What’s happening: The Health Resources and Services Administration (HRSA) finalized requirements and procedures for the 340B Drug Discount Program’s administrative dispute resolution (ADR) process.
What else to know: The regulation is effective June 18.
The final rule establishes an ADR process that allows all 340B-covered entities, regardless of the size of the organization or monetary value of the claim, to use it to address claims being disputed with drug companies.
Specifically, the new finalized ADR process:
- Establishes a dispute resolution process that is reflective of an administrative process rather than a trial-like proceeding and consists of 340B program subject matter experts from HRSA’s Office of Pharmacy Affairs
- Allows covered entities to bring forth claims where they have been overcharged by a drug company, including where the drug company or its wholesaler denies access to 340B pricing
- Allows claims for ADR panel review even if the particular issue at stake is subject to concurrent federal court review
- Requires decisions be reached by the ADR process within one year of submission of claims for ADR review
- Includes a reconsideration process for parties dissatisfied with a 340B ADR panel’s decision
