The Biden administration plans to withdraw its 340B administrative dispute resolution (ADR) regulation and replace it with an entirely new rule.

News Alert: Biden Administration Plans to Scrap Existing 340B Dispute Resolution Rule and Publish New One Shortly

The Biden administration plans to replace its 340B administrative dispute resolution (ADR) regulation with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”

The administration fleshed out its intentions for the 340B ADR system late yesterday in a semiannual governmentwide compendium of forthcoming regulatory actions. Last month, it disclosed only that the U.S. Health Resources and Services Administration (HRSA) was seeking White House approval to publish a notice of proposed rulemaking about the ADR process. That Nov. 18 public notice was silent about the proposed rule’s purpose and scope.

The Biden administration plans to replace its 340B administrative dispute resolution (ADR) regulation with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”

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