Department of Health and Human Services, Office of Inspector General Issues Compliance Effectiveness Guide, which has Broad Implications for Health Care Compliance Programs

By Michael E. Clark and Amanda L. Bassen

On March 27, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued a 53-page resource guide on compliance program effectiveness, titled “Measuring Compliance Program Effectiveness: A Resource Guide” (“Compliance Guide”). The Compliance Guide is broken into seven compliance program elements, each containing numerous suggestions on how and what to measure with respect to each element. The OIG explained that its purpose in issuing the Compliance Guide was to provide health care organizations with as many ideas as possible for measuring the elements of their compliance programs, which would allow any type of health care organization to choose those that best suit its needs. The OIG cautions that the Compliance Guide should not be used as a “checklist” but rather be tailored to an organization’s particular needs in any given year. 

While the Compliance Guide is, in theory, useful to health care organizations in evaluating the effectiveness of their compliance programs, it is in reality a double-edged sword. The government typically uses the fact of an organization’s compliance program as evidence of knowledge of what is required under the law. With such a comprehensive Compliance Guide, the government will now have a basis to claim that a health care organization should have known of a particular risk or implemented any number of the recommended metrics enumerated by the Compliance Guide to test the effectiveness of its compliance program. Such a vast array of options will lead to possible reasonable inferences to be drawn as to knowledge and compliance.

The Compliance Guide is one of several pursuits the United States government has taken in recent years that signals its renewed interest surrounding corporate compliance. For example, on November 3, 2015, the U.S. Department of Justice’s Fraud Section retained a full-time compliance expert to provide expert guidance to the DOJ prosecutors as to the existence and effectiveness of corporate compliance programs and remediation efforts in connection with the prosecution of corporate entities. The DOJ’s corporate compliance expert is developing benchmarks for evaluating corporate compliance and remediation measures and, in cases requiring ongoing assessment, providing guidance to help prosecutors and corporate monitors determine whether such measures are effective and in accordance with agreed-upon corporate resolutions.

On February 8, 2017, the Fraud Section also published an “Evaluation of Corporate Compliance Programs,” which lists topics and sample questions it considers in evaluating the effectiveness of corporate compliance programs. These guidelines outline the factors that federal prosecutors should consider, known as the “Filip Factors,” in determining whether to prosecute corporate wrongdoing. The intended purpose is to provide transparency as to the Fraud Section’s review of compliance programs but, in reality, like the Compliance Guide, likely will lead to a heightened standard of accountability.
These recent measures indicate the increased concern by the United States government about corporate compliance. While the government claims these programs help corporations in assessing the effectiveness of their compliance programs, they also make it easier for the government to prove intent and the knowledge of corporate wrongdoing. While it will be impossible and inefficient to try to implement all of these recent measures, compliance counsel should ensure that they are well-versed in the new guidelines, and have a well thought-out rationale for the measures they choose to adopt.