On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered entities participating in the 340B Program, as well as for the contract pharmacies providing services to those covered entities.

While the Guidance covers a number of proposed changes and “clarifications” in some depth, there are several key areas for providers and manufacturers to consider. However, it is important to remember the Guidance is “draft” guidance. Consequently, it is important for both providers and manufacturers to submit their comments on the Guidance. With that said, the following are eight key points that providers and manufacturers should consider:

1. “Child Site” Registration and Eligibility

Generally speaking, “covered entities” are typically Federally Qualified Health Centers and certain types of hospitals or clinics. However, there has long been a question about outpatient clinics associated with these facilities. The Guidance goes into great detail explaining which facilities can be covered entities, particularly in the case of off-site outpatient facilities and clinics affiliated with parent covered entities. Previously, non-hospital covered entities were often considered entities that receive certain federal grants, contracts, designations, or projects. However, the Guidance states that a non-hospital covered entity may also include associated healthcare delivery sites that are located off-campus. The covered entity must demonstrate that these “child sites” satisfy certain requirements and must register them, and the Guidance proposes listing child sites in the public 340B database. HHS is seeking comments on alternatives to demonstrating the eligibility of off-site outpatient facilities.