[co-author: Wendy Kronmiller, Erickson Living, Baltimore, MD]

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide (Guide). The Guide is the joint work product of a group of 40 compliance professionals and OIG staff who met in January to discuss suggested ways to evaluate a compliance program.

This Guide is notable because it provides direction to industry for assessing the effectiveness of a compliance program. The OIG has long encouraged health care organizations to implement compliance programs, consisting of seven specific elements, and to measure the effectiveness of these compliance programs. Additionally, Chapter 8 of the U.S. Sentencing Guidelines provides that an organization can receive credit if it has implemented an effective compliance program, and the U.S. Department of Justice also recently released compliance program guidance related to such sentencing review. However, “effective” has not been defined by the OIG or U.S. Sentencing Commission, and OIG guidance does not address the specific issue of how to measure “effectiveness.”

The Guide’s over 50 pages provide 401 ideas on what and how to measure the seven elements of an effective compliance program. The areas addressed in the Guide include the following:

• Standards, Policies, and Procedures, including policy/procedure access, accountability, understanding, and updates.
• Compliance Program Administration, including the roles and responsibilities of the Board of Directors, Compliance Officer, and Compliance Committee.
• Screening and Evaluation of Employees, Physicians, Vendors and other Agents, including accountability, conflicts of interest, and disclosures.
• Communication, Education, and Training on Compliance Issues, including risk-specific training, training and communication plans, and accountability.
• Monitoring, Auditing, and Internal Reporting Systems, including risk assessments, work plans, corrective action, and non-retaliation.
• Discipline for Non‐Compliance, including consistency, awareness, and documentation.
• Investigations and Remedial Measures, including process, quality, consistency, and documentation.

The purpose of the extensive, but non-exhaustive, list is “to give health care organizations as many ideas as possible, be broad enough to help any type of organization, and let the organization choose which ones best suit its needs.” By way of example, Element 1 related to Standards, Policies, and Procedures is organized by program attributes to be measured (“what to measure”) and corresponding suggestions (“how to measure”), such as ensuring that compliance program rule changes are effectively communicated by conducting an “[a]udit to ensure there is adequate communication to employees, including changes in policy/procedure.” The Guide draws on available industry resources, such as the CHC Candidate Handbook, to ensure all elements of a compliance program were covered. Compliance officers can use the Guide to build or strengthen compliance plans and motivate necessary change in organizations.

It is important to note, as HHS Inspector General Daniel Levinson reiterated when announcing the Guide at HCCA’s annual Compliance Institute, that no organization is expected to adopt all or even a large number of the suggestions at any given time, and the list is not intended to serve as a checklist or certification program. Rather, an organization should select measures based upon the organization’s specific needs, resources, and risks as part of its ongoing compliance program assessment. As compliance professionals and their counsel attempt to measure and demonstrate compliance program effectiveness, the Guide is another welcome and practical tool to use in that effort.

*This summary was originally published by the American Health Lawyers Association. It was authored by Sarah K. diFrancesca (Cooley LLP, New York, NY) and Wendy Kronmiller (Erickson Living, Baltimore, MD) and reviewed by Mary Holloway Richard (Phillips Murrah PC, Oklahoma City, OK).

Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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