OIG periodically makes updates to its Integrity Agreement (IA) and Corporate Integrity Agreement (CIA) model language. It is important for healthcare organizations – even those not subject to a CIA – to monitor changes to OIG’s model agreements because changes to the template language reflect OIG’s evolving expectations concerning compliance program design and effectiveness. Over the past several months, OIG has made several revisions to its IA and CIA model language. These changes, among other things, signal an increased focus on the Compliance Committee’s role in core compliance functions and an increased focus on compliance controls designed to promote compliance with the Stark Law and Anti-Kickback Statute.

By way of background, OIG may negotiate a CIA or IA with healthcare providers, suppliers and other entities as part of the settlement of federal healthcare program investigations involving civil false claims authorities. Providers or entities agree to IA or CIA obligations, and in exchange, OIG agrees not to seek their exclusion from participation in federal healthcare programs.

IAs and CIAs have many common elements, but each one has components that are tailored to the specific facts at issue, including the alleged underlying conduct that resulted in the settlements. Many IAs and CIAs include requirements for audits by Independent Review Organizations (IROs), including Claims Reviews and Arrangements Reviews. Over the past several months, for at least some...

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