The Health Resources and Services Administration (HRSA) announced that it will move forward with a 340B rebate model pilot program, effective Jan. 1, 2027. The pilot provides a rebate mechanism, instead of upfront discounts, to allow drug manufacturers to apply the 340B ceiling price to certain drugs sold to covered entities. The rebate would apply to the transaction between the manufacturer and the covered entity. The pilot will apply to the NDC-11s of drugs in the Medicare Drug Price Negotiation Program for 2026 and 2027, regardless of payer, and will last at least one year.
The rebate program would be voluntary for the manufacturer, and the manufacturer would need to apply to HRSA to use such a rebate.
You can read the HRSA announcement here and our most recent comments on the pilot from April here.
Meanwhile, there are currently multiple 340B reform vehicles in Congress.
In the House, Reps. Scott Peters (D-Calif.) and John Joyce (R-Pa.) introduced the SECURE 340B Act. If made law, the bill would pause manufacturer rebate models for four years while a new patient definition is created and standards for contract pharmacies, data sharing, and transparency take effect. It would establish a clear, statutory definition of “patient” based on previous federal guidance and direct HRSA to use an independent, conflict-free clearinghouse to securely manage prescription-level data, verify claims, and protect privacy. Learn more about the SECURE 340B Act here.
Meanwhile, U.S. Sens. Tim Kaine (D-Va.), Jerry Moran (R-Kan.), Tammy Baldwin (D-Wis.), Shelley Moore Capito (R-W. Va.), John Hickenlooper (D-Colo.), and John Boozman (R-Ark.) introduced the SUSTAIN 340B Act in an effort to reform the 340B program. If passed into law, it would end any 340B rebate model program within one year and require the Department of Health and Human Services to transition to the clearinghouse established in the legislation.
The bill would also do the following:
1. Reiterate the original intent of the 340B program and clarify that the program provides point-of-purchase discounts, as opposed to rebates.
2. Require audits of covered entities with a large number of contract pharmacies, and standardize contractual requirements between covered entities and contract pharmacies. The bill does not place numeric or geographic limitations on the use of contract pharmacies.
3. Establish the definition of an eligible patient under the 340B program and covered services for these patients.
4. Establish a 340B data clearinghouse operated by an independent, third-party entity to prevent diversion and duplicate discounts in the 340B program.
5. Prevent insurers from discriminating against 340B covered entities and their contract pharmacies.
Read more about the SUSTAIN 340B Act here.
Additionally, Sen. Bill Cassidy (R-La.), chairman of the Health, Education, Labor and Pensions Committee, released a legislative discussion draft of the 340B Drug Pricing Integrity and Affordability for Patients Act (340B for Patients Act). Among other things, the bill would clarify that manufacturers must ship drugs to a contract pharmacy and define conditions for contract pharmacies to participate in the 340B program.
It would allow third-party administrators to charge covered entities only a flat fee amount per unit of service consistent with the fair market value of the service and applicable state and federal law. Contract pharmacy remuneration must also be a flat fee amount per each dispense and cannot exceed 125 percent of the average per-prescription dispensing fee paid to that pharmacy by all third-party payers in the most recent calendar year. The bill also requires covered entities to have compliance procedures to avoid duplication of 340B discounts. Cassidy is asking for stakeholder feedback by Aug. 28 to 340bforpatients@help.senate.gov.
NCPA will continue to monitor the bills.
