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Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics
Session Chair(s)
Paul Sheives, JD, MS
Vice President, Reimbursement and Regulatory Policy
American Clinical Laboratory Association (ACLA), United States
The future of personalized medicine is dependent upon the development of rational reimbursement and coverage policies. These policies must reflect the real value companion diagnostics play in targeting important breakthrough medical therapies to ensure that patients are receiving the therapy most suited to their specific condition. This session will discuss the following key elements that are critical to ensuring appropriate decisions are taken reflecting the market-based value and importance of diagnostics in patient health and well-being: Working with payers on coverage policies to support appropriate adoption and use of the co-developed diagnostic; working with payers on coding and billing policies to distinguish co-developed diagnostics from tests analyzing the same or similar biomarkers, but which have not been validated or labeled specifically for use with the therapeutic; outreach to customers and treating physicians to explain test-specific coverage and payment policies; plus a case study to illustrate the importance of managing expectations and negotiations with payers/price-setters.
Learning Objective : Describe the reimbursement environment and trends with respect to coverage and reimbursement of diagnostics; Explain the ability to utilize tips in negotiations and discussions with payers for appropriate coverage decisions.
Speaker(s)
Panelist
Paul Sheives, JD, MS
American Clinical Laboratory Association (ACLA), United States
Vice President, Reimbursement and Regulatory Policy
Panelist
Gary Gustavsen, MS
Health Advances, United States
Manager
Panelist
Laura Housman, MBA, MPH
Novartis Molecular Diagnostics, United States
Vice President, Global Market Access
Panelist
Valerie Guild
AIM at Melanoma, United States
President
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