#ACIFCPA

ACI’s FCPA & Anti-Corruption for the Life Sciences Industry

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 Track Complete 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

UpperExtremity

0% 50% 100%

WGH

USA

Latin America

Japan

EMEA

Canada

BMTI

Asia / Australia

Completion of Health Care Provider Fee for Service Agreements by 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

Nu

mb

er o

f In

corre

ct R

esp

on

ses

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 13Q2 13Q3 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

Corrective and Preventative Action Committee

CAPA Input Sources

0

5

10

15

20

25

Investigations HCP SpendViolation 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’s FCPA & Anti-Corruption for the Life Sciences Industry

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 detection based on predefined indicators can help isolate risky transactions and 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

In t

ho

usa

nd

s

Vendor payment activity

What-if scenario

Trend Analysis

For illustrative purposes only

#ACIFCPA

Using text analytics to identify anomalous expenses 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