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A Guide to HRSA’s 340B Rebate Model Pilot Program

HRSA's new Pilot Program changes how covered entities receive 340B pricing starting January 1, 2027. This guide explains how the model works. It also gives you a practical framework for getting ready, including the exact questions to ask internally and of your TPA. 

On August 3, 2026, HRSA introduced the most significant change to 340B's price mechanism since the program's inception in 1992. 

Instead of a discount applied at purchase, qualifying manufacturers will pay a rebate after a drug is dispensed. This guide covers what that shift actually means and what a covered entity needs to figure out before the Pilot takes effect on January 1, 2027.

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What You'll Learn

  • Understand how the rebate model replaces the upfront 340B discount, and why this marks the first change to the program's core pricing mechanism since 1992.
  • Know the exact deadlines that govern the process, including the 45-day submission window and the 10-day payment window.
  • Recognize where the real operational gap sits: combining pharmacy and medical claims data into a single submission, a capability most TPAs haven't yet tested in production.
  • Grasp the financial stakes of a denied claim, and how HRSA's rules currently give manufacturers more room to justify a denial than covered entities have to prevent one.
  • See how much of your 340B program the Pilot actually touches today, and why that scope is likely to expand.