Stakeholders Weigh in on Forthcoming 340B Dispute Resolution Rule

Health care providers are pleased that the 10-year wait for a binding 340B administrative dispute resolution system is almost over. But they say it’s not the forum for addressing drug manufacturers’ denials of 340B pricing for drugs dispensed by contract pharmacies. | Source: Shutterstock

Stakeholders Weigh in on HRSA’s Forthcoming 340B Dispute Resolution Rule

Federal health care grantees in the 340B drug discount program are pleased but wary about federal health officials’ disclosure yesterday that, after a 10-year wait, rules for a binding 340B administrative dispute resolution (ADR) system are on their way. 340B hospitals say even if the rules create a system they can back, the mechanism won’t resolve their concerns about pharmaceutical manufacturer denials of 340B pricing on drugs shipped to contract pharmacies. Drug manufacturers are keeping mum until the final rule is released. Health care lawyers say although the way the government is finalizing the rule is questionable, the rule probably could stand up in court.

As we reported yesterday (breaking the news on Twitter), the U.S. Health Resources and Services Administration (HRSA) on Nov. 17 sent the White House Office of Management and Budget (OMB) a final rule to implement a decade-old congressional directive to create a binding 340B ADR process to replace the 340B program’s voluntary system. Groups representing 340B health centers and HIV/AIDS clinics have sued U.S. Health and Human Services (HHS) Secretary Alex Azar and his department over their failure to stop drug manufacturers’ recent denials of 340B pricing. One of the types of relief they want is a federal court order requiring Azar to promulgate the 340B binding ADR final rule.