HHS Releases RFI on New 340B Rebate Model
•February 13, 2026
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Why It Matters
The decision will shape the future of the 340B drug pricing program, directly affecting hospital finances and drug access for vulnerable populations.
Key Takeaways
- •HHS opens RFI for 340B rebate pilot program
- •Comments accepted until March 19, 2026
- •HRSA seeks evidence on model design and impact
- •AHA cautions against costly burden on rural hospitals
- •Potential policy shift could alter 340B drug pricing dynamics
Pulse Analysis
The 340B Drug Pricing Program, established to help safety‑net hospitals stretch scarce resources, has faced mounting scrutiny over its pricing mechanisms and transparency. As drug costs continue to rise, policymakers are exploring alternative structures, such as a rebate model, that could align incentives between manufacturers, pharmacies, and providers. By soliciting detailed input from hospitals, manufacturers, and advocacy groups, HRSA aims to gather the empirical foundation needed to craft a pilot that balances fiscal responsibility with patient access.
The request for information, published on February 13, outlines a comprehensive questionnaire covering operational logistics, projected savings, and potential administrative burdens. Stakeholders have until March 19 to submit evidence‑based comments, offering a rare opportunity to shape federal policy before any regulatory changes are codified. For hospitals—particularly those in rural or underserved regions—the stakes are high; a rebate model could either unlock new revenue streams or, as the American Hospital Association warns, impose substantial new costs that strain already thin margins.
If HRSA proceeds with a pilot, the ripple effects could extend across the pharmaceutical supply chain. Manufacturers might adjust pricing strategies to accommodate rebate calculations, while pharmacies could see shifts in reimbursement workflows. Ultimately, the outcome will influence how quickly vulnerable patients receive essential medicines and could set a precedent for broader drug pricing reforms. Industry watchers will monitor the RFI responses closely, as they will signal the direction of future 340B policy and its impact on the healthcare ecosystem.
HHS releases RFI on new 340B rebate model
The Department of Health and Human Services Feb. 13 issued a request for information on a new 340B rebate model program. The RFI said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, will accept comments through March 19.
The RFI asks 340B stakeholders to provide answers to a long list of questions so that HRSA can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. HRSA expressly encourages commenters to “include supporting facts, research, and evidence.”
In a statement, Aimee Kuhlman, AHA vice president of advocacy and grassroots, said, “The AHA welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy.”
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