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 are 340B covered entities handling ceiling price disputes under HRSA oversight in 2026?

In 2026, HRSA shifted from passive review to active enforcement, requiring covered entities to verify quarterly ceiling price files and document any overcharge resolutions. Hospitals must now initiate manufacturer refunds, maintain detailed paper trails, and reconcile pricing mismatches promptly to avoid compliance citations during audits.