This page includes a list of common compliance issues that we have noted in recent accreditation reviews. For an extensive list of examples of compliance and noncompliance by criterion, please see the Compliance Library.
An accredited provider uses the following definition of a commercial interest in its policies/forms: “A commercial interest is any entity producing health care goods or services consumed by, or used on, patients.”
In this example, the provider’s definition of a commercial interest is outdated. The ACCME expanded the definition in 2007 to be more inclusive of other actions that would cause an entity to be considered a commercial interest.
The current definition reads: “A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.” Providers must have a mechanism that obtains financial relationships with all companies that fit within this definition in order to demonstrate that all conflicts of interest are identified and resolved and that all required information is disclosed to learners. Failure to do so would result in noncompliance in C7 (SCS 2, 6).
The following are examples of providers' agreements with commercial supporters.
<CME provider> is responsible for control of content and selection of organizers, presenters and moderators. Company/Commercial Supporter, or its agents, will respond only to <CME provider> initiated requests for suggestions of presenters or sources of possible presenters. Company will suggest more than one name (if possible); and will provide speaker qualifications…
<CME provider> may solicit assistance in the planning and production of the activity from [Grantor]. Acceptance by <CME provider> of advice or services concerning speakers, moderators, authors, invitees, or other educational matters, including content, shall not be a condition of support for this activity. [Grantor] may provide services in support of the preparation of activity materials; however, these materials shall not, by their content or format, advance the specific proprietary interests of [Grantor]. If [Grantor] offers to provide a presentation reporting results of scientific research, [Grantor] shall provide to <CME provider> a detailed outline in order to confirm the scientific integrity of the presentation.
In these examples, the providers’ policies allow commercial interests to control CME content through influencing decisions made about faculty, including faculty selection, and by providing assistance in the preparation of activity materials. These policy statements, if acted upon, would result in noncompliance in C7 (SCS 1.1).
An accredited provider asks for all persons in control of content to disclose their own relevant financial relationships with ACCME-defined commercial interests, but does not explicitly include those of the spouse or partner of the person in the request.
ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. The provider should demonstrate that it makes everyone who is in a position to control the content of a CME activity aware of this in the context of obtaining disclosure.
An accredited provider uses experts, who are the employees of ACCME-defined commercial interests, as faculty to present abstracts of clinical trials research on recently developed products of their employer. The provider ensures that in each case, the employees do not use the product names or include any promotional messaging, and that research on other therapeutic approaches is included.
This provider is in noncompliance. The use of employees or owners of ACCME-defined commercial interests as faculty and planners of accredited CME is prohibited, except in the specific situations permitted by the ACCME that maintain independence as specified here.
In its self-study report, an accredited provider indicated that the acknowledgement of commercial support may include corporate logos and slogans if they are not product promotional in nature. Evidence in performance-in-practice for 2 of 3 activities that received commercial support demonstrated that the provider acknowledged commercial support using the commercial supporters’ corporate logos.
Regarding the April 2014 modifications to Standards for Commercial Support 4.3 and 6.4 and the Commercial Support Acknowledgement Policy related to prohibiting the use of commercial interests’ logos in the disclosure of commercial support, the ACCME expects that, by May 2015, all activities that are current at that time and future activities will be in compliance. Including corporate logos of ACCME-defined commercial interests in making disclosure of commercial support for activities that occur after May 2015 will result in noncompliance.
An accredited provider’s mechanism to resolve conflict of interest for all persons, including those who planned the activities, is to conduct a review of the content prior to the activity, using an expert with no relevant financial relationships.
The practice described in this example would not resolve the conflict of interest for those who planned the activity, and will result in noncompliance with C7 (SCS 2.3). The mechanism to resolve a conflict must be appropriate to these individuals’ roles and responsibilities in the CME activity. Review of content would not resolve conflict for individuals whose responsibilities include, for example, the selection of topics or speakers. The provider might instead ensure that these individuals are recused from planning when it relates to their relevant financial relationships.
In performance-in-practice, an accredited provider presented evidence demonstrating that employees of ACCME-defined commercial interests presented content that was related to their companies’ products or businesslines. The provider did not designate the sessions presented by the commercial interest employees for CME credit. These sessions were scheduled back-to-back in the same space as the educational sessions offered for CME credit.
When employees of ACCME-defined commercial interests control content as planners and/or faculty and the content is related to the company’s products or business lines, then the content is considered by the ACCME to be promotional. 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 permitted by the ACCME. One strategy utilized by providers in an attempt to ensure independence is to offer sessions presented by commercial interest employees without CME credit. If a provider chooses to allow this, it must ensure that promotional sessions are separate from the accredited educational activity, and the separation of education and promotion must be made explicitly clear to learners. Intermingling promotional and educational sessions immediately before or after and in the same space as the sessions offered for CME credit does not meet the expectations of the ACCME. As stated in C9 (SCS 4.2): for live, face-to-face CME, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CME activity. Providers cannot allow representatives of commercial interests to engage in sales or promotional activities while in the space or place of the CME activity.
An accredited provider asks those in control of content to disclose “significant financial relationships” with commercial interests.
The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months. Inherent in any amount is the incentive to maintain or increase the value of the relationship. In this example, the use of the word “significant” suggests an amount of relative value, rather than an amount of any value, and could result in some relevant financial relationships not being disclosed to the provider and, therefore, to the learner, and would prevent the identification and resolution of all conflicts of interest. This would result in noncompliance in C7 (SCS 2, 6).