OIG and HCCA Issue Resource Guide for Measuring Compliance Program Effectiveness.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued a resource guide (“Resource Guide”) on measuring compliance program effectiveness, in conjunction with the Health Care Compliance Association (HCCA).  On January 17, 2017, the OIG hosted a roundtable of compliance professionals to discuss methods for measuring the effectiveness of compliance programs.  The roundtable aimed to solicit ideas for reviewing the seven standard elements of a compliance program.  These ideas were then compiled to form the final Resource Guide.  The roundtable noted that the Resource Guide is not a “checklist” to assess a compliance program.  Instead, the Resource Guide attempts to list as many program measurement options as possible, while being broad enough to assist any type of organization.  In result, the Resource Guide provides compliance program measurement options for organizations of different sizes, operational complexity, industry sectors, resource levels, and compliance programs.  Although the Resource Guide addresses the seven standard elements of a compliance program, it does not follow the OIG compliance guidance documents in detail.

The compliance effectiveness roundtable participants recommended that organizations should not use all or even a large number of the Resource Guide’s ideas, as this would be impractical.  Accordingly, the OIG notes that the organization’s risk areas, size, resources, industry segment and other individual attributes should determine the frequency of using any particular compliance program measurement option listed in the Resource Guide.

The roundtable addressed the following compliance program elements:

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; and
7. Investigations and Remedial Measures.

The roundtable and resulting Resource Guide viewed effectiveness in terms of “outcome”.  For example, conducting compliance training for all covered employees is a process outcome metric.  How well the participants learned the lessons and retained them is a factor of outcome or effectiveness of the training.  Many of the Resource Guide list items relate to compliance processes.  Organizations should also account for how, and by whom, determinations for listed items are made.

The Resource Guide indicates the following main methods to measure compliance program effectiveness:

1. Employee Surveys – The Resource Guide frequently suggests the use of surveys to learn about employee knowledge, understanding, and attitudes related to particular compliance issues. The use of surveys was referenced almost 60 times throughout the lists pertaining to all seven element categories.  Various OIG compliance guidance documents also list surveys as a means for measuring compliance program effectiveness.  There are two types of surveys: (1) a Knowledge Survey that measures employees’ knowledge and understanding of the compliance program, and (2) a Compliance Culture Survey that measures employee attitudes and perceptions concerning organization compliance.  Both survey types were cited as tools to determine how well compliance operations were functioning.  Accordingly, validated and tested survey results are highly valuable if they are administered independently and ensure anonymity of respondents.  If the survey results can be benchmarked against a large universe of organizations using the identical survey instrument, the value of the survey increases.  As such, survey results can provide powerful evidence of compliance program effectiveness to executive leadership, the Board, and outside authorities.
2. Independent Compliance Program Effectiveness Evaluation – The OIG compliance guidance documents note that all program managers are responsible for ongoing monitoring of their areas of responsibility. Concurrently, there must be ongoing auditing by those independent of these program areas.  Independent auditing verifies that monitoring is taking place and that the internal monitoring is effective in addressing high-risk areas.  The Resource Guide provides useful insight into accomplishing this unique task.  Specifically, independent audits of program effectiveness must be conducted by an outside, independent, and objective party.  An independent compliance program effectiveness evaluation can examine compliance across all seven elements, and address most of the ideas listed in the Resource Guide.

The HCCA-OIG Resource Guide is available at:

https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf.