US 340B Rebate Pilot 2027

In late July 2026 the Health Resources and Services Administration (HRSA) announced a revised 340B Rebate Model Pilot that will start on 1 January 2027. The pilot shifts the discount mechanism: manufacturers will sell drugs at non‑340B prices and later provide retrospective rebates so that covered entities receive a net price equal to the 340B ceiling. Manufacturers must submit detailed rebate‑submission plans by 24 August 2026, with HRSA expected to approve them by late September. The program initially covers about 25 drugs, roughly 5.5 % of total 340B sales, and requires unit‑level rebate processing with payments due within ten days of claim submission.

A follow‑up notice on 4 August 2026 reiterated the same start date and structure, emphasizing that safety‑net hospitals, community health centers and other covered entities will pay full wholesale acquisition cost up front and claim rebates later. The announcement noted that patients should see no change in prescription prices at launch and that most providers will receive payments from wholesalers after rebates are received. It also highlighted consulting advice for Federally Qualified Health Centers to strengthen eligibility, compliance, and pharmacy strategies to maximize savings for low‑income services.