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

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Discussion AgendaDiscussion Agenda

Issues in Question in Industry Issues in Question in Industry Investigations.Investigations.

Use of Deferred Prosecution Agreements Use of Deferred Prosecution Agreements to Assure Compliance Best Practices.to Assure Compliance Best Practices.

Compliance safeguards relating to HCP Compliance safeguards relating to HCP Consulting Arrangements.Consulting Arrangements.

Other Industry Compliance Safeguards Other Industry Compliance Safeguards relating to HCP and Hospital Customers.relating to HCP and Hospital Customers.

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Issues In InvestigationsIssues In Investigations

HCP Arrangements: consulting, product HCP Arrangements: consulting, product development, clinical research. development, clinical research.

HCP arrangements to maintain or grow HCP arrangements to maintain or grow business, move market share. business, move market share.

Entertainment, meals, gifts to HCPs and Entertainment, meals, gifts to HCPs and customers.customers.

Transparency, Disclosure, Management of Transparency, Disclosure, Management of Conflict of Interest. Conflict of Interest.

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Deferred Prosecution AgreementsDeferred Prosecution Agreements

IntermuneIntermune

PfizerPfizer

New Jersey USAO Orthopedic Device New Jersey USAO Orthopedic Device CasesCases

Jazz PharmaceuticalsJazz Pharmaceuticals

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DOJ Use of Monitors DOJ Use of Monitors March 7, 2008 PolicyMarch 7, 2008 Policy

Avoid Conflict of Interest.Avoid Conflict of Interest.

Assure Independence.Assure Independence.

Focus Scope of Monitor Work On Conduct Focus Scope of Monitor Work On Conduct at Issue.at Issue.

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DOJ Use of Monitors DOJ Use of Monitors March 7, 2008 PolicyMarch 7, 2008 Policy

Appropriate Monitor Communications to Appropriate Monitor Communications to Government.Government.

Company Right to Accept or Reject Company Right to Accept or Reject Monitor’s Recommendations.Monitor’s Recommendations.

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DOJ Use of Monitors DOJ Use of Monitors March 7, 2008 PolicyMarch 7, 2008 Policy

Monitor Disclosure of Misconduct To Monitor Disclosure of Misconduct To Government. Government.

Duration and Extension Of Monitor Duration and Extension Of Monitor Arrangement.Arrangement.

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Before the DPA/CIA: Lessons LearnedBefore the DPA/CIA: Lessons Learned

The relative subjectivity of an effective The relative subjectivity of an effective compliance program.compliance program.

Preparing for “extreme” transparency.Preparing for “extreme” transparency.

One size fits all?One size fits all?

Industry-wide versus individual entity Industry-wide versus individual entity resolution agreements: advantages and resolution agreements: advantages and challenges.challenges.

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Operationalizing a DPAOperationalizing a DPA

DPA versus compliance program DPA versus compliance program implementation: high stakes for mistakes.implementation: high stakes for mistakes.

The potential quagmire of retrospection.The potential quagmire of retrospection.

Scope of a DPA.Scope of a DPA.

Post-DPA training needs.Post-DPA training needs.

Emotional reactions of different Emotional reactions of different constituencies.constituencies.

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The Tipping Point: Going Beyond the The Tipping Point: Going Beyond the DPA/CIADPA/CIA

Building and sustaining a burning platform.Building and sustaining a burning platform.

The future is now: prognosticating The future is now: prognosticating compliance/enforcement trends.compliance/enforcement trends.

Speed of change: Speed of change:

– Can the trajectory be too fast? What if it is not fast Can the trajectory be too fast? What if it is not fast enough?enough?

– How can the compliance function become more How can the compliance function become more agile? agile?

– How do you build the boat while you are trying to row How do you build the boat while you are trying to row it?it?

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Uncharted Territory: The Transactional Uncharted Territory: The Transactional Compliance ModelCompliance Model

Potential Conflicts.Potential Conflicts.

Potential Advantages.Potential Advantages.

Special Recruiting Needs:Special Recruiting Needs:

– LegalLegal

– FinancialFinancial

– Compliance as a profession Compliance as a profession

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Two is (not always) better than One: Two is (not always) better than One: Navigating a DPA and CIANavigating a DPA and CIA

Complementary/discrete philosophies.Complementary/discrete philosophies.

Short term challenges.Short term challenges.

Long term advantages.Long term advantages.

First impression issues for Independent First impression issues for Independent Review Organizations.Review Organizations.

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Compliance Safeguards for HCP Compliance Safeguards for HCP CollaborationsCollaborations

Needs Assessment documented for all money Needs Assessment documented for all money flowing to HCPs. flowing to HCPs.

Documented payment for performance. Documented payment for performance.

Sales Force Firewall for all non-product Sales Force Firewall for all non-product activities. activities.

Re-structure product development teams and Re-structure product development teams and compensation. compensation.

No entertainment or gifts. No entertainment or gifts.

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Other Industry Compliance InitiativesOther Industry Compliance Initiatives

Hospital Conflict of Interest Policies. Hospital Conflict of Interest Policies.

AAOS Standards of Professionalism, April AAOS Standards of Professionalism, April 2007 2007

Physician Network Conflict of Interest Policies. Physician Network Conflict of Interest Policies.

AdvaMed-Beyond Code of Ethics: Payment AdvaMed-Beyond Code of Ethics: Payment Sunshine Act and disclosure standards.Sunshine Act and disclosure standards.

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Contact InformationContact Information

Kathleen McDermott, EsquireKathleen McDermott, EsquireSonnenschein Nath & Rosenthal LLPSonnenschein Nath & Rosenthal LLPWashington, DCWashington, DC(202) 408-3274(202) 408-3274kmcdermott@sonnenschein.comkmcdermott@sonnenschein.com

Laura O’Donnell, EsquireLaura O’Donnell, EsquireZimmer Holdings, Inc.Zimmer Holdings, Inc.Warsaw, IN 46580-2746Warsaw, IN 46580-2746(574) 371-8637(574) 371-8637Laura.odonnell@zimmer.comLaura.odonnell@zimmer.com