Blog Post

Corporate Integrity Agreements Provide Insight Into Compliance Priorities

Richard P. Kusserow | June 2023

CIA terms pinpoint OIG compliance priorities

At any given time, over 300 OIG CIAs are in force, with more being added each year, whereby organizations agree to terms and conditions to avoid potential exclusion from participation in Federal health care financed programs. These agreements have the purpose of ensuring those organizations that violated the law will operate in compliance in the future. Over the years, the terms and conditions have evolved. CIAs are contractual agreements committing the affected party to undertake a defined set of legally enforceable compliance obligations. Mandates in various CIAs today depend upon the nature of the issues that led to the settlement. However, with few exceptions underlying violations that lead to CIAs are related to the Anti-Kickback Statute (AKS), whereby claims submitted arising from a corrupt arrangement are considered potentially false and fraudulent under the False Claims Act (FCA). These CIAs are useful for Compliance Officers as they highlight and identify what the OIG considers critical for compliance programs and provide useful insight into what should be examined internally. The following are some of the most common requirements cited in CIAs that many have used in internal compliance monitoring:

  1. Compliance Program must evidence effective application of all seven standard elements.
  2. No employment/contracting of excluded parties.
  3. Disclosure of any investigation of any potential violation of law or regulation.
  4. Ensuring written guidance addresses and promotes compliance.
  5. Engaging in focused arrangement reviews.
  6. Establishing and maintaining an Arrangements Database
  7. Targeting compliance education and training to include FCA, AKS, and Stark laws.
  8. Evaluating claims processing to determine error rates.
  9. Repaying identified overpayments within 30 days.
  10. Being kept aware of any changes in business locations or status.
  11. Active board compliance involvement and oversight of the compliance program.

Other terms and conditions are warnings to organizations that fail to have effective compliance programs. These include having certifications/attestations by board members, CEOs, executives, & Compliance Officers that the compliance program is effective; and where they find the board was unable to provide adequate oversight they had to engage a Compliance Expert to assist with compliance program reviews so that they can properly attest to its operation. CIAs have also over the years increased the role and scope of the Independent Review Organization (IRO).

Giving consideration to the consequence of the government finding failure of a compliance program for preventing wrongful and illegal activity, Compliance Officers should consider having an independent Compliance Program Effectiveness Evaluation that addresses all the points noted in this blog.

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About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.

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