Value Health Voices

Quest Diagnostics CMO Dr. Yuri Fesko joins Value Health Voices to decode the Clinical Laboratory Fee Schedule, the impact of PAMA and SALSA, and the future of precision medicine. Episode Resources: Learn more about Quest DiagnosticsExplore Quest's Consumer-Initiated TestingHow does a flawed government policy threaten the very foundation of modern medicine? Nearly every clinical decision, from a routine check-up to advanced cancer treatment, begins with data from a lab test. But the system that determines the value and payment for these critical services is under threat. In this episode, we explore the complex world of clinical laboratory services policy and payment with an unparalleled expert, Dr. Yuri Fesko, Chief Medical Officer of Quest Diagnostics. We uncover how a poorly designed law could cripple patient access to testing, especially in rural communities, and stifle the life-saving innovation happening in diagnostics. This deep-dive conversation with Dr. Yuri Fesko breaks down the most pressing issues facing clinical laboratories today. We start with the Clinical Laboratory Fee Schedule (CLFS) and the disastrous impact of the Protecting Access to Medicare Act (PAMA). Dr. Fesko explains how PAMA’s flawed data collection, which surveyed only the largest, most efficient labs, has led to proposed reimbursement cuts of up to 15% annually, threatening the viability of smaller hospital and independent labs across the country. We then discuss the bipartisan RESULTS Act, a proposed solution to create a more accurate and equitable system. The discussion also tackles the immense administrative burden of prior authorization for lab testing, a major friction point for clinicians that delays diagnoses and care. We explore how technology, like Quest’s adoption of the Epic EMR system, aims to streamline this broken process. A significant portion of our conversation focuses on the challenges surrounding reimbursement for advanced diagnostics. Dr. Fesko provides a fascinating look into cutting-edge innovations like Minimal Residual Disease (MRD) testing in oncology, a revolutionary tool that can detect trace amounts of cancer DNA in the blood to help guide treatment decisions and avoid unnecessary, toxic chemotherapy. We also navigate the intricate landscape of laboratory-developed tests (LDT) regulation, weighing the pros and cons of proposed FDA oversight versus the existing accreditation framework. Finally, we touch on patient-centric improvements like price transparency, the power of lab data in public health initiatives, and the critical importance of interoperability in ensuring patients own and control their health records. This episode is an essential guide to understanding the policy, payment, and innovation that will define the future of diagnostic medicine. About Our Guest: Dr. Yuri Fesko is the Chief Medical Officer of Quest Diagnostics. With a background in internal medicine, hematology, and oncology, Dr. Fesko leads Quest's medical groups, payer access and reimbursement strategies, and research activities. He brings a unique perspective from the front lines of both clinical practice and the leadership of one of the world's largest laboratory services companies, offering deep insights into the regulatory and financial pressures impacting patient care and diagnostic innovation. Timestamps: (00:00) Why Lab Testing is the Foundation of Medicine (05:43) The Clinical Laboratory Fee Schedule (CLFS) Explained (09:22) PAMA: A Flawed Law Threatening Lab Services (14:51) The RESULTS Act: A Bipartisan Fix for PAMA (18:24) The Burden of Prior Authorization for Lab Testing (26:07) Improving the Patient Experience with Price Transparency (30:56) Innovation: Reimbursement for Minimal Residual Disease (MRD) Testing (41:52) The Complex Regulation of Laboratory-Developed Tests (LDTs) (46:15) Big Data: How Lab Results Shape Public Health (55:49) Future Risks & Opportunities for Clinical Labs