[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Notices]
[Pages 15201-15202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10174 and CMS-R-64]


Agency Information Collection Activities: Submission for OMB 
Review; 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 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 April 1, 2024.

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

[[Page 15202]]

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 with change of 
a currently approved collection; Title of 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.)
    2. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Indirect Medical Education and Direct Graduate Medical 
Education; Use: Section 1886(d)(5)(B) of the Social Security Act 
requires additional payments to be made under the Medicare Prospective 
Payment System (PPS) for the indirect medical educational costs a 
hospital incurs in connection with interns and residents (IRs) in 
approved teaching programs. In addition, title 42, part 413, sections 
75 through 83 implement section 1886(d) of the Act by establishing the 
methodology for Medicare payment for the costs of direct graduate 
medical educational activities.
    The information collected on IRs is used by Part- A Medicare 
Administrative Contractors (MAC) to verify the number of IRs FTE used 
in the calculation of Medicare payments for IME and GME. The IR data 
submitted by the hospitals to the MACs is uploaded into CMS' Intern and 
Resident Information System (IRIS) database to identify duplicate FTEs 
reported for any IR.
    The MACs use the information collected on IRs to ensure that all 
program payments for IME and GME are accurate and are in accordance 
with Medicare regulations. The IR data submitted by the hospitals to 
the MACs are used to audit the Medicare cost reports filed by the 
hospitals. Form Number: CMS-R-64 (OMB control number: 0938-0456); 
Frequency: Monthly; Affected Public: Private sector and Federal 
Government; Number of Respondents: 1,245; Total Annual Responses: 
1,245; Total Annual Hours: 2,490. (For policy questions regarding this 
collection contact Owen Osaghae at 410-786-7550.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-04341 Filed 2-29-24; 8:45 am]
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