *
(g)................................
------------------------------------------------------------------------

[[Page 36018]]

shown in Table 89, only the maximum burden will be used.
QCDR Self-Nomination: \42\ The proposed requirements and burden
associated with QCDR self-nomination will be submitted to OMB for
approval under control number 0938-1314 (CMS-10621).
---------------------------------------------------------------------------

\42\ We do not anticipate any changes in the CEHRT process for
health IT vendors as we transition to MIPS. Hence, health IT vendors
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

QCDRs interested in submitting quality, Promoting Interoperability,
and improvement activities performance category data to us on their
participants' behalf will need to complete a self-nomination process to
be considered qualified to submit on behalf of MIPS eligible clinicians
or groups.
In the CY 2018 Quality Payment Program final rule, previously
approved QCDRs in good standing (that are not on probation or
disqualified) that wish to self-nominate using the simplified process
can attest, in whole or in part, that their previously approved form is
still accurate and applicable (82 FR 53808). Existing QCDRs in good
standing that would like to make minimal changes to their previously
approved self-nomination application from the previous year, may submit
these changes, and attest to no other changes from their previously
approved QCDR application, for CMS review during the self-nomination
period, from September 1 to November 1 (82 FR 53808). This simplified
self-nomination process will begin for the 2019 MIPS performance
period.
For this proposed rule, the burden associated with QCDR self-
nomination will vary depending on the number of existing QCDRs that
will elect to use the simplified self-nomination process in lieu of the
full self-nomination process as described in the CY 2018 Quality
Payment Program final rule (82 FR 53808 through 53813). The self-
nomination form is submitted electronically using the web-based tool
JIRA. For the CY 2018 performance period, 150 QCDRs were approved to
submit MIPS data.
For this CY 2019 Quality Payment Program rule, we are proposing
adjustments to the number of respondents (from 113 to 200) based on
more recent data and a revised definition of ``respondent'' to account
for self-nomination applications received but not approved. We are also
proposing adjustments to the time burden estimates per respondent based
on our review of the current burden estimates against the existing
policy as well as proposing a range of time burden estimates which
reflect the availability of a simplified self-nomination process for
previously approved QCDRs.
For the 2017 MIPS performance period, we received 138 self-
nomination applications from QCDRs and for the 2018 MIPS performance
period, we received 176 self-nomination applications. In continuance of
this trend for the 2019 MIPS performance period, we estimate 200 self-
nomination applications will be received from QCDRs desiring approval
to report MIPS data, an increase of 87 respondents.
We estimate that the self-nomination process for QCDRs to submit on
behalf of MIPS eligible clinicians or groups for MIPS will involve
approximately 3 hours per QCDR to submit information required at the
time of self-nomination as described in the CY 2017 Quality Payment
Program final rule including basic information about the QCDR, describe
the process it will use for completion of a randomized audit of a
subset of data prior to submission, provide a data validation plan, and
provide results of the executed data validation plan by May 31 of the
year following the performance period (81 FR 77383 through 77384).
However, for the simplified self-nomination process, we estimate 0.5
hours per QCDR to submit this information. The self-nomination form is
submitted electronically using the web-based tool JIRA.
In addition, QCDRs calculate their measure results. QCDRs must
possess benchmarking capabilities (for QCDR measures) that compare the
quality of care a MIPS eligible clinician provides with other MIPS
eligible clinicians performing the same quality measures. For QCDR
measures, the QCDR must provide to us, if available, data from years
prior (for example, 2017 data for the 2019 MIPS performance period)
before the start of the performance period. In addition, the QCDR must
provide to us, if available, the entire distribution of the measure's
performance broken down by deciles. As an alternative to supplying this
information to us, the QCDR may post this information on their website
prior to the start of the performance period, to the extent permitted
by applicable privacy laws. The time it takes to perform these
functions may vary depending on the sophistication of the entity, but
we estimate that a QCDR will spend an additional 1 hour performing
these activities per measure and assume that each QCDR will submit
information for 9 QCDR measures, for a total burden of 9 hours per QCDR
(1 hr per measure x 9 measures). The estimated average of 9 measures
per QCDR is based on the number of QCDR measure submissions received in
the 2017 and 2018 MIPS performance periods and is the same for each
QCDR regardless of whether they elect to use the simplified or full
self-nomination process.
In the 2017 MIPS performance period, we received over 1,000 QCDR
measure submissions. In the 2018 MIPS performance period, we received
over 1,400 QCDR measure submissions. For the 2019 MIPS performance
period, we anticipate this trend will continue, and therefore, estimate
we will receive a total of approximately 1,800 QCDR measure
submissions, resulting in an average of 9 measure submissions per QCDR
(1,800 measure submissions/200 QCDRs).
In the CY 2018 Quality Payment Program final rule, the burden
associated with self-nomination of a QCDR was estimated to be 10 hours
(82 FR 53907). For this proposed rule, we are increasing the burden
associated with self-nomination to 12 hours because QCDRs are no longer
required provide an XML submission and are not subject to a mandatory
interview; both of which were completed as part of the PQRS QCDR self-
nomination process upon which the previous assumption of 10 hours was
based, while simultaneously accounting for an increase in the number of
QCDR measure submissions being submitted.
As shown in Table 64, we estimate that the staff involved in the
QCDR self-nomination process will continue to be computer systems
analysts or their equivalent, who have an average labor cost of $89.18/
hr. Assuming that the hours per QCDR associated with the self-
nomination process ranges from a minimum of 9.5 hours (for the
simplified self-nomination process) to 12 hours (for the full self-
nomination process), we estimate that the annual burden will range from
2,025 hours ([150 QCDRs x 9.5 hr] + [50 QCDRs x 12 hr]) to 2,400 hours
(200 QCDRs x 12 hr) at a cost ranging between $180,590 (2,025 hr x
$89.18/hr) and $214,032 (2,400 hr x $89.18/hr), respectively (see Table
64).
Independent of the change to our per response time estimate, the
increase in the number of respondents results in an adjustment of 870
hours and $77,587 (87 registries x 10 hr x $89.18/hr). Accounting for
the change in the number of qualified registries, the change in time
per QCDR to self-nominate results in an adjustment of between 25 hours
and $2,230 ([150 registries x-0.5 hr] + [50 registries x 2 hr] at
$89.18/hr) and 400 hours and $35,672 (200 registries x 2 hr x $89.18/

[[Page 36019]]

hr). When these two adjustments are combined, the net impact ranges
between 895 (870 + 25) hours at $79,817 ($77,587 + $2,230) and 1,270
(870 + 400) hours at $113,259 ($77,587 + $35,672).
QCDRs must comply with requirements on the submission of MIPS data
to CMS. The burden associated with the QCDR submission requirements
will be the time and effort associated with calculating quality measure
results from the data submitted to the QCDR by its participants and
submitting these results, the numerator and denominator data on quality
measures, the Promoting Interoperability performance category, and
improvement activities data to us on behalf of their participants.
These requirements are currently approved by OMB under control number
0938-1314 (CMS-10621) with no changes being proposed. We expect that
the time needed for a QCDR to accomplish these tasks will vary along
with the number of MIPS eligible clinicians submitting data to the QCDR
and the number of applicable measures. However, we believe that QCDRs
already perform many of these activities for their participants. We
believe the estimate noted in this section represents the upper bound
of QCDR burden, with the potential for less additional MIPS burden if
the QCDR already provides similar data submission services.
Based on the assumptions previously discussed, we provide an
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures
results and numerator and denominator data on MIPS eligible clinicians.

Table 64--Estimated Burden for QCDR Self-Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Number of QCDR Simplified Self- 150 0
Nomination Applications submitted (a)..
Number of QCDR Full Self-Nomination 50 200
Applications submitted (b).............
Total Annual Hours Per QCDR for 9.5 9.5
Simplified Process (c).................
Total Annual Hours Per QCDR for Full 12 12
Process (d)............................
-------------------------------
Total Annual Hours for QCDRs (e) = 2,025 2,400
(a) * (c) + (b) * (d)..............
------------------------------------------------------------------------
Cost Per Simplified Process Per QCDR $847.21 $847.21
(@computer systems analyst's labor rate
of $89.18/hr.) (f).....................
Cost Per Full Process Per QCDR $1,070.16 $1,070.16
(@computer systems analyst's labor rate
of $89.18/hr.) (g).....................
-------------------------------
Total Annual Cost for QCDRs (h) = $180,590 $214,032
(a) * (f) + (b) * (g)..............
------------------------------------------------------------------------

Both the minimum and maximum burden shown in Table 64 will be
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to review of self-nomination process
and the number of respondents. For purposes of calculating total burden
associated with the proposed rule as shown in Table 89, only the
maximum burden will be used.
CMS-Approved CAHPS for MIPS Survey Vendors: This rule does not
propose any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to CMS-approved CAHPS for MIPS survey
vendors. The CMS-approved CAHPS for MIPS survey vendor requirements and
burden are currently approved by OMB under control number 0938-1222
(CMS-10450). Consequently, we are not making any MIPS survey vendor
changes under that control number.
8. Quality Payment Program ICRs Regarding Data Submission (Sec. Sec.
414.1325 and 414.1335)
Under our current policies, two groups of clinicians will submit
quality data under MIPS: Those who submit as MIPS eligible clinicians
and other eligible clinicians who opt to submit data voluntarily but
will not be subject to MIPS payment adjustments. While the proposed
expansion of the definition of a MIPS eligible clinician to new
clinician types and the opt-in process for MIPS participation discussed
in sections III.H.3.a and III.H.3.c.(6) of this proposed rule could
affect respondent counts, all of the new potential respondents had the
opportunity to participate in PQRS. Therefore, consistent with our
assumptions in the CY 2017 and CY 2018 Quality Payment Program final
rules that PQRS participants that are not QPs would have participated
in MIPS as voluntary respondents (81 FR 77501 and 82 FR 53908,
respectively), we anticipate that this rule's proposed expansion of the
definition of a MIPS eligible clinician will not have any incremental
effect on any of our currently approved burden estimates. Our
respondent assumptions regarding QPs have been updated using the APM
Participation List for the third snapshot date of the 2017 QP
performance period in place of the 2017 QP determination data used to
estimate respondents in the CY 2018 Quality Payment Program final rule
(82 FR 53908). With this exception, our respondent assumptions remain
the same as approved in the approved PRA.
For the purpose of the following analyses, we assume that a total
of 763,383 clinicians who participated in PQRS for the reporting
periods occurring in 2016 and who are not QPs in Advanced APMs in the
2017 MIPS performance period will continue to submit quality data in
the 2019 MIPS performance period. This number differs from the
currently approved estimate (OMB 0938-1314, CMS-10621) of 134,802 due
to more QPs being identified and removed. We assume that 100 percent of
APM Entities in MIPS APMs will submit quality data to CMS as required
under their models.\43\
---------------------------------------------------------------------------

\43\ We estimate that 120,508 clinicians that participated in
the 2016 PQRS will be QPs who will not be not required to submit
MIPS quality performance category data under MIPS, and are not
included in the numerator or denominator of our participation rate.
This is a difference of 19,859 compared to the number of QPs in the
CY 2018 Quality Payment Program final rule (82 FR 53908).
---------------------------------------------------------------------------

As discussed in section III.H.3.h.(1).(b) of this proposed rule, we
are proposing to replace the term ``submission mechanism'' with the
terms ``collection type'' and ``submission type.'' ``Submission
mechanism'' is presently used to refer not only to the mechanism by
which data is submitted, but also to certain types of measures and
activities on which data are submitted to the entities submitting such
data in the Quality Payment Program.
Apart from clinicians that became QPs in the 2017 MIPS performance
period, we assume that clinicians will continue to submit quality data
for the same collection types they used under the 2016 PQRS. As
discussed in the CY

[[Page 36020]]

2018 Quality Payment Program final rule (82 FR 53905), when describing
the burden for the virtual group application process, we assume that
the 80 TINs that elect to form 16 virtual groups will continue to
collect and submit MIPS data using the same collection and submission
types as they did when reporting under the 2016 PQRS, but the
submission will be at the virtual group, rather than group level. Our
burden estimates for the quality performance category do not include
the burden for the quality data that APM Entities submit to fulfill the
requirements of their models. The burden is excluded as sections 3021
and 3022 of the Affordable Care Act state the Shared Savings Program
and the testing, evaluation, and expansion of Innovation Center models
tested under section 1115A of the Act (or section 3021 of the
Affordable Care Act) are not subject to the PRA (42 U.S.C. 1395jjj(e)
and 1315a(d)(3), respectively).\44\ Tables 65, 66, and 67 explain our
revised estimates of the number of organizations (including groups,
virtual groups, and individual MIPS eligible clinicians) submitting
data on behalf of clinicians segregated by collection type.
---------------------------------------------------------------------------

\44\ Our estimates do reflect the burden on MIPS APM
participants of submitting Promoting Interoperability performance
category data, which is outside the requirements of their models.
---------------------------------------------------------------------------

Table 65 provides our estimated counts of clinicians that will
submit quality performance category data as MIPS individual clinicians
or groups in the 2019 MIPS performance period. First, we estimated the
number of clinicians that submit data as an individual clinician or
group during the 2019 MIPS performance period using 2016 PQRS data on
individuals and groups by collection type and excluded clinicians
identified as QPs using the APM Participation List for the third
snapshot date of the 2017 QP performance period.
For the 2019 performance period, respondents will have the option
to submit quality performance category data via claims, direct, log in
and upload, and CMS Web Interface submission types. For this proposed
rule, participation data by submission type and user research data to
inform burden assumptions are not available to estimate burden by
submission type. As a result, we continue to estimate the burden for
collecting data via collection type: Claims, QCDR and MIPS CQMs, eCQMs,
and the CMS Web Interface. As we gain more experience with the program,
we may revise this approach in the future.
For the claims collection type, in section III.H.3.h.(1).(b) of
this rule, we propose to limit the Medicare Part B claims collection
type to small practices beginning with the 2021 MIPS payment year and
to allow clinicians in small practices to report claims as a group. We
assume in our currently approved burden analysis that any clinician
that submits quality data codes to us for the claims collection type is
intending to do so for the Quality Payment Program. We made this
assumption originally in the CY 2016 Quality Payment Program final rule
to ensure that we fully accounted for any burden that may have resulted
from our policies. In some cases, however, clinicians may be submitting
quality data codes not only for claims collection type, but also for
MIPS CQM and QCDR collection types. Some registries and QCDRs utilize
data from claims to populate their datasets when submitting on behalf
of clinicians. We are not able to separate out when a clinician submits
a quality data code solely for the claim collection type or when a
clinician is also submitting these codes for MIPS CQM or QCDR
collection types. In addition, we see a large number of voluntary
reporters for the claims collection type. Approximately half of the
274,702 clinicians we estimate will submit quality data via claims (see
Table 65) are MIPS eligible clinicians while the other half are
voluntary reporters which means our burden include estimates for a
large number of voluntary reporters. Approximately 60 percent of these
274,702 clinicians are in practices with more than 15 clinicians;
however, over 80 percent of the number in practices larger than 15
clinicians are either voluntary reporters, group reporters, or are also
reporting quality data through another collection type. Approximately
25,000 clinicians in non-small practices are both MIPS eligible and
scored based only on claims data. Overall, we find that approximately
47 percent of the clinicians reporting claims in non-small practices
would also qualify for facility-based reporting, and therefore, would
not be required to submit quality data. It is unclear why many
clinicians are submitting quality data via an alternate collection type
and we currently lack data to estimate both the number of clinicians
who would be impacted by this proposal and the potential behavioral
response of those clinicians who would be required to switch to another
collection type. As a result, we propose to continue using the
assumption that all clinicians (except QPs) who submitted data to 2016
PQRS via the claims collection type would continue to do so for MIPS in
order to avoid overstating the impact of the proposed change. We intend
to update this burden estimate with additional data as it becomes
available. We also seek comment on potential other assumptions for
capturing the claims burden.
Due to data limitations, our burden estimates for all quality
collection types continue to assume that clinicians who submitted data
in PQRS (except QPs) would continue to do so using the same collection
types in MIPS. Using our proposed terminology, clinicians who used a
QCDR or Registry would now collect measures via QCDR or MIPS CQM
collection type; clinicians who used the EHR in PQRS would elect the
eCQM collection type, and groups that elected the CMS Web Interface for
PQRS would elect the CMS Web Interface for MIPS.
In addition, participation data for the 2017 MIPS performance
period was unavailable in time for this proposed rule, with the
exception of CMS Web Interface respondents. If actual participation
data for the 2017 MIPS performance period is available in time to meet
our final rule's publication schedule, we will use this data and revise
our estimates in that rule. Based on these methods, Table 65 shows that
in the 2019 MIPS performance period, an estimated 274,702 clinicians
will submit data as individuals for the claims collection type; 267,736
clinicians will submit data as individuals or as part of groups for the
MIPS CQM or QCDR collection types; 129,188 clinicians will submit data
as individuals or as part of groups via eCQM collection types; and
91,757 clinicians will submit as part of groups via the CMS Web
Interface.
Table 65 provides estimates of the number of clinicians to collect
quality measures data via each collection type, regardless of whether
they decide to submit as individual clinicians or as part of groups.
Because our burden estimates for quality data submission assume that
burden is reduced when clinicians elect to submit as part of a group,
we also separately estimate the expected number of clinicians to submit
as individuals or part of groups.

[[Page 36021]]

Table 65--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
CMS web
Claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect 274,702 267,736 129,188 91,757 763,383
data by collection type (as
individual clinicians or
groups) in Quality Payment
Program Year 3 (excludes QPs)
(a)............................
* Number of clinicians to 278,039 255,228 131,133 93,867 758,267
collect data by collection type
(as individual clinicians or
groups) in Quality Payment
Program Year 2 (excludes QPs)
(b)............................
Difference between Year 3 and -3,337 +12,508 -1,945 -2,110 +5,116
Year 2 (c) = (a)-(b)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

In the CY 2018 Quality Payment Program final rule (82 FR 53625
through 53626), beginning with the 2019 MIPS performance period, we
allow MIPS eligible clinicians to submit data for multiple collection
types for a single performance category. Therefore, we are capturing
the burden of any eligible clinician that may have historically
collected to PQRS via multiple collection types, as we assume they
would continue to collect via multiple collection types and that our
MIPS scoring methodology will take the highest score. Hence, the
estimated numbers of individual clinicians and groups to collect via
the various collection types are not mutually exclusive, and reflect
the occurrence of individual clinicians or groups that collected data
via multiple collection types under the 2016 PQRS.
Table 66 uses methods similar to those described for Table 65 to
estimate the number of clinicians to submit data as individual
clinicians via each collection type in Quality Payment Program Year 3.
We estimate that approximately 274,702 clinicians will submit data as
individuals using the claims collection type; approximately 103,268
clinicians will submit data as individuals using MIPS CQMs or QCDR
collection types; and approximately 52,028 clinicians will submit data
as individuals using eCQMs collection type.

Table 66--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
Collection Type
----------------------------------------------------------------------------------------------------------------
CMS web
Claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit 274,702 103,268 52,028 0 429,998
data as individuals in Quality
Payment Program Year 3
(excludes QPs) (a).............
* Number of Clinicians to submit 278,039 104,281 52,709 0 435,029
data as individuals in Quality
Payment Program Year 2
(excludes QPs) (b).............
Difference between Year 3 and -3,337 -1,013 -681 0 -5,031
Year 2 (c) = (a)-(b)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

To be consistent with the policy in the CY 2018 Quality Payment
Program final rule that for MIPS eligible clinicians who collect
measures via claims, MIPS CQM, eCQM, or QCDR collection types and
submit more than the required number of measures (82 FR 53735 through
54736), we will score the clinician on the required measures with the
highest assigned measure achievement points, our columns in Table 66
are not mutually exclusive.
Table 67 provides our estimated counts of groups or virtual groups
to submit quality data on behalf of clinicians for each collection type
in the 2019 MIPS performance period and reflects our assumption that
the formation of virtual groups will reduce burden. Except for groups
comprised entirely of QPs, we assume that groups that submitted quality
data as groups under the 2016 PQRS will continue to submit quality data
either as groups or virtual groups for the same collection types as
they did as a group or TIN within a virtual group for the 2019 MIPS
performance period. The first step was to estimate the number of groups
or virtual groups to collect data via each collection type during the
2019 MIPS performance period using 2016 PQRS data on groups collecting
through various collection types and excluding clinicians identified as
QPs using the APM Participation List for the third snapshot date of the
2017 QP performance period. The second and third steps in Table 67
reflect our currently approved assumption that virtual groups will
reduce the burden for quality data submission by reducing the number of
organizations to submit quality data on behalf of clinicians. We assume
that 40 groups that previously collected on behalf of clinicians via
QCDR or MIPS CQM collection types will elect to form 8 virtual groups
that will collect via QCDR and MIPS CQM collection types. We assume
that another 40 groups that previously collected on behalf of
clinicians via eCQM collection types will elect to form another 8
virtual groups that will collection via eCQM collection types. Hence,
the second step in Table 67 is to subtract out the estimated number of
groups under each collection type that will elect to form virtual
groups, and the third step in Table 67 is to add in the estimated
number of virtual groups that will submit on behalf of clinicians for
each collection type.
Specifically, we assumed that 3,788 groups and virtual groups will
submit data for the QCDR or MIPS CQM collection types on behalf of
164,468 clinicians; 1,501 groups and virtual groups will submit for
eCQM collection types on behalf of 77,160 eligible clinicians; and 286
groups will submit data via the CMS Web Interface on behalf of 91,757
clinicians. Groups cannot elect to collect via claims collection type.

[[Page 36022]]

Table 67--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
CMS web
Claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data 0 3,820 1,533 286 5,639
by collection type (on behalf
of clinicians) in Quality
Payment Program Year 3
(excludes QPs) (a).............
Subtract out: Number of groups 0 40 40 0 80
to collect data by collection
type on behalf of clinicians in
Quality Payment Program Year 3
that will submit as virtual
groups in Quality Payment
Program Year 3 (b).............
Add in: Number of virtual groups 0 8 8 0 16
to collect data by collection
type on behalf of clinicians in
Quality Payment Program Year 3
(c)............................
Number of groups to collect data 0 3,788 1,501 286 5,575
by collection type on behalf of
clinicians in Quality Payment
Program Year 3 (d) = (a)-(b) +
(c)............................
* Number of groups to collect 0 2,936 1,509 296 4,741
data by collection type on
behalf of clinicians in Quality
Payment Program Year 2 (e).....
Difference between Year 3 and 0 852 -8 -10 834
Year 2 (f) = (d)-(e)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

The burden estimates associated with submission of quality
performance category data have some limitations. We believe it is
difficult to quantify the burden accurately because clinicians and
groups may have different processes for integrating quality data
submission into their practices' work flows. Moreover, the time needed
for a clinician to review quality measures and other information,
select measures applicable to their patients and the services they
furnish, and incorporate the use of quality data codes into the
practice workflows is expected to vary along with the number of
measures that are potentially applicable to a given clinician's
practice and by the collection type. Further, these burden estimates
are based on historical rates of participation in the PQRS program, and
the rate of participation in MIPS is expected to differ. In addition,
the submission type used to submit MIPS data may also vary from these
estimates due to more accurate information being unavailable at this
time for this proposed rule.
We believe the burden associated with submitting quality measures
data will vary depending on the collection type selected by the
clinician, group, or third-party. As such, we separately estimate the
burden for clinicians, groups, and third parties to submit quality
measures data by the collection type used. For the purposes of our
burden estimates for the claims, MIPS CQM and QCDR, and eCQM collection
types, we also assume that, on average, each clinician or group will
submit 6 quality measures.
We estimate an increase in the number of QPs from 100,649 in CY
2018 Quality Payment Program final rule to 120,508 for this proposed
rule (82 FR 53908) and since they are excluded from submitting MIPS
data, a decrease to our estimated number of respondents by submission
and collection type relative to the estimates in the CY 2018 Quality
Payment Program final rule (82 FR 53912 through 53915). As noted
previously in this section, information collections associated with the
Shared Savings Program and the testing, evaluation, and expansion of
CMS Innovation Center models tested under section 1115A of the Act (or
section 3021 of the Affordable Care Act) are not subject to the PRA.
Quality Payment Program Identity Management Application Process:
The proposed requirements and burden associated with the application
process will be submitted to OMB for approval under control number
0938-1314 (CMS-10621).
In the CY 2018 Quality Payment Program final rule, the time
associated with the Identity Management Application Process was
described as ``Obtain Account in CMS-Specified Identity Management
System'' and included in the ICR for Quality Data Submission by
Clinicians and Groups: EHR Submission (82 FR 53914) for a total burden
of 54,218 hours (1 hr x 54,218 respondents). After our review of the
quality data submission process, we determined the burden associated
with the application process (3,741 hours) should be accounted for in a
separate ICR. Our per respondent burden estimate remains unchanged at 1
hour per response.
For an individual, group, or third-party to submit MIPS quality,
improvement activities, or Promoting Interoperability performance
category data using either the log in and upload or the log in and
attest submission type or to access feedback reports, the submitter
must have a CMS Enterprise Portal user account. Once the user account
is created, registration is not required again for future years.
Based on the number of new TINs registered in the 2017 MIPS
performance period, we estimate 3,741 eligible clinicians, groups, or
third-parties will register for new accounts for the 2019 MIPS
performance period. As shown in Table 68 it would take 1 hour at
$89.18/hr for a computer systems analyst (or their equivalent) to
obtain an account for the CMS Enterprise Portal. In aggregate we
estimate an annual burden of 3,741 hours (3,741 registrations x 1 hr/
registration) at a cost of $333,622 (3,741 hr x $89.18/hr) or $89.18
per registration.

Table 68--Estimated Burden for Quality Payment Program Identity
Management Application Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of New TINs completing the Identity Management 3,741
Application Process (a)................................

[[Page 36023]]

Total Hours Per Application (b)......................... 1
---------------
Total Annual Hours for completing the Identity 3,741
Management Application Process (c) = (a) * (b).....
Cost Per Application @ computer systems analyst's labor $89.18
rate of $89.18/hr.) (d)................................
---------------
Total Annual Cost for completing the Identity $333,622
Management Application Process (e) = (a) * (d).....
------------------------------------------------------------------------

Quality Data Submission by Clinicians: Claims-Based Collection
Type: The proposed requirements and burden associated with clinicians'
claims-based data submissions will be submitted to OMB for approval
under control number 0938-1314 (CMS-10621).
As noted in Table 65, based on 2016 PQRS data and 2017 MIPS
eligibility data, we assume that 274,702 individual clinicians will
collect and submit quality data via the claims collection type. We
continue to anticipate that the claims submission process for MIPS is
operationally similar to the way the claims submission process
functioned under the PQRS. Specifically, clinicians will need to gather
the required information, select the appropriate quality data codes
(QDCs), and include the appropriate QDCs on the claims they submit for
payment. Clinicians will collect QDCs as additional (optional) line
items on the CMS-1500 claim form or the electronic equivalent HIPAA
transaction 837-P, approved by OMB under control number 0938-1197. This
rule's proposed provisions would not necessitate the revision of either
form.
For this CY 2019 Quality Payment Program rule, we are proposing
adjustments to the number of respondents based on more recent data and
adjustments to our per respondent time estimates so that they correctly
align with the number of required measures for which MIPS data must be
submitted (6 measures) in comparison to the number of measures
previously required under PQRS (9 measures).
The total estimated burden of claims-based submission will vary
along with the volume of claims on which the submission is based. Based
on our experience with PQRS, we estimate that the burden for submission
of MIPS quality data will range from 0.15 to 7.2 hours per clinician, a
reduction from the range of 0.22 to 10.8 hours as set out in the CY
2018 Quality Payment Program final rule (82 FR 53912). In the same
rule, the 33 percent reduction in the number of measures (from 9 to 6)
was erroneously omitted from our burden calculations; it is reflected
in this proposed rule's burden estimates. The wide range of estimates
for the time required for a clinician to submit quality measures via
claims reflects the wide variation in complexity of submission across
different clinician quality measures. As shown in Table 69, we estimate
that the cost of quality data submission using claims will range from
$13.38 (0.15 hr x $89.18/hr) to $642.10 (7.2 hr x $89.18/hr). The
burden will involve becoming familiar with MIPS data submission
requirements. We believe that the start-up cost for a clinician's
practice to review measure specifications is 7 hours, consisting of 3
hours at $107.38/hr for a practice administrator, 1 hour at $206.44/hr
for a clinician, 1 hour at $43.96/hr for an LPN/medical assistant, 1
hour at $89.18/hr for a computer systems analyst, and 1 hour at $36.98/
hr for a billing clerk.
The estimate for reviewing and incorporating measure specifications
for the claims collection type is higher than that of QCDRs/Registries
or eCQM collection types due to the more manual, and therefore, more
burdensome nature of claims measures.
Considering both data submission and start-up requirements, the
estimated time (per clinician) ranges from a minimum of 7.15 hours
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this
regard the total annual burden rages from 1,964,119 hours (7.15 hr x
274,702 clinicians) to 3,900,768 hours (14.2 hr x 274,702 clinicians).
The estimated annual cost (per clinician) ranges from $712.08 ($13.38 +
$322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80
($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total
annual burden ranges from a minimum of $195,609,800 (274,702 clinicians
x $712.08) to a maximum of $368,320,442 (274,702 clinicians x
$1,340.80).
Table 69 summarizes the range of total annual burden associated
with clinicians submitting quality data via claims.
Independent of the change in the number of respondents, the change
in estimated time per clinician results in a burden adjustment of
between -20,853 hours at -$1,860,081 (278,039 clinicians x -0.075 hr x
$89.18/hr) and -1,000,941 hours at -$89,261,641 (278,039 clinicians x -
3.6 hr x $89.18/hr). Accounting for the change in the time burden per
respondent, the decrease in number of respondents results in a total
adjustment of between -23,860 hours at -$2,376,211 (-3,337 respondents
x $712.08/respondent) and -47,385 hours at -$4,474,249 (-3,337
respondents x $1,340.80/respondent). When these two adjustments are
combined, the net adjustment ranges between -44,713 (-20,853-23,860)
hours at -$4,236,292 (-$1,860,081-$2,376,211) and -1,048,326 (-
1,000,941-47,385) hours at -$93,735,890 (-$89,261,641-$4,474,249).

Table 69--Estimated Burden for Quality Performance Category:
Clinicians Using the Claims Collection Type
----------------------------------------------------------------------------------------------------------------
Maximum burden
Minimum burden Median burden estimate
----------------------------------------------------------------------------------------------------------------
Number of Clinicians (a)........................................ 274,702 274,702 274,702
Hours Per Clinician to Submit Quality Data (b).................. 0.15 1.05 7.2
Number of Hours Practice Administrator Review Measure 3 3 3
Specifications (c).............................................
Number of Hours Computer Systems Analyst Review Measure 1 1 1
Specifications (d).............................................

[[Page 36024]]

Number of Hours LPN Review Measure Specifications (e)........... 1 1 1
Number of Hours Billing Clerk Review Measure Specifications (f). 1 1 1
Number of Hours Clinician Review Measure Specifications (g)..... 1 1 1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) + 7.15 8.05 14.2
(g)............................................................
-----------------------------------------------
Total Annual Hours (i) = (a) * (h).......................... 1,964,119 2,211,351 3,900,768
Cost to Submit Quality Data (@ computer systems analyst's labor $13.38 $93.64 $642.10
rate of $89.18/hr.) (j)........................................
Cost to Review Measure Specifications (@ practice $322.14 $322.14 $322.14
administrator's labor rate of $107.38/hr.) (k).................
Cost to Review Measure Specifications (@ computer systems $89.18 $89.18 $89.18
analyst's labor rate of $89.18/hr.) (l)........................
Cost to Review Measure Specifications (@ LPN's labor rate of $43.96 $43.96 $43.96
$43.96/hr.) (m)................................................
Cost to Review Measure Specifications (@ billing clerk's labor $36.98 $36.98 $36.98
rate of $36.98/hr.) (n)........................................
Cost to Review Measure Specifications (@ physician's labor rate $206.44 $206.44 $206.44
of $206.44/hr.) (o)............................................
-----------------------------------------------
Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m) $712.08 $792.34 $1,340.80
+ (n) + (o)................................................
-----------------------------------------------
Total Annual Cost (q) = (a) * (p)....................... $195,609,800 $217,657,383 $368,320,442
----------------------------------------------------------------------------------------------------------------

Quality Data Submission by Individuals and Groups Using MIPS CQM
and QCDR Collection Types: This rule does not propose any new or
revised reporting, recordkeeping, or third-party disclosure
requirements related to this quality data submission. However, we are
proposing adjustments to the number of respondents based on more recent
data. The adjusted burden will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
As noted in Tables 65, 66, and 67 and based on the 2016 PQRS data
and 2017 MIPS eligibility data, we assume that 267,736 clinicians will
submit quality data as individuals or groups using MIPS CQM or QCDR
collection types. Of these, we expect 103,268 clinicians, as shown in
Table 66, to submit as individuals and 3,788 groups, as shown in Table
67, are expected to submit on behalf of the remaining 164,468
clinicians. Given that the number of measures required is the same for
clinicians and groups, we expect the burden to be the same for each
respondent collecting data via MIPS CQM or QCDR, whether the clinician
is participating in MIPS as an individual or group.
Under the MIPS CQM and QCDR collection types, the individual
clinician or group may either submit the quality measures data directly
to us, log in and upload a file, or utilize a third-party vendor to
submit the data to us on the clinician's or group's behalf.
We estimate that the burden associated with the QCDR collection
type is similar to the burden associated with the MIPS CQM collection
type; therefore, we discuss the burden for both together below. For
MIPS CQM and QCDR collection types, we estimate an additional time for
respondents (individual clinicians and groups) to become familiar with
MIPS submission requirements and, in some cases, specialty measure sets
and QCDR measures. Therefore, we believe that the burden for an
individual clinician or group to review measure specifications and
submit quality data total 9.083 hours at $858.86. This consists of 3
hours at $89.18/hr for a computer systems analyst (or their equivalent)
to submit quality data along with 2 hours at $107.38/hr for a practice
administrator, 1 hour at $89.18/hr for a computer systems analyst, 1
hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for
a billing clerk, and 1 hour at $206.44/hr for a clinician to review
measure specifications. Additionally, clinicians and groups will need
to authorize or instruct the qualified registry or QCDR to submit
quality measures' results and numerator and denominator data on quality
measures to us on their behalf. We estimate that the time and effort
associated with authorizing or instructing the quality registry or QCDR
to submit this data will be approximately 5 minutes (0.083 hours) per
clinician or group (respondent) for a cost of $7.40 (0.083 hr x $89.18/
hr for a computer systems analyst).
In aggregate we estimate an annual burden of 972,390 hours (9.083
hr/response x 107,056 groups plus clinicians submitting as individuals)
at a cost of $92,738,331 (107,056 responses x $866.26/response). The
decrease in number of respondents results in a total adjustment of -
1,462 hours at -$139,467 (-161 respondents x $866.26/respondent). Based
on these assumptions, we have estimated in Table 70 the burden for
these submissions.

Table 70--Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the MIPS CQM/
QCDR Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)...... 103,268
Number of groups submitting via QCDR or MIPS CQM on 3,788
behalf of individual clinicians (b)....................
Number of Respondents (groups plus clinicians submitting 107,056
as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Report Quality Data (d)......... 3
Number of Hours Practice Administrator Review Measure 2
Specifications (e).....................................

[[Page 36025]]

Number of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)... 1
Number of Hours Billing Clerk Review Measure 1
Specifications (h).....................................
Number of Hours Clinician Review Measure Specifications 1
(i)....................................................
Number of Hours Per Respondent to Authorize Qualified 0.083
Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g) 9.083
+ (h) + (i) + (j)......................................
---------------
Total Annual Hours (l) = (c) * (k).................. 972,390
Cost Per Respondent to Submit Quality Data (@ computer $267.54
systems analyst's labor rate of $89.18/hr.) (m)........
Cost to Review Measure Specifications (@ practice $214.76
administrator's labor rate of $107.38/hr.) (n).........
Cost Computer System's Analyst Review Measure $89.18
Specifications (@ computer systems analyst's labor rate
of $89.18/hr.) (o).....................................
Cost LPN Review Measure Specifications (@ LPN's labor $43.96
rate of $43.96/hr.) (p)................................
Cost Billing Clerk Review Measure Specifications (@ $36.98
clerk's labor rate of $36.98/hr.) (q)..................
Cost Clinician Review Measure Specifications (@ $206.44
physician's labor rate of $206.44/hr.) (r).............
Cost for Respondent to Authorize Qualified Registry/QCDR $7.40
to Report on Respondent's Behalf (@ computer systems
analyst's labor rate of $89.18/hr.) (s)................
---------------
Total Annual Cost Per Respondent (t) = (m) + (n) + $866.26
(o) + (p) + (q) + (r) + (s)........................
---------------
Total Annual Cost (u) = (c) * (t)............... $92,738,331
------------------------------------------------------------------------

Quality Data Submission by Clinicians and Groups: eCQM Collection
Type: This rule does not propose any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to this
quality data submission. However, we are proposing adjustments to the
number of respondents based on more recent data. The adjusted burden
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
As noted in Tables 65, 66, and 67, based on 2016 PQRS data and 2017
MIPS eligibility data, we assume that 129,188 clinicians will elect to
use the eCQM collection type; 52,028 clinicians are expected to submit
eCQMs as individuals; and 1,501 groups are expected to submit eCQMs on
behalf of 77,160 clinicians. We expect the burden to be the same for
each respondent using the eCQM collection type, whether the clinician
is participating in MIPS as an individual or group.
In the CY 2018 Quality Payment Program final rule, the time
required for users to obtain an account for the CMS Enterprise Portal
was included in this Quality Data Submission by Clinicians and Groups:
eCQM Collection Type ICR (82 FR 53914). However, in this CY 2019
Quality Payment Program rule, we are proposing a separate ICR for this
activity (now described as the Quality Payment Program Identity
Management Application Process; see Table 68) and to reduce (by 1 hour)
our per respondent burden estimate for this ICR commensurately. We are
also proposing an adjustment to the number of respondents based on more
recent data.
Under the eCQM collection type, the individual clinician or group
may either submit the quality measures data directly to us from their
eCQM, log in and upload a file, or utilize an eCQM data submission
vendor to submit the data to us on the clinician's or group's behalf.
To prepare for the eCQM collection type, the clinician or group
must review the quality measures on which we will be accepting MIPS
data extracted from eCQMs, select the appropriate quality measures,
extract the necessary clinical data from their eCQM, and submit the
necessary data to the CMS-designated clinical data warehouse or use a
health IT vendor to submit the data on behalf of the clinician or
group. We assume the burden for collecting quality measures data via
eCQM is similar for clinicians and groups who submit their data
directly to us from their CEHRT and clinicians and groups who use an
eCQM data submission vendor to submit the data on their behalf. This
includes extracting the necessary clinical data from their EHR and
submitting the necessary data to the CMS-designated clinical data
warehouse.
We continue to estimate that it will take no more than 2 hours at
$89.18/hr for a computer systems analyst to submit the actual data
file. The burden will also involve becoming familiar with MIPS
submission. In this regard we estimate it would take 6 hours for a
clinician or group to review measure specifications. Of that time, we
estimate 2 hours at $107.38/hr for a practice administrator, 1 hour at
$206.44/hr for a clinician, 1 hour at $89.18/hr for a computer systems
analyst, 1 hour at $43.96/hr for a LPN/medical assistant, and 1 hour at
$36.98/hr for a billing clerk.
In aggregate we estimate an annual burden of 428,232 hours (8 hr x
53,529 groups and clinicians submitting as individuals) at a cost of
$41,200,201 (53,529 responses x $769.68/response) (see Table 71).
Independent of the change in the number of respondents, removing
the time burden associated with completing the Quality Payment Program
Identity Management Application Process results in an adjustment to the
total burden of -54,218 hours and -$4,835,161 (54,218 respondents x -1
hr x $89.18/hr). Accounting for the change in the per respondent time
estimate, the decrease in number of respondents results in a total
adjustment of -5,512 hours at -$530,309 (-689 respondents x $769.68/
respondent). When these two adjustments are combined, the net
adjustment is -59,730 (-54,218-5,512) hours at -$5,365,470 (-
$4,835,161-$530,309).

[[Page 36026]]

Table 71--Estimated Burden for Quality Performance Category: Clinicians
(Submitting Individually or as Part of a Group) Using the eCQM
Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)...... 52,028
Number of Groups submitting via EHR on behalf of 1,501
individual clinicians (b)..............................
Number of Respondents (groups and clinicians submitting 53,529
as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Submit MIPS Quality Data File to 2
CMS (d)................................................
Number of Hours Practice Administrator Review Measure 2
Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)... 1
Number of Hours Billing Clerk Review Measure 1
Specifications (h).....................................
Number of Hours Clinicians Review Measure Specifications 1
(i)....................................................
Annual Hours per Respondent (j) = (d) + (e) + (f) + (g) 8
+ (h) + (i)............................................
---------------
Total Annual Hours (k) = (c) * (j).................. 428,232
Cost Per Respondent to Submit Quality Data (@ computer $178.36
systems analyst's labor rate of $88.10/hr.) (l)........
Cost to Review Measure Specifications (@ practice $214.76
administrator's labor rate of $105.16/hr.) (m).........
Cost to Review Measure Specifications (@ computer $89.18
systems analyst's labor rate of $88.10/hr.) (n)........
Cost to Review Measure Specifications (@ LPN's labor $43.96
rate of $43.12/hr.) (o)................................
Cost to Review Measure Specifications (@ clerk's labor $36.98
rate of $36.12/hr.) (p)................................
Cost to D21Review Measure Specifications (@ physician's $206.44
labor rate of $202.08/hr.) (q).........................
Total Cost Per Respondent (r) = (l) + (m) + (n) + $769.68
(o) + (p) + (q)....................................
---------------
Total Annual Cost (s) = (c) * (r)............... $41,200,201
------------------------------------------------------------------------

Quality Data Submission via CMS Web Interface: The proposed
requirements and burden associated with this data submission will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As discussed in section III.H.3.h.(2)(a)(ii)(A)(bb) of this rule,
we are proposing a 40 percent reduction in the number of measures (from
15 to 9 measures) for which clinicians are required to submit quality
data via the CMS Web Interface. To account for the decrease in
measures, we are also proposing to decrease our per respondent time
estimate.
We assume that 286 groups will submit quality data via the CMS Web
Interface based on the number of groups who submitted quality data via
the CMS Web Interface during the 2018 MIPS performance period. This is
a decrease of 10 groups from the currently approved number provided in
the CY 2018 Quality Payment Program final rule (82 FR 53915) due to
receipt of more current data. We anticipate that approximately 91,757
clinicians will be represented.
The burden associated with the group submission requirements is the
time and effort associated with submitting data on a sample of the
organization's beneficiaries that is prepopulated in the CMS Web
Interface. In the CY 2018 Quality Payment Program final rule, we
estimated that it would take, on average, 74 hours for each group to
submit quality measures data via the CMS Web Interface (82 FR 53915).
Of those hours, approximately half (or 37 hr) are unaffected by the
number of required measures while the other half (37 hr) are affected
proportionately by the number of required measures (60 percent of 37 hr
is adjusted to 22.2 hr). Accounting for the proposed reduction in
required measures, our revised estimate for the time to submit data via
the CMS Web Interface for the 2019 MIPS performance period is 59.2
hours (37 hr + 22.2 hr), a reduction of 14.8 hours or 40 percent of the
currently approved 37 hour time estimate. Considering only the time
which varies based on the number of required measures, the process of
entering or uploading data requires approximately 2.5 hours of a
computer systems analyst's time per measure (22.2 hr/9 measures). Our
estimate for submission includes the time needed for each group to
populate data fields in the web interface with information on
approximately 248 eligible assigned Medicare beneficiaries, submit the
data (we will partially pre-populate the CMS Web Interface with claims
data from their Medicare Part A and B beneficiaries). The patient data
either can be manually entered, uploaded into the CMS Web Interface via
a standard file format, which can be populated by CEHRT, or submitted
directly. Each group must provide data on 248 eligible assigned
Medicare beneficiaries (or all eligible assigned Medicare beneficiaries
if the pool of eligible assigned beneficiaries is less than 248) for
each measure. In aggregate we estimate an annual burden of 16,931 hours
(286 groups x 59.2 hr) at a cost of $1,509,907 (16,931 hr x $89.18/hr).
Independent of the change in the number of respondents, the
decrease in total burden resulting from the decrease in required
measures is -4,381 hours at -$390,679 (296 groups x -14.8 hr x $89.18/
hr). Accounting for the decrease in total time, the decrease in number
of respondents results in a total adjustment of -592 hours at -$52,794
(-10 respondents x $5,279/respondent). When these adjustments are
combined, the net adjustment is -4,973 (-4,381-592) hours at -$443,473
(-$390,679-$52,794).
Based on the assumptions discussed in this section, Table 72
summarizes the burden for groups submitting to MIPS via the CMS Web
Interface.

Table 72--Estimated Burden for Quality Data Submission via the CMS Web
Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Eligible Group Practices (a).................. 286

[[Page 36027]]

Total Annual Hours Per Group to Submit (b).............. 59.2
---------------
Total Annual Hours (c) = (a) * (b).................. 16,931
Cost Per Group to Report (@ computer systems analyst's $5,279
labor rate of $89.18/hr.) (d)..........................
---------------
Total Annual Cost (e) = (a) * (d)................... $1,509,907
------------------------------------------------------------------------

Beneficiary Responses to CAHPS for MIPS Survey: This rule does not
propose any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the survey. However, we are
proposing adjustments to our currently approved burden estimates based
on more recent data. The adjusted burden will be submitted to OMB for
approval under control number 0938-1222 (CMS-10450).
In this CY 2019 Quality Payment Program rule, we are proposing
adjustments to the number of groups electing to report on the CAHPS for
MIPS survey as well as the average number of beneficiaries per group
based on more recent data.
Under MIPS, groups of 25 or more clinicians can elect to contract
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as
one of their 6 required quality measures. Beneficiaries that choose to
respond to the CAHPS for MIPS survey will experience burden.
The usual practice in estimating the burden on public respondents
to surveys such as CAHPS is to assume that respondent time is valued,
on average, at civilian wage rates. As explained in section V.A. of
this proposed rule, BLS data sets out an average hourly wage for
civilians in all occupations to be $24.34/hr. Although most Medicare
beneficiaries are retired, we believe that their time value is unlikely
to depart significantly from prior earnings expense, and we have used
the average hourly wage to compute our cost estimate for the
beneficiaries' time.
For the 2019 MIPS performance period, we assume that 241 groups
will elect to report on the CAHPS for MIPS survey, which is equal to
the number of groups participating in CAHPS for MIPS for the 2017 MIPS
performance period and a decrease from the 461 groups currently
approved by OMB. Table 73 shows the estimated annual burden for
beneficiaries to participate in the CAHPS for MIPS Survey. Based on the
number of complete and partially complete surveys for groups
participating in CAHPS for MIPS survey administration for the 2017 MIPS
performance period, we assume that an average of 273 beneficiaries will
respond per group for the 2019 MIPS performance period. Therefore, the
CAHPS for MIPS survey will be administered to approximately 65,793
beneficiaries per year (241 groups x an average of 273 beneficiaries
per group responding). This is an adjustment to our currently approved
132,307 beneficiary estimate.
The CAHPS for MIPS survey that will be administered in the 2019
MIPS performance period is unchanged from the survey administered in
the 2018 MIPS performance period. In that regard we continue to
estimate an average administration time of 12.9 minutes (or 0.215 hr)
at a pace of 4.5 items per minute for the English version of the
survey. For the Spanish version, we estimate an average administration
time of 15.5 minutes (assuming 20 percent more words in the Spanish
translation). However, since less than 1 percent of surveys were
administered in Spanish for reporting year 2016, our burden estimate
reflects the time for administering the English version of the survey.
Given that we expect approximately 65,793 respondents, we estimate
an annual burden of 14,145 hours (65,793 respondents x 0.215 hr/
respondent) at a cost of $344,289 (14,145 hr x $24.34/hr).
The decrease in the number of beneficiaries responding to the CAHPS
for MIPS survey results in an adjustment to the total time burden of -
14,301 hours and -$348,087 (-66,514 beneficiaries x 0.215 hr x $24.34/
hr).

Table 73--Estimated Burden for Beneficiary Participation in CAHPS for
MIPS Survey
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Eligible Group Practices Administering CAHPS 241
for MIPS (a)...........................................
Number of Beneficiaries Per Group Responding to Survey 273
(b)....................................................
Number of Total Beneficiary Respondents (c) = (a) * (b). 65,793
Number of Hours Per Beneficiary Respondent (d).......... 0.215
Cost (@ labor rate of $24.34/hr.) (e)................... $24.34/hr
---------------
Total Annual Hours (f) = (c) * (d).................. 14,145
---------------
Total Annual Cost for Beneficiaries Responding $344,289
to CAHPS for MIPS (g) = (c) * (e)..............
------------------------------------------------------------------------

Group Registration for CMS Web Interface: This rule does not
propose any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the group registration. However, we
are proposing adjustments to our currently approved burden estimates
based on more recent data. The adjusted burden will be submitted to OMB
for approval under control number 0938-1222 (CMS-10450).
In this CY 2019 Quality Payment Program rule, we are proposing to
adjust the number of respondents based on more recent data and an
adjustment to our per response time estimate based on our review of the
currently approved estimates against the existing registration process.

[[Page 36028]]

Groups interested in participating in MIPS using the CMS Web
Interface for the first time must complete an on-line registration
process. After first time registration, groups will only need to opt
out if they are not going to continue to submit via the CMS Web
Interface. In Table 74 we estimate that the registration process for
groups under MIPS involves approximately 0.25 hours at $89.18/hr for a
computer systems analyst (or their equivalent) to register the group.
Although the registration process remains unchanged from the CY 2018
Quality Payment Program final rule, a review of the steps required for
registration warranted a reduction of 0.75 hours in estimated burden
per group (82 FR 53917).
We assume that approximately 67 groups will elect to use the CMS
Web Interface submission type for the first time during the 2019 MIPS
performance period based on the number of new registrations received
during the CY 2018 registration period; an increase of 57 compared to
the number of groups currently approved by OMB under control number
0938-1314 (CMS-10621). In aggregate we estimate a burden of 16.75 hours
(67 new registrations x 0.25 hr/registration) at a cost of $1,494
(16.75 hr x $89.18/hr).
Independent of the decrease in time burden per group, the increase
in the number of groups registering to submit MIPS data via the CMS Web
Interface results in an adjustment to the total time burden of 57 hours
at $5,083 (57 groups x 1 hr x $89.18/hr). Accounting for the increase
in the number of groups, the decrease in time burden per group to
register results in an adjustment to the total burden of -50.25 hours
at -$4,481 (67 groups x-0.75 hrs x $89.18/hr). When these adjustments
are combined, the net adjustment is 6.75 hours (57-50.25) at $602
($5,083 -$4,481).

Table 74--Estimated Burden for Group Registration for CMS Web Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of New Groups Registering for CMS Web Interface 67
(a)....................................................
Annual Hours Per Group (b).............................. 0.25
---------------
Total Annual Hours (c) = (a) * (b).................. 16.75
Labor Rate to Register for CMS Web Interface @computer $89.18/hr
systems analyst's labor rate) (d)......................
---------------
Total Annual Cost for CMS Web Interface Group $1,494
Registration (e) = (a) * (d).......................
------------------------------------------------------------------------

Group Registration for CAHPS for MIPS Survey: This rule does not
propose any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the group registration. However, we
are proposing adjustments to our currently approved burden estimates
based on more recent data. The adjusted burden will be submitted to OMB
for approval under control number 0938-1222 (CMS-10450).
In this CY 2019 Quality Payment Program rule, we are proposing to
adjust our currently approved number of respondents based on more
recent data and adjust our per respondent time estimate based on our
review of the current burden estimates against the existing
registration process.
Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward
the MIPS quality performance category and, as a patient experience
measure, it also fulfills the requirement to submit at least one high
priority measure in the absence of an applicable outcome measure.
Groups that wish to administer the CAHPS for MIPS survey must register
by June of the applicable 12-month performance period, and
electronically notify CMS of which vendor they have selected to
administer the survey on their behalf. For the 2019 MIPS performance
period, we assume that 454 groups will enroll in the MIPS for CAHPS
survey based on the number of groups which elected to register during
the CY 2017 registration period; a decrease of 7 compared to the number
of groups currently approved by OMB under the aforementioned control
number (82 FR 53917).
As shown in Table 75, we assume that the staff involved in the
group registration for CAHPS for MIPS Survey will mainly be computer
systems analysts (or their equivalent) who have an average labor cost
of $89.18/hr. We assume the CAHPS for MIPS Survey registration burden
consists of 0.25 hours to register for the survey as well as 0.5 hours
to select the CAHPS for MIPS Survey vendor that will be used and
electronically notify CMS of their selection. In this regard the total
time for CAHPS for MIPS registration is 0.75 hours. Although the
registration process remains unchanged from the CY 2018 Quality Payment
Program final rule, after we reviewed the steps required for
registration more thoroughly, we believe that the burden was less than
we had originally estimated. In that regard we propose to reduce the
estimated burden from 1.5 hours to 0.75 hours per respondent
In aggregate we estimate an annual burden of 340.50 hours (454
groups x 0.75 hr per group) at a cost of $30,366 (340.50 hr x $89.18/
hr).
Independent of the change in time per group, the decrease in the
number of groups registering results in an adjustment to the total
burden of -10.5 hours at -$936 (-7 groups x 1.5 hrs x $89.18/hr).
Accounting for the decrease in the number of groups registering, the
decrease in time per group to register results in an adjustment to the
total burden of -340.5 hours at -$30,366 (454 groups x-0.75 hr x
$89.18/hr). When these adjustments are combined, the net adjustment is
-351 hours (-10.5-340.5) at -$31,302 (-$936-$30,366).

Table 75--Estimated Burden for Group Registration for CAHPS for MIPS
Survey
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Groups Registering for CAHPS (a).............. 454
Total Annual Hours for CAHPS Registration (b)........... 0.75
---------------
Total Annual Hours for CAHPS Registration (c) = (a) 340.5
* (b)..............................................

[[Page 36029]]

Labor Rate to Register for CAHPS (computer systems $89.18/hr
analyst) (d)...........................................
---------------
Total Annual Cost for CAHPS Registration (e) = (a) * $30,366
(d)................................................
------------------------------------------------------------------------

9. Quality Payment Program ICRs Regarding the Nomination of Quality
Measures
This rule does not propose any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
group registration. However, we are proposing adjustments to our
currently approved burden estimates based on more recent data. We are
also proposing to account for burden associated with policies that have
been finalized but whose burden were erroneously excluded from our
estimates. The new and adjusted burden will be submitted to OMB for
approval under control number 0938-1314 (CMS-10621).
As discussed in section III.H.3.h.(2)(b)(i) of this proposed rule,
quality measures are selected annually through a call for quality
measures under consideration, with a final list of quality measures
being published in the Federal Register by November 1 of each year.
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit
a ``Call for Quality Measures'' each year. Specifically, the Secretary
must request that eligible clinician organizations and other relevant
stakeholders identify and submit quality measures to be considered for
selection in the annual list of MIPS quality measures, as well as
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act,
eligible clinician organizations are professional organizations as
defined by nationally recognized specialty boards of certification or
equivalent certification boards.
As we described in the CY 2017 Quality Payment Program final rule
(81 FR 77137), we will accept quality measures submissions at any time,
but only measures submitted during the timeframe provided by us through
the pre-rulemaking process of each year will be considered for
inclusion in the annual list of MIPS quality measures for the
performance period beginning 2 years after the measure is submitted.
This process is consistent with the pre-rulemaking process and the
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
To identify and submit a quality measure, eligible clinician
organizations and other relevant stakeholders use a one-page online
form that requests information on background, gap analysis which
includes evidence for the measure, reliability validity, endorsement
and a summary which includes how the proposed measure relates to the
Quality Payment Program and the rationale for the measure. In addition,
proposed measures must be accompanied by a completed Peer Review
Journal Article form.
As shown in Table 76, we estimate that approximately 140
organizations, including clinicians, CEHRT developers, and vendors,
will submit measures for the Call for Quality Measures process; an
increase of 100 compared to the number of organizations currently
approved by OMB. In keeping with the focus on clinicians as the primary
source for recommending new quality measures, we are using practice
administrators and clinician time for our burden estimates. We also
estimate it will take 0.5 hours per organization to submit an activity
to us, consisting of 0.3 hours at $107.38/hr for a practice
administrator to make a strategic decision to nominate and submit a
measure and 0.2 hours at $206.44/hr for clinician review time.
The 0.5 hour estimate assumes that submitters will have the
necessary information to complete the nomination form readily
available, which we believe is a reasonable assumption. Additionally,
some submitters familiar with the process or who are submitting
multiple measures may require significantly less time, while other
submitters may require more if the opposite is true; on average we
believe 0.5 hours is a reasonable average across all submitters.
Consistent with the CY 2017 Quality Payment Program final rule, we
also estimate it will take 4 hours at $206.44/hr for a clinician (or
equivalent) to complete the Peer Review Journal Article Form (81 FR
77153 through 77155). This assumes that measure information is
available and testing is complete in order to have the necessary
information to complete the form, which we believe is a reasonable
assumption. While the requirement for completing the Peer Review
Journal Article was previously included in the CY 2017 Quality Payment
Program final rule, the time required for completing the form was
erroneously excluded from our burden estimates.
As shown in Table 76, in aggregate we estimate an annual burden of
630 hours (140 organizations x 4.5 hr/response) at a cost of $125,896
(140 x [(0.3 hr x $107.38/hr) + (4.2 hr x $206.44/hr)].
Independent of the change in time per organization, the change in
the number of organizations nominating new quality measures results in
an adjustment of 50 hours at $7,350 (100 organizations x [(0.3 hr x
$107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change
in respondents, the change in burden to nominate a quality measure
results in an adjustment of 560 hours at $115,606 (140 organizations x
4 hr x $206.44/hr). When these adjustments are combined, the total
adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606).

Table 76--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Quality Measures 140
(a)....................................................
Number of Hours Per Practice Administrator to Identify 0.30
and Propose Measure (b)................................
Number of Hours Per Clinician to Identify Measure (c)... 0.20
Number of Hours Per Clinician to Complete Peer Review 4.00
Article Form (d).......................................

[[Page 36030]]

Annual Hours Per Response (e) = (b) + (c) + (d)......... 4.50
---------------
Total Annual Hours (f) = (a) * (e).................. 630
Cost to Identify and Submit Measure (@ practice $32.21
administrator's labor rate of $107.38/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer $867.05
Review Article Form (@ physician's labor rate of
$206.44/hr.) (h).......................................
---------------
Total Annual Cost Per Respondent (i) = (g) + (h).... $899.26
---------------
Total Annual Cost (j) = (a) * (i)............... $125,896
------------------------------------------------------------------------

10. Quality Payment Program ICRs Regarding Promoting Interoperability
Data (Sec. 414.1375)
The proposed requirements and burden discussed under this section
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
For the 2019 MIPS performance period, clinicians and groups can
submit Promoting Interoperability data through direct, log in and
upload, or log in and attest submission types. We have worked to
further align the Promoting Interoperability performance category with
other MIPS performance categories. With the exception of submitters who
elect to use the log in and attest submission type for the Promoting
Interoperability performance category which is not available for the
quality performance category, we anticipate that most organizations
will use the same data submission type for the both of these
performance categories and that the clinicians, practice managers, and
computer systems analysts involved in supporting the quality data
submission will also support the Promoting Interoperability data
submission process. Hence, the following burden estimates show only
incremental hours required above and beyond the time already accounted
for in the quality data submission process. While this analysis
assesses burden by performance category and submission type, we
emphasize that MIPS is a consolidated program and submission analysis
and decisions are expected to be made for the program as a whole.
Promoting Interoperability Reweighting Applications: As established
in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS
eligible clinicians who meet the criteria for a significant hardship or
other type of exception may submit an application requesting a zero
percent weighting for the Promoting Interoperability performance
category in the following circumstances: Insufficient internet
connectivity, extreme and uncontrollable circumstances, lack of control
over the availability of CEHRT, and decertified EHR technology (81 FR
77240 through 77243 and 82 FR 53680 through 53686).
Table 77 summarizes the burden for clinicians to apply for
reweighting the Promoting Interoperability performance category to zero
percent due to a significant hardship exception (including a
significant hardship exception for small practices) or as a result of a
decertification of an EHR. Participation data for the 2017 MIPS
performance period was unavailable in time for this proposed rule.
However, assuming that the actual participation data for the 2017 MIPS
performance period is available in time to meet our final rule's
publication schedule, we will use this data and revise our estimates in
that rule. As a result, we assume 87,211 respondents (eligible
clinicians or groups) will submit a request to reweight the Promoting
Interoperability performance category to zero percent due to a
significant hardship (including small practices) or EHR decertification
through the Quality Payment Program based on 2016 data from the
Medicare EHR Incentive Program and the first 2019 payment year MIPS
eligibility and special status file. We estimate that 5,941 respondents
(eligible clinicians or groups) will submit a request for reweighting
the Promoting Interoperability performance category to zero percent due
to extreme and uncontrollable circumstances, insufficient internet
connectivity, lack of control over the availability of CEHRT, or as a
result of a decertification of an EHR. An additional 81,270 respondents
will submit a request for reweighting the Promoting Interoperability
performance category to zero percent as a small practice experiencing a
significant hardship. In total, this represents an increase of 46,566
from the number of respondents currently approved by OMB.
The application to request a reweighting to zero percent for the
Promoting Interoperability performance category is a short online form
that requires identifying the type of hardship experienced or whether
decertification of an EHR has occurred and a description of how the
circumstances impair the ability to submit Promoting Interoperability
data, as well as some proof of circumstances beyond the clinician's
control. We estimate it would take 0.25 hours at $89.18/hr for a
computer system analyst to submit the application. This is a reduction
from the 0.5 hours estimated in the CY 2018 Quality Payment Program
final rule due to a revised assessment of the application process (82
FR 53918). As shown in Table 77, in aggregate we estimate an annual
burden of 21,803 hours (87,211 applications x 0.25 hr/application) at a
cost of $1,944,369 (21,803 hr x $89.18/hr).
Independent of the change to the number of respondents, the
decrease in the amount of time to submit a reweighting application
results in an adjustment of -10,161.25 hours at -$906,180 (40,645
respondents x -0.25 hr x $89.18/hr). Accounting for the decrease in
time per respondent, the increase in the number of respondents
submitting reweighting applications results in an adjustment of
11,641.5 hours at $1,038,188 (46,566 respondents x 0.25 hr x $89.18
hr). When these adjustments are combined, the total adjustment is
1,480.25 hours (11,641.5-10,161.25) at $132,008 ($1,038,188-$906,180).

[[Page 36031]]

Table 77--Estimated Burden for Promoting Interoperability Reweighting
Applications
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Eligible Clinicians or Groups Applying Due to 5,941
Significant Hardship and Other Exceptions (a)..........
Number of Eligible Clinicians or Groups Applying Due to 81,270
Significant Hardship as Small Practice (b).............
Total Respondents Due to Hardships, Other Exceptions and 87,211
Hardships for Small Practices (c)......................
Hours Per Applicant per application submission (d)...... 0.25
---------------
Total Annual Hours (e) = (a) * (c).................. 21,802.75
Labor Rate for a computer systems analyst (f)........... $89.18/hr
---------------
Total Annual Cost (g) = (a) * (f)................... $1,944,369
------------------------------------------------------------------------

Submitting Promoting Interoperability Data: In this CY 2019 Quality
Payment Program proposed rule, we are proposing an adjustment to the
number of respondents based on more recent data and a decrease to the
per respondent time estimate due to our proposed net reduction of 3
measures (6 removed measures and 3 new measures) for which clinicians
are required to submit data, as discussed in section III.H.3.h.(5)(f)
of this proposed rule.
A variety of organizations will submit Promoting Interoperability
data on behalf of clinicians. Clinicians not participating in a MIPS
APM may submit data as individuals or as part of a group. In the CY
2017 Quality Payment Program final rule (81 FR 77258 through 77260,
77262 through 77264), we established that eligible clinicians in MIPS
APMS other than the Shared Savings Program may submit data for the
Promoting Interoperability performance category as individuals or as
part of a group, whereas eligible clinicians participating in the
Shared Savings Program are limited to submitting data through the ACO
participant TIN. In section III.H.3.h.(6)(c)(ii) of this proposed rule,
we propose to extend this flexibility to allow for both individual and
group reporting by eligible clinicians participating in the Shared
Savings Program.
Because group TINs in APM Entities are able to submit Promoting
Interoperability data to fulfill the requirements of submitting to
MIPS, we have included MIPS APMs groups in our burden estimates for the
Promoting Interoperability performance category. Consistent with the
list of APMs that are MIPS APMs on the Quality Payment Program
website,\45\ we assume that 3 MIPS APMs that do not also qualify as
Advanced APMs will operate in the 2019 MIPS performance period: Track 1
of the Shared Savings Program, CEC (one-sided risk arrangement), and
the OCM (one-sided risk arrangement). Further, we assume that group
TINs will submit Promoting Interoperability data on behalf of partial
QPs that elect to participate in MIPS. We plan to revisit these
assumptions as when we receive data submitted for the 2017 MIPS
performance period.
---------------------------------------------------------------------------

\45\ https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Comprehensive-List-of-APMs.pdf.
---------------------------------------------------------------------------

As shown in Table 78, based on data from the 2016 Medicare and
Medicaid EHR Incentive Programs, the 2016 PQRS data, and 2017 MIPS
eligibility data, we estimate that 50,878 individual MIPS eligible
clinicians and 2,998 groups will submit Promoting Interoperability
data. These estimates reflect that under the policies in the CY 2017
Quality Payment Program final rule and in the CY 2018 Quality Payment
Program final rule, certain MIPS eligible clinicians will be eligible
for automatic reweighting of the Promoting Interoperability performance
category to zero percent, including MIPS eligible clinicians that are
hospital-based, ambulatory surgical center-based, non-patient facing
clinicians, physician assistants, nurse practitioners, clinician nurse
specialists, and certified registered nurse anesthetists (81 FR 77238
through 77245 and 82 FR 53680 through 53687). As discussed in section
III.H.3.h.(5)(h)(ii) of this proposed rule, starting with the 2021 MIPS
payment year, we are proposing to automatically reweight the Promoting
Interoperability performance category for clinician types new to MIPS:
Physical therapists, occupational therapists, clinical social workers,
and clinical psychologists. These estimates also account for the
reweighting exceptions finalized in the CY 2017 and CY 2018 Quality
Payment Program final rules, including for MIPS eligible clinicians in
small practices, as well as exceptions due to decertification of an
EHR.
Further, we anticipate that the 460 Shared Savings Program Track 1
ACOs will submit data at the ACO participant TIN-level, for a total of
13,537 group TINs. We anticipate that the three APM Entities electing
the one-sided track in the CEC model will submit data at the group TIN-
level, for a total of 17 group TINs submitting data. And finally, we
anticipate that the 192 APM Entities in the OCM (one-sided risk
arrangement) will submit data at APM Entity level. The total estimated
number of respondents is estimated at 67,622.

Table 78--Estimated Number of Respondents To Submit Promoting
Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
Number of
respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting 50,878
Interoperability (a)...................................
Number of groups to submit Promoting Interoperability 2,998
(b)....................................................
Shared Savings Program ACO Group TINs (c)............... 13,537
CEC one-sided risk track participants \46\ (d).......... 17
OCM one-sided risk arrangement Group TINs (e)........... 192
---------------

[[Page 36032]]

Total (f) = (a) + (b) + (c) + (d) + (e)............. 67,622
------------------------------------------------------------------------

While we estimate that 67,622 respondents will be submitting data
under the Promoting Interoperability performance category, this
reduction of 150,593 respondents from the currently approved total of
218,215 is a result of more accurate estimation of the number of
hospital-based MIPS eligible clinicians, clinicians in small practices,
and the number of group TINs submitting for MIPS APMs; and also
accounting for respondents which may submit data via two or more
submission or collection types and would thus be double-counted
otherwise.
---------------------------------------------------------------------------

\46\ The 3 CEC APM Entities reflected in the burden estimate are
the non-large dialysis organizations participating in the one-sided
risk track.
---------------------------------------------------------------------------

In the CY 2018 Quality Payment Program final rule we estimated it
takes 3 hours for a computer system analyst to collect and submit
Promoting Interoperability performance category data (82 FR 53920). For
this proposed rule, we estimate the time required to submit such data
should be reduced by 20 minutes to 2.67 hours due to our proposal to
reduce the number of measures for which clinicians are required to
submit data, as discussed in section III.H.3.h.(5)(f) of this proposed
rule. As shown in Table 79, the total time for an organization to
submit data on the specified Promoting Interoperability objectives and
measures is estimated to be 180,325 hours (67,622 respondents x 2.67
incremental hours for a computer analyst's time above and beyond the
clinician, practice manager, and computer system's analyst time
required to submit quality data) at a cost of $16,081,413 (180,325 hr x
$89.18/hr).
Independent of the change in the number of respondents, the
reduction in estimated time to submit Promoting Interoperability data
results in a decrease in burden of -72,738.33 hours at -$6,486,805
(218,215 respondents x-0.33 hr x $89.18/hr). Acccounting for the
decreased per respondent time, the decrease in the number of
respondents results in an adjustment to the total burden of -401,581.33
hours at -$35,813,023 (-150,593 respondents x 2.67 hrs x $89.18/hr).
When these adjustments are combined, the total adjustment is -
474,319.67 hours (-72,738.33-401,581.33) at -$42,299,828 (-$6,486,805-
$35,813,023).

Table 79--Estimated Burden for Promoting Interoperability Performance
Category Data Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of respondents submitting Promoting 67,622
Interoperability data on behalf of clinicians (a)......
Total Annual Hours Per Respondent (b)................... 2.67
---------------
Total Annual Hours (c) = (a) * (b).................. 180,325
Labor rate for a computer systems analyst to submit $89.18/hr
Promoting Interoperability data/hr.) (d)...............
---------------
Total Annual Cost (e) = (a) * (d)................... $16,081,413
------------------------------------------------------------------------

11. Quality Payment Program ICRs Regarding the Nomination of Promoting
Interoperability (PI) Measures
This rule does not propose any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
nomination of Promoting Interoperability measures. However, we are
proposing adjustments to our currently approved burden estimates based
on more recent data. The adjusted burden will be submitted to OMB for
approval under control number 0938-1314 (CMS-10621).
Consistent with our requests for stakeholder input on quality
measures and improvement activities, we are also requesting potential
measures for the Promoting Interoperability performance category that
measure patient outcomes, emphasize patient safety, support improvement
activities and the quality performance category, and build on the
advanced use of CEHRT using 2015 Edition standards and certification
criteria. Promoting Interoperability measures may be submitted via a
designated submission form that includes the measure description,
measure type (if applicable), reporting requirement, and CEHRT
functionality used (if applicable).
We estimate 47 organizations will submit Promoting Interoperability
measures, based on the number of organizations submitting measures
during the CY 2017 nomination period. This is an increase of 7 from the
estimate currently approved by OMB under the aforementioned control
number. We estimate it will take 0.5 hours per organization to submit
an activity to us, consisting of 0.3 hours at $107.38/hr for a practice
administrator to make a strategic decision to nominate that activity
and submit an activity to us via email and 0.2 hours at $206.44/hr for
a clinician to review the nomination. As shown in Table 80, in
aggregate we estimate an annual burden of 235 hours (47 organizations x
0.5 hr/response) at a cost of $3,455 (47 x [(0.3 hr x $107.38/hr) +
(0.2 hr x $206.44/hr)]. The increase in the number of respondents
results in an adjustment of 3.5 hours and $514.50 (7 respondents x 0.5
hrs x $73.50 per respondent).

[[Page 36033]]

Table 80--Estimated Burden for Call for Promoting Interoperability
Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Promoting 47
Interoperability Measures (a)..........................
Number of Hours Per Practice Administrator to Identify 0.30
and Propose Measure (b)................................
Number of Hours Per Clinician to Identify Measure (c)... 0.20
Annual Hours Per Respondent (d) = (b) + (c)............. 0.50
---------------
Total Annual Hours (e) = (a) * (d).................. 23.50
Cost to Identify and Submit Measure (@practice $32.21
administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Measure (@ physician's $41.29
labor rate of $206.44/hr.) (g).........................
---------------
Total Annual Cost Per Respondent (h) = (f) + (g).... $73.50
---------------
Total Annual Cost (i) = (a) * (h)............... $3,455
------------------------------------------------------------------------

12. Quality Payment Program ICRs Regarding Improvement Activities
Submission (Sec. Sec. 414.1305, 414.1355, 414.1360, and 414.1365)
The proposed requirements and burden discussed under this section
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77511 through 77512) and the CY 2018 Quality Payment Program
final rule (82 FR 53920 through 53922) for our previous burden
estimates for improvement activities under the Quality Payment Program.
The CY 2018 Quality Payment Program final rule provides: (1) That
for activities that are performed for at least a continuous 90 days
during the performance period, MIPS eligible clinicians must submit a
``yes'' response for activities within the Improvement Activities
Inventory (82 FR 53651); (2) that the term ``recognized'' is accepted
as equivalent to the term ``certified'' when referring to the
requirements for a patient-centered medical home and would receive full
credit for the improvement activities performance category (82 FR
53649); and (3) that for the 2020 MIPS payment year and future years,
to receive full credit as a certified or recognized patient-centered
medical home or comparable specialty practice, at least 50 percent of
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
In the CY 2017 Quality Payment Program final rule, we describe how
we determine MIPS APM scores (81 FR 77185). We compare the requirements
of the specific MIPS APM with the list of activities in the Improvement
Activities Inventory and score those activities in the same manner that
they are otherwise scored for MIPS eligible clinicians (81 FR 77817
through 77831). If, by our assessment, the MIPS APM does not receive
the maximum improvement activities performance category score, then the
APM Entity can submit additional improvement activities, although, as
we noted, we anticipate that MIPS APMs in the 2019 MIPS performance
period will not need to submit additional improvement activities as the
models will already meet the maximum improvement activities performance
category score (81 FR 77185).
A variety of organizations and in some cases, individual
clinicians, will submit improvement activity performance category data.
For clinicians who are not part of APMs, we assume that clinicians
submitting quality data as part of a group through direct, log in and
upload, and CMS Web Interface submission types will also submit
improvement activities data. In the CY 2017 Quality Payment Program
final rule (81 FR 77264), APM Entities only need to report improvement
activities data if the CMS-assigned improvement activities score is
below the maximum improvement activities score. Our CY 2018 Quality
Payment Program final rule burden estimates assumed that all APM
Entities will receive the maximum CMS-assigned improvement activities
score (82 FR 53921 through 53922).
As represented in Table 81, we estimate that 387,347 clinicians
will submit improvement activities as individuals during the 2019 MIPS
performance period, 5,575 groups will submit improvement activities on
behalf of clinicians, and an additional 16 virtual groups will submit
improvement activities, resulting in 392,938 total respondents.
The estimate of 387,347 individual clinicians is a distinct count
by TIN/NPI of clinicians who submitted quality data under 2016 PQRS
using an individual submission mechanism (claims, EHR, QCDR/Registry)
and accounts for clinicians who submitted data using multiple
submission mechanisms in order to increase the accuracy of our estimate
of the number of individuals who will submit improvement activities.
However, actual participation data for the 2017 MIPS performance period
was unavailable in time for this proposed rule. Assuming actual
participation data for the 2017 MIPS performance period is available in
time to meet our final rule's publication schedule, we will use that
data and revise our estimates in that rule.
Our burden estimates assume there will be no improvement activities
burden for MIPS APM participants. We will assign the improvement
activities performance category score at the APM level. We also assume
that the MIPS APM models for the 2019 MIPS performance period will
qualify for the maximum improvement activities performance category
score and the APM Entities will not need to submit any additional
improvement activities. Again, assuming actual participation data for
the 2017 MIPS performance period is available in time to meet
publication schedule for the final rule, we will use that data and
revise our estimates in that rule. In Table 81, we estimate that
approximately 392,938 respondents will be submitting data under the
improvement activities performance category.

[[Page 36034]]

Table 81--Estimated Numbers of Organizations Submitting Improvement
Activities Performance Category Data on Behalf of Clinicians
------------------------------------------------------------------------
Count
------------------------------------------------------------------------
Number of clinicians to participate in improvement 387,347
activities data submission as individuals during the
2019 MIPS performance period (a).......................
Number of Groups to submit improvement activities on 5,575
behalf of clinicians during the 2019 MIPS performance
period (b).............................................
Number of Virtual Groups to submit improvement 16
activities on behalf of clinicians during the 2019 MIPS
performance period (c).................................
---------------
Total Number of Respondents (Groups, Virtual Groups, 392,938
and Individual Clinicians) to submit improvement
activities data on behalf of clinicians during the
2019 MIPS performance period (d) = (a) + (b) + (c).
---------------
Total Number of Respondents (Groups, Virtual Groups, 439.786
and Individual Clinicians) to submit improvement
activities data on behalf of clinicians during the
2018 MIPS performance period (e)...................
Difference between 2019 MIPS performance period and 2018 -46,848
MIPS performance period (f) = (d)-(e)..................
------------------------------------------------------------------------

As described in section III.H.3.h.(4)(b) of this preamble, for
purposes of the 2021 MIPS payment year, we are proposing to revise
Sec. 414.1360(a)(1) to more accurately reflect the data submission
process for the improvement activities performance category. In
particular, instead of ``via qualified registries; EHR submission
mechanisms; QCDR, CMS Web Interface; or attestation,'' as currently
stated, we are revising the first sentence to state that data would be
submitted ``via direct, log in and upload, and log in and attest.'' The
revision would more closely align with the actual submission experience
users have. We propose to decrease our burden estimates since the
actual submission experience of the user is such that improvement
activities data is submitted as part of the process for submitting
quality and Promoting Interoperability data, resulting in less
additional required time to submit improvement activities data.
The CY 2018 Quality Payment Program final rule, we estimated it
would take 1 hour for a computer system analyst to submit data on the
specified improvement activities (82 FR 53922). As a result of our
proposal, we estimate that the per response time required per
individual or group is 5 minutes at $89.18/hr for a computer system
analyst to submit by logging in and manually attesting that certain
activities were performed in the form and manner specified by CMS with
a set of authenticated credentials. Additionally, as stated in the CY
2018 Quality Payment Program final rule, the same improvement activity
may be reported across multiple performance periods so many MIPS
eligible clinicians will not have any additional information to submit
for the 2019 MIPS performance period (82 FR 53921).
We are also proposing to add 6 new improvement activities for CY
2019 and future years, modify 5 existing improvement activities for CY
2019 and future years, and remove 1 existing improvement activity for
CY 2019 and future years. Because MIPS eligible clinicians are still
required to submit the same number of activities, we do not expect
these proposals to affect our collection of information burden
estimates. In addition, in order for an eligible clinician or group to
receive credit for being a patient-centered medical home or comparable
specialty practice, the eligible clinician or group must attest in the
same manner as any other improvement activity.
As shown in Table 82, we estimate an annual burden of 32,745 hours
(392,938 responses x 5 minutes/60) at a cost of $2,920,199 (32,745 hr x
$89.18/hr). Differences from the CY 2018 Quality Payment Program rule
are based on updated QP data from the 2017 MIPS performance period,
specifically the APM Participation List for the third snapshot date of
the 2017 QP performance period.
Independent of the change to our per response time estimate, the
decrease in the number of respondents results in an adjustment of -
46,848 hours at -$4,177,904 (-46,848 respondents x 1 hr x $89.18/hr).
Accounting for the change in number of respondents, the decrease in the
time to submit improvement activities data results in an adjustment of
-360,193 hours at -$32,122,027 (392,938 respondents x 55 minutes/60 x
$89.18/hr). When these adjustments are combined, the total adjustment
is -407,041 hours (-46,848-360,193) hours at -$36,299,931 (-$4,177,904-
$32,122,027).

Table 82--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Number of Respondents (Groups, Virtual Groups, and 392,938
Individual Clinicians) to submit improvement activities
data on behalf of clinicians during the 2019 MIPS
performance period (a).................................
Total Annual Hours Per Respondent (b)................... 5 minutes
---------------
Total Annual Hours (c).............................. 32,745
Labor rate for a computer systems analyst to submit $89.18/hr
improvement activities (d).............................
---------------
Total Annual Cost (e) = (a) * (d)................... $2,920,184
------------------------------------------------------------------------

13. Quality Payment Program ICRs Regarding the Nomination of
Improvement Activities (Sec. 414.1360)
The proposed requirements and burden discussed under this section
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
We refer readers to the CY 2018 Quality Payment Program final rule
for our previous burden estimates for nomination of improvement
activities under the Quality Payment Program (82 FR 53922). In this CY
2019 Quality Payment Program rule, we are proposing

[[Page 36035]]

to adjust the number of respondents based on more recent data and
adjust our per response time estimate based on our review of our
currently approved burden estimates against the existing process for
nomination of improvement activities. We are also proposing to adopt
one new criteria and remove one existing criteria for nominating new
improvement activities beginning with the CY 2019 performance period
and future years. Furthermore, we are making clarifications to: (1)
Considerations for selecting improvement activities for the CY 2019
performance period and future years; and (2) the weighting of
improvement activities. We believe these proposals will not affect our
currently approved burden estimates since they do not substantively
impact the level of effort previously estimated to nominate an
Improvement Activity.
We are also proposing to change the performance year for which the
nominations would apply, such that improvement activities nominations
received in a particular year will be vetted and considered for the
next year's rulemaking cycle for possible implementation in the
following year. Additionally, we are modifying the Improvement Activity
submission form by adding a data field to allow submitters to clearly
denote submission of a modification. This is to clarify the process for
submitting modifications of existing Improvement Activities as
discussed in the CY 2018 Quality Payment Program final rule (82 FR
53656). Finally, we are proposing to change the submission timeframe
for the Call for Activities from February 1st through March 1st to
February 1st through June 30th providing approximately four additional
months for stakeholders to submit nominations. We believe these
proposals will not affect our our currently approved burden estimates
since we believe that the number of nominations is unlikely to change,
but the quality of the nominations is likely to increase given the
additional time provided.
For the 2018 MIPS performance period, we provided opportunity for
stakeholders to propose new activities formally via the Annual Call for
Activities nomination form that was posted on the CMS website (82 FR
53657). The 2018 Annual Call for Activities lasted from March 2, 2017
through March 1, 2018 for which we received 72 nominations consisting
of a total of 125 activities which were evaluated for the Improvement
Activities Under Consideration (IAUC) list for possible inclusion in
the CY 2019 Improvement Activities Inventory. Based on the number of
activities being evaluated during the 2018 Annual Call for Activities
(125 activities), we estimate that the total number of nominations we
will receive for the 2019 Annual Call for Activities would continue to
be 125, unchanged from the number of activities evaluated in CY 2018,
which is a decrease from the 150 nominations currently approved by OMB.
In the CY 2018 Quality Payment Program final rule, we estimated
that it takes 0.5 hours to nominate an improvement activity (82 FR
53922). As shown in Table 83, due to a review of the nomination process
including the criteria required to nominate an improvement activity, we
now estimate it would take 2 hours (per organization) to submit an
activity to us. Of those hours, we estimate it would take 1.2 hours at
$107.38/hr for a practice administrator or equivalent to make a
strategic decision to nominate and submit that activity and 0.8 hours
at $206.44/hr for a clinician's review. In aggregate we estimate an
annual burden of 250 hours (125 nominations x 2 hr/nomination) at a
cost of $36,751 (125 x [(1.2 hr x $107.38/hr) + (0.8 hr x $206.44/
hr)]).
The percentage of practice administrator and clinician labor in
relation to the total is unchanged from the CY 2018 Quality Payment
Program final rule (82 FR 53922).
Independent of the change to our per response time estimate, the
decrease in the number of nominations results in an adjustment of -12.5
hours and -$1,837 (-25 activities x [(0.3 hr x $107.38/hr) + (0.2 hr x
$206.44/hr)]). Accounting for the decrease in the number of nominated
improvement activities, the increase in time per nominated improvement
activity results in an adjustment of 187.5 hours and $27,563 (125
activities x [(0.9 hr x $107.38/hr) + (0.6 hr x $206.44/hr)]). When
these adjustments are combined, the total adjustment is 175 hours
(187.5 -12.5) and $25,726 ($27,563 -$1,837).

Table 83--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Improvement 125
Activities (a).........................................
Number of Hours Per Practice Administrator to Identify 1.2
and Propose Activity (b)...............................
Number of Hours Per Clinician to Identify Activity (c).. 0.8
Annual Hours Per Respondent (d) = (b) + (c)............. 2
---------------
Total Annual Hours (e) = (a) * (d).................. 250
Cost to Identify and Submit Activity (@ practice $128.86
administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Activity (@ physician's $165.15
labor rate of $206.44/hr.) (g).........................
---------------
Total Annual Cost Per Respondent (h) = (f) + (g).... $294.01
Total Annual Cost (i) = (a) * (h)................... $36,751
------------------------------------------------------------------------

14. Quality Payment Program ICRs Regarding CMS Study on Factors
Associated With Reporting Quality Measures
During each performance year, eligible clinicians are recruited to
participate in the CMS study on the burden associated with reporting
quality measures. Eligible clinicians who are interested in
participating can sign up whereby an adequate sample size is then
selected by CMS from this group of potential participants. This study
is ongoing, and participants are recruited on a yearly basis. Current
participants can sign up when the study year ends.
Section 1848(s)(7) of the Act, as added by section 102 of the MACRA
(Pub. L. 114-10) states that Chapter 35 of title 44, United States
Code, shall not apply to the collection of information for the
development of quality measures. Consequently, we are not setting out
such burden since the study shall inform us (and our contractors) on
the root causes of clinicians' performance measure data collection and
data submission burdens and challenges that hinders accurate and timely
quality

[[Page 36036]]

measurement activities. We refer readers to the discussion of this
policy in the regulatory impact analysis section (section VII.F.7) of
this proposed rule.
15. Quality Payment Program ICRs Regarding the Cost Performance
Category (Sec. 414.1350)
The cost performance category relies on administrative claims data.
The Medicare Parts A and B claims submission process (OMB control
number 0938-1197) is used to collect data on cost measures from MIPS
eligible clinicians. MIPS eligible clinicians are not required to
provide any documentation by CD or hardcopy. Moreover, this rule's
proposed provisions would not necessitate the need to add or revise or
delete any claims data fields. Therefore, we do not anticipate any new
or additional submission requirements and/or burden for MIPS eligible
clinicians.
16. Quality Payment Program ICRs Regarding Partial QP Elections (Sec.
414.1430)
This rule does not propose any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to QP
elections. However, we are proposing adjustments to our currently
approved burden estimates based on more recent data. The adjusted
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
APM Entities may face a data submission burden under MIPS related
to Partial QP elections. Advanced APM participants will be notified
about their QP or Partial QP status as soon as possible after each QP
determination. Where Partial QP status is earned at the APM Entity
level the burden of Partial QP election would be incurred by a
representative of the participating APM Entity. Where Partial QP status
is earned at the eligible clinician level, the burden of Partial QP
election would be incurred by the eligible clinician. For the purposes
of this burden estimate, we assume that all MIPS eligible clinicians
determined to be Partial QPs will participate in MIPS.
Based on our predictive QP analysis for the 2019 QP performance
period, we estimate that 6 APM Entities and 75 eligible clinicians will
make the election to participate as a Partial QP in MIPS (see Table
84), an increase of 64 from the 17 elections currently approved by OMB
under the aforementioned control number. We estimate it will take the
APM Entity representative or eligible clinician 15 minutes (0.25 hr) to
make this election. In aggregate we estimate an annual burden of 20.25
hours (81 respondents x .25 hr/election) at a cost of $1,805.90 (20.25
hours x $89.18/hr). The increase in the number of Partial QP elections
results in an adjustment of 16 hours and $1,431 (64 elections x 0.25
hrs x $89.18/hr).

Table 84--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of respondents making Partial QP election (6 APM 81
Entities, 75 eligible clinicians) (a)..................
Total Hours Per Respondent to Elect to Participate as 0.25 hours
Partial QP (b).........................................
Total Annual Hours (c) = (a) * (b)...................... 20.25 hours
Labor rate for computer systems analyst (d)............. $89.18/hr
---------------
Total Annual Cost (d) = (c) * (d)................... $1,805.90
------------------------------------------------------------------------

17. Quality Payment Program ICRs Regarding Other Payer Advanced APM
Determinations: Payer-Initiated Process (Sec. 414.1440) and Eligible
Clinician Initiated Process (Sec. 414.1445)
As indicated below, the proposed requirements and burden discussed
under this section will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
Payer Initiated Process (Sec. 414.1440): This rule does not
propose any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the Payer Initiated Process.
However, we are proposing adjustments to our currently approved burden
estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
Beginning in Quality Payment Program Year 3, the All-Payer
Combination Option will be an available pathway to QP status for
eligible clinicians participating sufficiently in Advanced APMs and
Other Payer Advanced APMs. The All-Payer Combination Option allows for
eligible clinicians to achieve QP status through their participation in
both Advanced APMs and Other Payer Advanced APMs. In order to include
an eligible clinician's participation in Other Payer Advanced APMs in
their QP threshold score, we will need to determine if certain payment
arrangements with other payers meet the criteria to be Other Payer
Advanced APMs. To provide eligible clinicians with advance notice prior
to the start of a given performance period, and to allow other payers
to be involved prospectively in the process, the 2018 CY Quality
Payment Program final rule established a payer-initiated process for
identifying payment arrangements that qualify as Other Payer Advanced
APMs (82 FR 53844). The payer-initiated process for Other Payer
Advanced APM determinations began in CY 2018 for Medicaid, Medicare
Health Plans, and payers participating in CMS multi-payer models.
Payers seeking to submit payment arrangement information for Other
Payer Advanced APM determination through the payer-initiated process
are required to complete a Payer Initiated Submission Form,
instructions for which can be found at https://qpp.cms.gov/Determinations made in 2018 are applicable for the Quality Payment
Program Year 3. Also in that rule the remaining other payers, including
commercial and other private payers, may request that we determine
whether other payer arrangements are Other Payer Advanced APMs starting
prior to the 2020 QP performance period and each performance period
thereafter (82 FR 53867).
As shown in Table 85, we estimate that in 2019 for the 2020 QP
performance period 165 payer-initiated requests for Other Payer
Advanced APM determinations will be submitted (15 Medicaid payers, 100
Medicare Advantage Organizations, and 50 Multi-payers), a decrease of
135 from the 300 total requests currently approved by OMB under the
aforementioned control number. We estimate it would take 10 hours at
$89.18/hr for a computer system analyst per arrangement submission. In
aggregate we estimate an annual burden of 1,650 hours (165 submissions
x 10 hr/submission) at a cost of $147,147 (1,650 hr x $89.18/hr). The
decrease in the number of payer-

[[Page 36037]]

initiated requests results in an adjustment of -1,350 hours and -
$120,393 (-135 requests x 10 hr x $89.18/hr).

Table 85--Estimated Burden for Other Payer Advanced APM Identification
Determinations: Payer-Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of other payer payment arrangements (15 Medicaid, 165
100 Medicare Advantage Organizations, 50 Multi-payers)
(a)....................................................
Total Annual Hours Per other payer payment arrangement 10
(b)....................................................
---------------
Total Annual Hours (c) = (a) * (b).................. 1,650
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------
Total Annual Cost for Other Payer Advanced APM $147,147
determinations (e) = (a) * (d).....................
------------------------------------------------------------------------

Eligible Clinician Initiated Process (Sec. 414.1445): This rule
does not propose any new or revised reporting, recordkeeping, or third-
party disclosure requirements related to the Eligible Clinician
Initiated Process. However, we are proposing adjustments to our
currently approved burden estimates based on more recent data. The
adjusted burden will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
Beginning in Quality Payment Program Year 3, the All-Payer
Combination Option will be an available pathway to QP status for
eligible clinicians participating sufficiently in Advanced APMs and
Other Payer Advanced APMs. The All-Payer Combination Option allows for
eligible clinicians to achieve QP status through their participation in
both Advanced APMs and Other Payer Advanced APMs. In order to include
an eligible clinician's participation in Other Payer Advanced APMs in
their QP threshold score, we will need to determine if certain payment
arrangements with other payers meet the criteria to be Other Payer
Advanced APMs.
To provide eligible clinicians with advance notice prior to the
start of a given performance period, and to allow other payers to be
involved prospectively in the process, the CY 2018 Quality Payment
Program final rule provided a payer-initiated identification process
for identifying payment arrangements that qualify as Other Payer
Advanced APMs (82 FR 53854). In the same rule, under the Eligible
Clinician Initiated Process, APM Entities and eligible clinicians
participating in other payer arrangements would have an opportunity to
request that we determine for the year whether those other payer
arrangements are Other Payer Advanced APMs (82 FR 53857-53858).
However, to appropriately implement the statutory requirement to
exclude from the All Payer Combination Option QP threshold calculations
certain Title XIX payments and patients, we determined it would be
problematic to allow APM Entities and eligible clinicians to request
determinations for Title XIX payment arrangements after the conclusion
of the QP performance period because any late-identified Medicaid APM
or Medicaid Medical Home Model that meets the Other Payer Advanced APM
criteria could unexpectedly affect QP threshold calculations for every
other clinician in that state (or county). Thus, the CY 2018 Quality
Payment Program final rule provided that APM Entities and eligible
clinicians may request determinations for any Medicaid payment
arrangements in which they are participating at an earlier point, prior
to the start of a given QP performance period (82 FR 53858). This would
allow all clinicians in a given state or county to know before the
beginning of the performance period whether their Title XIX payments
and patients would be excluded from the all-payer calculations that are
used for QP determinations for the year under the All-Payer Combination
Option. This Medicaid specific eligible clinician-initiated
determination process for Other Payer Advanced APMs also began in CY
2018, and determinations made in 2018 are applicable for the Quality
Payment Program Year 3. Eligible clinicians or APM Entities seeking
submit payment arrangement information for Other Payer Advanced APM
determination through the Eligible Clinician-Initiated process are
required to complete an Eligible Clinician Initiated Submission Form,
instructions for which can be found at https://qpp.cms.gov/.
As shown in Table 86, we estimate that 150 other payer arrangements
will be submitted by APM Entities and eligible Other Payer Advanced APM
determinations, an increase of 75 from the 75 total requests currently
approved by OMB under the aforementioned control number.
We estimate it would take 10 hours at $89.18/hr for a computer
system analyst per arrangement submission. In aggregate we estimate an
annual burden of 1,500 hours (150 submissions x 10 hr/submission) at a
cost of $133,770 (1,500 hr x $89.18/hr). The increase in the number of
clinician-initiated requests results in an adjustment of 750 hours and
$66,885 (75 requests x 10 hr x $89.18/hr).

Table 86--Estimated Burden for Other Payer Advanced APM Determinations:
Eligible Clinician Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of other payer payment arrangements from APM 150
Entities and eligible clinicians.......................
Total Annual Hours Per other payer payment arrangement 10
(b)....................................................
---------------
Total Annual Hours (c) = (a) * (b).................. 1,500
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------

[[Page 36038]]

Estimated Total Annual Cost for Other Payer Advanced $133,770
APM determinations (e) = (a) * (d).................
------------------------------------------------------------------------

Submission of Data for QP Determinations under the All-Payer
Combination Option (Sec. 414.1440): The following reflects the burden
associated with the first year of data collection resulting from
policies set out in the CY 2018 Quality Payment Program final rule.
Because no collection of data was required prior to the CY 2019
performance period, the requirements and burden were not submitted to
OMB for approval. However, by virtue of this proposed rulemaking the
requirements and burden will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
The CY 2017 Quality Payment Program final rule, provided that
either APM Entities or individual eligible clinicians must submit by a
date and in a manner determined by us: (1) Payment arrangement
information necessary to assess whether each other payer arrangement is
an Other Payer Advanced APM, including information on financial risk
arrangements, use of CEHRT, and payment tied to quality measures; (2)
for each payment arrangement, the amounts of payments for services
furnished through the arrangement, the total payments from the payer,
the numbers of patients furnished any service through the arrangement
(that is, patients for whom the eligible clinician is at risk if actual
expenditures exceed expected expenditures), and (3) the total number of
patients furnished any service through the arrangement (81 FR 77480).
The rule also specified that if we do not receive sufficient
information to complete our evaluation of another payer arrangement and
to make QP determinations for an eligible clinician using the All-Payer
Combination Option, we would not assess the eligible clinicians under
the All-Payer Combination Option (81 FR 77480).
In the CY 2018 Quality Payment Program final rule, we explained
that in order for us to make QP determinations under the All-Payer
Combination Option using either the payment amount or patient count
method, we would need to receive all of the payment amount and patient
count information: (1) Attributable to the eligible clinician or APM
Entity through every Other Payer Advanced APM; and (2) for all other
payments or patients, except from excluded payers, made or attributed
to the eligible clinician during the QP performance period (82 FR
53885). We also finalized that eligible clinicians and APM Entities
will not need to submit Medicare payment or patient information for QP
determinations under the All-Payer Combination Option (82 FR 53885).
The CY 2018 Quality Payment Program final rule noted that we will
need this payment amount and patient count information for the periods
January 1 through March 31, January 1 through June 30, and January 1
through August 31 (82 FR 53885). We noted that the timing may be
challenging for APM Entities or eligible clinicians to submit
information for the August 31 snapshot date. If we receive information
for either the March 31 or June 30 snapshots, but not the August 31
snapshot, we will use that information to make QP determinations under
the All-Payer Combination Option. This payment amount and patient count
information is to be submitted in a way that allows us to distinguish
information from January 1 through March 31, January 1 through June 30,
and January 1 through August 31 so that we can make QP determinations
based on the two proposed snapshot dates (82 FR 30203 through 30204).
The CY 2018 Quality Payment Program final rule specified that APM
Entities or eligible clinicians must submit all of the required
information about the Other Payer Advanced APMs in which they
participate, including those for which there is a pending request for
an Other Payer Advanced APM determination, as well as the payment
amount and patient count information sufficient for us to make QP
determinations by December 1 of the calendar year that is 2 years prior
to the payment year, which we refer to as the QP Determination
Submission Deadline (82 FR 53886).
In section III.H.4.g.(4)(b) of this rule, we are proposing to add a
third alternative to allow QP determinations at the TIN level in
instances where all clinicians who have reassigned billing rights to
the TIN participate in a single APM Entity. This option would therefore
be available to all TINs participating in Full TIN APMs, such as the
Medicare Shared Savings Program. It would also be available to any
other TIN for which all clinicians who have reassigned billing rights
to the TIN are participating in a single APM Entity. To make QP
determinations under the All-Payer Combination Option at the TIN level
as proposed using either the payment amount or patient count method, we
would need to receive, by December 1 of the calendar year that is 2
years prior to the payment year, all of the payment amount and patient
count information: (1) Attributable to the eligible clinician, TIN, or
APM Entity through every Other Payer Advanced APM; and (2) for all
other payments or patients, except from excluded payers, made or
attributed to the eligible clinician(s) during the QP performance
period for the periods January 1 through March 31, January 1 through
June 30, and January 1 through August 31 sufficient for us to make QP
determinations.
As shown in Table 87, we assume that 4 APM Entities, 8 TINs, and 80
eligible clinicians will submit data for QP determinations under the
All-Payer Combination Option in 2019. We estimate it will take the APM
Entity representative, TIN representative, or eligible clinician 5
hours at $107.38/hr for a practice administrator to complete this
submission. In aggregate, we estimate an annual burden of 460 hours (92
respondents x 5 hr) at a cost of $49,395 (460 hr x $107.38/hr).

Table 87--Estimated Burden for the Submission of Data for All-Payer QP
Determinations
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of APM Entities submitting data for All-Payer QP 4
Determinations (a).....................................

[[Page 36039]]

Number of TINs submitting data for All-Payer QP 8
Determinations (b).....................................
Number of eligible submitting data for All-Payer QP 80
Determinations (c).....................................
Hours Per respondent QP Determinations (d).............. 5
---------------
Total Hours (g) = [(a) * (d)] + [(b) * (d)] + [(c) * 460
(d)]...............................................
Labor rate for a Practice Administrator ($107.38) (h)... $107.38/hr
---------------
Total Annual Cost for Submission of Data for All- $49,395
Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------

18. Quality Payment Program ICRs Regarding Voluntary Participants
Election To Opt-Out of Performance Data Display on Physician Compare
(Sec. 414.1395)
The proposed requirements and burden associated with this data
submission will be submitted to OMB for approval under control number
0938-1314 (CMS-10621).
We estimate that 10 percent of the total clinicians and groups who
will voluntarily participate in MIPS will also elect not to participate
in public reporting. This results in a total of 10,433 (10 percent x
104,326 voluntary MIPS participants), a decrease of 11,967 from the
total respondents currently approved by OMB under the aforementioned
control number due to the reduction in voluntary participation in MIPS
overall. As we discussed earlier in this section, voluntary respondents
are the clinicians that submitted data to PQRS, are not QPs, and are
expected to be excluded from MIPS after applying the eligibility
requirements discussed in section III.H.3.a. of this rule. In
implementing the proposed opt-in policy, we estimated that 33 percent
of clincians that exceed 1 of the low-volume critieria, but not all 3,
would elect to opt-in to MIPS, become MIPS eligible, and no longer be
considered a voluntary reporter. This logic was also applied in the
regulatory impact analysis of this rule. Table 88 shows that for these
voluntary participants, we estimate it would take 0.25 hours at $89.18/
hr for a computer system analyst to submit a request to opt-out. In
aggregate we estimate an annual burden of 2,608.25 hours (10,433
requests x 0.25 hr/request) at a cost of $232,604 (2,608.25 hr x
$89.18/hr).
The decrease in the number of respondents due to policies proposed
in this rule results in a decrease of -2,991.75 hours (-11,967
respondents x 0.25 hr) and -$266,804 (-2,991.75 hours x $89.18/hr).

Table 88--Estimated Burden for Voluntary Participants To Elect Opt Out
of Performance Data Display on Physician Compare
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Voluntary Participants Opting Out of Physician 10,433
Compare (a)............................................
Total Annual Hours Per Opt-out Requester (b)............ 0.25
---------------
Total Annual Hours for Opt-out Requester (c) = (a) * 2,608.25
(b)................................................
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------
Total Annual Cost for Opt-out Requests (e) = (a) * $232,604
(d)................................................
------------------------------------------------------------------------

19. Summary of Annual Quality Payment Program Burden Estimates
Table 89 summarizes this proposed rule's burden estimates for the
Quality Payment Program. In order to understand the burden implications
of the policies proposed in this rule, we have also estimated a
baseline burden of continuing the policies and information collections
set forth in the CY 2018 Quality Payment Program final rule into the
2019 MIPS performance period. Our baseline burden estimates reflect the
recent availability of data sources to more accurately reflect the
number of the organizations exempt from the Promoting Interoperability
performance category and to more accurately reflect the exclusion of
QPs from all MIPS performance categories.

Table 89--Summary of Proposed Quality Payment Program Burden Estimates and Requirements
----------------------------------------------------------------------------------------------------------------
Currently
Currently Proposed Change in approved Proposed Change in
Requirement approved respondents respondents total burden total burden total burden
respondents hours hours hours
----------------------------------------------------------------------------------------------------------------
ICRs Under OMB Control Number 0938-1314 (CMS-10621)
----------------------------------------------------------------------------------------------------------------
Sec. 414.1400 Registry 120 150 30 1,200 450 -750
self-nomination *..........
Sec. 414.1400 QCDR self- 113 200 87 1,130 2,400 1,270
nomination *...............
Sec. 414.1325 and 414.1335 0 3,741 3,741 0 3,741 3,741
CMS Enterprise Portal User
Account Registration.......
Sec. 414.1325 and 414.1335 278,039 274,702 -3,337 4,949,094 3,900,768 -1,048,326
(Quality Performance
Category) Claims Collection
Type.......................
Sec. 414.1325 and 414.1335 107,217 107,056 -161 973,852 972,390 -1,462
(Quality Performance
Category) QCDR/MIPS CQM
Collection Type............

[[Page 36040]]

Sec. 414.1325 and 414.1335 54,218 53,529 -689 487,962 428,232 -59,730
(Quality Performance
Category) eCQM Collection
Type.......................
Sec. 414.1325 and 414.1335 296 286 -10 21,904 16,931.2 -4,972.8
(Quality Performance
Category) CMS Web Interface
Submission Type............
Sec. 414.1325 and 414.1335 10 67 57 10 16.75 6.75
(Quality Performance
Category) Registration and
Enrollment for CMS Web
Interface..................
(Quality Performance 40 140 100 20 630 610
Category) Call for Quality
Measures...................
Sec. 414.1375 (Promoting 40,645 87,211 46,566 20,323 21,803 1,480
Interoperability
Performance Category)
Application for Promoting
Interoperability
Reweighting................
Sec. 414.1375 (Promoting 218,215 67,622 -150,593 654,645 180,325 -474,320
Interoperability
Performance Category) Data
Submission.................
(Promoting Interoperability 40 47 7 20 23.5 3.5
Performance Category) Call
for Promoting
Interoperability Measures..
Sec. 414.1360 (Improvement 439,786 392,938 -46,848 439,786 32,744.8 -407,041.2
Activities Performance
Category) Data Submission..
Sec. 414.1360 (Improvement 150 125 -25 75 250 -175
Activities Performance
Category) Nomination of
Improvement Activities.....
Sec. 414.1430 Partial 17 81 64 4.25 20.25 16
Qualifying APM Participant
(QP) Election..............
Sec. 414.1440 Other Payer 300 165 -135 3,000 1,650 -1,350
Advanced APM
Identification: Payer
Initiated Process..........
Sec. 414.1445 Other Payer 75 150 75 750 1,500 750
Advanced APM
Identification: Eligible
Clinician Initiated Process
Sec. 414.1440 Submission 0 92 92 0 460 460
of Data for All-Payer QP
Determinations under the
All-Payer Combination
Option.....................
Sec. 414.1395 (Physician 22,400 10,433 -11,967 5,600 2,608.25 -2,991.75
Compare) Opt Out for
Voluntary Participants.....
-----------------------------------------------------------------------------------
Subtotal................ 1,161,681 998,735 -162,946 7,559,375 5,566,944 -1,992,782
----------------------------------------------------------------------------------------------------------------
ICRs Under OMB Control Number 0938-1222 (CMS-10450)
----------------------------------------------------------------------------------------------------------------
Sec. 414.1325 and 414.1335 132,307 65,793 -66,514 29,108 14,145 -14,963
(CAHPS for MIPS Survey)
Beneficiary Participation..
Sec. 414.1325 and 414.1335 461 454 -7 691.5 340.5 -351
(CAHPS for MIPS Survey)
Group Registration.........
-----------------------------------------------------------------------------------
Subtotal................ 132,768 66,247 -66,521 29,800 14,485.5 -15,314
-----------------------------------------------------------------------------------
Total............... 1,294,449 1,064,982 -229,467 7,589,175 5,581,429 -2,008,096
----------------------------------------------------------------------------------------------------------------
* These two ICRs were combined in a single ICR in the CY 2018 Quality Payment Program final rule (82 FR 53906
through 53907).

Table 90 provides the reasons for changes in the estimated burden
for information collections in this proposed rule. We have divided the
reasons for our change in burden into those related to new policies and
those related to changes in the baseline burden of continued Quality
Payment Program Year 2 policies that reflect updated data and methods.

Table 90--Reasons for Change in Burden Compared to the Currently
Approved CY 2018 Information Collection Burdens
------------------------------------------------------------------------
Changes to
``baseline'' of
Changes in burden burden continued Year
Table in collection of due to finalized 2 policy (italics are
information Year 3 policies changes in number of
respondents' due to
updated data)
------------------------------------------------------------------------
Table 63: Qualified Registry None............. After a review of the
Self-Nomination. self-nomination
process, we
determined it is
more accurate to
separately assess
the burden of
Qualified Registry
and QCDR self-
nomination rather
than aggregate them
in the same ICR.
Review of self-
nomination process
resulted in a
decrease in
estimated time
needed to complete
simplified self-
nomination (-9.5 hr.
computer system
analyst time) and
full self-nomination
(-7 hr. computer
system analyst
time).
Increase in the
number of
respondents as the
number of qualified
registries enrolling
increases and the
basis for estimating
the number of
respondents is
updated to reflect
the number of self-
nomination
applications
received in place of
the number of
qualified registries
being approved.
Table 64: QCDR Self-Nomination None............. After a review of the
self-nomination
process, we
determined it is
more accurate to
separately assess
the burden of
Qualified Registry
and QCDR self-
nomination rather
than aggregate them
in the same ICR.
Review of self-
nomination process
resulted in an
increase in
estimated time
needed to complete
simplified self-
nomination (-0.5 hr.
computer system
analyst time) and
full self-nomination
(+2 hr. computer
system analyst
time).
Increase in the
number of
respondents as the
number of QCDRs
enrolling increases
and the basis for
estimating the
number of
respondents is
updated to reflect
the number of self-
nomination
applications
received in place of
the number of QCDRs
being approved.

[[Page 36041]]

Table 68: Quality Payment None............. Decreased number of
Program Identity Management respondents due to
Application Process. updates to the
identity management
system being used
for data submission;
only new respondents
submitting quality
data using the CMS
Enterprise Portal
need to create a new
account, versus
system where all
respondents
submitting via EHR
needed to register
for user account
annually.
Table 69: Quality Performance None............. Decreased number of
Category Claims Collection respondents due to
Type. increase in the
number of QPs
excluded from
submitting data.
Correction to
estimate to account
for reduced number
of required measures
compared to PQRS (6
in MIPS; 9 in PQRS)
reduced estimated
time to submit data.
Table 70: Quality Performance None............. Decreased number of
Category QCDR/MIPS CQM respondents due to
Collection Type. increase in the
number of QPs
excluded from
submitting data.
Table 71: Quality Performance None............. Decreased number of
Category eCQM Collection Type. respondents due to
increase in the
number of QPs
excluded from
submitting data.
Table 72: Quality Performance Decrease in Decrease in the
Category CMS Web Interface. number of number of
required respondents as fewer
measures eligible group
resulted in practices elected to
reduction in submit data using
estimated time the CMS Web
needed to submit Interface.
data (-14.8 hrs
computer system
analyst time).
Table 73: Beneficiary None............. Decrease in the
Responses to CAHPS for MIPS number of
Survey. respondents as fewer
eligible group
practices elect to
have vendors
administer the CAHPS
for MIPS survey and
fewer beneficiaries
per group respond to
the survey, on
average.
Table 74: Registration for CMS None............. Increase in the
Web Interface. number of
respondents as more
groups register to
submit data using
the CMS Web
Interface.
Review of
registration process
resulted in decrease
in estimated time to
register. (-0.75 hr.
computer system
analyst time).
Table 75: Registration for None............. Decrease in the
CAHPS for MIPS Survey. number of
respondents as fewer
eligible group
practices elect to
have vendors
administer the CAHPS
for MIPS survey.
Review of
registration process
resulted in decrease
in estimated time to
register. (-0.75 hr.
computer system
analyst time).
Table 76: Call for Quality None............. Increase in the
Measures. number of new
quality measures
being nominated.
Inclusion of time
required to complete
Peer Review Journal
Article Form
resulted in increase
in time to nominate
a quality measure.
This was a
requirement in the
CY 2017 Quality
Payment Program
final rule (81 FR
77153 through
77155), but was not
included in burden
estimates. (+4 hrs
Physician time).
Table 77: Application for None............. Increase in the
Promoting Interoperability number of
Reweighting. respondents as the
estimated number of
APM Entities with
hardship approval
was previously not
included.
Review of application
process resulted in
decrease in
estimated time to
apply (-0.25 hr
computer system
analyst time).
Table 79: Promoting Decrease in Decrease in the
Interoperability Performance number of number of
Category Data Submission. required respondents due to
measures increase in the
resulted in estimate of hospital-
reduction in based clinicians and
estimated time clinicians in small
needed to submit practices, more
data (-.33 hr accurate estimate of
computer system the number of TINs
analyst time). submitting data for
MIPS APMs, and
accounting for
individuals which
may have submitted
quality data via two
or more submission
or collection types.
Table 80: Call for Promoting None............. Increase in the
Interoperability Measures. number of new
Promoting
Interoperability
measures being
nominated.
Table 82: Improvement None............. Decreased number of
Activities Submission. respondents due to
increase in the
number of QPs
excluded from
submitting data and
accounting for
individuals which
may have submitted
quality data via two
or more submission
or collection types.
Review of submission
process resulted in
decrease in
estimated to submit
(-0.92 hr computer
system analyst
time).
Table 83: Nomination of None............. Review of nomination
Improvement Activities. process resulted in
increase in
estimated time to
nominate a new
improvement activity
(+0.9 hrs Practice
Administrator time;
+0.6 hrs Physician
time).
Table 84: Partial QP Election. None.............
Table 85: Other Payer Advanced None............. Decrease in the
APM Identification: Other number of
Payer Initiated Process. anticipated other
payer arrangements
submitted for
identification as
Other Payer Advanced
APMs.
Table 86: Other Payer Advanced None............. Increase in the
APM Identification: Eligible number of
Clinician Initiated Process. anticipated other
payer arrangements
submitted by APM
Entities and
eligible clinicians
for identification
as Other Payer
Advanced APMs.
Table 87: Submission of Data Reflects new None.
for All-Payer QP policy in this
Determinations under the All- proposed rule.
Payer Combination Option.
Table 88: Voluntary Decrease in the None.
Participants to Elect to Opt number of
Out of Performance Data respondents as a
Display on Physician Compare. result of fewer
individuals and
groups being
excluded from
MIPS eligibility.
------------------------------------------------------------------------

C. Summary of Annual Burden Estimates for Proposed Requirements

[[Page 36042]]

Table 91--Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total annual
Regulation section(s) under Title OMB control Respondents Responses Burden per response burden Labor cost of Total cost ($)
42 of the CFR No. *** (hours) (hours) reporting ($/hr) *
--------------------------------------------------------------------------------------------------------------------------------------------------------
414.94(j) (AUC consultations).... 0938-1345 586,386 43,181,818 0.033 (2 min)........ 1,425,000 varies............... 119,275,350
Quality Payment Program (See 0938-1314 (**) (162,946) varies............... (1,992,782) varies............... (177,891,746)
Subtotal Under Table 89).
Quality Payment Program (See 0938-1222 (66,521) (66,521) varies............... (15,314) varies............... (394,855)
Subtotal Under Table 89).
----------------------------------------------------------------------------------------------------------------------
Total........................ ............ 1,187,338 42,952,351 varies............... (583,096) varies............... (59,011,251)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* With respect to the PRA, this rule would not impose any non-labor costs.
** We are unable to accurately calculate a total number of respondents for the Quality Payment Program. In many cases, individuals, groups, and entities
have responded to multiple data collections and there is no unified way to identify unique respondents.
*** OMB and CMS' PRA package ID numbers: OMB 0938-1345 (CMS-10654), OMB 0938-1314 (CMS-10621), and OMB 0938-1222 (CMS-10450). 0938-1222 (CMS-10450).

D. Submission of PRA-Related Comments

We have submitted a copy of this rule's information collection and
recordkeeping requirements to OMB for review and approval. These
requirements are not effective until they have been approved by the
OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections discussed above, please visit CMS's
website at www.cms.hhs.gov/PaperworkReductionActof1995, or call the
Reports Clearance Office at 410-786-1326.
We invite public comments on these potential information collection
requirements. If you wish to comment, please refer to the DATES and
ADDRESSES sections of this rulemaking for instructions. We will
consider all ICR-related comments received by the date and time
specified in the DATES section, and, when we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.

VI. Response to Comments

Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.

VII. Regulatory Impact Analysis

A. Statement of Need

This proposed rule makes payment and policy changes under the
Medicare PFS and implements required statutory changes under the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the
Achieving a Better Life Experience Act (ABLE), the Protecting Access to
Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act
of 2015, the Consolidated Appropriations Act of 2016, and the
Bipartisan Budget Act of 2018. This proposed rule also makes changes to
payment policy and other related policies for Medicare Part B, Part D,
and Medicare Advantage.
In addition, section 218(b) of the PAMA added section 1834(q) of
the Act directing the Secretary to establish a 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
for the furnishing professional or facility to include on the Medicare
claim information about the ordering professional's consultation with
specified applicable AUC through a qualified CDSM. This proposed rule
is necessary to make policy changes under Medicare fee-for-service.
Therefore, we include a detailed regulatory impact analysis to assess
all costs and benefits of available regulatory alternatives and
explained the selection of these regulatory approaches that we believe
adhere to section 1834(q) of the Act and, to the extent feasible,
maximize net benefits.
This proposed rule also makes payment and policy changes under the
Medicare Physician Fee Schedule and makes required statutory changes
under the MACRA, as amended by section 51003 of the Bipartisan Budget
Act of 2018.
Proposed new policies for CY 2019 are detailed throughout this
proposed rule. For example, the proposals associated with modernizing
Medicare physician payment by recognizing communication technology-
based services are described in section II.D. of this proposed rule,
while the proposals associated with E/M visits are described in section
II.I. of this proposed rule. Several proposals using innovative
technology that enables remote services would expand access to care and
create more opportunities for patients to access more personalized care
management as well as connect with their physicians more quickly. These
proposals would support access to care using telecommunications
technology by: Paying clinicians for virtual check-ins--brief, non-
face-to-face appointments via communications technology; paying
clinicians for evaluation of patient-submitted photos; and expanding
Medicare-covered telehealth services to include prolonged preventive
services.
Several provisions in the proposed rule would also help to free
electronic health records to be powerful tools to support efficient
care while giving physicians more time to spend with their patients,
especially those with complex needs, rather than on paperwork.
Specifically, the E/M proposal would: Simplify, streamline, and offer
flexibility in documentation and coding requirements for E/M visits,
which make up about 40 percent of allowed charges under the PFS and
consume much of clinicians' time; reduce unnecessary physician
supervision of radiologist assistants during diagnostic services; and
remove burdensome and overly complex functional reporting requirements
for outpatient therapy. In addition, Section VII.H. of this Regulatory
Impact Analysis details the economic effect of these proposed policies
on Medicare providers and beneficiaries.

B. Overall Impact

We examined the impact of this rule as required by Executive Order
12866 on Regulatory Planning and Review (September 30, 1993), Executive
Order 13563 on Improving Regulation and Regulatory Review (February 2,
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.
L. 96-354), section 1102(b) of the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of 1995 (March

[[Page 36043]]

22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We estimate, as discussed in this section, that the PFS provisions
included in this proposed rule would redistribute more than $100
million in 1 year. Therefore, we estimate that this rulemaking is
``economically significant'' as measured by the $100 million threshold,
and hence also a major rule under the Congressional Review Act.
Accordingly, we prepared an RIA that, to the best of our ability,
presents the costs and benefits of the rulemaking. The RFA requires
agencies to analyze options for regulatory relief of small entities.
For purposes of the RFA, small entities include small businesses,
nonprofit organizations, and small governmental jurisdictions. Most
hospitals, practitioners and most other providers and suppliers are
small entities, either by nonprofit status or by having annual revenues
that qualify for small business status under the Small Business
Administration standards. (For details see the SBA's website at http://www.sba.gov/content/table-small-business-size-standards (refer to the
620000 series)). Individuals and states are not included in the
definition of a small entity.
The RFA requires that we analyze regulatory options for small
businesses and other entities. We prepare a regulatory flexibility
analysis unless we certify that a rule would not have a significant
economic impact on a substantial number of small entities. The analysis
must include a justification concerning the reason action is being
taken, the kinds and number of small entities the rule affects, and an
explanation of any meaningful options that achieve the objectives with
less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and
suppliers are considered to be small entities, based upon the SBA
standards. There are over 1 million physicians, other practitioners,
and medical suppliers that receive Medicare payment under the PFS.
Because many of the affected entities are small entities, the analysis
and discussion provided in this section, as well as elsewhere in this
proposed rule is intended to comply with the RFA requirements regarding
significant impact on a substantial number of small entities.
For example, the effects of changes to payment rates for
practitioners, other providers, and suppliers are discussed in VII.C.
of this proposed rule. Alternative options considered to the proposed
payment rates are discussed generally in section VII.F of this proposed
rule, while specific alternatives for individual codes are discussed
throughout this rule, especially in section II.H.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. The PFS does not
reimburse for services provided by rural hospitals; the PFS pays for
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural
hospitals. We did not prepare an analysis for section 1102(b) of the
Act because we determined, and the Secretary certified, that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits on state,
local, or tribal governments or on the private sector before issuing
any rule whose mandates require spending in any 1 year of $100 million
in 1995 dollars, updated annually for inflation. In 2018, that
threshold is approximately $150 million. This proposed rule will impose
no mandates on state, local, or tribal governments or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
Executive Order 13771, entitled Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This
proposed rule is considered an E.O. 13771 regulatory action because it
is expected to result in regulatory costs. The estimated impact would
be $5 million in costs in 2019, $4.114 billion in costs in 2020, and
$44 million in cost savings in 2021 and thereafter. Annualizing these
costs and cost savings in perpetuity and discounting at 7 percent back
to 2016, we estimate that this rule would generate $174 million in
annualized net costs for E.O. 13771 accounting purposes. Details on the
estimated costs of this rule can be found in the following analyses.
We prepared the following analysis, which together with the
information provided in the rest of this preamble, meets all assessment
requirements. The analysis explains the rationale for and purposes of
this proposed rule; details the costs and benefits of the rule;
analyzes alternatives; and presents the measures we would use to
minimize the burden on small entities. As indicated elsewhere in this
proposed rule, we are implementing a variety of changes to our
regulations, payments, or payment policies to ensure that our payment
systems reflect changes in medical practice and the relative value of
services, and implementing statutory provisions. We provide information
for each of the policy changes in the relevant sections of this
proposed rule. We are unaware of any relevant federal rules that
duplicate, overlap, or conflict with this proposed rule. The relevant
sections of this proposed rule contain a description of significant
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or
decreases in RVUs may not cause the amount of expenditures for the year
to differ by more than $20 million from what expenditures would have
been in the absence of these changes. If this threshold is exceeded, we
make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services
compare payment rates for CY 2018 with payment rates for CY 2019 using
CY 2017 Medicare utilization. The payment

[[Page 36044]]

impacts in this proposed rule reflect averages by specialty based on
Medicare utilization. The payment impact for an individual practitioner
could vary from the average and would depend on the mix of services he
or she furnishes. The average percentage change in total revenues would
be less than the impact displayed here because practitioners and other
entities generally furnish services to both Medicare and non-Medicare
patients. In addition, practitioners and other entities may receive
substantial Medicare revenues for services under other Medicare payment
systems. For instance, independent laboratories receive approximately
83 percent of their Medicare revenues from clinical laboratory services
that are paid under the Clinical Laboratory Fee Schedule.
The annual update to the PFS conversion factor (CF) was previously
calculated based on a statutory formula; for details about this
formula, we refer readers to the CY 2015 PFS final rule with comment
period (79 FR 67741 through 67742). Section 101(a) of the MACRA
repealed the previous statutory update formula and amended section
1848(d) of the Act to specify the update adjustment factors for
calendar years 2015 and beyond. The update adjustment factor for CY
2019, as required by section 53106 of the Bipartisan Budget Act of
2018, is 0.25 percent before applying other adjustments.
To calculate the proposed conversion factor for this year, we
multiplied the product of the current year conversion factor and the
update adjustment factor by the budget neutrality adjustment described
in the preceding paragraphs. We estimate the CY 2019 PFS conversion
factor to be 36.0463, which reflects the budget neutrality adjustment
under section 1848(c)(2)(B)(ii)(II) and the 0.25 percent update
adjustment factor specified under section 1848(d)(18) of the Act. We
estimate the CY 2019 anesthesia conversion factor to be 22.2986, which
reflects the same overall PFS adjustments with the addition of
anesthesia-specific PE and MP adjustments.

Table 92--Calculation of the Proposed CY 2019 PFS Conversion Factor
------------------------------------------------------------------------

------------------------------------------------------------------------
CY 2018 Conversion Factor......... .................... 35.9996
Statutory Update Factor....... 0.25 percent ..............
(1.0025).
CY 2019 RVU Budget Neutrality -0.12 percent ..............
Adjustment. (0.9988).
CY 2019 Conversion Factor......... .................... 36.0463
------------------------------------------------------------------------

Table 93--Calculation of the Proposed CY 2019 Anesthesia Conversion
Factor
------------------------------------------------------------------------

------------------------------------------------------------------------
CY 2018 National Average .................... 22.1887
Anesthesia.
Conversion Factor.................
Statutory Update Factor....... 0.25 percent ..............
(1.0025).
CY 2019 RVU Budget Neutrality -0.12 percent ..............
Adjustment. (0.9988).
CY 2019 Anesthesia Fee 0.365 percent ..............
Schedule Practice Expense and (1.00365).
Malpractice Adjustment.
CY 2019 Conversion Factor......... .................... 22.2986
------------------------------------------------------------------------

Table 94 shows the payment impact on PFS services of the proposals
contained in this proposed rule. To the extent that there are year-to-
year changes in the volume and mix of services provided by
practitioners, the actual impact on total Medicare revenues would be
different from those shown in Table 94 (CY 2019 PFS Estimated Impact on
Total Allowed Charges by Specialty). The following is an explanation of
the information represented in Table 94.
Column A (Specialty): Identifies the specialty for which
data are shown.
Column B (Allowed Charges): The aggregate estimated PFS
allowed charges for the specialty based on CY 2017 utilization and CY
2018 rates. That is, allowed charges are the PFS amounts for covered
services and include coinsurance and deductibles (which are the
financial responsibility of the beneficiary). These amounts have been
summed across all services furnished by physicians, practitioners, and
suppliers within a specialty to arrive at the total allowed charges for
the specialty.
Column C (Impact of Work RVU Changes): This column shows
the estimated CY 2019 impact on total allowed charges of the changes in
the work RVUs, including the impact of changes due to potentially
misvalued codes and the proposed changes to documentation and payment
for the office/outpatient E/M code set. For additional information on
this proposal see section II.I. of this proposed rule.
Column D (Impact of PE RVU Changes): This column shows the
estimated CY 2019 impact on total allowed charges of the changes in the
PE RVUs.
Column E (Impact of MP RVU Changes): This column shows the
estimated CY 2019 impact on total allowed charges of the changes in the
MP RVUs, which are primarily driven by the required five-year review
and update of MP RVUs.
Column F (Combined Impact): This column shows the
estimated CY 2019 combined impact on total allowed charges of all the
changes in the previous columns. Column F may not equal the sum of
columns C, D, and E due to rounding.

Table 94--CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty
----------------------------------------------------------------------------------------------------------------
Impact of Impact of PE Impact of MP
Specialty Allowed work RVU RVU changes RVU changes Combined
charges (mil) changes (%) (%) (%) impact * (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
TOTAL........................... $92,173 0 0 0 0
ALLERGY/IMMUNOLOGY.............. 238 1 -6 0 -5

[[Page 36045]]

ANESTHESIOLOGY.................. 1,889 0 0 0 0
AUDIOLOGIST..................... 67 0 0 -1 -1
CARDIAC SURGERY................. 293 -1 -1 1 -1
CARDIOLOGY...................... 6,590 0 -1 0 -1
CHIROPRACTOR.................... 749 0 1 0 0
CLINICAL PSYCHOLOGIST........... 770 0 2 0 2
CLINICAL SOCIAL WORKER.......... 725 0 2 0 2
COLON AND RECTAL SURGERY........ 165 0 1 0 1
CRITICAL CARE................... 340 -1 0 0 0
DERMATOLOGY..................... 3,477 1 -2 0 -1
DIAGNOSTIC TESTING FACILITY..... 728 0 -4 0 -4
EMERGENCY MEDICINE.............. 3,110 0 0 0 0
ENDOCRINOLOGY................... 480 0 -1 0 -1
FAMILY PRACTICE................. 6,176 0 1 0 1
GASTROENTEROLOGY................ 1,750 -1 1 0 1
GENERAL PRACTICE................ 423 0 1 0 1
GENERAL SURGERY................. 2,079 0 0 0 1
GERIATRICS...................... 196 -2 1 0 -1
HAND SURGERY.................... 213 2 1 0 2
HEMATOLOGY/ONCOLOGY............. 1,737 -1 -3 0 -4
INDEPENDENT LABORATORY.......... 640 0 4 0 4
INFECTIOUS DISEASE.............. 645 -1 1 0 0
INTERNAL MEDICINE............... 10,698 0 1 0 1
INTERVENTIONAL PAIN MGMT........ 863 2 1 0 3
INTERVENTIONAL RADIOLOGY........ 384 1 -1 0 0
MULTISPECIALTY CLINIC/OTHER PHYS 148 -1 0 0 -1
NEPHROLOGY...................... 2,182 -1 0 0 -1
NEUROLOGY....................... 1,521 -1 -1 0 -2
NEUROSURGERY.................... 798 0 0 1 1
NUCLEAR MEDICINE................ 50 -1 -1 0 -1
NURSE ANES/ANES ASST............ 1,163 0 0 0 0
NURSE PRACTITIONER.............. 4,043 1 2 0 2
OBSTETRICS/GYNECOLOGY........... 635 3 1 0 4
OPHTHALMOLOGY................... 5,437 0 -1 0 -1
OPTOMETRY....................... 1,301 1 0 0 1
ORAL/MAXILLOFACIAL SURGERY...... 67 1 -2 0 -1
ORTHOPEDIC SURGERY.............. 3,730 1 0 0 1
OTHER........................... 31 0 5 0 4
OTOLARNGOLOGY................... 1,206 2 -3 0 -1
PATHOLOGY....................... 1,158 0 -1 0 -1
PEDIATRICS...................... 61 -1 0 0 -1
PHYSICAL MEDICINE............... 1,102 -1 0 0 -1
PHYSICAL/OCCUPATIONAL THERAPY... 3,930 0 -1 0 -1
PHYSICIAN ASSISTANT............. 2,447 1 0 0 1
PLASTIC SURGERY................. 373 1 0 0 1
PODIATRY........................ 1,958 -1 0 0 -2
PORTABLE X-RAY SUPPLIER......... 98 0 1 0 1
PSYCHIATRY...................... 1,177 0 2 0 3
PULMONARY DISEASE............... 1,709 -2 0 0 -2
RADIATION ONCOLOGY AND RADIATION 1,760 0 -2 0 -2
THERAPY CENTERS................
RADIOLOGY....................... 4,891 0 0 0 0
RHEUMATOLOGY.................... 540 -1 -3 0 -4
THORACIC SURGERY................ 356 -1 -1 1 -1
UROLOGY......................... 1,733 2 1 0 3
VASCULAR SURGERY................ 1,144 0 -2 0 -1
----------------------------------------------------------------------------------------------------------------
* Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2019 PFS Impact Discussion
a. Changes in RVUs
The most widespread specialty impacts of the proposed RVU changes
are generally related to the changes to RVUs for specific services
resulting from the Misvalued Code Initiative, including proposed RVUs
for new and revised codes. Because office/outpatient E/M codes comprise
a large volume of services in the PFS, much of the specialty level
impacts are being driven by our proposal to establish a single payment
rate for new patients and a single PFS rate for established patients
for E/M visits levels 2-5 as well as other adjustments including: The
E/M

[[Page 36046]]

Multiple Procedure Payment Adjustment, the HCPCS G-code add-ons to
recognize additional relative resources for certain kinds of visits,
HCPCS G-codes to describe podiatric E/M visits, the technical
adjustment to the PE methodology, and the HCPCS G-code for 30 minutes
of prolonged services. For specific information on these proposals, see
II.I. of this proposed rule. The estimated impacts for some
specialties, including obstetrics/gynecology, urology, independent
labs, and clinical psychologists, reflect increases relative to other
physician specialties. These increases can largely be attributed to
proposed increases in value for particular services, the proposed
updates to supply and equipment pricing, and the proposed valuation of
the E/M office visit codes that had a positive impact on specialties
reporting a higher proportion of level 2 and level 3 office visits.
The estimated impacts for several specialties, including allergy/
immunology, diagnostic testing facilities, hematology/oncology,
radiation therapy centers, and podiatry, reflect decreases in payments
relative to payment to other physician specialties. Allergy/immunology
experiences a decrease due to a reduction in PE RVUs based on updated
supply pricing for certain codes frequently billed by this specialty.
For the other specialties, these decreases can largely be attributed to
proposed revaluation of individual procedures, proposed decreases in
relative payment as a result of proposed updates to prices for medical
supplies and equipment, and the continued implementation of previously
finalized code-level reductions that are being phased-in over several
years. For independent laboratories, it is important to note that these
entities receive approximately 83 percent of their Medicare revenues
from services that are paid under the Clinical Laboratory Fee Schedule.
As a result, the estimated 1 percent reduction for CY 2019 is only
applicable to approximately 17 percent of the Medicare payment to these
entities.
Additionally, specialties such as podiatry and dermatology that
would experience a decrease in payments are those that bill a large
portion of E/M visits on the same day as procedures, and therefore
would see a reduction based on the application of the E/M MPPR
adjustments. Other specialties, such as rheumatology and hematology/
oncology are estimated to experience a decrease in payments due to the
E/M proposals because they may tend to bill greater proportion of level
4 and 5 E/M visits and the add-on codes for inherent visit complexity
may not fully mitigate a reduction in their payments. Specialties such
as OB/GYN and urology would see an increase in payments from these
proposals, due to a combination of single PFS rates for E/M visit
levels and the add-on codes for inherent visit complexity. For a more
thorough discussion of the specialty level impacts of these proposals,
see section II.I. of this proposed rule.
We often receive comments regarding the changes in RVUs displayed
on the specialty impact table, including comments received in response
to the proposed rates. We remind stakeholders that although the
estimated impacts are displayed at the specialty level, typically the
changes are driven by the valuation of a relatively small number of new
and/or potentially misvalued codes. The percentages in the table are
based upon aggregate estimated PFS allowed charges summed across all
services furnished by physicians, practitioners, and suppliers within a
specialty to arrive at the total allowed charges for the specialty, and
compared to the same summed total from the previous calendar year.
Therefore, they are averages, and may not necessarily be representative
of what is happening to the particular services furnished by a single
practitioner within any given specialty.
b. Impact
Column F of Table 94 displays the estimated CY 2019 impact on total
allowed charges, by specialty, of all the RVU changes. A table showing
the estimated impact of all of the changes on total payments for
selected high volume procedures is available under ``downloads'' on the
CY 2019 PFS proposed rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these
procedures for sake of illustration from among the procedures most
commonly furnished by a broad spectrum of specialties. The change in
both facility rates and the nonfacility rates are shown. For an
explanation of facility and nonfacility PE, we refer readers to
Addendum A on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

D. Effect of Changes Related to Telehealth

As discussed in section II.D. of this proposed rule, we are
proposing to add two new codes, HCPCS codes G0513 and G0514, to the
list of Medicare telehealth services. Although we expect these changes
to have the potential to increase access to care in rural areas, based
on recent telehealth utilization of services already on the list,
including services similar to the proposed additions, we estimate there
will only be a negligible impact on PFS expenditures from the proposed
additions. For example, for services already on the list, they are
furnished via telehealth, on average, less than 0.1 percent of the time
they are reported overall. This proposal is responsive to longstanding
stakeholder interest in expanding Medicare payment for telehealth
services. The restrictions placed on Medicare telehealth by the statute
limit the magnitude of utilization; however, CMS believes there is
value in allowing physicians and patients the greatest flexibility when
appropriate.

E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of
Hospitals Paid Under the PFS

As discussed in section II.G of this proposed rule, we are
proposing a PFS Relativity Adjuster of 40 percent for CY 2019, meaning
that nonexcepted items and services furnished by nonexcepted off-campus
PBDs would be paid under the PFS at a rate that is 40 percent of the
OPPS rate. In developing our proposal to maintain the PFS Relativity
Adjuster at 40 percent, we updated our analysis to include a full year
of claims data. We estimated site-specific PFS rates for the technical
component of a service for the entire range of HCPCS codes furnished in
nonexcepted off campus PBDs. Next we compared the average, weighted by
claim line volume, of the site specific rate under the PFS compared to
the average rate under the OPPS, also weighted by claim line volume.
This calculation resulted in a relative rate of approximately 40
percent, supporting a proposal to maintain the PFS Relativity Adjuster
at 40 percent. There will be no additional savings for CY 2019 relative
to CY 2018 because our proposed PFS Relativity Adjuster of 40 percent
maintains the current rate which was finalized for CY 2018.

F. Other Provisions of the Proposed Regulation

1. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments
In section II.N. of this rule, we proposed that effective January
1, 2019, WAC based payments for Part B drugs made under section
1847A(c)(4) of the Act would utilize a 3 percent add-on in place of the
6 percent add-on that is

[[Page 36047]]

currently being used. If this proposal is finalized, we would also
permit MACs to use an add-on percentage of up to 3 percent for WAC-
based payments for new drugs.
We anticipate that the proposed reduction to the add-on payment
made for a subset of Part B drugs will result in savings to the
Medicare program by bringing payment amounts for newly approved drugs
closer to acquisition costs. The proposed 3 percent add-on is
consistent with MedPAC's analysis and recommendations as well as
discounts observed by MedPAC in their June 2017 Report to the Congress.
We have also considered how CMS's experience with WAC-based pricing for
recently marketed new drugs and biologicals compares to MedPAC's
findings. Although the number of new drugs that are priced using WAC is
very limited, the average difference between WAC and ASP-based payment
limits for a group of 3 recently approved drugs and biologicals that
appeared on the ASP Drug Pricing Files (including one biosimilar
biological product) was 9.0 percent. Excluding the biosimilar
biological product results in a difference of 3.5 percent. The
difference was determined by comparing a partial quarter WAC-based
payment amount determined under section 1847A(c)(4) of the Act to the
next quarter's ASP-based payment amount. These findings are in general
agreement with MedPAC's findings.
Although we are able to provide examples of the relative
differences between ASP and WAC based payment limits, and we anticipate
some savings from the proposals, we cannot estimate the magnitude of
savings over time because we cannot determine how many new drugs and
biologicals subject to partial quarter pricing will appear on the ASP
Drug Pricing files in the future or how many Part B claims for these
products will be paid. This limitation also applies to contractor-
priced drugs and biologicals that have HCPCS codes and are in their
first quarter of sales. Finally, the claims volume for contractor-
priced drugs and biologicals that are billed using miscellaneous or Not
Otherwise Classified codes, such as J3490 and J3590, cannot be
quantified. We would like to note that for the three drugs discussed in
the preceding paragraph, Medicare Part B payments for individual doses
of each drug range from approximately $3,000 to $10,000. The payment
changes proposed in this rule would have resulted in a little less than
$100 to $300 savings in Medicare allowed charges for each dose.
Although we cannot estimate the overall savings to the Medicare
Program or to beneficiaries, we would like to point out that this
change in policy is likely to decrease copayments for individual
beneficiaries who are prescribed new drugs. Given that launch prices
for single doses for some new drugs may range from tens to hundreds of
thousands of dollars, a 3 percentage point reduction in the total
payment allowance will reduce a patient's 20 percent Medicare Part B
copayment. This proposed approach can result in savings to an
individual beneficiary and can help Medicare beneficiaries afford to
pay for new drugs by reducing out of pocket expenses.
The 3 percent add-on is expected to reduce the difference between
acquisition cost and certain WAC-based Part B drug payments, creating
greater parity between the two. Based on MedPAC's June 2017 Report to
Congress, we do not anticipate that this change will result in payments
amounts that are below acquisition cost or that the proposals will
impair providers' or patients' access to Part B drugs.
2. Proposed Changes to the Regulations Associated With the Ambulance
Fee Schedule
As discussed in section III B.2. of this proposed rule, section
50203(a) of the Bipartisan Budget Act of 2018 amended section
1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons
set forth in those subsections through December 31, 2022. The ambulance
extender provisions are enacted through legislation that 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. As a result, there are no policy proposals associated with
these legislative provisions or associated impact in this rule. We are
proposing only to revise the dates in Sec. 414.610(c)(1)(ii) and
(c)(5)(ii) to conform the regulations to these self-implementing
statutory requirements.
In addition, as discussed in section III.B. 3. of this proposed
rule, section 53108 of the BBA amended section 1834(l)(15) of the Act
to increase the payment reduction from 10 percent to 23 percent
effective for ambulance services furnished on or after October 1, 2018
consisting of non-emergency basic life support services (BLS) involving
transports of an individual with end stage renal disease for renal
dialysis services furnished other than on an emergency basis by a
provider of services or a renal dialysis facility. The 10 percent
reduction applies for such ambulance services furnished during the
period beginning on October 1, 2013 and ending on September 30, 2018.
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. As a result, there are no
policy proposals associated with these legislative provisions or
associated impact in this rule. We are proposing to revise Sec.
414.610(c)(8) to conform the regulations to this self-implementing
statutory requirement.
3. Clinical Laboratory Fee Schedule: Proposed Change to the Majority of
Medicare Revenues Threshold in Definition of Applicable Laboratory
As discussed in section III.A. of this proposed rule, 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 titled,
Medicare Clinical Diagnostic Laboratory Tests Payment System final rule
(CLFS final rule), published in the June 23, 2016 Federal Register,
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
payor data) collected during a ``data collection period'' for their
component ``applicable laboratories.'' In general, the payment amount
for each clinical diagnostic laboratory test (CDLT) on the CLFS
furnished beginning January 1, 2018, is based on the applicable
information collected during the 6-month data collection period and
reported to us during 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

[[Page 36048]]

from the CLFS during a data collection period, for its CDLTs that are
not advanced diagnostic laboratory tests (ADLTs).
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. 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 to revise the majority of Medicare revenues threshold
component of the definition of applicable laboratory at Sec.
414.502(3) to exclude Medicare Advantage payments under Medicare Part C
from the definition of total Medicare revenues (that is, the
denominator of the majority of Medicare threshold equation). This
change would permit laboratories with a significant Medicare Part C
revenue component to meet the majority of Medicare revenues threshold
and potentially qualify as an applicable laboratory (if it also meets
the low expenditure threshold). As a result, a broader representation
of the laboratory industry may report applicable information from which
to determine payment rates under the CLFS. For a complete discussion of
our proposal to revise the majority of Medicare revenues threshold
component of the definition of applicable laboratory under the Medicare
CLFS, we refer readers to section III A. of this proposed rule.
a. Estimation of Increased Reporting
To estimate the potential impact of excluding Medicare Advantage
plan payments from total Medicare revenues (that is, the denominator of
the low expenditure threshold) on the number of laboratories meeting
the majority of Medicare revenues threshold, using CY 2017 Medicare
claims data, we compared the number of billing NPIs that would have met
the majority of Medicare revenues threshold with Medicare Advantage
plan revenues included in total Medicare revenues (which is the current
requirement) versus the number of billing NPIs that would meet the
majority of Medicare revenues threshold had Medicare Advantage plan
payments been excluded from total Medicare revenues (which is the
proposed change). We found that excluding Medicare Advantage plan
payments from total Medicare revenues increased the level of
laboratories meeting the majority of Medicare revenues threshold by
approximately 43 percent. In other words, we estimate that excluding
Medicare Advantage plan payments from total Medicare revenues (the
denominator) of the majority of Medicare revenues threshold, and
keeping the numerator constant (that is revenues from only the CLFS and
or PFS) yields an increase of 43 percent in the number of laboratories
meeting the majority of Medicare revenues threshold.
As discussed on the CLFS website, our summary analysis of data
reporting from the initial data reporting period under the Medicare
CLFS private payor rate-based payment system, indicated that we
received applicable information from 1,942 applicable laboratories
reporting over 4.9 million records. Applying the projected 43 percent
increase to the number of applicable laboratories from the first data
reporting period (1,942 x 1.43) yields an estimated 2,777 laboratories
that would meet the majority of Medicare revenues threshold, which
reflects an additional 835 laboratories. Provided all other required
criteria for applicable laboratory status are met (including the low
expenditure threshold of receiving at least $12,500 in CLFS revenues
during a data collection period) a laboratory would report applicable
information for the next data reporting period.
To determine the estimated reporting burden for an applicable
laboratory, we looked at the distribution of reported records that
occurred for the first data reporting period. The average number of
records reported for an applicable laboratory for the first data
reporting period was 2,573. The largest amount of records reported for
an applicable laboratory was 457,585 while the smallest amount reported
was 1 record. A summary of the distribution of reported records from
the first data collection period is illustrated in Table 95.

Table 95--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
--------------------------------------------------------------------------------------------------------------------------------------------------------

Presuming that all of the additional laboratories that are
projected to meet the majority of Medicare revenues threshold, that is
approximately 835, also meet all of the criteria necessary to receive
applicable laboratory status, as defined at Sec. 414.502, they would
be an applicable laboratory and report applicable information for the
next data reporting period, January 1, 2020 through March 31, 2020.
Using the mid-point of the percentile distribution of reported records
from the initial data reporting period, that is approximately 300
records reported per applicable laboratory (50th percentile for the
first data reporting period was 294), we estimate an additional 250,500
records would be reported for the next data reporting period (835
laboratories x 300 records per laboratory = 250,500). This represents
an increase in data reporting of about 5 percent over the number of
records reported for the initial data reporting period (250,500
additional records/4,995,877 = .05). In other words, using the
approximate mid-point of reported records for the first data reporting
period, we estimate that our proposed change to the majority of
Medicare revenues threshold would increase the total amount of records
reported by approximately 5 percent. As illustrated in Table 95, 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

[[Page 36049]]

less records as compared to the midpoint.
b. Minimal Impact Expected on CLFS Rates
We note that there would only be an associated Medicare cost or
savings to the extent that the additional applicable laboratories are
paid at a higher (or lower) private payor rate, as compared to other
laboratories that reported previously and to the extent that the volume
of services performed by these ``additional'' applicable laboratories
is significant enough to make an impact on the weighted median of
private payor rates. We have no reason to believe that increasing the
level of participation would result in a measurable cost difference
under the CLFS. Given that the largest laboratories with the highest
test volumes, by definition, dominate the weighted median of private
payor rates, and the largest laboratories reported data for the
determination of CY 2018 CLFS rates and are expected to report again,
we do not expect the additional reported data resulting from our
proposed change to the majority of Medicare revenues threshold to have
a predictable, direct impact on CLFS rates. However, we believe that
this proposal responds directly to stakeholder concerns regarding the
number of applicable laboratories reporting applicable information for
the initial data reporting period. Therefore, in an effort to increase
the number of laboratories qualifying for applicable laboratory status,
we are proposing a change to the majority of Medicare revenues
threshold so that laboratories furnishing tests to a significant level
of Medicare Part C enrollees may qualify as applicable laboratories and
report data to us.
4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
The CY 2016 PFS final rule with comment period established an
evidence-based process and transparency requirements for the
development of AUC and stated that the AUC development process
requirements, as well as the application process that organizations
must comply with to become qualified PLEs did not impact CY 2016
physician payments under the PFS (80 FR 71362). The CY 2017 PFS final
rule identified the requirements CDSMs must meet for qualification and
stated that the CDSM requirements, as well as the application process
that CDSM developers must comply with for their mechanisms to be
specified as qualified under this program, did not impact CY 2017
physician payments under the PFS (81 FR 80546). The CY 2018 PFS rule
finalized the effective date of January 1, 2020, on which the AUC
consulting and reporting requirements will begin, and extended the
voluntary consulting and reporting period to 18 months. Therefore, we
stated these proposals did not impact CY 2018 physician payments under
the PFS (82 FR 53349) and noted we would provide an impact statement
when applicable in future rulemaking.
This proposed rule includes proposals to modify the Medicare AUC
Program and addresses the impacts related to the actions taken by
ordering professionals who order advanced diagnostic imaging services
and those who furnish the professional and technical components of
advanced diagnostic imaging services. The proposed rule proposes to
modify the consultation requirement in Sec. 414.94(j); therefore, this
analysis estimates the impact of consultations by ordering
professionals. The proposed rule proposes to clarify the reporting
requirement in Sec. 414.94(k), and this analysis estimates the impact
of reporting AUC consultation information. The proposed rule also
proposes to modify the significant hardship exceptions in Sec.
414.94(i), therefore this analysis estimates the impact of a self-
attestation process for ordering professionals. We also estimate the
further reaching impacts of the AUC program in the detailed analysis
that follows, assuming that some ordering professionals will purchase a
qualified CDSM integrated within their existing EHR and others may
purchase an EHR system in order to obtain an integrated qualified CDSM.
We believe that in the beginning of this program due to the additional
action required on the part of the ordering professional, it may take
longer for a Medicare beneficiary to obtain an order for an advanced
diagnostic imaging service, and therefore, we have calculated an
estimated impact to Medicare beneficiaries.
This proposed rule discusses options to report the required claims-
based AUC consultation information required in Sec.
414.94(g)(1)(iv)(B) and we estimate the impact of our proposal to use
existing coding methods (G-codes and HCPCS modifiers) to report that
information. Finally, we measure the estimated impact on furnishing
professionals and facilities of the proposed expansion of the
definition of applicable setting in Sec. 414.94(b). While the
consultation and reporting requirements of this program are effective
beginning January 1, 2020 with an Educational and Operations Testing
Period, we attempt in this analysis to identify areas of potential
qualitative benefits to both Medicare beneficiaries and the Medicare
program.
a. Impact of Consultations by Ordering Professionals
In this proposed rule, we are proposing modifications to the AUC
program largely in response to public comments and recommendations as
we believe these modifications are also important in minimizing burden
of the AUC program on ordering professionals, furnishing professionals,
and facilities. Specifically, we include a proposal regarding who, when
not personally performed by the ordering professional, may consult AUC
through a qualified CDSM and still meet the requirements of our
regulations. In the CY 2018 PFS final rule, we estimated the consulting
requirement based on the 2 minute effort of a family and general
practitioner to result in an annual burden of 1,425,000 hours
(43,181,818 consultations (Part B analytics 2014 claims data) x 0.033
hr/consultation) at a cost of $275,139,000 (82 FR 53349).
An important difference from last year's analysis is that this
year's analysis includes estimates for non-physician practitioners that
order advanced diagnostic imaging services. For the purposes of this
analysis, we assume that orders for advanced diagnostic imaging
services would be placed by ordering professionals that are non-
physician practitioners in the same percent as the numbers of non-
physician practitioners are relative to the total number of non-
institutional providers. Therefore, this analysis assumes that 40
percent of all advanced diagnostic imaging services would be ordered by
non-physician practitioners. While non-physician practitioners may not
order advanced diagnostic imaging services in the same proportion as
their numbers, we did not have other data to use for this estimate. We
specifically solicit comment and data on alternative assumptions about
the number of non-physician practitioners who order advanced imaging
services.
In addition, in this proposed rule we propose that auxiliary
personnel may perform the AUC consultation when under the direction of,
and incident to, the ordering professional's services. Due to this
proposed change, we estimate that the majority, or as many as 90
percent, of practices would employ the use of auxiliary personnel,
working under the direction of the ordering professional, to interact
with the CDSM for AUC consultation for advanced diagnostic imaging
orders. We also considered leaving the policy unchanged, and smaller
modifications to that could expand who performs the

[[Page 36050]]

consultation to a single type of non-physician practitioner. However,
we believe this proposal maximizes burden reduction effort as
illustrated in the following updated estimate of consultation burden.
To estimate the burden of this modification, we calculated the
effort of a 2-minute consultation with a qualified CDSM by a registered
nurse (occupation code 29-1141) with mean hourly wage of $35.36 and 100
percent fringe benefits to be $2.33/consultation ($35.36/hour x 2 x
0.033 hour). If 90 percent of consultations (1,282,500 hours) are
performed by such auxiliary personnel then annually the burden estimate
would be $90,698,400 (1,282,500 hours x $70.72/hour) for auxiliary
personnel to consult. We acknowledge that some AUC consultations will
not be performed by other auxiliary personnel, therefore the remaining
total annual burden we estimate is $31,810,275 for this proposed
consultation requirement. As a result of these assumptions and
calculations, we estimate a reduction in consultation burden from cost
of $275,139,000 to $122,508,675, which results in a proposed net burden
reduction of $152,630,325.
b. Impact of Significant Hardship Exceptions for Ordering Professionals
We previously identified exceptions to the requirement that
ordering professionals consult specified applicable AUC when ordering
applicable imaging services (81 FR 80170). Our original intention was
to design the AUC hardship exception process in alignment with the EHR
Incentive Program and then the MIPS ACI performance category (now
promoting interoperability). However, in this proposed rule, we propose
to modify the significant hardship exception criteria under Sec.
414.94(i)(3) to be specific to the Medicare AUC program and independent
of other Medicare programs both in policy and process. Specifically, we
are proposing that all ordering professionals self-attest if they are
experiencing a significant hardship at the time of placing an advanced
diagnostic imaging order. Since the Medicare EHR Incentive Program has
ended and we are unable to continue incorporating regulation that is no
longer in effect, we did not consider leaving this policy unchanged. We
also considered using a hardship application submission process.
However, we believe that this proposed self-attestation process
maximizes burden reduction effort as illustrated in the following
updated estimate of ordering professionals subject to a consultation
burden.
To estimate the impact of our proposal to modify this section and
create a hardship exception specific to this program we attempted to
identify how many ordering professionals would be subject to this
program.
Medicare non-institutional Part B claims for the first 6 months of
2014 shows that for claims for an advanced diagnostic imaging service
that listed an NPI for the ordering/referring provider, up to 90-
percent of claims include only 18 different provider specialties. These
specialties include: Emergency Medicine; Internal Medicine; Family
Practice; Cardiology; Hematology/Oncology; Orthopedic Surgery;
Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary
Disease; General Surgery; Neurosurgery; Medical Oncology;
Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic
Radiology. We then used CMS data that served to create Table II.8 of
the 2014 Medicare Statistics Book and were able to identify how many
practitioners in each of those specialties were participating in
Medicare program. Table II.8 of the 2014 Medicare Statistics Book
combines many of these specialties into higher level groupings and
displays the total number of practitioners participating in the
Medicare program. However, we used more granular information that
identifies the number of practitioners participating in the Medicare
program by an individual specialty rather than higher level groupings
(table available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/2016/Downloads/PROVIDERS/2016_CPS_MDCR_PROVIDERS_6.pdf). For example, Table
II.8 of the 2014 Medicare Statistics Book combines all surgeons into
one category whereas we used detailed information for the individual
surgical specialties of general surgery and orthopedic surgery for this
estimate.
Using this more specific data for the 18 specialties, we estimate
the count of practitioners that will be ordering professionals under
the AUC program to be 586,386. There are limitations as we do not have
data on the actual number of practitioners who order advanced
diagnostic imaging services because information about the ordering
professional is not required to be included on the Medicare claim form
for advanced diagnostic imaging services.
In the absence of data on the breadth of professionals who would be
required to consult AUC, we assumed that professionals in the
specialties listed earlier could potentially be subject to these
requirements because some professionals within a specialty may order
these imaging services. We specifically request comments and data on
the numbers of professionals in the specialties that actually order
advanced imaging services.
With respect to the hardship exception, based on 2016 data from the
Medicare EHR Incentive Program and the 2019 payment year MIPS
eligibility and special status file, we estimated that 6,699
respondents in the form of eligible clinicians, groups, or virtual
groups will submit a request for a reweighting to zero for the
advancing care information performance category due to extreme and
uncontrollable circumstances or as a result of a decertification of an
EHR. For the purposes of this analysis, we cautiously estimate that
each of the 6,699 respondents represents a unique ordering professional
and that all respondents who experience extreme and uncontrollable
circumstances or have an EHR that is decertified are ordering
professionals who would self-attest to a significant hardship exception
under the AUC program. Nevertheless, we have used this information to
update our estimate that there are 579,687 ordering professionals
subject to this program.
We believe that the proposed significant hardship exception at
Sec. 414.94(i) would further reduce the burden of this program if
finalized for four reasons. First, due to the availability of a
significant hardship exception there will likely be fewer ordering
professionals consulting specified applicable AUC. Second, the self-
attestation process is a less burdensome proposal when compared to the
alternative of a hardship application process that may have both
regulatory impact and information collection requirements. Third, any
application or case-by-case determination would necessitate immediate
infrastructure development by CMS directly or through one or more
Medicare Administrative Contractors (MACs), which adds burden and
impact to this program. Finally, the proposed self-attestation process
requires no verification on the part of the furnishing professional or
facility required to report AUC consultation information on the
Medicare claim, thus minimizing burden for both ordering professionals,
furnishing professionals and facilities. While some of the efficiencies
gained from a self-attestation process are qualitative in nature and
difficult to measure, such as the streamlined

[[Page 36051]]

reporting, we believe that relative to other regulatory approaches this
proposal uses a least burdensome approach.
We recognize that ordering professionals would store documentation
supporting the self-attestation of a significant hardship. Storage of
this information could involve the use of automated, electronic, or
other forms of information technology at the discretion of the ordering
professional. We estimate that the average time for office clerical
activities associated with this task to be 10 minutes. To estimate the
burden of this storage, we expect that a BLS occupation title 43-6013
Medical Secretary with a mean hourly rate of $17.25 and 100-percent
fringe benefits would result in a calculated effort of 10 minutes of
clerical work to be $5.76 ($17.25/hour x 2 x 0.167 hour). If 6,699
separate ordering professionals require that a Medical Secretary
perform the same clerical activity on an annual basis, then this
equates to a cost of approximately $38,596 per year. We seek comment to
inform these burden estimates.
c. Impact of Consultations Beyond the Impact to Ordering Professionals
While we have already discussed the time and effort to consult
specified applicable AUC through a qualified CDSM here and in previous
rulemaking (81 FR 80170), we believe the impact of this program is
extensive as it will apply to every advanced diagnostic imaging service
(for example, magnetic resonance imaging (MRI), computed tomography
(CT) or positron emission tomography (PET)) and crosses almost every
medical specialty. Therefore, we also have described in this detailed
analysis the impacts of AUC consultation beyond the act of consulting
specified applicable AUC.
(1) Transfers From Ordering Professionals to Qualified CDSMs and EHR
Systems
The first additional impact we identified is upstream in the
workflow of the AUC consultation and represents the acquisition cost,
training, and maintenance of a qualified CDSM. These 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 established by the
Secretary. Currently, none are established by the Secretary.
Additionally, for the purposes of this program, as required by statute,
one or more of such mechanisms is available free of charge. For this
impact analysis we will assume three potential scenarios as low,
medium, and higher burden assessments of this consultation requirement.
First, we assume that some number of ordering professionals consults a
qualified CDSM available free of charge. Second, we assume that some
number purchase a qualified CDSM to integrate within an existing EHR
system. Third, we assume that some do not currently have an EHR system
and, as a result of the statutory requirement to consult with AUC,
would purchase an EHR system with an integrated qualified CDSM to
consult specified applicable AUC for the purposes of this program.
In the lowest estimate of burden, every AUC consultation would take
place using a qualified CDSM available free of charge integrated into
an EHR system and add no additional cost to the requirement in Sec.
414.94(j) of this proposed rule. While we did not base this estimate on
absolute behaviors by all those who have ordered advanced diagnostic
imaging services, we believe it is reasonable to estimate that as many
as 75 percent of an assumed annual 40,000,000 orders for advanced
diagnostic imaging services could occur at no additional cost beyond
the time and effort to perform the consultation.
In contrast, some ordering professionals may choose to purchase a
qualified CDSM that is integrated within their EHR. To estimate how
many ordering professionals may choose to purchase an integrated
qualified CDSM, we consulted the 2015 National Electronic Health
Records Survey \47\ (NEHRS), which is conducted by the National Center
for Health Statistics (NCHS) and sponsored by the Office of the
National Coordinator for Health Information Technology (ONC). NEHRS is
a nationally representative mixed mode survey of office-based
physicians that collects information on physician and practice
characteristics, including the adoption and use of EHR systems. In the
United States in 2015, 86.9 percent of office-based physicians used any
EHR/EMR, with significantly higher adoption by general or family
practice physicians (92.7 percent, p-value <0.05), and slightly lower
for medical non-primary care physicians (84.4 percent). Given that
approximately 87 percent of office-based physicians have adopted EHR
systems, we believe it is likely that the majority will prefer a
qualified CDSM integrated with EHR. While we note that qualified CDSMs
available free of charge are also integrated within one or more EHR
systems, the following exercise estimates the time and effort to
purchase, install, train, and maintain a qualified CDSM integrated into
an EHR system.
---------------------------------------------------------------------------

\47\ Jamoom E, Yang N. Table of Electronic Health Record
Adoption and Use among Office-based Physicians in the U.S., by
State: 2015 National Electronic Health Records Survey. 2016.
---------------------------------------------------------------------------

Again, as stated above, we do not have data on the number of
clinicians who order advanced diagnostic imaging services, and we have
made overarching assumptions to look at particular specialty areas that
in our claims analysis order these advanced diagnostic imaging
services. We assumed all individual clinicians in these specialty areas
could potentially be subject to these requirements. Adding the number
of clinicians in each of the specialty areas results in 586,386
ordering professionals. We also did not make a distinction between
individual professionals and groups, as further explained below.
To calculate the impact of a single purchase, we believe that
ordering professionals, either in groups or individually, would spend
an estimated $15,000 for a one-time purchase of an integrated qualified
CDSM, including installation and training. We assume that all of these
costs are based on market research and incurred over the course of 5
years. We also assume that the $15,000 purchase would be made by each
ordering professional and did not take into account the potential that
a group practice might incur a discounted price per user based on the
number of ordering professionals in the practice. These assumptions
could significantly alter the impact estimate and we seek comment on
such assumptions.
Given the difficult nature of deriving these estimates based on
limited data, we solicit comment and information on the preference that
physicians and practitioners might have for using an integrated
qualified CDSM--a free CDSM or a CDSM that is not free but integrated
within an existing EHR system. Also, if purchased, whether this would
be purchased at the group practice level to be made available to all
clinicians in the practice for the same cost that would be incurred by
a single practitioner purchasing the same qualified CDSM, and whether
the cost of purchasing a CDSM would be incurred in a single year or
over multiple years.
For the purposes of estimating the transfer of costs from ordering
professionals to qualified CDSM developers, of the estimated 579,687
practitioners that are likely subject to this program, we excluded
181,653 ordering professionals with specialties whose practitioners
order on average fewer than 20 advanced diagnostic imaging services per
year (physician

[[Page 36052]]

assistant, nurse practitioner, and diagnostic radiology). The
assumption is that lower volume ordering professionals would select a
qualified CDSM that is free of charge. This updates the estimate to
consider 398,034 ordering professionals who may purchase an integrated
qualified CDSM. To this end, if we assume 346,290 (398,034 ordering
professionals x 87 percent) ordering professionals already have an EHR
system and 30 percent of these ordering professionals (346,290 x 30
percent, or 103,887) make this purchase for $15,000 and spend $1,000
annually to maintain their system for 5 years (initial acquisition cost
in year 1 and maintenance costs in years 2-5), then the total annual
cost is estimated to be $394,770,600 ((103,887 x $19,000)/5 years)).
It is also reasonable to assume that some ordering professionals
may not need additional training in using a qualified CDSM because the
EHR Incentive Program required CDS as a core measure. In addition, the
program incentivized use of computerized provider order entry (CPOE)--
an electronic submission of pharmacy, laboratory, or radiology orders.
To determine readiness among Medicare practitioners for these and other
measures, the 2011 Meaningful Use Census \48\ (RTI International, 2012)
observed that those participating in the EHR Incentive Program in 2011
on average met and exceeded the established 30 percent threshold for
meaningful use of CPOE in Stage 1. Analysis of the distribution of
performance on these measures shows that 86 percent of eligible
participants were well over the established thresholds. It is important
to note that the CPOE measure had a higher threshold in Stage 2, and 60
percent of eligible participants in 2011 attested to meaningful use are
already meeting this higher threshold. This report suggests that some
ordering professionals may be well prepared to adopt a qualified
clinical decision support mechanism, as this experience offset may
yield lower costs and burden to learn to incorporate decision support
into the ordering workflow through shorter training times.
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\48\ Vincent, A. EHR Incentive Program: 2011 Meaningful Use
Census. RTI Internatoinal. November 2012.
---------------------------------------------------------------------------

Additionally, some ordering professionals may choose to purchase a
certified EHR system to use a qualified CDSM already integrated within
the EHR. The first estimate of capital costs for certified EHR system
was identified in the first year of the EHR incentive program as an
estimated cost of approximately $54,000 (75 FR 44518), which adjusted
for inflation using the Consumer Price Index for All Urban Consumers
(CPI-U) U.S. city average series for all items, not seasonally
adjusted, represents $62,050.40 in 2018. If we assume that 346,290
ordering professionals subject to this program have adopted EHR, then
we will also assume that 51,744 ordering professionals (398,034
ordering professionals x 13 percent) have not adopted an EHR system.
Most physicians who have not yet invested in the hardware,
software, testing, and training to implement EHRs may continue to work
outside the EHR for a number of reasons--lack of standards, lack of
interoperability, limited physician acceptance among their peers,
maintenance costs, and lack of capital. Adoption of EHR technology
necessitates major changes in business processes and practices
throughout a provider's office or facility. Business process
reengineering on such a scale is not undertaken lightly. Therefore,
while we cannot estimate the business decisions of all ordering
professionals, we assume for the purposes of this analysis that as a
result of this program some ordering professionals will purchase an EHR
system in order to access a qualified CDSM that is integrated into that
EHR system for the purposes of acquiring long-term process efficiencies
in consulting specified applicable AUC.
We do not have data on the characteristics of physicians who have
not purchased an EHR system. However, for the purpose of estimating the
transfer of costs from ordering professionals to EHR systems, we will
assume based on research from business advisors \49\ that 30 percent,
or 15,523 ordering professionals (51,744 ordering professionals x 30
percent) will seek to purchase an EHR system at an estimated cost of
$62,050.40 for a total one-time cost of $963,208,359.20 in EHR system
and integrated qualified CDSM infrastructure. As we believe not every
ordering professional in this example would purchase such
infrastructure immediately, for the purposes of this estimate, we
annualized this cost over 5 years to $192,641,671.84/year. We recognize
that qualified CDSMs 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 established by the Secretary.
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\49\ McCormack M, ``EHR Software Buyer Report--2014'' available
at https://www.softwareadvice.com/resources/ehr-buyer-report-2014/.
---------------------------------------------------------------------------

These estimates are highly sensitive to our assumptions of both the
percent of physicians who would purchase an EHR system as a result of
this program and the costs of an EHR system. We recognize that due to
the limited data available to make these assumptions our estimates are
likely high and we seek comment and information about these
assumptions. These estimates might be viewed as an upper bound of the
impact of this program beyond consultation with a free tool and note
that at the time of publication there were three free tools available
as indicated on the CMS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html.
(2) Impact to Medicare Beneficiaries
Additionally, we believe that the additional 2-minute consultation
will impact the Medicare beneficiary when their advanced diagnostic
imaging service is ordered by the ordering professional by introducing
additional time to their office visit. To estimate this annual cost, we
multiplied the annual burden of 1,425,000 hours by the BLS occupation
code that represents all occupations in the BLS (00-0000) as mean
hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of
$68,001,000 per year. Over time, there may be process efficiencies
implemented in one or more practices similar to the benefits of
deploying CDS \50\ (Berner, 2009; Karsh, 2009) that decrease this
estimate. For example, we will assume that every time an advanced
diagnostic imaging service is ordered, it is the result of a visit by a
Medicare beneficiary for evaluation and management. Then, let us assume
that 50 percent of practices implemented an improvement process that
streamlined the AUC consultation such that Medicare beneficiaries who
visited those practices spent the same amount of time in the
physician's office regardless of whether an advanced diagnostic imaging
service was ordered. As a result of this improvement process in
practice we could estimate such efficiency would offset the estimated
burden by $34,000,500 annually. Although we cannot at this time
identify

[[Page 36053]]

a concrete solution, we are seeking comment on this detailed analysis
to inform future rulemaking.
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\50\ Berner ES. Clinical decision support systems: State of the
Art. AHRQ Publication No. 09-0069-EF. Rockville, Maryland: Agency
for Healthcare Research and Quality. June 2009. Karsh B-T. Clinical
practice improvement and redesign: how change in workflow can be
supported by clinical decision support. AHRQ Publication No. 09-
0054-EF. Rockville, Maryland: Agency for Healthcare Research and
Quality. June 2009.
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d. Considering the Impact of 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 in the opinion of some commenters, reporting unique
consultation identifiers (UCIs) would be a less burdensome and
preferred approach. We had the opportunity to engage 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. Practically examining
the workflow of an order for an advanced diagnostic imaging service
before and after implementation of the Medicare AUC program, we see
that in general the process remains largely unchanged. Before and after
the implementation of this program, an ordering professional could
employ support staff to transmit an order for an advanced diagnostic
imaging service from his or her office to an imaging facility,
physician office, or hospital that furnishes advanced diagnostic
imaging services. After implementation of this program, the ordering
professionals, furnishing professionals and facilities must adapt this
existing workflow to accommodate new information not previously
required on orders for advanced diagnostic imaging services.
We considered leaving the policy unchanged, and we also considered
writing new regulations requiring larger modifications to the form for
manner by which AUC consultation information is communicated from the
ordering professional to the furnishing professional or facility.
However, we believe the proposal described in this proposed rule
minimizes burden and maximizes efficiency by reporting through
established coding methods, to include G-codes and modifiers, to report
the required AUC information on Medicare claims.
(1) Impact on Transmitting Order for Advanced Diagnostic Imaging
Services
We estimate that including AUC consultation information on the
order to the furnishing professional or facility is estimated as the
additional 5 minutes spent by a medical secretary (43-6013), at a mean
hourly rate of $17.25 plus 100 percent fringe to transmit the order for
the advanced diagnostic imaging service. We believe the estimate of 5
minutes is an estimate that accounts for different transmittal methods,
such as through an integrated EHR system, by facsimile, or via
telephone call directly to the office of the furnishing professional or
facility. In aggregate, if we assume that 40,000,000 advanced
diagnostic imaging services are ordered annually, then the total annual
burden to communicate additional information in the order is estimated
as $114,540,000 ($17.25/hr x 2 x 0.083 hr x 40,000,000 orders).
(2) Impact on CDSM Developers
We believe that in considering a distinct UCI we also considered
updating the requirements of a qualified CDSM in Sec.
414.94(g)(1)(vi)(B). This would incur additional costs for the
developers of these mechanisms to accommodate formatting changes if
instructed by CMS. We continue to believe that participation by CDSM
developers in this program is voluntary, that any considerations of
proposed changes to this policy maximize benefits and minimize burden
to ordering professionals and furnishing professionals and facilities.
Internally, CMS has explored the possibility of using a UCI to
determine feasibility, and provide a detailed estimate of costs to
develop, test, and implement an update in the form and manner of the
UCI generated by the CDSM.
To estimate the costs to develop, test, and implement this update,
we will provide a relevant case study. In 1998, the Year 2000
Information and Readiness Disclosure Act (Pub. L. 105-271) was passed
to ensure continuity of operations in the year 2000. At the time of
passage, millions of information technology computer systems, software
programs, and semiconductors were not capable of recognizing certain
dates after December 31, 1999, and without modification would read
dates in the year 2000 and thereafter as if those dates represented the
year 1900 or thereafter, or would have failed to process those dates
entirely. The federal government had budgeted $8,300,000,000 to
continue processing dates in 2000 and beyond (Department of Commerce,
1999). Additional estimates to repair the date in a form and manner
accommodating the year 2000 varied, but one estimate \51\ from analysis
of the 1998-99 budget bill of the state of California estimated
$241,000,000 to repair 3,000 systems, or $80,333.33 per system, which
adjusted for inflation using the CPI-U, U.S. city average series for
all items, not seasonally adjusted, represents $123,775.95 per system
in 2018. If all 16 qualified CDSMs performed an update to the
formatting of the UCI to appear on certification or documentation of
every AUC consultation, then the one-time total cost incurred by all
CDSM developers would be $1,980,415.20. Although this does not
represent a direct transfer of costs from CDSM developers to savings
and efficiencies for ordering professionals, furnishing professionals
and facilities, we do believe that as a result of such a policy
modification that the ordering professional could directly communicate
a single AUC UCI, and furnishing professionals and facilities can
report UCI in place of identifying each individual CDSM qualified for
the purposes of this program.
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\51\ LAO Analysis of the 1998-99 Budget Bill Information
Technology Issues. Information Technology Issues Analysis of the
1998-99 Budget Bill. The Year 2000 (``Y2K'') Computer Problem.
Published February 18, 1998. Accessed March 25, 2018 at http://www.lao.ca.gov/analysis_1998/info_tech_anl98.html.
---------------------------------------------------------------------------

e. Impact of Expanding Applicable Setting on Furnishing Professionals
and Facilities
We expect that an AUC consultation must take place for every
applicable imaging service furnished in an applicable setting and paid
for under an applicable payment system. In the CY 2017 PFS final rule
(81 FR 80170) we codified the definition of applicable setting in Sec.
414.94(b) to include 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 this proposed rule, we also include a
proposal to add independent diagnostic testing facilities to the
definition of applicable settings under this program. This proposal is
based on the following factors from 2016 CMS Statistics: (1) An
independent diagnostic testing facility is independent both of an
attending or consulting physician's office and of a hospital; (2)
diagnostic procedures when performed by an independent diagnostic
testing facility are paid under the PFS; (3) independent facilities
have increased 5,120 percent from 4,828 in 1990 to 252,044 in 2015; (4)
of those facilities, 1,125 received total payments in excess of
$100,000 in 2015; (5) there were 37,038 radiology non-institutional
providers utilized by fee-for-service Medicare beneficiaries for all
Part B

[[Page 36054]]

non-institutional provider services in 2015, of which 14,341 received
total payments in excess of $100,000 in 2015. Taken together, we
believe this proposal will result in a more even application of the
Medicare AUC program.
To estimate the impact of modifications to this proposal, we assume
based on data derived from the CCW's 2014 Part B non-institutional
claim line file, which includes services covered by the Part B benefit
that were furnished during calendar year 2014, that approximately
40,000,000 advanced diagnostic imaging services are furnished annually,
but questioned whether for the purposes of this estimate we should
attribute equal weight for these services furnished by each of the
following places: (1) A physician's office; (2) a hospital outpatient
department; (3) an ambulatory surgical center; and (4) an independent
diagnostic testing facility. Therefore, we sought to determine the
frequency of advanced diagnostic imaging services furnished by each
setting.
For this estimation, we analyzed 2014 Medicare Part B claims data
to weight the various applicable settings subject to this program. For
this estimate, we analyzed a count of total services furnished for the
following 7 Current Procedural Terminology (CPT) codes for advanced
diagnostic imaging studies: 70450--computed tomography, head or brain,
without contrast material; 74177--computed tomography, abdomen and
pelvis, without contrast material; 70553--magnetic resonance (e.g.,
proton) imaging, brain (including brain stem), without contrast
material, followed by contrast material(s) and further sequences;
72148--magnetic resonance (e.g., proton) imaging, spinal canal and
contents, lumbar, without contrast material; 78452--Myocardial
perfusion imaging, tomographic single-photon emission computed
tomography (SPECT) including attenuation correction, qualitative or
quantitative wall motion, ejection fraction by first pass or gated
technique, additional quantification, when performed, multiple studies,
at rest and/or stress (exercise or pharmacologic) and/or redistribution
and/or rest reinjection; 78492--myocardial imaging, positron emission
tomography (PET), perfusion, multiple studies at rest and/or stress;
78803--radiopharmaceutical localization of tumor or distribution of
radiopharmaceutical agent(s), tomographic SPECT; which represented
10,000,000 total services or approximately a 25 percent sample of the
40,000,000 total advanced diagnostic imaging services furnished under
Part B in 2014.
In this sample, we found the following total services and percent
of total services for each of the following settings: (1) Physician's
office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient
department, 7,465,279 total services, 70.9 percent; (3) ambulatory
surgical center, 1,062 total services, 0.01 percent; (4) independent
diagnostic testing facility, 58,900 total services, 0.6 percent. We
also examined whether the total services furnished in 2015 for each
setting increased more than 10 percent from 2014. We found the
following total services and percent change from 2014 for each of the
following settings: (1) Physician's office, 2,944,144 total services, 2
percent decrease; (2) hospital outpatient department, 7,854,997 total
services, 5 percent increase; (3) ambulatory surgical center, 2,900
total services, 173 percent increase; (4) independent diagnostic
testing facility, 65,479 total services, 11 percent increase. Taken
together, we believe these estimates that attribute 70 percent of all
advanced diagnostic imaging services to outpatient, 28 percent to
physician's office, and 1 percent each to ambulatory surgical centers
and independent diagnostic testing facilities, respectively is
generalizable to the total number of visits by Medicare beneficiaries
to each of those applicable settings, respectively.
We do not expect that for the purposes of this program furnishing
professionals and facilities will need to create new billing practices;
however, we assume that the majority of furnishing professionals and
facilities will work to alter billing practices through automation
processes that accommodate AUC consultation information when furnishing
advanced diagnostic imaging services to Medicare beneficiaries.
Therefore, we believe a transfer of costs and benefits will be made
from furnishing professionals and facilities to medical billing
companies to create, test, and implement changes in billing practice
for all affected furnishing professionals and facilities.
As mentioned earlier, the 2016 CMS Statistics identified 37,038
radiology non-institutional providers (Table II.8), and 5,470
ambulatory surgical centers (Table II.5) as of December 31, 2015.
Because the classification of independent facilities includes both
diagnostic radiology and diagnostic laboratory tests, we will assume
that 50 percent of the 252,044 facilities existing in 2015 according to
2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic
imaging services. The American Hospital Association Hospital Statistics
published in 2018 by Health Forum, an affiliate of the American
Hospital Association, identifies the total number of all U.S.
registered hospitals to be 5,534. Taken together, we have identified an
estimated 174,064 furnishing professionals (37,038 radiologists + 5,470
ASCs + 126,022 independent diagnostic testing facilities + 5,534
hospitals). We will assume for the purposes of this calculation that
every identified furnishing professional and facility will choose to
update their processes for the purposes of this program in the same way
by purchasing an automated solution to reporting AUC consultation
information.
The effective date of January 1, 2020 provides some but not
extensive time to prepare to update billing processes to accept and
report AUC consultation information. Requirements at Sec. 414.94(k)
include the following additional information that must be reported: (1)
The qualified CDSM consulted by the ordering professional; (2)
information indicating 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; (3) the NPI of
the ordering professional who consulted specified applicable AUC as
required in paragraph (j) of this section, if different from the
furnishing professional. Although we are not familiar with any
automated billing solution currently available that accommodates this
new information, we seek comment on our estimate that based on medical
billing and coding for experienced professionals (http://www.mb-guide.org/), which provides estimates ranging from $1,000 to $50,000 for
medical billing software, for the purposes of this calculation such a
solution will cost each furnishing professional or facility an
estimated $10,000. We believe this is an estimate based on the
assumption that the number of available furnishing professionals and
facilities does not equal the number of professionals and facilities
furnishing advanced diagnostic imaging services in the Medicare program
and although we recognize that more than one furnishing professional or
facility may use the same billing service, the combined effectiveness
for an automated solution may decrease overall cost. However, this is
not an impact on behavior that we could assess before the start of this
program and we are seeking feedback on these and other estimates
presented. Therefore, given these assumptions, we estimate that the

[[Page 36055]]

one-time update will cost $1,740,640,000 (174,064 x $10,000).
The Congressional Budget Office estimates that section 218 of the
PAMA would save approximately $200,000,000 in benefit dollars over 10
years from FY 2014 through 2024, which could be the result of
identification of outlier ordering professionals and also includes
section 218(a) of the PAMA--a payment deduction for computed tomography
equipment that is not up to a current technology standard. Because we
have not yet proposed a mechanism or calculation for outlier ordering
professional identification and prior authorization, we are unable to
quantify that impact at this time.
f. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
We believe that the first 5 years of this program will be dedicated
to implementation activities, from installation of the technology to
training to operational and behavioral changes. Information on the
benefits of adopting qualified CDSMs or automating billing practices
specifically meeting the requirements in this proposed rule does not
yet exist--and information on benefits overall is limited. Nonetheless,
we believe there are benefits that can be obtained by ordering
professionals, furnishing professionals and facilities, beneficiaries
and technology infrastructure developers including qualified CDSM
developers, EHR systems developers, and medical billing practices. We
describe these estimated benefits in more detail in the following
sections.
(1) Estimates of Savings
It has been suggested that one-third of imaging procedures are
inappropriate, costing the United States between $3 billion and $10
billion annually \52\ (Stein, 2003). Data derived from the CCW 2014
Part B non-institutional claim line file, which includes services
covered by the Part B benefit that were furnished during CY 2014,
identified approximately $3,300,000,000 in total payments for advanced
diagnostic imaging services. If implementation of this program led to a
30 percent decrease in total payments, then we would expect
$990,000,000 in fewer payments annually. To address this suggestion,
the insertion of a pause in the ordering workflow to introduce AUC is a
potentially beneficial and cost-effective solution. Some believe \53\
that savings could be achieved through the reduction of inappropriate
orders, and expenses associated with radiology benefit managers (Hardy,
2010). Indeed, the Institute for Clinical Systems Improvement in
Bloomington, Minnesota, performed a clinical decision support pilot
project \54\ to (1) improve the utility of diagnostic radiology tests
ordered, (2) reduce radiation exposure, (3) increase efficiency, (4)
aid in shared decision making, and (5) save Minnesota $84,000,000 in 3
years (Miliard, 2010). It is hypothesized \55\ that these benefits are
the result of educating ordering professionals on the appropriate test
for a set of clinical symptoms, rather than just adding time and
electronic obstacles between ordering physicians and advanced
diagnostic imaging services (Sistrom et al., 2009) as such transfer of
knowledge can alter clinical practice.
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\52\ Stein C. Code red: Partners program aims to rein in
skyrocketing costs of diagnostic imaging. Boston Globe, 2003.
\53\ Hardy, K. Decision Support for Rad Reports. Radiology
Today. Vol. 11, No. 1, p. 16., 2010.
\54\ Miliard, M. Nuance, ICSI aim to prevent unnecessary imaging
tests. Healthcare IT News. November 10, 2010.
\55\ Sistrom CL, Dang PA, Weilburg JB, et al., Effect of
Computerized Order Entry with Integrated Decision Support on the
Growth of Outpatient Procedure Volumes: Seven-year Time Series
Analysis. Radiology. 251(1), 2009.
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The Center for Health Care Solutions at Virginia Mason Medical
Center in Seattle, Washington examined approaches to control imaging
utilization, including external authorization methods and clinical
decision support systems. A retrospective cohort study \56\ was
performed by Blackmore and colleagues in 2011 of the staged
implementation of evidence-based clinical decision support for the
following advanced diagnostic imaging services: Lumbar MRI; brain MRI;
and sinus CT. Brain CT was included as a control. The number of
patients imaged as a proportion of patients with selected clinical
conditions before and after the decision support interventions were
determined from billing data from a regional health plan and from
institutional radiology information systems. The imaging utilization
rates after the implementation of clinical decision support resulted in
decreases for lumbar MRI (p-value = 0.001), head MRI (p-value = 0.05),
and sinus CT (p-value = 0.003), while a decrease in control service
head CT was not statistically significant (p-value = 0.88). Although
there are limitations to this retrospective claims data analysis, the
authors concluded that clinical decision support is associated with
large decreases in the inappropriate utilization of advanced diagnostic
imaging services.
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\56\ Blackmore, CC; Mecklenburg, RS; Kaplan GS. Effectiveness of
Clinical Decision Support in Controlling Inappropriate Imaging.
Journal of the American College of Radiology. 8(1) 2011.
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It seems reasonable from this and other studies \57\ of local
implementation of clinical decision support (Curry and Reed, 2011; Ip
et al., 2012) to assume that there may be some savings when regulations
become effective January 1, 2020; however, there are also a few
hesitations to extrapolating these and other findings broadly to the
Medicare population. First, ordering professionals in this program are
aware that CMS will pay for advanced diagnostic imaging services that
do not adhere to the specified applicable AUC consulted. This awareness
may impact the level of interest or extent of behavior modification
from exposing ordering professionals to a qualified CDSM. Second, the
statute distinguishes between the ordering professional, furnishing
professional and facility, recognizing that the professional who orders
an applicable imaging service is usually not the same professional or
facility reporting to Medicare for that service when furnished. As a
result, some ordering professionals may believe that since they are not
required to submit AUC consultation information directly to CMS, there
are no direct consequences of adhering to specified applicable AUC.
Third, many advanced diagnostic imaging services may not have relevant
or applicable AUC. Indeed a recent study \58\ implementing CDS was only
able to prospectively generate a score for 26 percent and 30 percent of
requests for advanced diagnostic imaging services before and after
implementation of decision support, respectively (Moriarity et al.,
2015). Without AUC available, there can be no decision support
intervention into the workflow of the ordering professional. Fourth,
even when an ordering professional identifies an advanced diagnostic
imaging service recognized as adhering to specified applicable AUC from
one qualified PLE, discordance between AUC from different specialty
societies has been reported \59\

[[Page 36056]]

(Winchester et al., 2016), suggesting that full benefits and savings
cannot be realized without standard levels of appropriateness. Taken
together, these concerns will form the basis for our continued
examination of the impact of this and future rulemaking to maximize the
benefits of this program.
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\57\ Curry, L. and Reed, M.H. Electronic decision support for
diagnostic imaging in a primary care setting. J Am Med Inform Assoc.
2011; 18: 267-270; Ip, I.K., Schneider, L.I., Hanson, R. et al.
Adoption and meaningful use of computerized physician order entry
with an integrated clinical decision support system for radiology:
Ten-year analysis in an urban teaching hospital. J Am Coll Radiol.
2012; 9: 129-136.
\58\ Moriarity, AK, Klochko C, O'Brien M, Halabi S. The Effect
of Clinical Decision Support for Advanced Inpatient Imaging. Journal
of American College of Radiology. 12(4) 2015.
\59\ Winchester DE et al., Discordance Between Appropriate Use
Criteria for Nuclear Myocardial Perfusion Imaging from Different
Specialty Societies: A potential concern for health policy. JAMA
Cardiol. 1(2) 2016:207-210.
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(2) Benefits to Medicare Beneficiaries
Although qualified CDSMs are not required to demonstrate that their
tools provide measurable benefits, we believe that as a result of
installation and use, some ordering professionals may find benefits to
the patients they serve. For example, if a qualified CDSM creates a
flag or alert to obsolete tests, then the patient will benefit from
avoiding unnecessary testing. The same outcome would be likely if a
qualified CDSM implemented algorithms that recognize advanced
diagnostic imaging services that may produce inaccurate results because
of medications being taken by the patient. In addition, if the CDSM
provides standardized processes for advanced diagnostic imaging orders
or clarification for confusing test names, then the patient benefits
from a potential decrease in medical errors. Finally, we believe it is
reasonable to assume that some improvements in shared decision making
could result from use of a qualified CDSM, because some CDSMs could
provide cost information associated with advanced diagnostic imaging
services and/or identify situations of repeated testing.
5. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals Medicaid Promoting Interoperability Program
Requirements for Eligible Professionals (EPs)
In the Medicaid Promoting Interoperability Program, to keep eCQM
specifications current and minimize complexity, we are proposing to
align the eCQMs available for Medicaid EPs in 2019 with those available
for MIPS eligible clinicians for the CY 2019 performance period. 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 as many EPs are expected to report eCQMs to meet the
quality performance category of MIPS and therefore should be prepared
to report on those 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. State expenditures to make any systems changes required
as a result of this proposal would be eligible for ninety percent
enhanced Federal financial participation.
For 2019, we are proposing that Medicaid EPs would report on any
six eCQMs that are relevant to the EP's scope of practice, including at
least one outcome measure, or if no applicable outcome measure is
available or relevant, at least one high priority measure, regardless
of whether they report via attestation or electronically. This policy
would generally align with the MIPS reporting requirement for providers
using the eCQM collection type for the quality performance category,
which is established in Sec. 414.1335(a)(1). We are also proposing
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 for the quality performance category
in MIPS. 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 order to help states to make incentive payments to Medicaid EPs
by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the
Act, we are proposing 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 Payments on or before December 31,
2021. Similarly, we are proposing 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
Payments on or before December 31, 2021.
We are proposing 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 CMS, through
their State Medicaid HIT Plan (SMHP). Providing states with the
flexibility to set an alternative, earlier last possible date for the
EHR or eCQM reporting period for Medicaid EPs in 2021 would make it
easier for states to ensure that all payments are made by the December
31, 2021 deadline, especially for states whose prepayment process may
take longer than the 61 days provided by an October 31, 2021 deadline.
We expect that this proposal would have only a minimal impact on
states, by requiring minor adjustments to state systems to meet
specifications for the proposed reporting periods, especially because
we are also proposing to permit states to set a different end date for
all EHR and eCQM reporting periods for Medicaid EPs in 2021. As
previously noted, state expenditures for any systems changes required
as a result of this proposal would be eligible for 90 percent enhanced
Federal financial participation.
Finally, we are proposing changes to the EP Meaningful Use
Objective 6, (Coordination of care through patient engagement) Measure
1 (View, Download, or Transmit) and Measure 2 (Secure Electronic
Messaging), and to EP Meaningful Use Objective 8, Measure 2 (Syndromic
surveillance reporting). We are proposing to amend these measures in
response to feedback about the burdens they create for EPs seeking to
demonstrate meaningful use, and about how they may not be fully aligned
with how states and public health agencies collect syndromic
surveillance data. These proposed amendments are expected to reduce
provider burden. Again, we expect that any changes these proposals
might require to state systems would be minimal and that state
expenditures to make any such changes would also be eligible for 90
percent enhanced federal financial participation.
6. Medicare Shared Savings Program
We are proposing certain modifications to our rules regarding
quality measures. Specifically we are proposing: (1) A policy to add
two Patient of Care Experience Survey measures, and (2) a policy to
remove four claims-based outcome measures. Both of these proposed
policies are generally expected to have a minimal impact on affected
ACOs. We do not anticipate any overall impact for these proposed
policies because potential individual ACO impacts are more likely to
offset one another rather than build to a substantial total in terms of
costs or savings.

[[Page 36057]]

7. Physician Self-Referral Law
The physician self-referral law provisions are discussed in section
III.G. of this proposed rule. We are proposing regulatory updates to
implement the provisions of section 50404 of the Bipartisan Budget Act
of 2018 pertaining to the writing and signature requirements in certain
compensation arrangement exceptions to the statute's referral and
billing prohibitions. The proposed regulatory language for the writing
requirement reflects current policy, so we do not anticipate that it
would have an impact. We expect that the proposal regarding temporary
non-compliance with signature arrangements would reduce burden by
giving parties additional time to obtain all required signatures.
8. Changes Due to Updates to the Quality Payment Program
In section III.H. of this proposed rule, we included our proposals
for the Quality Payment Program. In this section of the proposed rule,
we present the overall and incremental impacts to the expected QPs and
associated APM incentive payments. In MIPS, we analyze the total impact
and incremental impact of statutory changes to eligibility from the
Bipartisan Budget Act of 2018 as well as proposals to expand MIPS
eligibility by expanding the MIPS eligible clinician definition and
adding a third criterion for the low-volume threshold and an opt-in
policy option for any clinician that exceeds at least one, but not all,
of the low-volume threshold criteria. Finally, we estimate the payment
impacts by practice size based on various proposals to modify the MIPS
final score, proposals for the performance threshold and additional
performance threshold, and as required by the Bipartisan Budget Act of
2018, the impact of applying the MIPS payment adjustments to covered
professional services (services for which payment is made under, or is
based on,the Physician Fee Schedule and that are furnished by an
eligible clinician) rather than items and services covered under Part
B.
The submission period for the first MIPS performance period ended
in early 2018, however, the final data sets were not available in time
to incorporate into this analysis. If technically feasible, we intend
to use data from the CY 2017 MIPS performance period in the final rule.
a. Estimated Incentive Payments to QPs in Advanced APMs and Other Payer
Advanced APMs
From 2019 through 2024, through the Medicare Option, eligible
clinicians receiving a sufficient portion of Medicare Part B payments
for covered professional services or seeing a sufficient number of
Medicare patients through Advanced APMs as required to become QPs would
receive a lump-sum APM Incentive Payment equal to 5 percent of their
estimated aggregate payment amounts for Medicare covered professional
services in the preceding year. In addition, beginning in payment year
2021, in addition to the Medicare Option, eligible clinicians may
become QPs through the All-Payer Combination Option. The All-Payer
Combination Option will allow eligible clinicians to become QPs by
meeting the QP thresholds through a pair of calculations that assess a
combination of both Medicare Part B covered professional services
furnished through Advanced APMs and services furnished through Other
Payer Advanced APMs.
The APM Incentive Payment is separate from and in addition to the
payment for covered professional services furnished by an eligible
clinician during that year. Eligible clinicians who become QPs for a
year would not need to report to MIPS and would not receive a MIPS
payment adjustment to their Part B physician fee schedule payments.
Eligible clinicians who do not become QPs, but meet a slightly lower
threshold to become Partial QPs for the year, may elect to report to
MIPS and would then be scored under MIPS and receive a MIPS payment
adjustment, but do not receive the APM Incentive Payment. For the 2019
Medicare QP Performance Period, we define Partial QPs to be eligible
clinicians in Advanced APMs who have at least 40 percent, but less than
50 percent, of their payments for Part B covered professional services
through an Advanced APM Entity, or furnish Part B covered professional
services to at least 20 percent, but less than 35 percent, of their
Medicare beneficiaries through an Advanced APM Entity. If the Partial
QP elects to be scored under MIPS, they would be subject to all MIPS
requirements and would receive a MIPS payment adjustment. This
adjustment may be positive, negative or neutral. If an eligible
clinician does not meet either the QP or Partial QP standards, the
eligible clinician would be subject to MIPS, would report to MIPS, and
would receive the corresponding MIPS payment adjustment.
Beginning in 2026, payment rates for services furnished by
clinicians who achieve QP status for a year would be increased each
year by 0.75 percent for the year, while payment rates for services
furnished by clinicians who do not achieve QP status for the year would
be increased by 0.25 percent. In addition, MIPS eligible clinicians
would receive positive, neutral, or negative MIPS payment adjustments
to payment for their Part B physician fee schedule services in a
payment year based on performance during a prior performance period.
Although MACRA amendments established overall payment rate and
procedure parameters until 2026 and beyond, this impact analysis covers
only the third payment year (2021 MIPS payment year) of the Quality
Payment Program in detail.
In section III.H.4.g.(4)(b) of this proposed rule, we propose to
add a third alternative to allow requests for QP determinations at the
TIN level in instances where all clinicians who have reassigned billing
rights under the TIN participate in a single APM Entity. This option
would therefore be available to all TINs participating in Full TIN
APMs, such as the Medicare Shared Savings Program. It would also be
available to any other TIN for whom all clinicians who have reassigned
billing rights to the TIN are participating in a single APM Entity. We
are further proposing that this third alternative will only be
available to eligible clinicians who meet the Medicare threshold at the
APM Entity level; it will not be available for eligible clinicians who
meet the Medicare threshold individually.
In section III.H.4.g.(4)(c)(ii), we also propose to extend the same
weighting methodology to TIN level Medicare Threshold Scores in
situations where a TIN is assessed under the Medicare Option as part of
an APM Entity group, and receives a Medicare Threshold Score at the APM
Entity group level. In this scenario, we believe that the Medicare
portion of the TIN's All-Payer Combination Option Threshold Score
should not be lower than the Medicare Threshold Score that they
received by participating in an APM Entity group (82 FR 53881 through
53882). We note this extension of the weighting methodology would only
apply to a TIN when that TIN represents a subset of the eligible
clinicians in the APM Entity, because when the TIN and the APM Entity
are the same there is no need for this weighted methodology. We propose
to calculate the TIN's QP Threshold Scores both on its own and with
this weighted methodology, and then use the most advantageous score
when making a QP determination. We believe that, as

[[Page 36058]]

it does for QP determinations made at the APM Entity level, this
approach promotes consistency between the Medicare Option and the All-
Payer Combination Option to the extent possible. Additionally, the
proposed application of this weighting approach in the case of a TIN
level QP determination would be consistent with our established policy.
These proposals affect the estimated number of QPs for the 2021
payment year. We estimate that approximately 8,100 additional eligible
clinicians in 8 TINs would become QPs if these policies are finalized
representing TIN level QP determinations under the All-Payer
Combination Option. Therefore, they would be excluded from MIPS, and
qualify for the lump sum incentive payment based on 5 percent of their
Part B allowable charges for covered professional services, which are
estimated to be approximately $545 million in the 2019 performance
year. We also estimate the corresponding increase of the APM incentive
payment of 5 percent of Part B allowed charges for QPs would be
approximately $27 million for the 2021 payment year.
Overall, we estimate that between 160,000 and 215,000 eligible
clinicians would become QPs, therefore be excluded from MIPS, and
qualify for the lump sum incentive payment based on 5 percent of their
Part B allowable charges for covered professional services in the
preceding year, which are estimated to be between approximately $12,000
million and $16,000 million in total for the 2019 performance year. We
estimate that the aggregate total of the APM incentive payment of 5
percent of Part B allowed charges for QPs would be between
approximately $600 and $800 million for the 2021 payment year.
We project the number of eligible clinicians that will be QPs, and
thus excluded from MIPS, using several sources of information. First,
the projections are anchored in the most recently available public
information on Advanced APMs. The projections reflect Advanced APMs
that will be operating during the 2019 QP performance period, as well
as Advanced APMs anticipated to be operational during the 2019 QP
performance period. The projections also reflect an estimated number of
eligible clinicians that would attain QP status through the All-Payer
Combination Option. The following APMs are expected to be Advanced APMs
in performance year 2019, including the Next Generation ACO Model,
Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care
(CEC) Model (Two-Sided Risk Arrangement), Vermont All-Payer ACO
Model,\60\ Comprehensive Care for Joint Replacement Payment Model
(CEHRT Track), Oncology Care Model (Two-Sided Risk Arrangement),
Medicare ACO Track 1+ Model, Bundled Payment for Care Improvement
Advanced, Maryland Total Cost of Care Model (Maryland Care Redesign
Program; Maryland Primary Care Program), and the Shared Savings Program
Tracks 2 and 3. We used the APM Participant Lists (see 81 FR 77444
through 77445 for information on the APM participant lists and QP
determination) on the most recent MDM provider extract for the
Predictive QP determination file for 2018 QP performance period to
estimate QPs for the 2019 QP performance period. We examine the extent
to which Advanced APM participants would meet the QP thresholds of
having at least 50 percent of their Part B covered professional
services or at least 35 percent of their Medicare beneficiaries
furnished Part B covered professional services through the Advanced APM
Entity.
---------------------------------------------------------------------------

\60\ Vermont ACOs will be participating in an Advanced APM
during 2018 through a modified version of the Next Generation ACO
Model. The Vermont Medicare ACO Initiative is expected to be an
Advanced APM beginning in 2019.
---------------------------------------------------------------------------

b. Estimated Number of Clinicians Eligible for MIPS Eligibility
(1) Summary of Proposals Related to MIPS Eligibility and Application of
MIPS Payment Adjustments
We are making three sets of proposed policy changes that would
impact the number of MIPS eligible clinicians starting with CY 2019
MIPS performance period and the CY 2021 MIPS payment year. Two of the
proposed changes affect the low-volume threshold and the third affects
the definition of a MIPS eligible clinician. We briefly describe each
of these changes later in this section.
First, in section III.H.3.c.(2) of this proposed rule, we proposed
changes to our policy to comply with the Bipartisan Budget Act of 2018.
Specifically, we are proposing to update the low-volume threshold
starting with the 2020 MIPS payment year to be based on covered
professional services (services for which payment is made under, or is
based on the Physician Fee Schedule and that are furnished by an
eligible clinician) rather than items and services covered under Part
B, as provided in section 1848(q)(1)(B) as amended by section
51003(a)(1)(A)(i) of the Bipartisan Budget Act of 2018. This proposal
may affect the previously finalized calculation for the low-volume
threshold for certain clinicians because payment for items, such as
Part B drugs, which were previously considered in the low-volume
determination, are now excluded. In addition, section 51003(a)(1)(E) of
the Bipartisan Budget Act of 2018 revised section 1848(q)(6)(E) to
apply the MIPS payment adjustments to covered professional services
rather than to items and services covered under Part B. This change is
effective with the 2019 MIPS payment year. Its effect on the amount of
payment adjustments under MIPS is included in this analysis.
Second, in section III.H.3.a. of this proposed rule, beginning with
the 2021 MIPS payment year, we are proposing to expand the definition
of MIPS eligible clinicians to include physical therapists,
occupational therapists, clinical social workers, and clinical
psychologists. Specifically, we are proposing to define as a MIPS
eligible clinician, as identified by a unique billing TIN and NPI
combination used to assess performance, as any of the following: 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), a physical therapist, an occupational therapist, a clinical
social worker, and a clinical psychologist; and a group that includes
such clinicians.
Third, as discussed in sections III.H.3.c.(4) and III.H.3.c.(5) of
this proposed rule, in addition to the amendments to comply with
Bipartisan Budget Act of 2018, we are proposing to modify our
definition of the low-volume threshold by adding a third criterion (for
``covered professional services''). If this proposal is finalized, the
low-volume threshold would now include a third criterion: Set at 200
covered professional services to Part B-enrolled individuals. Taken
together, if this proposal is finalized, the low-volume threshold would
be as follows: (1) Those with $90,000 or less in allowed charges for
covered professional services; or (2) 200 or fewer Part B-enrolled
individuals who are furnished Medicare physician fee schedule services;
or (3) 200 or fewer covered professional services. The low volume
threshold assessment is applied at the TIN/NPI level for individual
reporting, the TIN level for group reporting, or the APM Entity Level
for reporting under the APM scoring standard. We are further proposing
any clinician who exceeds the low-volume threshold on at least one, but
not all three, low-volume threshold criteria may elect to opt-in to
MIPS to be

[[Page 36059]]

measured on performance, thereby qualifying to receive a positive,
neutral, or negative MIPS payment adjustment based on performance. The
absence of of the opt-in within this cohort means they are not MIPS
eligible clinicians. If a MIPS eligible clinician does not meet at
least one of these low-volume criteria, they are excluded from MIPS.
For purposes of this impact analysis we refer to these revisions to the
low-volume threshold and its application collectively as the ``opt-in
policy''.
We discuss how these three proposed changes impact MIPS eligibility
and payments, later in this section.
(2) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior to Low-Volume Threshold
To estimate the number of clinicians for the CY 2019 performance
period, our scoring model used the CY 2019 MIPS payment year
eligibility file as described in the CY 2017 Quality Payment Program
Final Rule (81 FR 77069 through 77070). We included 1.5 million
clinicians (see Table 96) who had Physician Fee Schedule claims from
September 1, 2015 to August 31, 2016 and included a 60-day claim run-
out. We used data from September 1, 2015 to August 31, 2016 to maximize
the overlap with the performance data in our model.
We assessed covered professional services (services for which
payment is made under, or is based on the Physician Fee Schedule and
that are furnished by an eligible clinician) \61\ to understand the
incremental impact of basing the low-volume threshold on covered
professional services rather than all items and services under Part B.
---------------------------------------------------------------------------

\61\ The date range for these covered professional services is
September 1, 2016 to August 31, 2017.
---------------------------------------------------------------------------

Clinicians are ineligible for MIPS (and are excluded from MIPS
payment adjustment) if they are newly enrolled to Medicare; are QPs;
are partial QPs who elect to not participate in MIPS; are not one of
the clinician types included in the definition for MIPS eligible
clinician; or do not exceed the low-volume threshold. Therefore, we
excluded these clinicians when calculating those clinicians eligible
for MIPS. For our baseline population, we restricted to clinicians who
are 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). For the proposed MIPS eligible population for the CY 2021 MIPS
payment year, we add in clinicians who are physical therapists,
occupational therapists, clinical social workers, and clinical
psychologists.
As noted previously, we excluded QPs from our scoring model, since
these clinicians are not eligible for MIPS. To determine which QPs
should be excluded, we used the APM Participation List for the third
snapshot date of the 2017 QP performance period because these data were
available by TIN and NPI and could be merged into our model. We assumed
that all partial QPs would participate in MIPS and included them in our
scoring model and eligibility counts. The estimated number of QPs
excluded from our model is lower than the projected number of QPs
(160,000 to 215,000) for the 2019 QP performance period due to the
expected growth in APM participation. Due to data limitations, we
cannot identify specific clinicians who may become QPs in the 2019
Medicare QP Performance Period; hence, our model may overestimate the
fraction of clinicians and allowed charges for covered professional
services that will remain subject to MIPS after the exclusions.
We also excluded newly enrolled Medicare clinicians from our model.
To identify newly enrolled Medicare clinicians, we continued the
assumption applied in the CY 2018 Quality Payment Program final rule
that clinicians (NPIs) are newly enrolled if they have Physician Fee
Schedule charges in the eligibility file but no Physician Fee Schedule
charges in 2015. This newly enrolled modeling methodology attempts to
simulate those newly enrolled, but does not exactly match the policies
finalized under Sec. Sec. 414.1305 and 414.1310 which uses information
from the Provider Enrollment, Chain and Ownership System (PECOS and
previous claims submissions).
We also excluded a small percentage of clinicians (20,411) for whom
we have limited performance data. Although these clinicians may in fact
be eligible for MIPS, we did not have sufficient data to estimate
performance.\62\
---------------------------------------------------------------------------

\62\ We excluded clinicians that submitted via measures groups
under the 2016 PQRS, since that data submission mechanism was
eliminated under MIPS, and we did not anticipate being able to
accurately predict performance. Additionally, we also excluded
clinicians in the CPC model if we did not have their quality data.
---------------------------------------------------------------------------

In section III.H.3.j.(4)(d) of the proposed rule, we propose to
waive the payment consequences (positive, negative or neutral
adjustments) of MIPS and to waive the associated MIPS reporting
requirements adopted to implement the payment consequences for certain
participating clinicians in the MAQI Demonstration subject to
conditions outlined in the Demonstration, starting with the 2020 MIPS
payment period. Removing eligible clinicians from MIPS may affect the
payment adjustments for other MIPS eligible clinicians in each year the
waiver is offered. However, we are unable to identify the specific TIN/
NPIs in our model would be affected by this proposal; therefore, we are
unable to account for this proposal in the eligibility or payment
adjustment tables.
(b) Assumptions Related to the Low-Volume Threshold
The low-volume threshold policy may be applied at the individual
(that is, TIN/NPI) or group (that is, TIN or APM entity) levels based
on how data are submitted. If no data are submitted, then the low-
volume threshold is applied at the TIN/NPI level. We also propose that
a clinician or group that exceeds at least one but not all three low-
volume threshold criteria may become MIPS eligible by submitting data
to MIPS and electing to opt-in, thereby getting measured on performance
and receiving a MIPS payment adjustment.
For the purposes of modeling, we made assumptions on group
reporting to apply the low-volume threshold. One extreme and unlikely
assumption is that no practices elect group reporting and the low-
volume threshold would always be applied at the individual level.
Although we believe a scenario in which only these clinicians would
participate as individuals is unlikely, this assumption is important
because it quantifies the minimum number of MIPS eligible clinicians.
For the model, we estimate there are approximately 218,000 clinicians
who would be MIPS eligible because they exceed the low volume threshold
as individuals and are not otherwise excluded. In Table 96, we identify
clinicians under this assumption as having ``required eligibility.''
Based on historic data, we anticipate that group and APM Entities
will submit data to MIPS. Therefore, if we revise our model's group
reporting assumption such that all clinicians that were participating
in ACOs in 2016 (including ACOs participating under the Shared Savings
Program, Pioneer ACO Model, or Next Generation ACO Model) or who
reported to 2016 PQRS as a group would continue to do so in MIPS, then
the MIPS eligible clinician population would increase by almost 390,000
clinicians for a total MIPS eligible population of approximately
608,000. In Table 96, we identify these

[[Page 36060]]

clinicians who do not meet the low-volume threshold individually but
are anticipated to submit to MIPS as a group based on previous
participation in legacy programs as having ``group eligibility.''

Table 96--Description of MIPS Eligibility Status for CY 2021 MIPS Payment Year Using the Proposed Assumptions
***
----------------------------------------------------------------------------------------------------------------
Cumulative
Eligibility status Predicted participation status Number of number of
in MIPS among clinicians * clinicians clinicians
----------------------------------------------------------------------------------------------------------------
Required eligibility (always subject to a MIPS Participate in MIPS............. 186,549 186,549
payment adjustment because individual Do not participate in MIPS...... 31,921 218,470
clinicians exceed the low-volume threshold in
all 3 criteria).
Group eligibility (only subject to payment Submit data as a group.......... 389,670 608,140
adjustment because clinicians' groups exceed
low-volume threshold in all 3 criteria and
submit as a group).
Opt-In eligibility (only subject to a Elect to opt-in and submit data. 42,025 ** 650,165
positive, neutral, or negative adjustment
because the individual or group exceeds the
low-volume threshold in at least 1 criterion
but not all 3, and they elect to opt-in to
MIPS and submit data).
Not MIPS eligible:
Potentially MIPS eligible (not subject to Do not opt-in; or Do not submit 482,574 1,132,739
payment adjustment for non-participation; as a group.
could be eligible for one of two reasons:
(1) Meet group eligibility or (2) opt-in
eligibility criteria).
Below the low-volume threshold (never Not applicable.................. 88,070 1,220,809
subject to payment adjustment; both
individual and group is below all 3 low-
volume threshold criteria).
Excluded for other reasons (Non-eligible Not applicable.................. 302,172 1,522,981
clinician type, newly-enrolled, QP).
----------------------------------------------------------------------------------------------------------------
* Participation in MIPS defined as previously submitting quality or EHR data for PQRS. Our assumptions for group
reporting are based on 2016 PQRS group reporting.
** Estimated MIPS Eligible Population.
*** Facility-based eligible clinicians are not modeled separately in this table and are captured in the
individual eligible category. This table does not consider the impact of the MAQI Demonstration waiver.

To model the proposed opt-in policy, we assumed that 33 percent of
the clinicians who exceed at least one low-volume threshold and
submitted data to 2016 PQRS would elect to opt-in to MIPS. We selected
a random sample of 33 percent of clinicians without accounting for
performance or investment in quality reporting. We believe this
assumption of 33 percent is reasonable because some clinicians may
choose not to submit data due to performance, practice size, or
resources or alternatively, some may submit data, but elect to be a
voluntary reporter and not be subject to a MIPS payment adjustment
based on their performance. We seek comment on these assumptions,
including whether modeling eligibility only among clinicians or groups
who submitted at least 6 quality measures to PQRS would be more
appropriate. This 33 percent participation assumption is identified in
Table 96 as ``Opt-In eligibility''. We estimate an additional 42,000
clinicians would be eligible through this policy for a total MIPS
eligible population of approximately 650,000.
There are approximately 482,000 clinicians who are not MIPS
eligible, but could be if their practice decides to participate. We
describe this group as ``Potentially MIPS eligible.'' This is the
unlikely scenario in which all group practices elect to submit data as
a group and all clinicians that could elect to opt-into MIPS do elect
to opt-in. This assumption is important because it quantifies the
maximum number of MIPS eligible clinicians. When this unlikely scenario
is modeled, we estimate that the MIPS eligible clinician population
could be as high as 1.1 million clinicians.
Finally, there are some clinicians who would not be MIPS eligible
either because they are below the low-volume threshold on all three
criteria (approximately 88,000) or because they are excluded for other
reasons (approximately 302,000).
Since eligibility among some clinicians is contingent on submission
to MIPS, we will not know the exact number of MIPS eligible clinicians
until the submission period for the CY 2019 MIPS performance period is
closed. For this impact analysis, we are using the estimated population
of 650,165 MIPS eligible clinicians described above.
(3) Impact of MIPS Eligibility Proposals
We illustrate in Table 97 how each proposed policy for the CY 2021
payment year affects the estimated number of MIPS eligible clinicians.
In the CY 2018 Quality Payment Program final rule, 604,006 MIPS
eligible clinicians were included in our scoring model (82 FR 53930).
After updating the population to exclude the additional QPs identified
in the 2017 performance period final QP file, the new baseline
population is 591,010. All incremental impact estimates are relative to
this baseline.

[[Page 36061]]

Table 97--Incremental Change Table for 2021 MIPS Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Estimated
number of MIPS effect of
eligible policy changes Estimated % Estimated Part Estimated PFS Estimated %
Policy changes * clinicians on number of change from B amount paid amount paid change in PFS
impacted by MIPS eligible baseline (mil) (mil) from baseline
policy change clinicians
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline: Applying previously finalized policy.......... N/A 591,010 N/A 54,748 45,163 N/A
Policy Change 1: Low-volume threshold (LVT) -1,173 589,837 -0.2 N/A 45,101 -0.1
determination based on covered professional services
(as required by Bipartisan Budget Act of 2018).........
Policy Change 2: Expansion of eligible clinician types 18,303 608,140 2.9 N/A 45,831 1.5
to include physical therapists, occupational
therapists, clinical social workers, and clinical
psychologists based with policy change 1...............
Policy Change 3: Cumulative change of Opt-in Policy with 42,025 650,165 10.0 N/A 47,401 5.0
policy changes 1 and 2.................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* This table does not consider the impact of the MAQI Demonstration waiver.

First, as shown in Table 97, the first row shows the effect of
changing the application of the MIPS payment adjustments, as required
by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply
them to covered professional services (services for which payment is
made under, or is based on, the Medicare Physician Fee Schedule and are
furnished by an eligible clinician) rather than to items and services
covered under Part B. As shown, the baseline amount paid for Part B is
$54.7 billion, compared with $45.1 billion in covered professional
services, which is a difference of almost $10 billion. Under this
change, the payment adjustments, beginning in the 2019 MIPS payment
year, will only be applied to covered professional services.
In Table 97, under the first policy change, basing the low-volume
threshold on covered professional services (services provided under the
physician fee schedule rather than items and services covered under
Part B) has minimal impact in terms of clinicians (less than half of
one percent decrease).
When the second policy change, to expand the definition of MIPS
eligible clinician types, was added to the first policy change, the
total effect is small. The change in the potential MIPS eligible
clinician population increased by less than 3 percent and the amount
paid in the Physician Fee Schedule increased by 1.5 percent.
When the third policy change, which implements the opt-in policy,
is added to the other two policies, the estimated number of MIPS
eligible clinicians increases by 10.0 percent. The estimated increase
in the amount paid in the Physician Fee Schedule is 5.0 percent.
c. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
In sections III.H.3.h., III.H.3.i. and III.H.3.j. of this proposed
rule, we are making several proposals which impact the measures and
activities that impact the performance category scores, final score
calculation, and the MIPS payment adjustment. We discuss these
proposals in more detail in section VII.F.8.c.(2) as we describe our
methodology to estimate MIPS payments for the 2021 MIPS payment year.
We note that many of the MIPS policies from the CY 2018 Quality Payment
Program final rule were only defined for the 2018 MIPS performance
period and 2020 MIPS payment year (including the performance threshold,
the additional performance threshold, the policy for redistributing the
weights of the performance categories, and many scoring policies for
the quality performance category) which precludes us from developing a
baseline for the 2019 MIPS performance period and 2021 MIPS payment
year if there were no new regulatory action. Therefore, our impact
analysis looks at the total effect of the proposed MIPS policy changes
on the MIPS final score and payment adjustment for CY 2019 MIPS
performance period/CY 2021 MIPS payment year.
The payment impact for an eligible clinician in MIPS is based on
their final score, which is a value determined by their performance in
the four MIPS performance categories: Quality, cost, improvement
activities, and Promoting Interoperability.
The performance and participation data submitted for the 2017 MIPS
performance period were not available in time to estimate the final
score and the projected payment adjustments for MIPS eligible
clinicians in this proposed rule. Therefore, as discussed in section
VII.F.8. of this proposed rule, we used the most recently available
data from historic programs. We will use MIPS performance data for the
final rule should that data become available.
The estimated payment impacts presented in this proposed rule
reflect averages by practice size based on Medicare utilization. The
payment impact for a MIPS eligible clinician could vary from the
average and would depend on the combination of services that the MIPS
eligible clinician furnishes. The average percentage change in total
revenues would be less than the impact displayed here because MIPS
eligible clinicians generally furnish services to both Medicare and
non-Medicare patients; this program does not impact payment from non-
Medicare patients. In addition, MIPS eligible clinicians may receive
Medicare revenues for services under other Medicare payment systems,
such as the Medicare Federally Qualified Health Center Prospective
Payment System or Medicare Advantage that would not be affected by MIPS
payment adjustment factors.
(2) Methodology To Assess Impact
To estimate participation in MIPS for the CY 2019 Quality Payment
Program for this proposed rule, we used data

[[Page 36062]]

from the 2016 Physician Quality Reporting System (PQRS) and the
Medicare and Medicaid EHR Incentive Programs. Our scoring model
includes the 650,165 estimated number of MIPS eligible clinicians as
described in section VII.F.8.b of this proposed rule.
To estimate the impact of MIPS on eligible clinicians, we used
recently available data, including 2015 and 2016 PQRS data, 2015 and
2016 CAHPS for PQRS data, 2016 Quality and Resource Use Reports (QRUR)
and 2018 Value Modifier (VM) data, 2016 Medicare and Medicaid EHR
Incentive Program data, data prepared to support the 2017 performance
period initial determination of clinician and special status
eligibility (available via the NPI lookup on qpp.cms.gov) \63\, the
2017 published MIPS measure benchmarks, the APM Participation List for
the third snapshot date of the 2017 QP performance period to identify
QP clinicians, and other available data to model the scoring provisions
described in this regulation. We calculated a hypothetical final score
for each MIPS eligible clinician based on quality, cost, Promoting
Interoperability, and improvement activities performance categories.
Because we lack detailed performance information for virtual groups, we
are unable to assess performance for virtual groups as an entity.
---------------------------------------------------------------------------

\63\ The time period for this eligibility file (September 1,
2015 to August 31, 2016) maximizes the overlap with the performance
data in our model.
---------------------------------------------------------------------------

(a) Methodology To Estimate the Quality Performance Category Score
We estimated the quality performance category score using measures
submitted to PQRS for the 2016 performance period, the 2016 CAHPS for
PQRS data, and the all-cause hospital readmissions measure from the
2016 QRUR/2018 VM analytic file. For quality measures collected via
claims, eCQMs, MIPS CQM, QCDR, and CMS-approved survey vendor
collection types, we applied the published benchmarks developed for the
2018 MIPS performance period. For quality measures collected and
submitted via the CMS Web Interface, we applied the published
benchmarks developed for the 2016/2017 reporting years for the Shared
Savings Program where available, and did not calculate scores for
measures for which Shared Savings Program benchmarks did not exist. For
the all-cause hospital readmission measure, we used available published
benchmark for CY 2017 MIPS performance period which is the most recent
public benchmark available.
We assigned measure achievement points as finalized in the CY 2017
and CY 2018 Quality Payment Program final rules (81 FR 77282 and 82 FR
53718) and as discussed in section III.H.3.i.(1)(b)(iii) of this
proposed rule. As proposed in III.H.3.i.(1)(b)(iii)(A) of this proposed
rule, we would continue to apply the 3-point floor for measures that
cannot be reliably scored against a baseline benchmark in the 2019 MIPS
performance period.
In section III.H.3.h.(2)(b)(iii) of this proposed rule, we propose
to remove many measures that were previously able to be reported in
PQRS and in previous MIPS performance periods. For our estimates, we
assumed that clinicians who reported claims, eCQM, MIPS CQM and QCDR
measures that are proposed to be removed would find alternate measures;
therefore, we assigned points to these measures and included them in
our scoring model. For CY 2019, we maintained the policies for scoring
measures that do not meet the quality category requirements (case
minimum, benchmark, and data completeness) as described in the CY 2018
Quality Payment Program final rule (82 FR 53727 through 53730). As
finalized in the CY 2018 Quality Payment Program final rule, we also
applied a 7-point cap for measures that are topped out for two or more
years (82 FR 53726 through 53727).
In section III.H.3.h.(2)(a)(iii)(A)(bb) of this proposed rule, we
propose to remove several Web Interface measures. For that collection
type, which has a standard set of measures, we estimated performance on
the measures that we propose to continue.
As proposed in sections III.H.3.i.(1)(b)(ix) and (x) of this
proposed rule, we maintained the cap on bonus points for high-priority
measures and end-to-end electronic bonus points at 10 percent of the
denominator and, beginning with the 2019 MIPS performance period,
discontinue high priority bonus points for CMS Web Interface Reporters.
Because we are not able to use MIPS performance data in our models at
this time, we continued our assumption in the CY 2018 Quality Payment
Program final rule to assign the end-to-end electronic bonus: 1 point
for every submitted eCQM and for each measure submitted via CMS Web
Interface if the group indicated that they submitted using their EHR
with a cap of 10 percent of the total possible measure achievement
points. To be consistent with our small practice bonus proposal in
section III.H.3.i.(1)(b)(viii) of this proposed rule, we added 3
measure achievement points to the quality performance category score
for small practices that had a quality performance category score
greater than 0 points.
As finalized in the CY 2018 Quality Payment Program final rule (82
FR 53625 through 52626) and further discussed in III.H.3.h.(2)(a)(iii)
of this proposed rule, we are allowing MIPS eligible clinicians and
groups to submit data collected via multiple collection types within a
performance category beginning with the 2019 performance period. The
requirements for the performance categories remain the same regardless
of the number of collection types used. We do not apply the validation
process that is discussed in section III.H.3.i.(1)(b)(vii) of this
proposed rule.
To estimate the impact of improvement for the quality performance
category, we estimated a quality performance category percent score
using 2015 and 2016 PQRS data, 2015 and 2016 CAHPS for PQRS data, and
2015 and 2016 QRUR data. For eligible clinicians with an estimated
quality performance category score less than or equal to a 30 percent
score in the previous year, we compared 2019 performance to an assumed
2018 quality score of 30 percent for their improvement score as
described in III.H.3.i.(1)(b)(xiii) of this proposed rule.
Due to data limitations, we are unable to model all the policies
proposed in this rule. We are not able to incorporate the policy to
reduce the denominator for the quality performance category score by 10
points for groups that registered for CAHPS for MIPS but were unable to
report due to insufficient sample size as discussed in section
III.H.3.i.(1)(b)(iii)(B) of this proposed rule. We also did not apply
the proposed scoring policy for measures that are significantly
impacted by clinical guideline or other changes discussed in section
III.H.3.i.(1)(b)(vi) of this proposed rule.
Our model applied the MIPS APM scoring standards proposed in
section III.H.3.h.(6) of this proposed rule to quality data from MIPS
eligible clinicians that participated in the Shared Savings Program,
the Pioneer ACO Model, and the Next Generation ACO Model in 2016.
(b) Methodology To Estimate the Cost Performance Category Score
In section III.H.3.h.(3)(b) of this proposed rule, we propose to
add 8 episode-based measures. For the episode-based measures, we used
the proposed episode specifications discussed in section
III.H.3.h.(3)(b) of

[[Page 36063]]

this proposed rule and claims data from June 2016 through May 2017. We
estimated the cost performance category score using the total per
capita cost measure (TCPC) and Medicare Spending Per Beneficiary (MSPB)
measures from the value modifier (VM) program, as that is the most
recently available data, and the 8 newly developed episode-cost
measures prepared for MIPS. The values of the 2 VM measures are those
computed for the 2018 VM using data from calendar year 2016. Cost
measure scores were used only when the associated case size met or
exceeded the previously finalized or newly proposed case minimum: 20
for the TCPC measure, 35 for MSPB, 10 for procedural episodes, and 20
for acute medical inpatient medical condition episodes. The VM measures
are computed for the TIN; thus, each VM measure score was assigned to
each MIPS eligible clinician in the TIN regardless of whether they
submit as an individual or as a group. The episode-based measures are
computed for both the TIN/NPI and the TIN; these measure scores were
assigned to clinicians based on the clinician's submission status,
which in this modeling was based on the quality domain. For clinicians
participating as individuals, the TIN/NPI level score was used if
available and if the minimum case size was met. For clinicians
participating as groups, the TIN level score was used, if available,
and if the minimum case size was met. For clinicians with no measures
meeting the minimum case requirement, we did not estimate a score for
the cost performance category, and the weight for the cost performance
category was reassigned to the quality performance category. The raw
cost measure scores were mapped to scores on the scale of 1-10, using
benchmarks developed based on all measures that met the case minimum
during the relevant performance period. For the episode-based cost
measures, separate benchmarks were developed for TIN/NPI level scores
and TIN level scores. For each clinician, a cost performance category
score was computed as the average of the measure scores available for
the clinician, as described previously.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
As discussed in section III.H.3.i.(1)(d) of this proposed rule, we
are implementing facility-based measurement for the 2019 MIPS
performance period. In facility-based measurement, we determine the
eligible clinician's MIPS score based on Hospital VBP performance score
for eligible clinicians or groups who primarily furnish services within
a hospital. Given that we are not requiring eligible clinicians to opt-
in to facility-based measurement, it is possible that a MIPS an
eligible clinician or a group is eligible for facility-based
measurement and participates in MIPS as an individual or a group. In
these cases, we use the higher combined quality and cost performance
category scores.
Data was not available to attribute specific hospital VBP
performance score to MIPS eligible clinicians, hence we made the
following assumptions. For MIPS eligible clinicians and groups who are
eligible for facility-based measurement and who previously submitted
quality data to PQRS (which we used to estimate the quality performance
category score), we did not estimate a facility-based score. We instead
calculated a MIPS quality and cost score based on the available quality
measures and cost data. Some clinicians who previously submitted PQRS
quality data may receive a higher score through facility-based
measurement, but we are unable to identify those clinicians due to data
limitations and therefore believe the score based on their submitted
data is more likely to reflect their performance.
For MIPS eligible clinicians that did not previously submit data to
PQRS and were eligible for facility-based measurement, we estimated a
facility-based score by taking the median MIPS quality and cost
performance score. We believe it is important to develop an estimate
for this cohort because we would have otherwise assigned this group a
quality performance category percent score of zero percent which we
believe would have underestimated their MIPS final score. Given the
data limitations in assigning a specific hospital score to a clinician,
we selected the median MIPS quality and cost performance scores as that
represents the quality cost performance category scores that a
clinician working in a hospital with median performance would receive.
(d) Methodology To Estimate the Promoting Interoperability Performance
Category Score
As discussed in section III.H.3.h.(5)(d)(ii) of this proposed rule,
we are proposing to modify the measures and scoring for the Promoting
Interoperability performance category score. We proposed to simplify
scoring by eliminating the concept of base and performance scores and
focusing on a smaller set of measures which are scored on performance.
We estimated Promoting Interoperability performance category scores
using data from the CY 2016 Medicare and Medicaid EHR Incentive
Programs. Because the EHR Incentive Programs data are based on
attestation at the NPI level, the Promoting Interoperability
performance category scores are based on the individual level
regardless of whether the clinician was part of a group submission or
part of an APM entity. We did not calculate a group or APM score for
the Promoting Interoperability performance category.
Although we had attestation information for the Medicare EHR
Incentive Program, we did not have detailed attestation information for
the Medicaid EHR Incentive Program. Therefore, we used incentive
payments (excluding incentive payments for the adoption,
implementation, and upgrade of CEHRT) as a proxy for attestation for
Medicaid EHR Incentive Program participants. To proxy performance, we
used the 2016 Medicare EHR Incentive Program data and estimated the
median score among Medicare eligible clinicians submitting data for
four Promoting Interoperability measures that had data available in the
2016 Medicare EHR Incentive Program. For the e-Prescribing objective,
we used the e-Prescribing measure and did not assume any bonus points
for the Query of Prescription Drug Monitoring Program (PDMP) or the
Verify Opioid Treatment Agreement measures. For the Health Information
Exchange objective, we used the Health Information Exchange measure to
proxy performance for the two proposed measures in the objective:
Support Electronic Referral Loops by Sending Health Information and
Support Electronic Referral Loops by Receiving and Incorporating Health
Information. For the Provider to Patient Exchange objective, we used
the Provide Patient Access to View, Download, or Transmit measure to
estimate performance for the proposed Provide Patients Electronic
Access to Their Health Information measure. For the Public Health and
Clinical Data Exchange objective, we assumed that clinicians would meet
the proposed reporting requirements and would receive 10 points for the
objective. We combined the median scores for each measure, which led to
an estimated MIPS Promoting Interoperability performance category
median score of 73 points. This estimated MIPS Promoting
Interoperability performance category score was applied to all eligible
clinicians that attested to participating in the EHR Incentive Programs
in our scoring model. The selection of a 73 point Promoting
Interoperability

[[Page 36064]]

performance category score is lower than the maximum score of 100
percentage points. Our rationale for selecting a 73 point performance
category score is that the proposed revision of the Promoting
Interoperability criteria would lead to lower scores due to fewer
clinicians being able to report measures and achieve maximum
performance for the Health Information Exchange Promoting
Interoperability Objective. We do not expect all MIPS eligible
clinicians participating in MIPS to receive a score of 73 for the
Promoting Interoperability performance category; however, we believe
this is a reasonable approach given the unavailability of MIPS CY 2017
performance period data in time for this proposed rule. We anticipate
using actual MIPS performance period data in the final rule if
available in time. We expect that a large proportion of eligible
clinicians who submit EHR Incentive Program data will likely achieve a
Promoting Interoperability performance category score of 73 points.
For those eligible clinicians who did not attest in either the 2016
Medicare or Medicaid EHR Incentive Program, we evaluated whether the
MIPS eligible clinician could have their Promoting Interoperability
performance category score reweighted. As finalized in the CY 2017 (81
FR 77069 through 77070) and CY 2018 (82 FR 53625 through 52626) Quality
Payment Program final rules, the Promoting Interoperability performance
category weight is set equal to 0 percent, and the weight is
redistributed to the quality or improvement activities performance
category for non-patient facing MIPS eligible clinicians, hospital-
based MIPS eligible clinicians, ASC-based MIPS eligible clinicians, or
those who request and are approved for a significant hardship or other
type of exception, including a significant hardship exception for small
practices, or clinicians who are granted an exception based on
decertified EHR technology (82 FR 53780 through 53786). We are also
proposing in section III.H.3.h.(5)(h) of this proposed rule to continue
automatic reweighting for NPs, PAs, CNSs and CRNAs and to add an
automatic reweighting policy for physical therapists, occupational
therapist, clinical social workers, and clinical psychologists, which
we have incorporated into our model. We used the non-patient facing and
hospital-based indicators and specialty and small practice indicators
as calculated in the initial MIPS eligibility run for the 2017 MIPS
performance period (81 FR 77069 through 77070). For significant
hardship exceptions, we used the 2016 final approved significant
hardship file from the Medicare EHR Incentive Program. If a MIPS
eligible clinician did not attest and did not qualify for a reweighting
of their Promoting Interoperability performance category, the Promoting
Interoperability performance category score was set to 0 percent.
(e) Methodology To Estimate the Improvement Activities Performance
Category Score
We modeled the improvement activities performance category score
based on 2016 APM participation and historic participation in 2016 PQRS
and 2016 Medicare and Medicaid EHR Incentive Programs. We are not
proposing any policy changes that impact scoring for the improvement
activities performance category. Our model identified 2016 participants
in the Shared Savings Program, Next Generation ACO Model and the
Pioneer ACO Model, and assigned them an improvement activity score of
100 percent, consistent with our policy to assign an improvement
activities score of 100 percent to ACO participants who were not
excluded due to being QPs. Due to limitations in 2016 data, our model
was not able to include 2016 participants in APMs other than the Shared
Savings Program, the Pioneer ACO Model, and the Next Generation ACO
Model.
Clinicians and groups not participating in a MIPS APM were assigned
an improvement activities performance category score based on their
performance in the quality and Promoting Interoperability performance
categories. MIPS eligible clinicians whose 2016 PQRS data meets all the
MIPS quality submission criteria (for example, submitting 6 measures
with data completeness, including one outcome or high priority
measures) and had an estimated Promoting Interoperability performance
category score of 73 percent (if Promoting Interoperability is
applicable to them) were assigned an improvement activities performance
category score of 100 percent. MIPS eligible clinicians who did not
participate in 2016 PQRS or the 2016 Medicare or Medicaid EHR Incentive
Program (if it was applicable), received an improvement activity
performance category score of 0 percent, with the rationale that these
clinicians may be less likely to participate in MIPS if they have not
previously participated in other programs.
For the remaining MIPS eligible clinicians not assigned an
improvement activities performance category score of 0 or 100 percent
in our model, we assigned a score that corresponds to submitting one
medium-weighted improvement activity. The MIPS eligible clinicians
assigned an improvement activity performance category score
corresponding to a medium-weighted activity include (a) those who
submitted some quality measures under the 2016 PQRS but did not meet
the MIPS quality submission criteria or (b) those who did not submit
any quality data under the 2016 PQRS who attested under the Medicare
EHR Incentive program or received an incentive payment (excluding adopt
implement and upgrade payments) from the Medicaid EHR Incentive
Program. We assumed that these clinicians may be likely to partially,
but not fully, participate in the improvement activities category. For
non-patient facing clinicians, clinicians in a small practice
(consisting of 15 or fewer professionals), clinicians in practices
located in a rural area, clinicians in a geographic healthcare
professional shortage area (HPSA) practice or any combination thereof,
the medium weighted improvement activity was assigned one-half of the
total possible improvement activities performance category score (20
out of a 40 possible points or 50 percent). The remaining MIPS eligible
clinicians who were not assigned an improvement activities performance
category score of 0, 50, or 100 percentage points were assigned a score
corresponding to one medium-weighted activity (10 out of 40 possible
points or 25 percent). The policy finalized in the CY 2018 Quality
Payment Program final rule at Sec. 414.1380(b)(3), and discussed in
section III.H.3.i.(1)(e)(i)(D) of this proposed rule, states that a
MIPS eligible clinician or group in a practice that is certified as a
patient-centered medical home or comparable specialty practice, as
determined by the Secretary, receives full credit for performance on
the improvement activities performance category. In other words, MIPS
eligible clinicians in a patient centered medical home or comparable
specialty societies would qualify for an improvement activities
performance category score of 100 percent. However, due to lack of
available data, we were not able to identify MIPS eligible clinicians
in patient-centered medical homes or comparable specialty societies in
our scoring model.
(f) Methodology To Estimate the Complex Patient Bonus
In sections III.H.3.i.(2)(a)(ii) of this proposed rule, we are
proposing to continue the complex patient bonus. Consistent with the
policy to define complex patients as those with high

[[Page 36065]]

medical risk or with dual eligibility, our scoring model calculated the
bonus by using the average Hierarchical Condition Category (HCC) risk
score, as well as the MIPS eligible clinician's patients dual eligible
proportion calculated for each NPI in the 2016 Physician and Other
Supplier Public Use File. The dual eligible proportion for each MIPS
eligible clinician was multiplied by 5. We also generated a group
average HCC risk score by weighing the scores for individual clinicians
in each group by the number of beneficiaries they have seen. We
generated group dual eligible proportions using the weighted average
dual eligible patient ratio for all MIPS eligible clinicians in the
groups, which was then multiplied by 5. The complex patient bonus was
calculated by adding together the average HCC risk score and the
percent of dual eligible patients multiplied by 5, with a 5-point cap.
(g) Methodology To Estimate the Final Score
As proposed in sections III.H.3.h.(2)(a)(ii), III.H.3.h.(3)(a),
III.H.3.h.(4)(a), III.H.3.h.(5)(d)(i) and summarized in section
III.H.3.i.(2)(b) of this proposed rule, our model assigns a final score
for each TIN/NPI by multiplying each performance category score by the
corresponding performance category weight, adding the products
together, multiplying the sum by 100 points, and adding the complex
patient bonus. After adding any applicable bonus for complex patients,
we reset any final scores that exceeded 100 points equal to 100 points.
For MIPS eligible clinicians who were assigned a weight of zero percent
for the Promoting Interoperability due to a significant hardship or
other type of exception, the weight for the Promoting Interoperability
performance category was redistributed to the quality performance
category. For MIPS eligible clinicians who did not have a cost
performance category score, the weight for the cost performance
category was redistributed to the quality performance category. In our
scoring model, we did not address scenarios where a zero percent weight
would be assigned to the quality performance category or the
improvement activities performance category.
(h) Methodology To Estimate the MIPS Payment Adjustment
As described in section III.H.3.j.(1) of this proposed rule, we
applied a hierarchy to determine which final score should be used for
the payment adjustment for each MIPS eligible clinician when more than
one final score is available (for example if a clinician qualifies for
a score for an APM entity and a group score, we select the APM entity
score).
We then calculated the parameters of an exchange function in
accordance with the statutory requirements related to the linear
sliding scale, budget neutrality, minimum and maximum adjustment
percentages and aggregate exceptional performance payment adjustment
amounts (as finalized under Sec. 414.1405), using a performance
threshold of 30 points and an exceptional performance threshold of 80
points (as proposed in sections III.H.3.j.(2) and III.H.3.j.(3) of this
proposed rule). We used these resulting parameters to estimate the
positive or negative MIPS payment adjustment based on the estimated
final score and the Medicare Physician Fee Schedule paid amount. We
considered other performance thresholds which are discussed in section
VII.G. of this proposed rule.
In the CY 2017 (81 FR 77522) and CY 2018 (82 FR 53932) Quality
Payment Program final rules, we applied a 90 percent participation
assumption for clinicians in all practice sizes and an alternative of
80 percent participation because participation in legacy programs
(PQRS, the VM, and Medicare/Medicaid EHR Incentive programs) may
underestimate our expected participation in MIPS. Given the proposed
changes in eligibility and the proposed opt-in policy in section
VII.F.8.b. of this proposed rule, we believe that the percentage of
eligible clinicians participating in MIPS will increase, so we did not
apply a participation assumption.
(3) Impact of Payments by Practice Size
Using the assumptions provided above, our model estimates that $372
million would be redistributed through budget neutrality and that the
maximum positive payment adjustments are 5.6 percent after considering
the MIPS payment adjustment and the additional MIPS payment adjustment
for exceptional performance.
Table 98 shows the impact of the payments by practice size and
whether the clinicians submitted data to either PQRS or the Medicare or
Medicaid EHR Incentive program. We continue to monitor the effects of
participation, particularly for clinicians in small practices;
therefore we present the summary results stratified by whether a
clinician is expected to submit data to MIPS because they had submitted
data to either PQRS or the Medicare or Medicaid EHR Incentive Programs,
or if the clinician is facility-based. Clinicians in small practices
(1-15 clinicians) that we estimate would participate in MIPS perform as
well as or better than mid-size practices. Overall, clinicians in small
practices participating in MIPS would receive a 1.9 percent increase in
their paid amount, which is similar to the payment amount received by
the total MIPS eligible clinician population. After considering the
positive adjustments and subtracting the negative adjustments, eligible
clinicians in small practices would have an increase in funds which is
consistent with all MIPS eligible clinicians. Table 98 also shows that
96.1 percent of MIPS eligible clinicians that participate in MIPS are
expected to receive positive or neutral payment adjustments. Among
those who we estimate would not submit data to MIPS, 88 percent are in
small practices (28,096 out of 31,921 clinicians). To address
participation concerns, we have policies targeted towards small
practices including technical assistance and special scoring policies
to minimize burden and facilitate small practice participation in MIPS
or APMs. Again, we plan to update these numbers in the final rule when
we have actual MIPS participation for the 2017 MIPS performance period.

[[Page 36066]]

Table 98--MIPS Estimated Payment Year 2021 Impact on Total Estimated Paid Amount by Participation Status and Practice Size *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined impact
Percent eligible of negative and
Percent eligible clinicians with a positive
Number of MIPS clinicians with positive Percent eligible adjustments and
Practice size * eligible positive or adjustment with clinicians with exceptional
clinicians neutral payment exceptional negative payment performance
adjustment payment adjustment payment as
adjustment percent of paid
amount **
--------------------------------------------------------------------------------------------------------------------------------------------------------
Among those submitting data ***
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15................................................. 110,284 92.5 46.4 7.5 1.9
(2) 16-24................................................ 27,798 89.1 35.5 10.9 1.3
(3) 25-99................................................ 128,988 93.2 44.2 6.8 1.5
(4) 100+................................................. 351,174 98.8 65.3 1.2 2.5
----------------------------------------------------------------------------------------------
Overall.............................................. 618,244 96.1 56.2 3.9 2.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Among those not submitting data
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15................................................. 28,096 0.0 0.0 100.0 -6.1
(2) 16-24................................................ 1,282 0.0 0.0 100.0 -6.0
(3) 25-99................................................ 1,871 0.0 0.0 100.0 -5.9
(4) 100+................................................. 672 0.0 0.0 100.0 -6.1
----------------------------------------------------------------------------------------------
Overall.............................................. 31,921 0.0 0.0 100.0 -6.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Practice size is the total number of TIN/NPIs in a TIN.
** 2014, 2015 and 2016 data used to estimate 2019 payment adjustments. Payments estimated using 2015 and 2016 dollars.
*** Includes facility-based clinicians whose quality data is submitted through hospital programs.

d. Potential Costs of Compliance With the Promoting Interoperability
and Improvement Activities Performance Categories for Eligible
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability
Performance Category
In section III.H.3.h.(5)(c) of this proposed rule, we discuss the
requirement to use EHR technology certified to the 2015 Edition
beginning with the 2019 MIPS performance period for the Promoting
Interoperability performance category. As discussed in section V.B.3 of
this proposed rule, we assume a slight decrease in overall information
collection burden costs for the Promoting Interoperability performance
category related to having fewer measures to submit.
With respect to any costs unrelated to data submission, although
this proposal would require some investment in systems updates, our
policy prior to this regulation as reflected in Sec. 414.1305, is that
2015 Edition CEHRT will be required beginning with the 2019 MIPS
performance period/2021 MIPS payment year (82 FR 53671). Therefore, we
do not anticipate any additional costs due to this regulation.
(2) Potential Costs of Compliance With Improvement Activities
Performance Category
Under the policies established in the CY 2017 Quality Payment
Program final rule, the costs for complying with the improvement
activities performance category requirements could have potentially led
to higher expenses for MIPS eligible clinicians. Costs per full-time
equivalent primary care clinician for improvement activities will vary
across practices, including for some activities or certified patient-
centered medical home practices, in incremental costs per encounter,
and in estimated costs per (patient) member per month.
Costs for compliance with previously finalized policies may vary
based on panel size (number of patients assigned to each care team) and
location of practice among other variables. For example, Magill (2015)
conducted a study of certified patient-centered medical home practices
in two states.\64\ That study found that costs associated with a full-
time equivalent primary care clinician, who was associated with
certified patient-centered medical home practices, varied across
practices. Specifically, the study found an average cost of $7,691 per
month in Utah practices, and an average of $9,658 in Colorado
practices. Consequently, incremental costs per encounter were $32.71
for certified patient-centered medical home practices in Utah and
$36.68 in Colorado (Magill, 2015). The study also found that the
average estimated cost per patient member, per month, for an assumed
panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado.
However, given the lack of comprehensive historical data for
improvement activities, we are unable to quantify those costs in detail
at this time. The findings presented in these papers have not changed.
Due to the unavailability of MIPS CY 2017 performance period data in
time for this proposed rule, we do not know which improvement
activities clinicians have elected. As a result, it is difficult to
quantify the costs, cost savings, and benefits associated
implementation of improvement activities. We will report the costs and
benefits of implementing the improvement activities for the final rule
if the performance data are received in time.
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\64\ Magill et al. ``The Cost of Sustaining a Patient-Centered
Medical Home: Experience from 2 States.'' Annals of Family Medicine,
2015; 13:429-435.
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We have considered factors that also contribute to the difficulty
of identifying compliance costs for the improvement activities
performance category in the CY 2018 Quality Payment Program final rule
(82 FR 53845).

[[Page 36067]]

Although we are unable to quantify the compliance costs of the
improvement activities performance category, we do believe that because
we are proposing an opt-in policy (as described in section II.C.2.c of
this proposed rule), we would add approximately 87,000 additional
clinicians to the MIPS eligible clinicians. In the section V.B.4 of
this proposed rule, we have assumed that those who have elected to opt-
in have already been voluntary reporters in MIPS and would not have
additional compliance costs as a result of this regulation. Thus, we
believe the overall potential cost of compliance would not increase
because of this proposed rule.
Further, we anticipate that the vast majority of clinicians
submitting improvement activities data to comply with existing MIPS
policies could continue to submit the same activities under the
policies established in this proposed rule. Previously finalized
improvement activities continue to apply for the current and future
years unless otherwise modified per rule-making (82 FR 54175); we are
only proposing modifications to a few activities and proposing to
remove one improvement activity in this proposed rule. We refer readers
to Table H in the Appendix of the CY 2017 Quality Payment Program final
rule (81 FR 77177 through 77199) and Tables F and G in the Appendix of
the CY 2018 Quality Payment Program final rule (82 FR 54175 through
54229) for our previously finalized 112 improvement activities
established in the Improvement Activities Inventory. In section
III.H.3.h.(4)(d)(ii) of this proposed rule, we are proposing 6 new
improvement activities, 5 modifications and 1 removal of an existing
activity.
Similarly, we believe that third parties who submit data on behalf
of clinicians who prepared to submit data in the transition year will
not incur additional costs as a result of this proposed rule. We
request comments that provide additional information that would enable
us to quantify the costs, costs savings, and benefits associated with
implementation of improvement activities in the inventory.
In section III.H.3.h.(4)(e) of this proposed rule, we discuss how
eligible clinicians can participate in the CMS study on burdens
associated with reporting quality measures for each MIPS performance
period. Eligible clinicians who are interested in participating can
sign up and an adequate sample size is then selected by CMS from these
potential participants. In the CY 2018 Quality Payment Program final
rule, the sample size for the CY 2018 performance period was set at a
minimum of 102 MIPS eligible clinicians (81 FR 77196). Each study
participant is required to complete a survey prior to submitting MIPS
data and another survey after submitting MIPS data. In section
III.H.3.h.(4)(e) of this proposed rule, for the CY 2019 performance
period, we are proposing an increase to the sample size to a minimum of
200 MIPS eligible clinicians. However, we are proposing to make the
focus group a requirement only for a selected subset of the study
participants beginning with the CY 2019 performance period and future
years. Thus, out of the minimum of 200 study participants as proposed
above, we would select a minimum number of 100 clinicians to
participate in focus groups, this selection will be done primarily by
purposive sampling, and may apply random sampling only in a situation
when we have to pick between same/similar participants. Completing each
survey is estimated to require approximately 15 minutes; therefore, the
annual hourly burden per participant is approximately 30 minutes. The
annual hourly burden associated with the increase in sample size from
102 to 200 is estimated to be 49 hours (98 clinician's x 0.5 hours).
The total estimated annual cost burden is estimated to be $10,116
($206.44/hour x 49 hours). While the sample size of the study is
increasing, we are not proposing a change to the sample size of MIPS
eligible clinicians participating in the focus group, so no burden is
estimated for participating in that activity.
e. Assumptions & Limitations
We would like to note several limitations to our estimates of MIPS
eligible clinicians' eligibility and participation, negative MIPS
payment adjustments, and positive payment adjustments for the 2021 MIPS
payment year. We based our analyses on the data prepared to support the
2017 performance period initial determination of clinician and special
status eligibility (available via the NPI lookup on qpp.cms.gov),\65\
participant lists using the APM Participation List for the third
snapshot date of the 2017 QP performance period and historical PQRS
data, the Medicare/Medicaid EHR Incentive Programs data, including
CAHPS for PQRS, and the VM. No scoring model, including the one
presented in this proposed rule, can fully reflect MIPS eligible
clinicians' behavioral responses to MIPS because there is no substitute
for actual data. The scoring model assumes that quality measures or the
Medicare/Medicaid EHR Incentive Programs data submitted and the
distribution of scores on those measures would be similar under the
Quality Payment Program in the 2021 MIPS payment year as they were
under the 2016 PQRS program. We will update results with the analysis
of actual MIPS performance data if it is available in time for the
publication of the final rule. The scoring model does not reflect the
growth in Advanced APM participation between 2018 and 2019 (Quality
Payment Program Years 2 and 3) because that data is not available at
the detailed level needed for our scoring analysis.
---------------------------------------------------------------------------

\65\ The time period for this eligibility file (September 1,
2015 to August 31, 2016) maximizes the overlap with the performance
data in our model.
---------------------------------------------------------------------------

In our MIPS eligible clinician assumptions, we assumed that 33
percent of the opt-in eligible clinicians that participated in PQRS
would elect to opt-in to the MIPS program. It is difficult to predict
whether clinicians will elect to opt-in to participate in MIPS with the
proposed policy.
There are additional limitations to our estimates: (1) We only
estimated the potential impact of facility-based scoring for MIPS
eligible clinicians that are eligible for facility-based measurement
and would have a quality performance category score of zero from
failure to submit quality data; (2) because we used historic data, we
assumed participation in the Promoting Interoperability and Improvement
Activities performance categories would be similar to prior years in
other relevant programs; (3) we assumed performance for those two
categories based on population norm and not individual performance; (4)
we anticipate the scores for these performance categories may differ
once we receive actual MIPS performance data, and (5) to the extent
that there are year-to-year changes in the data submission, volume and
mix of services provided by MIPS eligible clinicians, the actual impact
on total Medicare revenues will be different from those shown in Table
98. Due to the limitations described, there is considerable uncertainty
around our estimates that is difficult to quantify in detail.

G. Alternatives Considered

This proposed rule contains a range of policies, including some
provisions related to specific statutory provisions. The preceding
preamble provides descriptions of the statutory provisions that are
addressed, identifies those policies when discretion has been

[[Page 36068]]

exercised, presents rationale for our proposed policies and, where
relevant, alternatives that were considered. For purposes of the
payment impact on PFS services of the policies contained in this
proposed rule, we presented the estimated impact on total allowed
charges by specialty. The alternatives we considered, as discussed in
the preceding preamble sections, would result in different payment
rates, and therefore, result in different estimates than those shown in
Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by
Specialty).
For purposes of the payment impact on the Quality Payment Program,
we view the performance threshold and the additional performance
threshold to be the critical factors affecting the distribution of
payment adjustments under the Quality Payment Program, and the
alternatives that we considered focus on those policies. We ran
estimates with performance thresholds of 25 and 35 as an alternative to
30, so that we could estimate a more moderate increase of the
performance threshold and a more aggressive increase. We also ran the
models with an additional performance threshold of 70 instead of the
proposed 80 points. This alternative would maintain the additional
performance threshold that was in years 2 and 3. In the model with a
performance threshold of 30 and an additional performance threshold of
70, we estimate that $372 million will be redistributed through budget
neutrality, and there will be a maximum payment adjustment of 4.3
percent and 8.7 percent of MIPS eligible clinicians will receive a
negative payment adjustment after considering the MIPS payment
adjustment and the additional MIPS payment adjustment for exceptional
performance. In the model with a performance threshold of 25 and an
additional performance threshold of 80, we estimate that $340 million
will be redistributed through budget neutrality, and there will be a
maximum payment adjustment of 5.4 percent and 6.9 percent of MIPS
eligible clinicians will receive a negative payment adjustment after
considering the MIPS payment adjustment and the additional MIPS payment
adjustment for exceptional performance. In the model with a performance
threshold of 35 and an additional performance threshold of 80, we
estimate that $408 million will be redistributed through budget
neutrality, and there will be a maximum payment adjustment of 5.8
percent and 10.9 percent of MIPS eligible clinicians will receive a
negative payment adjustment after considering the MIPS payment
adjustment and the additional MIPS payment adjustment for exceptional
performance.
We ran estimates on the potential change in population if we set
the third low volume threshold set at 100 as an alternative to 200
covered services. We estimate that 50,260 clinicians would elect to
opt-in for a total population of 658,400. We also estimated the effect
of applying the opt-in policy without adding the third low-volume
threshold criterion. We estimate that 19,621 clinicians would elect to
opt-in for a total population of 627,761.

H. Impact on Beneficiaries

There are a number of changes in this proposed rule that would have
an effect on beneficiaries. In general, we believe that many of these
changes, including those intended to improve accuracy in payment
through regular updates to the inputs used to calculate payments under
the PFS, would have a positive impact and improve the quality and value
of care provided to Medicare providers and beneficiaries.
1. Evaluation and Management Documentation
For example, we estimate that the evaluation and management (E/M)
visit documentation changes proposed in section II.I of this proposed
rule may significantly reduce the amount of time practitioners spend
documenting these services. While little research is available on
exactly how much time physicians and non-physician practitioners spend
specifically documenting E/M visits, according to one recent estimate,
primary care physicians spend on average, 84 minutes or 1.4 hours per
day (24 percent of the time that they spend working within an EHR)
documenting progress notes.\66\ Another study found that primary care
physicians spend an average of 2.1 hours per day writing progress notes
(both in-clinic and remote access).\67\ Assuming an average of 20
patient visits per day, one E/M visit per patient, and using the higher
figure of 2.1 hours per day spent documenting these visits, we estimate
that documentation of an average outpatient/office E/M visit takes 6.3
minutes.\68\
---------------------------------------------------------------------------

\66\ Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the
EHR: Primary care physician workload assessment using EHR event log
data and time-motion observations. Ann Fam Med. 2017;15:427-33.
\67\ Tai-Seale M, Olson CW, Li J, et al. Electronic health
record logs indicate that physicians split time evenly between
seeing patients and desktop medicine. Health Aff (Milwood).
2017;36:655-62.
\68\ 20 patient visits per day based on the average number
reported in the Physicians Foundation 2016 Survey of America's
Physicians, available online at https://physiciansfoundation.org/wp-content/uploads/2018/01/Biennial_Physician_Survey_2016.pdf.
---------------------------------------------------------------------------

We believe that our proposals to reduce redundancy in visit
documentation, to allow auxiliary staff and the beneficiary to enter
certain information in the medical record that would be verified but
not required to be re-documented by the billing practitioner, to allow
the choice of visit level and documentation based on MDM or time as
alternatives to the current framework, and to require only minimum
documentation (the amount required for a level 2 visit) for all visits
except level 1 visits may reduce the documentation time by one quarter
of the current time for the average office/outpatient visit. Under this
assumption, these proposals would save clinicians approximately 1.6
minutes of time per office/outpatient E/M visit billed to Medicare. For
a full-time practitioner whose panel of patients is 40 percent Medicare
(60 percent other payers), this would translate to approximately 51
hours saved per year.\69\
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\69\ Forty percent of 20 total patients per day = 8 Medicare
vists per day. (Eight visits per day) * (1.6 minutes per visit) *
(240 days per year) = 51.2 hours.
---------------------------------------------------------------------------

We note that stakeholders have emphasized to us in public comments
that whatever reductions may be made to the E/M documentation
guidelines for purposes of Medicare payment, physicians and non-
physician practitioners will still need to document substantial
information in their progress notes for clinical, legal, operational,
quality reporting and other purposes, as well as potentially for other
payers. Furthermore, there may be a ramp-up period for physicians and
non-physician practitioners to implement the proposed documentation
changes in their clinical workflow and EHR such that the effects of
mitigating documentation burden may not be immediately realized.
Accordingly, we believe the total amount of time practitioners spend on
E/M visit documentation may remain high, despite the time savings that
we estimate in this section could result from our E/M documentation
proposals. These and all other improvements to payment accuracy that we
are proposing for CY 2019 are described in greater detail in section
II.I of this proposed rule. We welcome public comments on our
assumptions for the estimated reduction in documentation burden related
to these proposals.

[[Page 36069]]

2. Modernizing Medicare Physician Payment by Recognizing Communication
Technology-Based Services
As noted in section II.D. of this proposed rule, 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.
The use of communication technology-based services will provide new
options for physicians to treat patients. These services could help to
avoid unnecessary office visits, could consist of services that are
already occurring but are not being separately paid, or could
constitute new services. Medicare would pay $14 per visit in the first
year for these communication technology-based services, compared with
$92 per visit for the corresponding established patient visits.
Practitioners have a choice of when to use the communication
technology-based services. Because of the low payment rate relative to
that for an office visit, we are assuming that usage of these services
will be relatively low. In addition, we expect that the number of new
or newly billable visits and subsequent treatments will outweigh the
number of times that communication technology-based services will be
used instead of more costly services. As a result, we expect that the
financial impact of paying for the communication technology-based
services will be an increase in Medicare costs. We estimate that usage
of these services will result in fewer than 1 million visits in the
first year but will eventually result in more than 19 million visits
per year, ultimately increasing payments under the PFS by about 0.2
percent. In order to maintain budget neutrality in setting proposed
rates for CY 2019, we assumed the number of services that would result
in a 0.2 percent reduction in the proposed conversion factor.
As with all estimates, and particularly those for new benefits,
this outcome is highly uncertain. Because communication technology-
based services is a new area for healthcare coverage, the available
information on which to base estimates is limited and is usually not
directly applicable, particularly to a new Medicare benefit. The cost
and utilization estimates are based on Medicare claims data together
with a study published in Health Affairs,\70\ which examined the cost
and utilization of telehealth in the private sector. While this study
was the most applicable for an estimate, we note that the results from
this program may be different because Medicare experience may differ
from private sector behavior and because the study was limited to acute
respiratory infection visits. We also note that the study cites the use
of direct-to-consumer telehealth companies, many of which provide
access to care 24 hours per day, 7 days per week, 365 days per year,
whereas the service described by HCPCS code GVCI1 is limited to only
established patients.
---------------------------------------------------------------------------

\70\ Ashwood, J.S. (2017 March) Direct-To-Consumer Telehealth
May Increase Access To Care But Does Not Decrease Spending. Health
Affairs.
---------------------------------------------------------------------------

We are also proposing to make separate payment for these services
when furnished by RHCs and FQHCs. A potential estimate of utilization
and overall cost of these services by RHCs and FQHCs could be derived
by comparing their use of chronic care management and other care
management services to the same services furnished by practitioners
paid under the PFS, since these care management services are also
separately billable and do not take place in-person. Based on this
comparison, and without considering potential variables and issues
specific to these services, the impact of this proposal would be less
than $1 million in additional Medicare spending in the first year and
could eventually result in up to $20 million in spending per year in
future years. These estimates are uncertain and could change after
further consideration of the potential variables and issues specific to
these services.
3. Outpatient Therapy Services
As noted in section II.M. of this proposed rule, we are also
proposing to end functional reporting for outpatient therapy services
as part of our burden reduction efforts in response to the RFI on CMS
Flexibilities and Efficiencies that was issued in the CY 2018 PFS
proposed rule (82 FR 34172 through 34173). Our functional reporting
system currently requires therapy practitioners and providers to
report, whenever functional reporting is required, non-payable HCPCS G-
codes and modifiers--typically in pairs--to convey information about
the beneficiary's functional limitation category and functional status
throughout the PT, OT, or SLP episode of care. In addition, each time
functional reporting is required on the claim, the therapy provider
must also document the functional reporting G-codes and their modifiers
in the medical record. In this proposed rule, we are proposing to
eliminate this requirement that therapy practitioners and providers
report HCPCS G-codes and modifiers or document in the medical record to
convey functional reporting status for PT, OT or SLP episode of care.
In order to quantify the amount of burden reduction, we decided to
estimate the total amount of time that therapy practitioners spend
doing functional reporting. To do this, we first looked at our data for
CY 2017 for professional claims by the type of plan of care reported
primarily by therapists in private practice (TPPs), including physical
therapists, occupational therapists, and speech-language pathologists.
We found that the overall utilization of the 42 functional reporting
HCPCS G-codes totaled 15,456,421 single units, or 7,728,211 pairs.
We then considered the time, on average, it might take to report on
the claim and document in the medical record each pair of HCPCS G-
codes. We note this includes the time it takes to make the initial
determination of the HCPCS G-code functional limitation category, as
well as the time needed to make each initial and/or subsequent
assignments for the applicable severity modifiers in order to define
the patient's functional status. We then made the assumption that it
would take between 1 minute and 1.5 minutes, on average, to report the
HCPCS G-code and modifier pair each time functional reporting is
required. Using the total utilization of G-code pairs and the range of
1 minute to 1.5 minutes, we calculated that TPPs would have saved
between 128,804 and 193,206 hours (or 7,728,211 to 11,592,317 minutes)
collectively in CY 2017 if the functional reporting requirements had
not been in place. We believe this is a reasonable projection for the
potential savings to TPPs, physicians and certain nonphysician
practitioners in future years if we finalize our proposal to end
functional reporting effective January 1, 2019.
Because therapy services are also furnished by providers of
outpatient therapy services such as hospitals, SNFs and rehabilitation
agencies that submit institutional claims, typically representing a
greater amount of expenditures than practitioners submitting
professional claims, we calculated additional savings for these
providers using the same time assumptions of 1 to 1.5 minutes to report
the HCPCS G-code and modifier

[[Page 36070]]

pair each time functional reporting is required. Our 2017 data show a
total utilization of the functional reporting HCPCS G-codes is
29,053,921 single units, or 14,526,961 pairs, indicating that therapy
providers would have collectively saved between 242,116 to 363,174
hours (or 14,526,961 to 21,790,442 minutes) for CY 2017 if the
functional reporting requirements had not been effective during that
year.
4. Physician Supervision of Diagnostic Imaging Procedures
We believe that the proposed changes to the physician supervision
requirements for RAs furnishing diagnostic imaging procedures in this
proposed rule as described in section II.F. of this proposed rule may
significantly reduce burden for physicians. While approximately 215,000
diagnostic imaging services per year are currently performed that
require personal supervision, we are not able to determine the number
of these services that are performed by an RA due to limitations in the
claims data. As a result, we are not able to quantify the amount of
time potentially saved by physicians and practitioners under our
proposal to now require direct supervision of diagnostic imaging
procedures done by RAs. That said, stakeholders representing the
practitioner community have indicated that changing the required
supervision level for RAs will result in a redistribution of workload
from radiologists to RAs, potentially resulting in improved practice
efficiency and patient satisfaction. Stakeholders have stated that
practitioners that utilize RAs have experienced improvements in
practice efficiency, as use of RAs allows radiologists more time for
professional services such as interpretation of images, and these
practitioners cite greater flexibility that results in reduced wait
times. Furthermore, stakeholders contend that the Medicare supervision
requirements currently create disincentives to use RAs, as
practitioners cannot make full use of them for Medicare patients, and
this proposed change to the supervision requirement would allow RAs to
be more fully utilized. For these reasons, we believe our proposal will
contribute to burden reduction for physicians and practitioners
providing diagnostic imaging procedures for Medicare beneficiaries.
5. Beneficiary Liability
Many proposed policy changes could result in a change in
beneficiary liability as it relates to coinsurance (which is 20 percent
of the fee schedule amount, if applicable for the particular provision
after the beneficiary has met the deductible). To illustrate this
point, as shown in our public use file Impact on Payment for Selected
Procedures available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2018
national payment amount in the nonfacility setting for CPT code 99203
(Office/outpatient visit, new) was $109.80, which means that in CY
2018, a beneficiary would be responsible for 20 percent of this amount,
or $21.96. Based on this proposed rule, using the CY 2019 CF, the CY
2019 national payment amount in the nonfacility setting for CPT code
99203, as shown in the Impact on Payment for Selected Procedures table,
is $134.45, which means that, in CY 2019, the final beneficiary
coinsurance for this service would be $26.89.

H. Impact on Beneficiaries in the Quality Payment Program

There are several changes in this rule that would have an effect on
beneficiaries. In general, we believe that many of these changes,
including those intended to improve accuracy in payment through regular
updates to the inputs used to calculate payments under the Physician
Fee Schedule, would have a positive impact and improve the quality and
value of care provided to Medicare beneficiaries. For example, several
of the new proposed measures include patient-reported outcomes, which
may be used to help patients make more informed decisions about
treatment options. Patient-reported outcome measures provide
information on a patient's health status from the patient's point of
view and may also provide valuable insights on factors such as quality
of life, functional status, and overall disease experience, which may
not otherwise be available through routine clinical data collection.
Patient-reported outcomes are factors frequently of interest to
patients when making decisions about treatment.\71\ Further, the
proposed policy changes in the Promoting Interoperability performance
category shifts the focus to the interoperable, seamless exchange of
electronic information. With the requirement that program participants
use 2015 Edition CEHRT, the interoperable exchange of patient health
information should be easier because the certification criteria are
designed to facilitate information exchange. In combination with the
newly proposed Promoting Interoperability measure to receive and
incorporate health information, beneficiaries should begin to
experience improved care coordination and care transitions because
clinicians have improved access to the beneficiaries' health
information across the spectrum of care.
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\71\ Institute of Medicine. 2013. Delivering High-Quality Cancer
Care: Charting a New Course for a System in Crisis. Washington, DC:
The National Academies Press. https://doi.org/10.17226/18359.
---------------------------------------------------------------------------

Impact on Other Health Care Programs and Providers
We estimate that CY 2019 Quality Payment Program will not have a
significant economic effect on eligible clinicians and groups and
believe that MIPS policies, along with increasing participation in APMs
over time may succeed in improving quality and reducing costs. This may
in turn result in beneficial effects on both patients and some
clinicians, and we intend to continue focusing on clinician-driven,
patient-centered care.

I. Estimating Regulatory Familiarization Costs

If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this rule, we should
estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's rule will be the number of reviewers of this
rule. We acknowledge that this assumption may understate or overstate
the costs of reviewing this rule. It is possible that not all
commenters reviewed last year's rule in detail, and it is also possible
that some reviewers chose not to comment on the rule. For these reasons
we thought that the number of past commenters would be a fair estimate
of the number of reviewers of this rule. We welcomed any comments on
the approach in estimating the number of entities which will review
this rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this rule, and
therefore for the purposes of our estimate we assume that each reviewer
reads approximately 50 percent of the rule. We sought comments on this
assumption.
Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $107.38 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average
reading speed, we estimate that it would take approximately 8.0 hours

[[Page 36071]]

for the staff to review half of this rule. For each facility that
reviews the rule, the estimated cost is $859.04 (8.0 hours x $107.38).
Therefore, we estimated that the total cost of reviewing this
regulation is $5,105,275 ($859.04 x 5,943 reviewers).

J. Accounting Statement

As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 98 and 99
(Accounting Statements), we have prepared an accounting statement. This
estimate includes growth in incurred benefits from CY 2018 to CY 2019
based on the FY 2019 President's Budget baseline.

Table 99--Accounting Statement: Classification of Estimated Expenditures
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers. Estimated increase in
expenditures of $0.3 billion
for PFS CF update.
From Whom To Whom?..................... Federal Government to
physicians, other
practitioners and providers
and suppliers who receive
payment under Medicare.
------------------------------------------------------------------------

Table 100--Accounting Statement: Classification of Estimated Costs,
Transfer, and Savings
------------------------------------------------------------------------
Category Transfer
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers $0.1 billion.
of beneficiary cost coinsurance.
From Whom to Whom?..................... Beneficiaries to Federal
Government.
------------------------------------------------------------------------

L. Conclusion

The proposed rule proposes to modify the consultation requirement
in Sec. 414.94(j); therefore, this analysis estimates the impact of
consultations by ordering professionals. We previously estimated a
total annual burden of $275,139,000, but estimate this modification
would decrease burden to an annual cost of $122,508,675. We also
estimate the broader impacts of this requirement, assuming that some
ordering professionals will purchase a qualified CDSM with one-time
maximum cost estimate and annual training and maintenance estimate
maximum of $394,770,600 annually for 5 years. Still, other ordering
professionals who do not currently use an EHR system and are subject to
this program may purchase an EHR system. For all ordering professionals
subject to this program and estimated to not currently use EHR, an
estimated annualized cost maximum of $192,641,671.84 over 5 years would
be incurred for all such ordering professionals to obtain an integrated
qualified CDSM. We believe that in the beginning of this program, it
may take longer for a Medicare beneficiary to obtain an order for an
advanced diagnostic imaging service. As a result of this assumption, we
have calculated an estimated impact to Medicare beneficiaries of
$68,001,000 per year with a potential offset of $34,000,500 annually if
process efficiencies are developed to integrate consultation with a
qualified CDSM into the existing workflow of ordering an advanced
diagnostic imaging service. This proposed rule discusses the use of G-
codes and modifiers to report AUC consultation information on claims
and an alternative reporting method using a UCI. Those estimated
impacts are discussed previously. We estimate the impact of
transmitting such additional information on an order for an advanced
diagnostic imaging service to be $111,884,000 annually. Finally, we
measure the estimated impact on furnishing professionals and facilities
of the proposed expansion of the definition of applicable setting in
Sec. 414.94(b) to be the one-time update to modify billing systems at
cost of $1,740,640,000. Although the consultation and reporting
requirements of this program are effective beginning January 1, 2020
with an Educational and Operations Testing Period, we attempt in this
analysis to identify areas of potential qualitative benefits to both
Medicare beneficiaries and the Medicare program.
The analysis in the previous sections, together with the remainder
of this preamble, provided an initial Regulatory Flexibility Analysis.
The previous analysis, together with the preceding portion of this
preamble, provides a Regulatory Impact Analysis. In accordance with the
provisions of Executive Order 12866, this regulation was reviewed by
the Office of Management and Budget.

List of Subjects

42 CFR Part 405

Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.

42 CFR Part 411

Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

Administrative practice and procedure, Biologics, Drugs, Health
facilities, Health professions, Kidney diseases, Medicare, Reporting
and recordkeeping requirements.

42 CFR Part 415

Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 495

Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Health professions, Health records,
Medicaid, Medicare, Penalties, Reporting and recordkeeping
requirements.

For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 continues to read as follows:

[[Page 36072]]

Authority: Secs. 205(a), 1102, 1142, 1861, 1862(a), 1869, 1871,
1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C.
405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk,
1395rr, and 1395ww(k)), and sec. 353 of the Public Health Service
Act (42 U.S.C. 263a).

0
2. Section 405.2401 is amended in paragraph (b) by--
0
a. Revising the introductory text of the definition of ``Federally
qualified health center''; and
0
b. Revising the definition of ``Secretary''.
The revisions read as follows:

Sec. 405.2401 Scope and definitions.

* * * * *
(b) * * *
Federally qualified health center (FQHC) means an entity that has
entered into an agreement with CMS to meet Medicare program
requirements under Sec. 405.2434 and--
* * * * *
Secretary means the Secretary of Health and Human Services or his
or her delegate.
* * * * *
0
3. Section 405.2464 is amended by--
0
a. Revising paragraphs (a)(1), (b) heading, and (b)(1);
0
b. Redesignating paragraphs (c) and (d) as paragraphs (d) and (e),
respectively;
0
c. Adding a new paragraph (c); and
0
d. Revising newly redesignated paragraphs (d) and (e).
The revisions and additions read as follows:

Sec. 405.2464 Payment rate.

(a) Payment rate for RHCs that are authorized to bill under the
reasonable cost system. (1) Except as specified in paragraphs (d) and
(e) of this section, an RHC that is authorized to bill under the
reasonable cost system is paid an all-inclusive rate that is determined
by the MAC at the beginning of the cost reporting period.
* * * * *
(b) Payment rate for FQHCs that are authorized to bill under the
prospective payment system. (1) Except as specified in paragraphs (d)
and (e) of this section, a per diem rate is calculated by CMS by
dividing total FQHC costs by total FQHC daily encounters to establish
an average per diem cost.
* * * * *
(c) Payment for FQHCs that are authorized to bill as grandfathered
tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per
visit rate for Medicare as set annually by the Indian Health Service
for each beneficiary visit for covered services. There are no
adjustments to this rate.
(d) Payment for care management services. For chronic care
management services furnished between January 1, 2016 and December 31,
2017, payment to RHCs and FQHCs is at the physician fee schedule
national non-facility payment rate. For care management services
furnished on or after January 1, 2018, payment to RHCs and FQHCs is at
the rate set for each of the RHC and FQHC payment codes for care
management services.
(e) Payment for communication technology-based and remote
evaluation services. For communication technology-based and remote
evaluation services furnished on or after January 1, 2019, payment to
RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment
codes for communication technology-based and remote evaluation
services.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
4. The authority citation for part 410 continues to read as follows:

Authority: Secs. 1102, 1834, 1871, 1881, and 1893 of the Social
Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).

0
5. Section 410.32 is amended by adding paragraph (b)(4) to read as
follows:

Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests: Conditions.

* * * * *
(b) * * *
(4) Supervision requirement for RRA or RPA. Diagnostic tests that
are performed by a registered radiologist assistant (RRA) who is
certified and registered by the American Registry of Radiologic
Technologists or a radiology practitioner assistant (RPA) who is
certified by the Certification Board for Radiology Practitioner
Assistants, require only a direct level of physician supervision, as
permitted by state law and state scope of practice regulations.
* * * * *

Sec. 410.59 [Amended]

0
6. Section 410.59 is amended by removing paragraph (a)(4).

Sec. 410.60 [Amended]

0
7. Section 410.60 is amended by removing paragraph (a)(4).
0
8. Section 410.61 is amended by revising paragraph (c) to read as
follows:

Sec. 410.61 Plan of treatment requirements for outpatient
rehabilitation services.

* * * * *
(c) Content of the plan. The plan prescribes the type, amount,
frequency, and duration of the physical therapy, occupational therapy,
or speech-language pathology services to be furnished to the
individual, and indicates the diagnosis and anticipated goals.
* * * * *

Sec. 410.62 [Amended]

0
9. Section 410.62 is amended by removing paragraph (a)(4).
0
10. Section 410.78 is amended by--
0
a. Adding paragraphs (b)(3)(ix), (x), and (xi);
0
b. Revising paragraph (b)(4) introductory text, and
0
c. Adding paragraph (b)(4)(iv).
The additions and revision read as follows:

Sec. 410.78 Telehealth services.

* * * * *
(b) * * *
(3) * * *
(ix) A renal dialysis facility (only for purposes of the home
dialysis monthly ESRD-related clinical assessment in section
1881(b)(3)(B) of the Act).
(x) The home of an individual (only for purposes of the home
dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of
the Act).
(xi) A mobile stroke unit (only for purposes of diagnosis,
evaluation, or treatment of symptoms of an acute stroke provided in
accordance with section 1834(m)(6) of the Act).
(4) Except as provided in paragraph (b)(4)(iv) of this section,
originating sites must be:
* * * * *
(iv) The geographic requirements specified in paragraph (b)(4) of
this section do not apply to the following telehealth services:
(A) Home dialysis monthly ESRD-related clinical assessment services
furnished on or after January 1, 2019, at an originating site described
in paragraph (b)(3)(vi), (ix) or (x) of this section, in accordance
with section 1881(b)(3)(B) of the Act; and
(B) Services furnished on or after January 1, 2019, for purposes of
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
* * * * *

Sec. 410.105 [Amended]

0
11. Section 410.105 is amended--
0
a. In paragraph (c)(1)(ii) by removing the phrase ``that are consistent
with the patient function reporting on the claims for services''; and
0
b. By removing paragraph (d).

[[Page 36073]]

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT

0
12. The authority citation for part 411 continues to read as follows:

Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).

0
13. Section 411.353 is amended by--
0
a. Revising paragraph (g)(1); and
0
b. Removing and reserving paragraph (g)(2).
The revision reads as follows:

Sec. 411.353 Prohibition on certain referrals by physicians and
limitations on billing.

* * * * *
(g) * * *
(1) An entity may submit a claim or bill and payment may be made to
an entity that submits a claim or bill for a designated health service
if--
(i) The compensation arrangement between the entity and the
referring physician fully complies with an applicable exception in this
subpart except with respect to the signature requirement of the
exception; and
(ii) The parties obtain the required signature(s) within 90
consecutive calendar days immediately following the date on which the
compensation arrangement became noncompliant and the compensation
arrangement otherwise complies with all criteria of the applicable
exception.
(2) [Reserved]
0
14. Section 411.354 is amended by adding paragraph (e) to read as
follows:

Sec. 411.354 Financial relationship, compensation, and ownership or
investment interest.

* * * * *
(e) Special rule on compensation arrangements--(1) Application.
This paragraph (e) applies only to compensation arrangements as defined
in section 1877 of the Act and this subpart.
(2) Writing requirement. In the case of any requirement in this
subpart for a compensation arrangement to be in writing, such
requirement may be satisfied by a collection of documents, including
contemporaneous documents evidencing the course of conduct between the
parties.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
15. The authority citation for part 414 continues to read as follows:

Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

0
16. Section 414.65 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Removing paragraph (a)(1);
0
c. Redesignating paragraphs (a)(2) and (3) as paragraphs (a)(1) and
(2), respectively; and
0
d. Adding paragraph (b)(3).
The revision and addition reads as follows:

Sec. 414.65 Payment for telehealth services.

(a) Professional service. The Medicare payment amount for
telehealth services described under Sec. 410.78 of this chapter is
equal to the current fee schedule amount applicable for the service of
the physician or practitioner, subject to paragraphs (a)(1) and (2) of
this section, but must be made in accordance with the following
limitations:
* * * * *
(b) * * *
(3) No originating site facility fee payment is made to an
originating site described in Sec. 410.78(b)(3)(x) or (xi) of this
chapter; or to an originating site for services furnished under the
exception at Sec. 410.78(b)(4)(iv)(A) or (B) of this chapter.
* * * * *
0
17. Section 414.94 is amended:
0
a. In paragraph (b), revising the definition of ``Applicable setting'';
and
0
b. Revising paragraphs (i)(3), (j), and (k) introductory text.
The revisions read as follows:

Sec. 414.94 Appropriate use criteria for advanced diagnostic imaging
services.

* * * * *
(b) * * *
Applicable setting means a physician's office, a hospital
outpatient department (including an emergency department), an
ambulatory surgical center, an independent diagnostic testing facility,
and any other provider-led outpatient setting determined appropriate by
the Secretary.
* * * * *
(i) * * *
(3) Significant hardships for ordering professionals who experience
any of the following:
(i) Insufficient internet access.
(ii) EHR or CDSM vendor issues.
(iii) Extreme and uncontrollable circumstances.
(j) Consulting. (1) Ordering Professionals and, when performed as
an ``incident to'' service, auxiliary personnel 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.
(2) The AUC consultation specified in this paragraph (j) may be
performed by auxiliary personnel (as defined in Sec. 410.26(a)(1) of
this chapter) under the direction of, and incident to, the ordering
professional's services.
(k) Reporting. The following information must be reported on
Medicare claims for advanced diagnostic imaging services furnished in
an applicable setting, paid for under an applicable payment system
defined in paragraph (b) of this section, and ordered on or after
January 1, 2020.
* * * * *
0
18. Section 414.502 is amended in the definition of ``Applicable
laboratory'' by revising paragraph (3) introductory text to read as
follows:

Sec. 414.502 Definitions.

* * * * *
Applicable laboratory * * *
(3) In a data collection period, receives more than 50 percent of
its Medicare revenues, which includes fee-for-service payments under
Medicare Parts A and B, prescription drug payments under Medicare Part
D, and any associated Medicare beneficiary deductible or coinsurance
for services furnished during the data collection period from one or a
combination of the following sources:
* * * * *

Sec. 414.610 [Amended]

0
19. Section 414.610 is amended:
0
a. In paragraphs (c)(1)(ii) introductory text and (c)(5)(ii) by
removing the date ``December 31, 2017'' and adding in its place the
date ``December 31, 2022''; and
0
b. By revising paragraph (c)(8).
The revision reads as follows:

Sec. 414.610 Basis of payment.

* * * * *
(c) * * *
(8) Transport of an individual with end-stage renal disease for
renal dialysis services. For ambulance services furnished during the
period October 1, 2013 through September 30, 2018, 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)) furnished other than on an
emergency basis by a provider of services or a renal dialysis facility,
the fee schedule amount otherwise applicable (both base rate and
mileage) is reduced by 10 percent. For such services furnished on or
after October 1, 2018, the fee schedule amount

[[Page 36074]]

otherwise applicable (both base rate and mileage) is reduced by 23
percent.
* * * * *

Sec. 414.904 [Amended]

0
20. Section 414.904 is amended in paragraph (e)(4) by removing the
phrase ``acquisition cost or the applicable Medicare Part B drug
payment'' and adding in its place the phrase ``acquisition cost or the
Medicare Part B drug payment''.
0
21. Section 414.1305 is amended by--
0
a. Revising the definition of ``Ambulatory Surgical Center (ASC)-based
MIPS eligible clinician'';
0
b. Adding in alphabetical order definitions for ``Collection type'' and
``Health IT vendor'';
0
c. Revising the definitions of ``High priority measure'', ``Hospital-
based MIPS eligible clinician'', and ``Low volume threshold'';
0
d. Adding in alphabetical order a definition for ``MIPS determination
period'';
0
e. Revising the definitions of ``MIPS eligible clinician'', ``Non-
patient facing MIPS eligible clinician'', ``Qualified Clinical Data
Registry (QCDR)'', ``Qualifying APM Participant (QP)'', and ``Small
practice''; and
0
f. Adding in alphabetical order a definition for ``Submission type'',
``Submitter type'', and ``Third party intermediary''.
The revisions and additions read as follows:

Sec. 414.1305 Definitions.

* * * * *
Ambulatory Surgical Center (ASC)-based MIPS eligible clinician
means:
(1) For the 2019 and 2020 MIPS payment years, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the Place of
Service (POS) codes used in the HIPAA standard transaction as an
ambulatory surgical center setting based on claims for a period prior
to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the POS) codes
used in the HIPAA standard transaction as an ambulatory surgical center
setting based on claims for the MIPS determination period.
* * * * *
Collection type means a set of quality measures with comparable
specifications and data completeness criteria, including, as
applicable: Electronic clinical quality measures (eCQMs); MIPS Clinical
Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B claims
measures, the CMS Web Interface measures, the CAHPS for MIPS survey,
and administrative claims measures.
* * * * *
Health IT vendor means an entity that supports the health IT
requirements on behalf of a MIPS eligible clinician (including
obtaining data from a MIPS eligible clinician's CEHRT).
* * * * *
High priority measure means:
(1) For the 2019 and 2020 MIPS payment years, an outcome (including
intermediate-outcome and patient-reported outcome), appropriate use,
patient safety, efficiency, patient experience, or care coordination
quality measure.
(2) Beginning with the 2021 MIPS payment year, an outcome
(including intermediate-outcome and patient-reported outcome),
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure.
Hospital-based MIPS eligible clinician means:
(1) For the 2019 and 2020 MIPS payment years, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the Place of
Service (POS) codes used in the HIPAA standard transaction as an
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a
period prior to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the POS codes
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, off campus outpatient hospital, or
emergency room setting based on claims for the MIPS determination
period.
* * * * *
Low-volume threshold means:
(1) For the 2019 MIPS payment year, the low-volume threshold that
applies to an individual eligible clinician or group that, during the
low-volume threshold determination period described in paragraph (4) of
this definition, has Medicare Part B allowed charges less than or equal
to $30,000 or provides care for 100 or fewer Medicare Part B-enrolled
individuals.
(2) For the 2020 MIPS payment year, the low-volume threshold that
applies to an individual eligible clinician or group that, during the
low-volume threshold determination period described in paragraph (4) of
this definition, has allowed charges for covered professional services
less than or equal to $90,000 or furnishes covered professional
services to 200 or fewer Medicare Part B-enrolled individuals.
(3) Beginning with the 2021 MIPS payment year, the low-volume
threshold that applies to an individual eligible clinician or group
that, during the MIPS determination period, has allowed charges for
covered professional services less than or equal to $90,000, furnishes
covered professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals.
(4) For the 2019 and 2020 MIPS payment years, the low-volume
threshold determination period is a 24-month assessment period
consisting of:
(i) 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 to the performance
period; and
(ii) 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 2019 MIPS payment year, each segment of the low-volume threshold
determination period includes a 60-day claims run out. For the 2020
MIPS payment year, each segment of the low-volume threshold
determination period includes a 30-day claims run out.
* * * * *
MIPS determination period means:
(1) Beginning with the 2021 MIPS payment year and future years, a
24-month assessment period consisting of:
(i) An initial 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, and that includes a 30-day claims run out; and
(ii) A second 12-month segment beginning on October 1 of the
calendar year preceding the applicable performance period and ending on
September 30 of the calendar year in which the applicable performance
period occurs.

[[Page 36075]]

(2) Subject to Sec. 414.1310(b)(1)(iii), an individual eligible
clinician or group that is identified as not exceeding the low-volume
threshold or as a certain type of MIPS eligible clinician during the
first segment of the MIPS determination period will continue to be
identified as such for the applicable MIPS payment year regardless of
the results of the second segment of the MIPS determination period. An
individual eligible clinician or group for which the unique billing TIN
and NPI combination is established during the second segment of the
MIPS determination period will be assessed based solely on the results
of that segment.
MIPS eligible clinician as identified by a unique billing TIN and
NPI combination used to assess performance, means any of the following
(except as excluded under Sec. 414.1310(b)):
(1) For the 2019 and 2020 MIPS payment years:
(i) A physician (as defined in section 1861(r) of the Act);
(ii) A physician assistant, a nurse practitioner, and clinical
nurse specialist (as such terms are defined in section 1861(aa)(5) of
the Act);
(iii) A certified registered nurse anesthetist (as defined in
section 1861(bb)(2) of the Act); and
(iv) A group that includes such clinicians.
(2) For the 2021 MIPS payment year and future years:
(i) A clinician described in paragraph (1) of this definition;
(ii) A physical therapist or occupational therapist;
(iii) A clinical social worker (as defined in section 1861(hh)(1)
of the Act);
(iv) A clinical psychologist (as defined by the Secretary for
purposes of section 1861(ii) of the Act); and
(v) A group that includes such clinicians.
* * * * *
Non-patient facing MIPS eligible clinician means:
(1) For the 2019 and 2020 MIPS payment year, an individual MIPS
eligible clinician who bills 100 or fewer patient facing encounters
(including Medicare telehealth services defined in section 1834(m) of
the Act), as described in paragraph (3) of this definition, during the
non-patient facing determination period described in paragraph (4) of
this definition, and a group or virtual group provided that more than
75 percent of the NPIs billing under the group's TIN or virtual group's
TINs, as applicable, meet the definition of a non-patient facing
individual MIPS eligible clinician during the non-patient facing
determination period described in paragraph (4) of this definition.
(2) Beginning with the 2021 MIPS payment year, an individual MIPS
eligible clinician who bills 100 or fewer patient facing encounters
(including Medicare telehealth services defined in section 1834(m) of
the Act), as described in paragraph (3) of this definition, during the
MIPS determination period, and a group or virtual group provided that
more than 75 percent of the NPIs billing under the group's TIN or
virtual group's TINs, as applicable, meet the definition of a non-
patient facing individual MIPS eligible clinician during the MIPS
determination period.
(3) For purposes of this definition, a patient-facing encounter is
an instance in which the individual MIPS eligible clinician or group
bills for items and services furnished such as general office visits,
outpatient visits, and procedure codes under the PFS, as specified by
CMS.
(4) For the 2019 and 2020 MIPS payment year, the non-patient facing
determination period is a 24-month assessment period consisting of:
(i) 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
(ii) 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 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 2019 MIPS
payment year, each segment of the non-patient facing determination
period includes a 60-day claims run out. 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.
* * * * *
Qualified Clinical Data Registry (QCDR) means an entity with
clinical expertise in medicine and quality measurement development that
collects medical or clinical data on behalf of a MIPS eligible
clinician for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients.
* * * * *
Qualifying APM Participant (QP) means an eligible clinician
determined by CMS to have met or exceeded the relevant QP payment
amount or QP patient count threshold under Sec. 414.1430(a)(1),
(a)(3), (b)(1), or (b)(3) for a year based on participation in an APM
Entity that is also participating in an Advanced APM.
* * * * *
Small practice means:
(1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer
eligible clinicians.
(2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer
eligible clinicians during a 12-month assessment period 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 includes a 30-day claims run out.
(3) Beginning with the 2021 MIPS payment year, a TIN consisting of
15 or fewer eligible clinicians during the MIPS determination period.
* * * * *
Submission type means the mechanism by which the submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface.
Submitter type means the MIPS eligible clinician, group, or third
party intermediary acting on behalf of a MIPS eligible clinician or
group, as applicable, that submits data on measures and activities
under MIPS.
Third party intermediary means an entity that has been approved
under Sec. 414.1400 to submit data on behalf of a MIPS eligible
clinician, group, or virtual group for one or more of the quality,
improvement activities, and promoting interoperability performance
categories.
* * * * *
0
22. Section 414.1310 is amended by revising paragraphs (a), (b)(1)(ii)
and (iii), (d), and (e)(1) and (2) to read as follows:

Sec. 414.1310 Applicability.

(a) Program implementation. Except as specified in paragraph (b) of
this section, MIPS applies to payments for covered professional
services furnished by MIPS eligible clinicians on or after January 1,
2019.
(b) * * *
(1) * * *
(ii) Is a Partial Qualifying APM Participant and does not elect to

[[Page 36076]]

participate in MIPS as a MIPS eligible clinician; or
(iii) Does not exceed the low-volume threshold. Beginning with the
2021 MIPS payment year, if an individual eligible clinician, group, or
APM Entity group in a MIPS APM exceeds at least one, but not all, of
the low-volume threshold criteria and elects to participate in MIPS as
a MIPS eligible clinician, the individual eligible clinician, group, or
APM Entity group is treated as a MIPS eligible clinician for the
applicable MIPS payment year. For APM Entity groups in MIPS APMs, only
the APM Entity group election can result in the APM Entity group being
treated as MIPS eligible clinicians for the applicable payment year.
* * * * *
(d) Clarification. In no case will a MIPS payment adjustment factor
(or additional MIPS payment adjustment factor) apply to payments for
items and services furnished during a year by a eligible clinician,
including an eligible clinician described in paragraph (b) or (c) of
this section, who is not a MIPS eligible clinician, including an
eligible clinician who voluntarily reports on applicable measures and
activities under MIPS.
(e) Requirements for groups. (1) Except as provided under Sec.
414.1370(f)(2), each MIPS eligible clinician in the group will receive
a MIPS payment adjustment factor (or additional MIPS payment adjustment
factor) based on the group's combined performance assessment.
(2) For individual MIPS eligible clinicians to participate in MIPS
as a group, all of the following requirements must be met:
(i) Groups must meet the definition of a group at all times during
the applicable performance period.
(ii) Individual eligible clinicians that elect to participate in
MIPS as a group must aggregate their performance data across the
group's TIN.
(iii) Individual eligible clinicians that elect to participate in
MIPS as a group will have their performance assessed at the group level
across all four MIPS performance categories.
(iv) Groups must adhere to an election process established by CMS,
as applicable.
* * * * *
0
23. Section 414.1315 is revised to read as follows:

Sec. 414.1315 Virtual groups.

(a) Eligibility. (1) For a MIPS payment year, a solo practitioner
or a group of 10 or fewer eligible clinicians may elect to participate
in MIPS as a virtual group with at least one other such solo
practitioner or group. The election must be made prior to the start of
the applicable performance period and cannot be changed during the
performance period. A solo practitioner or group may elect to be in no
more than one virtual group for a performance period, and, in the case
of a group, the election applies to all MIPS eligible clinicians in the
group.
(2) Except as provided under Sec. 414.1370(f)(2), each MIPS
eligible clinician in the virtual group will receive a MIPS payment
adjustment factor (or additional MIPS payment adjustment factor) based
on the virtual group's combined performance assessment.
(b) Election deadline. The election deadline is December 31 of the
calendar year preceding the applicable performance period.
(c) Election process. For the 2020 MIPS payment year and future
years, the virtual group election process is as follows:
(1) Stage 1: Virtual group eligibility determination. (i) For the
2020 MIPS payment year, the virtual group eligibility determination
period is an assessment period of up to 5 months beginning on July 1
and ending as late as November 30 of the calendar year preceding the
applicable performance period, and that includes a 30-day claims run
out.
(ii) Beginning with the 2021 MIPS payment year, the virtual group
eligibility determination period aligns with the first segment of the
MIPS determination period, which is a 12-month assessment period
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, and that
includes a 30-day claims run out.
(2) Stage 2: Virtual group formation. (i) Solo practitioners and
groups that elect to participate in MIPS as a virtual group must
establish a formal written agreement that satisfies paragraph (c)(3) of
this section prior to the election.
(ii) A designated virtual group representative must submit an
election, on behalf of the solo practitioners and groups that compose a
virtual group, to participate in MIPS a virtual group for a performance
period in a form and manner specified by CMS by the election deadline
specified in paragraph (b) of this section.
(iii) The virtual group election must include each TIN and NPI
associated with the virtual group and contact information for the
virtual group representative.
(iv) Once an election is made, the virtual group representative
must contact their designated CMS contact to update any election
information that changed during a performance period at least one time
prior to the start of an applicable submission period.
(3) Virtual group agreement. The virtual group arrangement must be
set forth in a formal written agreement among the parties, consisting
of each solo practitioner and group that composes a virtual group. The
agreement must comply with the following requirements:
(i) Identifies each party by name, TIN, and each NPI under the TIN,
and includes as parties only the solo practitioners and groups that
compose the virtual group.
(ii) Is for a term of at least one performance period.
(iii) Requires each party to notify each NPI under the party's TIN
regarding their participation in the MIPS as a virtual group.
(iv) Sets forth each NPI's rights and obligations in, and
representation by, the virtual group, but not limited to, the reporting
requirements and how participation in the MIPS as a virtual group the
NPI's ability to participate in the MIPS outside of the virtual group.
(v) Describes how the opportunity to receive payment adjustments
will encourage each member of the virtual group (and each NPI under
each TIN in the virtual group) to adhere to quality assurance and
improvement.
(vi) Requires each party to update its Medicare enrollment
information, including the addition or removal of NPIs billing under
its TIN, on a timely basis in accordance with Medicare program
requirements and to notify the other parties of any such changes within
30 days of the change.
(vii) Requires completion of a close-out process upon termination
or expiration of the agreement that requires each party to furnish all
data necessary for the parties to aggregate their data across the
virtual group's TINs.
(viii) Expressly requires each party to participate in the MIPS as
a virtual group and comply with the requirements of the MIPS and all
other applicable laws (including, but not limited to, Federal criminal
law, the Federal False Claims Act, the Federal anti-kickback statute,
the Federal civil monetary penalties law, the Federal physician self-
referral law, and the Health Insurance Portability and Accountability
Act of 1996).
(ix) Is executed on behalf of each party by an individual who is
authorized to bind the party.

[[Page 36077]]

(d) Virtual group reporting requirements. For solo practitioners
and groups of 10 or fewer eligible clinicians to participate in MIPS as
a virtual group, all of the following requirements must be met:
(1) Virtual groups must meet the definition of a virtual group at
all times during the applicable performance period.
(2) Solo practitioners and groups of 10 or fewer eligible
clinicians that elect to participate in MIPS as a virtual group must
aggregate their performance data across the virtual group's TINs.
(3) Solo practitioners and groups of 10 or fewer eligible
clinicians that elect to participate in MIPS as a virtual group will
have their performance assessed at the virtual group level across all
four MIPS performance categories.
(4) Virtual groups must adhere to the election process described in
paragraph (c) of this section.
0
24. Section 414.1320 is amended by revising paragraphs (b)(2) and
(c)(2) and adding paragraphs (d) and (e) to read as follows:

Sec. 414.1320 MIPS performance period.

* * * * *
(b) * * *
(2) Promoting Interoperability and improvement activities
performance categories is a minimum of a continuous 90-day period
within CY 2018, up to and including the full CY 2018 (January 1, 2018
through December 31, 2018).
(c) * * *
(2) Promoting Interoperability and improvement activities
performance categories is a minimum of a continuous 90-day period
within CY 2019, up to and including the full CY 2019 (January 1, 2019
through December 31, 2019).
(d) Beginning with the 2022 MIPS payment year, the performance
period for:
(1) The quality and cost performance categories is the full
calendar year (January 1 through December 31) that occurs 2 years prior
to the applicable MIPS payment year.
(2) The improvement activities performance categories is a minimum
of a continuous 90-day period within the calendar year that occurs 2
years prior to the applicable MIPS payment year, up to and including
the full calendar year.
(e) For purposes of the 2022 MIPS payment year, the performance
period for:
(1) The Promoting Interoperability performance category is a
minimum of a continuous 90-day period within the calendar year that
occurs 2 years prior to the applicable MIPS payment year, up to and
including the full calendar year.
(2) [Reserved]
0
25. Section 414.1325 is revised to read as follows:

Sec. 414.1325 Data submission requirements.

(a) Applicable performance categories. (1) Except as provided in
paragraph (a)(2) of this section or under Sec. 414.1370, as
applicable, individual MIPS eligible clinicians and groups must submit
data on measures and activities for the quality, improvement
activities, and Promoting Interoperability performance categories in
accordance with this section. Except for the Medicare Part B claims
submission type, the data may also be submitted on behalf of the
individual MIPS eligible clinician or group by a third party
intermediary described at Sec. 414.1400.
(2) There are no data submission requirements for:
(i) The cost performance category or administrative claims-based
quality measures. Performance in the cost performance category and on
such measures is calculated by CMS using administrative claims data,
which includes claims submitted with dates of service during the
applicable performance period that are processed no later than 60 days
following the close of the applicable performance period.
(ii) The quality or cost performance category, as applicable, for
MIPS eligible clinicians and groups that are scored under the facility-
based measurement scoring methodology described in Sec. 414.1380(e).
(b) Data submission types for individual MIPS eligible clinicians.
An individual MIPS eligible clinician may submit their MIPS data using:
(1) For the quality performance category, the direct, login and
upload, and Medicare Part B claims (for small practices only beginning
with the 2021 MIPS payment year) submission types.
(2) For the improvement activities or Promoting Interoperability
performance categories, the direct, login and upload, or login and
attest submission types.
(c) Data submission types for groups. Groups may submit their MIPS
data using:
(1) For the quality performance category, the direct, login and
upload, Medicare Part B claims (for small practices only beginning with
the 2021 MIPS payment year), and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians or a third party
intermediary submitting on behalf of a group) submission types.
(2) For the improvement activities or Promoting Interoperability
performance categories, the direct, login and upload, or login and
attest submission types.
(d) Use of multiple data submission types. Beginning with the 2021
MIPS payment year, MIPS eligible clinicians, groups, and virtual groups
may submit their MIPS data using multiple data submission types for any
performance category described in paragraph (a)(1) of this section, as
applicable; provided, however, that the MIPS eligible clinician, group,
or virtual group uses the same identifier for all performance
categories and all data submissions.
(e) Data submission deadlines. The data submission deadlines are as
follows:
(1) For the direct, login and upload, login and attest, and CMS Web
Interface submission types, March 31 following the close of the
applicable performance period or a later date as specified by CMS.
(2) For the Medicare Part B claims submission type, data must be
submitted on claims with dates of service during the applicable
performance period that must be processed no later than 60 days
following the close of the applicable performance period.
0
26. Section 414.1330 is revised to read as follows:

Sec. 414.1330 Quality performance category.

(a) For a MIPS payment year, CMS uses the following quality
measures, as applicable, to assess performance in the quality
performance category:
(1) Measures included in the MIPS final list of quality measures
established by CMS through rulemaking;
(2) QCDR measures approved by CMS under Sec. 414.1400;
(3) Facility-based measures described in Sec. 414.1380; and
(4) MIPS APM measures described in Sec. 414.1370.
(b) Unless a different scoring weight is assigned by CMS,
performance in the quality performance category comprises:
(1) 60 percent of a MIPS eligible clinician's final score for MIPS
payment year 2019.
(2) 50 percent of a MIPS eligible clinician's final score for MIPS
payment year 2020.
(3) 45 percent of a MIPS eligible clinician's final score for MIPS
payment year 2021.
0
27. Section 414.1335 is amended by revising paragraphs (a)(1), (2), and
(3) to read as follows:

Sec. 414.1335 Data submission criteria for the quality performance
category.

(a) * * *
(1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR
measures. (i) Subject to paragraph (a)(1)(ii) of this section,

[[Page 36078]]

submit data on at least six measures including at least one outcome
measure. If an applicable outcome measure is not available, report one
other high priority measure. If fewer than six measures apply to the
MIPS eligible clinician or group, report on each measure that is
applicable.
(ii) MIPS eligible clinicians and groups that report on a specialty
or subspecialty measure set, as designated in the MIPS final list of
quality measures established by CMS through rulemaking, must submit
data on at least six measures within that set. If the set contains
fewer than six measures or if fewer than six measures within the set
apply to the MIPS eligible clinician or group, report on each measure
that is applicable.
(2) For CMS Web Interface measures. (i) Report on all measures
included in the CMS Web Interface. The group must report on the first
248 consecutively ranked beneficiaries in the sample for each measure
or module.
(ii) If the sample of eligible assigned beneficiaries is less than
248, then the group must report on 100 percent of assigned
beneficiaries.
(iii) The group is required to report on at least one measure for
which there is Medicare patient data.
(3) For the CAHPS for MIPS survey. (i) For the 12-month performance
period, a group that wishes to voluntarily elect to participate in the
CAHPS for MIPS survey must use a survey vendor that is approved by CMS
for the applicable performance period to transmit survey measures data
to CMS.
(ii) [Reserved]
* * * * *
0
28. Section 414.1340 is amended by revising paragraphs (a) introductory
text, (b) introductory text, and (c) to read as follows:

Sec. 414.1340 Data completeness criteria for the quality performance
category.

(a) MIPS eligible clinicians and groups submitting quality measures
data on QCDR measures, MIPS CQMs, or the eCQMs must submit data on:
* * * * *
(b) MIPS eligible clinicians and groups submitting quality measure
data on the Medicare Part B claims measures must submit data on:
* * * * *
(c) Groups submitting quality measures data on CMS Web Interface
measures or the CAHPS for MIPS survey, must meet the data submission
requirement on the sample of the Medicare Part B patients CMS provides.
0
29. Section 414.1350 is revised to read as follows:

Sec. 414.1350 Cost performance category.

(a) Specification of cost measures. For purposes of assessing
performance of MIPS eligible clinicians on the cost performance
category, CMS specifies cost measures for a performance period.
(b) Attribution. (1) Cost measures are attributed at the TIN/NPI
level.
(2) For the total per capita cost measure, beneficiaries are
attributed using a method generally consistent with the method of
assignment of beneficiaries under Sec. 425.402 of this chapter.
(3) For the Medicare Spending per Beneficiary (MSPB) measure, an
episode is attributed to the MIPS eligible clinician who submitted the
plurality of claims (as measured by allowed charges) for Medicare Part
B services rendered during an inpatient hospitalization that is an
index admission for the MSPB measure during the applicable performance
period.
(4) For the acute condition episode-based measures specified for
the 2017 performance period, an episode is attributed to each MIPS
eligible clinician who bills at least 30 percent of inpatient
evaluation and management (E&M) visits during the trigger event for the
episode.
(5) For the procedural episode-based measures specified for the
2017 performance period, an episode is attributed to each MIPS eligible
clinician who bills a Medicare Part B claim with a trigger code during
the trigger event for the episode.
(6) For the acute inpatient medical condition episode-based
measures specified beginning with the 2019 performance period, an
episode is attributed to each MIPS eligible clinician who bills
inpatient E&M claim lines during a trigger inpatient hospitalization
under a TIN that renders at least 30 percent of the inpatient E&M claim
lines in that hospitalization.
(7) For the procedural episode-based measures specified beginning
with the 2019 performance period, an episode is attributed to each MIPS
eligible clinician who renders a trigger service as identified by
HCPCS/CPT procedure codes.
(c) Case minimums. (1) For the total per capita cost measure, the
case minimum is 20.
(2) For the Medicare spending per beneficiary measure, the case
minimum is 35.
(3) For the episode-based measures specified for the 2017
performance period, the case minimum is 20.
(4) For the procedural episode-based measures specified beginning
with the 2019 performance period, the case minimum is 10.
(5) For the acute inpatient medical condition episode-based
measures specified beginning with the 2019 performance period, the case
minimum is 20.
(d) Scoring weight. Unless a different scoring weight is assigned
by CMS under section 1848(q)(5)(F) of the Act, performance in the cost
performance category comprises:
(1) Zero percent of a MIPS eligible clinician's final score for
MIPS payment year 2019.
(2) 10 percent of a MIPS eligible clinician's final score for MIPS
payment year 2020.
(3) 15 percent of a MIPS eligible clinician's final score for MIPS
payment year 2021.
0
30. Section 414.1355 is amended by revising paragraphs (a), (b)
introductory text, and (c) to read as follows:

Sec. 414.1355 Improvement activities performance category.

(a) For a MIPS payment year, CMS uses improvement activities
included in the MIPS final inventory of improvement activities
established by CMS through rulemaking to assess performance in the
improvement activities performance category.
(b) Unless a different scoring weight is assigned by CMS under
section 1848(q)(5)(F) of the Act, performance in the improvement
activities performance category comprises:
* * * * *
(c) The following are the list of subcategories, of which, with the
exception of Participation in an APM, include activities for selection
by a MIPS eligible clinician or group:
(1) Expanded practice access, such as same day appointments for
urgent needs and after-hours access to clinician advice.
(2) Population management, such as monitoring health conditions of
individuals to provide timely health care interventions or
participation in a QCDR.
(3) Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients or other
clinicians, and use of remote monitoring or telehealth.
(4) Beneficiary engagement, such as the establishment of care plans
for individuals with complex care needs, beneficiary self-management
assessment and training, and using shared decision making mechanisms.
(5) Patient safety and practice assessment, such as through the use
of clinical or surgical checklists and practice assessments related to
maintaining certification.
(6) Participation in an APM.

[[Page 36079]]

(7) Achieving health equity, such as for MIPS eligible clinicians
that achieve high quality for underserved populations, including
persons with behavioral health conditions, racial and ethnic
minorities, sexual and gender minorities, people with disabilities,
people living in rural areas, and people in geographic HPSAs.
(8) Emergency preparedness and response, such as measuring MIPS
eligible clinician participation in the Medical Reserve Corps,
measuring registration in the Emergency System for Advance Registration
of Volunteer Health Professionals, measuring relevant reserve and
active duty uniformed services MIPS eligible clinician activities, and
measuring MIPS eligible clinician volunteer participation in domestic
or international humanitarian medical relief work.
(9) Integrated behavioral and mental health, such as measuring or
evaluating such practices as: Co-location of behavioral health and
primary care services; shared/integrated behavioral health and primary
care records; cross training of MIPS eligible clinicians, and
integrating behavioral health with primary care to address substance
use disorders or other behavioral health conditions, as well as
integrating mental health with primary care.
0
31. Section 414.1360 is amended by revising paragraph (a)(1) to read as
follows:

Sec. 414.1360 Data submission criteria for the improvement activities
performance category.

(a) * * *
(1) Via direct, login and upload, and login and attest. For the
applicable performance period, submit a yes response for each
improvement activity that is performed for at least a continuous 90-day
period during the applicable performance period.
* * * * *

Sec. 414.1365 [Removed]

0
32. Section 414.1365 is removed.
0
33. Section 414.1370 is amended by revising paragraphs (b)(3), (f)(2),
(g)(4), (h)(4) heading, (h)(5)(i)(A) and (B), and (h)(5)(ii)
introductory text to read as follows:

Sec. 414.1370 APM scoring standard under MIPS.

* * * * *
(b) * * *
(3) The APM bases payment on quality measures and cost/utilization;
and
* * * * *
(f) * * *
(2) MIPS eligible clinicians who participate in a group or have
elected to participate in a virtual group and who are also on a MIPS
APM Participation List will be included in the assessment under MIPS
for purposes of producing a group or virtual group score and under the
APM scoring standard for purposes of producing an APM Entity score. The
MIPS payment adjustment for these eligible clinicians is based solely
on their APM Entity score; if the APM Entity group is exempt from MIPS
all eligible clinicians within that APM Entity group are also exempt
from MIPS.
(g) * * *
(4) Promoting Interoperability (PI). (i) For the 2019 and 2020 MIPS
payment years, each Shared Savings Program ACO participant TIN must
report data on the Promoting Interoperability performance category
separately from the ACO, as specified in Sec. 414.1375(b)(2). The ACO
participant TIN scores are weighted according to the number of MIPS
eligible clinicians in each TIN as a proportion of the total number of
MIPS eligible clinicians in the APM Entity group, and then aggregated
to determine an APM Entity score for the ACI performance category.
(ii) For the 2019 and 2020 MIPS payment years, for APM Entities in
MIPS APMs other than the Shared Savings Program, CMS uses one score for
each MIPS eligible clinician in the APM Entity group to derive a single
average APM Entity score for the Promoting Interoperability performance
category. Beginning with the 2021 MIPS payment year, for APM Entities
in MIPS APMs including the Shared Savings Program, CMS uses one score
for each MIPS eligible clinician in the APM Entity group to derive a
single average APM Entity score for the Promoting Interoperability
performance category. The score for each MIPS eligible clinician is the
higher of either:
(A) A group score based on the measure data for the Promoting
Interoperability performance category reported by a TIN for the MIPS
eligible clinician according to MIPS submission and reporting
requirements for groups; or
(B) An individual score based on the measure data for the Promoting
Interoperability performance category reported by the MIPS eligible
clinician according to MIPS submission and reporting requirements for
individuals.
(iii) In the event that a MIPS eligible clinician participating in
a MIPS APM receives an exception from the Promoting Interoperability
performance category reporting requirements, such eligible clinician
will be assigned a null score when CMS calculates the APM Entity's
Promoting Interoperability performance category score under the APM
scoring standard.
(A) If all MIPS eligible clinicians in an APM Entity have been
excepted from reporting the Promoting Interoperability performance
category, the performance category weight will be reweighted to zero
for the APM Entity for that MIPS performance period.
(B) [Reserved]
(h) * * *
(4) Promoting Interoperability. * * *
(5) * * *
(i) * * *
(A) In 2017, the improvement activities performance category is
reweighted to 25 percent and the Promoting Interoperability performance
category is reweighted to 75 percent; and
(B) Beginning in 2018, the Promoting Interoperability performance
category is reweighted to 75 percent and the improvement activities
performance category is reweighted to 25 percent.
(ii) If CMS reweights the Promoting Interoperability performance
category to zero percent:
* * * * *
0
34. Section 414.1375 is amended by--
0
a. Revising the section heading, paragraphs (a), (b) introductory text,
and (b)(2); and
0
b. Removing paragraph (b)(3).
The revisions and addition read as follows:

Sec. 414.1375 Promoting Interoperability (PI) performance category.

(a) Final score. Unless a different scoring weight is assigned by
CMS under sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), or 1848(q)(5)(F)
of the Act, performance in the Promoting Interoperability performance
category comprises 25 percent of a MIPS eligible clinician's final
score for each MIPS payment year.
(b) Reporting for the Promoting Interoperability performance
category. To earn a performance category score for the Promoting
Interoperability performance category for inclusion in the final score,
a MIPS eligible clinician must:
* * * * *
(2) Report MIPS--Promoting Interoperability objectives and
measures. Report on the objectives and associated measures as specified
by CMS for the Promoting Interoperability performance category for the
performance period as follows:
(i) For the 2019 and 2020 MIPS payment years: For each base score
measure, as applicable, report the numerator (of at least one) and
denominator, or yes/no statement, or claim an exclusion for each
measure

[[Page 36080]]

that includes an option for an exclusion; and
(ii) Beginning with the 2021 MIPS payment year:
(A) Report that the MIPS eligible clinician completed the actions
included in the Security Risk Analysis measure during the year in which
the performance period occurs; and
(B) For each required measure, as applicable, report the numerator
(of at least one) and denominator, or yes/no statement, or an exclusion
for each measure that includes an option for an exclusion.
0
35. Section 414.1380 is revised to read as follows:

Sec. 414.1380 Scoring.

(a) General. MIPS eligible clinicians are scored under MIPS based
on their performance on measures and activities in four performance
categories. MIPS eligible clinicians are scored against performance
standards for each performance category and receive a final score,
composed of their performance category scores, and calculated according
to the final score methodology.
(1) Performance standards. (i) For the quality performance
category, measures are scored between zero and 10 measure achievement
points. Performance is measured against benchmarks. Measure bonus
points are available for submitting high-priority measures, submitting
measures using end-to-end electronic reporting, and in small practices
that submit data on at least 1 quality measure. Beginning with the 2020
MIPS payment year, improvement scoring is available in the quality
performance category.
(ii) For the cost performance category, measures are scored between
1 and 10 points. Performance is measured against a benchmark. Starting
with the 2024 MIPS payment year, improvement scoring is available in
the cost performance category.
(iii) For the improvement activities performance category, each
improvement activity is assigned a certain number of points. The points
for all submitted activities are summed and scored against a total
potential performance category score of 40 points.
(iv) For the Promoting Interoperability performance category, each
measure is scored against a maximum number of points. The points for
all submitted measures are summed and scored against a total potential
performance category score of 100 points.
(2) [Reserved]
(b) Performance categories. MIPS eligible clinicians are scored
under MIPS in four performance categories.
(1) Quality performance category--(i) Measure achievement points.
For the 2019, 2020, and 2021 MIPS payment years, MIPS eligible
clinicians receive between 3 and 10 measure achievement points
(including partial points) for each measure required under Sec.
414.1335 on which data is submitted in accordance with Sec. 414.1325
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the
case minimum requirement at paragraph (b)(1)(iii) of this section, and
meets the data completeness requirement at Sec. 414.1340. The number
of measure achievement points received for each such measure is
determined based on the applicable benchmark decile category and the
percentile distribution. MIPS eligible clinicians receive zero measure
achievement points for each measure required under Sec. 414.1335 on
which no data is submitted in accordance with Sec. 414.1325. MIPS
eligible clinicians that submit data in accordance with Sec. 414.1325
on a greater number of measures than required under Sec. 414.1335 are
scored only on the required measures with the greatest number of
measure achievement points. Beginning with the 2021 MIPS payment year,
MIPS eligible clinicians that submit data in accordance with Sec.
414.1325 on a single measure via multiple collection types are scored
only on the data submission with the greatest number of measure
achievement points.
(A) Lack of benchmark or case minimum. (1) Except as provided in
paragraph (b)(1)(i)(A)(2) of this section, for the 2019, 2020, and 2021
MIPS payment years, MIPS eligible clinicians receive 3 measure
achievement points for each submitted measure that meets the data
completeness requirement, but does not have a benchmark or meet the
case minimum requirement.
(2) The following measures are excluded from a MIPS eligible
clinician's total measure achievement points and total available
measure achievement points:
(i) Each submitted CMS Web Interface-based measure that meets the
data completeness requirement, but does not have a benchmark or meet
the case minimum requirement, or is redesignated as pay-for-reporting
for all Shared Savings Program accountable care organizations by the
Shared Savings Program; and
(ii) Each administrative claims-based measure that does not have a
benchmark or meet the case minimum requirement.
(B) Lack of complete data. (1) Except as provided in paragraph
(b)(1)(i)(B)(2) of this section, for each submitted measure that does
not meet the data completeness requirement:
(i) For the 2019 MIPS payment year, MIPS eligible clinicians
receive 3 measure achievement points;
(ii) For the 2020 and 2021 MIPS payment years, MIPS eligible
clinicians other than small practices receive 1 measure achievement
point, and small practices receive 3 measure achievement points; and
(iii) Beginning with the 2022 MIPS payment year, MIPS eligible
clinicians other than small practices receive zero measure achievement
points, and small practices receive 3 measure achievement points.
(2) MIPS eligible clinicians receive zero measure achievement
points for each submitted CMS Web Interface-based measure that does not
meet the data completeness requirement.
(ii) Benchmarks. Benchmarks will be based on collection type, from
all available sources, including MIPS eligible clinicians and APMs, to
the extent feasible, during the applicable baseline or performance
period.
(A) Each benchmark must have a minimum of 20 individual clinicians
or groups who reported the measure meeting the case minimum requirement
at paragraph (b)(1)(iii) of this section and the data completeness
requirement at Sec. 414.1340 and having a performance rate that is
greater than zero.
(B) CMS Web Interface collection type uses benchmarks from the
corresponding reporting year of the Shared Savings Program.
(iii) Minimum case requirements. Except for the all-cause hospital
readmission measure, the minimum case requirement is 20 cases. For the
all-cause hospital readmission measure, the minimum case requirement is
200 cases.
(iv) Topped out measures. CMS will identify topped out measures in
the benchmarks published for each Quality Payment Program year.
(A) For the 2020 MIPS payment year, each topped out measure
specified by CMS through rulemaking receives no more than 7 measure
achievement points, provided that the benchmark for the applicable
collection type is identified as topped out in the benchmarks published
for the 2018 MIPS performance period.
(B) Beginning with the 2021 MIPS payment year, each measure (except
for measures in the CMS Web Interface) for which the benchmark for the
applicable collection type is identified as topped out for 2 or more
consecutive years receives no more than 7 measure achievement points in
the second consecutive year it is identified as topped out, and beyond.

[[Page 36081]]

(v) Measure bonus points. MIPS eligible clinicians receive measure
bonus points for the following measures, except as otherwise required
under Sec. 414.1335, regardless of whether the measure is included in
the MIPS eligible clinician's total measure achievement points.
(A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of
this section, MIPS eligible clinicians receive 2 measure bonus points
for each outcome and patient experience measure and 1 measure bonus
point for each other high priority measure. Beginning with the 2021
MIPS payment year, MIPS eligible clinicians do not receive such measure
bonus points for CMS Web Interface measures.
(1) Limitations. (i) Each high priority measure must have a
benchmark at paragraph (b)(1)(ii) of this section, meet the case
minimum requirement at (b)(1)(iii) of this section, meet the data
completeness requirement at Sec. 414.1340, and have a performance rate
that is greater than zero.
(ii) For the 2019, 2020, and 2021 MIPS payment years, the total
measure bonus points for high priority measures cannot exceed 10
percent of the total available measure achievement points.
(iii) Beginning with the 2021 MIPS payment year, MIPS eligible
clinicians that collect data in accordance with Sec. 414.1325 on a
single measure via multiple collection types receive measure bonus
points only once.
(B) End-to-end electronic reporting. Subject to paragraph
(b)(1)(v)(B)(1) of this section, MIPS eligible clinicians receive 1
measure bonus point for each measure (except claims-based measures)
submitted with end-to-end electronic reporting for a quality measure
under certain criteria determined by the Secretary.
(1) Limitations. (i) For the 2019, 2020, and 2021 MIPS payment
years, the total measure bonus points for measures submitted with end-
to-end electronic reporting cannot exceed 10 percent of the total
available measure achievement points.
(ii) Beginning with the 2021 MIPS payment year, MIPS eligible
clinicians that collect data in accordance with Sec. 414.1325 on a
single measure via multiple collection types receive measure bonus
points only once.
(C) Small practices. Beginning with the 2021 MIPS payment year,
MIPS eligible clinicians in small practices receive 3 measure bonus
points if they submit data to MIPS on at least 1 quality measure.
(vi) Improvement scoring. Improvement scoring is available to MIPS
eligible clinicians that demonstrate improvement in performance in the
current MIPS performance period compared to performance in the
performance period immediately prior to the current MIPS performance
period based on measure achievement points.
(A) Improvement scoring is available when the data sufficiency
standard is met, which means when data are available and a MIPS
eligible clinician has a quality performance category achievement
percent score for the previous performance period and the current
performance period.
(1) Data must be comparable to meet the requirement of data
sufficiency which means that the quality performance category
achievement percent score is available for the current performance
period and the previous performance period and quality performance
category achievement percent scores can be compared.
(2) Quality performance category achievement percent scores are
comparable when submissions are received from the same identifier for
two consecutive performance periods.
(3) If the identifier is not the same for 2 consecutive performance
periods, then for individual submissions, the comparable quality
performance category achievement percent score is the highest available
quality performance category achievement percent score associated with
the final score from the prior performance period that will be used for
payment for the individual. For group, virtual group, and APM Entity
submissions, the comparable quality performance category achievement
percent score is the average of the quality performance category
achievement percent score associated with the final score from the
prior performance period that will be used for payment for each of the
individuals in the group.
(4) Improvement scoring is not available for clinicians who were
scored under facility-based measurement in the performance period
immediately prior to the current MIPS performance period.
(B) The improvement percent score may not total more than 10
percentage points.
(C) The improvement percent score is assessed at the performance
category level for the quality performance category and included in the
calculation of the quality performance category percent score as
described in paragraph (b)(1)(vii) of this section.
(1) The improvement percent score is awarded based on the rate of
increase in the quality performance category achievement percent score
of MIPS eligible clinicians from the previous performance period to the
current performance period.
(2) An improvement percent score is calculated by dividing the
increase in the quality performance category achievement percent score
from the prior performance period to the current performance period by
the prior performance period quality performance category achievement
percent score multiplied by 10 percent.
(3) An improvement percent score cannot be lower than zero
percentage points.
(4) For the 2020 and 2021 MIPS payment year, we will assume a
quality performance category achievement percent score of 30 percent if
a MIPS eligible clinician earned a quality performance category score
less than or equal to 30 percent in the previous year.
(5) The improvement percent score is zero if the MIPS eligible
clinician did not fully participate in the quality performance category
for the current performance period.
(D) For the purpose of improvement scoring methodology, the term
``quality performance category achievement percent score'' means the
total measure achievement points divided by the total available measure
achievement points, without consideration of measure bonus points or
improvement percent score.
(E) For the purpose of improvement scoring methodology, the term
``improvement percent score'' means the score that represents
improvement for the purposes of calculating the quality performance
category percent score as described in paragraph (b)(1)(vii) of this
section.
(F) For the purpose of improvement scoring methodology, the term
``fully participate'' means the MIPS eligible clinician met all
requirements in Sec. Sec. 414.1335 and 414.1340.
(vii) Quality performance category score. A MIPS eligible
clinician's quality performance category percent score is the sum of
all the measure achievement points assigned for the measures required
for the quality performance category criteria plus the measure bonus
points in paragraph (b)(1)(v) of this section. The sum is divided by
the sum of total available measure achievement points. The improvement
percent score in paragraph (b)(1)(vi) of this section is added to that
result. The quality performance category percent score cannot exceed
100 percentage points.
(A) Beginning with the 2021 MIPS payment year, for MIPS eligible
clinicians that submit data on a measure significantly impacted by
clinical guideline changes or other changes that CMS believes may pose
patient safety

[[Page 36082]]

concerns, the total available measure achievement points category are
reduced by 10 points.
(B) Beginning with the 2021 MIPS payment year, for groups that
register for the CAHPS for MIPS survey but do not meet the minimum
beneficiary sampling requirements, the total available measure
achievement points are reduced by 10 points.
(viii) ICD-10 updates. Beginning with the 2018 MIPS performance
period, measures significantly impacted by ICD-10 updates, as
determined by CMS, will be assessed based only on the first 9 months of
the 12-month performance period. For purposes of this paragraph
(b)(1)(viii), CMS will make a determination as to whether a measure is
significantly impacted by ICD-10 coding changes during the performance
period. CMS will publish on the CMS website which measures require a 9-
month assessment process by October 1st of the performance period if
technically feasible, but by no later than the beginning of the data
submission period at Sec. 414.1325(f)(1).
(2) Cost performance category. For each cost measure attributed to
a MIPS eligible clinician, the clinician receives one to ten
achievement points based on the clinician's performance on the measure
during the performance period compared to the measure's benchmark.
Achievement points are awarded based on which benchmark decile range
the MIPS eligible clinician's performance on the measure is between.
CMS assigns partial points based on the percentile distribution.
(i) Cost measure benchmarks are determined by CMS based on cost
measure performance during the performance period. At least 20 MIPS
eligible clinicians or groups must meet the minimum case volume
specified under Sec. 414.1350(c) for a cost measure in order for a
benchmark to be determined for the measure. If a benchmark is not
determined for a cost measure, the measure will not be scored.
(ii) A MIPS eligible clinician must meet the minimum case volume
specified under Sec. 414.1350(c) to be scored on a cost measure.
(iii) The cost performance category percent score is the sum of the
following, not to exceed 100 percent:
(A) The total number of achievement points earned by the MIPS
eligible clinician divided by the total number of available achievement
points; and
(B) The cost improvement score, as determined under paragraph
(b)(2)(iv) of this section.
(iv) The cost improvement score is determined for a MIPS eligible
clinician that demonstrates improvement in performance in the current
MIPS performance period compared to their performance in the
immediately preceding MIPS performance period.
(A) The cost improvement score is determined at the measure level
for the cost performance category.
(B) The cost improvement score is calculated only when data
sufficient to measure improvement is available. Sufficient data is
available when a MIPS eligible clinician or group participates in MIPS
using the same identifier in 2 consecutive performance periods and is
scored on the same cost measure(s) for 2 consecutive performance
periods. If the cost improvement score cannot be calculated because
sufficient data is not available, then the cost improvement score is
zero.
(C) The cost improvement score is determined by comparing the
number of measures with a statistically significant change (improvement
or decline) in performance; a change is determined to be significant
based on application of a t-test. The number of cost measures with a
significant decline is subtracted from the number of cost measures with
a significant improvement, with the result divided by the number of
cost measures for which the MIPS eligible clinician or group was scored
for 2 consecutive performance periods. The resulting fraction is then
multiplied by the maximum cost improvement score.
(D) The cost improvement score cannot be lower than zero percentage
points.
(E) The maximum cost improvement score for the 2020, 2021, 2022,
and 2023 MIPS payment years is zero percentage points.
(v) A cost performance category percent score is not calculated if
a MIPS eligible clinician or group is not attributed any cost measures
for the performance period because the clinician or group has not met
the minimum case volume specified by CMS for any of the cost measures
or a benchmark has not been created for any of the cost measures that
would otherwise be attributed to the clinician or group.
(3) Improvement activities performance category. Subject to
paragraphs (b)(3)(i) and (ii) of this section, the improvement
activities performance category score equals the total points for all
submitted improvement activities divided by 40 points, multiplied by
100 percent. MIPS eligible clinicians (except for non-patient facing
MIPS eligible clinicians, small practices, and practices located in
rural areas and geographic HPSAs) receive 10 points for each medium-
weighted improvement activity and 20 points for each high-weighted
improvement activity required under Sec. 414.1360 on which data is
submitted in accordance with Sec. 414.1325. Non-patient facing MIPS
eligible clinicians, small practices, and practices located in rural
areas and geographic HPSAs receive 20 points for each medium-weighted
improvement activity and 40 points for each high-weighted improvement
activity required under Sec. 414.1360 on which data is submitted in
accordance with Sec. 414.1325.
(i) For MIPS eligible clinicians participating in APMs, the
improvement activities performance category score is at least 50
percent.
(ii) For MIPS eligible clinicians in a practice that is certified
or recognized as a patient-centered medical home or comparable
specialty practice, as determined by the Secretary, the improvement
activities performance category score is 100 percent. For the 2019 MIPS
payment year, at least one practice site within a group's TIN must be
certified or recognized as a patient-centered medical home or
comparable specialty practice. For the 2020 MIPS payment year and
future years, at least 50 percent of the practice sites within a
group's TIN must be recognized as a patient-centered medical home or
comparable specialty practice. MIPS eligible clinicians that wish to
claim this status for purposes of receiving full credit in the
improvement activities performance category must attest to their status
as a patient-centered medical home or comparable specialty practice in
order to receive this credit. A practice is certified or recognized as
a patient-centered medical home if it meets any of the following
criteria:
(A) The practice has received accreditation from one of four
accreditation organizations that are nationally recognized;
(1) The Accreditation Association for Ambulatory Health Care;
(2) The National Committee for Quality Assurance (NCQA);
(3) The Joint Commission; or
(4) The Utilization Review Accreditation Commission (URAC).
(B) The practice is participating in a Medicaid Medical Home Model
or Medical Home Model.
(C) The practice is a comparable specialty practice that has
received the NCQA Patient-Centered Specialty Recognition.
(D) The practice has received accreditation from other certifying
bodies that have certified a large number of medical organizations and
meet national guidelines, as determined by the Secretary. The Secretary
must

[[Page 36083]]

determine that these certifying bodies must have 500 or more certified
member practices, and require practices to include the following:
(1) Have a personal physician/clinician in a team-based practice.
(2) Have a whole-person orientation.
(3) Provide coordination or integrated care.
(4) Focus on quality and safety.
(5) Provide enhanced access.
(4) Promoting Interoperability performance category. (i) For the
2019 and 2020 MIPS payment years, a MIPS eligible clinician's Promoting
Interoperability performance category score equals the sum of the base
score, performance score, and any applicable bonus scores, not to
exceed 100 percentage points. A MIPS eligible clinician cannot earn a
performance score or bonus score unless they have earned a base score.
(A) A MIPS eligible clinician earns a base score by reporting for
each base score measure, as applicable: The numerator (of at least one)
and denominator, or a yes/no statement, or an exclusion.
(B) A MIPS eligible clinician earns a performance score by
reporting on the performance score measures specified by CMS. A MIPS
eligible clinician may earn up to 10 or 20 percentage points as
specified by CMS for each performance score measure reported.
(C) A MIPS eligible clinician may earn the following bonus scores:
(1) A bonus score of 5 percentage points for reporting to one or
more additional public health agencies or clinical data registries.
(2) A bonus score of 10 percentage points for attesting to
completing one or more improvement activities specified by CMS using
CEHRT.
(3) For the 2020 MIPS payment year, a bonus score of 10 percentage
points for submitting data for the measures for the base score and the
performance score generated solely from CEHRT as defined in Sec.
414.1305 for 2019 and subsequent years.
(ii) For the 2021 MIPS payment year, a MIPS eligible clinician's
Promoting Interoperability performance category score equals the sum of
the scores for each of the required 6 measures and any applicable bonus
scores, not to exceed 100 points.
(A) A MIPS eligible clinician earns a score for each measure by
reporting, as applicable: The numerator (of at least one) and
denominator, or a yes/no statement, or an exclusion.
(B) A MIPS eligible clinician may earn a bonus score of 5 points
each for two optional measures.
(iii) Beginning with the 2022 MIPS payment year, a MIPS eligible
clinician's Promoting Interoperability performance category score
equals the sum of the scores for each of the required 8 measures, not
to exceed 100 points.
(A) A MIPS eligible clinician earns a score for each measure by
reporting, as applicable: The numerator (of at least one) and
denominator, or a yes/no statement, or an exclusion.
(B) [Reserved]
(c) Final score calculation. Each MIPS eligible clinician receives
a final score of 0 to 100 points for a performance period for a MIPS
payment year calculated as follows. If a MIPS eligible clinician is
scored on fewer than 2 performance categories, he or she receives a
final score equal to the performance threshold.

------------------------------------------------------------------------

-------------------------------------------------------------------------
For the 2019 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight)+ (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)],
not to exceed 100 points.
For the 2020 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight) + (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)] x
100 + [the complex patient bonus + the small practice bonus], not
to exceed 100 points.
Beginning with the 2021 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight) + (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)] x
100 + the complex patient bonus, not to exceed 100 points.
------------------------------------------------------------------------

(1) Performance category weights. The weights of the performance
categories in the final score are as follows, unless a different
scoring weight is assigned under paragraph (c)(2) of this section:
(i) Quality performance category weight is defined under Sec.
414.1330(b).
(ii) Cost performance category weight is defined under Sec.
414.1350(d).
(iii) Improvement activities performance category weight is defined
under Sec. 414.1355(b).
(iv) Promoting Interoperability performance category weight is
defined under Sec. 414.1375(a).
(2) Reweighting the performance categories. (i) In accordance with
paragraph (c)(2)(ii) of this section, a scoring weight different from
the weights specified in paragraph (c)(1) of this section will be
assigned to a performance category, and its weight as specified in
paragraph (c)(1) of this section will be redistributed to another
performance category or categories, in the following circumstances:
(A) CMS determines based on the following circumstances that there
are not sufficient measures and activities applicable and available
under section 1848(q)(5)(F) of the Act.
(1) For the quality performance category, CMS cannot calculate a
score for the MIPS eligible clinician because there is not at least one
quality measure applicable and available to the clinician.
(2) For the cost performance category, CMS cannot reliably
calculate a score for the cost measures that adequately captures and
reflects the performance of the MIPS eligible clinician.
(3) Beginning with the 2021 MIPS payment year, for the quality,
cost, improvement activities, and Promoting Interoperability
performance categories, the MIPS eligible clinician joins an existing
practice during the final 3 months of the performance period year that
is not participating in MIPS as a group or joins a practice that is
newly formed during the final 3 months of the performance period year.
(4) For the Promoting Interoperability performance category
beginning with the 2021 MIPS payment year, the MIPS eligible clinician
is a physical therapist, occupational therapist, clinical social
worker, or clinical psychologist. In the event that a MIPS eligible
clinician submits data for the Promoting Interoperability performance
category, the scoring weight specified in

[[Page 36084]]

paragraph (c)(1) of this section will be applied and its weight will
not be redistributed.
(5) For the Promoting Interoperability performance category for the
2019, 2020, and 2021 MIPS payment years, the MIPS eligible clinician is
a nurse practitioner, physician assistant, clinical nurse specialist,
or certified registered nurse anesthetist. In the event that a MIPS
eligible clinician submits data for the Promoting Interoperability
performance category, the scoring weight specified in paragraph (c)(1)
of this section will be applied and its weight will not be
redistributed.
(6) Beginning with the 2020 MIPS payment year, for the quality,
cost, and improvement activities performance categories, the MIPS
eligible clinician demonstrates through an application submitted to CMS
that they were subject to extreme and uncontrollable circumstances that
prevented the clinician from collecting information that the clinician
would submit for a performance category or submitting information that
would be used to score a performance category for an extended period of
time. Beginning with the 2021 MIPS payment year, in the event that a
MIPS eligible clinician submits data for the quality, cost, or
improvement activities performance categories, the scoring weight
specified in paragraph (c)(1) of this section will be applied and its
weight will not be redistributed.
(7) For the 2019 MIPS payment year, for the quality and improvement
activities performance categories, the MIPS eligible clinician was
located in an area affected by extreme and uncontrollable circumstances
as identified by CMS. In the event that a MIPS eligible clinician
submits data for a performance category, the scoring weight specified
in paragraph (c)(1) of this section will be applied and its weight will
not be redistributed.
(8) Beginning with the 2020 MIPS payment year, for the quality,
cost, and improvement activities performance categories, the MIPS
eligible clinician was located in an area affected by extreme and
uncontrollable circumstances as identified by CMS. In the event that a
MIPS eligible clinician submits data for the quality or improvement
activities performance categories, the scoring weight specified in
paragraph (c)(1) of this section will be applied and its weight will
not be redistributed.
(B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that
the proportion of MIPS eligible clinicians who are physicians as
defined in section 1861(r) of the Act and earn a Promoting
Interoperability performance category score of at least 75 percent is
75 percent or greater. The estimation is based on data from the
performance period that occurs four years before the MIPS payment year
and does not include physicians for whom the Promoting Interoperability
performance category is weighted at zero percent.
(C) Under section 1848(o)(2)(D) of the Act, a significant hardship
exception or other type of exception is granted to a MIPS eligible
clinician based on the following circumstances for the Promoting
Interoperability performance category. In the event that a MIPS
eligible clinician submits data for the Promoting Interoperability
performance category, the scoring weight specified in paragraph (c)(1)
of this section will be applied and its weight will not be
redistributed.
(1) The MIPS eligible clinician demonstrates through an application
submitted to CMS that they lacked sufficient internet access during the
performance period, and insurmountable barriers prevented the clinician
from obtaining sufficient internet access.
(2) The MIPS eligible clinician demonstrates through an application
submitted to CMS that they were subject to extreme and uncontrollable
circumstances that caused their CEHRT to be unavailable.
(3) The MIPS eligible clinician was located in an area affected by
extreme and uncontrollable circumstances as identified by CMS.
(4) The MIPS eligible clinician demonstrates through an application
submitted to CMS that 50 percent or more of their outpatient encounters
occurred in practice locations where they had no control over the
availability of CEHRT.
(5) The MIPS eligible clinician is a non-patient facing MIPS
eligible clinician as defined in Sec. 414.1305.
(6) The MIPS eligible clinician is a hospital-based MIPS eligible
clinician as defined in Sec. 414.1305.
(7) The MIPS eligible clinician is an ASC-based MIPS eligible
clinician as defined in Sec. 414.1305.
(8) Beginning with the 2020 MIPS payment year, the MIPS eligible
clinician demonstrates through an application submitted to CMS that
their CEHRT was decertified either during the performance period for
the MIPS payment year or during the calendar year preceding the
performance period for the MIPS payment year, and the MIPS eligible
clinician made a good faith effort to adopt and implement another CEHRT
in advance of the performance period. In no case may a MIPS eligible
clinician be granted this exception for more than 5 years.
(9) Beginning with the 2020 MIPS payment year, the MIPS eligible
clinician demonstrates through an application submitted to CMS that
they are in a small practice as defined in Sec. 414.1305, and
overwhelming barriers prevent them from complying with the requirements
for the Promoting Interoperability performance category.
(ii) A scoring weight different from the weights specified in
paragraph (c)(1) of this section will be assigned to a performance
category, and its weight as specified in paragraph (c)(1) of this
section will be redistributed to another performance category or
categories, as follows:
(A) For the 2019 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
Reweight Reweight Reweight
scenario if no scenario if no scenario if no
Weighting for promoting quality improvement
Performance category the 2019 MIPS interoperability performance activities
payment year performance category performance
(%) category score percent score category score
(%) (%) (%)
----------------------------------------------------------------------------------------------------------------
Quality....................................... 60 85 0 75
Cost.......................................... 0 0 0 0
Improvement Activities........................ 15 15 50 0
Promoting Interoperability.................... 25 0 50 25
----------------------------------------------------------------------------------------------------------------

(B) For the 2020 MIPS payment year:

[[Page 36085]]

----------------------------------------------------------------------------------------------------------------
Promoting
Reweighting scenario Quality (%) Cost (%) Improvement interoperability
activities (%) (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 50 10 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 60 0 15 25
--No Promoting Interoperability........... 75 10 15 0
--No Quality.............................. 0 10 45 45
--No Improvement Activities............... 65 10 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 10 90 0
Quality..................................
--No Promoting Interoperability and no 90 10 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 10 0 90
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Promoting
Reweighting scenario Quality (%) Cost (%) Improvement interoperability
activities (%) (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 45 15 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 60 0 15 25
--No Promoting Interoperability........... 70 15 15 0
--No Quality.............................. 0 15 40 45
--No Improvement Activities............... 60 15 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 15 85 0
Quality..................................
--No Promoting Interoperability and no 85 15 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 15 0 85
----------------------------------------------------------------------------------------------------------------

(iii) For MIPS eligible clinicians submitting data as a group or
virtual group, in order for the Promoting Interoperability performance
category to be reweighted in accordance with paragraph (c)(2)(ii) of
this section, all of the MIPS eligible clinicians in the group must
qualify for reweighting based on the circumstances described in
paragraph (c)(2)(i) of this section.
(3) Complex patient bonus. For the 2020 and 2021 MIPS payment
years, provided that a MIPS eligible clinician, group, virtual group or
APM entity submits data for at least one MIPS performance category for
the applicable performance period for the MIPS payment year, a complex
patient bonus will be added to the final score for the MIPS payment
year, as follows:
(i) For MIPS eligible clinicians and groups, the complex patient
bonus is calculated as follows: [The average HCC risk score assigned to
beneficiaries (pursuant to the HCC risk adjustment model established by
CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS
eligible clinician or seen by clinicians in a group] + [the dual
eligible ratio x 5].
(ii) For APM entities and virtual groups, the complex patient bonus
is calculated as follows: [The beneficiary weighted average HCC risk
score for all MIPS eligible clinicians, and if technically feasible,
TINs for models and virtual groups which rely on complete TIN
participation within the APM entity or virtual group, respectively] +
[the average dual eligible ratio for all MIPS eligible clinicians, and
if technically feasible, TINs for models and virtual groups which rely
on complete TIN participation, within the APM entity or virtual group,
respectively, x 5].
(iii) The complex patient bonus cannot exceed 5.0.
(4) Small practice bonus. A small practice bonus of 5 points will
be added to the final score for the 2020 MIPS payment year for MIPS
eligible clinicians, groups, virtual groups, and APM Entities that meet
the definition of a small practice as defined at Sec. 414.1305 and
participate in MIPS by submitting data on at least one performance
category in the 2018 MIPS performance period.
(d) Scoring for APM Entities. MIPS eligible clinicians in APM
Entities that are subject to the APM scoring standard are scored using
the methodology under Sec. 414.1370.
(e) Scoring for facility-based measurement. For the payment in 2021
MIPS payment year and subsequent years and subject to paragraph
(e)(6)(vi) of this section, a MIPS eligible clinician or group may be
scored under the quality and cost performance categories using
facility-based measures under the methodology described in this
paragraph (e).
(1) General. The facility-based measurement scoring standard is the
MIPS scoring methodology applicable for MIPS eligible clinicians
identified as meeting the requirements in paragraph (e)(2) of this
section.
(i) The measures for facility-based measurement consist of the
measure set finalized for the fiscal year VBP program for which payment
begins during the applicable MIPS performance period.
(ii) Beginning with the 2021 MIPS payment year, the scoring
methodology

[[Page 36086]]

applicable for MIPS eligible clinicians scored with facility-based
measurement is the Total Performance Score methodology adopted for the
Hospital VBP Program, for the fiscal year for which payment begins
during the applicable MIPS performance period.
(2) Eligibility for facility-based measurement. MIPS eligible
clinicians are eligible for facility-based measurement for a MIPS
payment year if they are determined to be facility-based as an
individual clinician or as part of a group, as follows:
(i) Facility-based individual determination. A MIPS eligible
clinician is facility-based if the clinician meets all of the following
criteria:
(A) 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 performance period with
a 30-day claims run out.
(B) Furnishes at least 1 covered professional service in sites of
service identified by the place of service codes used in the HIPAA
standard transaction as an inpatient hospital, or emergency room
setting.
(C) Can be attributed, under the methodology specified in paragraph
(e)(5) of this section, to a facility with a VBP score for the
applicable period.
(ii) Facility-based group determination. A facility-based group is
a group in which 75 percent or more of its eligible clinician NPIs
billing under the group's TIN meet the requirements under paragraph
(e)(2)(i) of this section.
(3) [Reserved]
(4) Data submission for facility-based measurement. There are no
data submission requirements for individual clinicians scored under
facility-based measurement. A group must submit data in the improvement
activities or Promoting Interoperability performance categories in
order to be scored as a facility-based group.
(5) Determination of applicable facility score. (i) A facility-
based clinician is scored with facility-based measurement using the
score derived from the value-based purchasing score for the facility at
which the clinician provided services to the most Medicare
beneficiaries during the year the claims are drawn from in paragraph
(e)(2) of this section. If there is an equal number of Medicare
beneficiaries treated at more than one facility, the value-based
purchasing score for the highest scoring facility is used.
(ii) A facility-based group is scored with facility-based
measurement using the score derived from the value-based purchasing
score for the facility at which the plurality of clinicians identified
as facility-based would have had their score determined under paragraph
(e)(5)(i) of this section.
(6) MIPS performance category scoring under the facility-based
measurement scoring standard--(i) Measures. The quality and cost
measures are those adopted under the value-based purchasing program of
the facility for the year described in paragraph (e)(1)(i) of this
section.
(ii) Benchmarks. The benchmarks are those adopted under the value-
based purchasing program of the facility program for the year described
in paragraph (e)(1)(i) of this section.
(iii) Performance period. The performance period for facility-based
measurement is the performance period for the measures adopted under
the value-based purchasing program of the facility program for the year
described in paragraph (e)(1)(i) of this section.
(iv) Quality. The quality performance category percent score is
established by determining the percentile performance of the facility
in the value-based purchasing program for the specified year as
described in paragraph (e)(1)(i) of this section and awarding a score
associated with that same percentile performance in the MIPS quality
performance category percent score for those MIPS-eligible clinicians
who are not eligible to be scored using facility-based measurement for
the MIPS payment year. This score will not include a consideration of
improvement in the MIPS quality performance category score.
(v) Cost. The cost performance category percent score is
established by determining the percentile performance of the facility
in the value-based purchasing program for the specified year as
described in paragraph (e)(1)(i) of this section and awarding a score
associated with that same percentile performance in the MIPS cost
performance category percent score for those MIPS eligible clinicians
who are not eligible to be scored using facility-based measurement for
the MIPS payment year. This score will not include a consideration of
improvement in cost measures.
(A) Other cost measures. MIPS eligible clinicians who are scored
under facility-based measurement are not scored on cost measures
described in paragraph (b)(2) of this section.
(B) [Reserved]
(vi) Use of score from facility-based measurement. The MIPS quality
and cost performance category scores will be based on the facility-
based measurement scoring methodology described in paragraph (e)(6) of
this section unless a clinician or group receive a higher combined MIPS
quality and cost performance category scores through another MIPS
submission.
0
36. Section 414.1395 is amended by revising paragraphs (b) and (c) to
read as follows:

Sec. 414.1395 Public reporting.

* * * * *
(b) Maintain existing public reporting standards. With the
exception of data that must be mandatorily reported on Physician
Compare, for each program year, CMS relies on established public
reporting standards to guide the information available for inclusion on
Physician Compare. The public reporting standards require data included
on Physician Compare to be statistically valid, reliable, and accurate;
comparable across collection types; and meet the reliability threshold.
And, to be included on the public facing profile pages, the data must
also resonate with website users, as determined by CMS.
(c) First year measures. For each program year, CMS does not
publicly report any first year measure for the first 2 years, meaning
any measure in its first 2 years of use in the quality and cost
performance categories. After the first 2 years, CMS reevaluates
measures to determine when and if they are suitable for public
reporting.
* * * * *
0
37. Section 414.1400 is revised to read as follows:

Sec. 414.1400 Third party intermediaries.

(a) General. (1) MIPS data may be submitted on behalf of a MIPS
eligible clinician, group, or virtual group by any of the following
third party intermediaries:
(i) A QCDR;
(ii) A qualified registry;
(iii) A health IT vendor; or
(iv) A CMS-approved survey vendor.
(2) QCDRs, qualified registries, and health IT vendors may submit
MIPS data for any of the following MIPS performance categories:
(i) Quality, except for data on the CAHPS for MIPS survey;
(ii) Improvement activities; or
(iii) Promoting Interoperability, if the MIPS eligible clinician,
group, or virtual group is using CEHRT.
(3) CMS-approved survey vendors may submit data on the CAHPS for
MIPS survey for the MIPS quality performance category.

[[Page 36087]]

(4) To be approved as a third party intermediary, an entity must
agree to meet the applicable requirements of this section, including,
but not limited to, the following:
(i) A third party intermediary's principle place of business and
retention of any data must be based in the U.S.
(ii) If the data is derived from CEHRT, a QCDR, qualified registry,
or health IT vendor must be able to indicate its data source.
(iii) All data must be submitted in the form and manner specified
by CMS.
(5) All data submitted to CMS by a third party intermediary on
behalf of a MIPS eligible clinician, group or virtual group must be
certified by the third party intermediary as true, accurate, and
complete to the best of its knowledge. Such certification must be made
in a form and manner and at such time as specified by CMS.
(b) QCDR approval criteria--(1) QCDR self-nomination. For the 2020
and 2021 MIPS payment years, entities seeking to qualify as a QCDR must
self-nominate September 1 until November 1 of the CY preceding the
applicable performance period. For the 2022 MIPS payment year and
future years, entities seeking to qualify as a QCDR must self-nominate
during a 60-day period during the CY preceding the applicable
performance period (beginning no earlier than July 1 and ending no
later than September 1). Entities seeking to qualify as a QCDR for a
performance period must provide all information required by CMS at the
time of self-nomination and must provide any additional information
requested by CMS during the review process. For the 2021 MIPS payment
year and future years, existing QCDRs that are in good standing may
attest that certain aspects of their previous year's approved self-
nomination have not changed and will be used for the applicable
performance period.
(2) Establishment of a QCDR entity. (i) Beginning with the 2022
MIPS Payment Year, the QCDR must have at least 25 participants by
January 1 of the year prior to the applicable performance period.
(ii) If the entity uses an external organization for purposes of
data collection, calculation, or transmission, it must have a signed,
written agreement with the external organization that specifically
details the responsibilities of the entity and the external
organization. The written agreement must be effective as of September 1
of the year preceding the applicable performance period.
(3) QCDR measures for the quality performance category. (i) For
purposes of QCDRs submitting data for the MIPS quality performance
category, CMS considers the following types of quality measures to be
QCDR measures:
(A) Measures that are not included in the MIPS final list of
quality measures described in Sec. 414.1330(a)(1) for the applicable
MIPS payment year; and
(B) Measures that are included in the MIPS final list of quality
measures described in Sec. 414.1330(a)(1) for the applicable MIPS
payment year, but have undergone substantive changes, as determined by
CMS.
(ii) For the 2020 MIPS payment year and future years, an entity
seeking to become a QCDR must submit specifications for each measure,
activity, and objective that the entity intends to submit to for MIPS
(including the information described in paragraphs (b)(3)(ii)(A) and
(B) of this section) at the time of self-nomination. In addition, no
later than 15 calendar days following CMS approval of any QCDR measure
specifications, the entity must publicly post the measure
specifications for each QCDR measure (including the CMS-assigned QCDR
measure ID) and provide CMS with a link to where this information is
posted.
(A) For QCDR measures, the entity must submit the measure
specifications for each QCDR measure, including: Name/title of
measures, NQF number (if NQF-endorsed), descriptions of the
denominator, numerator, and when applicable, denominator exceptions,
denominator exclusions, risk adjustment variables, and risk adjustment
algorithms.
(B) For MIPS quality measures, the entity must submit the MIPS
measure IDs and specialty-specific measure sets, as applicable.
(C) Beginning with the 2021 MIPS payment year, as a condition of a
QCDR measure's approval for purposes of MIPS, the QCDR measure owner
would be required to agree to enter into a license agreement with CMS
permitting any approved QCDR to submit data on the QCDR measure
(without modification) for purposes of MIPS and each applicable MIPS
payment year.
(iii) A QCDR must include the CMS-assigned QCDR measure ID when
submitting data on any QCDR measure to CMS.
(c) Qualified registry approval criteria--(1) Qualified registry
self-nomination. For the 2020 and 2021 MIPS payment years, entities
seeking to qualify as a qualified registry must self-nominate from
September 1 until November 1 of the CY preceding the applicable
performance period. For the 2022 MIPS payment year and future years,
entities seeking to qualify as a qualified registry must self-nominate
during a 60-day period during the CY preceding the applicable
performance period (beginning no earlier than July 1 and ending no
later than September 1). Entities seeking to qualify as a qualified
registry for a performance period must provide all information required
by CMS at the time of self-nomination and must provide any additional
information requested by CMS during the review process. For the 2021
MIPS payment year and future years, existing qualified registries that
are in good standing may attest that certain aspects of their previous
year's approved self-nomination have not changed and will be used for
the applicable performance period.
(2) Establishment of a qualified registry entity. Beginning with
the 2022 MIPS Payment Year, the qualified registry must have at least
25 participants by January 1 of the year prior to the applicable
performance period.
(d) Health IT vendor approval criteria. Health IT vendors must meet
the criteria specified at Sec. 414.1400(a)(4).
(e) CMS-approved survey vendor approval criteria. Entities seeking
to be a CMS-approved survey vendor for any MIPS performance period must
submit a survey vendor application to CMS in a form and manner
specified by CMS for each MIPS performance period for which it wishes
to transmit such data. The application and any supplemental information
requested by CMS must be submitted by deadlines specified by CMS. For
an entity to be a CMS-approved survey vendor, it must meet the
following criteria:
(1) The entity must have sufficient experience, capability, and
capacity to accurately report CAHPS data, including:
(i) At least 3 years of experience administering mixed-mode surveys
(that is, surveys that employ multiple modes to collect date),
including mail survey administration followed by survey administration
via Computer Assisted Telephone Interview (CATI);
(ii) At least 3 years of experience administering surveys to a
Medicare population;
(iii) At least 3 years of experience administering CAHPS surveys
within the past 5 years;
(iv) Experience administering surveys in English and one of the
following languages: Cantonese, Korean, Mandarin, Russian, or
Vietnamese;
(v) Use equipment, software, computer programs, systems, and
facilities that can verify addresses and phone numbers of sampled
beneficiaries, monitor interviewers,

[[Page 36088]]

collect data via CATI, electronically administer the survey and
schedule call-backs to beneficiaries at varying times of the day and
week, track fielded surveys, assign final disposition codes to reflect
the outcome of data collection of each sampled case, and track cases
from mail surveys through telephone follow-up activities; and
(vi) Employ a program manager, information systems specialist, call
center supervisor and mail center supervisor to administer the survey.
(2) The entity has certified that it has the ability to maintain
and transmit quality data in a manner that preserves the security and
integrity of the data.
(3) The entity has successfully completed, and has required its
subcontractors to successfully complete, vendor training(s)
administered by CMS or its contractors.
(4) The entity has submitted a quality assurance plan and other
materials relevant to survey administration, as determined by CMS,
including cover letters, questionnaires and telephone scripts.
(5) The entity has agreed to participate and cooperate, and has
required its subcontractors to participate and cooperate, in all
oversight activities related to survey administration conducted by CMS
or its contractors.
(6) The entity has sent an interim survey data file to CMS that
establishes the entity's ability to accurately report CAHPS data.
(f) Remedial action and termination of third party intermediaries.
(1) If CMS determines that a third party intermediary (that is, a QCDR,
health IT vendor, qualified registry, or CMS approved survey vendor)
has ceased to meet one or more of the applicable criteria for approval,
or has submitted data that is inaccurate, unusable, or otherwise
compromised, CMS may take one or more of the following remedial actions
after providing written notice to the third party intermediary:
(i) Require the third party intermediary to submit a corrective
action plan (CAP) to CMS to address the identified deficiencies or data
issue, including the actions it will take to prevent the deficiencies
or data issues from recurring. The CAP must be submitted to CMS by a
date specified by CMS.
(ii) If the third party intermediary has a data error rate of 3
percent or more, publicly disclose the entity's data error rate on the
CMS website until the data error rate falls below 3 percent.
(2) CMS may immediately or with advance notice terminate the
ability of a third party intermediary to submit MIPS data on behalf of
a MIPS eligible clinician, group, or virtual group for one or more of
the following reasons:
(i) CMS has grounds to impose remedial action;
(ii) CMS has not received a CAP within the specified time period or
the CAP is not accepted by CMS; and
(iii) The third party intermediary fails to correct the
deficiencies or data errors by the date specified by CMS.
(3) For purposes of paragraph (e) of this section, CMS may
determine that submitted data is inaccurate, unusable, or otherwise
compromised if the submitted data:
(i) Includes, without limitation, TIN/NPI mismatches, formatting
issues, calculation errors, or data audit discrepancies; and
(ii) Affects more than three percent (but less than five percent)
of the total number of MIPS eligible clinicians or group for which data
was submitted by the third party intermediary.
0
38. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(6) and (d)(5);
0
b. Revising paragraph (e) and;
0
c. Adding paragraphs (f) and (g).
The additions and revision read as follows:

Sec. 414.1405 Payment.

* * * * *
(b) * * *
(6) The performance threshold for the 2021 MIPS payment year is 30
points.
* * * * *
(d) * * *
(5) The additional performance threshold for the 2021 MIPS payment
year is 80 points.
(e) Application of adjustments to payments. Except as specified in
paragraph (f) of this section, in the case of covered professional
services (as defined in section 1848(k)(3)(A) of the Act) furnished by
a MIPS eligible clinician during a MIPS payment year beginning with
2019, the amount otherwise paid under Part B with respect to such
covered professional services and MIPS eligible clinician for such
year, is multiplied by 1, plus the sum of the MIPS payment adjustment
factor divided by 100, and as applicable, the additional MIPS payment
adjustment factor divided by 100.
(f) Exception to application of MIPS payment adjustment factors to
model-specific payments under Section 1115A APMs. The payment
adjustment factors specified under paragraph (e) of this section are
not applicable to payments:
(1) Made only to participants in a model tested under section 1115A
of the Act;
(2) That would otherwise be subject to the requirement to apply the
MIPS payment adjustment factors if the payment is made with respect to
a MIPS eligible clinician to participating in a section 1115A model;
and
(3) Are model-specific payments that have a specified payment
amount; or use a methodology for calculating a model-specific payment
that is paid in a consistent manner to participants to which
application of the MIPS payment adjustment factors would potentially
interfere with CMS's ability to effectively evaluate the impact of the
APM.
0
39. Section 414.1415 is amended by revising paragraphs (a)(1)(i),
(b)(1) through (3), (c) introductory text, (c)(3)(i)(A), and (c)(6) to
read as follows:

Sec. 414.1415 Advanced APM criteria.

(a) * * *
(1) * * *
(i) Require at least 50 percent, or for QP Performance Periods
beginning in 2019, 75 percent of eligible clinicians in each
participating APM Entity group, or for APMs in which hospitals are the
APM Entities, each hospital, to use CEHRT to document and communicate
clinical care to their patients or health care providers; or
* * * * *
(b) * * *
(1) To be an Advanced APM, an APM must include quality measure
performance as a factor when determining payment to participants for
covered professional services under the terms of the APM.
(2) At least one of the quality measures used in the payment
arrangement as specified in paragraph (c)(1) of this section must:
(i) For QP Performance Periods before January 1, 2020, have an
evidence-based focus, be reliable and valid, and meet at least one of
the following criteria:
(A) Used in the MIPS quality performance category, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures
under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January 1,
2020, be:
(A) Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.

[[Page 36089]]

(3) In addition to the quality measure described under paragraph
(b)(2) of this section, the quality measures upon which an Advanced APM
bases the payment in paragraph (b)(1) of this section must include at
least one additional measure that is an outcome measure unless CMS
determines that there are no available or applicable outcome measures
included in the MIPS final quality measures list for the Advanced APM's
first QP Performance Period. Beginning January 1, 2020, the included
outcome measure must satisfy the criteria in paragraph (b)(2) of this
section.
(c) Financial risk. To be an Advanced APM, except as described in
paragraph (c)(6) of this section, an APM must either meet the financial
risk standard under paragraph (c)(1) or (2) of this section and the
nominal amount standard under paragraph (c)(3) or (4) of this section
or be an expanded Medical Home Model under section 1115A(c) of the Act.
* * * * *
(3) * * *
(i) * * *
(A) For QP Performance Periods beginning in 2017, through 2024, 8
percent of the average estimated total Medicare Parts A and B revenue
of all providers and suppliers in participating APM Entities; or
* * * * *
(6) Capitation. A full capitation arrangement meets this Advanced
APM criterion. For purposes of this part, a full capitation arrangement
means a payment arrangement in which a per capita or otherwise
predetermined payment is made under the APM for all items and services
furnished to a population of beneficiaries during a fixed period of
time, and no settlement is performed to reconcile or share losses
incurred or savings earned by the APM Entity. Arrangements between CMS
and Medicare Advantage Organizations under the Medicare Advantage
program (42 U.S.C. 422) are not considered capitation arrangements for
purposes of this paragraph (c)(6).
* * * * *
0
40. Section 414.1420 is amended by revising paragraphs (b), (c)(2) and
(3), (d) introductory text, (d)(3)(i), and (d)(7) to read as follows:

Sec. 414.1420 Other payer advanced APM criteria.

* * * * *
(b) Use of CEHRT. To be an Other Payer Advanced APM, CEHRT must be
used by at least 50 percent, or for QP Performance Periods on or after
January 1, 2020, 75 percent of participants in each participating APM
Entity group, or each hospital if hospitals are the APM Entities, in
the other payer arrangement to document and communicate clinical care.
(c) * * *
(2) At least one of the quality measures used in the payment
arrangement as specified in paragraph (c)(1) of this section must:
(i) For QP Performance Period before January 1, 2020, have an
evidence-based focus, be reliable and valid, and meet at least one of
the following criteria:
(A) Used in the MIPS quality performance category, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures
under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January 1,
2020, be:
(A) Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) To meet the quality measure use criterion under paragraph
(c)(1) of this section, a payment arrangement must:
(i) For QP Performance Periods before January 1, 2020, use an
outcome measure if there is an applicable outcome measure on the MIPS
quality measure list. This criterion also applies for payment
arrangements determined to be Other Payer Advanced APMs on or before
January 1, 2020, but only for the Other Payer Advanced APM
determination made with respect to the arrangement for the CY 2020 QP
Performance Period (regardless of whether that determination is a
single- or multi-year determination).
(ii) For QP Performance Periods on or after January 1, 2020, in
addition to the quality measure described under paragraph (c)(2) of
this section, use at least one additional measure that is an outcome
measure and meets the criteria in paragraph (c)(2)(ii) of this section
if there is such an applicable outcome measure on the MIPS quality
measure list.
(d) Financial risk. To be an Other Payer Advanced APM, except as
described in paragraph (d)(7) of this section, a payment arrangement
must meet either the financial risk standard under paragraph (d)(1) or
(2) of this section and the nominal amount standard under paragraph
(d)(3) or (4) of this section, or be a Medicaid Medical Home Model with
criteria comparable to an expanded Medical Home Model under section
1115A(c) of the Act.
* * * * *
(3) * * *
(i) For QP Performance Periods 2019 through 2024, 8 percent of the
total combined revenues from the payer to providers and other entities
under the payment arrangement if financial risk is expressly defined in
terms of revenue; or, 3 percent of the expected expenditures for which
an APM Entity is responsible under the payment arrangement.
* * * * *
(7) Capitation. A full capitation arrangement meets this Other
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this
section, a full capitation arrangement means a payment arrangement in
which a per capita or otherwise predetermined payment is made under the
payment arrangement for all items and services furnished to a
population of beneficiaries during a fixed period of time, and no
settlement is performed for the purpose of reconciling or sharing
losses incurred or savings earned by the participant. Arrangements made
directly between CMS and Medicare Advantage Organizations under the
Medicare Advantage program (42 U.S.C. 422) are not considered
capitation arrangements for purposes of this paragraph (c)(7).
* * * * *
0
41. Section 414.1440 is amended by revising paragraphs (d)(1) through
(3) to read as follows:

Sec. 414.1440 Qualifying APM participant determination: All-payer
combination option.

* * * * *
(d) * * *
(1) CMS performs QP determinations following the QP Performance
Period using payment amount and/or patient count information submitted
from January 1 through each of the respective QP determination dates:
March 31, June 30, and August 31. CMS will use data for the same time
periods for the Medicare and other payer portions of Threshold Score
calculations under the All-Payer Combination Option. CMS will use the
payment amount or patient count method, applying the more advantageous
of the two for both the Medicare and other payer portions of the
Threshold score calculation, regardless of the method used for the
Medicare Threshold Score calculation.

[[Page 36090]]

(2) An APM Entity may request that CMS make QP determinations at
the APM Entity level, an eligible clinician may request that CMS make
QP determinations at the eligible clinician level, and an eligible
clinician or an APM Entity may request that CMS makes QP determinations
at the TIN-level in instances where all clinicians who reassigned
billing rights to the TIN are participating in a single APM Entity. CMS
makes QP determinations at either the APM Entity, eligible clinician,
or TIN level. Eligible clinicians assessed at the eligible clinician
level under the Medicare Option at Sec. 414.1425(b)(2) will be
assessed at the eligible clinician level only under the All-Payer
Combination Option. Eligible Clinicians may meet the Medicare and the
All-Payer Combination Option thresholds using the payment amount method
for both thresholds, the patient account method for both thresholds, or
the payment amount method for one threshold and the patient account
method for the other threshold.
(3) CMS uses data at the same level for the Medicare and other
payer portions of Threshold Score calculations under the All-Payer
Combination Option. When QP determinations are made at the eligible
clinician or, at the TIN level when all clinicians who have reassigned
billing rights to the TIN are included in a single APM Entity; and if
the Medicare Threshold score for the APM Entity group is higher than
when calculated for the eligible clinician or TIN, CMS makes QP
determinations using a weighted Medicare Threshold Score that is
factored into an All-Payer Combination Option Threshold Score.
* * * * *
0
42. Section 414.1445 is amended by revising paragraph (b)(1) and adding
paragraphs (c)(2)(i) and (ii) to read as follows:

Sec. 414.1445 Determination of other payer advanced APMs.

* * * * *
(b) * * *
(1) Payer initiated Other Payer Advanced APM determination process.
Beginning in 2018, and each year thereafter, at a time determined by
CMS a payer with a Medicare Health Plan payment arrangement may
request, in a form and manner specified by CMS, that CMS determine
whether a Medicare Health Plan payment arrangement meets the Other
Payer Advanced APM criteria set forth in Sec. 414.1420. A payer with a
Medicare Health Plan payment arrangement must submit its requests by
the annual Medicare Advantage bid deadline of the year prior to the
relevant QP Performance Period.
* * * * *
(c) * * *
(2) * * *
(i) Based on the submission by an eligible clinician or payer of
evidence that CMS determines sufficiently demonstrates that CEHRT is
used as specified in Sec. 414.1420(b) by participants in the payment
arrangement, CMS will consider the CEHRT criterion in Sec. 414.1420(b)
is satisfied for that payment arrangement.
(ii) [Reserved]
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
CERTAIN SETTINGS

0
43. The authority citation for part 415 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).

0
44. Section 415.172 is amended by revising paragraph (b) to read as
follows:

Sec. 415.172 Physician fee schedule payment for services of teaching
physicians.

* * * * *
(b) Documentation. 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 the teaching
physician was present at the time the service is furnished. 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.
* * * * *
0
45. Section 415.174 is amended--
0
a. In paragraph (a)(3)(iii) by adding ``and'' at the end of the
paragraph;
0
b. In paragraph (a)(3)(iv) by removing ``; and'' and adding a period in
its place;
0
c. By removing paragraph (a)(3)(v); and
0
d. By adding paragraph (a)(6).
The addition reads as follows:

Sec. 415.174 Exception: Evaluation and management services furnished
in certain centers.

(a) * * *
(6) The medical records must document the extent of the teaching
physician's participation in the review and direction of services
furnished to each beneficiary. 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.
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY
INCENTIVE PROGRAM

0
46. The authority citation for part 495 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).

0
47. Section 495.4 is amended in the definition of ``EHR reporting
period'' by adding reserved paragraph (1)(iv) and adding paragraph
(1)(v) to read as follows:

Sec. 495.4 Definitions.

* * * * *
EHR reporting period. * * *
(1) * * *
(iv) [Reserved]
(v) Under the Medicaid Promoting Interoperability Program, for the
CY 2021 payment year:
(A) For the EP first demonstrating he or she is a meaningful EHR
user, any continuous 90-day period within CY 2021 that ends before
October 31, 2021, or that ends before an earlier date in CY 2021 that
is specified by the state and approved by CMS in the State Medicaid HIT
plan described at Sec. 495.332.
(B) For the EP who has successfully demonstrated he or she is a
meaningful EHR user in any prior year, any continuous 90-day period
within CY 2021 that ends before October 31, 2021, or that ends before
an earlier date in CY 2021 that is specified by the state and approved
by CMS in the State Medicaid HIT plan described at Sec. 495.332.
* * * * *
0
48. Section 495.24 is amended by revising paragraphs (d)(6)(i)(B) and
(d)(8)(i)(B)(2), to read as follows:

Sec. 495.24 Stage 3 meaningful use objectives and measures for EPs,
eligible hospitals and CAHs for 2019 and subsequent years.

* * * * *
(d) * * *
(6) * * *
(i) * * *
(B) Measures. In accordance with paragraph (a)(2) of this section,
an EP must satisfy 2 out of the 3 following measures in paragraphs
(d)(6)(i)(B)(1) through (3) of this section except those measures for
which an EP qualifies for an exclusion under paragraph (a)(3) of this
section.
(1) During the EHR reporting period, more than 5 percent of all
unique

[[Page 36091]]

patients (or their authorized representatives) seen by the EP actively
engage with the electronic health record made accessible by the
provider and do either of the following:
(i) View, download or transmit to a third party their health
information;
(ii) Access their health information through the use of an API that
can be used by applications chosen by the patient and configured to the
API in the provider's CEHRT; or
(iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of
this section.
(2) A secure message was sent using the electronic messaging
function of CEHRT to the patient (or their authorized representatives),
or in response to a secure message sent by the patient, for more than 5
percent of all unique patients seen by the EP during the EHR reporting
period.
(3) Patient generated health data or data from a nonclinical
setting is incorporated into the CEHRT for more than 5 percent of all
unique patients seen by the EP during the EHR reporting period.
* * * * *
(8) * * *
(i) * * *
(B) * * *
(2) Syndromic surveillance reporting. The EP is in active
engagement with a public health agency to submit syndromic surveillance
data from an urgent care setting, or from any other setting from which
ambulatory syndromic surveillance data are collected by the state or a
local public health agency.
* * * * *
0
49. Section 495.332 is amended by adding paragraphs (f)(3), (4), and
(5) to read as follows:

Sec. 495.332 State Medicaid health information technology (HIT) plan
requirements.

* * * * *
(f) * * *
(3) An alternative date within CY 2021 by which all ``EHR reporting
periods'' (as defined under Sec. 495.4) for the CY 2021 payment year
for Medicaid EPs demonstrating they are meaningful EHR users must end.
The alternative date selected by the state must be earlier than October
31, 2021, and must not be any earlier than the day prior to the
attestation deadline for Medicaid EPs attesting to that state.
(4) An alternative date within CY 2021 by which all clinical
quality measure reporting periods for the CY 2021 payment year for
Medicaid EPs demonstrating they are meaningful EHR users must end. The
alternative date selected by the state must be earlier than October 31,
2021, and must not be any earlier than the day prior to the attestation
deadline for Medicaid EPs attesting to that state.
(5) For the CY 2019 payment year and beyond, a state-specific
listing of which clinical quality measures selected by CMS are
considered to be high priority measures for purposes of Medicaid EP
clinical quality measure reporting.
* * * * *

Dated: June 22, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: June 28, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

Note: The following appendices will not appear in the Code of
Federal Regulations.

BILLING CODE 4120-01-P

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[FR Doc. 2018-14985 Filed 7-12-18; 4:15 pm]
BILLING CODE 4120-01-C