Kauffman Summer Legal Institute
The Law and Policy of Affordable Health Care Innovation
DRAFT

Objective
Produce a Kauffman report with any appropriate caveats, to outline changes in law and policy that most likely would promote more affordable health care innovation.

Organizers
Robert Litan (Kauffman), Lesa Mitchell (Kauffman), Robert Cook-Deegan (Duke)

Format
Each panel begins with a short lead off presentation to stimulate discussion on the chosen topic. The following conference structure is highly preliminary and suggestive. Participants on each of the panels will have broad leeway to present or discuss their important subject even if it is only loosely related to the designated topic. This is important as the overall purpose of the meeting is to elicit a broad range of ideas that later can be remolded into a potentially more suitable structure for purposes of the written document.

Thursday, July 7

I. Setting the Stage (Carl J. Schramm)

II. The First Health Care Innovation Problem: Declining Marginal Productivity of R&D Spending. How can we fix?

1. Macro issue: what impediments prevent the data sharing and post-mortem kind of analysis of drugs, medical procedures, and so on that we have long had in aircraft accidents with the NTSB? Can sharing of data and models expedite discovery and reduce cost? Will new EMR/data system be the new platform that permits many new entrants into health care? (Stephen Friend, Susan Love)
2. Changes in IP law/policy (Arti Rai, Lesa Mitchell)
3. Litigation a related issue, which leads to zero risk mentality at the FDA, and so on. How can this be changed, both as a policy/legal matter and as a political matter? Are health courts one or a total answer?
4. Dying in translation. Why does this happen? Is a dominant culture of basic science at NIH the root problem? What's the evidence that fixing that would improve pace of applications? (Rob Califf)
5. Other arenas where innovation seems healthy but has not yet broken through to commercialization, why and how to fix?
   1. Stem cells
   2. Full-genome sequence (Robert Cook Deegan)
6. Fixing the FDA

Friday, July 8

III. The Health Care Innovation Problem: Inefficient Organizational Forms (including inefficient use of technology)

1. How to get EMR actually to solve real problems in health care (Susan Love)
2. Is vertical integration the answer (ACOs, the Mayo way)? (Scott Harrington, Frank Prendergast)
3. How to align incentives between utilization and health outcomes and address the "overtreated" problem (Shannon Brownlee)

IV. Yet Another Health Care Innovation Dilemma: The Bias Toward Cost-Increasing Innovation (the role of third party insurance; business models that rely on high barriers to entry and strong exclusivity): Can any role for market forces be carved into/out of the 2010 Health Care bill, or do we need to start over, and how? (David Gratzer, David Hyman)

Saturday, July 9

V. Roundtable on Other Ways to Promote Cost-Reducing Innovation (Paula Ehrlich, George Poste, Greg Simon)

VI. Promoting Health Care Innovation Through More Entrepreneurship

1. New firms or types of firms, e.g. CVS/Walgreen minute clinics (Steve Friend)
2. Entrepreneurship/reorganization of existing firms, such as Big Pharma (Frank Douglas, George Poste)

VII. Discussion of report preparation