The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows certain eligible “covered entities” to purchase outpatient prescription drugs at discounted rates from participating drug manufacturers. The purpose of the Omnibus Guidance is to assist covered entities and drug manufacturers in complying with the 340B Program’s requirements. Since implementation of the 340B Program, HRSA and its prime vendor for the 340B Program, Apexus, have issued several guidance documents and FAQs regarding various aspects of the 340B Program; however, ambiguities from this guidance still exist. The Omnibus Guidance proposes to clarify and revise certain aspects of the current guidance. Highlights of the proposals in the Omnibus Guidance are summarized below. Public comments on the Omnibus Guidance are due to the HRSA by October 27, 2015.

Eligible Patients -

To receive a 340B Program drug from a covered entity, an individual must qualify as a “patient” of that covered entity. Currently, an individual is generally considered to be a patient of a covered entity if (1) the covered entity maintains records of the individual’s health care at the covered entity; (2) the individual receives health care from an employee or contractor of the covered entity, with the covered entity maintaining ultimate responsibility for the individual’s care; and (3) the individual receives a range of health care services from the covered entity consistent with the range of services for which the covered entity receives federal funding.