Notice2023-06964
Agency Information Collection Activities: Submission for OMB Review; 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 4, 2023
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 (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.
Full Text
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<title>Federal Register, Volume 88 Issue 64 (Tuesday, April 4, 2023)</title>
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[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19957-19958]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06964]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10495 and CMS-10108]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
[[Page 19958]]
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 (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 May 4, 2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <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 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: 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, 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.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Managed
Care and Supporting Regulations; Use: Information collected includes
information about managed care programs, grievances and appeals,
enrollment broker contracts, and managed care organizational capacity
to provide health care services. Medicaid enrollees use the information
collected and reported to make informed choices regarding health care,
including how to access health care services and the grievance and
appeal system. States use the information collected and reported as
part of its contracting process with managed care entities, as well as
its compliance oversight role. We use the information collected and
reported in an oversight role of state Medicaid managed care programs.
Among the proposed changes, this iteration: (1) adds burden for a
new submission process, via online portal, for states to submit
contracts to CMS and to note an omission from prior packages for the
burden for states to submit their managed care plan contracts via
email, and (2) adds burden to provide a reporting template for those
states that implemented COVID-19 specific risk mitigation strategies to
their managed care plan contracts. This template will ensure that
states provide consistent and complete reporting of the outcomes of
these risk mitigation strategies. Form Number: CMS-10108 (OMB control
number: 0938-0920); Frequency: Occasionally; Affected Public: Private
sector (business or other for-profit and not-for-profit institutions),
and State, local or Tribal Government; Number of Respondents: 5,053;
Total Annual Responses: 13,743,255; Total Annual Hours: 1,682,636. For
policy questions regarding this collection contact Amy Gentile at 410-
786-3499.
Dated: March 30, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-06964 Filed 4-3-23; 8:45 am]
BILLING CODE 4120-01-P
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