Following a federal court rejection earlier this year of a previously announced pilot program to alter how the 340B Drug Pricing Program is administered, the Department of Health and Human Services’  Health Resources and Services Administration has announced that it will implement a revised 340B Rebate Model Pilot Program.

Under this new model, qualifying drug manufacturers will be able to provide the 340B ceiling price to eligible 340B providers through rebates, an approach manufacturers have increasingly sought, rather than the upfront discounts that providers prefer.

According to a HRSA news release, the agency believes its new model will:

  • Improve claims-level transparency and accountability through transaction-level verification.
  • Strengthen verification of eligible 340B transactions before rebates are issued.
  • Prevent duplicate discounts.
  • Generate better data to inform oversight and future policymaking.
  • Preserve the long-term sustainability of the 340B program.

Acknowledging many of the concerns voiced by 340B-participating providers in response to a recent request for information, HRSA believes its revised model balances the burden on program stakeholders with the benefits of transparency and program integrity, building into its pilot program the following protections:

  • The scope is limited to a specific set of drugs – those in the Medicare Drug Price Negotiation Program for 2026 and 2027.  That amounts to 25 drugs from 13 companies that together account for less than 5.5 percent of the 340B program’s total 2025 sales.
  • Manufacturers must permit covered entities to order the selected drugs under existing distribution mechanisms.
  • Manufacturer data collection is limited to a specific list of data elements that participating 340B entities should already have readily available.
  • Manufacturers must ensure that rebates are paid within 10 calendar days of completed data submission.
  • Manufacturers may not deny rebates based on eligibility or compliance concerns with diversion or Medicaid duplicate discounts.
  • Participating 340B entities can raise concerns about manufacturers not meeting the 10-day requirement for payment of rebates and concerns about denials to HRSA, which will have the authority to terminate manufacturers’ participation in the program.

Manufacturers have until August 24 to submit plans to participate in the model and HRSA plans to issue approvals, if any, by September 24.  The 340B rebate pilot will begin on January 1, 2027.

Learn more about HRSA’s 340B pilot program from its formal notice, this HRSA news release, and the Fierce Healthcare article “Revised 340B Rebate Model Pilot Program moves forward, despite provider pushback.”