HHS has finalized its rule regulating the 340B Administrative Dispute Resolution (ADR) process as required under the Affordable Care Act. The rule outlines an ADR process that allows all 340B covered entities, regardless of the size of the organization or monetary value of the claim, to dispute claims with drug companies. Specifically, the rule will:

• Allow covered entities to bring claims where they have been overcharged by a drug company including where the drug company or its wholesaler denies access to 340B pricing.
• Allow claims for ADR panel review, even if the particular issue at stake is subject to simultaneous federal court review.
• Require decisions be reached by the ADR process within one year of submission of claims for ADR review.
• Include a reconsideration process for parties dissatisfied with the 340B ADR panel’s decision.