Session

Moderator & Panelists

Timing

Breakfast/networking session

All attendees

8:00 a.m. – 9:00 a.m.

Welcome and Introduction:

• Objectives of the summit
• Recap of advisory boards and specific industry proposed solution 
• Discussion of today’s interactive summit model
• Introduction of speaker

Introduction – James C. Greenwood, President and CEO, Biotechnology Industry Organization

• Dr. Bruce Quinn, Senior Health Policy Advisor, Foley Hoag LLP

9:00 a.m. – 9:15 a.m.

Introductory Speaker:

• Challenges facing reimbursement of molecular diagnostics

• Dr. Reed Tuckson, Executive Vice President and Chief of Medical Affairs, United Health Group

9:15 a.m. – 9:45 a.m.

Panel 1:

• Evidentiary standards and data requirements for payer coverage

Expert moderator – Kristin Ciriello Pothier, Partner, Health Advances

• Jerry Conway, Vice President of Reimbursement & Payer Strategy, Foundation Medicine
• Dr. Jeff Allen, PhD, Executive Director, Friends of Cancer Research
• Tamara Syrek Jensen, J.D., Deputy Director, coverage and Analysis Group, CMS
• Matthew Zubiller, Vice President for Decision Management Business, McKesson Corporation.

9:45 a.m. – 11:15 a.m.

Break

11:15 a.m. – 11:30 a.m.

Panel 2:

• Becoming the standard of care:  Inclusion of new molecular diagnostics into clinical guidelines

• Expert Moderator –    Gail L. Daubert, J.D., Partner, Reed Smith
•  Joan McClure, Vice President of Clinical Information and Publications, National Comprehensive Cancer Network
• Dr. Tadd Lazarus, Chief Medical Officer/Medical Affairs, QIAGEN

• Steve Shak, Chief Medical Officer & Executive Vice President of Research & Development, Genomic Health

11:30 a.m. – 12:45 p.m.

Lunch served & short break

12:45 p.m. – 1:15 p.m.

Luncheon keynote session:   

• Current Issues in Reimbursement of Molecular Diagnostics at CMS

Introduction – Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

• Interviewer - Dr. Bruce Quinn, Senior Health Policy Advisor, Foley Hoag LLP
• Louis B. Jacques, M.D., Director, Coverage and Analysis Group, CMS

1:15 p.m. – 1:45 p.m.

• 20 minutes speech
• 10 minutes Q&A

Panel 3:

• Issues impacting market access, such as companion diagnostics and physician/patient education

Expert moderator – Dr. Jared Schwartz, Chief Medical Officer, Aperio

• Andrea Ferris, President of the LUNGevity Foundation
• Kelly Burgeson, Executive Director, Access and Reimbursement, Oncology, Boehringer Ingelheim Pharmaceuticals
• Mike Kolodziej, M.D., National Medical Director for Oncology Strategies, Office of the Chief Medical Officer, Aetna
• Paul Landauer, Senior Director, Global Healthcare Policy and Market Access, Abbott Molecular

1:45 p.m. – 3:15 p.m.

Break

3:15 p.m. – 3:30 p.m.

Panel 4:

• Incentivizing personalized medicine diagnostic development

Expert moderator –Vicki Seyfert-Margolis, Ph.D., Chief Scientific and Strategy Officer, Precision Health Holdings and Chief Executive Officer and Founder, MyOwnMed

• Hawazin Faruki, DrPH, Managing Director, Clinical Diagnostic Strategies, LLC
• Marc Boutin, Executive Vice President & Chief Operations Officer, National Health Council

• Mary Dwight, Vice President of Government Affairs, Cystic Fibrosis Foundation
• Stephen L. Eck, M.D., Ph.D.,Vice President, Global Head of Oncology Medical Science, Astellas Pharma 

3:30 p.m. – 4:45 p.m.

Concluding session:

• Overview of solutions discussed during today’s summit and next steps

• Amy M. Miller, Ph.D., Vice President, Public Policy, Personalized Medicine Coalition
• Paul Sheives, J.D., Director, Diagnostics and Personalized Medicine Policy, Biotechnology Industry Organization

4:45 p.m. – 5:00 p.m.

Reception begins

5:00 p.m.