Notice2025-05530
Agency Information Collection Activities: Submission for OMB Review; 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
April 1, 2025
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 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.
Full Text
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<title>Federal Register, Volume 90 Issue 61 (Tuesday, April 1, 2025)</title>
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[Federal Register Volume 90, Number 61 (Tuesday, April 1, 2025)]
[Notices]
[Pages 14373-14374]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10912]
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 May 1, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <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 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: New Collection; Title of
Information Collection: Medicare Transaction Facilitator for 2026 and
2027 under Sections 11001 and 11002 of the Inflation Reduction Act
(IRA); Use: Under the authority in sections 11001 and 11002 of the
Inflation Reduction Act of 2022 (Pub. L. 117-169), the Centers for
Medicare & Medicaid Services (CMS) is implementing the Medicare Drug
Price Negotiation Program, codified in sections 1191 through 1198 of
the Social Security Act (``the Act''). The Act establishes the
Negotiation Program to negotiate maximum fair prices (``MFPs''),
defined at 1191(c)(3) of the Act, for certain high expenditure, single
source selected drugs covered under Medicare Part B and Part D
(``selected drugs''). In accordance with section 1193(a) of the Act,
any Primary Manufacturer of a selected drug that continues to
participate in the Negotiation Program and reaches agreement upon an
MFP must provide access to the MFP to MFP-eligible individuals, defined
in section 1191(c)(2)(A) of the Act, and to pharmacies, mail order
services, other dispensing entities, providers and suppliers with
respect to such MFP-eligible individuals who are dispensed that
selected drug during a price applicability period. The purpose of this
information collection request (ICR) is for CMS to collect information
from manufacturers of drugs covered under Part D selected for
negotiation under the Inflation Reduction Act for the initial price
applicability years 2026 and 2027 and the dispensing entities that
dispense the selected drugs to MFP-eligible individuals. To facilitate
the effectuation of the MFP, CMS will engage a Medicare Transaction
Facilitator (``MTF''). The MTF system will be composed of two modules:
the MTF Data Module (MTF DM), and the MTF Payment Module (MTF PM).
Medicare Transaction Facilitator Data Elements: The MTF system will
be composed of two modules: the MTF Data Module (MTF DM), and the MTF
Payment Module (MTF PM). Primary Manufacturers participating in the
Negotiation Program are required to participate in the MTF DM. Further,
CMS intends to propose in future rulemaking to require Part D plan
sponsors to include in their pharmacy agreements provisions requiring
dispensing entities to participate in the MTF DM for purposes of data
exchange. As such, for the purposes of this ICR, CMS assumes full
participation in the MTF DM by affected Primary Manufacturers and
dispensing entities. Meanwhile, participation in the MTF PM, for use in
passing through payment from the Primary Manufacturer to dispensing
entities, will be optional for Primary Manufacturers; as a result,
dispensing entities may receive fund transfers from the MTF PM, or via
an alternative process established by a Primary Manufacturer. As
discussed in section 40.4 of the Medicare Drug Price Negotiation
Program: Final Guidance, Implementation of Sections 1191-1198 of the
Social Security Act for Initial Price Applicability Year 2027 and
Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and
2027 (``final guidance''),\1\ CMS will engage the MTF DM to facilitate
the exchange of certain claim-level data elements and payment elements
for selected drugs. The data exchange component of the MTF will involve
both the transmission of certain claim-level data elements to the
Primary Manufacturer and receipt of claim-level payment elements from
the Primary Manufacturer. Both Primary Manufacturers and dispensing
entities will need to provide certain information at the onset of their
enrollment in the MTF DM system to facilitate effectuation of the MFP
via refunds from Primary Manufacturers. Both Primary Manufacturers and
dispensing entities will be able to submit complaints and disputes
through their participation in the MTF DM. Primary Manufacturers
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will also submit information to fulfill their requirement to provide an
MFP Effectuation Plan and transmit recurring data submissions
reflecting their payment elements, as described in the final guidance.
Given these information collection requirements, this ICR includes the
following forms: (A) Drug Price Negotiation Program MTF DM Dispensing
Entity and Third-Party Support Enrollment Form; (B) Drug Price
Negotiation Program MTF DM Primary Manufacturer Maximum Fair Price
(MFP) Effectuation Plan Form; (C) Drug Price Negotiation Program MTF DM
Primary Manufacturer Payment Elements Form; and (D) Drug Price
Negotiation Program Complaint and Dispute Intake Form. Form Number:
CMS-10912 (OMB control number: 0938-New); Frequency: Once and Daily;
Affected Public: Private sector, Business or other for-profit, and
individuals; Number of Respondents: 85,853; Total Annual Responses:
93,120; Total Annual Hours: 877,510. (For policy questions regarding
this collection contact Brennan Folsom at 667-414-0014.)
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\1\ <a href="https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf">https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf</a>.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2025-05530 Filed 3-27-25; 11:15 am]
BILLING CODE 4120-01-P
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