Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics

Track:
Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 26, 1:45PM - 3:15PM

Session Number:
351

Room Number:
253C

Level:
Intermediate

Type:
Session

Title:
Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics

Chair(s):
Paul Sheives, JD,MS
Director for Diagnostics and Personalized Medicine Policy
Biotechnology Industry Organization (BIO), United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Panelist
Paul Sheives, JD,MS
Director for Diagnostics and Personalized Medicine Policy
Biotechnology Industry Organization (BIO), United States