Mitigating Commercial Bias
Ensuring Integrity & Independence in CME
It is essential that Accredited Continuing Education provides healthcare professionals with a protected space in which to teach and learn, free from the influence of organizations that may have an incentive to insert commercial bias into education. Interactions between industry and healthcare professionals are valued, legitimate, and often lead to advances in patient care. Financial relationships between healthcare professionals and industry are similarly widespread, inevitable and legitimate. However, these interactions and relationships must not be allowed to influence the topic or content of continuing education.
To ensure the integrity and independence of continuing medical education, anyone in a position to influence educational content must disclose all financial relationships with ineligible companies* before contributing to the educational activity. Relationships must be reviewed for relevance to the proposed topic and content, and then steps must be taken to mitigate the potential for bias. If mitigation is impossible, the planner or presenter cannot contribute to those aspects of educational planning and content where financial relationships exist.
After disclosure and mitigation, a list of relevant financial relationships of those involved in the activity is shared with learners, describing any strategies used to mitigate commercial bias. Finally, learners evaluate each activity for the perception of commercial bias during their post-course evaluation.
The University of Michigan Medical School at Michigan Medicine expects all educational planners and presenters to protect the independence and integrity of medical education. The Office of CME and Lifelong Learning has expertise and tools to help valued speakers contribute to educational activities at Michigan Medicine while mitigating commercial bias.
Identifying Financial Relationships and Mitigating Commercial Bias
Step 1. Disclose All Financial Relationships
All individuals able to control or influence educational topics or content must provide a list of their financial relationships with ineligible companies over the previous 24 months, regardless of the dollar amount or any self-perceived relevance of the relationship to the content. Financial disclosures must be received for all presenters at least five business days prior to the scheduled activity. Failure to do so could result in our inability to award CME credit for participation.
Ineligible companies are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. These organizations were formerly referred to as commercial interests.
- Pharmaceutical companies or distributors
- Device manufacturers or distributors
- Advertising, marketing, or communication firms whose clients are ineligible companies
- Bio-medical startups that have begun a governmental regulatory approval process
- Compounding pharmacies that manufacture proprietary compounds
- Diagnostic labs that sell proprietary products
- Growers, distributors, manufacturers, or sellers of medical foods and dietary supplements
- Manufacturers of health-related wearable products
- Pharmacy benefit managers
- Reagent manufacturers or sellers
Some financial relationships with companies such as non-profits, government agencies, and healthcare deliverers do not require disclosure. Examples of these organizations (termed eligible companies) include:
- Schools of medicine or health science universities
- Healthcare delivery systems: Hospitals, Ambulatory procedure centers, Infusion centers, Rehabilitation centers, Nursing homes
- Pharmacies that do not manufacture proprietary compounds
- Blood banks
- Diagnostic labs that do not sell proprietary products
- Electronic health records companies
- Government or military agencies
- Group medical practices
- Health profession membership organizations
- Health law firms
- Insurance or managed care companies
- Publishing or education companies
- Software or game developers
To ensure adequate time for disclosure and mitigation, all individuals involved in planning, presenting, and/or authoring educational content must register with MiCME (the cloud based administrative system for CME at Michigan Medicine).
For each role the individual must complete the My Financial Relationships form once per year. If an individual’s reported relationships change or a new relationship begins, this form must be updated by the individual.
Step 2. Mitigate Financial Relationships
The Office of CME and Lifelong Learning will review all financial relationships for relevance to the topic or proposed content. Our office will work directly with individuals to:
- Exclude any owners or employees of companies of interest from participating in the CME activity, except in very rare instances.
Owners are defined as individuals who have an ownership interest in a company, except for stockholders of publicly traded companies, or holders of shares through a pension or mutual fund.
Employees are defined as individuals hired to work for another person or business (the employer) for compensation and who are subject to the employer's direction as to the details of how to perform the job.
- Mitigate relevant financial relationships in order to avoid commercial bias; or, recuse individuals with relevant financial relationships that cannot be mitigated.
OCME-LL will follow up with Educational Planners as needed to address any questions, concerns, or recusals.
Step 3. Share Information with Participants
Educational Planners must share information about all relevant financial relationships and mitigation steps with participants before the activity begins. To facilitate this important last step, MiCME generates an Activity Information Sheet (a one-page flyer summarizing the identification and mitigation of relevant financial relationships for all individuals in control of educational content). The Activity Information Sheet can be easily shared with participants by email, included in print and electronic materials, or by physically posting or projecting at the activity.
Step 4. Evaluation and Monitoring
Following the completion of a CME activity, participants complete a brief evaluation of the activity to ensure the activity was free from bias. The Educational Planner must review completed evaluations to confirm the activity was free of commercial bias as expected. If biased content is detected, the Educational Planners should contact the Office of CME and Lifelong Learning so that appropriate action can be taken for future activities.
Frequently Asked Questions
Q. Are there any Financial Relationships that do not need to be identified?
Yes, there is no need to disclose financial relationships with companies whose mission and function include:
- Providing clinical services directly to patients
- The education of healthcare professionals
- Serving as a fiduciary to patients, the public, or population health.
A full list of such organizations can be found here
Q. Who cannot plan or present educational content at a CME activity?
- Individuals who refuse to identify their financial relationships.
- Individuals who are employees or owners of an ineligible company, except in some very rare instances.
Q. When should mitigation of relevant financial relationships take place?
All financial relationships must be identified and mitigated before the individual assumes their assigned role in the activity, whether that is planning the content or delivering a lecture. The timing depends upon the individual’s role in the activity:
- For Planners and Co-Planners, all relevant financial relationships must be identified and mitigated before the application can be submitted.
- For presenters, all relevant financial relationships must be identified and mitigated before the start of the CME activity.
Q. How can the identification and mitigation process be monitored to ensure it remains on track and the activity can go ahead as planned?
The Activity Coordinator uses the Financial Relationship Mitigation Summary to monitor which financial forms have been completed and if any financial relationships have been identified. The OCME-LL Financial Relationships Mitigator will review and assess all financial relationships for relevance to the proposed educational topic or content, and propose mitigation steps (if possible). Once all financial information has been finalized, the Activity Information Sheet can be easily shared with participants by email, physically posting at the activity, or included in print or electronic activity materials.
Q. Must physicians in training complete a disclosure of all financial relationships before presenting at a CME activity?
Yes, in general all physicians in training are required to complete the disclosure process before contributing to an educational activity providing CME credit. However, they are not required to complete a disclosure before presenting information regarding the care of a specific patient in which they helped to provide direct clinical care (for instance a case discussion at a morbidity and mortality conference).
Q. Are planners or presenters only required to disclose financial relationships that they consider relevant to the topic or content of the educational activity?
No, they must disclose all financial relationships with ineligible companies.
Q. Can a planner or presenter decide for themselves which financial relationships are relevant to the educational activity?
No, they must disclose all financial relationships with sufficient time for the Financial Relationship Mitigator in the Office of CME and Lifelong Learning to review and provide mitigation steps, should this be possible.