DOJ and Corporate Compliance Program Risk Assessment

Why This Topic Matters

Organizations that participate in federally regulated healthcare programs need to understand how compliance programs are reviewed and what elements prosecutors may examine. The article helps readers assess whether their compliance framework, policies, and risk-management process are aligned with DOJ expectations.

Article Sections

1. Risk Assessment

   Introduces the role of risk assessment in evaluating a compliance program and discusses broad factors prosecutors may consider when reviewing a company’s risk profile.

2. Risk Management Process

   Frames questions about how an organization identifies, analyzes, and addresses risks and how information or metrics support the compliance program.

3. Risk-Tailored Resource Allocation

   Explores the general concept of directing attention and resources to higher-risk areas within a compliance program.

4. Updates and Revisions

   Covers the importance of reviewing risk assessments and updating policies and procedures over time.

5. Policies and Procedures

   Discusses DOJ expectations for compliance policies and procedures, including their design, accessibility, operational integration, and oversight.

6. Design

   Addresses the process for creating and implementing policies and procedures and the types of internal participation involved.

7. Comprehensiveness

   Focuses on the breadth of policies and procedures and their relationship to the organization’s evolving regulatory environment.

8. Accessibility

   Covers how policies and procedures are communicated and made available across the organization and related parties.

9. Responsibility for Operational Integration

   Looks at how policies and procedures are integrated into operations and reinforced through internal controls.

10. Gatekeepers

    Addresses guidance and training for key personnel involved in approvals, certifications, and escalation of concerns.