New Proposed 340B ADR Rule Has Been Released

On Nov. 30, the Biden Administration released proposed changes to the Alternative Dispute Resolution (ADR) rule. The ADR process is the way for manufacturers and covered entities to resolve disputes related to duplicate discounts, diversions, or overcharges within the 340B drug discount program. The new rule differs from the current ADR Process in several key ways: 1) Removal of the requirements to follow the Federal Rules of Evidence and Rules of Civil Procedure; 2) Limiting the ADR Panel members to 340B subject matter experts from the Office of Pharmacy Affairs; 3) Requiring all parties engage in good-faith dispute resolution efforts before initiating the ADR process; 4) Limiting claims to disputes involving overcharges, duplicate discounts, and diversion; 5) Establishing a reconsideration process for ADR Panel decisions; and 6) The 340B ADR Panel may suspend review of a claim if the specific issue that would be brought forth in a claim is the same as or similar to an issue that is pending in Federal court. NACHC will review and provide a comment letter template; comments are due Jan. 30, 2022.

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