APR 11, 2018 10:30 AM PDT

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

C.E. CREDITS: P.A.C.E. CE | Florida CE
  • 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 &
      Roger D. Klein, MD JD is an Expert with the Federalist Society Regulatory Transparency Project's FDA & Health Working Group, a former HHS Advisor to FDA, CMS and CDC, and a leading authority on public policies related to the implementation of precision medicine. A physician and an attorney, Dr. Klein was previously Medical Director of Molecular Oncology at Cleveland Clinic, and is presently a Faculty Fellow at the Arizona State University Sandra Day O'Connor College of Law's Center for Law, Science & Innovation. He has served in leadership roles in many cancer-related professional society committees, including current Chair of the Association for Molecular Pathology's (AMP's) Solid Tumors Division. He also serves on the American Society of Clinical Oncology's Government Relations Committee, and has been a member of the American Medical Association's CPT Molecular Pathology Advisory Group since its inception. Notably, Dr. Klein was an Expert and key spokesperson for AMP in its landmark lawsuit in which the U.S. Supreme Court invalidated patents on "the breast cancer genes." He is a frequent guest on national radio and television programs and a regular opinion contributor to The Hill, Real Clear Health, Investor's Business Daily, the Daily Caller, and other periodicals. Dr. Klein completed post-graduate medical training at Yale Medical School and obtained his J.D. from Yale Law School.


    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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