HRSA Moves Forward on 340B Rebate Model

18 Mar HRSA Moves Forward on 340B Rebate Model

After a brief posting delay, HRSA’s Request for Information (RFI) on a potential new 340B rebate model is now officially open for comment. The RFI deadline has been extended to April 20, 2026.

At the same time, HRSA released a separate Information Collection Request (ICR) estimating the administrative burden of a future rebate pilot. The ICR is set to publish February 26, and comments will be due 60 days from publication.

Taken together, these actions show that HRSA is actively preparing the framework for a rebate model tied to IRA-negotiated drugs for 2026 and 2027.

The administrative record is being built now.

Two Separate Comment Processes

HRSA has opened two distinct comment tracks:

1. Request for Information (RFI)
Seeks feedback on whether HRSA should move forward with a rebate model and how it should be structured.
Deadline: April 20

2. Information Collection Request (ICR)
Estimates the administrative burden of implementing a rebate pilot, including weekly claims-level data submissions by covered entities.
Deadline: 60 days after publication

The ICR is where HRSA sets its official burden assumptions under the Paperwork Reduction Act.

We encourage covered entities to comment on one or both.

What HRSA Is Estimating

The ICR assumes:

• 14,600 covered entities impacted
• 52 claims-level submissions per year (weekly)
• 5 hours per submission
• 260 hours annually per entity

HRSA also states that much of the required data is already maintained and that the burden “may not be significant.”

If that does not reflect your operational reality, this is the moment to correct it.

Why This Matters

These burden estimates become part of the federal record. If they are not challenged with concrete data, they stand.

The prior rebate pilot was blocked in part because the agency failed to adequately analyze and explain the operational and financial impact on covered entities, this process is HRSA’s opportunity to address that gap, and fix the procedural weaknesses that got the first pilot blocked.

If the operational impact is understated now, those lower estimates may later be cited as justification for moving forward.

What to Bring Into Your Comments

Consider documenting:

• Actual hours required to extract, validate, format, and transmit claims data
• Reconciliation time for denials, corrections, and disputes
• Vendor fees or system upgrade costs
• Internal FTE impact across billing, pharmacy, finance, and compliance
• Cash flow modeling (monthly purchase volume and rebate lag impact)
• Exposure if rebate timing is delayed or contested

In practical terms:

• It may take X hours, not 5
• It may require Y FTE support
• It may cost Z in system or vendor expenses
• It may shift cash flow by $___ per month

Specific numbers carry weight.

Submit RFI & ICR Feedback on HRSA’s 340B Rebate Model

RFI (policy feedback): <FEDERAL REGISTER / COMMENT LINK>

ICR (burden estimate feedback): <ICR / INSTRUCTIONS FOR COMMENT>

This is about making sure the operational assumptions are accurate before they are finalized. We urge you to consider commenting to help set the record.

We will continue to update you as we receive new information. Please reach out for any questions or support.