SC25: Coverage and Reimbursement for Advanced Diagnostics

TUESDAY, MARCH 3 | 6:30 - 9:30 PM (DINNER PROVIDED)

ABOUT THIS COURSE:

Market access for diagnostics developers is more complex and challenging than ever. New compliance requirements and payer demands for more detailed information compel companies/laboratories to be as good at communicating the value of their products as they are at developing them. We will discuss some of the intricacies and realities of proving long-term value to stakeholders including clinical data and real-world evidence on the benefits of testing.

TOPICS TO BE COVERED:

• Investigating the Background, Implications and Future Outlook of Medicare Reforms to the Clinical Laboratory Fee Schedule
• Development of the value proposition for commercial payers: Key evidence requirements
• Trends in laboratory benefits
• The role of national guidelines in establishing commercial payer coverage
• Know key decision points for optimization of your revenue cycle operations
• Strategically meet industry billing requirements head-on, while minimizing your costs and boosting your bottom-line

COURSE AGENDA:

6:00 pm Dinner Buffet

6:30 Course Welcome and Introductions

6:40 Latest Updates on Medicare Coverage: Local and National

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

7:10 How Do I Get a CPT Code and What are My Options?

Victoria Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Medical and Molecular Genetics, Indiana University School of Medicine; President, Association of Molecular Pathology

7:45 Dessert Break 

8:00 Payer Presentation Prep: Successful Strategies

Lon Castle, MD, CMO, Lab and Specialty Drug Services, eviCore healthcare

8:30 Healthcare Storytelling for Clinical Diagnostics – How to Do It…

Katherine Tynan, PhD, CEO, President, Tynan Consulting LLC

9:00 Q&A with Attendees and Speakers

9:30 Course Ends

INSTRUCTORS:

Katherine Tynan, PhD, CEO, President, Tynan Consulting LLC

Katherine is a seasoned biotechnology entrepreneur with a focus on business development, startup entrepreneurship, fundraising and strategic business planning for clinical diagnostic companies and investors. She has a breadth of experience in development and commercialization of new technologies for clinical diagnostics, including diagnostic reimbursement, financial analysis, operations, and product development. Katherine has served on and continues to work closely with the economic advisory committee for the Association of Molecular Pathology (AMP). She is actively sought after to speak and moderate sessions at industry meetings on the topics of reimbursement, new technologies and commercial challenges for emerging diagnostic tests. As a consultant, Katherine has worked with a number of early stage and established diagnostic companies guiding them through product development choices, market entry strategies, funding ($21M raised) and a diverse range of business development transactions. Prior to consulting, Katherine was at Vitra Bioscience (VP of Strategic Marketing), a venture-backed biotechnology tools company, where she managed a broad range of functional areas, including marketing, business development, operations, finance, legal, IP and participated in raising over $15M in capital. Previously, Katherine worked at Applied Biosystems in strategic planning (including Celera and Celera Diagnostics), business development, research management and product development roles. Prior to Applied Biosystems, Katherine directed the Molecular Genetics Department for Oncogenetics/Datagenetics, a start-up esoteric diagnostic services company (acquired by Impath and subsequently by Genzyme). Katherine also conducted postdoctoral studies on Marfan Syndrome at Stanford University and in conjunction with the Human Genome Project at Lawrence Livermore National Laboratory. She was board-certified by the American College of Medical Genetics (ACMG) in Clinical Molecular Genetics from 1993 through 2003. Katherine holds a PhD in Human Genetics from the University of Calgary, Canada and a BS (Hons) in Microbiology from University College Galway, Ireland.

Lon Castle, MD, CMO, Lab and Specialty Drug Services, eviCore healthcare

Dr. Lon Castle is responsible for the clinical performance of the Laboratory Medicine and Specialty Drug programs at eviCore healthcare. He has been working in the genomic and molecular diagnostic field for over a decade, designing and implementing programs that support personalized medicine initiatives that bring additional precision to the healthcare decisions facing physicians and their patients.

Previously, Dr. Castle worked as the Medical Director for Managed Care at CardioDx where he was responsible for discussing the science of their proprietary genomic test to detect coronary artery disease to payers. He also collaborated with payers on projects and program designs to demonstrate the clinical value of the test. As part of the Medical Affairs team, Dr. Castle was also involved in developing the clinical and health economic study designs.

Before CardioDx, Dr. Castle was employed at Medco Health Solutions (now Express Scripts) as the Senior Director for Clinical Innovation. During his 12 years there he worked on numerous projects, including the initial development of the company’s personalized medicine testing programs, demonstration projects with pharmaceutical manufacturers to establish the value of genetic markers for novel medications and publication of the organization’s annual Drug Trend Report.

Dr. Castle received his undergraduate degrees in Biology and English from Bucknell University in Lewisburg, PA. He received his medical degree from the Medical College of Ohio in Toledo. He completed his residency in Family and Community Medicine at the Medical Center of Delaware in Wilmington and his Sports Medicine fellowship at The Ohio State University in Columbus. Dr. Castle practiced sports medicine for over a decade at the Baylor College of Medicine and the Baylor Sports Medicine Institute in Houston, TX, serving as team physician for numerous professional, college and high school sports teams.

Victoria Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Medical and Molecular Genetics, Indiana University School of Medicine; President, Association of Molecular Pathology

Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. She is the Director of the Pharmacogenomics Laboratory and Molecular Genetics Laboratory at Indiana University School of Medicine. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute. Dr. Pratt is the President of Association of Molecular Pathology. Dr. Pratt is also the Past Chair of the Genetics, Clinical Practice and the Program committees and is currently a member of the Economic Affairs, Professional Relations committees for AMP. She is a former advisor of EurogenTest for genetic test validation. Dr. Pratt serves on the American Medical Association’s (AMA) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. In addition to her work, Dr. Pratt served on the Centers for Medicare and Medicaid Services Clinical Diagnostic Laboratory Tests Advisory Panel. Dr. Pratt continues to serve on the Centers for Disease Control and Prevention (CDC) GeT-RM program for reference materials for Molecular Genetics. She is currently serving on the National Academy of Medicine’s (formerly Institute of Medicine) Roundtable on Genomics and Precision Health. She also served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children. She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the CDC and the National Academy of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. Dr. Pratt has authored over 50 peer-reviewed manuscripts and book chapters. She is also an Associate Editor for the Journal of Molecular Diagnostics. Dr. Pratt graduated with a PhD in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994. Her fellowship training was in PhD Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI.

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

Bruce Quinn, MD, PhD, is a professional strategy consultant helping innovative companies achieve their goals under U.S. federal health policies. His consulting practice, with offices in Los Angeles and San Francisco, works with leading genomic, medical technology, and biopharma companies. Originally trained as a neuropathologist, earlier in his career he held tenure-track faculty positions at NYU Medical School and the Northwestern University School of Medicine. As a physician executive, he has held positions with Accenture’s healthcare strategies practice, the Medicare program, and with health policy groups in two law and lobbying firms. Recent publications have included articles on defining clinical utility for diagnostic tests and a review of the emerging digital genomics industry. In addition, his blog, www.DiscoveriesInHealthPolicy.com, covers innovative health care policy developments and receives over 100,000 hits per year. The website for Dr. Quinn’s firm is www.brucequinn.com.

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