HRSA issued the RFI to “seek[] comments on whether HRSA should implement a rebate model under the 340B Program and how best to operationalize any such rebate framework for stakeholders. The information collected through this RFI will assist HRSA in evaluating the operational, financial, and access to drugs for patients of a rebate model on covered entities, manufacturers, and other stakeholders across the drug supply chain.”

The specific topics that HRSA has identified as relevant areas for comment include the following:

• Administrative, operational, financial, and medication access concerns;
• Reliance interests in continuing to obtain the 340B ceiling prices through upfront discounts;
• Potential cash-flow impacts;
• Proposed alternatives and scope-limiting measures to inform a rebate pilot design;
• Suggestions for appropriately balancing stakeholder concerns regarding implementation of a rebate model against the agency’s goal of testing rebates in the 340B program;
• Data on the effectuation of the ceiling price through use of rebates;
• Data relevant to other federal healthcare programs, including the Medicare Drug Price Negotiation Program; and
• Suggestions to improve transparency and inform future policy decisions.

The RFI states: “With the information collected from this RFI, HRSA will evaluate if a potential 340B Rebate Model Pilot Program is in the public’s interest and, if so, determine a viable implementation strategy, consistent with the 340B statute.”

HRSA states in the RFI that it is committed to analyzing the comments received before implementing any new 340B rebate models. This statement is likely intended to address the prior litigation that resulted in the withdrawal of the previous rebate models after the court found that HRSA failed to engage in the required review of comments in response to the previous 340B Rebate Model Pilot Program.