The first thing you should do is realize that the clock is already ticking and you need to start preparing. There are many phases to implementing a Corporate Integrity Agreement (CIA) but Phase I actually starts before the CIA is even signed.
An important component of navigating a successful CIA is what happens before the CIA is executed. First and foremost, make sure the Compliance Officer is involved in all CIA discussions. All organizations should include the Compliance Officer in the CIA negotiations, or at least keep them apprised of each CIA draft as it is being negotiated.
A Compliance Officer is invaluable in understanding what the current compliance program looks like and determining the level difficulty or impossibility of implementing each CIA requirement. Ultimately, each requirement is approved from the OIG, but they will allow the organization to explain the challenges and perhaps get an implementation extension for that requirement or modification.
In some cases an organization may not have a compliance officer, or is looking to make a change. Recently, the OIG has stated that during CIA negotiations you should be making the determination as to whether or not you have the right person leading the compliance efforts. If the answer is no, then the CIA negotiation timeframe is the time to make that change, never after it has been executed and the stopwatch has started ticking. Hopefully you have the right person in the Compliance Officer role, and they can be a valuable resource during the negotiations.
As you are digesting the various CIA requirements, you need to get started putting together an implementation plan. A CIA contains many requirements and most are due within 90 to 120 days of the execution of the CIA; this may sound like a substantial amount of time, but from experience, I can tell you, time flies. A well thought out plan that is already underway when the CIA is executed will ensure that expectations are being met and you are prepared moving forward.
As you are putting the implementation plan together, one of the first questions which has to be asked is, "Do we have the necessary resources in the Compliance Department or organization to implement and successfully meet the CIA requirements?" If the answer is either "no" or "I don't know" you need to immediately start planning for additional staff. As we know, it typically takes a few months (at least) to hire new staff, not to mention the amount of time it will take to orient them to your organization and their role in CIA implementation, so plan accordingly.
When preparing your plan, don't forget to include a gap assessment to compare your current compliance program to the new CIA requirements. This gap assessment is integral to understanding where you may have initial challenges during the implementation phase and ongoing. This gap assessment is one of the key drivers of your implementation plan and resource needs. While reviewing your assessment, be honest with yourself in regards to the current level of compliance. This may be the only opportunity you have to build your compliance department to meet the OIG expectations of an effective compliance program.
And last but not least, how will you inform others about the CIA? Consider how soon you are communicating with your organization and what they should expect. Are you waiting until the press release comes out, or are you sharing information ahead of time and preparing for the initial impact of the announcement? I would suggest that providing some well-prepared talking points and discussion is extremely helpful if you have a large organization with multiple locations, centers, etc. You never know how the local media, referral sources, providers, or patients/families will react. Remember, a CIA isn't the end of the world - it provides an opportunity to resolve a government investigation, and move forward with continuing to focus on quality outcomes and an effective compliance program.
If you follow these steps, you are sure to make the CIA process much smoother and manageable. No plan is perfect, but start with the basics and you will be better prepared to succeed.
Written by Donna Thiel, Director of Compliance Integrity Team
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.
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