On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its perceived limited rulemaking authority granted by Congress. It is critical that stakeholders review HRSA’s proposal to consider how it would impact current and future 340B-related disputes, and to determine if the proposed rule goes far enough to level the 340B pricing playing field.

The proposed ADR rule implements a law which requires the Secretary of Health and Human Services (HHS) to establish and implement a binding ADR process for certain disputes arising under the 340B program. When finalized, this proposed rule appears to replace the 340B Program’s guidelines on the informal—and seldom used—dispute resolution process. We encourage covered entities, manufacturers and other stakeholders to carefully review the ADR proposal and submit comments on or before October 11, 2016.