The Health Resources & Services Administration Dec. 10 released a final rule that creates a panel to settle disputes between 340B hospitals and drugmakers.
The rule implements an administration dispute resolution, or ADR, process for the 340B drug-pricing program. HRSA indicated that hospitals may use the process to challenge recent drugmaker policies denying 340B discounts on drugs dispensed through community pharmacies.
Since September, six drugmakers have announced policies to stop giving 340B hospitals discounts on drugs that are dispensed through contract pharmacies, arguing it causes them to pay duplicate discounts. Hospitals say it is illegal for drugmakers to create such policies since it denies them drug discounts mandated by law.
The American Hospital Association released a statement Dec. 10 saying it believes the ADR process is an "important step forward in protecting 340B hospitals and clinics that have been overcharged by drug manufacturers through the program."
But, the AHA said, the dispute resolution process is not on its own sufficient to address drugmakers' attempts to cut discounts to hospitals that use contract pharmacies.
"These illegal acts require immediate relief rather than an ADR process," the AHA said.
A group that represents 340B hospitals, 340B Health, said the rule isn't an appropriate or timely solution to the problem.
"These manufacturer actions are a clear violation of the 340B statute, and the Department of Health and Human Services has the authority – and the responsibility – to block them immediately and order recourse for affected hospitals," said Maureen Testoni, 340B Health CEO.