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

The AHA May 25 published a report on the 340B Drug Pricing Program, its history and value to hospitals and patients, and details on 340B contract pharmacy…
The House Energy and Commerce Subcommittee on Health May 17 considered a series of health care bills, including a number focused on provisions that would…
The AHA strongly opposes legislation that would lead to additional site-neutral payment cuts and threaten access to patient care, Ashley Thompson, AHA senior…
More than 1,000 executive leaders from the nation’s top hospitals and health systems convened at the 2023 AHA Annual Membership Meeting, April 23-25 in…
The AHA, joined by the Arkansas Hospital Association and 340B Health, late Friday filed an amicus brief in the U.S. Court of Appeals for the 8th Circuit…
The Pharmaceutical Research and Manufacturers of America’s new ASAP 340B coalition “is another misguided attempt by drug companies to dismantle the 340B Drug…