There are many people who can share their perspectives on negotiating a Corporate Integrity Agreement, all with a variety of backgrounds and experiences. Keep in mind each person involved will bring different perspectives and thoughts. I will share my perspectives today based on my participation in the negotiation process and then ultimately implementing a CIA after the negotiations.
I found it helpful to listen to everyone’s experience while our organization was going through this process. The more I could learn, the more I could contribute to the negotiation process. I hope you will find this blog helpful to you as well, should you find yourself in a similar situation.
The first place to start is making sure you have outside counsel who has familiarity with the Office of Inspector General (OIG) and the CIA negotiation process. This is important because the learning curve is too great and time is of the essence in a CIA negotiation, leaving no room for wasting money and time working with someone who hasn’t been at the table before. Like all negotiations, there is a process to be followed, so working with someone who can help educate you beforehand will help reduce your stress, frustration and likely temper your expectations. You should always be prepared with reasonable expectations before negotiations begin.
My next piece of advice is to include the Compliance Officer from day one. As a Chief Compliance Officer, I always strongly recommend that the Compliance Officer have a role during the negotiations. At the HCCA Compliance Institute in March, a member of the Office of Counsel to the OIG also indicated that she feels it is a “must” that compliance officers are included in the negotiations and discussions with the OIG. The Compliance Officer’s role can be varied, but they are a wealth of knowledge as it relates to your current compliance program and will likely be managing the new CIA, so the sooner they understand what it entails, the better off the organization will be.
Do Your Research
While you are waiting for counsel to schedule all the meetings you should begin your homework. Start by reviewing several recent CIAs from your industry. You will quickly learn that there are many components of the CIA that are “boilerplate” or a part of every CIA. Make sure you read several examples so you know what the template should look like.
Once you start reviewing the CIAs, you can begin making a grid or document which outlines the likely elements and any concerns you may have related to your organization being able to meet said requirements. This is very important! You will need to make sure counsel is aware of any concerns you may have early on in the negotiations. The OIG may not be able to remove the requirement but may be able to give you extra time to implement or provide you with more information so you can better understand the expectation and start preparing.
Timing is Everything
Another critical factor, but one that is often overlooked, is the timing of the execution of the CIA. Negotiations can often take 6 to 12 months to negotiate. So by the end, you simply want the negotiations over and to get started implementing the CIA. But a strong word of caution is to think about the long-term timing impacts. Timing might seem low on the priority list during negotiations, but take this into careful consideration.
If you were executing a CIA in early October, you might think that it feels like an acceptable time of year, until you realize all of the reports and items that are required to be completed within the first 90 to 120 days, and then annually thereafter.
Let me give you a few examples based on an executed CIA of October 1:
As I believe you can quickly see by the examples above, the timing of the execution of the CIA is very important. As much as you may wish to “get it all done” remember what the long-term timing impact may be on your compliance team and your organization.
Implementing a CIA is a very difficult task and one that requires a significant amount of support throughout the organization. Therefore, make sure that you set yourself up for success when negotiating the CIA terms. Take the time to include the right people at the negotiation table, review the terms to make sure you fully understand what is expected within the CIA and by all means, make sure you plot out the timing of the requirements. If you follow all of these steps, it may not be an enjoyable process but I believe you will be as prepared as you can to take the next step in this new compliance journey.
Good luck and remember, the ProviderTrust Integrity team is always here to help!
Donna Thiel is the Director of our Compliance Integrity team, a consulting division of ProviderTrust. Donna works with compliance officers across the country to help reduce the stress and anxiety of this very difficult role.