[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Proposed Rules]
[Pages 59102-59113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-3321-NC]


Request for Information Regarding Implementation of the Merit-
Based Incentive Payment System, Promotion of Alternative Payment 
Models, and Incentive Payments for Participation in Eligible 
Alternative Payment Models

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

ACTION: Request for information.

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SUMMARY: Section 101 of the Medicare Access and CHIP Reauthorization 
Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) 
methodology for updates to the physician fee schedule (PFS) and 
replaces it with a new Merit-based Incentive Payment System (MIPS) for 
MIPS eligible professionals (MIPS EPs) under the PFS. Section 101 of 
the MACRA sunsets payment adjustments under the current Physician 
Quality Reporting System (PQRS), the Value-Based Payment Modifier (VM), 
and the Electronic Health Records (EHR) Incentive Program. It also 
consolidates aspects of the PQRS, VM, and EHR Incentive Program into 
the new MIPS. Additionally, section 101 of the MACRA promotes the 
development of Alternative Payment Models (APMs) by providing incentive 
payments for certain eligible professionals (EPs) who participate in 
APMs, by exempting EPs from MIPS if they participate in APMs, and by 
encouraging the creation of physician-focused payment models (PFPMs). 
In this request for information (RFI), we seek public and stakeholder 
input to inform our implementation of these provisions.

DATES: To be assured consideration, written or electronic comments must 
be received at one of the addresses provided below, no later than 5 
p.m. on November 2, 2015.

ADDRESSES: In commenting, refer to file code CMS-3321-NC. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of four 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-3321-NC, 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-3321-NC, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses:
    a. For delivery in Washington, DC--
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201

    (Because access to the interior of the Hubert H. Humphrey 
Building is not readily available to persons without Federal 
government identification, commenters are encouraged to leave their 
comments in the CMS drop slots located in the main lobby of the 
building. A stamp-in clock is available for persons wishing to 
retain a proof of filing by stamping in and retaining an extra copy 
of the comments being filed.)

    b. For delivery in Baltimore, MD--
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.

FOR FURTHER INFORMATION CONTACT: 

[[Page 59103]]

    Molly MacHarris, (410) 786-4461.
    Alison Falb, (410) 786-1169.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    Section 101 of the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) amended sections 
1848(d) and (f) of the Social Security Act (the Act) to repeal the 
sustainable growth rate (SGR) formula for updating Medicare physician 
fee schedule (PFS) payment rates and substitute a series of specified 
annual update percentages. It establishes a new methodology that ties 
annual PFS payment adjustments to value through a Merit-Based Incentive 
Payment System (MIPS) for MIPS eligible professionals (MIPS EPs). 
Section 101 of the MACRA also creates an incentive program to encourage 
participation by eligible professionals (EPs) in Alternative Payment 
Models (APMs). In the ``Medicare Program; Revisions to Payment Policies 
under the Physician Fee Schedule and Other Revisions to Part B for CY 
2016; Proposed Rule'' (80 FR 41686) (hereinafter referred to as the CY 
2016 PFS proposed rule), the Secretary of Health and Human Services 
(the Secretary) solicited comments regarding implementation of certain 
aspects of the MIPS and broadly sought public comments on the topics in 
section 101 of the MACRA, including the incentive payments for 
participation in APMs and increasing transparency of physician-focused 
payment models. As we move forward with the implementation of these 
provisions, there are additional areas on which we would like to 
receive public and stakeholder input and feedback.

A. The Merit-Based Incentive Payment System (MIPS)

    Section 1848(q) of the Act, as added by section 101(c) of the 
MACRA, requires establishment of the MIPS, applicable beginning with 
payments for items and services furnished on or after January 1, 2019, 
under which the Secretary is required to: (1) Develop a methodology for 
assessing the total performance of each MIPS EP according to 
performance standards for a performance period for a year; (2) using 
the methodology, provide for a composite performance score for each 
MIPS EP for each performance period; and (3) use the composite 
performance score of the MIPS EP for a performance period for a year to 
determine and apply a MIPS adjustment factor (and, as applicable, an 
additional MIPS adjustment factor) to the MIPS EP for the year. Under 
section 1848(q)(2)(A) of the Act, a MIPS EP's composite performance 
score is determined using four performance categories: Quality, 
resource use, clinical practice improvement activities, and meaningful 
use of certified EHR technology (CEHRT). Section 1848(q)(10) of the Act 
requires the Secretary to consult with stakeholders (through a request 
for information (RFI) or other appropriate means) in carrying out the 
MIPS, including for the identification of measures and activities for 
each of the four performance categories under the MIPS, the methodology 
to assess each MIPS EP's total performance to determine their MIPS 
composite performance score, the methodology to specify the MIPS 
adjustment factor for each MIPS EP for a year, and regarding the use of 
qualified clinical data registries (QCDRs) for purposes of the MIPS. We 
intend to use the feedback we receive on the CY 2016 PFS proposed rule 
and on this RFI as we develop our proposed policies for the MIPS.

B. Alternative Payment Models

    Section 101(e) of the MACRA promotes the development of, and 
participation in, APMs for physicians and certain practitioners. The 
statutory amendments made by this section have payment implications for 
EPs beginning in 2019. Specifically, this section: (1) Creates a 
payment incentive program that applies to EPs who are qualifying APM 
participants (QPs) for years from 2019 through 2024; (2) requires the 
establishment of a process for stakeholders to propose PFPMs to an 
independent ``Physician-Focused Payment Model Technical Advisory 
Committee'' (the Committee) that will review, comment on, and provide 
recommendations to the Secretary on the proposed PFPMs; and (3) 
requires the establishment of criteria for PFPMs for use by the 
Committee for making comments and recommendations to the Secretary. 
Section 1868(c)(2)(A) of the Act requires the use of an RFI in 
establishing criteria for PFPMs that could be used by the Committee. 
Additionally, Section 101(c) of the MACRA exempts QPs from MIPS.
    We are issuing this RFI to obtain input on policy considerations 
for APMs and for PFPMs. Topics of particular interest include: (1) 
Requirements to be considered an eligible alternative payment entity 
and QP; (2) the relationship between APMs and the MIPS; and (3) 
criteria for the Committee to use to provide comments and 
recommendations on PFPMs.

C. Technical Assistance to Small Practices and Practices in Health 
Professional Shortage Areas

    Section 1848(q)(11) of the Act, as added by section 101(c) of the 
MACRA, provides for technical assistance to MIPS EPs in small practices 
and practices in health professional shortage areas (HPSAs). In 
general, the section requires the Secretary to enter into contracts or 
agreements with appropriate entities (such as quality improvement 
organizations, regional extension centers (as described in section 
3012(c) of the Public Health Service Act (PHSA)), or regional health 
collaboratives) to offer guidance and assistance to MIPS EPs in 
practices of 15 or fewer professionals (with priority given to such 
practices located in rural areas, HPSAs (as designated under section 
332(a)(1)(A) of the PHSA), and medically underserved areas, and 
practices with low composite scores) with respect to the MIPS 
performance categories or in transitioning to the implementation of, 
and participation in, an APM. As we continue to develop our policies 
and approach for this support, we seek input on a few areas on what 
best practices should be utilized while providing this technical 
assistance.

II. Solicitation of Comments

A. The Merit-Based Incentive Payment System (MIPS)

    We are soliciting public input as we move forward with the planning 
and implementation of the MIPS. We are requesting information regarding 
the following areas:

[[Page 59104]]

1. MIPS EP Identifier and Exclusions
    Section 1848(q)(1)(C) of the Act defines a MIPS EP for the first 2 
years for which the MIPS applies to payments (and the performance 
periods for such years) as a physician (as defined in section 1861(r) 
of the Act), a physician assistant (PA), nurse practitioner (NP) and 
clinical nurse specialist (CNS) (as those are defined in section 
1861(aa)(5) of the Act), a certified registered nurse anesthetist 
(CRNA) (as defined in section 1861(bb)(2) of the Act), and a group that 
includes such professionals. Beginning with the third year of the 
program and for succeeding years, the statute defines a MIPS EP to 
include all the types of professionals identified for the first 2 
years. It also gives the Secretary discretion to specify additional 
EPs, as that term is defined in section 1848(k)(3)(B) of the Act, which 
could include a certified nurse midwife (as defined in section 
1861(gg)(2) of the Act), a clinical social worker (as defined in 
section 1861(hh)(1) of the Act), a clinical psychologist (as defined by 
the Secretary for purposes of section 1861(ii) of the Act), a 
registered dietician or nutrition professional, a physical or 
occupational therapist, a qualified speech-language pathologist, or a 
qualified audiologist (as defined in section 1861(ll)(3)(B) of the 
Act).
    Section 1848(q)(5)(I)(ii) of the Act requires that the Secretary 
establish a process to allow individual MIPS EPs and group practices of 
not more than 10 MIPS EPs to elect, with respect to a performance 
period for a year, to be a virtual group with at least one other 
individual MIPS EP or group practice. Section 1848(q)(5)(I)(iii)(III)) 
of the Act requires that the process provide that a virtual group be a 
combination of Tax Identification Numbers (TINs).
    CMS currently uses a variety of identifiers to associate an EP 
under different programs. For example, under the PQRS for individual 
reporting, CMS uses a combination of a TIN and National Provider 
Identifier (NPI) to assess eligibility and participation, where each 
unique TIN and NPI combination is treated as a distinct EP and is 
separately assessed for purposes of the program. Under the Group 
Practice Reporting Option (GPRO) under PQRS, eligibility and 
participation are assessed at the TIN level. Under the EHR Incentive 
Program, CMS utilizes the NPI to assess eligibility and participation. 
And under the VM, performance and payment adjustments are assessed at 
the TIN level. Additionally, under certain models such as the Pioneer 
Accountable Care Organization (ACO) Model, CMS also assigns a program-
specific identifier (in the case of the Pioneer ACO Model, an ACO ID) 
to the organization(s), and associates that identifier with individual 
EPs that are, in turn, identified through a combination of a TIN and an 
NPI. CMS will need to select and operationalize a specific identifier 
to associate with an individual MIPS EP or a group practice.
    We seek comment on what specific identifier(s) should be used to 
appropriately identify MIPS EPs for purposes of determining 
eligibility, participation, and performance under the MIPS performance 
categories. Specifically, we seek comment on the following questions:
     Should we use a MIPS EP's TIN, NPI or a combination 
thereof? Should we create a distinct MIPS Identifier?
     What are the advantages/disadvantages associated with 
using existing identifiers, either individually or in combination?
     What are the advantages/disadvantages associated with 
creating a distinct MIPS identifier?
     Should a different identifier be used to reflect 
eligibility, participation, or performance as a group practice vs. as 
an individual MIPS EP? If so, should CMS use an existing identifier or 
create a distinct identifier?
     How should we calculate performance for MIPS EPs that 
practice under multiple TINs?
     Should practitioners in a virtual group and virtual group 
practices have a unique virtual group identifier that is used in 
addition to the TIN?
     How often should we require an EP or group practice to 
update any such identifier(s) within the Medicare Provider Enrollment, 
Chain, and Ownership System (PECOS)? For example, should EPs be 
required to update their information in PECOS or a similar system that 
would pertain to the MIPS on an annual basis?
    Additionally, we note that depending upon the identifier(s) chosen 
for MIPS EPs, there could be situations where a given MIPS EP may be 
part of a ``split TIN''. For example, in the scenario where the 
identifier chosen for MIPS EPs is a TIN (as is utilized by the VM 
currently), and a portion of that TIN is exempt from MIPS due to being 
part of a qualifying APM, we will have a split TIN.
    In the above scenario, what safeguards should be in place to ensure 
that we are appropriately assessing MIPS EPs and exempting only those 
EPs that are not eligible for MIPS?
    We also recognize that depending upon the identifier(s) chosen for 
MIPS EPs, there could be situations where a given MIPS EP would be 
assessed under the MIPS using multiple identifiers. For example, as 
noted above, individual EPs are assessed under the PQRS based on unique 
TIN/NPI combinations. Therefore, individual EPs (each with a unique 
NPI) who practice under multiple TINs are assessed under the PQRS as a 
distinct EP for each TIN/NPI combination. For example, under PQRS an EP 
could receive a negative payment adjustment under one unique TIN/NPI 
combination, but not receive it under another unique TIN/NPI 
combination.
     What safeguards should be in place to ensure that MIPS EPs 
do not switch identifiers if they are considered ``poor-performing''?
     What safeguards should be in place to address any 
unintended consequences, if the chosen identifier is a unique TIN/NPI 
combination, to ensure an appropriate assessment of the MIPS EPs 
performance?
2. Virtual Groups
    Section 1848(q)(5)(I) of the Act requires the Secretary to 
establish a process to allow an individual MIPS EP or a group practice 
of not more than 10 MIPS EPs to elect for a performance period for a 
year to be a virtual group with other such MIPS EPs or group practices. 
CMS quality programs, such as the PQRS, have used common identifiers 
such as a group practice's TIN to assess individual EPs' quality 
together as a group practice. The virtual group option under the MIPS 
allows a group's performance to be tied together even if the EPs in the 
group do not share the same TIN. CMS seeks comment on what parameters 
should be established for these virtual groups. We seek comment on the 
following questions:
     How should eligibility, participation, and performance be 
assessed under the MIPS for voluntary virtual groups?
     Assuming that some, but not all, members of a TIN could 
elect to join a virtual group, how should remaining members of the TIN 
be treated under the MIPS, if we allow TINs to split?
     Should there be a maximum or a minimum size for virtual 
groups? For example, should there be limitations on the size of a 
virtual group, such as a minimum of 10 MIPS EPs, or no more than 100 
MIPS EPs that can elect to be in a given virtual group?
     Should there be a limit placed on the number of virtual 
group elections that can be made for a particular performance period 
for a year as this provision is rolled out? We are considering limiting 
the number of voluntary virtual groups to no more

[[Page 59105]]

than 100 for the first year this provision is implemented in order for 
CMS to gain experience with this new reporting configuration. Are there 
other criteria we should consider? Should we limit for virtual groups 
the mechanisms by which data can be reported under the quality 
performance category to specific methods such as QCDRs or utilizing the 
Web interface?
     If a limit is placed on the number of virtual group 
elections within a performance period, should this be done on a first-
come, first-served basis? Should limits be placed on the size of 
virtual groups or the number of groups?
     Under the voluntary virtual group election process, what 
type of information should be required in order to make the election 
for a performance period for a year? What other requirements would be 
appropriate for the voluntary virtual group election process?
    Section 1848(q)(5)(I)(ii) of the Act provides that a virtual group 
may be based on appropriate classifications of providers, such as by 
specialty designations or by geographic areas. We seek comment on the 
following questions:
     Should there be limitations, such as that MIPS EPs 
electing a virtual group must be located within a specific 50 mile 
radius or within close proximity of each other and be part of the same 
specialty?
3. Quality Performance Category
    Section 1848(q)(2)(B)(i) of the Act describes the measures and 
activities for the quality performance category under the MIPS. Under 
section 1848(q)(2)(D) of the Act, the Secretary must, through notice 
and comment rulemaking by November 1 of the year before the first day 
of each performance period under the MIPS, establish the list of 
quality measures from which MIPS EPs may choose for purposes of 
assessment for a performance period for a year. CMS' experience under 
other quality programs, namely the PQRS and the VM, will help shape 
processes and policies for this performance category. We seek comment 
on the following areas:
a. Reporting Mechanisms Available for Quality Performance Category
    There are two ways EPs can report under the PQRS, as either an 
individual EP or as part of a group practice, and for reporting periods 
that occur during 2015, there are collectively 7 available mechanisms 
to report data to CMS as an individual EP and as a group practice 
participating in the PQRS GPRO. They are: Claims-based reporting; 
qualified registry reporting; QCDR reporting; direct EHR products; EHR 
data submission vendor products; Consumer Assessment of Healthcare 
Providers and Systems (CAHPS) for PQRS; and the GPRO Web Interface. 
Generally, to avoid the PQRS payment adjustment, EPs and group 
practices are required to report for the applicable reporting period on 
a specified number of measures covering a specified number of National 
Quality Strategy domains. (See 42 CFR 414.90 for more information 
regarding the PQRS reporting criteria.) If data is submitted on fewer 
measures than required, an EP is subject to a Measure Applicability 
Validation (MAV) process, which looks across an EP's services to 
determine if other quality measures could have been reported. We seek 
comment on the following questions related to these reporting 
mechanisms and criteria:
     Should we maintain all PQRS reporting mechanisms noted 
above under MIPS?
     If so, what policies should be in place for determining 
which data should be used to calculate a MIPS EP's quality score if 
data are received via multiple methods of submission? What 
considerations should be made to ensure a patient's data is not counted 
multiple times? For example, if the same measure is reported through 
different reporting mechanisms, the same patient could be reported 
multiple times.
     Should we maintain the same or similar reporting criteria 
under MIPS as under the PQRS? What is the appropriate number of 
measures on which a MIPS EP's performance should be based?
     Should we maintain the policy that measures cover a 
specified number of National Quality Strategy domains?
     Should we require that certain types of measures be 
reported? For example, should a minimum number of measures be outcomes-
based? Should more weight be assigned to outcomes-based measures?
     Should we require that reporting mechanisms include the 
ability to stratify the data by demographic characteristics such as 
race, ethnicity, and gender?
     For the CAHPS for PQRS reporting option specifically, 
should this still be considered as part of the quality performance 
category or as part of the clinical practice improvement activities 
performance category? What considerations should be made as we further 
implement CAHPS for all practice sizes? How can we leverage existing 
CAHPS reporting by physician groups?
     How do we apply the quality performance category to MIPS 
EPs that are in specialties that may not have enough measures to meet 
our defined criteria? Should we maintain a Measure-Applicability 
Verification Process? If we customize the performance requirements for 
certain types of MIPS EPs, how should we go about identifying the MIPS 
EPs to whom specific requirements apply?
     What are the potential barriers to successfully meeting 
the MIPS quality performance category?
b. Data Accuracy
    CMS' experience under the PQRS has shown that data quality is 
related to the mechanism selected for reporting. Some potential data 
quality issues specific to reporting via a qualified registry, QCDR, 
and/or certified EHR technology include: Inaccurate TIN and/or NPI, 
inaccurate or incomplete calculations of quality measures, missing data 
elements, etc. Since accuracy of the data is critical to the accurate 
calculation of a MIPS composite score, we seek comment on what 
additional data integrity requirements should be in place for the 
reporting mechanisms referenced above. Specifically:
     What should CMS require in terms of testing of the 
qualified registry, QCDR, or direct EHR product, or EHR data submission 
vendor product? How can testing be enhanced to improve data integrity?
     Should registries and qualified clinical data registries 
be required to submit data to CMS using certain standards, such as the 
Quality Reporting Document Architecture (QRDA) standard, which 
certified EHRs are required to support?
     Should CMS require that qualified registries, QCDRs, and 
health IT systems undergo review and qualification by CMS to ensure 
that CMS' form and manner are met? For example, CMS uses a specific 
file format for qualified registry reporting. The current version is 
available at: https://www.qualitynet.org/imageserver/pqrs/registry2015/index.htm. What should be involved in the testing to ensure CMS' form 
and manner requirements are met?
     What feedback from CMS during testing would be beneficial 
to these stakeholders?
     What thresholds for data integrity should CMS have in 
place for accuracy, completeness, and reliability of the data? For 
example, if a QCDR's calculated performance rate does not equate to the 
distinct performance values, such as the numerator exceeding the value 
of the denominator, should CMS re-calculate the data based on the

[[Page 59106]]

numerator and denominator values provided? Should CMS not require MIPS 
EPs to submit a calculated performance rate (and instead have CMS 
calculate all rates)? Alternatively, for example, if a QCDR omits data 
elements that make validation of the reported data infeasible, should 
the data be discarded? What threshold of errors in submitted data 
should be acceptable?
     If CMS determines that the MIPS EP (participating as an 
individual EP or as part of a group practice or virtual group) has used 
a data reporting mechanism that does not meet our data integrity 
standards, how should CMS assess the MIPS EP when calculating their 
quality performance category score? Should there be any consequences 
for the qualified registry, QCDR or EHR vendor in order to correct 
future practices? Should the qualified registry, QCDR or EHR vendor be 
disqualified or unable to participate in future performance periods? 
What consequences should there be for MIPS EPs?
c. Use of Certified EHR Technology (CEHRT) Under the Quality 
Performance Category
    Currently under the PQRS, the reporting mechanisms that use CEHRT 
require that the quality measures be derived from CEHRT and must be 
transmitted in specific file formats. For example, EHR technology that 
meets the CEHRT definition must be able to record, calculate, report, 
import, and export clinical quality measure (CQM) data using the 
standards that the Office of the National Coordinator for Health 
Information Technology (ONC) has specified, including use of the 
Quality Reporting Data Architecture (QRDA) Category I and III 
standards. We seek input on the following questions:
     Under the MIPS, what should constitute use of CEHRT for 
purposes of reporting quality data?
     Instead of requiring that the EHR be utilized to transmit 
the data, should it be sufficient to use the EHR to capture and/or 
calculate the quality data? What standards should apply for data 
capture and transmission?
4. Resource Use Performance Category
    Section 1848(q)(2)(B)(ii) of the Act describes the resource use 
performance category under MIPS as ``the measurement of resource use 
for such period under section1848(p)(3) of the Act, using the 
methodology under section 1848(r) of the Act as appropriate, and, as 
feasible and applicable, accounting for the cost of drugs under Part 
D.'' Section 1848(p)(3) of the Act specifies that costs shall be 
evaluated, to the extent practicable, based on a composite of 
appropriate measures of costs for purposes of the VM under the PFS. 
Section 1848(r) of the Act (as added by section 101(f) of the MACRA) 
specifies a series of steps and deliverables for the Secretary to 
develop ``care episode and patient condition groups and classification 
codes'' and ``patient relationship categories and codes'' for purposes 
of attribution of patients to practitioners, and provides for the use 
of these in a specified methodology for measurement of resource use. 
Under the MIPS, the Secretary must evaluate costs based on a composite 
of appropriate measures of costs using the methodology for resource use 
analysis specified in section 1848(r)(5) of the Act that involves the 
use of certain codes and claims data and condition and episode groups, 
as appropriate. CMS' experience under the VM will help shape this 
performance category. Currently under the VM, we use the following cost 
measures: (1) Total Per Capita Costs for All Attributed Beneficiaries 
measure; (2) Total Per Capita Costs for Beneficiaries with Specific 
Conditions (Diabetes, Coronary artery disease, Chronic obstructive 
pulmonary disease, and Heart failure); and (3) Medicare Spending per 
Beneficiary (MSPB) measure. We seek comment on the following questions:
     Apart from the cost measures noted above, are there 
additional cost or resource use measures (such as measures associated 
with services that are potentially harmful or over-used, including 
those identified by the Choosing Wisely initiative) that should be 
considered? If so, what data sources would be required to calculate the 
measures?
     How should we apply the resource use category to MIPS EPs 
for whom there may not be applicable resource use measures?
     What role should episode-based costs play in calculating 
resource use and/or providing feedback reports to MIPS EPs under 
section 1848(q)(12) of the Act?
     How should CMS consider aligning measures used under the 
MIPS resource use performance category with resource use based measures 
used in other parts of the Medicare program?
     How should we incorporate Part D drug costs into MIPS? How 
should this be measured and calculated?
     What peer groups or benchmarks should be used when 
assessing performance under the resource use performance category?
     CMS has received stakeholder feedback encouraging us to 
align resource use measures with clinical quality measures. How could 
the MIPS methodology, which includes domains for clinical quality and 
resource use, be designed to achieve such alignment?
    We also note that there will be forthcoming opportunities to 
comment on further development of care episode and patient condition 
groups and classification codes, and patient relationship categories 
and groups, as required by section 1848(r) of the Act.
5. Clinical Practice Improvement Activities Performance Category
    Section 1848(q)(2)(B)(iii) of the Act specifies that the measures 
and activities for the clinical practice improvement activities 
performance category must include at least the following subcategories 
of activities: Expanded practice access, population management, care 
coordination, beneficiary engagement, patient safety and practice 
assessment, and participation in an APM. The Secretary has discretion 
under this provision to add other subcategories of activities as well. 
The term ``clinical practice improvement activity'' is defined under 
section 1848(q)(2)(C)(v)(III) of the Act as an activity that relevant 
eligible professional 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. Under section 1848(q)(2)(C)(v) of the Act, we are 
required to use an RFI to solicit recommendations from stakeholders to 
identify and specify criteria for clinical practice improvement 
activities. In the CY 2016 PFS proposed rule (80 FR 41879), the 
Secretary sought comment on what activities could be classified as 
clinical practice improvement activities under the subcategories 
specified in section 1848(q)(2)(B)(iii) of the Act. In this RFI, we 
seek comment on other potential clinical practice improvement 
activities (and subcategories of activities), and on the criteria that 
should be applicable for all clinical practice improvement activities. 
We also seek comment on the following subcategories, in particular how 
measures or other demonstrations of activity may be validated and 
evaluated:
     A subcategory of Promoting Health Equity and Continuity, 
including (a) serving Medicaid beneficiaries, including individuals 
dually eligible for Medicaid and Medicare, (b) accepting new Medicaid 
beneficiaries, (c) participating in the network of plans in the 
Federally-facilitated Marketplace or state exchanges, and (d) 
maintaining adequate equipment and other

[[Page 59107]]

accommodations (for example, wheelchair access, accessible exam tables, 
lifts, scales, etc.) to provide comprehensive care for patients with 
disabilities.
     A subcategory of Social and Community Involvement, such as 
measuring completed referrals to community and social services or 
evidence of partnerships and collaboration with the community and 
social services.
     A subcategory of Achieving Health Equity, as its own 
category or as a multiplier where the achievement of high quality in 
traditional areas is rewarded at a more favorable rate for EPs that 
achieve high quality for underserved populations, including persons 
with behavioral health conditions, racial and ethnic minorities, sexual 
and gender minorities, people with disabilities, and people living in 
rural areas, and people in HPSAs.
     A subcategory of emergency preparedness and response, such 
as measuring EP 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 military EP activities, and measuring EP volunteer participation 
in humanitarian medical relief work.
     A subcategory of integration of primary care and 
behavioral health,\1\ 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 EPs;
---------------------------------------------------------------------------

    \1\ Primary and Behavioral Health Care Integration program and 
the SAMHSA-Health Resources and Services Administration's Center for 
Integrated Health Solutions (CIHS) (http://www.integration.samhsa.gov/). The CIHS provides support for 
integrated care efforts, including information on recommended 
screening tools and financing and reimbursement for services by 
state and insurance type.
---------------------------------------------------------------------------

    We also seek comment on what mechanisms should be used for the 
Secretary to receive data related to clinical practice improvement 
activities. Specifically, we seek comment on the following:
     Should EPs be required to attest directly to CMS through a 
registration system, Web portal or other means that they have met the 
required activities and to specify which activities on the list they 
have met? Or alternatively, should qualified registries, QCDRs, EHRs, 
or other health IT systems be able to transmit results of the 
activities to CMS?
     What information should be reported and what quality 
checks and/or data validation should occur to ensure successful 
completion of these activities?
     How often providers should report or attest that they have 
met the required activities?
    Additionally, we seek comment on the following areas of how we 
should assess performance on the clinical practice improvement 
activities category. Specifically:
     What threshold or quantity of activities should be 
established under the clinical practice improvement activities 
performance category? For example, should performance in this category 
be based on completion of a specific number of clinical practice 
improvement activities, or, for some categories, a specific number of 
hours? If so, what is the minimum number of activities or hours that 
should be completed? How many activities or hours would be needed to 
earn the maximum possible score for the clinical practice improvement 
activities in each performance subcategory? Should the threshold or 
quantity of activities increase over time? Should performance in this 
category be based on demonstrated availability of specific functions 
and capabilities?
     How should the various subcategories be weighted? Should 
each subcategory have equal weight, or should certain subcategories be 
weighted more than others?
     How should we define the subcategory of participation in 
an APM?
    Lastly, section 1848(q)(2)(B)(iii) of the Act requires the 
Secretary, in establishing the clinical practice improvement 
activities, to give consideration to the circumstances of small 
practices (15 or fewer professionals) and practices located in rural 
areas and in HPSAs (as designated under section 332(a)(1)(A) of the 
PHSA). We seek comment on the following questions relating to this 
requirement:
     How should the clinical practice improvement activities 
performance category be applied to EPs practicing in these types of 
small practices or rural areas?
     Should a lower performance threshold or different measures 
be established that will better allow those EPs to reach the payment 
threshold?
     What methods should be leveraged to appropriately identify 
these practices?
     What best practices should be considered to develop 
flexible and adaptable clinical practice improvement activities based 
on the needs of the community and its population?
6. Meaningful Use of Certified EHR Technology Performance Category
    Section 1848(q)(2)(B)(iv) of the Act specifies that the measures 
and activities for the meaningful use of certified EHR technology 
performance category under the MIPS are the requirements established 
under section 1848(o)(2) of the Act for determining whether an eligible 
professional is a meaningful EHR user of CEHRT. Under section 
1848(q)(5)(E)(i)(IV) of the Act, 25 percent of the composite 
performance score under the MIPS must be determined based on 
performance in the meaningful use of certified EHR technology 
performance category. Section 1848(q)(5)(E)(ii) of the Act gives the 
Secretary discretion to reduce the percentage weight for this 
performance category (but not below 15 percent) in any year in which 
the Secretary estimates that the proportion of eligible professionals 
who are meaningful EHR users is 75 percent or greater, resulting in an 
increase in the applicable percentage weights of the other performance 
categories. We seek comment on the methodology for assessing 
performance in this performance category. Additionally, we note that we 
are only seeking comments on the meaningful use performance category 
under the MIPS; we are not seeking comments on the Medicare and 
Medicaid EHR Incentive Programs.
     Should the performance score for this category be based be 
based solely on full achievement of meaningful use? For example, an EP 
might receive full credit (for example, 100 percent of the allotted 25 
percentage points of the composite performance score) under this 
performance category for meeting or exceeding the thresholds of all 
meaningful use objectives and measures; however, failing to meet or 
exceed all objectives and measures would result in the EP receiving no 
credit (for example, zero percent of the allotted 25 percentage points 
of the composite performance score) for this performance category. We 
seek comment on this approach to scoring.
     Should CMS use a tiered methodology for determining levels 
of achievement in this performance category that would allow EPs to 
receive a higher or lower score based on their performance relative to 
the thresholds established in the Medicare EHR Incentive program's 
meaningful use objectives and measures? For example, an EP who scores 
significantly higher than the threshold and higher than their peer 
group might receive a higher score than the median performer. How 
should such a methodology be developed?

[[Page 59108]]

Should scoring in this category be based on an EP's under- or over-
performance relative to the required thresholds of the objectives and 
measures, or should the scoring methodology of this category be based 
on an EP's performance relative to the performance of his or her peers?
     What alternate methodologies should CMS consider for this 
performance category?
     How should hardship exemptions be treated?
7. Other Measures
    Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use 
measures that are used for a payment system other than the PFS, such as 
measures for inpatient hospitals, for the purposes of the quality and 
resource use performance categories (but not measures for hospital 
outpatient departments, except in the case of items and services 
furnished by emergency physicians, radiologists, and 
anesthesiologists). We seek comment on how we could best use this 
authority, including the following specific questions:
     What types of measures (that is, process, outcomes, 
populations, etc.) used for other payment systems should be included 
for the quality and resource use performance categories under the MIPS?
     How could we leverage measures that are used under the 
Hospital Inpatient Quality Reporting Program, the Hospital Value-Based 
Purchasing Program, or other quality reporting or incentive payment 
programs? How should we attribute the performance on the measures that 
are used under other quality reporting or value-based purchasing 
programs to the EP?
     To which types of EPs should these be applied? Should this 
option be available to all EPs or only to those EPs who have limited 
measure options under the quality and resource use performance 
categories?
     How should CMS link an EP to a facility in order to use 
measures from other payment systems? For example, should the EP be 
allowed to elect to be analyzed based on the performance on measures 
for the facility of his or her choosing? If not, what criteria should 
CMS use to attribute a facility's performance on a given measure to the 
EP or group practice?
    Additionally, section 1848(q)(2)(C)(iii) of the Act allows and 
encourages the Secretary to use global measures and population-based 
measures for the purposes of the quality performance category. We seek 
comment on the following questions:
     What types of global and population-based measures should 
be included under MIPS? How should we define these types of measures?
     What data sources are available, and what mechanisms exist 
to collect data on these types of measures?
    Lastly, section 1848(q)(2)(C)(iv) of the Act requires the 
Secretary, for the measures and activities specified for the MIPS 
performance categories, to give consideration to the circumstances of 
professional types (or subcategories of those types based on practice 
characteristics) who typically furnish services that do not involve 
face-to-face interaction with patients when defining MIPS performance 
categories. For example, EPs practicing in certain specialties such as 
pathologists and certain types of radiologists do not typically have 
face-to-face interactions with patients. If measures and activities for 
the MIPS performance categories focus on face-to-face encounters, these 
specialists may have more limited opportunities to be assessed, which 
could negatively affect their MIPS composite performance scores as 
compared to other specialties. We seek comment on the following 
questions:
     How should we define the professional types that typically 
do not have face-to-face interactions with patients?
     What criteria should we use to identify these types of 
EPs?
     Should we base this designation on their specialty codes 
in PECOS, use encounter codes that are billed to Medicare, or use an 
alternate criterion?
     How should we apply the four MIPS performance categories 
to non-patient-facing EPs?
     What types of measures and/or clinical practice 
improvement activities (new or from other payments systems) would be 
appropriate for these EPs?
8. Development of Performance Standards
    Section 1848(q)(3)(B) of the Act requires the Secretary, in 
establishing performance standards with respect to measures and 
activities for the MIPS performance categories, to consider: historical 
performance standards, improvement, and the opportunity for continued 
improvement. We seek comment on the following questions:
     Which specific historical performance standards should be 
used? For example, for the quality and resource use performance 
categories, how should CMS select quality and cost benchmarks? Should 
CMS use providers' historical quality and cost performance benchmarks 
and/or thresholds from the most recent year feasible prior to the 
commencement of MIPS? Should performance standards be stratified by 
group size or other criteria? Should we use a model similar to the 
performance standards established under the VM?
     For the clinical practice improvement activities 
performance category, what, if any, historical data sources should be 
leveraged?
     How should we define improvement and the opportunity for 
continued improvement? For example, section 1848(q)(5)(D) of the Act 
requires the Secretary, beginning in the second year of the MIPS, if 
there are available data sufficient to measure improvement, to take 
into account improvement of the MIPS EP in calculating the performance 
score for the quality and resource use performance categories.
     How should CMS incorporate improvement into the scoring 
system or design an improvement formula?
     What should be the threshold(s) for measuring improvement?
     How would different approaches to defining the baseline 
period for measuring improvement affect EPs' incentives to increase 
quality performance? Would periodically updating the baseline period 
penalize EPs who increase performance by holding them to a higher 
standard in future performance periods, thereby undermining the 
incentive to improve? Could assessing improvement relative to a fixed 
baseline period avoid this problem? If so, would this approach have 
other consequences CMS should consider?
     Should CMS use the same approach for assessing improvement 
as is used for the Hospital Value-Based Purchasing Program? What are 
the advantages and disadvantages of this approach?
     Should CMS consider improvement at the measure level, 
performance category level (that is, quality, clinical practice 
improvement activity, resource use, and meaningful use of certified EHR 
technology), or at the composite performance score level?
     Should improvements in health equity and the reductions of 
health disparities be considered in the definition of improvement? If 
so, how should CMS incorporate health equity into the formula?
     In the CY 2016 PFS proposed rule (80 FR 41812), the 
Secretary proposed to publicly report on Physician Compare an item-
level benchmark derived using the Achievable Benchmark of Care 
(ABCTM) methodology.\2\ We seek

[[Page 59109]]

comment on using this methodology for determining the MIPS performance 
standards for one or more performance categories.
---------------------------------------------------------------------------

    \2\ Kiefe CI, Weissman NW., Allison JJ, Farmer R, Weaver M, 
Williams OD. Identifying achievable benchmarks of care: concepts and 
methodology. International Journal of Quality Health Care. 1998 Oct; 
10(5):443-7.
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9. Flexibility in Weighting Performance Categories
    Section 1848(q)(5)(F) of the Act requires the Secretary, if there 
are not sufficient measures and activities applicable and available to 
each type of EP, to assign different scoring weights (including a 
weight of zero) from those that apply generally under the MIPS. We seek 
comment on the following questions:
     Are there situations where certain EPs could not be 
assessed at all for purposes of a particular performance category? If 
so, how should we account for the percentage weight that is otherwise 
applicable for that category? Should it be evenly distributed across 
the remaining performance categories? Or should the weights be 
increased for one or more specific performance categories, such as the 
quality performance category?
     Generally, what methodologies should be used as we 
determine whether there are not sufficient measures and activities 
applicable and available to types of EPs such that the weight for a 
given performance category should be modified or should not apply to an 
EP? Should this be based on an EP's specialty? Should this 
determination occur at the measure or activity level, or separately at 
the specialty level?
     What case minimum threshold should CMS consider for the 
different performance categories?
     What safeguards should we have in place to ensure 
statistical significance when establishing performance thresholds? For 
example, under the VM one standard deviation is used. Should we apply a 
similar threshold under MIPS?
10. MIPS Composite Performance Score and Performance Threshold
     Section 1848(q)(5)(A) of the Act requires the Secretary to 
develop a methodology for assessing the total performance of each MIPS 
EP based on performance standards with respect to applicable measures 
and activities in each of the four performance categories. The 
methodology is to provide for a composite assessment for each MIPS EP 
for the performance period for the year using a scoring scale of 0 to 
100. Section 1848(q)(6)(D) of the Act requires the Secretary to compute 
a performance threshold to which the MIPS EP's composite performance 
score is compared for purposes of determining the MIPS adjustment 
factor for a year. The performance threshold must be either the mean or 
median of the composite performance scores for all MIPS EPs with 
respect to a prior period specified by the Secretary. Section 
1848(q)(6)(D)(iii) of the Act requires the Secretary for the first 2 
years of the MIPS, prior to the performance period for those years, to 
establish a performance threshold that is based on a period prior to 
the performance periods for those years. Additionally, the act requires 
the Secretary to take into account available data with respect to 
performance on measures and activities that may be used under the MIPS 
performance categories and other factors deemed appropriate. From our 
experience with the PQRS, VM, and the Medicare EHR Incentive Program, 
there is information available for prior periods for all MIPS 
performance categories except for clinical practice improvement 
activities. We are requesting information from the public on the 
following:
     How should we assess performance on each of the 4 
performance categories and combine the assessments to determine a 
composite performance score?
     For the quality and resource use performance categories, 
should we use a methodology (for example, equal weighting of quality 
and resource use measures across National Quality Strategy domains) 
similar to what is currently used for the VM?
     How should we use the existing data on quality measures 
and resource use measures to translate the data into a performance 
threshold for the first two years of the program?
     What minimum case size thresholds should be utilized? For 
example, should we leverage all data that is reported even if the 
denominators are small? Or should we employ a minimum patient 
threshold, such as a minimum of 20 patients, for each measure?
     How can we establish a base threshold for the clinical 
practice improvement activities? How should this be incorporated into 
the overall performance threshold?
     What other considerations should be made as we determine 
the performance threshold for the total composite performance score? 
For example, should we link performance under one category to another?
11. Public Reporting
    We also seek comment on what should be the minimum threshold used 
for publicly reporting MIPS measures and activities for all of the MIPS 
performance categories on the Physician Compare Web site.
    In the CY 2016 PFS proposed rule (80 FR 41809), we indicated that 
we will continue using a minimum 20 patient threshold for public 
reporting through Physician Compare of quality measures (in addition to 
assessing the reliability, validity and accuracy of the measures). An 
alternative to a minimum patient threshold for public reporting would 
be to use a minimum reliability threshold. We seek comment on both 
concepts in regard to public reporting of MIPS quality measures on the 
Physician Compare Web site. We additionally seek comment on the 
following:
     Should CMS include individual EP and group practice-level 
quality measure data stratified by race, ethnicity and gender in public 
reporting (if statistically appropriate)?
12. Feedback Reports
    Section 1848(q)(12)(A) of the Act requires the Secretary, beginning 
July 1, 2017, to provide confidential feedback on performance to MIPS 
EPs. Specifically, we are required to make available timely 
confidential feedback to MIPS EPs on their performance in the quality 
and resource use performance categories, and we have discretion to make 
available confidential feedback to MIPS EPs on their performance in the 
clinical practice improvement activities and meaningful use of 
certified EHR technology performance categories. This feedback can be 
provided through various mechanisms, including the use of a web-based 
portal or other mechanisms determined appropriate by the Secretary. We 
seek comment on the following questions:
     What types of information should we provide to EPs about 
their practice's performance within the feedback report? For example, 
what level of detail on performance within the performance categories 
will be beneficial to practices?
     Would it be beneficial for EPs to receive feedback 
information related to the clinical practice improvement activities and 
meaningful use of certified EHR technology performance categories? If 
so, what types of feedback?
     What other mechanisms should be leveraged to make feedback 
reports available? Currently, CMS provides feedback reports for the 
PQRS, VM, and the Physician Feedback Program through a web-based 
portal. Should CMS continue to make feedback available through this 
portal? What other entities and vehicles could CMS

[[Page 59110]]

partner with to make feedback reports available? How should CMS work 
with partners to enable feedback reporting to incorporate information 
from other payers, and what types of information should be 
incorporated?
     Who within the EP's practice should be able to access the 
reports? For example, currently under the VM, only the authorized group 
practice representative and/or their designees can access the feedback 
reports. Should other entities be able to access the feedback reports, 
such as an organization providing MIPS-focused technical assistance, 
another provider participating in the same virtual group, or a third 
party data intermediary who is submits data to CMS on behalf of the EP, 
group practice, or virtual group?
     With what frequency is it beneficial for an EP to receive 
feedback? Currently, CMS provides Annual Quality and Resource Use 
Reports (QRUR), mid-year QRURs and supplemental QRURs. Should we 
continue to provide feedback to MIPS EPs on this cycle? Would there be 
value in receiving interim reports based on rolling performance periods 
to make illustrative calculations about the EP's performance? Are there 
certain performance categories on which it would be more important to 
receive interim feedback than others? What information that is 
currently contained within the QRURs should be included? More 
information on what is available within the QRURs is at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/2014-QRUR.html.
     Should the reports include data that is stratified by 
race, ethnicity and gender to monitor trends and address gaps towards 
health equity?
     What types of information about items and services 
furnished to the EP's patients by other providers would be useful? In 
what format and with what frequency?

B. Alternative Payment Models

    We are requesting information regarding the following areas:
1. Information Regarding APMs
    Section 1833(z)(1) of the Act, as added by section 101(e)(2) of the 
MACRA, establishes incentive payments for EPs who are QPs with respect 
to a year. The term ``qualifying APM participant'' is defined under 
section 1833(z)(2) of the Act, and provides in part that a specified 
percent (which differs depending on the year) of an EP's payments 
during the most recent period for which data are available must be 
attributable to services furnished through an ``eligible alternative 
payment entity'' (EAPM entity) as that term is defined under section 
1833(z)(3)(D) of the Act.
    The term APM, as defined in section 1833(z)(3)(C) of the Act, 
includes: Models under section 1115A of the Act (other than health care 
innovation awards); the Shared Savings Program under section 1899 of 
the Act; demonstrations under section 1866C of the Act (the Health Care 
Quality Demonstration Program); and demonstrations required by federal 
law.
    Under section 1833(z)(3)(D) of the Act, an EAPM entity is an entity 
that: (1) Participates in an APM that requires participants to use 
certified EHR technology and provides for payment for covered 
professional services based on quality measures comparable to the MIPS 
quality measures established under section 1848(q)(2)(B)(i) of the Act 
and (2) either bears financial risk for monetary losses under the APM 
that are in excess of a nominal amount or is a medical home expanded 
under section 1115A(c) of the Act.
    For the years 2019 through 2024, EPs who are QPs for a given year 
will receive an incentive payment equal to 5 percent of the estimated 
aggregate Part B Medicare payment amounts for covered professional 
services for the preceding year. Under section 1833(z)(1)(A), the 
estimated aggregate Medicare Part B payment amount for the preceding 
year may be based on a period of the preceding year that is less than 
the full year.
a. QPs and Partial Qualifying APM Participants (Partial QPs)
    Under section 1833(z)(2) of the Act, an EP may be determined to be 
a QP through: (1) Beginning for 2019, a Medicare payment threshold 
option that assesses the percent of Medicare Part B payments for 
covered professional services in the most recent period that is 
attributable to services furnished through an EAPM entity; or (2) 
beginning for 2021, either a Medicare payment threshold option or a 
combination all-payer and Medicare payment threshold option. The 
combination all-payer and Medicare payment threshold option assesses 
both: (1) The percent of Medicare payments for covered professional 
services in the most recent period that is attributable to services 
furnished through an EAPM entity; and (2) the percent of the combined 
Part B Medicare payments for covered professional services attributable 
to an EAPM entity and all other payments made by other payers made 
under similarly defined arrangements (except payments made by the 
Department of Defense or Veterans Affairs and payments made under Title 
XIX in a state in which no medical home or alternative payment model is 
available under the State program under that title). These arrangements 
must be arrangements in which: (1) Quality measures comparable to those 
used under the MIPS apply; (2) certified EHR technology is used; and 
(3) either the entity bears more than nominal financial risk if actual 
expenditures exceed expected expenditures or the entity is a medical 
home under Title XIX that meets criteria comparable to medical homes 
expanded under section 1115A(c) of the Act. For the combined all-payer 
and Medicare payment threshold option, the EP is required to provide to 
the Secretary the necessary information to make a determination as to 
whether the EP meets the all-payer portion of the threshold.
    For 2019 and 2020, the Medicare-only payment threshold requires 
that at least 25 percent of all Medicare payments be attributable to 
services furnished through an EAPM entity. This threshold increases to 
50 percent for 2021 and 2022, and 75 percent for 2023 and later years. 
The combination all-payer and Medicare payment threshold option is 
available beginning in 2021. The combined all-payer and Medicare 
payment thresholds are, respectively, 50 percent of all-payer payments 
and 25 percent of Medicare payments in 2021 and 2022, and 75 percent of 
all-payer payments and 25 percent of Medicare payments in 2023 and 
later years.
    Under section 1848(q)(1)(C)(ii) of the Act, the statute specifies 
that partial QPs are those who would be QPs if the threshold payment 
percentages under section 1833(z)(2) of the Act for the year were 
lower. For partial QPs, the Medicare-only payment thresholds are 20 
percent (instead of 25 percent) for 2019 and 2020, 40 percent (instead 
of 50 percent) for 2021 and 2022, and 50 percent (instead of 75 
percent) for 2023 and later years. For partial QPs, the combination 
all-payer and Medicare payment thresholds are, respectively, 40 percent 
(instead of 50 percent) all-payer and 20 percent (instead of 25 
percent) Medicare in 2021 and 2022, and 50 percent (instead of 75 
percent) all-payer and 20 percent (instead of 25 percent) Medicare in 
2023 and later years.
    Partial QPs are not eligible for incentive payments for APM 
participation under section 1833(z) of the Act. Partial QPs who, for 
the MIPS performance period for the year, do not report applicable MIPS 
measures and activities are not considered MIPS EPs. Partial QPs who 
choose to participate in MIPS are considered MIPS EPs. These

[[Page 59111]]

partial QPs will be subject to payment adjustments under MIPS.
b. Payment Incentive for APM Participation
    To help us establish criteria and a process for determining whether 
an EP is a QP or partial QP, this RFI requests information on the 
following issues.
     How should CMS define ``services furnished under this part 
through an EAPM entity''?
     What policies should the Secretary consider for 
calculating incentive payments for APM participation when the prior 
period payments were made to an EAPM entity rather than directly to a 
QP, for example, if payments were made to a physician group practice or 
an ACO? What are the advantages and disadvantages of those policies? 
What are the effects of those policies on different types of EPs (that 
is, those in physician-focused APMs versus hospital-focused APMs, 
etc.)? How should CMS consider payments made to EPs who participate in 
more than one APM?
     What policies should the Secretary consider related to 
estimating the aggregate payment amounts when payments are made on a 
basis other than fee-for-service (that is, if payments were made on a 
capitated basis)? What are the advantages and disadvantages of those 
policies? What are their effects on different types of EPs (that is, 
those in physician-focused APMs versus hospital-focused APMs, etc.)?
     What types of data and information can EPs submit to CMS 
for purposes of determining whether they meet the non-Medicare share of 
the Combination All-Payer and Medicare Payment Threshold, and how can 
they be securely shared with the federal government?
c. Patient Approach
    Under section 1833(z)(2)(D) of the Act, the Secretary can use 
percentages of patient counts in lieu of percentages of payments to 
determine whether an EP is a QP or partial QP.
     What are examples of methodologies for attributing and 
counting patients in lieu of using payments to determine whether an EP 
is a QP or partial QP?
     Should this option be used in all or only some 
circumstances? If only in some circumstances, which ones and why?
d. Nominal Financial Risk
     What is the appropriate type or types of ``financial 
risk'' under section 1833(z)(3)(D)(ii)(I) of the Act to be considered 
an EAPM entity?
     What is the appropriate level of financial risk ``in 
excess of a nominal amount'' under section 1833(z)(3)(D)(ii)(I) of the 
Act to be considered an EAPM entity?
     What is the appropriate level of ``more than nominal 
financial risk if actual aggregate expenditures exceed expected 
aggregate expenditures'' that should be required by a non-Medicare 
payer for purposes of the Combination All-Payer and Medicare Payment 
Threshold under sections 1833(z)(2)(B)(iii)(II)(cc)(AA) and 
1833(z)(2)(C)(iii)(II)(cc)(AA) of the Act?
     What are some points of reference that should be 
considered when establishing criteria for the appropriate type or level 
of financial risk, e.g., the MIPS or private-payer models?
e. Medicaid Medical Homes or Other APMs Available Under State Medicaid 
Programs
    EPs may meet the criteria to be QPs or partial QPs under the 
Combination All-Payer and Medicare Payment Threshold Option based, in 
part, on payments from non-Medicare payers attributable to services 
furnished through an entity that, with respect to beneficiaries under 
Title XIX, is a medical home that meets criteria comparable to medical 
homes expanded under section 1115A(c) of the Act. In addition, payments 
made under some State Medicaid programs, not associated with Medicaid 
medical homes, may meet the criteria to be included in the calculation 
of the combination all-payer and Medicare payment threshold option.
     What criteria could the Secretary consider for determining 
comparability of state Medicaid medical home models to medical home 
models expanded under section 1115A(c) of the Act?
     Which states' Medicaid medical home models might meet 
criteria comparable to medical homes expanded under section 1115A(c) of 
the Act?
     Which current Medicaid alternative payment models--besides 
Medicaid medical homes are likely to meet the criteria for 
comparability of state Medicaid medical homes to medical homes expanded 
under section 1115A(c) of the Act and should be considered when 
determining the all-payer portion of the Combination All-Payer and 
Medicare Payment Threshold Option?
f. Regarding EAPM Entity Requirements
    An EAPM entity is defined as an entity that (1) participates in an 
APM that requires participants to use certified EHR technology (as 
defined in section 1848(o)(4) of the Act) and provides for payment for 
covered professional services based on quality measures comparable to 
measures under the performance category described in section 
1848(q)(2)(B)(i) of the Act (the quality performance category); and (2) 
bears financial risk for monetary losses under the APM that are in 
excess of a nominal amount or is a medical home expanded under section 
1115A(c) of the Act.
(1) Definition
     What entities should be considered EAPM entities?
(2) Quality Measures
     What criteria could be considered when determining 
``comparability'' to MIPS of quality measures used to identify an EAPM 
entity? Please provide specific examples for measures, measure types 
(for example, structure, process, outcome, and other types), data 
source for measures (for example, patients/caregivers, medical records, 
billing claims, etc.), measure domains, standards, and comparable 
methodology.
     What criteria could be considered when determining 
``comparability'' to MIPS of quality measures required by a non-
Medicare payer to qualify for the Combination All-Payer and Medicare 
Payment Threshold? Please provide specific examples for measures, 
measure types, (for example, structure, process, outcome, and other 
types), recommended data sources for measures (for example, patients/
caregivers, medical records, billing claims, etc.), measure domains, 
and comparable methodology.
(3) Use of Certified EHR Technology
     What components of certified EHR technology as defined in 
section 1848(o)(4) of the Act should APM participants be required to 
use? Should APM participants be required to use the same certified EHR 
technology currently required for the Medicare and Medicaid EHR 
Incentive Programs or should CMS other consider requirements around 
certified health IT capabilities?
     What are the core health IT functions that providers need 
to manage patient populations, coordinate care, engage patients and 
monitor and report quality? Would certification of additional functions 
or interoperability requirements in health IT products (for example, 
referral management or population health management functions) help 
providers succeed within APMs?
     How should CMS define ``use'' of certified EHR technology 
as defined in section 1848(o)(4) of the Act by

[[Page 59112]]

participants in an APM? For example, should the APM require 
participants to report quality measures to all payers using certified 
EHR technology or only payers who require EHR reported measures? Should 
all professionals in the APM in which an eligible alternative payment 
entity participates be required to use certified EHR technology or a 
particular subset?
2. Information Regarding Physician-Focused Payment Models
    Section 101(e)(1) of the MACRA, adds a new subsection 1868(c) to 
the Act entitled, ``Increasing the Transparency of Physician-Focused 
Payment Models.'' This section establishes an independent ``Physician-
focused Payment Model Technical Advisory Committee'' (the Committee). 
The Committee will review and provide comments and recommendations to 
the Secretary on PFPMs submitted by stakeholders. Section 1868(c)(2)(A) 
of the Act requires the Secretary to establish, through notice and 
comment rulemaking following an RFI, criteria for PFPMs, including 
models for specialist physicians, that could be used by the Committee 
for making its comments and recommendations. In this RFI, we are 
seeking input on potential criteria that the Committee could use for 
making comments and recommendations to the Secretary on PFPMs proposed 
by stakeholders. CMS published an RFI requesting information on 
Specialty Practitioner Payment Model Opportunities on February 11, 
2014, available at http://innovation.cms.gov/files/x/specialtypractmodelsrfi.pdf. The comments received in response to that 
RFI will also be considered in developing the proposed rule for the 
criteria for PFPMs.
    PFPMs are not required by the MACRA to meet the criteria to be 
considered APMs as defined under section 1833(z)(3)(C) of the Act or to 
involve an EAPM entity as defined under section 1833(z)(3)(D) of the 
Act. However, we are interested in encouraging model proposals from 
stakeholders that will provide EPs the opportunity to become QPs and 
receive incentive payments (in other words, model proposals that would 
involve EAPM entities as defined in section 1833(z)(3)(D) of the Act). 
PFPMs proposed by stakeholders and selected for implementation by CMS 
will take time and resources to implement after being reviewed by the 
Committee and the Secretary. To expedite our ability to implement such 
models, we are interested in receiving comments now on criteria that 
would support development of PFPMs that involve EAPM entities.
a. Definition of Physician-Focused Payment Models
     How should ``physician-focused payment model'' be defined?
b. Criteria for Physician-Focused Payment Models
    We are required by section 1868(c)(2)(A) of the Act to establish by 
November 1, 2016, through rulemaking and following an RFI, criteria for 
PFPMs, including models for specialist physicians, that could be used 
by the Committee for making comments and recommendations to the 
Secretary. We intend to establish criteria that promote robust and 
well-developed proposals to facilitate implementation of PFPMs. To 
assist us with establishing criteria, this RFI requests information on 
the following fundamental issues.
     What criteria should be used by the Committee for 
assessing PFPM proposals submitted by stakeholders? We are interested 
in hearing suggestions related to the criteria discussed in this RFI as 
well as other criteria.
     Are there additional or different criteria that the 
Committee should use for assessing PFPMs that are specialist models? 
What criteria would promote development of new specialist models?
     What existing criteria, procedures, or standards are 
currently used by private or public insurance plans in testing or 
establishing new payment models? Should any of these criteria be used 
by the Committee for assessing PFPM proposals? Why or why not?
c. Required Information on Context of Model Within Delivery System 
Reform
    This RFI seeks feedback on information that could be required of 
stakeholders proposing models to provide for the consideration of the 
Committee.
    We are considering the following specific criteria for the 
Committee to use to make comments and recommendations related to model 
proposals submitted to the Committee. We are seeking feedback on 
whether these criteria should be included and, if so, whether they 
should be modified, and whether other criteria should be considered. 
Each of these criteria is considered for all models tested through the 
Center for Medicare and Medicaid Innovation (Innovation Center) during 
internal development. For a list of the factors considered in the 
Innovation Center's model selection process, see http://innovation.cms.gov/Files/x/rfi-Web sitepreamble.pdf. We seek comment on 
the following possible criteria:
     We are considering that proposed PFPMs should primarily be 
focused on the inclusion of participants in their design who have not 
had the opportunity to participate in another PFPM with CMS because 
such a model has not been designed to include their specialty.
     Proposals would state why the proposed model should be 
given priority, and why a model is needed to test the approach.
     Proposals would include a framework for the proposed 
payment methodology, how it differs from the current Medicare payment 
methodology, and how it promotes delivery system reforms.
     If a similar model has been tested or researched 
previously, either by CMS or in the private sector, the stakeholder 
would include background information and assessments on the performance 
of the similar model.
     Proposed models would aim to directly solve a current 
issue in payment policy that CMS is not already addressing in another 
model or program.
d. Required Information on Model Design
    For the Committee to comment and make recommendations on the merits 
of PFPMs proposed by stakeholders, we are considering a requirement 
that proposals include the same information that would be required for 
any model tested through the Innovation Center. For a list of the 
factors considered in the Innovation Center's model selection process, 
see http://innovation.cms.gov/Files/x/rfi-Web sitepreamble.pdf. This 
RFI requests comments on the usefulness of this information, which of 
the suggested information is appropriate to consider as criteria, and 
whether other criteria should be considered. The provision of 
information would not require particular answers in order for a PFPM to 
meet the criteria. Instead, a proposal would be incomplete if it did 
not include this information.
     Definition of the target population, how the target 
population differs from the non-target population and the number of 
Medicare beneficiaries that would be affected by the model.
     Ways in which the model would impact the quality and 
efficiency of care for Medicare beneficiaries.
     Whether the model would provide for payment for covered 
professional services based on quality measures, and if so, whether the 
measures are comparable to quality measures under the MIPS quality 
performance category.

[[Page 59113]]

     Specific proposed quality measures in the model, their 
prior validation, and how they would further the model's goals, 
including measures of beneficiary experience of care, quality of life, 
and functional status that could be used.
     How the model would affect access to care for Medicare and 
Medicaid beneficiaries.
     How the model will affect disparities among beneficiaries 
by race, and ethnicity, gender, and beneficiaries with disabilities, 
and how the applicant intends to monitor changes in disparities during 
the model implementation.
     Proposed geographical location(s) of the model.
     Scope of EP participants for the model, including 
information about what specialty or specialties EP participants would 
fall under the model.
     The number of EPs expected to participate in the model, 
information about whether or not EP participants for the model have 
expressed interest in participating and relevant stakeholder support 
for the model.
     To what extent participants in the model would be required 
to use certified EHR technology.
     An assessment of financial opportunities for model 
participants including a business case for their participation.
     Mechanisms for how the model fits into existing Medicare 
payment systems, or replaces them in part or in whole and would 
interact with or complement existing alternative payment models.
     What payment mechanisms would be used in the model, such 
as incentive payments, performance-based payments, shared savings, or 
other forms of payment.
     Whether the model would include financial risk for 
monetary losses for participants in excess of a minimal amount and the 
type and amount of financial performance risk assumed by model 
participants.
     Method for attributing beneficiaries to participants.
     Estimated percentage of Medicare spending impacted by the 
model and expected amount of any new Medicare/Medicaid payments to 
model participants.
     Mechanism and amount of anticipated savings to Medicare 
and Medicaid from the model, and any incentive payments, performance-
based payments, shared savings, or other payments made from Medicare to 
model participants.
     Information about any similar models used by private 
payers, and how the current proposal is similar to or different from 
private models and whether and how the model could include additional 
payers other than Medicare, including Medicaid.
     Whether the model engages payers other than Medicare, 
including Medicaid and/or private payers. If not, why not? If so, what 
proportion of the model's beneficiaries is covered by Medicare as 
compared to other payers?
     Potential approaches for CMS to evaluate the proposed 
model (study design, comparison groups, and key outcome measures).
     Opportunities for potential model expansion if successful.

C. Technical Assistance to Small Practices and Practices in Health 
Professional Shortage Areas

    Section 1848(q)(11) of the Act provides for technical assistance to 
small practices and practices in HPSAs. In general, under section 
1848(q)(11) of the Act, the Secretary is required to enter into 
contracts or agreements with entities such as quality improvement 
organizations, regional extension centers and regional health 
collaboratives beginning in Fiscal Year 2016 to offer guidance and 
assistance to MIPS EPs in practices of 15 or fewer professionals. 
Priority is to be given to small practices located in rural areas, 
HPSAs, and medically underserved areas, and practices with low 
composite scores. The technical assistance is to focus on the 
performance categories under MIPS, or how to transition to 
implementation of and participation in an APM.
    For section 1848(q)(11) of the Act--
     What should CMS consider when organizing a program of 
technical assistance to support clinical practices as they prepare for 
effective participation in the MIPS and APMs?
     What existing educational and assistance efforts might be 
examples of ``best in class'' performance in spreading the tools and 
resources needed for small practices and practices in HPSAs? What 
evidence and evaluation results support these efforts?
     What are the most significant clinician challenges and 
lessons learned related to spreading quality measurement, leveraging 
CEHRT to make practice improvements, value based payment and APMs in 
small practices and practices in health shortage areas, and what 
solutions have been successful in addressing these issues?
     What kind of support should CMS offer in helping providers 
understand the requirements of MIPS?
     Should such assistance require multi-year provider 
technical assistance commitment, or should it be provided on a one-time 
basis?
     Should there be conditions of participation and/or 
exclusions in the providers eligible to receive such assistance, such 
as providers participating in delivery system reform initiatives such 
as the Transforming Clinical Practice Initiative (TCPI; http://innovation.cms.gov/initiatives/Transforming-Clinical-Practices/), or 
having a certain level of need identified?

III. 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 document.

    Dated: September 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-24906 Filed 9-28-15; 11:15 am]
BILLING CODE 4120-01-P