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

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

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

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

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”

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

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

Question and Answer Jennifer Bragg, King & Spalding, jbragg@kslaw.com John Bentivoglio, King & Spalding, jbentivoglio@kslaw.com Peter Claude, PricewaterhouseCoopers, peter.claude@us.pwc.com