340B Program Omnibus Guidance: A Deeper Dive

September 3, 2015

Todd Nova and Richard Davis of Hall Render Killian Heath & Lyman PC (Lexology, 9/3) analyzed and summarized the 340B Drug Pricing Program Omnibus Guidance: “Most notably, these changes include potential updates to standards governing which patients are eligible to receive 340B-priced drugs. … The proposed guidance also serves to: i) confirm and/or reiterate prior 340B Program guidance issuances (e.g., multiple contract pharmacy locations are permitted without regard to distance or location); and ii) clarify the definition of Covered Outpatient Drugs in a manner that is perhaps more broad than many Covered Entities had previously considered.”