ABSTRACT
This chapter focuses on the regulatory and administrative framework under which an effective and compliant Clinical Co-Management Agreement (CCMA) is developed. It addresses the legal considerations and policy concerns that impact a CCMA. The federal fraud and abuse laws include the Ethics in Patient Referrals Act, the Anti-Kickback Statute, and the Civil Monetary Penalties Law. The risk of sanction under these regulatory schemes is exacerbated by the fact that neither CMS, the enforcement agency behind the Stark Law, nor the OIG, the enforcement agency behind the AKS and CMP, has published definitive guidelines on how CCMAs should be structured. Compensation for management services creates a financial relationship, so the CCMA must fall within a Stark exception, otherwise their referrals to the hospital could be viewed as suspect. Compensation from CCMAs for management services and meeting certain benchmarks triggers the law because, if structured incorrectly, a CCMA could appear to be a mechanism to pay for referrals under the Anti-Kickback Statute.
