[co-author: Ivy Miller]*
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently, the Health Resources and Services Administration (HRSA), which administers the 340B program, issued a set of FAQs providing additional guidance to 340B Covered Entities and manufacturers on the parameters of the Pilot Program.
The key takeaways of the FAQs are:
- HHS will implement a process for participants and other stakeholders to provide feedback on the Pilot Program in accordance with the Notice, but that it is “under no obligation to respond to or act on the comments.”
- HHS will publish a summary of all approved rebate plans.
- The rebate model only applies to a limited number of 340B covered outpatient drugs which are on the Medicare Drug Price Negotiation Program (MDPNP) Selected Drug List for initial price applicability year (IPAY) 2026, and which are listed in the FAQs; all other 340B drugs are still subject to upfront discounts.
- Manufacturers may limit their rebate plans to only certain 340B Covered Entity types.
- The rebate model is not limited to retail dispensing and may apply to physician or clinic-administered drugs on the MDPNP for IPAY 2026.
- Manufacturers may collect additional data as part of their rebate plans, but must provide “compelling supporting information” to justify the additional data elements, which HHS will review for 340B program compliance.
- Covered Entities should have access to the real-time rebate status of a claim, and should receive payment of rebate claims within 10 days; if not, Covered Entities should work with manufacturers and the IT platform vendor to resolve any issues, and if unable to resolve, may submit a complaint to HHS via email.
- HHS may revoke a manufacturer’s participation in the Pilot Program if “unable to timely resolve rebate reimbursement issues” or “trends toward not paying rebates within 10 days of data submissions.”
*Legal Intern
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