Notice2022-07760
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 12, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 70 (Tuesday, April 12, 2022)</title>
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[Federal Register Volume 87, Number 70 (Tuesday, April 12, 2022)]
[Notices]
[Pages 21660-21661]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07760]
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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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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,
[[Page 21661]]
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
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