New Corporate Compliance Guidance Issued by DOJ

If you had any doubt that the U.S. Department of Justice had plans to back off its crackdown on healthcare fraud under then new Trump administration, all you need to do is look at its recently released guidance on corporate compliance to understand that it will continue to keep the pressure on.

Titled Evaluation of Corporate Compliance Programs, the Feb. 8 formal guidance provides attorneys with a detailed analysis of how it evaluates such programs in fraud investigations.

The Compliance Program Guidance is divided into 11 sections and is presented as a set of topics and questions:

  • Analysis and Remediation of Underlying Conduct
  • Senior and Middle Management
  • Autonomy and Resources
  • Policies and Procedures
  • Risk Assessment
  • Training and Communications
  • Confidential Reporting and Investigation
  • Incentives and Disciplinary Measures
  • Continuous Improvement, Periodic Testing and Review
  • Third Party Management
  • Mergers & Acquisitions

Under each of these sections, the DOJ provides sample questions that prosecutors might use to further their investigation. Such questions include:

  • Were there prior opportunities to detect the misconduct in question, such as audit reports identifying relevant control failures or allegations, complaints, or investigations involving similar issues?
  • How have senior leaders, through their words and actions, encouraged or discouraged the type of misconduct in question?
  • Was compliance involved in training and decisions relevant to the misconduct?
  • What controls failed, or were absent, that would have detected or prevented the misconduct? Are they there now?
  • What disciplinary actions did the company take in response to the misconduct and when did they occur?

The new compliance program guidance is intended to provide more transparency about federal prosecutors’ review of compliance programs under the Filip factors. These are specific factors that prosecutors should consider when conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements.

Because a corporate compliance program must be evaluated in the specific context of a criminal investigation that triggers the application of the Filip Factors, the fraud section does not use any rigid formula to assess the effectiveness of corporate compliance programs, notes the DOJ.

The DOJ’s new guidance should serve as a resource for those who want to ensure that their healthcare organization is taking the proper steps toward preventing fraudulent activities. The Health Law Offices of Anthony C. Vitale assists clients in developing critical compliance programs. If you would like more information give us a call at 305-358-4500 or email us at and let’s discuss how we might be able to assist you.

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The Health Law Offices of Anthony C. Vitale