The Accreditation Council for Continuing Medical Education recently provided clarity on the roles of industry employees in planning and delivering CME activities. ACCME’s Standards for Commercial Support require that accredited continuing medical education be independent and free of control of commercial interests, and employees of industry have been prohibited from participating in accredited CME. ACCME now makes clear that employees of industry can be engaged in a “specific, limited role” in certain aspects of continuing education. Murray Kopelow, President and CEO of the ACCME, notes that the new guidance fulfills ACCME’s mission to “support the free flow of scientific exchange while safeguarding accredited CME from commercial influence.”
ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. Specifically, under Standard 1 of the ACCME’s Standards for Commercial Support, an accredited CME provider may not allow a commercial interest to control or influence:
- (a) Identification of CME needs;
- (b) Determination of educational objectives;
- (c) Selection and presentation of content;
- (d) Selection of all persons and organizations that will be in a position to control the content of the CME;
- (e) Selection of educational methods;
- (f) Evaluation of the activity.
“The use of employees of ACCME-defined commercial interests as faculty and planners or in other roles where they are in a position to control the content of accredited CME is prohibited, except in the specific situations specified here,” states the ACCME in its new guidance, released last week.
The ACCME identified three “special-use cases where employees of ACCME-defined commercial interests can have a specific, limited role in accredited CME activities.” ACCME notes that there are circumstances where an employee of an ACCME-defined commercial interest can make a scientific presentation within accredited CME about their company’s research and still be compliant with the ACCME Standards for Commercial Support.
- (1) 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.
- (2) 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.
- (3) 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.
ACCME also makes clear that, as in every accredited CME activity, the expectations of ACCME’s Standards for Commercial Support for the three situations must be met.
The new guidance included FAQ-type scenarios that show how ACCME’s new policies would play out in the workplace. See “Examples of Compliance and Noncompliance” here.
An accredited provider would be in compliance, for example, with ACCME standards where:
- An employee of an ACCME-defined commercial interest participates as a teacher in an accredited CME activity whose content is about the drug discovery process, itself, and is not about treatment or diagnostics. The activity is targeted to scientists whose research is focused on drug discovery.
- An employee of an ACCME-defined commercial interest participates as an author and presenter in an accredited CME “Scientific Poster Session” where the content of their presentation is limited to reporting research results (e.g., biology, physiology, physics) early in the drug discovery process so as to not include any discussion of product development. The provider demonstrates that the CME activity does not include any discussion or clinical recommendations concerning the use of products or devices of ACCME-defined commercial interests that could be used or prescribed for patients.
- An employee of an ACCME-defined commercial interest participates as a planning committee member, author, and trainer in an accredited CME activity on disaster management preparedness. In its Performance-in-Practice evidence, the provider demonstrates that the content of the CME activity (“disaster management”) is not related to the business lines or products of the employer, a medical device manufacturer.
- The accredited provider plans an intensive hands-on course to train physicians to perform vascular interventions using new FDA-approved medical devices and equipment. The course director asks several ACCME-defined commercial interests to provide equipment and medical devices for use in the CME activity and also to provide technicians (i.e., employees of the commercial interest) to operate the equipment during the CME activity. The accredited provider tracks the loaned equipment as in-kind commercial support. The course director plans the CME activity independent of the control of ACCME-defined commercial interests; she determines what procedures will be taught, instructs the commercial interest employees on their limited roles, and is present to oversee and participate in the instruction. The course director monitors the CME activity to ensure that demonstration and comments provided by the device technologists are technical only (i.e., about the safe and proper use of the equipment) and do not include clinical recommendations about the medical devices/equipment of the manufacturer(s).
A provider would NOT be in compliance where:
- The accredited provider uses an employee of an ACCME-defined commercial interest—a company that distributes pharmaceuticals—as faculty for a CME activity. From its Performance-in-Practice materials and subsequent accreditation Interview, it is determined that the provider failed to identify a pharmaceutical distributor as an ACCME-defined commercial interest because the forms it used to identify relevant financial relationships included language that did not accurately reflect all of the types of organizations included in the ACCME’s definition of a commercial interest.
- The accredited provider uses employees of ACCME-defined commercial interests as members of a CME committee that determines topics and speakers for accredited CME activities related to the products of their employer(s). In its Performance-in-Practice materials, the provider shows that it identifies relevant financial relationships for members of the CME committee and manages conflicts of interest using several strategies (e.g., peer-review of content, recusal from discussions related to their financial relationships). The identification and resolution of conflicts of interest (Standard 2 of the ACCME Standards for Commercial Support) is not a valid mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of CME activities related to the business lines and products of their employer, per Standard 1.
- The accredited provider uses employees of ACCME-defined commercial interests as authors and speakers in CME activities related to the business lines and products of their employer(s). In its Self-Study Report and Interview at reaccreditation, the provider describes that it ensures the independence of its CME activities by having commercial employees attest that the content they present about commercial products is ”fair and balanced.” This is not an acceptable mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of accredited CME that is related to the business lines and products of their employer.
ACCME’s latest guidance and accompanying FAQs are welcomed instruction. The policies that ACCME sets forth here can be traced to a 2010 controversy involving whether industry scientists would be able to present CME at an American Heart Association conference. The ACCME and AHA eventually reached an agreement, and ACCME released guidance that closely parallels what they have now released, five years later.