Kusserow on Compliance: Extending limited compliance resources

Co-Sourcing and On-Call Experts

Health care organization seek the most efficient and effective means to meet the great challenges of maintaining an effective compliance program in the ever-changing regulatory and enforcement environment. As compliance officers seek ways to supplement their limited in-house resources, Co-Sourcing has been evolving as preferred method when internal resourcing is lacking and out-sourcing the program to expert firms to provide a Designated Compliance Officer. Co-Sourcing involves using vendor expert services to supplement limited staff resources to carry out part of their workload. One of the most common Co-Sourcing methods is to engage firm with compliance experts on a “on-call” engagement agreement. This would permit using the experts only when and as needed, while maintaining control and direction of the program. This approach is also recognized by the OIG as a useful solution where an organization is limited in its compliance expertise and resources.

 

Co-Sourcing Benefits

  • Gains immediate access to specialized resources and experts not available internally
  • Less expensive to hire experts for limited services, than to hire full new full-time staff
  • Addresses the problem of an unexpected loss of staff and resulting resource issues
  • Brings the benefit of experience with other organizations
  • Provides subject matter expertise
  • Fills any lack of in-house expertise in selected areas
  • Facilitates meeting the ebb and flow of managing all the compliance obligations
  • Keeps organizations current with ever-changing regulatory and enforcement challenges
  • Accesses needed services, on-demand
  • Can be tasked to complete special projects
  • Fills a knowledge gap in training, fraud risk assessment, or other compliance-related needs
  • Meets obligations across multiple facilities in different jurisdictions
  • Develops best practice solutions to problems identified
  • Provides benchmarks of current processes against compliance standards
  • Implements or improves compliance effectiveness metrics
  • Quickly address new regulatory and emerging risks
  • Promptly and efficiently meets new leadership demands
  • Implements best practice standards and processes
  • Provides any sudden need for investigative or forensic expertise
  • Evaluates ongoing monitoring of compliance high risk areas
  • Assists in development of compliance work plans
  • Enables compliance officers to stay focused on program management and strategic planning
  • Increases flexibility in using experts who understand related laws/regulatory requirements
  • Performs operational and compliance auditing

For more information on how Co-Sourcing arrangements can work, contact Kashish Parikh-Chopra, JD at kchopra@strategicm.com or  (703) 535-1413.

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 Google+ or LinkedIn.

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Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Questions board-level compliance committees should be asking

HHS OIG compliance guidance calls for a Board-level committee to oversee the Compliance Program (CP). The HHS Inspector General noted that the best boards are those that are active, questioning, and exercise (constructive) skepticism in their oversight, asking probing questions about the compliance program. Boards need to know what type of questions they should be asking, and compliance officers should assist them with this problem. However, compliance officers in turn should be prepared to provide full and complete answers to them. The OIG and American Health Lawyers Association developed specific suggested questions that Board’s should be asking in their jointly produced “Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors” and “Corporate Responsibility and Health Care Quality (2007): A Resource for Health Care Boards of Directors”. The following are drawn from these advisory documents:

  1. Does the compliance officer have sufficient authority to implement the CP?
  2. What is the level of resources necessary to properly implement and operate the CP?
  3. Has the compliance officer been given the sufficient resources to carry out the mission?
  4. Have compliance-related responsibilities been delegated across all levels of management?
  5. What evidence is there that all employees are held equally accountable for compliance?
  6. How has the code been incorporated into corporate policies across the organization?
  7. What evidence is there that the code is understood and accepted across organization?
  8. Has management taken affirmative steps to publicize importance of code to employees?
  9. Have compliance-related policies been developed that address compliance risk areas?
  10. Are there policies/procedures for CP operation and how they should be reviewed/updated?
  11. What kind of document management ensures compliance-related documents are up to date?
  12. What is the scope of compliance-related education and training?
  13. What evidence is there of the effectiveness of CP training?
  14. What measures enforce training mandates and provide remedial training?
  15. What evidence is available that employees understand compliance expectations?
  16. How are compliance risks identified?
  17. What is the evidence that identified compliance risks are being addressed?
  18. Is the board being kept up to date on regulatory and industry compliance risks?
  19. How is the compliance program structured to address such risks?
  20. How are “at risk” operations assessed from a compliance perspective?
  21. Is conformance with the CP periodically evaluated?
  22. Does the CP undergo periodical independent evaluation of its effectiveness?
  23. What is the process for the evaluation and responding to suspected compliance violations?
  24. What kind of training is provided to those who conduct investigation of reported violations?
  25. How do the CO, HRM, and legal counsel coordinate in resolving compliance issues?
  26. What are the policies to ensure preservation of relevant CP documents and information?
  27. What policies address protection of “whistleblowers” and those accused of misconduct?
  28. What are the results of ongoing compliance monitoring by all program managers?
  29. How is ongoing compliance auditing being performed and by whom?
  30. How often is sanction-screening conducted and with what results?
  31. Are results from sanction-screening included in a signed report by the responsible parties?
  32. Has the CP been evaluated for effectiveness by a qualified independent reviewer?
  33. What evidence regarding effectiveness of hotline operation and follow-up investigations?
  34. What are the metrics being used to evidence CP effectiveness?
  35. What are the results of an independent review and assessment of the CP?

 

More information regarding available tools and resources available to assist in answering these questions, contact Daniel Peake at (dpeake@complianceresource.com) (703-236-9854).

 

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 Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Measuring culture using compliance benchmark surveys

– Evidencing compliance program effectivenes

– Provides quantifiable compliance program effectiveness metrics

– Internally developed and administered surveys lack credibility

The Sentencing Commission in its Federal Sentencing Guidelines states that businesses must “promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law.” The OIG in its Compliance Program Guidance for Hospitals noted that “as part of the review process, the compliance officer or reviewers should consider techniques such as…using questionnaires developed to solicit impressions of a broad cross-section of the hospital’s employees and staff.”  Daniel Peake of the Compliance Resource Center explains that a culture survey can identify gaps between the compliance culture that is intended and the one that employees actually experience. Importantly, it can identify whether the investments in the compliance program and employee attitudes and perception are truly aligned.  Surveys of this type can measure employee perceptions regarding the day-to-day management behavior.  However, to be truly useful, the culture survey should be a professionally developed, tested, validated, and independently administered. It would be best if responses to the individual questions can be evaluated, analyzed, and benchmarked against a large universe of organizations that have used the same questions. This permits comparisons to industry peers and national averages. Using the same survey every couple of year can assist in benchmarking and monitoring progress of a compliance program against its own results (i.e., trending historical company survey data). Results from a survey report should provide enormous value in identifying organization strengths as well as opportunities for improvement. This can help ensure the organization is on a track towards creating an organizational compliance culture of the highest quality. It can provide great insights into how effective the compliance program has been in changing and improving the compliance of an organization and signal not only strengths in the compliance program, but areas of potential weakness warranting attention. Culture surveys can measure:

  • beliefs and values that guide thinking and behavior of the workforce;
  • outcomes or the “impact” of compliance program activities;
  • the extent to which individuals and leaders demonstrate commitment to compliance; and
  • the current state of the compliance climate or culture.

 

For more information, contact Daniel Peake at (dpeake@complianceresource.com) (703-236-9854).

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 Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Meeting sanction checking mandates

As the HHS Inspector General, I created what is now referred to as the List of Excluded Individuals and Entities (LEIE) that was followed by OIG compliance guidance documents which call for checking employees, physicians, vendors, and contractors against the LEIE. The OIG considers all claims and costs associated with an excluded party as potentially false and fraudulent and can lead to significant financial penalties and more. The OIG Special Advisory Bulletin on the Effect of Exclusion provides very useful information in assessing this risk area. CMS mandates, as a condition of enrollment, providers may not employ or contract with individuals or entities that are excluded from participation in any federal health care program and call for checking not only against the LEIE, but also the General Service Administration’s (GSA) Excluded Parties List System (EPLS), now part of the System for Award Management (SAM). CMS further called upon State Medicaid Directors to establish their own sanction data base and requires providers to check it on a monthly basis. To date, 40 states have moved to establish their own Medicaid sanction lists with other states in the process of doing the same. This has increased the sanction screening burden exponentially, not only for the compliance office but other departments as well. HR often has responsibility of sanction checking new hires and periodically current employees. Procurement is also affected because they handle the screening of vendors and contractors. The Medical Credentialing Office must ensure checking on physicians who have been granted staff privileges.  Other federal sanction databases worth screening are maintained by the DEA and FDA, as well as the Department of the Treasury Office of Foreign Assets Control (OFAC) Terrorist Watch List.

Daniel Peake, of the Compliance Resource Center (CRC), works with clients to provide a variety of CRC services that includes providing sanction checking services, as well as the investigation and resolution of potential hits. He noted that the time and resources necessary for developing and maintaining a search engine, along with regularly collecting and updating sanction information from many databases is not very cost effective. This high cost of using internal resources to develop and manage the sanction checking has resulted in the great majority of health care entities subscribing to a vendor service that provides a search engine to their established databases. Vendors can afford the high cost of maintaining the currency of the data because they amortize the costs over many clients. The problem is that that vendor quality, cost, and reliability can vary enormously.  From experience, he offered the following tips for those considering a vendor:

 

Tips on choosing a vendor search engine service

  1. Know the cost up front with a fixed rate, not based upon per click searches.
  2. Contract should permit cancelling without cause at any time, if dissatisfied.
  3. Ensure vendor has liability insurance ($ 1 to 3 million preferably).
  4. Determine other services included (e.g. policy templates, regulatory updates, etc.).
  5. Determine how much “help desk” assistance is available to resolve potential hits.

 

For more information, contact Daniel Peake at (dpeake@complianceresource.com) (703-236-9854).

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 Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.