The U.S. Health Resources and Services Administration (HRSA) has just released for public inspection a final rule that “sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.” It will be formally published in the Federal Register on Dec. 14 and will take effect on Jan. 13, 2021. The purpose of the ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by the 340B statute, that a covered entity has violated the prohibition on diversion or duplicate discounts.
We will have more on this major 340B program development soon.
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