WASHINGTON, DC — The Department of Health and Human Services (HHS) issued a final rule revising the administrative dispute resolution (ADR) process under the 340B program. This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program, addressing the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.

According to the American Hospital Association, the ADR process allows all 340B-covered entities — regardless of the size of the organization or monetary value of the claim — to address claims at dispute with drug companies.

"The final rule contains several important process improvements, including a clear timeline for when ADR decisions must be made and an opportunity for reconsideration when parties are dissatisfied with the initial ADR decision," AHA General Counsel Chad Golder said. "The AHA is particularly pleased that the final rule makes clear that an overcharge claim includes instances where a drug company has limited a hospital's ability to purchase 340B drugs at or below the 340B ceiling price. This rule will help hold drug companies accountable for their rampant abuses of the 340B program and the patients it serves."

“340B Health is pleased that HRSA’s (Health Resources & Services Administration) final rule aligns with several of our recommendations for revisions and clarifications to the agency’s proposed rule," Maureen Testoni, president and CEO of 340B Health, said."We are particularly encouraged by the final rule clarifying that a covered entity’s ADR claims can include accusations that a drug company has limited the ability to purchase drugs at or below the 340B ceiling price and removing a proposed amendment to block ADR consideration of a claim similar to an issue pending in federal court. HRSA’s removal of potential conflicts of interest and unnecessary legal barriers are additional positive steps that will simplify and streamline the dispute resolution process for the benefit of all participants.”

This rule, which may be viewed in full here, will come into effect on June 18, 2024.