• 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    FDA Issues Final Guidance on Companion Diagnostic, LDT Draft Guidance to Follow
    On July 31st, the U.S. Food and Drug Administration (FDA) notified Congress of its plans to release the long-awaited draft guidance for the regulation of laboratory developed tests (LDTs). With this notification, the FDA released a preview of the draft guidance.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
  • ePolicy News July 2014

    July 10, 2014
    CY 2015 Medicare Physician Fee Schedule Released, Estimated to have a Positive Impact on Pathologists and Laboratories
    After years of drastic cuts to reimbursement, CMS takes a less aggressive approach to Medicare payment reform… Big data, information transparency, and stakeholder involvement are key asks of the provider community in this year’s proposed rule. Read more