The definition of commercial interest in the new Standards has stimulated some debate. Standard 1.1 defines a commercial interest as any proprietary entity producing healthcare goods or services. Non-healthcare-related companies are exempt, as they do not have any incentive to insert bias into CME, says Murray Kopelow, MD, chief executive,. Non-profit groups are also exempt. Standard 1.2 adds that a commercial interest cannot take the role of the nonaccredited partner in a joint sponsorship relationship.
"This isn’t saying that if you’re an FDA-regulated company, you’re a bad guy, and everybody else is fine," says Kopelow. "It has to do with your relationship and whether your interest is commercial in a healthcare product or service—and that’s quite broad. An organization that is fundamentally a unit of a device manufacturer or a pharmaceutical com- pany will be considered a commercial interest."
Does that mean that any medical education or communication company that has a promotional arm will be considered a commercial interest? In those cases, MECCs will have to adhere to the ACCME’s firewall policy, says Kopelow. "It doesn’t mean they have to go out of business or stop being CME providers, but they’re going to have to do it right."
The exemption for nonprofit organizations "seems to put some providers in a more protected category than others," says Karen Overstreet, EdD, RPh, president, Nexus Communications Inc., North Wales, Pa. "A not-for-profit [status] is simply a tax category; it has nothing to do with the quality of the work or the organization’s mission."
Kopelow disagrees. For an organization to attain 501(c) 3 status, "there must be no ‘self dealing’—the work of the organization must be in the public interest. ACCME is deferring to the higher authority of the law to regulate providers in this regard," he says.
But what about for-profit hospitals and medical schools? "The primary mission and purpose of these organizations is delivery of health care—regulated by other organizations, such as the Joint Commission on Accreditation of Healthcare Organizations," Kopelow says. "Some have complicated circumstances, with respect to commercial interests, that they will need to reflect upon and manage. Safeguards will have to be put in place so that any commercial interests inside these institutions do not control the content of CME. Fortunately, the framework for these management systems is often already in place in the context of research."
The bottom line, says Kopelow is whether the CME provider’s interests are aligned with the public interest.
"It’s like the curb on the side of the road. You’re either parallel to that curb or you are divergent to that curb."