Agency Information Collection Activities: Proposed Collection; Comment Request, 31150-31152 [2018-14336]
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31150
Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
requirements of CFPB’s Regulation B is
mandatory. Because the recordkeeping
and disclosure requirements of the
CFPB’s Regulation B require creditors to
retain their own records and to make
certain disclosures to customers, the
Freedom of Information Act (FOIA)
would only be implicated if the Board’s
examiners retained a copy of this
information as part of an examination of
a bank. Records obtained as a part of an
examination or supervision of a bank
are exempt from disclosure under FOIA
exemption (b)(8), for examination
material (5 U.S.C. 552(b)(8)). In
addition, the records may also be
exempt under FOIA exemption (b)(4) or
(b)(6). Records would be exempt under
(b)(4) if the records contained ‘‘trade
secrets and commercial or financial
information obtained from a person
[that is] privileged or confidential’’ and
the disclosure of the information is
likely to cause substantial harm to the
competitive position of the respondents
(5 U.S.C. 552(b)(4)). Records would be
exempt under (b)(6) if the records
contained personal information, the
disclosure of which would ‘‘constitute a
clearly unwarranted invasion of
personal privacy’’ (5 U.S.C. 552(b)(6)).
Current actions: On April 13, 2018,
the Board published a notice in the
Federal Register (83 FR 16098)
requesting public comment for 60 days
on the extension, without revision, of
the FR B. The comment period for this
notice expired on June 12, 2018. The
Board received one comment letter that
addressed matter outside the scope of
this proposal.
Board of Governors of the Federal Reserve
System, June 28, 2018.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2018–14305 Filed 7–2–18; 8:45 am]
[CDC–2018–0006; Docket Number NIOSH–
306]
sradovich on DSK3GMQ082PROD with NOTICES
Final National Occupational Research
Agenda for Services
17:07 Jul 02, 2018
Jkt 244001
Emily Novicki, M.A., M.P.H,
(NORACoordinator@cdc.gov), National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, Mailstop E–20, 1600 Clifton
Road NE, Atlanta, GA 30329, phone
(404) 498–2581 (not a toll free number).
SUPPLEMENTARY INFORMATION: On
January 29, 2018, NIOSH published a
request for public review in the Federal
Register [83 FR 4058] of the draft
version of the National Occupational
Research Agenda for Services. All
comments received were reviewed and
addressed where appropriate.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–14227 Filed 7–2–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10673]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
SUMMARY:
Centers for Disease Control and
Prevention
VerDate Sep<11>2014
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
The final document was
published on June 26, 2018.
ADDRESSES: The document may be
obtained at the following link: https://
www.cdc.gov/niosh/nora/sectors/serv/
agenda.html.
DATES:
AGENCY:
BILLING CODE 6210–01–P
AGENCY:
NIOSH announces the
availability of the final National
Occupational Research Agenda for
Services.
SUMMARY:
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information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
September 4, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ___, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10673 Medicare Advantage
Qualifying Payment Arrangement
Incentive (MAQI) Demonstration
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
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sradovich on DSK3GMQ082PROD with NOTICES
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New Collection (Request for a
new OMB control number); Title of
Information Collection: Medicare
Advantage Qualifying Payment
Arrangement Incentive (MAQI)
Demonstration; Use: The Centers for
Medicare & Medicaid Services (CMS)
may test a demonstration, under Section
402 of the Social Security Amendments
of 1968 (as amended), entitled the
Medicare Advantage Qualifying
Payment Arrangement Incentive (MAQI)
Demonstration (‘‘the Demonstration’’). If
it goes forward, the MAQI
demonstration could test whether
exempting, through the use of waiver
authority, clinicians who participate to
a sufficient degree in certain payment
arrangements with Medicare Advantage
Organizations (MAOs) (combined with
participation, if any, in Advanced
Alternative Payment Models (APMs)
with Medicare Fee-for-Service (FFS))
from the Merit-based Incentive Payment
System (MIPS) reporting requirements
and payment adjustment will increase
or maintain participation in payment
arrangements with MAOs similar to
Advanced APMs and change the
manner in which clinicians deliver care.
Clinicians may currently participate
in one of two paths of the Quality
Payment Program (QPP): (1) MIPS,
which adjusts Medicare payments based
on combined performance on measures
of quality, cost, improvement activities,
and advancing care information, or (2)
Advanced Alternative Payment Models
with Medicare (Advanced APMs), under
which eligible clinicians may earn an
incentive payment for sufficient
participation in certain payment
arrangements with Medicare fee-forservice (FFS) and other payers, and
starting in the 2019 performance period,
with other payers such as Medicare
Advantage, commercial payers, and
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17:07 Jul 02, 2018
Jkt 244001
Medicaid managed care. To participate
in the Advanced APM path of QPP for
a given year, eligible clinicians must
meet the criteria of Qualifying APM
Participants (QPs); in addition to
earning an APM incentive payment, QPs
are excluded from the MIPS reporting
requirements and payment adjustment.
An eligible clinician that does not
meet the criteria to be a QP for a given
year will be subject to MIPS for that year
unless the clinician meets certain other
MIPS exclusion criteria, such as being
newly enrolled in Medicare or meeting
the low volume threshold for Medicare
FFS patients. The MAQI Demonstration
could allow participating clinicians to
have the opportunity to be exempt from
MIPS reporting and payment
consequences for a given year if they
participate to a sufficient degree in
certain Qualifying Payment
Arrangements with MAOs (and
Advanced APMs with Medicare FFS)
during the performance period for that
year, without requiring them to be QPs
or otherwise meet the MIPS exclusion
criteria of QPP. Under a possible
Demonstration, clinicians might not be
required to have a minimum amount of
participation in an Advanced APM with
Medicare FFS in order to be exempt
from MIPS reporting requirements and
payment adjustments for a year, but if
they did have participation in Advanced
APMs with Medicare FFS, that
participation could also be counted
towards the thresholds that trigger the
waiver from MIPS reporting and
payment consequences. In addition, the
Demonstration could permit
consideration of participation in
‘‘Qualifying Payment Arrangements’’
with Medicare Advantage plans that
meet the criteria to be Other Payer
Advanced APMs a year before the AllPayer Combination Option is available.
In the Calendar Year 2018 Quality
Payment Program Final Rule, CMS
noted its intention ‘‘to develop a
demonstration project to test the effects
of expanding incentives for eligible
clinicians to participate in innovative
alternative payment arrangements under
Medicare Advantage that qualify as
Advanced APMs, by allowing credit for
participation in such Medicare
Advantage arrangements prior to 2019
and incentivizing participation in such
arrangements in 2018 through 2024.’’
(92 FR 53865).
The first performance period for the
Demonstration is tentatively planned for
2018 and the Demonstration would last
up to five years. Clinicians who meet
the definition of MIPS eligible clinician
under QPP as defined under 42 CFR
414.1305 would be eligible to
participate in the MAQI Demonstration.
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Currently, MIPS eligible clinicians
include physicians (including doctors of
medicine, doctors of osteopathy,
osteopathic practitioners, doctors of
dental surgery, doctors of dental
medicine, doctors of podiatric medicine,
doctors of optometry, and
chiropractors), physician assistants,
nurse practitioners, clinical nurse
specialists, and certified registered
nurse anesthetists. If the definition of
MIPS eligible clinician changes under
future rulemaking, the Demonstration
would use the updated definition to
define Demonstration eligibility.
Participation could last the duration
of the Demonstration, unless
participation is voluntarily or
involuntarily terminated under the
terms and conditions of the
Demonstration. Participants would have
the opportunity to submit the required
documentation and be evaluated for
MIPS waivers through the
Demonstration each year.
Should this demonstration move
forward, and in order to conduct an
evaluation and effectively implement
the MAQI Demonstration, CMS would
need to collect information from
Demonstration participants on (a)
payment arrangements with MAOs and
(b) Medicare Advantage (MA) payments
and patient counts. CMS would require
a new collection of this information as
this information is not already available
through other sources and/or has not
been previously approved for use under
the MAQI Demonstration. The
information collected in these forms
would allow CMS to evaluate whether
the payment arrangement that clinicians
have with MAOs meet the Qualifying
Payment Arrangement criteria, and
determine whether a clinician’s MAO
and FFS APM patient population or
payments meet demonstration
thresholds. Both of these areas are also
requirements for review and data
collection under QPP (i.e. the Eligible
Clinician-Initiated Other Payer
Advanced APM Determination form and
All-Payer QP Submission form), and
therefore similar to forms have been
prepared and reviewed under the QPP.
Given these similarities in forms,
burden estimates for the MAQI
Demonstration PRA package were
derived from burden analyses and
formulation done in conjunction with
the QPP forms; more specifically the
estimated burden associated with the
submission of payment arrangement
information for Other Payer Advanced
APM Determinations: Eligible ClinicianInitiated Process, and the estimated
burden associated with the submission
of data for All-Payer QP determinations.
CMS estimates the total hour burden per
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Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
respondent for the MAQI demonstration
to be 15 hours, to match the hours listed
in the equivalent QPP forms. Full detail
of how these estimates were derived can
be found in the forthcoming Calendar
Year 2019 Proposed QPP rule.
If Demonstration participants
submitted information, but did not meet
these conditions of the Demonstration,
their participation in the Demonstration
would not be terminated, but they
would not receive the waivers from
MIPS reporting requirements and
payment adjustments. Therefore, unless
they become QPs or are excluded from
MIPS for other reasons, the participating
clinicians would be subject to MIPS and
would face the MIPS payment
adjustments for the applicable year. We
are requesting approval of 2 information
collections associated with the MAQI
Demonstration: (a) A Qualifying
Payment Arrangement Submission Form
and (b) a Threshold Data Submission
Form. Form Number: CMS–10673 (OMB
control number: 0938–NEW);
Frequency: Annually; Affected Public:
Private sector—Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 100,000; Total
Annual Responses: 100,000; Total
Annual Hours: 1,500,000. (For policy
questions regarding this collection
contact John Amoh at john.amoh@
cms.hhs.gov.)
Dated: June 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–14336 Filed 6–29–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2012–N–0129]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:07 Jul 02, 2018
Jkt 244001
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection in an application for a
proposed biosimilar product and an
application for a supplement for a
proposed interchangeable product.
DATES: Submit either electronic or
written comments on the collection of
information by September 4, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 4,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 4, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA 2012–
N–0129 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; General
Licensing Provisions; Section 351(k)
Biosimilar Applications.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
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Agencies
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31150-31152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14336]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10673]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by September 4, 2018.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10673 Medicare Advantage Qualifying Payment Arrangement Incentive
(MAQI) Demonstration
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
approval from the Office of Management
[[Page 31151]]
and Budget (OMB) for each collection of information they conduct or
sponsor. The term ``collection of information'' is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA requires federal agencies to publish a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: New Collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI)
Demonstration; Use: The Centers for Medicare & Medicaid Services (CMS)
may test a demonstration, under Section 402 of the Social Security
Amendments of 1968 (as amended), entitled the Medicare Advantage
Qualifying Payment Arrangement Incentive (MAQI) Demonstration (``the
Demonstration''). If it goes forward, the MAQI demonstration could test
whether exempting, through the use of waiver authority, clinicians who
participate to a sufficient degree in certain payment arrangements with
Medicare Advantage Organizations (MAOs) (combined with participation,
if any, in Advanced Alternative Payment Models (APMs) with Medicare
Fee-for-Service (FFS)) from the Merit-based Incentive Payment System
(MIPS) reporting requirements and payment adjustment will increase or
maintain participation in payment arrangements with MAOs similar to
Advanced APMs and change the manner in which clinicians deliver care.
Clinicians may currently participate in one of two paths of the
Quality Payment Program (QPP): (1) MIPS, which adjusts Medicare
payments based on combined performance on measures of quality, cost,
improvement activities, and advancing care information, or (2) Advanced
Alternative Payment Models with Medicare (Advanced APMs), under which
eligible clinicians may earn an incentive payment for sufficient
participation in certain payment arrangements with Medicare fee-for-
service (FFS) and other payers, and starting in the 2019 performance
period, with other payers such as Medicare Advantage, commercial
payers, and Medicaid managed care. To participate in the Advanced APM
path of QPP for a given year, eligible clinicians must meet the
criteria of Qualifying APM Participants (QPs); in addition to earning
an APM incentive payment, QPs are excluded from the MIPS reporting
requirements and payment adjustment.
An eligible clinician that does not meet the criteria to be a QP
for a given year will be subject to MIPS for that year unless the
clinician meets certain other MIPS exclusion criteria, such as being
newly enrolled in Medicare or meeting the low volume threshold for
Medicare FFS patients. The MAQI Demonstration could allow participating
clinicians to have the opportunity to be exempt from MIPS reporting and
payment consequences for a given year if they participate to a
sufficient degree in certain Qualifying Payment Arrangements with MAOs
(and Advanced APMs with Medicare FFS) during the performance period for
that year, without requiring them to be QPs or otherwise meet the MIPS
exclusion criteria of QPP. Under a possible Demonstration, clinicians
might not be required to have a minimum amount of participation in an
Advanced APM with Medicare FFS in order to be exempt from MIPS
reporting requirements and payment adjustments for a year, but if they
did have participation in Advanced APMs with Medicare FFS, that
participation could also be counted towards the thresholds that trigger
the waiver from MIPS reporting and payment consequences. In addition,
the Demonstration could permit consideration of participation in
``Qualifying Payment Arrangements'' with Medicare Advantage plans that
meet the criteria to be Other Payer Advanced APMs a year before the
All-Payer Combination Option is available.
In the Calendar Year 2018 Quality Payment Program Final Rule, CMS
noted its intention ``to develop a demonstration project to test the
effects of expanding incentives for eligible clinicians to participate
in innovative alternative payment arrangements under Medicare Advantage
that qualify as Advanced APMs, by allowing credit for participation in
such Medicare Advantage arrangements prior to 2019 and incentivizing
participation in such arrangements in 2018 through 2024.'' (92 FR
53865).
The first performance period for the Demonstration is tentatively
planned for 2018 and the Demonstration would last up to five years.
Clinicians who meet the definition of MIPS eligible clinician under QPP
as defined under 42 CFR 414.1305 would be eligible to participate in
the MAQI Demonstration. Currently, MIPS eligible clinicians include
physicians (including doctors of medicine, doctors of osteopathy,
osteopathic practitioners, doctors of dental surgery, doctors of dental
medicine, doctors of podiatric medicine, doctors of optometry, and
chiropractors), physician assistants, nurse practitioners, clinical
nurse specialists, and certified registered nurse anesthetists. If the
definition of MIPS eligible clinician changes under future rulemaking,
the Demonstration would use the updated definition to define
Demonstration eligibility.
Participation could last the duration of the Demonstration, unless
participation is voluntarily or involuntarily terminated under the
terms and conditions of the Demonstration. Participants would have the
opportunity to submit the required documentation and be evaluated for
MIPS waivers through the Demonstration each year.
Should this demonstration move forward, and in order to conduct an
evaluation and effectively implement the MAQI Demonstration, CMS would
need to collect information from Demonstration participants on (a)
payment arrangements with MAOs and (b) Medicare Advantage (MA) payments
and patient counts. CMS would require a new collection of this
information as this information is not already available through other
sources and/or has not been previously approved for use under the MAQI
Demonstration. The information collected in these forms would allow CMS
to evaluate whether the payment arrangement that clinicians have with
MAOs meet the Qualifying Payment Arrangement criteria, and determine
whether a clinician's MAO and FFS APM patient population or payments
meet demonstration thresholds. Both of these areas are also
requirements for review and data collection under QPP (i.e. the
Eligible Clinician-Initiated Other Payer Advanced APM Determination
form and All-Payer QP Submission form), and therefore similar to forms
have been prepared and reviewed under the QPP.
Given these similarities in forms, burden estimates for the MAQI
Demonstration PRA package were derived from burden analyses and
formulation done in conjunction with the QPP forms; more specifically
the estimated burden associated with the submission of payment
arrangement information for Other Payer Advanced APM Determinations:
Eligible Clinician-Initiated Process, and the estimated burden
associated with the submission of data for All-Payer QP determinations.
CMS estimates the total hour burden per
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respondent for the MAQI demonstration to be 15 hours, to match the
hours listed in the equivalent QPP forms. Full detail of how these
estimates were derived can be found in the forthcoming Calendar Year
2019 Proposed QPP rule.
If Demonstration participants submitted information, but did not
meet these conditions of the Demonstration, their participation in the
Demonstration would not be terminated, but they would not receive the
waivers from MIPS reporting requirements and payment adjustments.
Therefore, unless they become QPs or are excluded from MIPS for other
reasons, the participating clinicians would be subject to MIPS and
would face the MIPS payment adjustments for the applicable year. We are
requesting approval of 2 information collections associated with the
MAQI Demonstration: (a) A Qualifying Payment Arrangement Submission
Form and (b) a Threshold Data Submission Form. Form Number: CMS-10673
(OMB control number: 0938-NEW); Frequency: Annually; Affected Public:
Private sector--Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 100,000; Total Annual Responses:
100,000; Total Annual Hours: 1,500,000. (For policy questions regarding
this collection contact John Amoh at [email protected].)
Dated: June 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-14336 Filed 6-29-18; 8:45 am]
BILLING CODE 4120-01-P