[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19957-19958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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