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.
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.)
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.”
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.
However, the issue of institutional conflict of interest is gaining importance to grantors. While MECCs affiliated with advertising agencies may appear to be more at risk than other providers for blurring the line between education and promotion, commercial supporters are increasingly concerned about conflicts of interest across provider types, says Mike Saxton, Med, FACME, senior director, team leader, Medical Education Group, U.S. Medical, Pfizer Inc., New York. “All conflicts of interest need to be addressed at the organizational level,” he says. “It's no longer enough to resolve conflicts of interest at the individual level. We need to be clear that whether a CME unit is part of a hospital, academic medical center, association, or MECC, if the parent organization's mission is not fundamentally aligned with patient care, there's a potential conflict of interest right at the heart of the relationship.” He agrees with ACCME's proposed position, adding, “Like many, I would say let's not stop there.”
Commercial supporters are increasingly raising questions about various types of financial relationships, he says. “If we have to pay a $50,000 fee — what many call ‘pay or play’ — for a satellite symposium, is that a conflict of interest? What about academic medical centers where clinical departments can bypass their CME office to go directly to the pharmaceutical company for a grant rather than going through their CME department — is that an organizational conflict? How about providers that allow a non-accredited company to secure grants and then they come to the provider for certification? What about a provider that gets 70 percent or 80 percent of funding from one commercial supporter — is that a conflict of interest? What about providers that use business development people — who are paid on a commission basis — to solicit grants? These are questions we need to address with policy changes.”
As for the first, and less controversial proposal — that providers will be found noncompliant if they enter into written agreements with grantors that specify how they plan to fulfill ACCME requirements — again, ACCME did not explain its rationale. However, providers do have some ideas. Steele says pharma companies' letters of agreement have become much more complex and challenging for providers. For instance, she cites a letter that specifically required a provider to use a particular company for outcomes assessment. Agreeing to that requirement would violate the Standards for Commercial Support, as providers are supposed to be in charge of all educational decisions. Steele expressed her concerns to the ACCME, saying that providers “need something with teeth in it so we can legitimately say to commercial supporters, ‘No, we can't do this,’ or ‘We won't sign this letter of agreement.’”
NAAMECC, however, does not support the proposal. “ACCME seems to be trying to stop supporters from inappropriately directing the activity, and of course that's what ACCME should be doing,” says Overstreet. “But as we point out in our response, many supporters are hiring educators now; they're hiring people who are much more knowledgeable and sophisticated regarding CME than in the past. And those people may have something constructive to bring to the table that doesn't influence content or faculty.” The ACCME's proposal might have the unintended result of driving underground productive and compliant discussion between providers and commercial supporters, she says. “I don't think that's good for anybody. The community needs to be more transparent, not less transparent.”
Steele disagrees. “There are a lot of things we shouldn't be talking to commercial supporters about anyway. Some providers who may be a little bit more naive may be talking to industry about things that aren't within their purview. [The proposal] shouldn't limit [appropriate] conversations.”
Saxton also supports the proposal. “Any ACCME policy that ensures that commercial interests are not requiring specific, predetermined solutions for any element of educational design is a good idea,” he says. “There are many ways we can play an appropriate supportive role and champion higher standards regarding outcomes, continuous assessments, various methods. But any time a commercial supporter requires, either explicitly or implicitly, any specific element of that educational process, that crosses the line.”
Rather than restrict dialogue, he thinks the proposed rule will facilitate it. “Any time that we remove the potential that a commercial interest can prescribe a solution, we're opening up dialogue.”
In addition to the example mentioned earlier, where a grantor required a provider to use a certain company for outcomes measurement, there have been other problems with letters of agreement, says Steele. Recently, for example, grantors have been asking providers to attest to the companies' business and compliance practices. Indemnity, arbitration, and refund clauses have also been problems.
To address these issues, Steele, representing SACME's board, is working with NAAMECC board member Mark H. Schaffer, EdM, vice president, CME compliance, Thomson Professional Postgraduate Services, Secaucus, N.J., to put together a position paper about letters of agreement. “You've got MECCs and academic providers working together on the same kinds of issues — that's a pretty strong coalition,” she says.
The Accreditation Council for CME has published a list of providers that received one or more exemplary compliance findings during the March, July, and November 2006 accreditation review periods. The numbers show that more MECCS (categorized as publishing/education companies) earned exemplary compliance than any other CME provider type except physician membership organizations.
In terms of percentages, MECCs are ahead. There are 154 MECCs, according to the ACCME 2006 data report. Thirty of them, or 19 percent, received exemplary compliance ratings. Of the 267 physician membership organization providers, 31, or 12 percent, earned exemplary compliance. There are 122 schools of medicine, of which 19, or 16 percent, were awarded exemplary ratings.
Of the 93 providers categorized as hospital/healthcare delivery systems, 12 (13 percent) received exemplary marks. In the smaller categories, three out of the 34 nonprofit (other) providers (9 percent), two out of the 14 insurance company/managed care company providers (14 percent), and two out of the 29 unclassified providers (7 percent) earned exemplary compliance.
NANCY DAVIS, PHD, has co-founded the National Institute for Quality Improvement and Education, and serves as its first executive director. The newly founded institute, based in Homestead, Pa., is a not-for-profit organization focusing on the integration of quality improvement and continuing education for healthcare professionals. Davis cofounded the organization with Lloyd Myers, RPh, president of the healthcare technology company CECity, which is providing startup support for NIQIE. Most recently, Davis served as the director of CME at the American Academy of Family Physicians, Leawood, Kan.
BRUCE BELLANDE, PHD, has joined CME Enterprise, Carmel, Ind., an ACCME-accredited provider, as president. A CME industry leader, Bellande previously served as Alliance for CME executive director for more than a decade, and has more than 30 years experience in the field.
PAUL D. WEBER has taken the helm as executive director of the Alliance for CME, Birmingham, Ala. A medical association executive with more than 30 years' experience in the healthcare field, Weber joins ACME from the California Medical Association, San Francisco, where he served as chief operating officer for the past two years.