Lexology April 18, 2024
Hall Render Killian Heath & Lyman PC

On Thursday, April 18, 2024, the Health and Human Services Department (“HHS”) published a Final Rule implementing 340B Program Administrative Dispute Resolution Regulations (“ADR Rule”), which can be found here. The ADR Rule is set to be published on April 19, 2024, and will go into effect 60 days after the publication date which should be Tuesday, June 18, 2024.

According to HHS, the final ADR Rule aims to accomplish five goals:

  1. Increase the accessibility of Administrative Dispute Resolution (“ADR”) for covered entities by moving away from a trial-like process to an administrative process that does not rely on the Federal Rules of Civil Procedure or the Federal Rules of Evidence and does not include a minimum threshold for...

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