The Accreditation Council for CME has proposed two new positions regarding the Standards for Commercial Support, one of which could have drastic consequences for medical education and communication companies. The first states that providers will be found noncompliant if they enter into written agreements for commercial support that stipulate how they plan to fulfill ACCME requirements. Second, the ACCME is recommending expanding the definition of commercial interest. It's this second proposal that has sparked strong protest from MECCs.

Currently, commercial interests are defined as companies that produce healthcare products or services, usually meaning pharmaceutical/biomedical companies. The new definition would cast a much wider net, also including companies that market, resell, or distribute healthcare goods or services, or that participate in and/or profit from the distribution, promotion, or sale of those products. While there are certain exemptions, such as for-profit hospitals, rehabilitation centers, and nursing homes, this new definition would include medical communication companies that are involved in marketing, clarifies Murray Kopelow, MD, chief executive, ACCME. (For the full text of the proposals, visit accme.org.)

The ACCME issued the proposal in February with a call for comment that extended until March 30. The responses will be analyzed and discussed at the ACCME's July 19 to 20 board meeting, says Kopelow, adding that he is not commenting to the press about the proposals until after that meeting.

MECCs Excluded

While a few MECCs are completely independent, the majority of MECCs are a division of a parent company or have a sister organization involved in marketing. If passed, the proposal would redefine most MECCs as commercial interests, which means they couldn't be accredited providers or joint sponsors, says Karen Overstreet, EdD, RPh, FACME, president, North American Association of Medical Education and Communication Cos.; and president, Indicia Medical Education, LLC, North Wales, Pa. “They'd have to go out of business or go into a different business or they would have to [work] behind the scenes and not be named as a joint sponsor — and that's the opposite of what we want,” she says.

The ramifications would extend far beyond MECCs, she says, as MECCs are involved, at least as joint sponsors, in numerous commercially supported CME activities. MECCs function as logistics planners, medical writers, and partners to medical schools and specialty societies. For instance, she says, the great majority of satellite symposia that take place at large medical association and society meetings involve MECCs.

While the ACCME did not specify why it was making the recommendation — and it issued the proposal before the U.S. Senate Finance Committee released its CME report, which seemed to paint medical education companies with a negative brush — there has long been concern in the academic provider community about MECCs' ties to the pharma industry. Because many med-ed companies do have parent/sister organizations that handle promotion for drug company clients, some academic providers believe that those MECCs are beholden to industry, that their education is not truly separate from promotion, and that they should not be accredited.

But NAAMECC disagrees, stating in its response to the ACCME's call for comment: “MECCs have already spent considerable time and resources to make sure that their CME arms are independent of commercial interests.”

In fact, Overstreet says, accredited MECCs are just as, if not more, compliant with ACCME guidelines as any other type of provider. “Because MECCs are looked at suspiciously by some people, in general MECCs are more conservative and have more rigorous policies for peer review and content validation than a lot of other providers do,” she says. “If you look at [ACCME] data, MECCs perform at least as well as other types of providers, and when dealing with commercial support, MECCs perform better than most providers, and so [the criticism about MECCs is not] evidence-based.” (See sidebar, page 14.)

Firewalls for All

If the intent of the proposal is to ensure the separation of marketing and education, then the ACCME should create a firewall policy applicable to all accredited providers' organizations; perhaps an updated version of its now-rescinded firewall policy, NAAMECC says in its comments. “We suspect that the real issue under discussion is that of institutional conflict of interest,” NAAMECC's response says. “We believe this is an important issue to address.” However, the ACCME should not single out entities for exclusion based on their tax status or organization type. “Bad behavior can occur anywhere in healthcare.”

When developing a firewall policy or new position statement, ACCME should not only consider the relationships between commercial interests and MECCs, but also financial relationships between pharma companies and medical schools, specialty societies, and hospitals, NAAMECC wrote. For instance, academic institutions may receive research grants from pharma companies or hold patents or other intellectual property rights to products developed or marketed by a commercial interest. “It's an issue of equity,” says Overstreet. “Specialty societies and medical schools in many instances have a much closer relationship to the sale of pharmaceutical products than MECCs.”

Marketing Versus Education

Others, however, say that comparing those relationships is equating apples and oranges. “The key concept is the marketing issue,” says Melinda Steele, president-elect of the Society for Academic CME; medical school provider section leader, Alliance for CME; and director, CME, Texas Tech University Health Sciences Center, Lubbock, Texas. “Yes, academic and specialty societies have financial relationships with industry, but usually there's a clear separation between marketing and research interests. I'm not saying that the people who do the clinical research are not involved in education — they are — but clear conflict of interest policies both at the institutional level and at the provider level resolve those issues. There are financial relationships everywhere, but when it comes down to marketing versus education, that's where the distinction needs to be made.”

She supports the proposed policy, saying, “If you're involved in marketing, maybe you shouldn't be involved in education. The redefinition would be “a chance for MECCs to examine what their business [model] really is and determine if they're in marketing or if they are in education,” says Steele.