AHPA submitted comments on: 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program (HRSA–2025–14619)

Click here for the full comment letter. Below are some key takeaways.

• Preserve the existing upfront 340B discount model.
  AHPA opposes replacing upfront discounts with retrospective rebates, arguing that the proposed framework would undermine the 340B program’s mission and may not align with its statutory framework. AHPA urges HRSA to reconsider the proposal unless a fundamental change is supported by clear legal authority, strong evidence, and broad stakeholder agreement.
• Protect covered entities from financial instability and added administrative costs.
  AHPA warns that requiring hospitals to purchase drugs at wholesale acquisition cost and wait for rebates would tie up funds needed for patient care, particularly at rural hospitals, critical access hospitals, and other safety-net providers. If the model proceeds, AHPA recommends requiring manufacturers to cover all additional administrative costs, including staffing, software, claims reconciliation, and dispute-related expenses.
• Make participation voluntary for both manufacturers and covered entities.
  AHPA argues that the proposed model is voluntary only for manufacturers because covered entities would effectively be required to participate when a manufacturer opts in. It recommends giving hospitals and other covered entities the option to retain upfront discounts rather than forcing them into potentially risky rebate arrangements.
• Establish strong transparency, data privacy, and manufacturer accountability protections.
  AHPA recommends using a single, neutral clearinghouse independent of drug manufacturers, limiting data collection to the minimum necessary, and excluding patient-level identifiers. It also urges HRSA to impose stronger enforcement mechanisms, including civil monetary penalties, interest on late rebates, and an expedited process for resolving improperly delayed or denied payments.
• Provide adequate implementation time and transparent measures of pilot success.
  If HRSA finalizes the pilot, AHPA recommends allowing hospitals at least 180 days to prepare and publicly identifying the metrics that will be used to evaluate the program. AHPA also considers the original 30-day comment period insufficient for stakeholders to evaluate such a substantial change.