HHS has finalized a rule to establish a 340B administrative dispute resolution process as required under the Affordable Care Act.
The ADR process allows all 340B-covered entities — regardless of the size of the organization or monetary value of the claim — to address claims at dispute with drug companies, according to the American Hospital Association.
The new process will include 340B program subject matter experts from the Health Resources and Services Administration's office of pharmacy affairs, allow covered entities to bring claims where they have been overcharged by a drug company including where the company or its wholesaler denies access to 340B pricing and require decisions be reached by the ADR process within one year of submission of claims. It will also include a reconsideration process for parties dissatisfied with the 340B ADR panel decision.
"The final rule contains several important process improvements, including a clear timeline for when ADR decisions must be made and an opportunity for reconsideration when parties are dissatisfied with the initial ADR decision," AHA General Counsel Chad Golder said. "The AHA is particularly pleased that the final rule makes clear that an overcharge claim includes instances where a drug company has limited a hospital's ability to purchase 340B drugs at or below the 340B ceiling price. This rule will help hold drug companies accountable for their rampant abuses of the 340B program and the patients it serves."
The rule will take effect 60 days after its publication in the Federal Register on April 19.
Click here to view the rule in full.