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The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress. Beyond the DOJ: Compliance Best Practices in the Orthopedic Environment March 26-28, 2008. Discussion Agenda. Issues in Question in Industry Investigations.

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The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress

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  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) 408-3274 • kmcdermott@sonnenschein.com • Laura O’Donnell, Esquire • Zimmer Holdings, Inc. • Warsaw, IN 46580-2746 • (574) 371-8637 • Laura.odonnell@zimmer.com

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