A Maine district court judge has issued a preliminary ruling prohibiting the Health Resources & Services Administration’s (HRSA) 340B Rebate Pilot Program from going into effect on January 1, 2026.
Earlier this year, HRSA announced a pilot program that would allow 340B discounts for certain drugs to be provided as a rebate after the purchase rather than an upfront discount. The American Hospital Association, Maine Hospital Association, and four health systems filed a lawsuit challenging the pilot program under the Administrative Procedure Act (APA). The judge issued a preliminary injunction holding that HRSA failed to abide by the APA and that covered entities would face irreparable harm if the program were to go into effect on January 1.
The government filed an emergency appeal in the First Circuit Court of Appeals to stay the district court’s injunction. The First Circuit denied the emergency motion, but “intends to rule on the broader stay request as soon as practicable.”