HRSA Launches 340B Rebate Model Pilot Program, Seeks Feedback

The Health Resources and Services Administration (HRSA) has announced the application process for a new initiative aimed at enhancing the 340B program. The 340B rebate model pilot program is designed to evaluate and approve rebate models for drug manufacturers. HRSA is inviting public comments on this initiative, with the goal of implementing approved models as early as January 1, 2026.

Participation in this pilot program is voluntary for manufacturers, but it is expected to be mandatory for 340B covered entities regarding the approved rebate models. The guidance provided by HRSA presents a more favorable framework for these entities compared to proposals made by certain drug manufacturers in late 2024. The pilot will focus on drugs selected for the Medicare drug price negotiation program (MDPNP), but it will not limit participation to Medicare Part D; rather, it will encompass drugs billed to any patient prescription drug benefit plans.

Stakeholders are encouraged to review the details of the 340B rebate models outlined in HRSA’s notice and to submit their comments by August 30, 2025. The agency is particularly interested in feedback on several key issues, which could influence the structure and implementation of the program.

Key Requirements for Participation and Feedback

Manufacturers interested in participating must submit their applications detailing their 340B rebate model plans to HRSA by September 15, 2025. HRSA aims to approve these plans by October 15, 2025. Once approved, the manufacturers must notify covered entities at least 60 days in advance of the implementation.

Plans submitted must comply with specific requirements, including ensuring that the manufacturer covers all administrative costs and that drugs continue to be purchased through established distribution channels. Additionally, data submission and information technology platforms must maintain HIPAA compliance to ensure the security of submitted data.

Manufacturers are required to allow rebate request data to be submitted up to 45 days after the drug is dispensed and must process rebates within 10 days of data submission. Notably, plans cannot deny 340B rebates for diversion or duplicate discounts; they must also provide clear reasons for any denials.

The notice specifies that data submission for rebate models will focus on certain pharmacy claim fields, including the date of service, RX number, fill number, and the 11-digit national drug code.

Areas for Stakeholder Input and Considerations

HRSA has outlined specific areas where stakeholder comments are particularly welcomed. These include suggestions for additional flexibilities to enhance efficiency for manufacturers, safeguards to protect covered entities from unintended negative consequences, and any other data elements that could improve implementation and evaluation of the pilot.

Stakeholders are also invited to raise concerns regarding potential implementation challenges, such as logistical or administrative burdens. The notice, while thorough, leaves certain critical questions unanswered, particularly regarding how HRSA-approved rebate plans will interact with state contract pharmacy protection laws.

For instance, stakeholders may be curious if HRSA’s involvement in regulating pharmacy claims data could strengthen manufacturers’ claims that the 340B statute preempts certain state laws. Additionally, clarity is needed on how the data submission requirements under the rebate model plans will align with other data collection efforts from the U.S. Department of Health and Human Services related to the MDPNP and Medicaid.

As the comment period closes shortly before the application deadline, stakeholders face a tight timeline to provide useful feedback. Questions remain regarding whether manufacturers can submit plans after September 15, 2025, and what recourse will be available to covered entities if manufacturers improperly deny rebates.

HRSA’s initiative represents a significant step towards refining the 340B program, and the upcoming pilot program provides an opportunity for both manufacturers and covered entities to shape its future. Stakeholders are urged to engage actively in the comment process to ensure their concerns and suggestions are considered in the final design.