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#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?
#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 $0
Departures 0 New Hires 0
Open Headcount 0
6 Month Consultant Needs Change
Proposed New Headcount -
0
10
20
30
40
50
60
2013 2012
Investigations Status
Cases Opened
Cases Closed
Competitor
0 10 20 30 40 50 60
2012Q4
2013Q1
2013Q2
2013Q3
2013Q4 *
Goal
CQRC Draft HCP Training Fully ExecutedOn TrackComplete At Risk
* Excludes Early Filing Agreements
0
0
0
0
0
0
#ACIFCPA
Top 5 Q4
1. XXXXX
2. XXXXX
3. XXXXX
4. XXXXX
5. XXXXX
Top 5 Q1
1. XXXXXX
2. XXXXXX
3. XXXXXX
4. XXXXXX
5. XXXXXX
Compliance Strategy
#ACIFCPA
0
50
100
150
200
USA EMEA Intl Japan
Service Neeeds Review Committee
Modifications Year To Date
New Events
Tier Changes
Hours Changes
Professional Affairs
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
12Q4 13Q1 13Q2 13Q3 13Q4
Budget
Actuals
Global Consulting Budget vs. Actual ($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
#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
#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
#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
#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
#ACIFCPA
#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
#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
#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?
#ACIFCPA
Anomaly detectionbasedon predefinedindicators
can help isolate riskytransactionsand entities
High-level view
Detailed view
Drill-down to a particular
region
For illustrative purposes only
#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
#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

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Detecting and Monitoring: Corruption Across your Operations

  • 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
  • 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