The AHA last week said it is “very disappointed” with a federal court decision that will exclude all drugs with an “orphan” designation from the 340B Drug Pricing Program for rural and cancer hospitals.

Denying rural and cancer hospitals access to these 340B discounts will “reduce access to critical services and treatments for some of the most vulnerable patients in society,” said AHA Executive Vice President Tom Nickels said in an Oct. 15 statement. “Sadly, the biggest beneficiary of this ruling is the pharmaceutical industry – it does nothing to help either patients or taxpayers.”

The U.S. District Court for the District of Columbia Oct. 14 ruled against the Department of Health and Human Services (HHS) in a lawsuit brought by the Pharmaceutical Research and Manufacturers of America. 

The 340B program requires drug companies participating in Medicaid to discount outpatient medications for hospitals and clinics to help low-income patients. 
The lawsuit challenged HHS’s 2014 interpretive rule that continued to allow hospitals subject to the orphan drug exclusion to purchase orphan drugs through the 340B program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. In its decision, the court ruled HHS’s guidance “is contrary to the plain language of the statute.” 

The AHA on Feb. 6 filed a friend-of-the-court brief in support of HHS.