The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate models that HRSA will be willing to review and approve. Approved 340B rebate models may be implemented as early as January 1, 2026.

While participation in the 340B rebate model pilot program is voluntary for manufacturers, participation appears to be mandatory for 340B covered entities with regard to the 340B rebate models that HRSA approves. HRSA indicated that it may modify or expand the pilot in future years.

The guidance is materially more favorable to 340B covered entities than the 340B rebate models that certain drug manufacturers proposed or attempted to implement in late 2024. The pilot will limit 340B rebate models to drugs that have been selected for the Medicare drug price negotiation program (MDPNP) and appears to further limit 340B rebate models to drugs that are billed to patients’ prescription drug benefit plans. However, the notice explicitly states that the 340B rebate model plans will apply to drugs selected for the MDPNP, regardless of payor – in other words, they will not be limited to Medicare Part D.

Stakeholders should carefully review the 340B rebate models described in the notice and consider submitting comments to HRSA. HRSA will accept comments through August 30, 2025.

Summary of the notice

Manufacturers that would like to participate in the pilot must submit applications describing their 340B rebate model plan to HRSA by September 15, 2025, for approval by October 15, 2025, and implementation by January 1, 2026. Manufacturers implementing approved 340B rebate models must provide at least 60 days’ notice to 340B covered entities. Among other requirements, any plan must ensure that:

• The manufacturer bears all administrative costs.
• Drugs will continue to be purchased through established distribution channels.
• The data submission/IT platforms are HIPAA compliant and all submitted data is secure.

Each plan must include certain elements, including allowing rebate request data to be submitted up to 45 days after dispense and paying rebates within 10 days of data submission. Manufacturers’ plans cannot deny 340B rebates for diversion or duplicate discounts and must provide information about the reason for denials. Data submission requirements are limited to the following pharmacy claim fields:

• Date of service.
• Date prescribed.
• RX number.
• Fill number.
• 11-digit national drug code.
• Quantity dispensed.
• Prescriber ID.
• Service provider ID.
• 340B ID.
• Rx bank identification number.
• Rx processor control number.

Request for comments on specific topics

HRSA explicitly set forth the following issues on which it seeks comment. Commenters are not limited to commenting on these issues; HRSA states that it will accept comments on all aspects of the pilot. Stakeholders should take the opportunity to provide HRSA with feedback on these issues and any other relevant topics or concerns.

• Are there any additional flexibilities to maximize efficiency and efficacy for participating manufacturers that should be considered in the pilot design?
• Are there any additional safeguards to mitigate unintended adverse impacts for covered entities that should be considered in the pilot design?
• Are there any additional data or reporting elements that should be required to improve implementation and evaluation of the pilot?
• Are there any potential implementation issues not yet sufficiently accounted for in the pilot design (e.g., logistical or administrative burdens)?

Open issues, questions, and concerns

The notice is fairly short and does not provide robust detail on many issues that are likely to be of interest and concern to 340B stakeholders. Some examples follow, but additional issue areas likely will arise with further opportunity to evaluate the notice.

• How will HRSA-approved 340B rebate model plans interact with state contract pharmacy protection laws? For example, does HRSA’s entry into regulating submission of pharmacy claims data strengthen manufacturers’ claims that the 340B statute preempts the state laws?
• How will the data submission required under any 340B rebate model plans interact with other recently announced US Department of Health and Human Services pharmacy data collection efforts in connection with the MDPNP and Medicaid? Will 340B covered entities be required to submit the same data elements to multiple portals for different purposes?
• Will/can drug manufacturers use 340B rebate model plans to monitor and enforce compliance with their contract pharmacy restriction policies?
• How might 340B rebate models be expanded in the future, including to address “the administration’s goals,” as alluded to in the notice?
• Given the extremely tight timeframe for comments, submission of plans, approval of plans, and implementation, what types of modifications to the parameters of the notice could be expected following the comment period? (There are only 15 days between the end of the comment period and the deadline to submit plans.)
• Can manufacturers submit plans for approval after September 15, 2025, with effective dates after January 1, 2026?
• If manufacturers improperly deny rebates, what recourse will 340B covered entities have other than reporting the denials to HRSA? Will HRSA allow manufacturers to deny rebates on claims for drugs dispensed in accordance with restrictions previously approved by federal appeals courts?