Negotiating Corporate Integrity Agreements: The Compliance Officer’s Role

1. Negotiating Corporate Integrity Agreements:The Compliance Officer’s Role Chris Anderson Chief Compliance Officer Gentiva Health Services

2. Look at the case elements Self Disclosure Qui Tam “Industry” Audit Hot Investigative Topics Billing Coding/ Procedures Sales Practices Pricing Schemes Utilization Trends Reliance by OIG on Integrity Agreements CIA’s moving towards “punitive assurances” Boiler plate agreements are moving towards customization Length of time increases Adds perhaps significant cost to “true settlement figure” CIA Preparation

3. Understand Your Case • Most, if not all, companies significantly utilize outside resources for internal or “shadow” audits. • Lag time between initial discovery/ investigation and settlement is typically lengthy. • Compliance Officer should take case points and ensure adequate internal systems are in place and proven prior to negotiation of a CIA.

4. Research Existing CIA’s • Understand what similar organizations have faced in final CIA. • Take advantage of professional networking to help determine negative impacts. • One constant: All CIA’s take a toll on financial and human resources regardless of existing compliance efforts.

5. Prepare Senior Leadership • Understand Senior Management’s negotiation temperament. • Quick Settlement • Protracted Discussions • Begin to define initial costs and work to keep or reduce cost level during negotiation. • Re-evaluate compliance program to ensure internal mechanisms are sufficient.

6. Negotiation- Part I • Involve Compliance Officer with direct OIG communications from the start. • Compliance Officer should constantly represent existing compliance program • Focus on proactive processes relating to issue that gave rise to investigation. • Show how processes have been effective in real terms. • Work to move the focus from standard requirements to existing effective internal processes. • Minimize reliance on IRO audit- Use internal resources as much as possible.

7. Negotiation- Part II • After drafts have been exchanged, work with senior management to better determine what is palatable and what must continue to be negotiated. • Regardless of negotiation position, the effectiveness of existing compliance efforts will generally be recognized. • Use counsel to better gauge soft and hard points. • Clarify or eliminate broad language or cumbersome verbiage. • Keep focus on issues that gave rise to investigation.

8. Negotiation- Part III • Take full advantage of whatever compliance resource available to demonstrate the need to mold the CIA to fit your compliance program. • Training, auditing systems, active and closed cases, etc. • Move IRO review to mirror existing internal review process. • Make sure timeframes for reports are realistic for your organization. • Implementation Report • Annual Report • Audit Period

9. Make an opportunity to meet with the OIG’s CIA Monitor that will be assigned to your CIA. Quickly determine and factor costs of implementation and on-going monitoring. Annotated CIA invaluable to compliance officer’s implementation of the Agreement. Prior to CIA finalization, review drafts to see where you went. Work with counsel and OIG to clearly address any unclear items. The negotiation team is not the same as the monitoring group- Leave no stone unturned. You have to run the CIA… Final Discussions