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.