The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), has announced the 340B Rebate Model Pilot Program, a new voluntary initiative for drug manufacturers to offer 340B ceiling prices via post-purchase rebates rather than traditional upfront discounts. Under the model, “a covered entity would pay for the drug at a higher price upfront and then, within 10 days receive a post-purchase rebate that reflects the difference between the higher initial price and the 340B price.”
The pilot is scheduled to begin on January 1, 2026, and will initially apply only to drugs listed on the CMS Medicare Drug Price Negotiation Selected Drug List for the 2026. Drug manufacturers interested in participating must submit detailed implementation plans to HRSA by September 15, 2025.
This rebate pilot program is designed, “primarily to address 340B and Maximum Fair Price (MFP) deduplication, but also to facilitate other aims such as the prevention of 340B Medicaid duplicate discounts and diversion.“ The pilot will rely on a secure IT platform to allow covered entities to submit pharmacy claims data up to 45 calendar days after the date of dispense for real-time rebate processing. Rebates may not be denied based on concerns related to diversion or Medicaid duplicate discounts. Any compliance issues must be addressed directly with HRSA.
Manufacturers participating in the pilot will be required to meet strict criteria. They must cover all administrative and technical costs, ensure data protection, and provide technical support to covered entities. HRSA emphasizes that no additional administrative costs should be passed on to the covered entities themselves.
Manufacturers must also submit periodic reports to HRSA detailing rebate processing outcomes, claim delays, denials, and other program-specific metrics.
HRSA will collect public comments on the pilot program’s design and application process. For complete program details and to access the full Federal Register notice, visit: Federal Register Notice: HRSA 340B Rebate Model Pilot Program (PDF)
Ready for expert guidance on your 340B program based on the latest industry events? Contact us today to learn how we can support your entity's success.
What does this mean for you?
It’s time to start reviewing the 2026 MFP drug list to see how it might affect your organization.
What you can do
Plan for the fact that you may need to pay more upfront for some drugs, and then get a rebate later—within about 10 days.