Evolving Expectations in Corporate Integrity Agreements.

For over 20 years, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has been informing the health care sector of the OIG’s Compliance expectations.

The OIG undertakes the following efforts:

• Issues Compliance guidance documents;
• Testifies before Congress regarding key findings;
• Publishes Semi-Annual Reports on OIG activities;
• Issues annual Work Plans;
• Promulgates “Safe Harbor” rules;
• Executes Advisory Opinions concerning the Anti-Kickback Statute;
• Negotiates Corporate Integrity Agreements;
• Produces podcasts on compliance topics; and
• Presents at the American Health Lawyers Association (AHLA), Health Care Compliance Association (HCCA), and other forums.

The OIG also publishes White Papers in conjunction with the AHLA to help individuals understand the OIG’s current position on Compliance.  The White Papers emphasize the OIG’s growing position of holding Boards accountable for proper oversight of Compliance within their organizations.

The OIG White Papers include the following:

• “An Integrated Approach to Corporate Compliance: A Resource for Health Care Boards of Directors”;
• “Corporate Responsibility and Corporate Compliance: A Resources for Health Care Boards of Directors”; and
• “Practical Guidance for Health Care Governing Boards on Compliance Oversight.”

These documents show that the OIG’s expectations and focus on Board accountability continue to evolve.  The OIG continues to modify CIA provisions to increase the oversight responsibilities and accountability of the individuals agreeing to settlement terms.  “Practical Guidance for Health Care Governing Boards on Compliance Oversight” explains the need for Boards to engage outside Compliance Experts.  To keep abreast of best practices, Compliance Officers should review the CIAs posted on the OIG website.

More recent CIAs include new and stringent requirements such as an increased use of certifications, mandates for Boards to engage Experts, annual Compliance Expert report filings, and an increased role for Independent Review Organizations.  The new certification requirements place a heavier personal burden on Boards, executives, and Compliance Officers, largely due to the potential for penalties.  CIAs often include a stipulated penalty for each day an organization is out of compliance with deadlines, and a $50,000 penalty for each false certification.  Further, false certifications may implicate the False Claims Act.  Compliance Officers should brief their Boards regarding the increased oversight responsibilities to ensure that Boards meet their obligations.