When a company has violated the law, it may enter into a Corporate Integrity Agreement (CIA) with the government as part of a settlement agreement. A CIA is a voluntary agreement that outlines certain actions a company must take to ensure compliance with regulations in the future.
The objective of a CIA is to hold a company accountable for its conduct and to ensure that it implements an effective compliance program. Government agencies, such as the Department of Health and Human Services (HHS) and the Department of Justice (DOJ), often require companies that violate regulations to enter into a CIA as a condition of settlement.
Corporate Integrity Agreements are tailored to fit the unique needs of each company. However, they typically contain several key provisions. Here are a few of the most common components of a CIA:
1. Appointment of a Corporate Compliance Officer (CCO)
A CIA will typically require the company to appoint a CCO responsible for monitoring and reporting to the government on the effectiveness of the company`s compliance program.
2. Establishment of a Compliance Program
The CIA will require the company to establish and maintain an effective compliance program. This will include written policies and procedures addressing specific areas of risk and training for relevant employees.
3. Implementation of a Risk Evaluation and Monitoring Program
The company must develop and implement a risk evaluation and monitoring program to identify, evaluate, and mitigate any compliance risks. This program should also include internal audits and reviews to ensure compliance with the CIA.
4. Implementation of a Reporting Program
The company must establish and maintain a reporting program to receive and address compliance concerns and complaints.
5. Government Review and Approval
The CIA will require the company to submit periodic reports to the government outlining its compliance efforts and progress. The government will review and approve these reports and may conduct periodic audits to ensure compliance with the CIA.
If a company fails to comply with the terms of the CIA, it may face additional fines or penalties or even potential exclusion from government programs, such as Medicare.
In conclusion, a Corporate Integrity Agreement is a tool used by the government to hold companies accountable for their actions and to ensure that they implement effective compliance programs to prevent future violations. Companies that enter into a CIA must take their obligations seriously and work diligently to comply with all of the requirements outlined in the agreement. Failure to comply can have serious consequences, including further penalties and exclusion from government programs.