By Erin Schwarz, CEO/Principal Consultant, Vinecity Consulting LLC
Disclaimer: I am not a representative of the Accreditation Council for Continuing Medical Education (ACCME) or California Medical Association/ IMQ, and anything written here is my personal opinion or interpretation. I cannot guarantee any results related to compliance with the ACCME’s criteria/standards or with any other organization’s rules. Some details have been changed in these stories to make them more universal. Please check with your stakeholders before implementing any changes.
Alliance National Learning Competency: NLC: 5.1.C
- Execute CE Activities and the CE program following sound and applicable business policies and practices by…
- C) Producing CE activities/interventions and administer the CE program in compliance with local, regional, state and federal laws and regulations.
In May 2015, the Accreditation Council for Continuing Medical Education (ACCME) clarified the rules regarding “Three Special Use-Cases” when it might be appropriate for accredited medical education organizers to utilize commercial-interest employees in accredited education. This clarification reinforced many providers’ belief that there are appropriate ways to use commercial-interest employees to add to the value of CE activities. However, the practice of doing so requires clear policies and careful documentation. In this article, we will explore several stories where an employee could be used in both inappropriate and appropriate ways.
Story #1: Vitamin Company CEO
A medical group provider invited an expert with numerous publications in scientific journals to speak on the science of supplementation and pain relief during an accredited activity. The expert disclosed in advance that he was the owner of a vitamin company.
First, in order to determine if this expert was an employee of a commercial interest, the provider investigated whether the vitamin company was a commercial interest. The products are used by patients, and the company both manufactures and re-sells these products, classifying it as a commercial interest under ACCME’s definition. Next, the provider investigated the nature of the ownership. ACCME has indicated that ownership and employment are synonymous but that there is a difference among stock purchase, stock options and true “ownership.” In this example, the person clarified that he was the CEO and owner of the company.
Because this person was an employee of a commercial interest, and the content of the lecture related to the products of his company, allowing him to lecture on the original topic would have been inappropriate.
The May 2015 ACCME clarification on employees of commercial interests includes one option that was relevant to this situation:
“Employees of ACCME-defined commercial interests can control the content of accredited CME activities (e.g., as planners, authors or speakers [including poster presentations]) when the content of the accredited CME activity is limited to basic science research (e.g., pre-clinical research, drug discovery) or the processes/ methodologies of research, themselves unrelated to a specific disease or compound/drug. In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.”
If the speaker’s contribution was limited to basic science, without including or relating to clinical applications or products, it might have been appropriate to use this speaker. In such a case, the provider would demonstrate and document adherence with controls that ensured this limitation.
In this instance, the provider decided that they did not want to limit the presenter to basic science. They opted to remove credit from the lecture, move the lecture to the end of the day and notify attendees that there would not be credit for this lecture. This method of managing the employment relationship was determined to be an alternate and appropriate way to use an employee of a commercial interest.
Story #2: Wife Employed by Orthopedic Device Company
A large medical society invited a number of experts to serve as abstract reviewers for an upcoming scientific meeting on diabetes prevention. One of the reviewers indicated on the disclosure in advance of the review that his wife was employed by an orthopedic device company. This reviewer is considered a leading expert in the field and it was important to include him as a reviewer.
ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. In this instance, the reviewer was therefore considered an employee of a commercial interest. The provider reviewed the orthopedic device company website carefully to learn about the products and business lines of the company. As a result of their review, the provider determined that the company in question did not make or sell any products related to diabetes prevention. ACCME indicates the following:
“Employees of ACCME-defined commercial interests can control the content of accredited CME activities when the content of the CME activity is not related to the business lines or products of their employer.”
After investigating the nature of the company relationship, the provider needed to demonstrate and document clear controls that ensured the content did not relate to the orthopedic device company. Unless there is a clear distinction between the subject matter and the products/business lines, the use of the “employee” would not have been appropriate.
In this instance, even though the relationship was investigated and managed at the outset, the provider had a pre-existing policy specifying that faculty/planners/authors of accredited activities may not be employees of a commercial interest. Due to adherence to the provider’s own policy, the provider was unable to utilize the reviewer immediately. Further management and proactive consideration was needed. They discussed the policy internally, elected to revise the policy, obtained approval from leadership and were then able to clear the reviewer to participate. In the end, the reviewer provided high-quality reviews that proved valuable to the society.
Story #3: Surgical Robot Technicians
A surgical society planned a hands-on course utilizing complicated surgical equipment, including a surgical robot. Technicians from the company producing the surgical robot were invited to participate, but strictly limited to discussing the operation of the equipment, without any clinical recommendations. They were informed of this limitation in advance and on-site by the course chair and agreed to follow the limitations.
ACCME indicates the following:
“Employees of ACCME-defined commercial interests can participate as technicians in accredited CME activities that teach the safe and proper use of medical devices. In this circumstance, the accredited provider must demonstrate that it implements processes to ensure that employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical recommendations concerning the business lines or products of their employer.”
Interestingly, despite the fact that the chair monitored the course and reported that the technicians followed the limitations, two attendees complained in the evaluation results that the robot company representatives were marketing their product. In this instance, even though the provider’s policy was followed, the attendees assumed that the mere presence of the representatives implied marketing. Had the organization, at the beginning of the course, conveyed to the attendees the reasons for the representatives’ inclusion, this perception may have been mitigated.
- If it serves the educational goals of the CME activity, a role for employees of commercial interests may be appropriate, but only in the specific, limited circumstances as defined by ACCME and, ideally, detailed in an organizational policy.
- When writing a policy, be careful not to hamper your organization’s ability to use experts with spouse/partners who may work in the medical field. Consider if there is an instance or exception when the organization might use an employee of a commercial interest such as in the second story.
- Ensure appropriate documentation of the decision making and implementation of your policies.
- Communication of your process for utilizing employees of commercial interests may reduce learners’ automatic assumption that their involvement is not appropriate.
- Investigate any questions that may arise concerning the nature of a disclosure. Directly question the individual, thoroughly research the company and, when in doubt, hold to the highest standards to ensure the accredited activity is balanced, unbiased and independent of the control of a commercial interest.