HRSA Issues 340B Rebate Model RFI: What Rural Hospitals Need to Know

Healthcare Policy Update
Feb 23, 2026
Article Background

What’s happening

The Health Resources and Services Administration (HRSA) issued a request for information (RFI) to inform next steps in the development and implementation of 340B rebate models. This RFI follows a previously announced planned demonstration that was voluntary for pharmaceutical manufacturers but mandatory for hospitals. That demonstration was withdrawn by HRSA after it was successfully challenged in court for failure to follow certain required procedural steps. Comments are due by March 19, 2026.

Of interest

HRSA states that it plans to use the information collected from the RFI to evaluate whether and how to move forward with a revised 340B rebate model demonstration. Hospitals may find it worthwhile to share experiences with the 340B program and thoughts on how a rebate model could impact their operations to inform potential future policymaking in this arena.

The RFI specifically calls out key areas for comment by stakeholders:

Costs to covered entities, including current administrative costs under the upfront 340B discount and how that would change under a rebate model; staffing impacts of a rebate model; systems and infrastructure that would be needed for implementation; and other anticipated costs or impacts
Payment and timing and potential cashflow impacts for covered entities
Rebate denials
Data collection by covered entities
Manufacturer efforts to avoid duplicate discounts
Manufacturer reporting requirements
Any program Integrity benefits of a rebate model

Our partners at McDermott, Will, & Schulte (MWS), one of healthcare’s most trusted and respected healthcare law firms, wrote an analysis of what the RFI includes and how covered entities should think about responding.

Why you should care

Many rural hospitals and health systems rely on the 340B program to ensure they can provide key services within their community. Changing the program’s structure would result in new upfront expenses for hospitals, could endanger their ability to continue providing these critical community services, and could threaten their financial viability.

Looking to learn more?

MWS offers valuable insights into why the RFI is important and what rural hospitals and health systems should include in their responses. Read more to see what they are saying about how your organization could be impacted.

Click here to read the MWS insight.