While the overall response to the new Standards has been very positive, there is one aspect that is generating concern among CME providers. Standard 4.5 says that a provider cannot use a commercial interest as the agent providing a CME activity to learners.

"We do not want providers to build in commercial interests and sales people as the dissemination strategy," says Murray Kopelow, MD, chief executive, Accreditation Council for CME. "They are going to have to use the mail." As to whether pharma sales reps can distribute activities, "That is not in ACCME’s Standards; somebody else regulates that."

While Kopelow says the purpose of the policy is to support the concept that CME and industry promotion must be separated, Jack Kues, PhD, assistant dean for CME, University of Cincinnati, questions the necessity for the rule. "This has nothing to do with the speakers or the content. This is simply access to CME that a commercial supporter is not influencing." The policy will increase expenses for CME providers, he says, who will have to purchase lists of physicians and mail activities to them. And that method will not be as effective as disseminating activities through sales reps. "The pharmaceutical reps have the advantage of knowing the physicians, and they explain a little bit about the activity when they hand the doctor the brochure or CD-ROM. It really saves the physician time. And often the physician won’t take that time—they’ll put the activity in the garbage without looking at it."

The policy creates a hardship not only for the provider, but for the commercial supporter as well, Kues says. "This is CME, so it’s unbiased, balanced, educational material that the pharmaceutical representatives use as a way to give something back to the physicians. An alternative to pizza, if you will. In fact, the American Medical Association would prefer that reps hand out CME activities rather than pizza, because CME is relevant to patient care. It’s not a golf ball, a pad, a pen, a clock, or food—it’s education."

Other providers had questions about how to interpret the policy. Are reps allowed to hand out invitations or brochures for CME activities? Kopelow responds, "Again, other agencies regulate that." Can the commercial supporter pay for the printing and mailing of a CME activity to potential participants? Yes, answers Kopelow. That process could be included in a letter of agreement between the provider and the commercial supporter.

Can CME providers allow commercial supporters to link from the supporter’s Web site to the CME provider’s Web site? Yes, responds Kopelow, clarifying that under the ACCME’s Internet policy, providers cannot allow pharmaceutical companies to put accredited activities on their Web sites.