HRSA sent a final rule to create a binding administrative dispute resolution (ADR) process for the 340B program to the White House for approval. Congress, more than 10 years ago as part of the Affordable Care Act (ACA), required U.S. Department of Health and Human Services (HHS) to publish a regulation establishing a binding 340B ADR system, to replace 340B’s then 14-year-old, informal dispute resolution process. Congress wanted the job done in 180 days. HRSA published an advanced notice of proposed rulemaking in Sept. 2010 and a proposed rule in Aug. 2016. The Trump administration withdrew the proposed rule, written by the Obama administration, in Aug. 2017, and HRSA never advanced a final rule, until now. HHS’s failure to do so and the impact of not having an ADR process in place to respond to the recent attacks on the 340B program are the basis of the NACHC 340B lawsuit. The final rule’s contents remain unknown for now so it is unclear whether or how much the final rule differs from the proposed version HRSA sought comment on more than four years ago.
