Achieving commercial success for an IVD product or an LDT assay is becoming progressively more difficult in the current healthcare environment. The combination of tightening a health care budget and the launch of a large number of expensive molecular tests creates complications for payers to respond in traditional ways. With the new PAMA legislation and the increasing role of private payers it is important to stay in the loop and to discuss the latest developments with your peers. The Third Annual Evidence-Based Reimbursement of Molecular Diagnostics is a unique forum that provides the participants with the opportunity to openly discuss and search for solutions to the A to Z coverage and reimbursement issues.
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Wednesday, November 19
7:30– 8:15 am 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. Please pick a topic of your choice and join in.
Medical Affairs as a Powerful Tool for Market Access and Coverage
Catherine Schnabel, Ph.D., Vice President, Translational Science, bioTheranostics, Inc.
Billing and Reimbursement in Advanced Diagnostics: Working with Private Payors and Government
Laurie Howard, Vice President, Reimbursement, LabCorp
Coverage and Reimbursement Decisions: Expectations, Logistics and More
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
CPT Coding Update
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine
8:45 Chairperson’s Opening Remarks
Terry Robins, Molecular RxDx Strategies
9:00 Joint Presentation: A Do-It-Yourself Guide to Partnerships between Payers and Molecular Diagnostic Companies
Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
Creating real-world evidence to support coverage of your test by payers can be a challenging process. While few provide a blueprint for success, some payers are open to collaborations designed to demonstrate the value of the test. This session will provide a step-by-step guide on how to design, pitch and execute the types of studies payers want to see when establishing coverage policies.
9:45 Medicare Coverage Process of an Epigenetic Test for Prostate Cancer Under the New MolDX Program
Jan Groen, Ph.D., President & CEO, MDxHealth
Validation, clinical utility and health economic data for an epigenetic test for prostate cancer, demonstrated an improvement of the diagnosis, a significant reduction in repeat biopsy procedures and a reduction in healthcare costs. To obtain Medicare coverage for the test one has to comply with the new MolDx program for multi-maker tests. In this case study we discuss the roadmap for an epigenetic test going through the MolDX program from Medicare.
10:15 System Economic Justification: Tools for Success in the New Reimbursement Environment
Gary Gustavsen, M.S., Vice President, Health Advances
With more and more innovative diagnostics hitting the market, scrutiny and evidentiary requirements from payers is at an all-time high. To meet these demands, developers must make large investments which in turn drive a need for premium pricing to capture a return. To justify this, system economic analyses have become a critical component of a diagnostic’s launch plan. This case study will review the process for such an analysis, the resulting outcomes, and highlight specific payer-facing tools for future use.
10:45 Networking Coffee Break
11:15 Payer Panel: Policies Review and What Is Ahead
Moderator: Andrew C. Fish, Executive Director, AdvaMedDx
Panelists: Tamara Syrek Jensen, Director of the Coverage and Analysis Group, CMS
Charles A. Stemple, D.O., M.B.A., Corporate Medical Director, Clinical Policy, Commercial, Humana, Inc.
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
12:30 pm Enjoy Lunch on Your Own
1:45 Chairperson’s Remarks
Joseph V. Ferrara, President, Boston Healthcare Associates, Inc.
2:00 The Evolving Role of Medical Affairs in the Genomic Testing Industry
Catherine Schnabel, Ph.D., Vice President, Translational Science, bioTheranostics, Inc.
With shifts towards evidence-based medicine and value-based models, the role for Medical Affairs in market access and reimbursement efforts continues to increase in importance. Integral to this is the evolution of Medical Affairs from a supportive and reactive function, to a strategic driver that leads key aspects of scientific discourse to respond to the needs and diversity of evidentiary requirements, and engages payers and providers accordingly. This presentation will highlight the impact of Medical Affairs and medical programs to strengthen access and reimbursement for bioTheranostics’ proprietary molecular tests.
2:30 A Reference Laboratory Perspective: A Discussion of Multiple Hurdles which Have to be Overcome to Minimize Disruptions in Cash Flow due to Lack of Coverage and Reimbursement in the Molecular Diagnostics Testing Space
Laurie Howard, Vice President, Reimbursement, LabCorp
Facing difficult Policy and Reimbursement obstacles, the Laboratory industry is dealing with many implications that will affect how they operate and are reimbursed in the future that will be addressed during this discussion. Key issues include: Pace of test development vs. pace of coverage guidelines issuance and reimbursement determination, physician demand for the test, and clinical utility for Private Payors and Government.
3:00 A Molecular Diagnostic Perfect Storm: The Convergence of Regulatory & Reimbursement Forces that Threaten Patient Access to Genomic Medicine
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine
Dark clouds of public policy are threatening the bright future of genomic medicine. Efforts by the U.S. Food and Drug Administration (FDA) to require premarket review of laboratory developed procedures (LDPs), and also an FDA proposal of a one test-one therapy model for companion diagnostics limit patient access to testing. Furthermore, the Centers for Medicare and Medicaid Services (CMS) has begun a trend towards non-coverage of the new molecular pathology current procedural terminology (CPT) codes and reduced payment for covered tests create a challenging environment for laboratories to translate new genomic discoveries into clinical applications. This talk will review the regulatory environment that is creating challenges for laboratories to keep their doors open.
3:30 Close of Conference
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