Legislative News

  1. 340B Omnibus Guidance Proposed

    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  The draft guidance is intended for covered entities, such as hospitals and certain clinics, enrolled in the 340B program and the drug manufacturers that are required to provide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.

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  2. CMS Publishes Memo

    The Centers for Medicare & Medicaid Services (CMS) recently published a memo entitled "Compliance With Any Willing Pharmacy (AWP) Requirements." The memo discusses guidance on complying with the AWP requirement.  According to CMS, the memo is in response to concerns with the “process some Part D sponsors have adopted for complying with the AWP requirement, particularly issues with transparency and timing of sponsors’ AWP contracting processes, as well as the content of their standard terms and conditions.”

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  3. ONC Hosting Webinar

    The ONC is hosting the ninth webinar of a 10-part series on health IT and patient safety, “Information Transparency and Health IT Safety” on August 20, 2015 from 1:00 p.m. - 2:30 p.m. EST. The webinar will feature perspectives on information transparency and health IT safety from the viewpoints of the patient, the practitioner, leaders of health systems improvement, and policymakers. Slides and audio of previous webinars in this series are also now available.

    Register today.

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  4. HHS Announces New Initiatives

    Health & Human Services (HHS) Secretary Burwell announced new initiatives to combat opioid abuse and expanding treatment and services for substance abuse. Included in the announcement, HHS states that the agency is making additional funding available to states and community health centers to expand the use of medication-assisted treatment for opioid use disorder, and is releasing guidance to help states implement innovative approaches to substance use disorder treatment.

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  5. FDA Grants Delay in DSCSA Tracking Requirements

    The FDA granted a delay for dispensers to comply with the drug tracking requirements set forth in the Drug Supply Chain Security Act (DSCSA). Dispensers now have until November 1, 2015 to implement the requirements. BGOV reported that three pharmacy organizations recently asked the FDA to delay the enforcement of the requirement, citing a compressed implementation timetable of a 2013 law and the potential for disruptions in the pharmaceutical supply chain. The FDA issued the industry guidance in response to that request. Manufacturers, wholesale distributors and repackagers originally had to meet these same requirements by January 1, 2015, although the FDA also granted them more time to comply.

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