A federal judge in Maine has blocked the Health Resources and Services Administration’s 340B Rebate Model Pilot Program, pausing an initiative that would have allowed drugmakers to offer rebates instead of upfront discounts to hospitals. Judge Lance Walker granted a temporary restraining order after hospital groups argued the pilot lacked a robust administrative record and could harm 340B hospitals that rely on immediate price concessions. The order halts implementation ahead of the program’s planned Jan. 1, 2026 start and requires further legal review. The rulings came through two related federal actions and reflect broader litigation over how the Inflation Reduction Act’s negotiation framework interacts with 340B program discounts. Drugmakers had supported the pilot as a way to deduplicate discounts for drugs selected under IRA negotiation. Hospital groups argued the pilot threatened access and financial stability for safety-net providers. The litigation adds near-term uncertainty for manufacturers, providers and payers who had begun operational planning around the rebate model.