HRSA finalizes rule on 340B dispute resolution process

The Health Resources and Services Administration today released its long-awaited final rule implementing an Affordable Care Act requirement that the agency establish a process to resolve disputes between 340B covered entities and drug manufacturers.

The final rule sets forth the administrative dispute process, including the composition of the decision-making body, the scope of claims, the information needed to support such claims, as well as the timeframe for the proceedings. It does not, however, directly address the issues AHA has raised with drug manufacturers restricting 340B hospitals’ use of contract pharmacy arrangements. 

In a statement, AHA Executive Vice President Tom Nickels said, “The AHA has long believed that an administrative dispute resolution process for the 340B drug pricing program is an important step forward in protecting 340B hospitals and clinics that have been overcharged by drug manufacturers through the program. This process should have been finalized a full decade ago, as the law and Congress called for.

“However, on its own, this ADR process is not sufficient to address drug companies’ repeated illegal attempts to attack 340B hospitals, and the patients and communities they serve. This includes their most recent efforts to undermine the program by limiting the distribution of certain 340B drugs to eligible hospitals, despite no statutory provisions allowing for such actions. These illegal acts require immediate relief rather than an ADR process.

“We continue to urge the Department of Health and Human Services’ Health Resources and Services Administration to take swift and decisive action to halt these pernicious tactics from drug companies and ensure that 340B drugs remain available and accessible to vulnerable communities across the country.”

AHA member 340B hospitals will receive a Special Bulletin with more details on the final rule.