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    Omnibus Guidelines expected to bring changes to the 340B program


    Key policy issues

    The Omnibus Guidelines are expected to clarify existing regulations and update eligibility criteria. More specifically, the guidance is slated to include the definition of an eligible patient, compliance requirements for contract pharmacies, and eligibility criteria for hospitals and off-site outpatient facilities.

    The 340B Winter Coalition also shed light on what may be included in the 2015 guidelines. Cmdr. Krista Pedley, the director of HRSA’s Office of Pharmacy Affairs, stated that the guidance may also include clarification on topics such as annual recertification, Medicaid fee-for-service and duplicate managed-care discounts, manufacturer refunds, and credits to covered entities.

    See also: U.S. senators want drugs imported from Canada

    Review and comment

    After OMB completes its 90-day review, the Omnibus Guidelines will be published in the Federal Register and open for public comment. During this 60-day comment period, stakeholders are encouraged to review the guidelines and provide feedback before the guidelines are finalized. 

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...


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