[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87429-87430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27684]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
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, 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 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