The Department of Health & Human Services (HHS) published its much anticipated draft omnibus guidance on the 340B program.  The draft guidance is intended for covered entities, such as hospitals and certain clinics, enrolled in the 340B program and the drug manufacturers that are required to provide discounts on outpatient drugs.

    Provisions in the draft guidance include:

    • Definition of an eligible patient
    • HHS's audit of a covered entity 
    • HHS's audit of a manufacturer   
    • Manufacturer's audit of a covered entity
    Comments are due October 27, 2015

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