Reference answer · 340b-program · reviewed quarterly
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Review cadence: quarterlyUnderlying federal data: refreshed weekly to annual per source
Q&A library · 340b-program

How does HRSA validate 340B ceiling price submissions and enforce refunds?

HRSA validates manufacturer 340B ceiling price submissions by comparing reported AMP and rebate data against historical trends and Medicaid filings, requesting documentation when anomalies arise. If overcharges are confirmed, HRSA requires manufacturers to correct pricing, maintain verifiable records, and promptly issue refunds to affected covered entities.

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