On July 31, the Health Resources and Service Administration (HRSA) announced an updated application process for a 340B Rebate Model Pilot Program (PDF), without a comment period. This announcement comes after HRSA’s original attempt to implement a 340B Rebate Model Pilot Program was halted following the U.S. District Court of Maine’s decision to issue a preliminary injunction on Dec. 29, 2025, prohibiting implementation of the ten individual rebate program applications [refer to Washington Highlights, Jan. 9].
The voluntary program will run for a minimum of one year, be open to applications only from manufacturers with Medicare Drug Price Negotiation Program Agreements for 2026 and 2027, and apply to the limited set of drugs that are subject to the program for those years. Manufacturers must submit plans by Aug. 24 for approval thirty days later and implementation by Jan. 1, 2027. Under the pilot program, approved manufacturers will be required to pay covered entities rebates within 10 days of claims submission and would be responsible for bearing the IT platform costs associated with the program. Covered entities must also receive 90 calendar days’ notice before implementing an approved rebate pilot plan, with instructions for registering for any IT platforms.
Lastly, unlike the 2025 340B Rebate Pilot Program Notice, HRSA included more details on how the agency will oversee the program. In the new notice, the agency specifies the pilot will include a defined pathway for covered entities to challenge denied claims. Tools will be made available for reporting rebate denials and will be made public on HRSA’s website within 30 calendar days of the pilot’s effective date.