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Claims by manufacturers, after the manufacturer has conducted an audit of a covered entity, that a covered entity has violated the prohibition on diversion or duplicate discounts.

Claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and.

Under the statute, the ADR process is designed to resolve: Section 340B(d)(3) of the Public Health Service Act requires the establishment of an Administrative Dispute Resolution (ADR) process for certain disputes under the 340B Program.

On November 30, 2022, the 340B Drug Pricing Program Administrative Dispute Resolution Notice of Proposed Rulemaking (NPRM) was published in the Federal Register (PDF - 315 KB).

Performance Measurement & Quality Improvementģ40B Drug Pricing Program Administrative Dispute Resolution Process – Notice of Proposed Rulemaking Summary.Training & Technical Assistance Overview.