The Health Resources and Services Administration (HRSA) launched a website with information on the 340B Drug Pricing Program administrative dispute resolution (ADR) process for covered entities and drug manufacturers.
In December, HRSA finalized an ADR process, which went into effect Jan. 13. Using the ADR process, covered entities can bring claims against manufacturers for being overcharged for covered outpatient drugs; manufacturers can bring claims against covered entities for violations of the prohibition against duplicate discounts or diversion.
HRSA notes that stakeholders should first attempt to resolve disputes in good faith before using the formal ADR process. Manufacturers must first conduct an audit of a covered entity before going through the ADR process. The ADR website offers additional guidance on the steps in the ADR process including:
- stakeholders submitting petition requests to a designated email address (340BADR@hrsa.gov);
- HRSA’s review of the petition and determination of whether a petition will move forward through the ADR process;
- a secure email and file transfer system to file the petition and upload relevant documents;
- once the petition is accepted, the selection of an ADR panel from the ADR board;
- the review of the petition and all evidence by the ADR panel, issuance of a final decision, and appropriate enforcement actions, including referral to the Department of Health and Human Services Office of Inspector General for civil monetary penalties.
The ADR website also contains frequently asked questions on the composition of the ADR panel and the ADR board, the monetary threshold for filing an ADR claim, the types of documentation stakeholders must provide as part of the ADR process, and filing combined claims. The FAQs also note the ADR process will be governed by the Federal Rules of Civil Procedure and the Federal Rules of Evidence.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.