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 issued 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. The comment period for the RFI closed on April 20, 2026. HRSA is currently reviewing the comments and determining next steps.