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On August 27, 2015, the Department of Health and Human Services (HHS) issued long-awaited proposed omnibus guidance for covered entities enrolled in the 340B Federal Drug Pricing Program, which allows certain safety-net providers to obtain discounted drugs. The guidance will be published in the August 28 edition of the Federal Register, and includes a revised definition of who qualifies as a patient for purposes of the program.

The guidance is intended to assist 340B covered entities and drug manufacturers in complying with program regulations. It will be finalized by HHS after consideration of public comments, which are due October 27.

McDonald Hopkins LLC is currently analyzing the implications of this guidance. A more substantive discussion of the proposed guidance will be provided in coming days.

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