If you’re in the realm of healthcare compliance (and we bet you likely are, seeing as you’re reading this article), you probably have an understanding of conflicts of interest (COI). What does the term mean, what is the risk that such actual or perceived conflicts could pose for your organization, and how does your department handle these situations/conflicts? However, you may still have a laundry list of concerns keeping you up at night, or—worse yet—maybe you haven’t even started to think about. Our goal is to share Yale New Haven Health Service’s (YNHHS) best COI-related practices and the methods we have developed to help us sleep better at night.
What is a COI?
A COI exists when an individual’s financial interests or outside activities could directly and significantly impact their roles/responsibilities within their organizations or vice versa. Simply said, a COI may arise when an individual’s professional obligations/judgement are compromised or influenced by (or could be perceived as such) their financial interests (or other interests) or relationships.
Why does the phrase “conflict of interest” have a negative connotation and cause the workforce to become defensive? Annually, the compliance department reminds the 4,500 covered individuals surveyed that not all disclosures are conflicts. And not all conflicts are “bad.” They just need to be managed. At YNHHS, educating our workforce on COI and the importance of being transparent is imperative to reduce risk. The world we live in now is quite different from 10 years ago—the abundance of new media sources and publicly available information can affect public perception by the government and patients alike. So much COI is based on perception. And at the end of the day, we can’t manage actual or perceived conflicts unless we’re in the know. Herein lies the reinforcement of overdisclosure and a rigorous survey/cross-check process.
Who is within your COI scope?
Who you survey matters. Is it the entire workforce or certain individuals/departments?
If you’re part of a small private practice, surveying all members of your workforce may be a completely feasible task. If manageable, that is the ideal scenario—full disclosure and transparency by all. However, if your compliance team supports a large healthcare organization with tens of thousands of workforce members, surveying all might be out of the question—especially given the nature of compliance and all the other substantial risks. Another consideration: Does your compliance team have a dedicated COI person? These factors determine the foundation of your COI program.
If your organization cannot survey all, survey those who impact the greatest level of risk. A thoughtful question to always remember: Who are your main decision-makers or those with the ability to influence others on decisions—either in patient care or the general business of your organization?
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Key executives
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Director level and above
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Certain departments/offices
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Contracting and procurement
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Legal and risk services
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Pharmacy
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Grants (especially where government funding is accepted)
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Development/foundation offices
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Physicians and advanced practice providers
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Committees that control decisions (i.e., a pharmacy & therapeutics committee or other clinical decision-making body)
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Board of trustees and any other similar officer-level positions
All these workforce members are at considerable risk for conflicts and hold highly influential positions.
How do you collect the data?
For the small private healthcare office, surveying the whole workforce might be easier via a paper disclosure form.
For a large healthcare organization, implementing an electronic database may be the best fit. Whether outsourced or homegrown, such technology will likely offer an electronic, paperless form to be distributed via email to your respondents. A variety of tools are offered, including built-in tracking methods and reporting, as well as the launch and monitoring of management plans.
At YNHHS, an electronic database is used to send out annual and transactional COI forms to covered individuals. This allows us to run various daily reports to communicate metrics to our leaders across the system.
Regardless of how the form is sent out, you must ensure that those surveyed complete the form. One hundred percent is always the goal, but we understand that this can be a real challenge.
Are you chasing down COI forms after the deadline? This can be a constant struggle, no matter the organization’s size. Instilling a culture of compliance with the workforce and support from leadership is crucial for COI completion. For those who do not complete their forms, what is the repercussion? Do you hold parking privileges? Pay? Credentialing? Research opportunities?