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    ePolicy News October 2014

    September 29, 2014
    House Subcommittee Examines FDA’s Plan to Regulate LDTs
    Last month, the House Energy and Commerce Health Subcommittee held a hearing to learn more about the highly anticipated guidance outlining the plan by the Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs). In July, the FDA notified Congress of its intent to issue two draft guidance documents regarding the oversight of LDTs. Read more
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    ePolicy News September 2014

    September 04, 2014
    ASCP Opposes CMS Consolidation of Prostate G-Codes, Use of Outpatient Data, Supports Restructuring of Misvalued Code timeline, and LCDs
    ASCP submitted comments on the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule Proposed Rule for CY 2015 on Sept. 2. In a letter to the Agency, ASCP outlined its opposition to the Agency’s plans to consolidate its four prostate biopsy G-codes, utilize hospital outpatient data to reduce physician payment rates, and revamp the Local Coverage Decision process. Read more
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    ePolicy News August 2014

    August 04, 2014
    FDA Issues Final Guidance on Companion Diagnostic, LDT Draft Guidance to Follow
    On July 31st, the U.S. Food and Drug Administration (FDA) notified Congress of its plans to release the long-awaited draft guidance for the regulation of laboratory developed tests (LDTs). With this notification, the FDA released a preview of the draft guidance. The Agency will formally publish its draft guidelines for public comment after 60 days. In addition, the Agency released a final guidance on the development, review, and approval of companion diagnostics. Read more

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