Kusserow on Compliance: Don’t forget the conflicts of interest compliance risk area

All Compliance Programs should consider Conflicts of Interest (COI) as a major compliance high-risk area that warrants close ongoing monitoring and auditing for compliance. Regulatory compliance requires that healthcare organizations secure annual conflict of interest disclosures from physicians, APPs, board members, and hospital leaders at the director level and above. Effective disclosure requires a thorough questionnaire to guide discernment of any conflicts. The questionnaire must walk individuals through their business relationships, revealing the potential for COI. Conflicts must then be reported on a disclosure form. As part of ongoing compliance monitoring, the following COI issues should be included:

  1. Reviewing existing policies and procedures. This is to ensure full understanding of the current COI process and involves reviewing current documentation related to current processes, as well as interviews with key leaders to gain insight on COI. COI Policies should define the types of disclosures that require a management and mitigation plan. The plan should prescribe the steps the organization will take to mitigate any bias or appearance of bias.
  2. Identifying opportunities to improve the COI process. It is important in order to analyze data and results of interviews to identify how: (a) COI Process can be improved; (b) the components needed in the process; and (c) how the COI process can be effectively operationalized in practice.
  3. Take remedial actions to improve effectiveness of COI processes. This includes:
    1. Determining who must submit COI information;
    2. Determining how the information is to be collected and controlled;
    3. Determining the COI review process;
    4. Determining the COI follow-up process, including informing people of the results of the review and following-up to verify that recommendations/decisions are being followed; and
    5. Tracking/reporting violations of COI policies and process, including forms for such reporting.


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.