Laura Ellis, HHS Office of Inspector General (OIG) Senior Counsel, has a reputation for managing the most difficult and complicated corporate integrity agreements (CIAs) on behalf of the OIG. At the recent Health Care Compliance Association (HCCA) Compliance Institute, she urged compliance officers not to sit on the sidelines while a CIA is being negotiated with the OIG. They should be actively involved in all facets of negotiation and should not wait to be involved until the agreement is signed and put into effect. She reminded everyone that once the CIA is signed, the compliance officer will be the face of the company to the OIG, not the attorneys. From years of experience, she has found attorneys negotiating terms and conditions of a CIA often don’t have the operational experience to fully understand all the implications of what is being committed to in terms and obligation. As a result, it is not uncommon for attorneys to come back to the OIG after a CIA has been executed to try to renegotiate points. This is triggered as result of management and the compliance officer realizing what is involved in meeting the terms and condition. Ellis stated that the OIG is not inclined to reopen CIA negotiations. The mistake was not having the compliance officer on the front end of negotiations and present during the negotiation process. As the CIA settlement process takes shape, the compliance officer needs to:
- be part of the negotiations;
- review and comment on all drafts;
- create a basic plan from the draft to determine what it takes to meet obligations;
- conduct a min-gap assessment of what it takes to do what the CIA would require;
- begin work on implementation strategies; and
- start the process to determine resource needs to meet obligations.
Ellis also made the point that attitude matters once a CIA is in place, and compliance officers should work with the monitor in an open and honest way. A positive working relationship between the monitor and the compliance officer is to everyone’s best interest. The earlier in the process that they get to know each other, the better.
Thomas Herrmann, J.D., was previously responsible on behalf of the OIG for negotiating CIAs and providing monitors, and subsequently gained many years of consulting experience working with more than a dozen clients with CIAs and as an independent review organization (IRO). He says that what many fail to understand is that, although the OIG is involved in the Department of Justice (DOJ) settlement process, a different OIG attorney will be assigned as negotiator for the CIA. Once the agreement is executed, it is passed on to a different OIG attorney to be the monitor to assure compliance with the terms of the CIA. A very common mistake is for attorneys to deal with issues handled by someone earlier in the process, or in effect, re-litigate. This is a big mistake. The OIG will not re-litigate or interpret decisions made by the DOJ. At the same time, the OIG monitor is definitely disinclined to deal with issues that were or should have been addressed with the OIG negotiator. Herrmann goes on to explains that the OIG views the organization’s legal counsel as filling an adversarial role, but once things are executed, the OIG does not want to continue dealing with the advocate. The focus of the relationship with the OIG should be on meeting the terms of the CIA. Herrmann sees it as a huge mistake for the legal counsel to continue making arguments or try to modify terms with the monitor, as this frequently leads to aggravation of matters and creates additional problems for the organization. The monitor wants to deal with how the organization will meet its obligations, and that means working with the compliance officer to determine how the terms and conditions of the CIA will be fulfilled. It behooves compliance officers to get to know their monitor as quickly as possible, evidence their commitment, and exhibit an attitude to work out what it takes to get the job done.
Carrie Kusserow has over 15 years’ compliance officer and consultant experience; in fact, she was brought in to be the compliance officer to an organization under a CIA while Laura Ellis was the monitor. Her experience with Ellis was precisely what Ellis explained during her presentation. Maintaining the focus on meeting the obligations of the agreement is very important for credibility and permits ironing out of issues. By listening carefully and responding to Ellis’ questions openly in a forthright manner, Kusserow developed a very good working relationship. This made work easier for everyone. Compliance officers need to listen carefully to what the monitor expresses, working as needed and then immediately following up to report actions taken. The focus must stay on getting the job done to the satisfaction of the OIG. It is also critical that the compliance officer at all times be “straight up” and honest with the OIG. If this is done, then a bond of trust can be developed that can iron out details that are sure to arise. This can permit seeking non-adversarial clarification of terms and conditions. On the other hand, failing to develop a proper working relationship with the monitor can result in lack of understanding and increased work for everyone. As such, as soon as the CIA is signed, the compliance officer should come into direct contact with the OIG monitor.
Suzanne Castaldo, J.D., has worked both as a litigator and compliance consultant dealing with numerous organizations with CIAs. She confirmed what Ellis noted about attorneys negotiating with the OIG without active involvement of either management or the compliance officer. In almost every case, it has created avoidable issues. She strongly recommends that anyone engaging a law firm to assist with CIA negotiations insist on including knowledgeable members of management and the compliance officer in all meetings with the OIG. All terms that are being negotiated should be reviewed and assessed by them to understand all implications and resulting work obligations. Many attorneys will not find this to their liking and may argue against it. However, not being part of this process reminds one of “arriving at the dance after it is over.”
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 © 2017 Strategic Management Services, LLC. Published with permission.