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Key Points:

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Department of Justice (DOJ) have repeatedly stated that independent compliance program effectiveness evaluations are a critical factor in evidencing compliance program effectiveness, and evaluations continue to grow in importance. Results from the 2020 SAI Global Healthcare Compliance Benchmark Survey (Survey), developed with and analyzed by Strategic Management Services, found that about half of the respondents reported conducting an independent evaluation of their compliance program within the last three years. However, elsewhere in the Survey, only about one third reported using independent experts to review their compliance program, relying instead upon self-assessment tools, checklists, and internally generated surveys. Compliance Officers, like all program managers, are responsible for verifying that the compliance program is operating as designed.  These methods (i.e., tools, checklists and internally generated surveys) can be useful for ongoing monitoring, but lack credibility for effectiveness evaluations and with executive leadership and government oversight agencies. At best, these are used as tools to conduct a “gap analysis” for elements that may be missing in a compliance program. Effectiveness relates to the outcome of a process, not the process itself and should be done through an independent evaluation by experts outside of the organization. Outside experts can verify that the Compliance Officer is conducting proper ongoing monitoring of the program and validate that goals and objectives are being met. Using outside experts to conduct ongoing evaluations is growing in importance. OIG Compliance Program Guidance documents have repeatedly reinforced its importance. These documents recommend independent reviews as an essential part of an effective compliance program evaluation, without which there would be little consideration for mitigation of penalties. The DOJ “Evaluation of Corporate Compliance Programs” states that, “[o]ne hallmark of an effective compliance program is its capacity to improve and evolve.” The DOJ highlights the importance of “effective implementation and evaluation measures” to determine if the compliance program is a “paper program” or one that is fully “implemented, reviewed, and revised, as appropriate, in an effective manner.” Regular, rigorous, and consistent independent review of compliance programs is now the expectation. All of this supports the need for periodic independent evaluations of compliance programs, in addition to internal monitoring.

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For more information about Survey results or conducting independent effectiveness evaluations, contact Richard Kusserow at rkusserow@strategicm.com.

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