Following a May court ruling that pharmaceutical manufacturers must receive Health Resources and Services Administration (HRSA) approval before replacing upfront 340B discounts with rebates, the Department of Health and Human Services has announced a new voluntary 340B Rebate Model Pilot Program. The Pilot will apply only to drugs included on CMS’ Medicare Drug Price Negotiation List and is set to begin in the 2026 plan year. HRSA’s Office of Pharmacy Affairs is inviting eligible pharmaceutical companies to participate for a minimum of one year and is currently seeking public input on the pilot’s design. The agency suggests the program could lay the groundwork for a broader rebate approach in the future. Learn more here.
Last Updated on August 26, 2025 by Aimed Alliance
