A Corporate Integrity Agreement (CIA) is a document that describes the obligations that a company working in the health sector in the United States performs with a federal authority or a state government under a civil scheme. At the federal level, the office of the Inspector General of the Department of Health and Justice Services and the Department of Justice are generally involved and, at the state level, the attorney general and state offices participating in Medicaid or Medicare are involved.  This article contains public domain material from the U.S. Department of Health and Health Services document: Corporate Integrity Agreements Snapshots (PDF). Call on April 14, 2018. i"Corporate Integrity Agreements." Work plan Reports and publications Inspector General U.S. Department of Health and Human Services. Available at: oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp. The CIA can be used to address issues of quality of care or corporate integrity.  Some CLAs require an independent organization to verify and monitor compliance with CIA conditions. Most CLAs require harm checks to identify errors and their underlying causes.
 The government authority can verify compliance through on-site visits.  If a company violates the agreement, the Agency can fine it and, if the problems cannot be resolved, the supplier may be excluded.  Managing the requirements of a CIA is never an easy task; it requires considerable human and financial resources to be able to successfully meet all its obligations. The first decisive step is to select the right IRO, as the company will work closely with this group of experts during the five years of the CIA. The lack of selection of an IRO with industry knowledge and experience of the IRO or surveillance could lead to a difficult relationship between the company and the IRO and a considerable increase in costs. Before the start of the IRO, the company and the IRO must agree on a work plan. The work plan should be as detailed as possible and include verification, evaluation, relevant systems and transaction control accounts. The protocols should be adapted to the themes outlined by the CIA.
When negotiating the work plan, the company must ensure that it has the resources to meet the requirements that the IRO imposes on the company and its employees, including in relation to the production of documents and staff interviews. While it is important for the company to be cooperative with the IRO, it must also ensure that it has the resources to meet the requirements of the work plan. On June 30, 2020, The Novartis Corporation entered into a Company Integrity Agreement (CIA) with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS). The IRO and its specialists must have a thorough understanding of life sciences and the pharmaceutical/biotech industry, and in particular federal health programs, rules and regulations. They must also be aware of the requirements that a CIA imposes on a company. Ideally, the IRO should have a mix of professionals with backgrounds such as compliance professionals, medical accountants and accountants, investigators, lawyers with previous government experience, professionals with internal experience, etc.