HRSA to Begin 340B Rebate Model Pilot on Jan. 1, 2027
The Health Resources and Services Administration (HRSA) issued a notice on July 31, 2026 announcing a revised 340B Rebate Model Pilot that will become effective on January 1, 2027. The pilot will allow participating drug manufacturers to sell drugs at non‑340B prices and then provide retrospective rebates to covered entities so that the net price matches the 340B ceiling price.
Manufacturers must submit pilot plans by August 24, 2026, and HRSA expects agency approvals by September 24, 2026. The model requires unit‑level rebate processing, with rebate payments due within ten calendar days of a complete claim submission. A 15‑day implementation grace period is provided for unreplenished accumulations, and covered entities are given at least 45 days after dispense to submit claims.
The pilot initially covers roughly 25 drugs selected for the Medicare Drug Price Negotiation Program for 2026‑2027, representing about 5.5 % of total 340B sales. Participating manufacturers must bear the costs of setting up rebate‑submission platforms that support real‑time reporting, data security, and interoperability with existing pharmacy and billing systems.
Entities: 340B Drug Pricing Program · Centers for Medicare & Medicaid Services (CMS) · Covered entities (healthcare providers) · Health Resources and Services Administration (HRSA) · Medicare Drug Price Negotiation Program · Participating drug manufacturers · Pharmaceutical manufacturers · Trump administration
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [● 3 SOURCES] The pilot is scheduled to take effect on January 1, 2027. (HRSA pilot timeline)
- [● 3 SOURCES] HRSA announced a revised 340B Rebate Model Pilot Program on July 31, 2026. (both)
- [● 2 SOURCES] Manufacturers must submit pilot plans to HRSA by August 24, 2026. (both)
- [● 3 SOURCES] The pilot will allow participating drug manufacturers to provide retrospective rebates instead of upfront discounts. (HRSA pilot description)
- [○ 1 SOURCE] The pilot includes a 15‑day implementation grace period for unreplenished accumulations. (first)
- [○ 1 SOURCE] Agency approvals for the pilot will be made by September 24, 2026. (first)
- [● 2 SOURCES] The pilot requires unit‑level rebate processing and rebate payments within ten calendar days of claim submission. (both)
- [○ 1 SOURCE] The Trump administration revised the pilot to target drugs and manufacturers involved in the first two rounds of the Medicare Drug Price Negotiation Program. (Trump administration statement)
- [○ 1 SOURCE] Manufacturers must allow at least 45 days for covered entities to submit claims after dispense. (second)
- [● 2 SOURCES] The pilot will take effect on January 1, 2027. (both)
- [○ 1 SOURCE] The pilot initially covers roughly 25 drugs selected for the Medicare Drug Price Negotiation Program for 2026‑2027, representing about 5.5 % of 340B sales. (second)