Federal Register #2026-15633

HRSA 340B Drug Pricing Program Rebate Model Pilot for Pharmaceutical Manufacturers

The Health Resources and Services Administration (HRSA), part of the U.S. Department of Health and Human Services (HHS), is launching a pilot program to test a new rebate model for the 340B Drug Pricing Program. - Government Buyer: - U.S. Department of Health and Human Services (HHS) - Health Resources and Services Administration (HRSA) - Program Overview: - Revised 340B Rebate Model Pilot Program - Allows qualifying pharmaceutical manufacturers to offer rebates instead of upfront discounts for certain drugs sold to covered entities - Aims to address operational complexities and improve compliance in the 340B Drug Pricing Program - OEMs and Vendors: - Targets pharmaceutical manufacturers (no specific companies named) - Products/Services Requested: - Participation plans from drug manufacturers for the rebate model - Applies to a limited set of drugs (no specific brands, models, or part numbers listed) - Unique/Notable Requirements: - Manufacturers must submit detailed rebate plans for HRSA approval - Plans must adhere to HRSA's standards and procedures - Focus on compliance with statutory 340B requirements - No specific drug products, part numbers, or quantities are identified in the notice - The pilot builds on established rebate program structures and is intended for a select group of drugs

Description

The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) and its Office of Pharmacy Affairs (OPA), announces the availability of a revised 340B Rebate Model Pilot Program. This pilot introduces a rebate mechanism allowing qualifying drug manufacturers to apply the 340B ceiling price for certain drugs sold to covered entities via rebates instead of upfront discounts. The program aims to implement this rebate approach for a limited set of drugs, building on established rebate programs. Eligible manufacturers must submit plans by August 24, 2026, for the pilot to be effective starting January 1, 2027.

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