The Department of Health and Human Services today issued a new proposed rule revising the 2020 final rule that established the 340B Administrative Dispute Resolution process. HHS notes that the proposed rule better aligns with the statutory requirements first put in place by the Affordable Care Act. The rule specifically proposes to:  

  • move the ADR process away from a trial-like proceeding and establish a more conventional administrative process;  
  • revise the ADR panel structure to consist of 340B program subject matter experts from the Health Resources and Services Administration’s Office of Pharmacy Affairs;  
  • ensure parties resolve disputes in good faith prior to invoking the ADR process;   
  • align the ADR process to statutory provisions on overcharges, duplicate discounts and diversion and;  
  • include a reconsideration process for parties dissatisfied with the 340B ADR panel decision. 

The proposed rule notes that any dispute between 340B covered entities and drug manufacturers that are subject to federal court review would not be eligible for the ADR process until the court process concludes. Comments are due to HHS by Jan. 30, 2023. AHA is reviewing the proposed rule and will submit comments. 
 

Related News Articles

Headline
Following the recent district court decision to remand to the Department of Health and Human Services the question of how to repay 340B hospitals for…
Headline
Drugmakers that participate in the 340B drug pricing program do not have to provide discounted 340B drugs to an unlimited number of contract pharmacies, the U.…
Headline
As drug prices continue to rise, the 340B drug pricing program continues to help hospitals expand access to comprehensive health services, including lifesaving…
Headline
The U.S. District Court for the District of Columbia today decided to allow the Department of Health and Human Services to propose an appropriate remedy for…
Perspective
The convening of the 118th Congress this week is a reminder of Washington’s highly-charged political environment. The once-in-a-century floor tussle over the…
Headline
The AHA today released a new report showing how the unlawful actions of drug companies to limit 340B pricing with community and specialty pharmacies are…