1. Technology, Productivity and Health Care Costs Robert S. Galvin, MD National Health Policy Conference February 7, 2006

2. 2 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Innovation As A Core Value of U.S. Healthcare IOM Safe Timely Effective Efficient Equitable Patient-Centered + Innovative

3. 3 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Technology Assessment and Coverage: Current State Not Working Well for Anyone Today Terrific Innovations Are Not Used Soon Enough Innovations With Minimal Benefit Are Overused No Clear Accountability – or Leadership – for Current Process System Will Be Increasingly Burdened With Growth of Imaging-Treatment Combinations and Personalized Medicine Breakthroughs.

4. The Cycle of Unaccountability Pharma / Device CliniciansPayersFDA Consumer-Patient “My job is innovation that helps people... its up to the doctors to control use.” “My job is doing everything I can to help my patient... if I say no to studies, I might get sued.” “We want to pay for the right things, but there’s little data and saying no jeopardizes our relationships.” “I want the best of everything. Don’t ask me to pay more.” “Safety, not cost- effectiveness, is my job.”

5. 5 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Breaking the Cycle Re-Thinking Evidence Re-Thinking Payment Leadership

6. 6 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Re-Thinking Evidence Regulatory Approval Existing Procedure New Procedure Existing Coding/Coverage/Payment Improved Health Outcomes New Code (15 mos. min) Expanded Coverage (1-5 yrs) New Payment (1-2 yrs) 0-7 years

7. 7 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Re-Thinking Payment Source: JAMA December, 1997 Millions of Dollars

8. 8 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Leadership: Think Differently Payers Suppliers From:“Not Sufficient Evidence to Cover” To:“How Can We Work Together to Develop Evidence While Delivering the Best Care?” From:“No News But Good News” To:“Willingness to Do Head-to-Head Trials and Follow the Evidence”

9. 9 Robert S. Galvin, MD National Health Policy Conference February 7, 2006 Leadership: Act Differently I.Payers Combine Early Coverage With Clinical Research Coverage With Evidence Development CMS-Initiated, Private Payers Should Adopt Expand Benefit Designs to Include Clinical Trials Insist on “Practical Clinical Trials” II.Suppliers Integrate Payers Into Product Development “Upstream” Input on Assessing Outcomes/Value “What Would You As a Payer Like to See From Our Clinical Trials?”