HRSA Announces Revised 340B Rebate Model Pilot Program to Strengthen Care in Rural and Medically Underserved Communities

Pilot strengthens transparency, accountability, and program integrity to support the long-term sustainability of the 340B Drug Pricing Program and help preserve access to care in rural and medically underserved communities

The Health Resources and Services Administration (HRSA) today announced the revised 340B Rebate Model Pilot Program, which will provide qualifying drug manufacturers with a voluntary pathway to provide the 340B ceiling price to covered entities through rebates, rather than upfront discounts, for a limited set of covered outpatient drugs to bolster transparency and program sustainability and preserve access to care for underserved communities.

The revised Pilot follows extensive stakeholder engagement, including a Request for Information that generated more than 2,400 public comments, and reflects feedback received from hospitals, health centers, manufacturers, pharmacies, patient advocates, and other stakeholders.

"The 340B Program plays an essential role in supporting safety-net providers that serve rural and medically underserved communities," said HRSA Administrator Tom Engels. "As the program has grown in both size and complexity, strengthening transparency, accountability, and program integrity has become increasingly important. This revised Pilot helps modernize program oversight by improving visibility into 340B transactions while helping preserve the program's long-term sustainability for the patients and communities it was created to serve."

The 340B Drug Pricing Program has expanded significantly, growing from $53.7 billion in 2022 to more than $100 billion in 2025. Growth in covered entity sites, contract pharmacy arrangements, specialty pharmaceuticals, and the increasing complexity of federal drug pricing programs has created new operational and oversight challenges.

Under the revised Pilot, participating manufacturers will provide timely rebates after validating eligible claims. A claims-based rebate approach will improve transparency by providing greater visibility into 340B transactions, strengthen 340B program integrity through transaction-level verification, help prevent 340B duplicate discounts, and support nonduplication under the Medicare Drug Price Negotiation Program.

The Pilot is expected to:

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

The revised Pilot is consistent with HRSA's statutory authority to approve manufacturer rebate plans as an alternative mechanism for effectuating the 340B ceiling price.

Eligible manufacturers seeking to participate in the Pilot must submit rebate plans to [email protected] by August 24, 2026. Rebate plans for selected drugs during the applicable pricing periods will become effective on January 1, 2027.

Additional information, including eligibility requirements and submission instructions, is available in the Federal Register Notice: (LINK).

About the 340B Drug Pricing Program

The 340B Drug Pricing Program requires participating drug manufacturers to provide discounts on covered outpatient drugs purchased by eligible safety-net providers. The program helps eligible covered entities stretch scarce federal resources to expand access to healthcare services for patients in rural, underserved, and medically vulnerable communities.

HRSA, an agency within the U.S. Department of Health and Human Services, improves access to healthcare for people who are geographically isolated or economically or medically vulnerable.

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