Overview
- HRSA published the revised 340B Rebate Model on July 31, 2026, replacing a planned universal upfront‑discount approach with an optional rebate pathway for qualifying manufacturers.
- Under the new plan, manufacturers must validate individual patient claims before paying rebates so the agency can see transactions and try to prevent drugs from receiving both 340B discounts and Medicare negotiation discounts.
- The pilot targets drugs and companies tied to the first two rounds of the Medicare Drug Price Negotiation Program and asks manufacturers to submit rebate plans to HRSA by Aug. 24, 2026 for arrangements that could begin Jan. 1, 2027.
- Hospital groups have sharply criticized the revision as a threat to safety‑net revenue and cash flow, while some opinion pieces and administration officials portray the change as needed oversight to ensure discounts reach patients.
- The move follows a court blockade of the original pilot and comes as scrutiny over 340B has grown after reported program spending rose from about $53.7 billion in 2022 to more than $100 billion in 2025, prompting calls from auditors and investigators for better safeguards.