APR 11, 2018 10:30 AM PDT

Medicare's New National Coverage Determination for Next Generation Sequencing: What Does it Mean for Diagnostic Laboratories?

Speaker
  • Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. Faculty Fellow at the Arizona State University Sandra Day O'Connor College of Law's Center for Law, Science &
    BIOGRAPHY

Abstract

On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for the use of Next Generation Sequencing (NGS) for tumor profiling in beneficiaries with cancer.  This national Medicare payment policy was formulated as part of a Food and Drug Administration (FDA) and CMS “Parallel Review Process” for Medical Devices, in response to a petition from Foundation Medicine, an NGS service provider.  Following FDA approval of Foundation’s FoundationOneCDx™ test in November 2017, CMS issued a proposed coverage determination that would have eliminated routine coverage of laboratory-developed NGS tests (LDTs).  In response to public comments, CMS issued a finalized NGS NCD that expanded the conditions of coverage for FDA-reviewed tests, while removing restrictions on payment for LDTs.  This webinar will discuss this NCD and explore its implications for payment of genomic profiling of tumors in Medicare patients with cancer.


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APR 11, 2018 10:30 AM PDT

Medicare's New National Coverage Determination for Next Generation Sequencing: What Does it Mean for Diagnostic Laboratories?



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