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The DOJ Releases Updated Compliance Program Guidelines

The U.S. Department of Justice (DOJ) Fraud Section has updated its Evaluation of Corporate Compliance Program guidelines. While the guidelines are not specific to healthcare, they can serve as an effective standard against which compliance staff could evaluate the efficacy of current compliance programs.

The updated guidelines include the following 11 major criteria for the compliance officer to evaluate compliance program: analysis and remediation of underlying misconduct, role and involvement of senior and middle management, autonomy of the compliance officers and their available resources, effectiveness of policies and procedures, utilization of risk assessment models, training of staff and communication with staff, the ability for staff to confidentially report compliance issues and the ensuing investigation’s independence, the use of incentives and disciplinary measures, evaluation of the compliance program and continuous improvement, testing and review, and behavior toward third-party management and during merger and acquisition.

While all the guidance could affect healthcare, one theme that seems to play heavily into the DOJ evaluation is the effectiveness of the reporting mechanism and the appropriateness of the corporate response to allegations or accountability lapses. The importance of substantive accountability measures that reach up to middle and upper management seems to be stressed.