2013 Archived Content
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Wednesday, October 23rd
8:00 Problem Solving Breakout Discussions with Continental Breakfast
Concurrent Problem Solving Breakout Sessions are interactive, topic-specific discussions hosted by a moderator. These sessions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners.
TABLE: Clinical Trials in Diagnostics
Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.
TABLE: Companion Diagnostics Commercialization Strategies
John R. Ridge, Director, Global Reimbursement and Healthcare Economics, Ventana Medical Systems, a member of the Roche Group
TABLE: CPT Code Worm Up
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine
8:55 Chairperson’s Remarks
9:00 Demonstrating Clinical Utility Towards Commercialization of Proprietary Molecular Diagnostics
Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.
The evolving landscape of molecular diagnostics in the practice of genomic medicine presents challenges to enabling commercialization of high complexity tests. For proprietary diagnostics in particular, where the evidence base is built versus leveraged, an integrative roadmap is critical towards demonstrating clinical utility. Building evidence strategies for multiple stakeholders and the impact on clinical adoption and access will be highlighted through discussion of CancerTYPE ID, a 92-gene expression-based assay used for definitive diagnosis of tumor type and determination of primary site in metastatic disease.
9:30 Beginning with the End in Mind: Planning to Address Payer Coverage Considerations
Pam Baker, Senior Director, Market Access & Policy, CardioDx, Inc.
Meaningful improvements in genetic and genomic-based diagnostic tests can make a significant impact on patients’ lives. However, without payer coverage, many diagnostic tests run the risk of remaining interesting concepts that weren’t able to impact the practice of medicine in any significant way. We’ll discuss how to navigate the sometimes unclear requirements for coverage by public and private payers and how to plan for these requirements early in the development phase. We’ll also discuss some of the main stumbling blocks to payer coverage for diagnostics, why they exist, and recommendations on how to avoid them.
10:00 Strategies for the Successful Launch of a Companion Diagnostic TestJohn R. Ridge, Director, Global Reimbursement and Healthcare Economics, Ventana Medical Systems, a member of the Roche GroupPersonalized healthcare in the form of companion diagnostic testing has the potential to transform Healthcare. The session will explore the various challenges that diagnostic manufacturers will face from payers and funding agencies to acquire payment for companion diagnostics. Through an analysis of the current environment for companion diagnostics, manufacturers will learn what they have to do throughout the product development process to successfully launch a companion diagnostic test.
10:30 Coffee Break in the Exhibit Hall
11:00 Understanding the Value of Advanced Diagnostics: Aligning Labs, Clinicians and Payers to Make Better Decisions
Matthew Zubiller, Vice President, Decision Management, McKesson Health Solutions
Today, over 3000 molecular diagnostic (MDx) tests are marketed for clinical use and new diagnostics are regularly emerging at a rate of several per month. No standardized system for uniquely identifying these tests or capturing and analyzing the clinical and financial impact of individual tests currently exists. The discussion will show how the coordinated effort between the AMA and McKesson will bring specificity to the use, identification, reporting and tracking of MDx tests. This coordinated process will help to improve communication and collaboration between clinicians, hospitals, labs and payers.
11:30 CPT Codes for Multigene Testing Using Next-Generation Sequencing: Opportunities and Challenges Ahead
Roger Klein, M.D., J.D., Department of Molecular Pathology, Cleveland Clinic Foundation
2013 heralds broad implementation of more transparent CPT coding for higher volume molecular pathology tests in the oncology and genetics arenas. A number of salient issues to include fee schedule placement and valuation of new molecular pathology CPT codes should be at least partially resolved. Advancements in new technologies such as next generation sequencing of gene panels, exomes and even full genomes pose new challenges for transparent and rational coding for labs and payers. This presentation will update and review developments on these and other topics of current interest.
12:00 Development of the new AMA Molecular Pathology CPT Codes
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine
With the completion of the Human Genome Project and increased understanding of the genes involved in human disease and cancer biology, clinical molecular testing has grown by leaps and bounds. New biomarkers were brought to market and largely reimbursed by using a molecular current procedural terminology (CPT) code stacking system where each step of the process had its own CPT code. At the request of payers, the American Medical Association (AMA) developed a new CPT coding system based on a white paper proposed by Association of Molecular Pathology (AMP). Since there are well over a thousand different molecular pathology tests, a tier system was created. Tier 1 where each individual test gets a unique CPT code was created to encompass the more commonly ordered category 1 tests throughout the country. Tier 2 where there are nine levels of complexity was created to address the more rarely ordered category 1 tests. This session will review the new CPT coding system.
12:30 Panel Discussion: What New Codes Mean for Various Diagnostics Stakeholders
Panelists: Speakers of the Session
1:00 End of Generating Evidence for Reimbursement Decisions: Diagnostics
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