Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18.   Most notably, the ADR Rule does not include a proposal that would have suspended any ADR petitions that raised issues that were currently pending in federal court.  RWC-340B had vigorously opposed that provision in the proposed rule because it would have suspended ADR claims related to manufacturer contract pharmacy restrictions until the court cases involving those disputes are decided.  RWC-340B argued in their comments that the ADR panel should be an independent reviewing body that is not bound by court decisions.

Key changes in the ADR Rule include:

  • HHS adopted a more streamlined process that is accessible to stakeholders than the original rule, including removing a requirement that the petition have at least $25,000 at stake and a one-year deadline for the ADR panel to issue decisions.
  • The new rule clarifies that covered entities may bring petitions against manufacturers that do not make 340B drugs available (which would include petitions related to manufacturer contract pharmacy restrictions).
  • The ADR panels will be chosen entirely from OPA staff. The prior final rule required that CMS officials be included in ADR panels.  Covered entities argued that CMS has an inherent conflict of interest in duplicate discount disputes.
  • The new rule requires that the petitioner submit evidence of a good faith effort to resolve the dispute with an ADR petition. Previously, HHS had encouraged these type of efforts to resolve a dispute but did not require documentation.
  • The rule includes a new process for a party to request reconsideration by HRSA of an ADR Panel’s decision.

The Powers team is continuing to analyze the rule and will provide a summary of any other significant provisions of the rule.  Please reach out to Powers with any questions.