CCH Regulatory Notice

Cook County Health (“CCH”) is committed to providing the highest quality care and to engaging in research that leads the way to new treatments and technologies. One of the hallmarks of a high-quality organization is an effective compliance plan.

CCH conducts compliance reviews to evaluate the effectiveness of operational policies and procedures, and to identify areas where compliance can be improved.  In a review of clinical research processes, CCH identified billing errors related to the care provided to research volunteers.  CCH determined that proper controls were not put in place to ensure that government payers were not improperly billed for research care. Services that are improperly billed to Medicare and Medicaid can in some cases be considered false claims. While there was no indication that CCH knowingly billed improperly for the services provided to research patients, CCH has voluntarily self-disclosed these billing errors made between January 1, 2017 through January 1, 2023, in the amount of $300,917.43 to the Department of Health & Human Services Office of Inspector General (“OIG”) and intends to reimburse governmental payers consistent with the OIG’s expectations.

CCH’s highest priority is and always has been providing the highest quality care for the people of Cook County. CCH will continue to conduct routine and targeted compliance reviews to avoid and correct deviations from legal and regulatory requirements. We appreciate the support of our researchers and staff during the course of this review.

Over the past 18 months, CCH has been working to establish a new Clinical Research Office (“CRO”). The CRO has developed the necessary structure, protocols, and best practices to ensure a safe, compliant, and innovative clinical trial program. We are pleased to announce that all CCH principal investigators are currently undergoing training on these new protocols, and CCH will be able to pursue new clinical trials in short order. The same protocols will be applied to all ongoing CCH clinical trials. The CRO will enable CCH to continue to contribute to the future of medicine, expand access to groundbreaking care for all, and ultimately, grow our research program.