Overview & Analysis
On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule entitled “340B Drug Pricing Program; Administrative Dispute Resolution” (Proposed Rule). The Proposed Rule follows the Advanced Notice of Proposed Rulemaking (APRM) issued by HRSA on September 20, 2010 and aims to establish requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process. Interested parties may submit written comments on or before October 11, 2016.
The Proposed Rule, if finalized, will replace the 340B Program’s 1996 guidelines on the informal dispute resolution process published on December 12, 1996. Unlike the prior… More