On Dec. 11, America’s Essential Hospitals and two other hospital associations filed an amicus brief with the U.S. District Court for the District of Maine in a lawsuit to stop the implementation of unlawful rebate models for the 340B Drug Pricing Program. Absent legal intervention, the Health Resources and Services Administration (HRSA) pilot program will begin Jan. 1, 2026.
The lawsuit, filed Dec. 1, alleges HRSA violated the Administrative Procedures Act with its substantive changes to 340B program operations. The suit requests an emergency injunction and a temporary restraining order, prohibiting HRSA from implementing the rebate pilot on Jan. 1, 2026. The court has scheduled oral arguments for Dec. 19. Several pharmaceutical manufacturers, as well as the Pharmaceutical and Research Manufacturers of America, also filed a motion with the court to intervene on behalf of the Department of Health and Human Services.
The brief, also signed by 340B Health, and the American Association of Medical Colleges, describes how rebate models will affect patients of essential hospitals and other 340B covered entities. Further supporting the arguments made in the lawsuit, the brief outlines how HRSA failed to provide sufficient explanation to change discount models, argues HRSA neglected to consider the costs and burden associated with participation on 340B hospitals, and describes how HRSA failed to provide adequate notice for the pilot. The brief also requests that the court grant the temporary restraining order.
The association separately sent a letter to HRSA on Dec. 1, describing several outstanding questions about the pilot program implementation, and requested a meeting to discuss these outstanding questions.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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