STATEMENT ON HRSA’S FINAL 340B ADMINISTRATIVE DISPUTE RESOLUTION RULE
WASHINGTON, D.C.— The Health Resources & Services Administration today released a final rule to implement an administrative dispute resolution process for the 340B drug pricing program. As Congress mandated in 2010, the process would establish a government panel to settle disagreements between covered entities and pharmaceutical manufacturers, such as a hospital’s claim that a drug company overcharged for 340B drugs.
The following statement is attributed to 340B Health President and CEO Maureen Testoni:
“340B Health is reviewing the administrative dispute resolution (ADR) plan that the Health Resources & Services Administration (HRSA) lays out in its final rule, a process that holds some promise for giving 340B hospitals a pathway to object to certain manufacturer overcharges. However, the ADR is not an appropriate or timely solution for refusals by Eli Lilly, AstraZeneca, Sanofi, Novartis, United Therapeutics, and Novo Nordisk to offer the 340B pricing that federal law requires. These manufacturer actions are a clear violation of the 340B statute, and the Department of Health and Human Services (HHS) has the authority – and the responsibility – to block them immediately and order recourse for affected hospitals.”
“We renew our call on HHS Secretary Alex Azar to protect 340B and the health care safety net by acting now, not deferring responsibility to an administrative panel that has not even formed. The process of implementing administrative dispute resolution and establishing the first decision on this issue will take many months and will have an unknown outcome for 340B hospitals being harmed now by manufacturers’ unlawful attacks on their community pharmacy partnerships. All the while, safety-net hospitals will continue to struggle without the program savings they rely on to care for low-income and rural patients in need. 340B Health will pursue every available avenue to prevent permanent harm to the 340B program and the hospitals and patients who rely on it.”
Contact: Richard Sorian at richard.sorian@340bhealth.org or 202-536-2285.