83 FR 31150 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 128 (July 3, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 128 (July 3, 2018)
| Page Range | 31150-31152 | |
| FR Document | 2018-14336 |
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)] [Notices] [Pages 31150-31152] From the Federal Register Online [www.thefederalregister.org] [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 http://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 [[Page 31152]] 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
![31150 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
requirements of CFPB’s Regulation B is SUMMARY: NIOSH announces the information collection for the proper
mandatory. Because the recordkeeping availability of the final National performance of the agency’s functions,
and disclosure requirements of the Occupational Research Agenda for the accuracy of the estimated burden,
CFPB’s Regulation B require creditors to Services. ways to enhance the quality, utility, and
retain their own records and to make DATES: The final document was clarity of the information to be
certain disclosures to customers, the published on June 26, 2018. collected, and the use of automated
Freedom of Information Act (FOIA) collection techniques or other forms of
ADDRESSES: The document may be
would only be implicated if the Board’s information technology to minimize the
examiners retained a copy of this obtained at the following link: https:// information collection burden.
information as part of an examination of www.cdc.gov/niosh/nora/sectors/serv/
DATES: Comments must be received by
a bank. Records obtained as a part of an agenda.html.
September 4, 2018.
examination or supervision of a bank FOR FURTHER INFORMATION CONTACT: ADDRESSES: When commenting, please
are exempt from disclosure under FOIA Emily Novicki, M.A., M.P.H, reference the document identifier or
exemption (b)(8), for examination (NORACoordinator@cdc.gov), National OMB control number. To be assured
material (5 U.S.C. 552(b)(8)). In Institute for Occupational Safety and consideration, comments and
addition, the records may also be Health, Centers for Disease Control and recommendations must be submitted in
exempt under FOIA exemption (b)(4) or Prevention, Mailstop E–20, 1600 Clifton any one of the following ways:
(b)(6). Records would be exempt under Road NE, Atlanta, GA 30329, phone 1. Electronically. You may send your
(b)(4) if the records contained ‘‘trade (404) 498–2581 (not a toll free number). comments electronically to http://
secrets and commercial or financial SUPPLEMENTARY INFORMATION: On www.regulations.gov. Follow the
information obtained from a person January 29, 2018, NIOSH published a instructions for ‘‘Comment or
[that is] privileged or confidential’’ and request for public review in the Federal Submission’’ or ‘‘More Search Options’’
the disclosure of the information is Register [83 FR 4058] of the draft to find the information collection
likely to cause substantial harm to the version of the National Occupational document(s) that are accepting
competitive position of the respondents Research Agenda for Services. All comments.
(5 U.S.C. 552(b)(4)). Records would be comments received were reviewed and 2. By regular mail. You may mail
exempt under (b)(6) if the records addressed where appropriate. written comments to the following
contained personal information, the address: CMS, Office of Strategic
disclosure of which would ‘‘constitute a John J. Howard,
Operations and Regulatory Affairs,
clearly unwarranted invasion of Director, National Institute for Occupational
Division of Regulations Development,
personal privacy’’ (5 U.S.C. 552(b)(6)). Safety and Health, Centers for Disease Control
and Prevention. Attention: Document Identifier/OMB
Current actions: On April 13, 2018, Control Number ___, Room C4–26–05,
the Board published a notice in the [FR Doc. 2018–14227 Filed 7–2–18; 8:45 am]
7500 Security Boulevard, Baltimore,
Federal Register (83 FR 16098) BILLING CODE 4163–19–P
Maryland 21244–1850.
requesting public comment for 60 days To obtain copies of a supporting
on the extension, without revision, of statement and any related forms for the
the FR B. The comment period for this DEPARTMENT OF HEALTH AND
HUMAN SERVICES proposed collection(s) summarized in
notice expired on June 12, 2018. The this notice, you may make your request
Board received one comment letter that Centers for Medicare & Medicaid using one of following:
addressed matter outside the scope of Services 1. Access CMS’ website address at
this proposal. https://www.cms.gov/Regulations-and-
[Document Identifier: CMS–10673] Guidance/Legislation/Paperwork
Board of Governors of the Federal Reserve
System, June 28, 2018. ReductionActof1995/PRA-Listing.html.
Agency Information Collection
Michele Taylor Fennell, 2. Email your request, including your
Activities: Proposed Collection;
Assistant Secretary of the Board. address, phone number, OMB number,
Comment Request
[FR Doc. 2018–14305 Filed 7–2–18; 8:45 am]
and CMS document identifier, to
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
BILLING CODE 6210–01–P
Medicaid Services. 3. Call the Reports Clearance Office at
ACTION: Notice. (410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Medicare & William Parham at (410) 786–4669.
HUMAN SERVICES Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION:
Centers for Disease Control and an opportunity for the public to
comment on CMS’ intention to collect Contents
Prevention
information from the public. Under the This notice sets out a summary of the
[CDC–2018–0006; Docket Number NIOSH– Paperwork Reduction Act of 1995 (the use and burden associated with the
306] PRA), federal agencies are required to following information collections. More
publish notice in the Federal Register detailed information can be found in
Final National Occupational Research concerning each proposed collection of each collection’s supporting statement
Agenda for Services information (including each proposed and associated materials (see
extension or reinstatement of an existing
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: National Institute for ADDRESSES).
Occupational Safety and Health collection of information) and to allow
60 days for public comment on the CMS–10673 Medicare Advantage
(NIOSH) of the Centers for Disease Qualifying Payment Arrangement
Control and Prevention (CDC), proposed action. Interested persons are
invited to send comments regarding our Incentive (MAQI) Demonstration
Department of Health and Human
Services (HHS). burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501–
this collection of information, including 3520), federal agencies must obtain
ACTION: Notice of availability.
the necessity and utility of the proposed approval from the Office of Management
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![31152 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
respondent for the MAQI demonstration proposed collection of information, • For written/paper comments
to be 15 hours, to match the hours listed including each proposed extension of an submitted to the Dockets Management
in the equivalent QPP forms. Full detail existing collection of information, and Staff, FDA will post your comment, as
of how these estimates were derived can to allow 60 days for public comment in well as any attachments, except for
be found in the forthcoming Calendar response to the notice. This notice information submitted, marked and
Year 2019 Proposed QPP rule. solicits comments on the information identified, as confidential, if submitted
If Demonstration participants collection in an application for a as detailed in ‘‘Instructions.’’
submitted information, but did not meet proposed biosimilar product and an Instructions: All submissions received
these conditions of the Demonstration, application for a supplement for a must include the Docket No. FDA 2012–
their participation in the Demonstration proposed interchangeable product. N–0129 for ‘‘Agency Information
would not be terminated, but they DATES: Submit either electronic or Collection Activities; Proposed
would not receive the waivers from written comments on the collection of Collection; Comment Request; General
MIPS reporting requirements and information by September 4, 2018. Licensing Provisions; Section 351(k)
payment adjustments. Therefore, unless ADDRESSES: You may submit comments Biosimilar Applications.’’ Received
they become QPs or are excluded from as follows. Please note that late, comments, those filed in a timely
MIPS for other reasons, the participating untimely filed comments will not be manner (see ADDRESSES), will be placed
clinicians would be subject to MIPS and considered. Electronic comments must in the docket and, except for those
would face the MIPS payment be submitted on or before September 4, submitted as ‘‘Confidential
adjustments for the applicable year. We 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
are requesting approval of 2 information electronic filing system will accept https://www.regulations.gov or at the
collections associated with the MAQI comments until midnight Eastern Time Dockets Management Staff between 9
Demonstration: (a) A Qualifying at the end of September 4, 2018. a.m. and 4 p.m., Monday through
Payment Arrangement Submission Form Comments received by mail/hand Friday.
and (b) a Threshold Data Submission delivery/courier (for written/paper • Confidential Submissions—To
Form. Form Number: CMS–10673 (OMB submissions) will be considered timely submit a comment with confidential
control number: 0938–NEW); if they are postmarked or the delivery information that you do not wish to be
Frequency: Annually; Affected Public: service acceptance receipt is on or made publicly available, submit your
Private sector—Business or other for- before that date. comments only as a written/paper
profit and Not-for-profit institutions; submission. You should submit two
Number of Respondents: 100,000; Total Electronic Submissions
copies total. One copy will include the
Annual Responses: 100,000; Total Submit electronic comments in the information you claim to be confidential
Annual Hours: 1,500,000. (For policy following way: with a heading or cover note that states
questions regarding this collection • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
contact John Amoh at john.amoh@ https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
cms.hhs.gov.) instructions for submitting comments.
Agency will review this copy, including
Dated: June 28, 2018. Comments submitted electronically,
the claimed confidential information, in
William N. Parham, III,
including attachments, to https://
its consideration of comments. The
www.regulations.gov will be posted to
Director, Paperwork Reduction Staff, Office second copy, which will have the
of Strategic Operations and Regulatory
the docket unchanged. Because your
claimed confidential information
Affairs. comment will be made public, you are
redacted/blacked out, will be available
solely responsible for ensuring that your
[FR Doc. 2018–14336 Filed 6–29–18; 8:45 am] for public viewing and posted on
comment does not include any
BILLING CODE 4120–01–P https://www.regulations.gov. Submit
confidential information that you or a
both copies to the Dockets Management
third party may not wish to be posted,
such as medical information, your or Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND contact information to be made publicly
HUMAN SERVICES anyone else’s Social Security number, or
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
Food and Drug Administration in the body of your comments and you
that if you include your name, contact
[Docket No. FDA 2012–N–0129]
information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
Agency Information Collection as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Comment Request; General Licensing and other applicable disclosure law. For
• If you want to submit a comment
Provisions; Section 351(k) Biosimilar more information about FDA’s posting
with confidential information that you
Applications of comments to public dockets, see 80
do not wish to be made available to the
AGENCY: Food and Drug Administration, public, submit the comment as a FR 56469, September 18, 2015, or access
HHS. written/paper submission and in the the information at: https://www.gpo.gov/
ACTION: Notice. manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or Agency) is Written/Paper Submissions read background documents or the
sradovich on DSK3GMQ082PROD with NOTICES
announcing an opportunity for public Submit written/paper submissions as electronic and written/paper comments
comment on the proposed collection of follows: received, go to https://
certain information by the Agency. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Under the Paperwork Reduction Act of written/paper submissions): Dockets docket number, found in brackets in the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and heading of this document, into the
required to publish notice in the Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
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Document Created: 2018-07-02 23:55:54
Document Modified: 2018-07-02 23:55:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by September 4, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 31150 |
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