HRSA Releases Proposed 340B Mega Guidance

Since its inception in 1992, the 340B Drug Pricing Program has required drug manufacturers to offer outpatient drugs to eligible healthcare organizations at significantly reduced prices. On Aug. 28, 2015, the Health Resources and Services Administration (HRSA) released its much-anticipated proposed 340B Drug Pricing Program Omnibus Guidance – or “mega-guidance” – in an effort to clarify some of the concerns that have been raised over the years. However, the mega-guidance has not yet been finalized; comments are due by Oct. 27, 2015. It is unclear if this mega-guidance will replace existing, limited guidance documents or how the guidance will be treated in terms of future HRSA audits.