How to Launch a Laboratory Test:
Everything You Wanted to Know but Were Afraid to Ask *
6:15-9:00pm Dinner Short Course
Instructors: Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc.
Tonya Dowd, Director, Reimbursement Policy, Quorum Consulting, Inc.
The workshop is designed to give a clear and complete overview/ guidance for any company or researcher who is planning to bring a molecular test on the market. In this session, the instructors will begin with a discussion covering FDA approval pathways, recent updates to molecular diagnostics regulations, the different levels of evidence that drive FDA approval and payer coverage, reimbursement fundamentals and the latest coding updates and laws that will impact coverage and payment across the diagnostics industry.
Following the presentation will be an interactive case study activity for participants to exercise their new knowledge of regulatory and reimbursement considerations for diagnostic tests. Participants will work together to determine whether diagnostic test cases would or would not have successful commercialization and why and finally regroup to discuss the actual outcomes.
Topics to include:
• Analytical validity of an assay
• Clinical validity of an assay
• Clinical utility of an assay
• How to assure it works over time – the pain and power of QSRs
• CLIA certification
• FDA approval
• Third party payers – CPT coding and reimbursement/billing
• Putting it all together – how to make a business decision
* Separate Registration Required
Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc.
Steve has more than 30 years of medical industry experience with 15+ years at FDA, where he founded and directed OIVD, the Office of In Vitro Diagnostics. Steve holds a deep understanding of IVD history and regulation from developing policy and representing the agency for many years. Steve comes to Myraqa from Blue Cross Blue Shield Association, where he has been extending his scope of work as an Associate Director, where he formed scientific valuations and policies. Steve earned his MD at Cornell University Medical College, MBA with distinction from SUNY at Buffalo and his BS from The Ohio State University.
Blog Posts by Steve Gutman, MD
Tonya Dowd, MPH, Director, Reimbursement Policy and Market Access
Ms. Dowd has been recognized as an accomplished leader in the healthcare reimbursement policy arena for over 20 years and possesses a thorough understanding of healthcare delivery systems, public and private payer reimbursement mechanisms, employer benefit design, and coverage and technology assessment processes for new and emerging medical technologies. As Director of Reimbursement Policy at Quorum, Ms. Dowd develops reimbursement policy and commercial strategies across Quorum’s portfolio of clients in the molecular diagnostics, medical device and biopharmaceutical arenas, including securing new coding methods, reimbursement and coverage guidelines with public and commercial payers.
Prior to joining Quorum Consulting, she spent nine years at Johnson & Johnson where her innovative reimbursement programs and creative payer interactions contributed to the successful commercialization of new technologies in the areas of general surgery, oncology, bariatric surgery, urology, gastroenterology, anesthesia, gynecology and otolaryngology franchises. Ms. Dowd played an integral role in the successful adoption of bariatric surgery across the country, including the development of Centers of Excellence criteria, while participating in the California Right Care Initiative, a state-wide quality assurance initiative which seeks to apply scientific evidence and outcomes improvement strategies to reduce morbidity and mortality among California’s 15 million commercial managed health plan enrollees in the areas of cardiovascular disease, diabetes and the reduction of hospital acquired infections. Ms. Dowd also successfully established unique benefit design changes with large and small self-insured employer groups to incentivize minimally invasive surgery for employees. Ms. Dowd was the first employee in the medical device sector at Johnson & Johnson to be recognized as the Best Account Manager, a testament of her ability to garner relationships with key stakeholders at payers, employers, and government agencies. Prior to her tenure at Johnson & Johnson, she co-founded a reimbursement consulting company and worked for numerous medical device and pharmaceutical companies, Covance Healthcare Economics and Outcomes Research and National Data Corporation (NDC).
Ms. Dowd holds an undergraduate degree from the University of Michigan in Health Policy and a Master of Public Health from the University of California Los Angeles and is a recognized leader as part of the UCLA Upsilon Phi Delta Honor Society. She currently resides in Southern California with her husband Tom and three children, and is an active Board member of the UCLA Health Services Alumni Association.
Master of Public Health, Healthcare Management and Policy, UCLA, Los Angeles, June 2009.
UCLA Upsilon Phi Delta Honor Society, 2009.
Global Health Certificate, August 2009.
Bachelor of Arts, June 1997, University of Michigan. Major: Health Care Policy Studies, Minor: Psychology