What is the Difference Between CME and Promotional Activities?
While some third-party stakeholders have expressed concern about the use of continuing medical education (CME) as an avenue of influence — often conflating provider education with promotional activities — there are in fact very strict safeguards in place to ensure the integrity of accredited CME events. Indeed, all major accrediting bodies, such as the Accreditation Council for Continuing Medical Education (ACCME), insist on the separation of education from all promotional activities, materials and messages, with stringent policies governing everything from the selection of faculty and attendees to the use of corporate logos and product-specific messaging.
Standards for Commercial SupporT
Many accreditors have directly adopted the Standards for Commercial Support (SCS) as promulgated by the ACCME, and have monitoring activities and disciplinary procedures in place, including the ability to revoke a program’s accreditation status if that program fails to live up to their rigorous standards. In addition to the ACCME SCS, the American Medical Association (AMA) has several ethical rules relevant to CME, manufacturers are bound by OIG guidelines and the AdvaMed and PhRMA Codes, and manufacturers have incorporated FDA’s Final Guidance on Industry-Supported Scientific and Educational Activities into their commercial support policies.
The ACCME SCS, and other similar standards of commercial support, create a principled firewall that prevents undue industry influence. As an overview, under the SCS, CME providers must ensure that the following decisions are made free of any control of a commercial supporter:
Providers must also show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. An individual who refuses to disclose relevant financial relationships must be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity. CME providers must implement a mechanism to identify and resolve all conflicts of interest prior to the education activity being developed and delivered to learners.
Providers must make all decisions regarding the disposition and disbursement of commercial support and cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as a condition of contributing funds or services. CME providers must have a written agreement that documents the terms, conditions, and purposes of the commercial support that binds the provider and its educational partner(s).
CME providers must also have written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers, and authors. Moreover, CME providers, the joint providers, or designated educational partners must pay directly any teacher or author honoraria or reimbursement of out-of–pocket expenses in compliance with the provider’s written policies and procedures. This means that an applicable manufacturer may never pay a faculty member directly nor can they make any other payment to the director of the activity, planning committee members, teachers, or authors, joint provider, or any others involved with the supported activity. In addition, CME providers are prohibited from using commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint provider, or educational partner. CME providers must produce accurate documentation detailing the receipt and expenditure of the commercial support.
The ACCME SCS also extends into arrangements for commercial exhibits or advertisements. Exhibits and ads cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities. Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. Educational materials that are part of a CME activity, such as slides, abstracts, and handouts, cannot contain any advertising, trade names, or product-group messages:
Individual faculty or CME presenters must disclose to learners any relevant financial relationships. This disclosure must include:
The ACCME SCS, and other similar standards of commercial support, create a principled firewall that prevents undue industry influence. As an overview, under the SCS, CME providers must ensure that the following decisions are made free of any control of a commercial supporter:
- Identification of CME needs;
- Determination of educational objectives;
- Selection and presentation of content;
- Selection of all persons and organizations that will be in a position to control the content of the CME;
- Selection of educational methods;
- Evaluation of the activity.
Providers must also show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. An individual who refuses to disclose relevant financial relationships must be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity. CME providers must implement a mechanism to identify and resolve all conflicts of interest prior to the education activity being developed and delivered to learners.
Providers must make all decisions regarding the disposition and disbursement of commercial support and cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as a condition of contributing funds or services. CME providers must have a written agreement that documents the terms, conditions, and purposes of the commercial support that binds the provider and its educational partner(s).
CME providers must also have written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers, and authors. Moreover, CME providers, the joint providers, or designated educational partners must pay directly any teacher or author honoraria or reimbursement of out-of–pocket expenses in compliance with the provider’s written policies and procedures. This means that an applicable manufacturer may never pay a faculty member directly nor can they make any other payment to the director of the activity, planning committee members, teachers, or authors, joint provider, or any others involved with the supported activity. In addition, CME providers are prohibited from using commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint provider, or educational partner. CME providers must produce accurate documentation detailing the receipt and expenditure of the commercial support.
The ACCME SCS also extends into arrangements for commercial exhibits or advertisements. Exhibits and ads cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities. Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. Educational materials that are part of a CME activity, such as slides, abstracts, and handouts, cannot contain any advertising, trade names, or product-group messages:
Individual faculty or CME presenters must disclose to learners any relevant financial relationships. This disclosure must include:
- the name of the individual;
- the name of the commercial interest(s);
- the nature of the relationship the person has with each commercial interest.
| CME vs. Promotional Activities |
