APR 12, 2017 12:00 PM PDT

PAMA: The First Reporting Period is Over. What Does This Legislation Mean for Laboratorie

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
      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.

    Abstract

    This presentation describes the new process by which the Centers for Medicare and Medicaid Services (CMS) will establish the prices the Agency pays for clinical diagnostic laboratory tests.  This revolutionary approach was
    mandated by Congress in the clinical laboratory provisions contained within Section 216 of the Protecting Access to Medicare Act of 2014.  In his talk Dr. Klein will discuss this legislation, accompanying CMS regulations, and their
    potential impacts on the laboratory industry


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