OIG Publishes Guide to Measure Compliance Program Effectiveness

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”), in collaboration with the Health Care Compliance Association, recently released a guide to assist health care organizations in measuring the effectiveness of their compliance programs. The guide, entitled Measuring Compliance Program Effectiveness: A Resource Guide (the “Guide”), was published on March 27, 2017, and follows the U.S. Department of Justice’s (“DOJ”) recently released memorandum entitled Evaluation of Corporate Compliance Programs. While the OIG’s and DOJ’s focus on compliance programs is not new, the combined level of detail set forth in these two publications underscores the critical and ever-growing importance that both the OIG and DOJ continue to place on compliance programs. 

The OIG’s stated purpose for publishing the Guide 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.” While the Guide lists hundreds of metrics with which to evaluate compliance programs, the OIG emphasizes that it should not be used as a “checklist” to be applied wholesale to assess a compliance program, as “one size truly does not fit all.” Rather, the OIG advises health care organizations to utilize the Guide in accordance with the organization’s needs, which will depend on, among other factors, the organization’s risk areas, size, resources, and industry segment. 

The Guide is divided into seven sections, which generally parallel the seven elements of compliance program effectiveness previously emphasized by the OIG in prior guidance. They are:

1. Standards, Policies, and Procedures
2. Compliance Program Administration
3. Screening and Evaluation of Employees, Physicians, Vendors, and Other Agents
4. Communication, Education, and Training on Compliance Issues
5. Monitoring, Auditing, and Internal Reporting Systems
6. Discipline for Non-Compliance
7. Investigations and Remedial Measures

Each section contains an elaborate list of compliance program standards and specific insights on how to measure effectiveness for each one. The Guide is by far the OIG’s most comprehensive resource on how the OIG evaluates compliance programs to date.

The strength of any organization’s compliance program is a critical factor that prosecutors consider when determining whether to bring charges against an organization, as explained in The Principles of Federal Prosecution of Business Organizations in the United States Attorney’s Manual. Health care organizations and their compliance staff, legal advisors, and governing bodies should make full use of the Guide to evaluate their current compliance programs and make any necessary improvements.

If you have any questions about the information in this alert, please contact Jonathan Feld (312-627-5680 or jfeld@dykema.com), Eric Klein (248-203-0891 or eklein@dykema.com), or your Dykema relationship attorney.