The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) on Oct. 30 announced its approval of eight drug manufacturers’ applications to participate in a voluntary 340B Rebate Model Pilot Program (PDF). In August, HRSA unveiled a voluntary rebate model pilot, limited to the 10 drugs eligible for negotiation through the Medicare Drug Price Negotiation Program in 2026 [refer to Washington Highlights, Aug. 1]. HRSA’s approval covers nine of the 10 Medicare negotiation-eligible drugs in 2026, and implementation of the rebate models begins on Jan. 1, 2026. Manufacturers must provide notice to covered entities on the specifics of their rebate models 60 days prior to implementation.
Under the pilot program, covered entities will purchase the affected drugs at wholesale price, and manufacturers must pay covered entities rebates within 10 days of claims submission. Covered entities will submit claims through the Beacon system, a third-party platform chosen by manufacturers for their rebate models. In its announcement approving the eight rebate models, HRSA expanded the data fields covered entities must report to manufacturers to include medical claims data fields.
The AAMC submitted comments in September opposing the use of 340B rebate models, noting the insufficient implementation timeline, the absence of information on how HRSA will enforce 340B compliance under a rebate model, the lack of a clear process for disputing improperly rejected rebate requests, and the substantial administrative burden these models would impose on 340B hospitals [refer to Washington Highlights, Sept. 12].
- Washington Highlights