CHA News

HRSA Issues Long-Awaited Proposed Rule on Administrative Dispute Resolution Process

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The Health Resources and Services Administration has issued a long-awaited proposed rule updating the 340B administrative dispute resolution (ADR) process. 

The proposed rule, which was issued Nov. 30, addresses five areas of stakeholder concern with the existing process: 

  • Establishes a dispute resolution process that is reflective of an administrative process rather than a trial-like proceeding 
  • Revises the structure of the 340B ADR panel so that it is comprised of 340B program subject-matter experts 
  • Ensures the parties have attempted to resolve their dispute prior to proceeding through the ADR process 
  • Aligns the ADR process with provisions in the 340B statute related to diversion, duplicate discounts, and overcharges 
  • Includes a reconsideration process for parties dissatisfied with a 340B ADR panel’s decision 

Comments on the rule are due Jan. 30, 2023. CHA is reviewing the rule and will make a detailed summary of it available shortly.