Kusserow’s Corner: Tips on Negotiating a Corporate Integrity Agreement

Corporate Integrity Agreements (CIAs) are a common feature in today’s health care sector with the OIG currently monitoring over 300 active ones. The OIG’s objective for negotiating a CIA is to ensure that the identified misconduct (e.g., false claims, improper arrangements, misleading marketing) is remedied and does not recur. Most arise from a settlement of a civil false claims case with the DOJ. They are negotiated and monitored by the OIG Counsel’s Office for usually for a period of five years. The organization consents to defined obligations of a CIA in exchange for the OIG not seeking an exclusion 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. An OIG attorney is assigned to monitor compliance with terms of the CIA. This attorney is different from the one who negotiated the CIA. There are some standard terms and conditions, as well as “case specific” requirements, as well as specific terms and conditions that vary according the nature of the case.

Goals for Negotiating a CIA

There are a number of goals for negotiating a CIA, including:

  1. Try to provide evidence to the OIG that a CIA is not needed.
  2. Provide evidence that the misconduct is being addressed by the current compliance program and internal controls.
  3. Provide convincing evidence that current safeguards ensure future integrity in Federal health care programs.
  4. Help the OIG understand and appreciate the business operations; and not assume fluency in how things work.

The law firm that handled the litigation and/or settlement process may be highly qualified in evaluating application of the law, but lack expertise and knowledge of the details of health care operations. In such cases, they may not appreciate the significance in what may be asked of their clients. It is advisable to have on hand a subject matter expert to assist legal counsel in ensuring:

  1. Terms and conditions under the CIA are clear and the scope of the IRO are well defined; and
  2. Full understanding of the implications of the commitments under the CIA.

Common Mistakes to Avoid

There are a number of mistakes in negotiating a CIA that can lead to aggravation of the terms and conditions. It is a mistake:

  • To continue arguing the case that has been settled by the court or with the DOJ. The OIG attorney is not interested in this line of reasoning and trying to re-litigate the case 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 to put the problem behavior in the past and move forward to reinstate their good standing.
  • To assume that the OIG attorneys assigned to develop terms of a CIA 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 DOJ.
  • To assume the OIG attorney has particular knowledge of the program manuals, Federal/State requirements related to the underlying case.
  • To believe the OIG attorneys understand operational issues associated with particular types of health care providers.

Negotiating CIA Terms 

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, 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 organization can evidence full compliance with the terms of the CIA in the first year, they are in a better position to ask for a reduction of the CIA period after a couple of IRO review reports.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2013 Strategic Management Services, LLC. Published with permission.