Pharmacies should know that the 340B Rebate Model Pilot Program (the pilot), previously set to go into effect Jan. 1, 2026, and that NCPA previously reported on and covered in a webinar, is currently paused. For now, pharmacies should proceed with their 340B business as usual.
On Dec. 31, 2025, the Health Resources and Services Administration's Office of Pharmacy Affairs (OPA) stated that it is pausing the implementation of the pilot for all covered entity types at this time. Manufacturers who were approved for participation in the pilot to effectuate 340B pricing through a rebate mechanism will now be required to continue to offer all their covered outpatient drugs to 340B covered entities at the 340B ceiling price as an up-front discount. OPA will update stakeholders on developments regarding the pilot as they arise.
This follows a U.S. District Judge in the District of Maine granting a temporary restraining order on Dec. 18, 2025, blocking the pilot, followed by a Dec. 29, 2025, preliminary injunction of the court preventing the government from implementing the pilot pending further order. The judge's ruling is a temporary pause of the pilot while the case proceeds.
In the case, the American Hospital Association, the Maine Hospital Association, and four safety-net hospitals had brought a suit on Dec. 1, 2025, arguing that the pilot violates the Administrative Procedure Act. Plaintiffs argued that the pilot would impose significant administrative and financial burdens on safety-net providers, and that the financial burdens specifically would amount to "hundreds of millions" in annual costs.
