Becker's Healthcare December 29, 2025
A federal judge granted a temporary restraining order blocking the Department of Health and Human Services from launching its 340B Rebate Model Pilot Program, which was scheduled to begin Jan. 1, 2026.
U.S. District Judge Lance Walker of the District of Maine issued the order Dec. 18 in a case brought by the American Hospital Association, the Maine Hospital Association and four safety-net hospitals. The plaintiffs argued the program violates the Administrative Procedure Act — a federal law that requires agencies to follow certain rulemaking steps such as public notice and comment before implementing new regulations.
Filed Dec. 1, the lawsuit challenges HHS’ plan to replace the longstanding upfront drug discount model with a rebate-based structure. Under the proposed model,...
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