1. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress
Beyond the DOJ: Compliance Best Practices in the Orthopedic Environment
March 26-28, 2008

2. Discussion Agenda
Issues in Question in Industry Investigations.
Use of Deferred Prosecution Agreements to Assure Compliance Best Practices.
Compliance safeguards relating to HCP Consulting Arrangements.
Other Industry Compliance Safeguards relating to HCP and Hospital Customers.

3. Issues In Investigations
HCP Arrangements: consulting, product development, clinical research.
HCP arrangements to maintain or grow business, move market share.
Entertainment, meals, gifts to HCPs and customers.
Transparency, Disclosure, Management of Conflict of Interest.

4. Deferred Prosecution Agreements
Intermune
Pfizer
New Jersey USAO Orthopedic Device Cases
Jazz Pharmaceuticals

5. DOJ Use of Monitors March 7, 2008 Policy
Avoid Conflict of Interest.
Assure Independence.
Focus Scope of Monitor Work On Conduct at Issue.

6. DOJ Use of Monitors March 7, 2008 Policy
Appropriate Monitor Communications to Government.
Company Right to Accept or Reject Monitor’s Recommendations.

7. DOJ Use of Monitors March 7, 2008 Policy
Monitor Disclosure of Misconduct To Government.
Duration and Extension Of Monitor Arrangement.

8. Before the DPA/CIA: Lessons Learned
The relative subjectivity of an effective compliance program.
Preparing for “extreme” transparency.
One size fits all?
Industry-wide versus individual entity resolution agreements: advantages and challenges.

9. Operationalizing a DPA
DPA versus compliance program implementation: high stakes for mistakes.
The potential quagmire of retrospection.
Scope of a DPA.
Post-DPA training needs.
Emotional reactions of different constituencies.

10. The Tipping Point: Going Beyond the DPA/CIA
Building and sustaining a burning platform.
The future is now: prognosticating compliance/enforcement trends.
Speed of change:
Can the trajectory be too fast? What if it is not fast enough?
How can the compliance function become more agile?
How do you build the boat while you are trying to row it?

11. Uncharted Territory: The Transactional Compliance Model
Potential Conflicts.
Potential Advantages.
Special Recruiting Needs:
Legal
Financial
Compliance as a profession

12. Two is (not always) better than One: Navigating a DPA and CIA
Complementary/discrete philosophies.
Short term challenges.
Long term advantages.
First impression issues for Independent Review Organizations.

13. Compliance Safeguards for HCP Collaborations
Needs Assessment documented for all money flowing to HCPs.
Documented payment for performance.
Sales Force Firewall for all non-product activities.
Re-structure product development teams and compensation.
No entertainment or gifts.

14. Other Industry Compliance Initiatives
Hospital Conflict of Interest Policies.
AAOS Standards of Professionalism, April 2007
Physician Network Conflict of Interest Policies.
AdvaMed-Beyond Code of Ethics: Payment Sunshine Act and disclosure standards.

15. Contact Information
Kathleen McDermott, Esquire
Sonnenschein Nath & Rosenthal LLP
Washington, DC
(202)
Laura O’Donnell, Esquire
Zimmer Holdings, Inc.
Warsaw, IN
(574)