Article
What starts on Jan. 1
HRSA published the revised pilot notice on July 31, 2026, and on Oct. 1 approved 10 manufacturers: AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, GSK, Merck, Pfizer and Teva. Only the NDC-11s of drugs selected for Medicare price negotiation in 2026 and 2027 are included. Hospitals buy at wholesale acquisition cost through usual channels, then submit claims-level pharmacy and medical data to recover the gap between that price and the 340B price. Manufacturers get 10 calendar days after a complete submission to pay or deny, and covered entities have at least 45 days from dispensing to file. One change from the 2025 version: manufacturers may now use pilot data to deduplicate Medicaid managed care discounts.
The cash and workload problem
The hospital pays full price first and waits. Eastern Maine Medical Center expects to advance roughly $14 million a year. A Maine Hospital Association survey projects lags of 11 days to a month before rebates arrive, while wholesaler payment terms run 7 to 15 days. AHA puts the sector’s added administrative cost above $1 billion a year; the government’s estimate is $537 million. Before January, leaders should:
- Size the float: multiply projected WAC spend on affected NDCs by a realistic payment lag.
- Test the data pipeline: confirm your split-billing and TPA vendors can produce the required claims fields within the filing windows.
- Read platform terms: HRSA bars platforms from aggregating, sharing or licensing covered-entity data for other purposes.
- Track rebates by manufacturer: denials and late payments need an owner and an escalation path.
Court and Congress
On Oct. 9, AHA, the Maine Hospital Association and four safety-net hospitals sued HHS in federal court in Maine. They allege Administrative Procedure Act violations and sought a temporary restraining order. The same court blocked the first version three days before its planned Jan. 1, 2026 start. None of the late-October coverage reviewed for this article reported a ruling on the new request. In Congress, AHA has endorsed the House 340B Rebate Model Delay Act (H.R. 10770), which would push the model back to 2029. On Oct. 27, AHA also filed comments supporting much of the Senate’s bipartisan SUSTAIN 340B Act (S. 5244). That bill would end rebate models, protect contract pharmacy access and create a neutral claims clearinghouse.
Lilly shows where the data fight is going
Eli Lilly is not among the pilot manufacturers, but it already conditions 340B pricing on claims data, including in-house pharmacy and medical claims, submitted through the 340B ESP platform. It began cutting off noncompliant hospitals on June 18. On Oct. 27, five Massachusetts hospitals, including Mass General, Brigham and Women’s and UMass Memorial Medical Center, sued Lilly in federal court under state consumer protection law, raising HIPAA concerns. UMass Memorial alone estimates at least $20 million a year in overpayments. Tampa General and Mary Hitchcock Memorial have brought similar challenges.
Sources
- HRSA approves 10 drug companies for participation in the 340B Rebate Model Pilot Program (AHA News, Oct 1, 2026)
- HRSA Announces 340B Rebate Model Pilot Program (Covington, Aug 3, 2026)
- 340B rebate model lawsuit seeks to halt 2027 rollout, citing hospital costs (HFMA, Oct 10, 2026)
- 5 Massachusetts hospitals sue Eli Lilly over 340B data demands (Becker’s Hospital Review, Oct 27, 2026)
- AHA comments on the SUSTAIN 340B Act (AHA News, Oct 28, 2026)