HHS wants to adjust how disputes about overcharging, duplicate discounts and diversions part of the 340B program are handled, according to a notice posted on the American Hospital Association's website.
In December 2020, the 340B Administration Dispute Resolution was enacted, and two years later, HHS said it needs to be less formal and costly to ensure the process is more efficient.
"Potential petitioners, many of whom are safety-net providers in under-resourced communities, may lack the resources to access ADR even if it would be in their best interest to do so," HHS said in its proposition, which was published Nov. 30 in the federal register. "In addition, reliance on the [Federal Rules of Evidence and Civil Procedure] could create unnecessary delays in what is intended to be a timely decision-making process."
The agency listed five goals in its proposed revision:
- 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 attempt to resolve disputes in good faith prior to invoking the ADR process
- Align the ADR process to statutory provisions on overcharges, duplicate discounts and diversion
- Include a reconsideration process for parties dissatisfied with the 340B ADR panel decision
Written comments on the proposal will be accepted through Jan. 30.
"The administration's administrative dispute resolution process proposal for the 340B drug pricing program is an important step in ensuring the integrity of the 340B program," Melinda Hatton, AHA's general counsel, said in a statement to Becker's. "We look forward to reviewing the proposal in detail and submitting comments to further improve the final rule. In addition, we continue to urge the Department of Health and Human Services to aggressively use all tools available to stop the harmful tactics from drug companies that are impacting 340B hospitals' ability to deliver care as Congress intended."