In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed Guidance addresses most 340B Program eligibility and compliance requirements that are not subject to HHS rulemaking authority. Of particular interest to entities participating in the 340B Program, the Proposed Guidance includes significantly revised definitions of drugs eligible for discounted 340B pricing and patients eligible to receive such discounted drugs. In addition, the Proposed Guidance would change current requirements related to compliance with the Group Purchasing Organization (GPO) prohibition, contracts with governmental entities to support eligibility, auditable record requirements, dispensing of 340B drugs to Medicaid managed care enrollees, and contract pharmacy oversight, among other topics. The Proposed Guidance is open for public comment until October 27, 2015.

This article highlights key takeaways of the Proposed Guidance and provides an outline of all provisions included in the Proposed Guidance. While portions of the Proposed Guidance reflects current published 340B Program guidance, many elements of the Proposed Guidance appear to articulate new interpretations of existing 340B Program requirements or written guidance consistent with HHS positions previously shared informally, through “frequently asked questions” and through audits of 340B entities. Notably, although not unexpectedly, the Proposed Guidance focuses heavily on eligibility and compliance obligations for 340B covered entities, with limited attention to new proposed requirements for manufacturers participating in the 340B Program.