August 12, 2025
HRSA Announces New 340B Rebate Model Pilot Program, Apply by September 2
On July 31, the Health Resources and Services Administration (HRSA) announced a 340B Rebate Model Pilot Program for drugs on the Centers for Medicare & Medicaid Services’ (CMS) Medicare Drug Price Negotiation Selected Drug List for the year 2026 from qualifying manufacturers meeting specific criteria.
The Health Resources and Services Administration’s (HRSA’s)Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting selected drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA is implementing the program to better understand the merits and shortcomings of the rebate model from the perspective of affected stakeholders, and to help shape future 340B rebate models that align with 340B statue and the Administration’s goals.
Organizations may submit Rebate Model Pilot plan and/or provide comments by September 2, 2025, by visiting the 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program Federal Register Notice.
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