HRSA Seeks Input on 340B Program Paperwork
Published Date: 2/26/2026
Notice
Summary
HRSA is planning a new 340B Rebate Model Pilot Program to help drug manufacturers and healthcare providers work together on drug pricing. They want your feedback on the application and reporting process before April 27, 2026. This pilot aims to improve how rebates are handled, making the 340B program fairer and more efficient without extra costs for participants.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Large Reporting Burden for Covered Entities
If you are a 340B covered entity, you may need to submit claims-level data to a third-party platform 52 times per year, with an expected average of 5 hours per submission. HRSA estimates 14,600 covered entities would produce 759,200 responses annually, totaling 3,796,000 annual burden hours.
Manufacturer Plan Submissions and Reports
Qualifying drug manufacturers (limited to manufacturers with Medicare Drug Price Negotiation Program Agreements for the initial price applicability years 2026 and 2027) would submit a single plan (8 hours) and monthly purchase reports (12 reports per year at 2 hours each). HRSA estimates 13 manufacturers, with 13 plan submissions and 156 monthly reports totaling 416 burden hours.
Monthly Data to Improve 340B Oversight
HRSA would require monthly data submissions to the 340B Prime Vendor to evaluate program integrity and increase transparency; monthly reporting is intended to reduce lag time in assessing 340B Program metrics and support ongoing evaluation of the pilot.
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