[Federal Register Volume 89, Number 208 (Monday, October 28, 2024)]
[Notices]
[Pages 85538-85539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10912]


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 December 27, 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:

[[Page 85539]]

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-10912 Medicare Transaction Facilitator for 2026 and 2027 under 
Sections 11001 and 11002 of the Inflation Reduction Act (IRA) 
Information Collection Request

    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 Collections

    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) Information Collection Request; 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''), 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 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: 821,560. 
(For policy questions regarding this collection contact Brennan Folsom 
at 667-414-0014.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-25009 Filed 10-25-24; 8:45 am]
BILLING CODE 4120-01-P