Lexology May 16, 2024
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR) Program (2024 Final Rule).
The 340B ADR process was mandated by the Affordable Care Act and enacted in 2012. The intended purpose of the ADR process was to resolve claims by 340B covered entities that manufacturers overcharged for covered outpatient drugs and, alternatively, resolve manufacturer claims against covered entities for diversion or duplicate discount violations determined during manufacturer audits. The 340B ADR process is an administrative process that provides stakeholders with an opportunity to have disputes evaluated by a third-party when covered entities and manufacturers are unable to...
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