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Office of Inspector General (OIG)

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. Office of Inspector General (OIG). Separate Agency within HHS Inspector General Act of 1978 Mission:

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Office of Inspector General (OIG)

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

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

  3. HHS-OIG: The Basics • Over 1500 employees • Washington, DC headquarters • 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 • Hearing Testimony • OIG Work Plan • 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 • Work with Department of Justice (DOJ) • Represent HHS interests • Intervention/declination recommendations • Coordination within HHS

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

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

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

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

  10. Corporate Integrity Agreements • Typically, a 5-year term • 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 • 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 • Annual Board Resolutions • Certifications from Management Team

  13. Recommendations • 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 • 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 • Enhanced public trust • Improved public health • Business benefits

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