The Third Annual Medical Device Regulatory Reimbursement and

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways To Protect Your Company Robert S. Litt Arnold & Porter LLC

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Legal as Input Or Why is a Lawyer Like an Insurance Policy? 1

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company One: Have a Real Compliance Program Show Your Commitment to Law, Don’t Tell It 2

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company DOJ: “A truly effective compliance program. . . may result in a decision to charge only the corporation’s employees and agents. ” 3

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company OIG: “A good faith effort by the company to comply. . . demonstrated by an effective compliance program, significantly reduces the risk of unlawful conduct and any penalties that result from such behavior. ” 4

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Training, Supervision and Discipline 5

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Two: Separate Science and Sales Safety Counts! 6

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Three: Sometimes the Envelope Breaks if You Push Too Hard 7

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Four: Investigate and Remediate 8

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Five: To Cooperate or Not To Cooperate? 9

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Six: Don’t Say Too Much Too Soon 10

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Seven: The Cost of Saving Your Company: • Throwing Culpable Individuals Overboard • Deferred Prosecution/Corporate Integrity Agreement • Monitor 11

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Seven Ways to Protect Your Company Resources: DOJ Mc. Nulty Memorandum: http: //www. usdoj. gov/dag/speeches/2006/mcnulty_memo. pdf DOJ Memo on Monitors: http: //www. usdoj. gov/dag/morford-useofmonitorsmemo-03072008. pdf HHS OIG Guidance on Compliance (Pharma): http: //oig. hhs. gov/authorities/docs/03/050503 FRCPGPharmac. pdf Recent Medical Device Criminal Settlements: can be found at http: //www. usdoj. gov/usao/nj/press/2007 releases. html, 9/27/07 releases 12