Pre-Conference Workshops
WEDNESDAY, April 14, 2010
8:30-12:00 pm
Workshop A
Molecular 101: Starting Up and Running a Molecular Lab
- Learn practical issues involved with bringing molecular technologies into your laboratory
- Select the right molecular test menu for your lab
- Understand the key financial considerations
- Gain insight into staffing requirements and training issues
- Understand the issues involved with integrating molecular tests into clinical practice
Bryan Cobb, PhD, FACMG, Manager of Clinical and Scientific Affairs, Roche Diagnostics
John Greg Howe, PhD, Assistant Professor of Laboratory Medicine, Director, Molecular Diagnostics Lab, Yale University
Duane Newton, PhD, D(ABMM), Clinical Associate Professor of Pathology and Director, Clinical Microbiology & Virology Laboratories, University of Michigan Hospitals and Health Centers
1:00-4:30 pm
Workshop B
Coding, Billing and Payment for Molecular Assays
- Understand the major billing system for medical services in the United States
- Find out Medicare’s most common reasons for denying claims
- Implement a step-by-step denials management process
- Watch for ICD-9 coding strategies that support medical necessity
- Understand screening services reimbursement strategies
- Identify noncoding denial traps and modifier mistakes
- Discuss the current issues in reimbursement for molecular assays
- Explain the use of modifiers for the technical and professional component billing of molecular assays
- Understand the variations in billing for different types of molecular assays
Diana Voorhees, MA, CLS, MT, SH, CLCP, Principal/CEO, DV & Associates, Inc.
Main Conference
THURSDAY, April 15, 2010
8:00-8:15 am
Welcome and Opening Remarks
8:15-9:00 am
Opening Keynote: The Future of Molecular Diagnostics
With the molecular diagnostics market poised to continue its double-digit growth rates, this area of testing is at a vital crossroads. To become fully integrated into health care practice, molecular diagnostics must present a clear value proposition and embrace platforms that enable better clinical decision-making. In this keynote address, Mara Aspinall, a veteran of Genzyme Genetics and now president and CEO of On-Q-ity, will discuss the key challenges that face the rapidly evolving field of molecular diagnostics and how they can best be addressed.
Mara Aspinall, President and CEO, On-Q-Ity
9:00-9:30 am
G-2’s Molecular Market Overview
- Overview of forces that have forged molecular diagnostics to its present state
- Estimates of market size, segmentation, and growth potential
- Insight into drivers of market growth and key challenges
Stephanie Murg, Editor, Diagnostic Testing and Technology Report, Washington G-2 Reports
9:30-10:15 am
Case Study: Building a Molecular Diagnostics Laboratory at National Jewish Health
- Review of the molecular program's history, workflow, staffing, technology, and current priorities
- Discussion of how the laboratory has shaped its test menu with cutting-edge offerings
- Strategies for growth through strategic partnerships with national laboratories, diagnostic companies, and pharmaceutical companies
Gary L. Smith, PhD, Executive Director, Advanced Diagnostic Laboratories, National Jewish Health
10:15-10:45 am
Networking Break
10:45-11:30 am
Business and Financial Strategies for Molecular Diagnostics
- Key factors to consider when bringing molecular diagnostics in-house or expanding your existing molecular diagnostics program
- How to develop a budget and financial priorities for your molecular diagnostics program
- Strategies for selecting and optimizing a molecular diagnostics platform and test menu that make financial sense for your laboratory
Bryan Moore, PhD, MBA, Marketing Manager, Roche Diagnostics
11:30-12:15 pm
Legal Issues for Molecular Diagnostics
- Insight into key intellectual property issues surrounding molecular testing
- Discussion of how gene patents may affect your laboratory and strategies for managing legal risk
- Overview of aspects of licensing
Lisa M. Treannie, Esq., Morse, Barnes-Brown & Pendleton, P.C.
12:15- 1:30 pm
Networking Lunch
1:30-2:15 pm
Optimizing Your Molecular Test Menu
- Gain insight into best practices for building and developing a menu of molecular diagnostic tests
- How to create a test menu that promises larger volumes and greater clinical utility versus offering a portfolio of esoteric tests that add prestige and reduce send-out costs
- Understand what pitfalls to avoid when integrating molecular diagnostics into your laboratory
Mark Lovell, MD, Associate Professor of Pathology, University of Colorado Denver; Chair, Department of Pediatric Pathology; Medical Director, Molecular Diagnostic Laboratory, The Children’s Hospital in Aurora, Colorado
2:15-3:00 pm
Case Study 3: Pioneering EGFR Testing at Partners HealthCare Laboratory for Molecular Medicine
- Review of the mission and current services of the Laboratory for Molecular Medicine, Partners HealthCare Center for Personalized Genetic Medicine
- Discussion of how the discovery that EGFR mutations in non-small cell lung tumors confer sensitivity to certain cancer drugs was made available as a predictive molecular diagnostic test
- Additional supporting data and barriers to the adoption of this technology
- Outlook on future techniques and applications for tumor genotyping panels
Victoria Joshi, PhD, Associate Director, Laboratory for Molecular Medicine, Partners HealthCare Center for Personalized Genetic Medicine
3:00-3:30 pm
Networking Break
3:30-4:15 pm
Case Study: Making the Most of Molecular Data at Signature Genomics
- Examination of the molecular diagnostics data glut in the new era of genomic medicine
- Discussion of how Signature Genomics has built its database of molecular diagnostic data and how it mines the accumulated data to extract useful information
- Strategies for transforming data generated through molecular testing into valuable information and useful knowledge
Bassem A. Bejjani, MD, FACMG, Chief Medical Officer, Signature Genomics
4:15-5:00 pm
Reimbursement for Molecular Diagnostics
- Overview of how medical and laboratory procedures are reimbursed
- Discussion of ways in which reimbursement for molecular testing differs from that for routine laboratory testing
- Review of issues encountered in technical and professional component reimbursement for molecular testing
Rina Wolf, Vice President of Commercialization Strategies, Consulting and Industry Affairs, XIFIN
5:00-6:00 pm
Networking Reception
FRIDAY, April 16, 2010
8:00-8:05 am
Introductory Remarks
8:05-8:45 am
Keynote: Molecular Diagnostics Gets Personal
As the market for healthcare services converges with the consumer market in the midst of continued advances in genomic technology, is molecular diagnostic testing entering a new phase of personal genomics? Are companies like 23andMe and Navigenics empowering consumers with valuable, actionable medical information or dabbling in “recreational genomics”? Pioneering molecular geneticist and Harvard Medical School Professor George Church, PhD, founder of the Personal Genome Project, will discuss these powerful trends with regard to the obstacles and opportunities they present for personalized medicine and molecular diagnostic testing.
George M. Church, PhD, Professor of Genetics, Harvard Medical School; Director, Center for Computational Genetics
8:45-9:30 am
Delivering on the Promise of Personalized Medicine
- Insight into how academic medical centers and healthcare providers are reconfiguring their organizations and systems to deliver truly personalized care
- How laboratories can get involved in the BIG Health Consortium, a National Cancer Institute partnership that promotes a network model for personalized medicine
- Review of the feasibility and key benefits of a rapid-learning health system that can deliver personalized medicine
Kenneth H. Buetow, PhD, Associate Director for Biomedical Informatics and Information Technology, NCI
9:30-10:00 am
Networking Break
10:00-10:45 am
Pharmacogenomics in the Clinical Lab
- Review of pharmacogenomics
- The key tests that labs need to know about and possibly plan on offering in the near future
- Considerations unique to pharmacogenomics, including results reporting, staff expertise, and technology, that labs should keep in mind when considering bringing on these tests
- Current regulatory issues affecting this area of testing
- The future outlook regarding pharmacogenomic testing in the clinical lab—in two years, five years, and 10 years
Alan H.B. Wu, PhD, Chief, Clinical Chemistry Laboratory, San Francisco General Hospital & Trauma Center
10:45-11:30 am
Molecular Diagnostics Regulatory Update
- Overview of the FDA's role and regulatory requirements for molecular diagnostics
- Insight into the FDA's approach to regulating in vitro diagnostic multivariate assays (IVDMIAs), analyte specific reagents (ASRs), and laboratory-developed tests (LDTs)
- Discussion of the FDA's cross-center activities in pharmacogenomics
Marina Kondratovich, PhD, Associate Director for Clinical Studies, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, U.S. Food & Drug Administration
11:30-12:15 pm
Genetic Counseling and the Clinical Laboratory
- Overview of how genetic counselors work with clinicians and laboratory professionals to provide information and support to patients and families who have members with genetic disorders and those who may be at risk for inherited conditions
- Strategies for integrating genetic counseling into molecular diagnostic testing programs at academic medical centers, hospital laboratories, and reference laboratories
Steven Keiles, Vice President and Director of Genetic Services, Ambry Genetics; President, National Society of Genetic Counselors
12:15-1:30 pm
Networking Lunch
1:30-2:15 pm
Next Steps: Tools and Technology to Manage Molecular Testing
- Review of key challenges for labs performing molecular diagnostics
- Discussion of technological solutions to improve management of all phases of molecular diagnostic testing
- Factors to consider when integrating automated tools into laboratory workflow
Matt Zubiller, Vice President and General Manager, Advanced Diagnostics Management, McKesson
2:15- 3:00 pm
Radiogenomics: Linking Molecular Diagnostics and Diagnostic Imaging
- A look at how molecular diagnostics is being integrated with diagnostic imaging
- How the rapidly developing area of radiogenomics can deliver better diagnostic accuracy and more precise prognostication
- Discussion of the potential future role of both diagnostic and interventional radiologists in genetic testing
Michael D. Kuo, MD, Associate Professor of Radiology and Pathology, Director of the Translational Integrative Radiology-Pathology Program, David Geffen School of Medicine, University of California-Los Angeles
3:00 pm
Adjournment
Program Subject to Change
Register Now, or call Jeff Watkins at 800-401-5937 ext. 4710 or email Jeff at jwatkins@ioma.com
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