The Health Resources and Services Administration issued a final rule, on April 19, 2024, titled “340B Drug Pricing Program; Administrative Dispute Resolution” that is published in Federal Register (PDF - 354 KB).
Section 340B(d)(3) of the Public Health Service Act requires the establishment of an Administrative Dispute Resolution (ADR) process to resolve:
- claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers; and
- claims by manufacturers, after the manufacturer has conducted an audit of a covered entity, that a covered entity has violated the prohibition on diversion or duplicate discounts.
This Final Rule finalizes new requirements and procedures to make the ADR process more accessible and efficient for stakeholders.
The Final Rule becomes effective on June 18, 2024, and HRSA will provide additional information, including a webinar, in the coming weeks on filing a claim.
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