Recent updates to the Health Resources and Services Administration’s (“HRSA”) regulatory agenda indicate that HRSA has delayed the much anticipated release of its final 340B Program Omnibus Guidance (also referred to as the “mega-guidance”) to the end of 2016. HRSA has also delayed publication of a final 340B manufacturer civil monetary penalty rule and proposed administrative dispute resolution rule.
While the reasons for the delay are not detailed, it is believed to be at least in part due to both the volume and complexity of the comments received on the proposed 340B Program Omnibus Guidance. The delay may also be in response to provisions impacting hospital-based payment under the Bipartisan Budget Act of 2015 as HRSA may be interested in assessing the implications of related proposed regulations that are expected to be released later this summer.
In addition, HRSA has delayed the release of two other rules affecting the 340B Drug Pricing Program: i) a final rule addressing 340B civil monetary penalties for manufacturers and 340B ceiling prices (anticipated release November 2016); and ii) a proposed rule implementing a binding administrative dispute resolution process (anticipated release September 2016). Each of these outstanding rules had been slated for release this May.
We will continue to monitor these developments as 2016 continues to unfold.