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 ).

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: Revision with change of currently approved collection; Title of Information Collection: Medicare Transaction Facilitator under Sections 11001 and 11002 of the Inflation Reduction Act (IRA); Use: The MTF consists of two key functionalities: (1) the MTF DM and (2) the MTF PM. Participation in the MTF PM is voluntary for Primary Manufacturers and no information will be collected by the MTF PM; the MTF PM is structured exclusively as a pass through mechanism to assist affected parties in the transfer of Primary Manufacturer funds. In accordance with sections 1193(a)(5) and 1196 of the Act, for the purposes of administering and monitoring compliance with the Negotiation Program, Primary Manufacturer participation in the MTF DM is mandatory. Because the Primary Manufacturer's participation in the MTF DM is mandatory and Primary Manufacturers with an active Medicare Drug Price Negotiation Program Agreement (“Agreement”) are already engaged in the Negotiation Program, CMS will leverage existing information to establish Primary Manufacturer access the MTF DM platform. The MTF DM will establish accounts for each Primary Manufacturer that is participating in the Negotiation Program and will provide information to each participating Primary Manufacturer to facilitate access to the MTF DM platform.

Under the authority of sections 1193 and 1196 of the Act, CMS is authorized to collect data and information required for negotiation, as well as any information necessary for administration and oversight of the program. The information collected by CMS will be used to operate the MTF which is a key facet in administering the Negotiation Program and facilitating MFP effectuation; MTF will also play a key role in CMS' oversight efforts as a central repository for monitoring access to the MFP and processing complaints and disputes. The MTF is an IT platform that enables the transmission of certain claims data and payment data, between the MTF DM, MTF PM, Primary Manufacturers, Part B providers, and dispensing entities to facilitate MFP effectuation for Medicare beneficiaries via dispensing entities and/or Part B providers. Form Number: CMS-10912 (OMB control number: 0938-1483); Frequency: Yearly; Affected Public: Private sector, Business or other for-profits; Number of Respondents: 73,925; Total Annual Responses: 73,925; Total Annual Hours: 274,980. (For policy questions regarding this collection contact Brennan Folsom at 667-414-0014 or Brennan.folsom@cms.hhs.gov.)

2. Type of Information Collection Request: Revision with change of currently approved collection; Title of Information Collection: Collection of Prescription Drug Event Data from Contracted Part D Providers for Payment; Use: CMS fundamental goal is to have the least burdensome data submission requirements necessary to acquire the data needed for accurate Medicare Part D payment and appropriate program oversight. CMS believes that claims data provide the most reliable approach to ensuring that payment calculations are accurate. Without claims-level data, we cannot verify the accuracy of payments related to reinsurance, risk corridors, low-income subsidies, CGDP reconciliation, MDP reconciliation, IRASA, and Selected Drug Subsidy.

This claims-level information is reported by Part D sponsors to CMS on the PDE record. CMS limits there data collection to only those critical data elements necessary for accurate payment-related calculations, along with other elements required for validation of the PDE record, quality monitoring, and program integrity and oversight.

The information users will be pharmacy benefit managers (PBMs), third party administrators and pharmacies, 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: Yearly; Affected Public: Private sector, Federal Government profits; Number of Respondents: 994; Total Annual Responses: 1,627,799,680; Total Annual Hours: 11,208. (For policy questions regarding this collection contact Shelly Winston at (443) 934-3621.)