On April 30, 2019, DOJ’s Criminal Division announced the release of an updated version of guidance previously issued in February 2017 regarding the evaluation of corporate compliance programs (Revised DOJ Compliance Guidance). The Revised DOJ Compliance Guidance is designed to assist prosecutors in making decisions with respect to: (1) the form of any resolution or prosecution, (2) monetary penalties, if any, and (3) compliance obligations contained in any corporate criminal resolution, such as monitorship or reporting obligations. The release of the Revised DOJ Compliance Guidance illustrates the enforcement community’s continued focus on and increasing expectations regarding compliance program effectiveness for many industries including healthcare.

DOJ continues to reiterate key themes from prior DOJ and OIG guidance relating to compliance program effectiveness. For example, the Revised DOJ Compliance Guidance emphasizes the importance of compliance culture and the tone set by senior leadership and Board members. The Revised DOJ Compliance Guidance also highlights the need for the Compliance Department to be appropriately resourced and positioned within the organization.

However, DOJ made changes to the organization and format of the guidance. Specifically, DOJ restructured the guidance to be organized around the following three “fundamental questions:”

• Is the corporation’s compliance program well designed?
• Is the program being applied earnestly and in good faith? In other words, is the program being implemented effectively?
• Does the corporation’s compliance program work in practice?

In accordance with this framework, the first section of the Revised DOJ Compliance Guidance discusses various hallmarks of a well-designed compliance program relating to risk assessment, company policies and procedures, training and communications, confidential reporting structure and investigation process, third-party management, and mergers and acquisitions. The second section details the features of effective implementation of a compliance program, including commitment by senior and middle management, autonomy and resources, incentives and disciplinary measures. The third and final section discusses metrics of whether a compliance program is in fact operating effectively, exploring a program’s capacity for continuous improvement, periodic testing and review, investigation of misconduct, and analysis and remediation of underlying misconduct.

The Revised DOJ Compliance Guidance also provides additional context regarding the importance of specific aspects of compliance programs and DOJ’s expectations for an effective compliance program.

To view DOJ’s announcement, click here. To review the revised DOJ Compliance Guidance, click here.