The Trump administration on Thursday signed off on a long-awaited dispute resolution process for the 340B drug discount program.
The dispute resolution process proposed in 2016 allows covered entities to force drugmakers into a process that would result in final, binding decisions by the agency. The policy is a win for safety-net providers. But it's unlikely to put to bed the heated conflict between providers and drugmakers over providers' use of contract pharmacies.
The administrative dispute resolution plan "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 (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," 340B Health CEO Maureen Testoni said in a statement.
The rule goes into effect next month, just days before President-elect Joe Biden takes office. It will be up to his administration to implement the rule.
According to the rule, the 340B Administrative Dispute Resolution Board will have at least six members. They will include representatives from the Health Resources and Services Administration, CMS and HHS' Office of the General Counsel. Under the final rule, HRSA's head honcho will choose a three-member panel from each of the those agencies to review claims by covered entities and manufacturers. That differs from the proposed rule, which would have allowed HRSA's administrator to pick a three-member panel plus one non-voting member from HRSA's Office of Pharmacy Affairs.
Drugmakers have taken increasingly aggressive actions to crack down on 340B drug discounts through contract pharmacies and demand more healthcare providers' data. If the trend continues at its current clip, the limitations on discounts could have a big impact on some covered entities' finances.
The Affordable Care Act directed HHS to establish a dispute resolution process for providers and drugmakers in the 340B program, but regulatory action had stalled for years. Community health sued in October to force HHS to expedite the creation of such a process, as providers have limited ability to sue drugmakers in court directly.