HHS States Intent to Withdraw 340B Rebate Pilot Appeal

In a Jan. 12 filing with the First Circuit Court of Appeals, the Department of Health and Human Services (HHS) pledged to withdraw its appeal of the preliminary injunction issued by the District Court of Maine on Dec. 29, 2025, which halted the 340B rebate pilot program.

In withdrawing the appeal, HHS states it will instead return "the approvals challenged in [the] litigation to the agency for reconsideration." If the appeal is withdrawn, it will leave in place the longstanding requirement that manufacturers provide up-front access to 340B Drug Pricing program discounts.

HHS had requested a stay pending the appeal. The First Circuit denied the stay of the injunction while the appeal is pending but continues to consider the appeal on the merits.

The pilot program would remain on hold while the agency reconsiders the approvals. At this time, manufacturers must continue to offer all 340B drugs to covered entities with an up-front discount.

Contact Director of Policy Rob Nelb, MPH, at [email protected] or 202.585.0127 with questions.