The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) on Aug. 1 announced an application process for a voluntary 340B Rebate Model Pilot Program (PDF). The announcement comes as a response to litigation from drug manufacturers pursuing 340B rebate models in 2024 without prior HHS approval [refer to Washington Highlights, Nov. 22, 2024].
The voluntary program would run for a minimum of one year, be open to applications only from manufacturers with Medicare Drug Price Negotiation Program Agreements for 2026, and apply to a limited set of drugs that are subject to the Medicare Drug Price Negotiation Program. Manufacturers must submit plans by Sept. 1 for approval by Oct. 15 and implementation by Jan. 1, 2026. Under the pilot program, approved manufacturers would be required to pay covered entities rebates within 10 days of claims submission and would be responsible for bearing the costs associated with the program. HRSA is accepting comments for 30 days following the publication, and the AAMC plans to respond.
Earlier this year, the AAMC submitted a letter to HHS Secretary Robert F. Kennedy Jr. outlining the association’s concerns with the 340B rebate models (PDF) proposed by five drug manufacturers and cautioning the department against adopting rebate models in upcoming guidance [refer to Washington Highlights, May 30].