New DOJ Guidance on Compliance Program Effectiveness

The Department of Justice (DOJ) issued new guidance on evaluating the effectiveness of corporate compliance programs.   This publication is an update to the prior guidance issued in February 2017.   

The OIG and DOJ have repeatedly indicated that simply having a compliance program is not sufficient.  The government’s expectation is that your compliance program is EFFECTIVE.  This document gives in depth insight into how investigators evaluate the effectiveness of your program based on the following three overarching areas:

  1. Is the program well designed?
  2. Is the program effectively implemented?
  3. Does the compliance program actually work in practice?

The government uses the answers to these questions to assist in determining appropriate resolution of compliance violations.  Healthcare organizations should use the answers to these questions to continually improve their program.

Often organizations struggle with how to actually measure and evaluate their program’s effectiveness.  This DOJ publication is designed to help by providing 61 new factors and questions to assist in evaluating the above three areas, including risk management, shared commitment, and continuous improvement.  In conjunction with this document, the prior guidance from February 2017 and the OIG resource guide for measuring compliance program effectiveness should be utilized.  The links for each of these are listed below.

The updated DOJ guidance can be accessed here:

The OIG guidance can be found here:

At HBE, we conduct compliance effectiveness reviews and can assist you in evaluating your compliance program based on the most recent guidance. 

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