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On April 19, 2024—fourteen years after the Congressional deadline—the Health Resources and Services Administration published its final rule for the 340B Administrative Dispute Resolution process. Although HRSA restarted its stalled ADR rulemaking in 2020 after two 340B grantee organizations sued, HRSA “encountered policy and operational challenges with implementation” and started over in November 2022.
As HRSA stated, “the purpose of the 340B ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit … that a covered entity has violated the prohibition on diversion or duplicate discounts.” In either case, the parties must engage in good faith efforts to resolve the dispute before filing.
The long-awaited final ADR rule represents a welcome development for 340B hospitals and grantees, but it is not without caveats. Here are three things
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