On February 13, HRSA released a NEW Request for Information (RFI) on a 340B rebate model. Following the dismissal of the American Hospital Association (AHA) lawsuit and withdrawal of the original pilot from 2025, HRSA is seeking detailed feedback on operational, financial, and administrative feasibility of another 340B Rebate Model by gathering input from interested parties regarding the potential use of rebate model. Public comments for the RFI are due on April 20 (an update from the original March 19 deadline).
The AHA lawsuit was successful due to lack of a thorough administrative process used to create the first rebate model pilot. The RFI this time around is much more detailed than the previous version to fix concerns expressed by the courts. It’s also expected that this Rebate Model will not go into effect as quickly, probably closer to early 2027.
NACHC is working on calculators and worksheets to help with preparing health centers and PCAs to submit comments. There will also be comment letter templates coming soon. NACHC is asking health centers and PCAs to provide more detailed local examples and data in comments to demonstrate the burden a 340B rebate model would place on health centers.
In addition, some members in Congress are working on a bill that would exempt health centers and many other covered entities from a Rebate Model, but we don’t know how quickly Congress will move and there are sure to be hurdles from manufacturers.
The RFI provides our best opportunity at this moment to try to get health centers exempted from the 340B rebate model through the regulatory process.
We will be sharing more information with the 340B health center leaders as it becomes available. As we face the uncertainty of another Rebate Model, we still have 1:1 TA available with Draffin Tucker if you should find you need assistance. Please reach out to Kim Kuhlmann or Lindsey Karlson with CHAD if you do need help.
