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August 15, 2022

Health Headlines– August 15, 2022


OIG Updates its Corporate Integrity Agreement Model – 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 healthcare organizations, OIG appears to have revised certain requirements in its IA and CIA model language. Examples of recent changes include: 

  • Arrangements Requirements for CIAs Without Arrangements Reviews: Historically, CIAs that did not include IRO Arrangements Reviews would not have explicit references to compliance obligations related to the Stark Law and Anti-Kickback Statute. New CIAs include arrangements-related requirements for policies and procedures and risk assessments, even for CIAs that do not include IRO Arrangements Reviews and the underlying settlement does not appear to include arrangements allegations.
  • Compliance Committee Responsibilities: Prior CIAs state the Compliance Committee shall support the Compliance Officer in fulfilling his/her responsibilities. New agreements assign the Compliance Committee specific oversight over key CIA elements including policies and procedures, training, and the risk assessment.
  • Compliance Officer Job Duties: Prior CIAs state that any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in the CIA. Recent CIAs take a more targeted approach, stating that the Compliance Officer shall not have any noncompliance job responsibilities that, in OIG’s discretion, may interfere or conflict with the Compliance Officer’s ability to perform the duties outlined in the CIA.
  • Requirement to Screen State Medicaid Lists: Historically, OIG has focused specific CIA screening requirements on the HHS/OIG List of Excluded Individuals/Entities (LEIE), and several years ago also included SAM.gov screening requirements. Recent agreements also explicitly require screening of “state Medicaid program exclusion lists that are publicly available.”
  • Transition Plan: OIG added new language to certain CIAs regarding a “transition plan” requirement that addresses whether and how the company’s compliance program will continue to include the compliance program requirements set forth in the CIA following the end of the CIA’s term.

King & Spalding will be hosting a Roundtable this fall to discuss in more detail OIG’s changes to its IA and CIA language and what this means for compliance program expectations. An invitation is forthcoming.

OIG CIAs and IAs are available here.

Reporters, Lauren S. Gennett, Atlanta, + 1 404 572 3592, lgennett@kslaw.com, and Isabella E. Wood, Atlanta, + 1 404 572 3527, iwood@kslaw.com.  

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