Agency Information Collection Activities: Submission for OMB Review; Comment Request
| Published date | 01 March 2024 |
| Record Number | 2024-04341 |
| Citation | 89 FR 15201 |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
| Section | Notices |
Federal Register, Volume 89 Issue 42 (Friday, March 1, 2024)
[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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