Agency Information Collection Activities: Proposed Collection; Comment Request

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-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.)

[FR Doc. 2024-25009 Filed 10-25-24; 8:45 am]

BILLING CODE 4120-01-P