[Federal Register Volume 87, Number 70 (Tuesday, April 12, 2022)]
[Notices]
[Pages 21660-21661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07760]



[[Page 21660]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10465 and CMS-10495]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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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 June 13, 2022.

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.

FOR FURTHER INFORMATION CONTACT: William N. 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-10465 Minimum Essential Coverage
CMS-10495 Data Collection and Submission, Registration, Attestation, 
Dispute and Resolution, Record Retention, and Assumptions Document 
Submission, for Open Payments

    Under the 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 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: Extension of a currently 
approved collection; Title of Information Collection: Minimum Essential 
Coverage; Use: The final rule titled ``Patient Protection and 
Affordable Care Act; Exchange Functions: Eligibility for Exemptions; 
Miscellaneous Minimum Essential Coverage Provisions,'' published July 
1, 2013 (78 FR 39494) designates certain types of health coverage as 
minimum essential coverage. Other types of coverage, not statutorily 
designated and not designated as minimum essential coverage in 
regulation, may be recognized by the Secretary of Health and Human 
Services (HHS) as minimum essential coverage if certain substantive and 
procedural requirements are met. To be recognized as minimum essential 
coverage, the coverage must offer substantially the same consumer 
protections as those enumerated in the Title I of the Affordable Care 
Act relating to non-grandfathered, individual health insurance coverage 
to ensure consumers are receiving adequate coverage. The final rule 
requires sponsors of other coverage that seek to have such coverage 
recognized as minimum essential coverage to adhere to certain 
procedures. Sponsoring organizations must submit to HHS certain 
information about their coverage and an attestation that the plan 
substantially complies with the provisions of Title I of the Affordable 
Care Act applicable to non-grandfathered individual health insurance 
coverage. Sponsors must also provide notice to enrollees informing them 
that the plan has been recognized as minimum essential coverage. Form 
Number: CMS-10465 (OMB Control Number 0938-1189); Frequency: 
Occasionally; Affected Public: Public and Private sectors; Number of 
Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 52.5. 
(For policy questions regarding this collection contact Russell Tipps 
at 301-492-4371.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Registration, 
Attestation, Dispute Resolution and Correction, Assumptions Document 
and Data Retention Requirements for Open Payments; Use: The Patient 
Protection and Affordable Care Act was enacted on March 23, 2010 (Pub. 
L. 111-148). This statute amended section 1128 of the Social Security 
Act (the Act) by adding a new subsection G that requires applicable 
manufacturers of drugs, devices, biologics, or medical supplies covered 
under title XVIII of the Act (Medicare) or a State plan under title XIX 
(Medicaid) or XXI of the Act (the Children's Health Insurance Program, 
or CHIP) to report annually to the Secretary certain payments or other 
transfers of value to physicians and teaching hospitals. Section 1128G 
of the Act also requires applicable manufacturers and applicable group 
purchasing organizations (GPOs) to report certain information regarding 
the ownership or investment interests held by physicians or the 
immediate family members of physicians in such entities,

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as well as any payments provided to such physicians. The submitted 
information facilitates various aspects of the program. The information 
collected through the registration process is used by CMS to validate 
registration for applicable manufacturers, applicable GPOs, covered 
recipients, and physician owners or investors that are registering for 
Open Payments. Details collected during the dispute resolution and 
correction process allows CMS to notify applicable manufacturers and 
applicable GPOs that a covered recipient or physician owner or investor 
is initiating a dispute regarding data submitted about them and allow 
CMS to relay the nature of the dispute. The assumptions documents 
submitted by applicable manufacturers or applicable GPOs assist CMS in 
providing guidance (for example, determining form and nature of payment 
categories, calculating the value of a payment, determining the date of 
payment, and reporting the terms of an ownership or investment 
interest). Form Number: CMS-10495 (OMB control number: 0938-1237); 
Frequency: Annually; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 1,612; Total Annual Responses: 
1,612; Total Annual Hours: 1,920,534. (For policy questions regarding 
this collection contact Kathleen Ott at 410-786-4246.)

    Dated: April 7, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-07760 Filed 4-11-22; 8:45 am]
BILLING CODE 4120-01-P