How Does A Corporate Compliance Program Differ From A Corporate Integrity Agreement

As a general rule, there are both 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. In addition to the sanctions, a provider may be excluded from participating in federal health programs because of a “substantial violation” by the CIA. This power of exclusion is contractual, not imposed by law. A significant violation is generally defined as one of three things: (1) failure to report a substantial default, corrective action and appropriate reimbursements; (2) repeated or flagrant violations of CIA provisions; or (3) does not respond to a letter of formal notice after defined sanctions. A supplier receives a substantial infringement notification and generally receives 30 days to remedy these essential violations. All treatment must be carried out to the satisfaction of the OIG that the supplier complies with the rules. If the supplier does not re-issue the essential infringement, the OIG may send a notification to the supplier and exclude the provider from participation in federal health programs with effect of 30 days from termination.

The supplier may challenge the exclusion by the contractual dispute resolution remedy. “Depending on the underlying behavior, you will often have an obligation to have the so-called “IRO,”” Holden says. It is an independent auditing body, often an audit firm, that is required to review the business of the company. “This may include monitoring a sample of accounts or examining physical relationships. Then they present this to the OIG as a work in its own right,” he says. Although the CIA has common elements, each agreement is tailored to the case and attempts to integrate existing voluntary compliance programs.