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ACI’sFCPA &Anti-Corruption Conference
- 1. #ACIFCPA ACI’sFCPA &Anti-Corruption forthe LifeSciencesIndustry Daniel Garen SVP & Chief Compliance Officer Wright Medical Technology, Inc. Detecting and Monitoring Corruption Across Your Operations: First-Hand Insights on How to Work with Compliance Monitors, and Leverage Your Internal Audit Function, Data Analytics and Metrics Brent White Vice President, Internal Audit Allergan Joshua Torok Associate Director, Internal Audit PPD, LLC April 28-29, 2014 Sara Vandermark Analytics Senior Manager Deloitte Financial Advisory Services LLP Tweeting about this conference?
- 2. #ACIFCPA Wright Compliance Dashboard Operations Status Administration Strategy Status Professional Affairs Status Review & Monitoring Annual Report IRO Management Aggregate Spend Transition Planning Q4 FCST Q4 ACT Q1 FCST Policy Updates 0 0 0 Training Events 0 0 0 Communications 0 0 0 Q4 BUDGET Q4 ACTUAL DIFFERENCE $0 $0 $0 Departures 0 New Hires 0 Open Headcount 0 6 Month Consultant Needs Change Proposed New Headcount - 0 10 20 30 40 50 60 2013 2012 Investigations Status Cases Opened Cases Closed Competitor 0 10 20 30 40 50 60 2012Q4 2013Q1 2013Q2 2013Q3 2013Q4 * Goal CQRC Draft HCP Training Fully ExecutedOn TrackComplete At Risk * Excludes Early Filing Agreements 0 0 0 0 0 0
- 3. #ACIFCPA Top 5 Q4 1. XXXXX 2. XXXXX 3. XXXXX 4. XXXXX 5. XXXXX Top 5 Q1 1. XXXXXX 2. XXXXXX 3. XXXXXX 4. XXXXXX 5. XXXXXX Compliance Strategy
- 4. #ACIFCPA 0 50 100 150 200 USA EMEA Intl Japan Service Neeeds Review Committee Modifications Year To Date New Events Tier Changes Hours Changes Professional Affairs 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 12Q4 13Q1 13Q2 13Q3 13Q4 Budget Actuals Global Consulting Budget vs. Actual ($m) Global Engagements YTD Foot & Ankle Hip & Knee Biologics Upper Extremity 0% 50% 100% WGH USA Latin America Japan EMEA Canada BMTI Asia/ Australia Completion of Health Care Provider Fee for Service Agreementsby Region Complete Pending 0 0 0 0 0 0 0 0 0
- 5. #ACIFCPA Review and Monitoring Top 5 Concerns – Q3 1. XXXXX 2. XXXXX 3. XXXXX 4. XXXXX 5. XXXXX Top 5 Concerns – Q4 1. XXXXX 2. XXXXX 3. XXXXX 4. XXXXX 5. XXXXX 0 5 10 15 20 25 30 35 40 45 50 Quarter 3 October and November Quarter 3 October and November November October Quarter 3 HCP Spend Comparison Documentation Errors and Omissions HCP Spend Violations Question Number Top 5 Questions Missed During Interviews 18 XXXXX 19 XXXXX 14 XXXXX 17 XXXXX 10 XXXXX 0 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 NumberofIncorrectResponses Question Number Interview Results 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
- 6. #ACIFCPA Investigations # of Cases 13Q1 13Q2 13Q3 13Q4 EOY 2013 EOY 2012 Issue Type 13Q1 13Q213Q3 13Q4 EOY 2013 EOY 2012 Cases Opened 0 0 0 0 0 0 Anti Bribery 0 0 0 0 0 0 Cases Closed 0 0 0 0 0 0 Concern 0 0 0 0 0 0 Competitor 0 0 0 0 0 0 Conflict of Interest 0 0 0 0 0 0 Falsification of Documents 0 0 0 0 0 0 Intake Method 13Q1 13Q2 13Q3 13Q4 EOY 2013 EOY 2012 Health Care Fraud & Abuse 0 0 0 0 0 0 Email 0 0 0 0 0 0 Inquiry 0 0 0 0 0 0 Walk In 0 0 0 0 0 0 Misconduct 0 0 0 0 0 0 Hotline Phone 0 0 0 0 0 0 Theft 0 0 0 0 0 0 Hotline Web 0 0 0 0 0 0 Violation of Policy 0 0 0 0 0 0 Letter/Mail 0 0 0 0 0 0 Other 0 0 0 0 0 0 Phone 0 0 0 0 0 0 Other 0 0 0 0 0 0 Area Involved 13Q1 13Q2 13Q3 13Q4 EOY 2013 EOY 2012 Sales 0 0 0 0 0 0 Management 0 0 0 0 0 0 Other 0 0 0 0 0 0
- 7. #ACIFCPA Correctiveand PreventativeActionCommittee CAPA Input Sources 0 5 10 15 20 25 Investigations HCP Spend Violation Reports CIA Items Other Assigned Action Items 0 10 20 30 40 50 60 70 80 90 Late Other Total Linear (Total) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
- 8. #ACIFCPA Administration • Compliance Budget Status: • Budget • Actual • Difference • Open Headcount: # • XXXXX • Transitions: # hires • Hires: XXXXXX • Six Month Consultant Needs: Decrease/Increase/Flat • XXXXXX (decrease) • XXXXXX (increase) • XXXXXX (decrease) • XXXXXX (flat) • Proposed New Headcount: # Q1 Q2 Q3 Q4 EOY $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
- 9. #ACIFCPA
- 10. #ACIFCPA Process Walk Throughs Personnel Interviews Compliance Culture Policy Knowledge Overall Adherence Detail Testing Ensures and risk areas are identified and routinely monitored as well as assuring that WMT has policies and procedures that are in line with Regulatory Guidelines. Review and Monitoring – Process Focus
- 11. #ACIFCPA Customer Facing / Focus Arrangement On-going DPA/CIA Processes Compliance Policy Compliance Project Activities: • Sales Force Audits • Healthcare Provider Spend • Consultant Contracts • Healthcare Provider Payments • Medical Education • Grants and Charitable Donations • Tone at the Top • Ride Alongs • Compliance Investigations Process • Transparency & Aggregate Spend • Sales Force Communication • Anti Bribery Anti Corruption – FCPA Review and Monitoring – Project Areas
- 12. #ACIFCPA ACI’sFCPA &Anti-Corruption forthe LifeSciencesIndustry Daniel Garen SVP & Chief Compliance Officer Wright Medical Technology, Inc. Detecting and Monitoring Corruption Across Your Operations: First-Hand Insights on How to Work with Compliance Monitors, and Leverage Your Internal Audit Function, Data Analytics and Metrics Brent White Vice President, Internal Audit Allergan Joshua Torok Associate Director, Internal Audit PPD, LLC April 28-29, 2014 Sara Vandermark Analytics Senior Manager Deloitte Financial Advisory Services LLP Tweeting about this conference?
- 13. #ACIFCPA Anomaly detectionbasedon predefinedindicators can help isolate riskytransactionsand entities High-level view Detailed view Drill-down to a particular region For illustrative purposes only
- 14. #ACIFCPA Predictive analytics can help identify trends and improper payments For illustrative purposes only Inthousands Vendor payment activity What-if scenario Trend Analysis For illustrative purposes only
- 15. #ACIFCPA Usingtext analyticsto identify anomalousexpenses Analyzing large text data sets and grouping it in clusters of strings by similarity can help identify abnormal text strings In this example, upon quick review of the clusters (each color is one cluster with similar text), a cluster containing “exotic massage” was identified, and set apart for further investigation. For illustrative purposes only