340B rebate pilot program pause continues: What’s next?
The 340B rebate pilot program, designed to modify the distribution of drug discounts to providers, remains on hold. The Health Resources and Services Administration (HRSA) had previously sought feedback from stakeholders on whether it should pursue a rebate-based model for the 340B program and how such a model should be structured. These comments were originally due March 19, but this critical comment period has now been extended to April 20.
What has happened so far?
The current 340B drug pricing program mandates that drug manufacturers provide outpatient medications at significant discounts to eligible providers, including those caring for vulnerable populations. This program represented $81.4 billion in outpatient drugs in 2024.
The 340B rebate pilot, originally set to begin Jan. 1, was to transition manufacturers from providing upfront drug discounts to issuing rebates to safety net providers. Covered entities would pay full list price at the point of purchase and subsequently submit detailed claims data to rebate platforms following the dispensing of eligible drugs. The pilot had been met with push back from providers and advocates given the administrative burden and potential cash-flow challenges while pending reimbursement.
What’s next?
In submitting comments, HRSA has advised that stakeholders should respond using estimates, ranges, aggregated data or general descriptions, and should not include privileged, confidential, or proprietary commercial or financial information.
HRSA is interested in receiving comments on a variety of issues, including:
- Administrative, operational, financial (including cash-flow) and medication access concerns in connection with 340B rebate models.
- Reliance interest in continuing to obtain discounted ceiling prices upfront.
- Proposed alternatives and scope-limiting measures to aid a rebate pilot design, including safeguards to project program integrity and prevent duplicative discounts.
HRSA has noted “the scope of the potential 340B rebate model pilot program will be limited to manufacturers with Medicare Drug Price Negotiation Program Agreements with the Centers for Medicare & Medicaid Services for the initial price applicability years 2026 and 2027.” This language in the public comment letter implies that the scope of a future pilot program could include more than the original 10 drugs from the initial planned pilot program, but also the 15 drugs with a 2027 initial price applicability year.
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