340B Dispute Resolution Final Rule Released

The U.S. Health Resources and Services Administration (HRSA) published a final rule that “sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process” in the Federal Register on Dec. 14. The rule takes effect on Jan. 13, 2021. The purpose of the ADR process is to resolve:

  • Claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers
  • 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.

The final rule incorporates a large majority of the suggestions that NACHC made in response to the original proposed rule.