Dr. Fleisher of Rubrum Advising, LLC

Dr. Fleisher will explore the fundamental question: Why do some FDA-approved technologies fail to receive Medicare coverage? The discussion will illuminate how CMS evaluates drugs, devices, and services for coverage determination, contrasting the processes used in traditional Medicare versus Medicare Advantage plans. Through compelling case studies, including monoclonal antibodies for Alzheimer's disease and the evolution of colorectal cancer screening coverage, Dr. Fleisher will demonstrate how these regulatory frameworks impact healthcare delivery. The presentation will conclude with a forward-looking examination of how artificial intelligence technologies will navigate these dual regulatory challenges.

Biography:

Lee A. Fleisher, MD, ML (Masters in Law) is the Founding Principal and CEO at Rubrum Advising, LLC,  a consulting firm dedicated to identifying strategic pathways, including regulatory counsel, to ensure the highest quality care is adopted and diffused across the healthcare sector. From July 2020-July 2023, he was the Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services.  In this capacity, he was responsible for executing all national clinical, quality, and safety standards for healthcare facilities and providers, as well as establishing coverage determinations for items and services that improve health outcomes for Medicare beneficiaries. He serves as a Senior Advisor of the Bipartisan Policy Center and FasterCures of the Milken Institute,  and Visiting Fellow of the Duke-Margolis Center.   From 2004 through July 2020, he was the Robert D. Dripps Professor and Chair of Anesthesiology and Critical Care and Professor of Medicine at the University of Pennsylvania and is currently Emeritus Professor and continues to practice clinically.  In 2007, he was elected to membership of the National Academy of Medicine.