On December 14, 2020, the Health and Resource Service Administration (HRSA) published a Final Rule specifying the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process. The process was established to support covered entities and manufacturers in resolving disputes regarding overcharging, duplicate discounts, or diversion. The Final Rule will be effective on January 13, 2021 and applies to all drug manufacturers and covered entities that participate in the 340B Program.
