340B HEALTH STATEMENT ON HRSA’S FINAL 340B ADMINISTRATIVE DISPUTE RESOLUTION (ADR) RULE
WASHINGTON, D.C. — Today, the Health Resources & Services Administration (HRSA) released a final rule making numerous changes to the 340B administrative dispute resolution (ADR) process, which is designed to use panels of government officials to adjudicate disagreements between covered entities and drug companies.
The following statement can be attributed to Maureen Testoni, president and CEO of 340B Health:
“340B Health is pleased that HRSA’s final rule aligns with several of our recommendations for revisions and clarifications to the agency’s proposed rule. We are particularly encouraged by the final rule clarifying that a covered entity’s ADR claims can include accusations that a drug company has limited the ability to purchase drugs at or below the 340B ceiling price and removing a proposed amendment to block ADR consideration of a claim similar to an issue pending in federal court. HRSA’s removal of potential conflicts of interest and unnecessary legal barriers are additional positive steps that will simplify and streamline the dispute resolution process for the benefit of all participants.”
“While we appreciate these improvements, we urge HRSA to reconsider our calls to exclude Medicaid managed care (MCO) claims from ADR review, direct panels to publish their full findings, and impose a 120-day time frame for decisions.”
“340B Health remains committed to working collaboratively with HRSA and other stakeholders to improve 340B, ensuring the program effectively serves its intended purpose of helping safety-net providers stretch scarce resources so that they may continue to provide equitable care to the nation's most vulnerable populations and rural communities.”
Contact: Jon Tilton at jon.tilton@340bhealth.org or 202-536-2285