On February 10, 2026, in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.), the U.S. District Court for the District of Maine vacated and remanded to HHS the 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 36,163 (Aug. 1, 2025), the Corrected 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 38,165 (Aug. 7, 2025), and the approvals of applications from drug manufacturers submitted pursuant to those notices (announced between October 30 and November 14, 2025).
HHS is reconsidering whether to implement a 340B Rebate Model Pilot Program consistent with its statutory authority. HRSA is issuing a Request for Information (RFI) to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program. For more information on how to submit a response to the RFI during the 30-day comment period please visit Request for Information: 340B Rebate Model Pilot Program.