In a unanimous vote last week, the Accreditation Council for CME Board of Directors voiced its approval for the new revision of the Standards for Commercial Support (available at www.accme.org).
For CME professionals who found the initial revision, released in January 2003, difficult to understand and worried that it would be impossible to enforce, these new Standards should come as a relief. Gone are the five pages of themes, elements, and numerous footnotes. Instead, the new, two-page document comprises six Standards, each with several points clearly delineated.
The CME community’s major concern regarding the initial draft was the stipulation precluding doctors from teaching if they had a conflict of interest. There is no such stipulation in the new version.
Under Standard 2: Resolution of Personal Conflicts of Interest, thesays that everyone who is in a position to control CME content must disclose all relevant financial relationships with any commercial interest. Anyone who refuses to disclose cannot have control of CME activities, and will be disqualified from being a planning committee member, a teacher, or an author.
This is a major change from the current Standards, where a refusal to disclose did not preclude people from planning CME activities or teaching them. However, "The Accreditation Review Committee and the Council have always said that if the majority of [your teachers] are refusing to disclose, you are out of compliance," explains Murray Kopelow, MD, chief executive, ACCME. "What is new is that CME providers have to make decisions and take actions on the basis of the conflict of interest information."
But what does conflict of interest mean? The ACCME is issuing its definition in a separate policy, which will say: Any financial relationship with a commercial interest that is relevant to the content is a conflict of interest, according to Kopelow. "There are no de minimis requirements," he says. "It’s not that $1,000 is fine, but $5,000 is too much." The reason the definition will be in a separate policy, rather than incorporated into the new Standards, is because "if it needs more clarification, or we need to change or modify it, we can do it more nimbly if it is outside of the Standards."
Managing Conflicts of Interest
Under Standard 2.3, CME providers must implement a mechanism to identify and resolve all conflicts of interest prior to the educational activity. But what procedures will satisfy the ACCME? "We are going to support [CME providers] with examples and explanations about the range [of acceptable methods]," says Kopelow. For instance, if a CME provider discovers that a speaker has a conflict of interest, the provider can choose a different speaker, or inform the speaker that he or she will not be allowed to make recommendations about specific drugs or treatments, but will just explain the physiology of the drugs. "It’s not as if [providers] have to pick one of those choices," says Kopelow. "Those are just examples of process. What they have to do is have a mechanism and the mechanism will be up to them."
The new Standards also include sections about managing relationships with commercial supporters, advertising and promotion, and preventing commercial bias in CME activities.
Now that the Board of Directors has approved the new Standards, they will be transmitted to the seven ACCME member organizations, which will have until the end of September to decide whether to approve the document. If they do approve it, CME providers will be expected to begin incorporating the changes immediately, says Kopelow. However, the ACCME will not begin making accreditation decisions about providers under the new Standards until November 2006, or beyond.
In forthcoming print issues of MM, we will offer more analysis and feedback on the new Standards. Let us know what you think. Contact Tamar Hosansky at (978)466-6358, or e-mail email@example.com