J. Veronica Xu, Esq., CHC, CHPC, CCEP, (veronica.xu@saberhealth.com) is the Chief Compliance Office with Saber Healthcare Group, headquartered in Cleveland, OH.
When people hear an organization is currently under a corporate integrity agreement (CIA), they often give a sympathetic sigh and say “Aw, sorry to hear that.” True, it is certainly not every organization’s goal to have a CIA in place, but when you have one, I think the best approach is to face it, learn from it, and make the best of it. Once you fully understand it, you may even start to appreciate it and find great partners and resources from it.
In this article, I will mainly focus on what the independent monitor’s (IM) responsibilities entail and what a long-term care (LTC) provider can do to build a positive relationship with its IM.
What is a CIA?
Many people are familiar with the term CIA, since it was introduced by the Office of Inspector General (OIG) within the Department of Health and Human Services (HHS) in the 1990s. CIAs are used as part of the civil settlement arrangement to resolve the allegations of fraud and abuse faced by healthcare providers. In exchange for the OIG’s agreement not to seek an exclusion of the healthcare provider from participation in Medicare, Medicaid, and other federal healthcare programs,[1] the provider consents to the obligations as part of the civil settlement. The objectives of these CIAs are to improve the quality of the care that healthcare organizations provide to patients and residents, and to promote compliance with laws and regulations:
A comprehensive CIA typically lasts five years and includes requirements to:
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Hire a compliance officer/appoint a compliance committee;
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Develop written standards and policies;
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Implement a comprehensive employee training program;
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Retain an independent review organization to conduct annual reviews;
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Establish a confidential disclosure program;
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Restrict employment of ineligible persons;
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Report overpayments, reportable events, and ongoing investigations/legal proceedings; and
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Provide an implementation report and annual reports to OIG on the status of the entity’s compliance activities.[2]
Whether your organization entered into a CIA with the OIG directly, or you inherited it through the acquisition of an entity that has one, you are required to comply with the obligations set forth therein, unless specified otherwise.
Other than the key elements of the compliance program, the specific requirements and obligations may vary slightly, because the CIAs are tailored to address certain issues identified in a particular setting, such as LTC providers, physicians groups, laboratories, pharmacies, etc. When a False Claims Act settlement resolves allegations of fraud that impact the quality of patient care, OIG may enter into a CIA with the provider. The CIA mandates that the provider retain an appropriately qualified monitoring team entity (the independent monitor) with clinical expertise to perform quality-related reviews.[3] The IM is selected by the OIG and will be responsible for assessing the effectiveness, reliability, and thoroughness of the provider’s systems and procedures.
