Kusserow on Compliance: Time for Compliance Program evaluation

  1. Have a 2021 workplan focusing on improving the Compliance Program
  2. Not having independent evaluations is evidence of lack of program effectiveness
  3. DOJ & OIG: Identifying & addressing weaknesses evidences program effectiveness

With 2020 coming to an end, it is time to look forward to the New Year and plan ways to identify areas for improvement of the Compliance Program, building off of results of independent evaluations. Both the OIG and DOJ stress the importance of evidencing Compliance Program (“CP”) effectiveness and that all programs are in progress, never completed. They see compliance officers identifying weakness and gaps that lead to improvements as positive evidence of an effective program. The DOJ “Evaluation of Corporate Compliance Programs” notes that there will always be ways the program can be improved and enhanced. The DOJ, in its 2020 Compliance Program Evaluation Guidelines noted: “One hallmark of an effective compliance program is its capacity to improve and evolve. The actual implementation of controls in practice will necessarily reveal areas of risk and potential adjustment.”  The DOJ highlights the importance of effective implementation and evaluation measures” to determine whether the compliance program a “paper program” or one that is fully “implemented, reviewed, and revised, as appropriate, in an effective manner.” DOJ prosecutors are directed to ask: Does the company evaluate periodically the effectiveness of the organization’s compliance program?” Regular, rigorous, and consistent review of compliance programs is now the expectation.  The OIG calls for ongoing monitoring and independent ongoing auditing of Compliance Programs to evidence continuous improvement.

There are three general ways for independent evaluations: (1) a complete compliance program evaluation; (2) a compliance program gap analysis; or (3) an independently developed and administered employee survey of compliance knowledge, attitude and perceptions.

  1. Compliance Program effectiveness evaluations is recognized by experts as by far the best method to evidence how well the program is functioning. It measures outcome by conducting a 360-degree evaluation that includes: (a) full document examination and review; (b) on site review and testing of operations in action; and (c) interviews of Board members, executives, selective key staff, and focus group meetings. If done properly, the resulting reports with be 60 to 100 pages that include findings, observations, along with recommendations and suggestions for program improvement.
  2. Compliance program gap analysis is about half of the cost or less than a full compliance program evaluation, but the reduction of costs is matched by the diminished value of results. It is primarily a document “checklist” review, focusing on output metrics, rather than outcome metrics related to program effectiveness. It is best used with organizations with new or incomplete programs, desiring assistance in identifying elements needed to complete development of their program.  It can identify gaps for inexperienced compliance officers but lacks details by which this can be accomplished.
  3. Independently developed, validated, and administered compliance surveys of employees is the least expensive means, at a fraction of the cost for either of the two other methods, for evidencing and benchmarking compliance program effectiveness. The use of surveys has long been advocated by regulatory bodies, including in the Federal Sentencing Guidelines, OIG Compliance Program Guidance and DOJ guidelines. These organizations advise using surveys of employees to gauge how well the program is functioning. Surveys that are anchored in a large database of organization, permit benchmarking an organization to the universe. Compliance knowledge surveys test knowledge of the compliance program structure and operations and can provide very credible empirical evidence of the advancement of program knowledge, understanding and effectiveness. Compliance culture surveys focuses on employee beliefs, attitudes, and perception concerning compliance, useful in measuring the extent to which individuals, coworkers, supervisors, and leaders demonstrate commitment to compliance. Both types of surveys should be considered as they are useful in benchmarking and measuring change in the compliance environment over a period and provide different dimensions and perspectives on a compliance program.

For more information on the difference in scope of work between a full compliance program evaluation and a gap analysis, send your queries to Richard Kusserow at rkussserow@strategicm.com.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: DOJ compliance program guidelines once again focus on sufficiency of compliance resources

The 2020 Department of Justice (DOJ) Compliance Program Guidance for prosecutors places increased emphasis on questioning the adequacy of compliance resources that the DOJ views as essential for any program’s effective functioning. The DOJ elaborated that prosecutors should ask questions concerning whether the program is “adequately resourced and empowered to function effectively.” Put differently, even the most artfully constructed program is doomed to fail without sufficient funding, qualified compliance personnel, and widespread support throughout all levels of an organization. A question for many health care organizations is whether the organization would pass DOJ scrutiny on this point.

Results from the 2020 SAI Global Healthcare Compliance Benchmark Survey developed with and analyzed by Strategic Management included information regarding the adequacy of resources for Compliance Officers in meeting their challenges. Reading the details of the responses in the Survey suggest that many compliance offices are likely operating with less than fully adequate resources to meet DOJ expectations. The Survey results indicated that the average compliance office staff levels are five individuals with about one third of respondents reporting only one full-or part-time person. In a related question, over half of respondents indicated they are expecting their budget to remain mostly the same with about one quarter expecting some increase, while at the same time assuming new responsibilities, most notably those related to HIPAA Privacy and Security. Given the average staffing level of compliance offices, increasing responsibilities, heightened enforcement by government agencies, and limited increases in budgetary resources, it is likely that most compliance offices are stretching their limited resources and would have difficulty meeting the DOJ standards. The Survey also found that many are turning to external vendors to provide services and tools, to stretch limited staff resources and to lower operating costs.

 

For more information on this subject, contact Richard Kusserow at rkusserow@strategicm.com

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: ‘Mock’ DOJ compliance program evaluations may be worthy of consideration

In 2018, Assistant Attorney General Brian Benczkowski developed guidance to educate prosecutors on taking a deep look into the sufficiency and proper functioning of a subject company’s compliance program, giving leniency to an organization with an effective compliance program. In 2019, the DOJ Compliance Program Guidance set the stage with 179 questions that prosecutors should use. The 2020 DOJ version advanced significantly upon the guidance and nearly doubled the number of factors and questions to be considered. It concentrated on a “deep dive” beyond the “paper program” in assessing the effectiveness of program operations. The guidance has now been extended from just the Criminal Division to include all of DOJ, including the Civil Division, where most health care cases are handled.

The multitude of questions and factors related creates a great challenge for Compliance Officers trying to convince prosecutors that their program meets these standards. Inasmuch as the DOJ would have already determined the organization has violated federal law, it is reasonable to expect the DOJ will want hard credible evidence from the Compliance Officer. The fact is, very few programs can withstand detailed examination by the DOJ. Compliance Officers may find a “Mock DOJ Compliance Program Evaluation” as a useful step to advance the program to meet the challenge.

A “Mock Review” is an assessment that mirrors the tenets of a formal evaluation by DOJ prosecutors. When Strategic Management performs such reviews, it take a very different approach from a traditional evaluation or “Gap” analysis.  Those reviews result in something like a report card, whereas the “Mock Review” is more limited and less costly consulting advisory engagement conducted in collaboration with the Compliance Officer that focuses on identifying ways to better document answers to the DOJ question. Results are action items to fortify and fix noted weaknesses and can be used foundation for the annual Compliance Office workplan. A “Mock Review” also has the benefit of evidencing the continuing improvement and advancement of the Compliance Program.

For more information on this subject, contact Richard Kusserow (rkusserow@stratgicm.com).

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Evidencing compliance culture is a major focus of the DOJ compliance guidance

“Has the company surveyed employees to gauge the compliance culture”

The DOJ 2020 Evaluation of Corporate Compliance Programs calls for prosecutors to “assess whether the company has established policies and procedures that incorporate the culture of compliance into its day-to-day operation.” The effectiveness of a compliance program requires a high-level commitment by company leadership to implement a culture of compliance from the middle and the top. Additionally, “beyond compliance structures, policies, and procedures, it is important for a company to create and foster a culture of ethics and compliance with the law at all levels of the company.” Prosecutors are told to review the company’s culture of compliance and give consideration to the following questions:

  1. “Has the company surveyed employees to gauge the compliance culture”
  2. “How often and how does the company measure its culture of compliance?”
  3. “What steps has company taken in response to its measurement of compliance culture?”

The challenge is finding the best method by which a compliance culture survey can be administered, analyzed, and evidence a positive compliance culture. This also means having results which are convincing and credible to both those surveyed and those who review the results. One answer is to employ the Compliance Benchmark Culture Survey© which has been employed since 1993 by hundreds of health care organizations and entities with survey population of over three quarters of a million employees. It is the only such survey focused exclusively on the health care sector. It is time tested, reliable and provides credible results meeting the tests of validity in the accuracy of measurement and reliability with the quality of the data obtained and overall survey viability. Unlike the Compliance Knowledge Survey© that uses dichotomous “yes-no” answers, a culture survey uses a Likert Scale where respondents specify their level of agreement or disagreement to a question or statement, thus capturing the intensity of their feelings for a given item. As such, using this type of survey applies when trying to gauge attitudes and perceptions of employees regarding the compliance program.

 

Compliance Benchmark Culture Surveys© are a very cost-effective method and excellent way to gather lots of information from many people. The cost of a most surveys is approximately $5,000 – 7,000.  This includes a 30 page plus report that provides a “deep-dive’” data analysis and interpretation of results for individual questions, panels, or overall scoring with suggested actions for making improvements. It can also be used for internal benchmarking of current results as a baseline against which future surveys can be benchmarked, as well as for external benchmarking against the universe of organizations using same using the same survey instrument.

 

For more information on this topic, contact Richard Kusserow at rkusserow@strategicm.com.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.