83 FR 47343 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 182 (September 19, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 182 (September 19, 2018)
| Page Range | 47343-47345 | |
| FR Document | 2018-20372 |
[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)] [Notices] [Pages 47343-47345] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20372] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10673] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by October 19, 2018. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 or Email: [email protected]. 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 http://www.cms.hhs.gov/PaperworkReductionActof1995. 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: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management 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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 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 [[Page 47344]] 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 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. Subsequent to publishing the 60-day Federal Register notice (83 FR 31150), there have been minor revisions made to the collection instrument to clarify information. There is no increase in the burden hours. 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].) [[Page 47345]] Dated: September 14, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-20372 Filed 9-18-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices 47343
of Offeror, requires each offeror to Dated: September 13, 2018. To obtain copies of a supporting
identify if the offeror is, within the last William Clark, statement and any related forms for the
three years, a successor to another entity Director, Office of Governmentwide proposed collection(s) summarized in
that received a Federal Government Acquisition Policy, Office of Acquisition this notice, you may make your request
award and, if so, to provide the Policy, Office of Governmentwide Policy. using one of following:
Commercial and Government Entity [FR Doc. 2018–20299 Filed 9–18–18; 8:45 am] 1. Access CMS’ website address at
(CAGE) code and legal name of the BILLING CODE 6820–EP–P http://www.cms.hhs.gov/Paperwork
predecessor. The information on ReductionActof1995.
predecessors is used to identify such 2. Email your request, including your
entities in the Federal Awardee DEPARTMENT OF HEALTH AND address, phone number, OMB number,
Performance and Integrity Information HUMAN SERVICES and CMS document identifier, to
System (FAPIIS) to allow retrieval of Paperwork@cms.hhs.gov.
integrity and performance data on the Centers for Medicare & Medicaid 3. Call the Reports Clearance Office at
most recent predecessor of an apparent Services (410) 786–1326.
successful offeror to whom award is [Document Identifier: CMS–10673] FOR FURTHER INFORMATION CONTACT:
anticipated. FAR 9.104–6 requires William Parham at (410) 786–4669.
contracting officers to consult FAPIIS Agency Information Collection SUPPLEMENTARY INFORMATION: Under the
before awarding a contract in excess of Activities: Submission for OMB Paperwork Reduction Act of 1995 (PRA)
the simplified acquisition threshold. Review; Comment Request (44 U.S.C. 3501–3520), federal agencies
The information on predecessors is must obtain approval from the Office of
AGENCY: Centers for Medicare & Management and Budget (OMB) for each
collected on an annual basis for
Medicaid Services, Department of collection of information they conduct
inclusion in the annual representations
Health and Human Services. or sponsor. The term ‘‘collection of
and certifications in the System for
ACTION: Notice. information’’ is defined in 44 U.S.C.
Award Management (SAM) for offerors
required to register in SAM. Offerors not SUMMARY: The Centers for Medicare & 3502(3) and 5 CFR 1320.3(c) and
required to register in SAM but required Medicaid Services (CMS) is announcing includes agency requests or
to provide the information in the an opportunity for the public to requirements that members of the public
provision at FAR 52.204–20 will do so comment on CMS’ intention to collect submit reports, keep records, or provide
as specified in the solicitation or information from the public. Under the information to a third party. Section
instructed by the contracting officer. Paperwork Reduction Act of 1995 3506(c)(2)(A) of the PRA (44 U.S.C.
(PRA), federal agencies are required to 3506(c)(2)(A)) requires federal agencies
C. Annual Reporting Burden to publish a 30-day notice in the
publish notice in the Federal Register
concerning each proposed collection of Federal Register concerning each
The burden to provide the
information, including each proposed proposed collection of information,
information required by the FAR
extension or reinstatement of an existing including each proposed extension or
provision at 52.204–20 when an offeror
collection of information, and to allow reinstatement of an existing collection
is registered in SAM is already covered
a second opportunity for public of information, before submitting the
by OMB Control Number 9000–0159,
comment on the notice. Interested collection to OMB for approval. To
System for Award Management
persons are invited to send comments comply with this requirement, CMS is
Registration (SAM). OMB Control
regarding the burden estimate or any publishing this notice that summarizes
Number 9000–0189 now will cover the
other aspect of this collection of the following proposed collection(s) of
burden for providing the required information for public comment:
information when the offeror is not information, including the necessity and
1. Type of Information Collection
required to register in SAM in utility of the proposed information
Request: New Collection (Request for a
accordance with the exceptions in FAR collection for the proper performance of
new OMB control number); Title of
4.1102(a). The Federal Procurement the agency’s functions, the accuracy of
Information Collection: Medicare
Data System (FPDS) for FY 2017 was the estimated burden, ways to enhance
Advantage Qualifying Payment
used to develop the estimated burden the quality, utility, and clarity of the
Arrangement Incentive (MAQI)
hours as shown below: information to be collected, and the use
Demonstration; Use: The Centers for
of automated collection techniques or
Respondents: 974. Medicare & Medicaid Services (CMS)
other forms of information technology to
Responses Per Respondent: 1. may test a demonstration, under Section
minimize the information collection
402 of the Social Security Amendments
Total Annual Responses: 974. burden.
of 1968 (as amended), entitled the
Hours Per Response: 0.1. DATES: Comments on the collection(s) of Medicare Advantage Qualifying
Total Burden Hours: 97.4. information must be received by the Payment Arrangement Incentive (MAQI)
OMB desk officer by October 19, 2018. Demonstration (‘‘the Demonstration’’). If
Affected Public: Businesses or other ADDRESSES: When commenting on the it goes forward, the MAQI
for-profit and not-for-profit institutions. proposed information collections, demonstration could test whether
Obtaining Copies: Requesters may please reference the document identifier exempting, through the use of waiver
obtain a copy of the information or OMB control number. To be assured authority, clinicians who participate to
collection documents from the General consideration, comments and a sufficient degree in certain payment
amozie on DSK3GDR082PROD with NOTICES1
Services Administration, Regulatory recommendations must be received by arrangements with Medicare Advantage
Secretariat Division (MVCB), 1800 F the OMB desk officer via one of the Organizations (MAOs) (combined with
Street NW, Washington, DC 20405, following transmissions: OMB, Office of participation, if any, in Advanced
telephone 202–501–4755. Please cite Information and Regulatory Affairs, Alternative Payment Models (APMs)
OMB Control No. 9000–0189, Attention: CMS Desk Officer, Fax with Medicare Fee-for-Service (FFS))
Identification of Predecessors, in all Number: (202) 395–5806 or Email: from the Merit-based Incentive Payment
correspondence. OIRA_submission@omb.eop.gov. System (MIPS) reporting requirements
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![Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices 47345
Dated: September 14, 2018. DEPARTMENT OF HOMELAND Reduction Act of 1995 (44 U.S.C. 3501
Martique Jones, SECURITY et seq.). This proposed information
Director, Regulations Development Group, collection was previously published in
Office of Strategic Operations and Regulatory U.S. Customs and Border Protection the Federal Register (Volume 83 FR
Affairs.
[1651–0029] Page 23286) on May 18, 2018, allowing
[FR Doc. 2018–20372 Filed 9–18–18; 8:45 am] for a 60-day comment period. This
BILLING CODE 4120–01–P Agency Information Collection notice allows for an additional 30 days
Activities: Application for Foreign- for public comments. This process is
Trade Zone Admission and/or Status conducted in accordance with 5 CFR
DEPARTMENT OF HEALTH AND Designation, and Application for 1320.8. Written comments and
HUMAN SERVICES Foreign-Trade Zone Activity Permit suggestions from the public and affected
agencies should address one or more of
Food and Drug Administration AGENCY: U.S. Customs and Border the following four points: (1) Whether
Protection (CBP), Department of the proposed collection of information
[Docket No. FDA–2018–D–3152] Homeland Security. is necessary for the proper performance
ACTION: 30-Day notice and request for of the functions of the agency, including
Postapproval Changes to Drug comments; extension of an existing whether the information will have
Substances; Draft Guidance for collection of information. practical utility; (2) the accuracy of the
Industry; Availability; Correction agency’s estimate of the burden of the
SUMMARY: The Department of Homeland proposed collection of information,
AGENCY: Food and Drug Administration, Security, U.S. Customs and Border including the validity of the
HHS Protection will be submitting the methodology and assumptions used; (3)
ACTION: Notice; correction. following information collection request suggestions to enhance the quality,
to the Office of Management and Budget utility, and clarity of the information to
SUMMARY: The Food and Drug (OMB) for review and approval in be collected; and (4) suggestions to
Administration is correcting a notice accordance with the Paperwork minimize the burden of the collection of
entitled ‘‘Postapproval Changes to Drug Reduction Act of 1995 (PRA). The information on those who are to
Substances; Draft Guidance for Industry; information collection is published in respond, including through the use of
Availability’’ that appeared in the the Federal Register to obtain comments appropriate automated, electronic,
Federal Register of September 11, 2018. from the public and affected agencies. mechanical, or other technological
The document announced a draft Comments are encouraged and will be collection techniques or other forms of
guidance that provides accepted no later than October 19, 2018 information technology, e.g., permitting
recommendations to holders of to be assured of consideration. electronic submission of responses. The
approved new drug applications, ADDRESSES: Interested persons are comments that are submitted will be
abbreviated new drug applications, new invited to submit written comments on summarized and included in the request
animal drug applications, abbreviated this proposed information collection to for approval. All comments will become
new animal drug applications, and the Office of Information and Regulatory a matter of public record.
holders of drug master files and Affairs, Office of Management and
veterinary master files who may want to Budget. Comments should be addressed Overview of This Information
make a change to the drug substance to the OMB Desk Officer for Customs Collection
manufacturing process during the drug and Border Protection, Department of Title: Application for Foreign-Trade
product application postapproval Homeland Security, and sent via Zone Admission and/or Status
period. The document was published electronic mail to dhsdeskofficer@ Designation, and Application for
with the incorrect docket number. This omb.eop.gov. Foreign-Trade Zone Activity Permit.
document corrects that error. FOR FURTHER INFORMATION CONTACT:
OMB Number: 1651–0029.
Form Numbers: 214, 214A, 214B,
FOR FURTHER INFORMATION CONTACT: Lisa Requests for additional PRA information
214C, and 216.
Granger, Office of Policy and Planning, should be directed to Seth Renkema, Type of Review: Extension (without
Food and Drug Administration, 10903 Chief, Economic Impact Analysis change).
New Hampshire Ave., Bldg. 32, Rm. Branch, U.S. Customs and Border Action: CBP proposes to extend the
3330, Silver Spring, MD 20993–0002, Protection, Office of Trade, Regulations expiration date of this information
301–796–9115. and Rulings, 90 K Street NE, 10th Floor, collection with no change to the burden
SUPPLEMENTARY INFORMATION: In the Washington, DC 20229–1177, hours or to CBP Forms 214, 214A, 214B,
Federal Register of Tuesday, September Telephone number (202) 325–0056 or 214C, and 216.
11, 2018 (83 FR 45944), in FR Doc. via email CBP_PRA@cbp.dhs.gov. Please Affected Public: Businesses.
2018–19666, on page 45944, the note that the contact information Abstract: Foreign trade zones (FTZs)
following correction is made: provided here is solely for questions are geographical enclaves located within
regarding this notice. Individuals the geographical limits of the United
On page 45944, in the first column, in
seeking information about other CBP States but for tariff purposes are
the header of the document, and also in
programs should contact the CBP considered to be outside the United
the third column under Instructions,
National Customer Service Center at States. Imported merchandise may be
‘‘Docket No. FDA–2018–D–3151’’ is
877–227–5511, (TTY) 1–800–877–8339, brought into FTZs for storage,
corrected to read ‘‘Docket No. FDA–
amozie on DSK3GDR082PROD with NOTICES1
or CBP website at https://www.cbp manipulation, manufacture or other
2018–D–3152’’.
.gov/. processing and subsequent removal for
Dated: September 12, 2018. SUPPLEMENTARY INFORMATION: CBP exportation, consumption in the United
Leslie Kux, invites the general public and other States, or destruction. A company
Associate Commissioner for Policy. Federal agencies to comment on the bringing goods into an FTZ has a choice
[FR Doc. 2018–20317 Filed 9–18–18; 8:45 am] proposed and/or continuing information of zone status (privileged/non-
BILLING CODE 4164–01–P collections pursuant to the Paperwork privileged foreign, domestic, or zone-
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Document Created: 2018-09-19 02:55:13
Document Modified: 2018-09-19 02:55:13
| 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 on the collection(s) of information must be received by the OMB desk officer by October 19, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 47343 |
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