1. The Role of the HHS Office of Inspector General Summit on Disclosure, Transparency, and Aggregate Spend March 5, 2009 Mary E. Riordan, Office of Counsel to the Inspector General

2. Office of Inspector General (OIG) Separate Agency within HHS Separate Agency within HHS Inspector General Act of 1978 Inspector General Act of 1978 Mission: Mission:  Promote economy, efficiency in HHS programs  Prevent, detect fraud and abuse in HHS programs

3. HHS-OIG: The Basics Over 1500 employees Over 1500 employees Washington, DC headquarters Washington, DC headquarters Components of particular interest: Components of particular interest:  Office of Evaluations and Inspections (OEI)  Office of Audit Services (OAS)  Office of Investigations  Office of Counsel

4. Relevant OIG Work Reports by OEI, OAS Reports by OEI, OAS Hearing Testimony Hearing Testimony OIG Work Plan OIG Work Plan Fraud and Abuse Work Fraud and Abuse Work OIG website: www.oig.hhs.gov

5. OIG Role in False Claims Act Cases Increasing numbers of False Claims Act (FCA) cases against drug and device manufacturers Increasing numbers of False Claims Act (FCA) cases against drug and device manufacturers Work with Department of Justice (DOJ) Work with Department of Justice (DOJ)  Represent HHS interests  Intervention/declination recommendations  Coordination within HHS

6. OIG Role in Settlement of False Claims Act Cases Signatory on behalf of HHS Signatory on behalf of HHS Resolution of Exclusion Issues Resolution of Exclusion Issues Negotiation of Corporate Integrity Agreements (CIAs) Negotiation of Corporate Integrity Agreements (CIAs)

7. Authority for Exclusions Section 1128 of the Social Security Act (42 U.S.C. § 1320a-7) Section 1128 of the Social Security Act (42 U.S.C. § 1320a-7) 42 C.F.R. Part 1001 42 C.F.R. Part 1001 Other authorities, e.g., CMPs Other authorities, e.g., CMPs Independent of DOJ Independent of DOJ

8. Exclusions: Mandatory and Permissive Mandatory- 42 U.S.C. § 1320a-7(a) Mandatory- 42 U.S.C. § 1320a-7(a) Permissive- 42 U.S.C. § 1320a-7(b) Permissive- 42 U.S.C. § 1320a-7(b) Applies to Indirect Providers (including Drug and Device Manufacturers) Applies to Indirect Providers (including Drug and Device Manufacturers)

9. Corporate Integrity Agreements Generally required if exclusion waived Generally required if exclusion waived Our Principle: continued participation in HHS programs with appropriate controls Our Principle: continued participation in HHS programs with appropriate controls Considerations: Considerations:  Nature of underlying conduct  Potential for future risk  Effectiveness of compliance program

10. Corporate Integrity Agreements Typically, a 5-year term Typically, a 5-year term Requires several measures, including: Requires several measures, including:  Compliance Officer/Committee  Code of Conduct/Written Policies  Training  Audits  Reports to OIG

11. “Enhanced” CIA Provisions Requirements Designed to Increase Transparency Requirements Designed to Increase Transparency  Notification of HCPs about settlement  Posting of Payment Information on Manufacturer’s website  Broad Definition of “Payments”  Interplay with Federal Legislation

12. “Enhanced” CIA Provisions Requirements Designed to Increase Accountability Requirements Designed to Increase Accountability  Annual Board Resolutions  Certifications from Management Team

13. Recommendations Support/Embrace Transparency Support/Embrace Transparency  Comprehensive Commitment to Transparency  About detailing relationships with HCPs  About consulting/contractual arrangements  About research activities  About educational activities  About publication activities

14. Recommendations Support/Embrace Transparency Support/Embrace Transparency  Establish systems and processes to collect and aggregate payment information  Make payment information publicly available  Post research results  Post grants information

15. Potential Outcomes? Better compliance with law Better compliance with law Enhanced public trust Enhanced public trust Improved public health Improved public health Business benefits Business benefits