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The rebate pilot returns
On July 31, HHS issued a revised 340B Rebate Model Pilot Program. It would let approved manufacturers meet the 340B ceiling price through after-the-fact rebates rather than upfront discounts. The pilot is limited to drugs selected for Medicare drug price negotiation for 2026 and 2027. Manufacturers must submit plans by Aug. 24, HRSA will decide by Sept. 24 and approved models would take effect Jan. 1, 2027, with a commitment of at least one year.
The move follows a federal court decision that vacated the original 2025 pilot. The AHA’s Rick Pollack said the association is deeply concerned, argued that HHS understated compliance and cash-flow costs, and said the AHA is considering all available options to stop the program.
What the Senate bill would do
On Aug. 5, Sens. Jerry Moran, Tammy Baldwin, Shelley Moore Capito, Tim Kaine, John Boozman and John Hickenlooper introduced the SUSTAIN 340B Act. Its main provisions would:
- Codify contract pharmacy use and require manufacturers to offer 340B pricing whether drugs are shipped to a covered entity or a contract pharmacy.
- Bar manufacturers from conditioning 340B pricing or limiting delivery to contract pharmacies.
- End the rebate pilot within one year of enactment, prohibit similar rebate models and create a national data clearinghouse to address duplicate discounts.
- Create a statutory definition of a 340B patient.
- Add documentation, reporting, auditing and recertification requirements for covered entities, contract pharmacies and child sites.
- Start a user fee in fiscal 2031 to fund HRSA oversight.
The AHA praised the Senate working group’s leadership but did not endorse the bill, saying it will review the details with its 340B members.
The trade-off for hospitals
The bill offers what 340B hospitals have sought for years: an end to manufacturer limits on contract pharmacies and protection from rebate models. In exchange, it brings a federal patient definition and new reporting and audit requirements. A narrow patient definition could reduce eligible prescriptions, and new reporting could add administrative cost.
What to do now
- Estimate the cash-flow effect if pilot drugs move to rebates in January, including the float between purchase and rebate.
- Test how the bill’s patient definition would affect your current eligible claims.
- Assess whether your 340B program could meet expanded reporting and audit requirements for child sites and contract pharmacies.
- Brief your congressional delegation with specific community benefits funded by 340B savings.
Archive entry for Aug 6, 2026, added Nov. 11, 2026.