Federal Register #0906-NEW

HRSA Seeks Public Comment on 340B Rebate Model Pilot Program Information Collection

The Health Resources and Services Administration (HRSA), under the Department of Health and Human Services, is seeking public comment on its proposed information collection for the 340B Rebate Model Pilot Program. - Government Buyer: - Department of Health and Human Services - Health Resources and Services Administration (HRSA) - Office of Pharmacy Affairs (OPA) - OEMs and Vendors: - No specific OEMs or commercial vendors are named; the opportunity is directed at drug manufacturers with Medicare Drug Price Negotiation Program Agreements and covered entities participating in the 340B program - Products/Services Requested: - Submission of 340B Rebate Model Pilot Program plans by qualifying drug manufacturers (11 anticipated submissions) - Monthly purchase data reports from approved drug manufacturers (11 anticipated monthly reports) - Claims-level data submissions from covered entities to manufacturers for rebate requests (15,249 anticipated submissions) - Unique or Notable Requirements: - Participation is limited to drug manufacturers with current Medicare Drug Price Negotiation Program Agreements for the initial price applicability years 2026 and 2027 - Covered entities must submit detailed claims data to manufacturers to request rebates - The program emphasizes enhanced program integrity, compliance monitoring, and regular data reporting - The pilot is designed to test and improve the 340B rebate process through structured data collection and reconciliation

Description

The Health Resources and Services Administration (HRSA) submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval regarding the 340B Rebate Model Pilot Program. The program involves collecting pilot plans from drug manufacturers, monthly purchase data reports, and claims data from covered entities to manufacturers for rebate requests. The notice seeks public comments on the burden and implementation of the pilot program, which aims to enhance 340B program integrity and compliance monitoring. The pilot will be limited to manufacturers with Medicare Drug Price Negotiation Program Agreements for 2026 and 2027.

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