The Department of Health and Human Services (HHS) Office of Inspector General (OIG) is currently monitoring over 300 active Corporate Integrity Agreements (CIAs). In 2014, the OIG entered into more than 40 new CIAs with most of the agreements arising from the settlement of a civil false claims case with the Department of Justice (DOJ). The OIG’s objective for negotiating CIAs is to ensure that the identified misconduct (whether false claims, improper arrangements, misleading marketing, etc.) does not reoccur. The Office of Counsel to the Inspector General (OCIG) negotiates and monitors these agreements which usually last for a period of five years. Through the CIA, an organization must agree to and comply with defined obligations set forth in the CIA and in exchange, the OIG will not seek to exclude the organization from participation in Federal health care programs. It is advisable for any entity entering into negotiations with the OIG to review similar CIAs for terms and conditions.
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. Additionally, an OIG attorney is assigned to monitor compliance with terms of the CIA and is a different attorney from the one who negotiated the CIA. Each CIA contains some standard and some specific terms and conditions as well as “case specific” requirements that vary according the nature of the case.
Provide Evidence to the OIG
- Indicate why a CIA may not be needed.
- Address how the misconduct is being addressed by the current compliance program and internal controls.
- Explain current safeguards employed to ensure future integrity in Federal health care programs.
It is also advisable to assist the OIG in understanding and appreciating the organization’s business operations. It is important not assume the OIG’s fluency in how things actually function. Misunderstandings in this arena could aggravate the burden of CIA provisions. As an added precaution it is also important to remember that although the law firm that handled the litigation and/or settlement process may be highly qualified in evaluating application of the law, it may simultaneously lack expertise and knowledge of health care operations or appreciate the significance of what may be asked for in the CIA.
Common Mistakes May Aggravate CIA Conditions
- Do not continue to argue the case that has been settled by the court or with the DOJ. The OIG is not interested in re-litigating the case and this will set the wrong tone and risk aggravating the outcome of the CIA. It is far better to make a fresh start with a commitment by putting the problem behavior in the past and moving forward to reinstate good standing.
- Do not assume that the OIG attorneys negotiating CIA terms are familiar with the detailed facts of the DOJ case. Those who may have been deeply involved with DOJ are not the same individuals who develop CIAs and are not likely to have any knowledge beyond the court decision or settlement terms with the DOJ.
- Do not assume the OIG attorney has particular knowledge of the program manuals or Federal/State requirements related to the underlying case.
- Do not assume that the OIG attorneys understand operational issues associated with particular types of health care providers.
Negotiating CIA Terms
It is extremely important to ensure that no issue needs future clarification after the CIA is signed. The time to identify potential problems in a CIA is before its effective date. To avoid future problems and costs in negotiating CIA terms, conditions and requirements, it is important to ensure:
- Scope and breadth of the CIA is clearly outlined and defined.
- 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.
- Clear understanding of applicable government regulations and manual provisions.
- What is considered to be an “error” and acceptable “error rate”.
- “Substantial” overpayments are defined.
- Entity is ready, willing, and able to comply with everything being proposed.
- Understanding the full scope of work to be conducted by an IRO.
Once a CIA is agreed to by all parties, consideration should be given to undertaking a “mock” review in advance of the IRO. This will better prepare the organization to meet 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 a reduction of the CIA period.Subscribe to blog