Updated Corporate Integrity Agreement Language

OIG’s Revised Model Corporate Integrity Agreement

The OIG made material changes in its standard Corporate Integrity Agreement (CIA) that provide guidance to voluntary compliance programs. The first CIA to include the new language was entered in August 2022. Material changes encompass the following items.

? Compliance Officer Role. The OIG strengthens language directing that compliance officers shall not have any noncompliance job responsibilities that may interfere or conflict with their ability to perform duties under the CIA. The change in language addresses OIG’s concern that compliance officers are seeing “intensive job creep” and being asked to perform duties that are not normally included in compliance roles, e.g., legal counsel, contract negotiation, clinical oversight duties, medical review and administrative appeals, internal audits.

? Compliance Committee Responsibilities. The OIG expanded language to set forth specific duties of the Compliance Committee (CC) which should include active participation by senior leaders. The new language requires that CCs review compliance policies and procedures on an annual basis, review training plans annually, be involved in implementation and oversight of the risk assessment and internal review process, and be involved in the development and implementation of a transition plan as the CIA concludes. Two best practices communicated are CEO participation in the CC and CC meeting attendance as a factor in performance reviews, e.g., bonuses tied to attendance.

? Risk Areas for Claims Review. Organizations in a CIA will submit an annual proposal to the OIG with higher risk areas identified by the organization’s risk assessment. Those higher risk areas will be considered for inclusion in the required claims review conducted by the Independent Review Organization (IRO). Claims review was also expanded to certain other provider types in their CIAs in addition to hospital CIAs.

? Overpayment Calculation. A significant change in CIA claims reviews involves calculation of overpayment refund amounts. OIG will now permit IROs to calculate the net overpayment by subtracting underpayments from overpayments in the claims review sample. The error rate is then used to extrapolate an actual overpayment amount the CIA will require the organization to refund. This process is in additional to any CMS decision on whether overpayments are satisfactorily repaid. The IRO audit team must now include a physician qualified to perform medical necessity reviews, since medical necessity is now a standard element in all CIA claims reviews.

? Transition Plans. Organizations are required to submit a transition plan as the final CIA year begins. The transition plan covers one or more years after the end of the CIA to try to prevent the organization from neglecting the compliance program built during the CIA. If misconduct occurs in organizations during or subsequent to their first CIA, the OIG has begun adding a higher monitoring level in the form of an independent monitor with more access to more documents and with investigative power.

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Source: Biotronik, Inc. Corporate Integrity Agreement (hhs.gov)