A corporate integrity agreement (CIA) is negotiated with a health care provider or health organization. This type of agreement is part of a regulation of federal health program investigations arising from false claims laws. In exchange for the agreement, the OIG agrees not to exclude the provider or agency from participating in federal health programs. The implementation and supervision of the CIA requires considerable human and financial resources. All types of organizations and providers may be affected, including pharmaceutical companies, medical technology companies, hospitals, care homes and long-term care centers and medical practices. The CIA contains provisions allowing the OIG to sanction companies for non-compliance with the terms of the contract. CIAs typically have a penalty of $2,500 for each day the company does not meet the requirements. The CIA can be used to address issues of quality of care or corporate integrity.  It is important to note that the OIG does not select the IRO. In addition, they do not give advice on how to select one, nor support the organizations that are supposed to be the IRO. It is entirely up to the entity or supplier to determine the most appropriate organization that should be engaged as an IRO. However, the OIG reserves the right to approve or reject the decision of the companies or IRO supplier within 30 days of the OIG`s written notification of the identity of the IRO. Typically, companies such as consultants, accountants (CPAs) or law firms are responsible for carrying out these tasks.
While most health organizations that have transaction agreements with the DOJ have spent a great deal of time, effort and money reaching an agreement, they have given little thought to the process of selecting an IRO that needed to be approved by the IG. In many cases, this has led to further problems and aggravations. The following discussion is intended to help any organization facing the prospects of a CIA think about how to find and select a qualified IRO. In recent years, the Office of Inspector General (OIG) has “adapted” Corporate Integrity Agreements (CIAS) to target and prevent misconduct that has served as the basis for billing an organization or individual with the federal government. Some of these specialized CIAs are highlighted below: There are usually on-site components and offsite components for the work of an IRO. On site, it is important to work to know first-hand how the business works. However, in cases where the necessary documents can be made available to the IRO in an appropriate and effective manner without consulting the supplier`s website, most of the IRO`s work can be done off-site. As a general rule, in a five-year CIA, where the GCG requires the maintenance of an IRO, it is stipulated that the IRO conducts a system or arrangement review for the first and fourth year.
In addition, the IRO is required to conduct an annual review of claims, transactions or expenses. The IRO reviews are designed to assess program operations that had weaknesses that led to problems resolved by a transaction agreement. 1 – See 42 U.C 1320a-7a; No. 1320a-7 (b) (7). 2 – The OIG has published a series of compliance program guidelines for different health care providers and applicants. A detailed list of these OIG compliance programs can be find on the OIG website: oig.hhs.gov/ fraud/complianceguidance.html.