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At any given time, the Department of Health and Human Services Office of Inspector General (OIG) is monitoring over 300 active Corporate Integrity Agreements (CIA). Many CIAs arise from a DOJ civil False Claims Act case. CIAs are intended to guard against future misconduct (e.g., false claims, improper arrangements, misleading marketing). The Office of Counsel to the Inspector General negotiates and monitors these agreements that are usually for a period of five years. An organization consents to defined obligations in the CIA in exchange for the OIG not seeking an exclusion from participation in federal health care programs. There are some standard terms and conditions, as well as “case specific” requirements that vary according the nature of the case. However, CIAs generally require the organization to retain an Independent Review Organization (IRO) to conduct specified reviews (e.g., systems, arrangements, transactions, claims, marketing, and expenditures reviews) to ensure compliance with the terms of the agreement. In some cases, there is also a mandate for an organization’s board of directors to engage a Compliance Expert to assist them in their compliance certifications. A separate OIG attorney then monitors compliance with the CIA’s terms.
10 CIA Negotiation Tips
- Organizations should be prepared to evidence to the OIG that a CIA is not needed because the issues identified in the CIA are being addressed by the current compliance program and internal controls. The current safeguards should ensure future integrity in federal health care programs to prove this.
- Leadership should assist the OIG in understanding and appreciating the business operations and not assume their fluency in how things function. The OIG’s misunderstandings could lead to aggravated CIA mandates.
- Those negotiating the CIA should be aware that the law firm handling the litigation and/or settlement process may be highly qualified in application of the law but may lack expertise and knowledge of health care operations or appreciate the significance of certain CIA requirements.
- Organizations cannot assume that the OIG attorneys negotiating the CIA terms are familiar with the facts of the DOJ case; those OIG individuals that were involved with the DOJ are not the same individuals who develop CIAs. Thus, the OIG attorneys are not likely to have any knowledge beyond the court decision or settlement terms with the DOJ.
- The OIG is not interested in re-litigating the case during CIA negotiations. Attempting to do so will set the wrong tone and risk aggravating the outcome of the CIA.
- Organizations should follow OIG’s advice and have their compliance officer be part of the negotiating process to ensure everyone understands the terms and consequences of the CIA. Also, once the CIA is signed, the OIG does not wish to hear from the attorney. The compliance officer should maintain contact with the OIG.
- Compliance officers should focus on making a commitment to put the problematic behavior in the past to reinstate their good standing.
- It is extremely important that no issue is left for future clarification after the CIA is signed. The time to identify potential problems in a CIA is before it is signed. To avoid future problems and costs in negotiating CIA terms, conditions, and requirements, organizations should ensure that:
- The scope and breadth of the CIA is clearly outlined and defined;
- All parties have a clear understanding of what is expected to evidence compliance with CIA terms;
- All terms and conditions are studied and understood;
- All “covered persons” and “relevant covered persons” are defined;
- There is a clear understanding of applicable government regulations and manual provisions;
- An “error” and acceptable “error rate” are defined;
- “Substantial” overpayments are defined;
- The entity is ready, willing, and able to comply with everything being proposed; and
- There is an understanding of the full scope of work to be conducted by an IRO.
- Organizations should move quickly to identify qualified candidates for the IRO and compliance expert functions. The more experience an organization has doing this type of work the better, as it evidences understanding of what is needed and this will project higher credibility to the OIG. Also, organizations should reference check candidates with past clients who used them as their IRO or compliance expert.
Once a CIA is agreed to by all parties, organizations should consider having a “mock” review in advance of the IRO review. If the IRO reports can evidence full compliance with the terms of the CIA in the first year, the organization is in a better position to make a case for reducing the CIA period.