Notice2023-27684
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
December 18, 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 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 88 Issue 241 (Monday, December 18, 2023)</title>
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[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87429-87430]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10174]
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 (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 February 16, 2024.
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, 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 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-10174 Collection of Prescription Drug Data from MA-PD, PDP and
Fallout Plans/Sponsors for Medicare Part D 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: Revision with change of
a currently approved collection; Title of
[[Page 87430]]
Information Collection: Collection of Prescription Drug Data from MA-
PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments; Use:
The PDE data is used in the Payment Reconciliation System to perform
the annual Part D payment reconciliation, any PDE data within the
Coverage Gap Phase of the Part D benefit is used for invoicing in the
CGDP, and the data are part of the report provided to the Secretary of
the Treasury for Section 9008.
Sections 11001 through 11004 of the Inflation Reduction Act of 2022
establish a Medicare Drug Negotiation Program for high-expenditure
drugs. Section 11102 of the Inflation Reduction Act of 2022 establishes
a Part D inflation rebate by manufacturers of certain single source
drugs and biologicals with prices increasing at a rate faster than the
rate of inflation. CMS will use data reported under sections 1860D-
15(c)(1)(C) and (d)(2), in part, to rank drugs by total expenditures
under Part D in order to select drugs for negotiation and to identify
units to calculate inflation rebates.
The information users will be pharmacy benefit managers (PBMs),
third party administrators and pharmacies, and the PDPs, MA-PDs,
Fallbacks, and other plans that offer coverage of outpatient
prescription drugs under the Medicare Part D benefit to Medicare
beneficiaries. The statutorily required data is used primarily for
payment and is used for claim validation as well as for other
legislated functions such as quality monitoring, program integrity and
oversight. In addition, the PDE data are used to support operations and
program development. Form Number: CMS-10174 (OMB control number: 0938-
0982); Frequency: Monthly; Affected Public: Private sector and Federal
Government; Number of Respondents: 856; Total Annual Responses:
1,499,064,780; Total Annual Hours: 62,918. (For policy questions
regarding this collection contact Shelly Winston at 410-786-3694.)
Dated: December 12, 2023.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-27684 Filed 12-15-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on December 18, 2023.
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