1. Practice Makes Perfect: A Model for Better Practices for Compliance
Date
Practice Makes Perfect:
A Model for Better Practices for Compliance
*connectedthinking
PwC

2. Application of the Model to Typical Categories of Misconduct
Agenda
Developing Your Program - Understanding How Improper Activity Can Occur
Application of the Model to Typical Categories of Misconduct
The Role of the Compliance Department – Putting Yourself in the Right Position

3. When Does Improper Activity Occur?
A Risk-Based Approach
Incentive/Pressure
Attributes Contributing to Increased Risk
Size, complexity and ownership attributes of the Company
Type, significance, likelihood and pervasiveness of the risk
Conditions Generally Present
Incentive/Pressure
Reason to perform an improper act
Attitude/Rationalization
Character or set of ethical values that allow
a person to knowingly and intentionally commit an improper act
Opportunity
Circumstances exist such as the absence
of controls, ineffective controls or ability
for someone to override controls
that allow improper acts to occur
Attitude/ Rationalization
Opportunity
PwC

4. Payments and Inducements
Metrics Utilized Punish Compliance or Reward Non-Compliance
Customer pressures are not resisted
Incentive/Pressure
Attitude/ Rationalization
Opportunity
No business rationale required
Perfunctory management/Legal review/approval
No support required to demonstrate FMV
No proof of performance required
Customer purchasing/use history allowed in justification
Inadequate “tone at the top”
Poor DM/RM role models
Poor Training
“I need my job/bonus”
“It will help/won’t hurt the patient”
PwC

5. Pricing and Reimbursement
Metrics Utilized Punish Compliance or Reward Non-Compliance
Customer pressures are not resisted
Incentive/Pressure
Attitude/ Rationalization
Opportunity
Inadequate Review of Reimbursement Scripts
DM ride-along process does not look to use of ROI/other models or other warning signs
Poor pre-qualification and/or monitoring of third party vendors
Insufficient involvement of Legal/Compliance in Contracting process/”side agreements”
Inadequate “tone at the top”
Poor Training
“I need my job/bonus”
“It will make/keep the customer happy”

6. Advertising and Promotion
Metrics Utilized Punish Compliance or Reward Non-Compliance
Customer pressures are not resisted
Incentive/Pressure
Attitude/ Rationalization
Opportunity
Easy access to scientific information
Medical departments distanced from external communications
Compliance not involved in training
DM ridealongs do not address off-label/false claim risk/activities.
Loose controls over physician training
Inadequate “tone at the top”
Poor Marketing role models
Poor Training
“I need my job/bonus”
“It will help/won’t hurt the patient”
PwC

7. The Role of the Compliance Department
Business
Legal
“What is Right for the Product”
“What is Right…”
Compliance
Your Role
Be Involved and Fluent in the Business
Assess Risk
Consider the Improper Acts Contributing Factors (Opportunity, Incentive, Attitude)
Build the program to address the Risks while considering the Factors
Keep the Balance
Keep the Program Current

8. Question and Answer Jennifer Bragg, King & Spalding, jbragg@kslaw.com
John Bentivoglio, King & Spalding,
Peter Claude, PricewaterhouseCoopers,