ON SEPTEMBER 28, 2004, the updated Accreditation Council for CME Standards for Commercial Support were finally approved. The new Standards were the main topic at the recent AMA Conference on CME Provider/Industry Collaboration in Baltimore. Three issues surfaced during the conference, which were reinforced in the published Background Rationale provided by the ACCME, that all parties to the CME Enterprise need to think about.
Resolving conflicts of interest: The ACCME states that a conflict occurs when individuals have a financial arrangement with a commercial interest and when opportunity exists to affect the content of a CME activity relative to the commercial interest. When those two events intersect, the ACCME provider is now required to “resolve the conflict.” The rub comes in what the ACCME interprets as acceptable methods of resolution. The ACCME said that a conflict can be resolved by removing the conflict (i.e., the faculty or planner renounces the relationship with the commercial interest), or by limiting the faculty's or planner's involvement with the content of the activity.
But in an updated publication, the ACCME softened the impact of this new rule by suggesting to providers that a “peer-review mechanism” may be used to resolve the conflict. This means that potential faculty or planners with an identified conflict can be strongly advised by the provider of content validation rules; the presenter's slides and materials could be reviewed by independent peers to assure unbiased and valid content; and the presenter can reference the best available evidence in the literature, the grade or level of that evidence, and identify the conclusions that the evidence support.
Control of content: The updated Standards state that commercial interests are not to influence content, faculty selection, etc. This was widely interpreted to mean that any input from commercial interests was no longer allowed. The ACCME now has softened that stand: While the commercial interest may not suggest or require that its views be included in a CME activity it supports, the provider may still request input from the commercial interest as long as they are not compelled to use the information or recommendations.
It is our view that regardless of how this rule has been softened, the OIG Advisory has caused supporters to tread lightly in this area of influencing content, and consequently most supporters are staying clear of this area.
MECCs in limbo: A pharmaceutical company executive asked at the AMA Conference whether the ACCME believed that a for-profit company, by definition, could truly act in the public interest. Murray Kopelow, MD, chief executive, ACCME, replied that the issue was “troublesome.” This left the status of those providers in limbo.
We think that there are two principles of CME that make it possible for a private interest to operate in the public interest.
Organizations that create a separate, pure educational division with oversight from a board of directors comprised of physicians and other professionals of stellar reputation, and have no pressure put on them related to CME content by the parent organization, are as able to be as objective as an academic organization.
Organizations with a thorough, independent content-validation process — reviewing course content for appropriate patient care recommendations, ensuring scientific objectivity of studies used in the activity, and looking for fair balance against a specific list of identified potential areas of conflict — in our opinion can provide the public assurance of the integrity of the CME process.
Steven M. Passin is president of Steve Passin & Associates in Newtown, Pa. He has also served as deputy health secretary for California. Contact him at Passin@PassinAssociates.com.