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The Devil is in the Details
The ongoing effort by accreditation and monitoring groups to separate commercial interests from continuing medical education (CME) funding appears to be raising as many questions as answers.
by Carolyn Gretton
It has been a year since Pfizer rocked the CME sector by announcing it would no longer fund physician CME programs provided by third-party medical education and communications companies. Other major pharma companies quickly followed with pledges to either end third-party funding or to disclose when third-party funding was used in their CME activities. On the provider side, communications companies have spun off their medical education units in an effort to establish a clear boundary between their promotional businesses and their CME operations. These moves were prompted mainly as a result of revised guidelines issued by the Accreditation Council for Continuing Medical Education (ACCME) calling for more stringent monitoring and disclosure of commercial involvement in CME. ACCME, a nonprofit accrediting body for organizations that produce CME in the United States, provides recommendations for the funding through its Standards for Commercial Support. Among other requirements, the ACCME standards mandate that all of those involved in the development and presentation of CME activities must disclose relevant financial relationships with commercial interests, and that anyone who refuses to disclose is disqualified from planning or teaching CME activities. However, experts note that the revised ACCME guidelines are only part of the impetus behind the changes roiling the CME sector. Chris Bogan, CEO of Best Practices, notes that there are a number of factors behind the recent decline in overall CME funding, not the least of which is the persistently sluggish U.S. economy, which has caused companies to rethink overall funding at all levels. “It’s not just the Pfizer issue: it’s Pfizer plus the overall public debate, the scrutiny, the regulatory issues, the change in healthcare,” Mr. Bogan says. “Even support for larger scientific societies and medical associations that deliver forms of CME is being closely scrutinized.” Some of this scrutiny is coming from the government. During a hearing on conflicts of interest in CME held in July by the U.S. Senate Special Committee on Aging, ACCME Chief Executive Murray Kopelow, M.D., outlined some of the steps taken by the ACCME in recent months to strengthen its standards enforcement and increase the system’s transparency and accountability. These include the development of a Web portal for collecting up-to-date program content and financing data from CME providers and an acceleration of its enforcement process for accredited CME providers found to be out of compliance with Standards for Commercial Support. Mr. Bogan views the greater transparency as a positive in the long run, but observes that in the short term, it has created funding pressures on smaller organizations and projects that now have to follow a much more formalized grant process. “Smaller projects — $1,000 or $2,000 activities, talks, or roundtables, for example — are being squeezed because of the greater effort involved in having to make a grant request,” he says. “At that level, it probably discourages some groups and types of programs from even applying for funding.” Controversial proposal Earlier this year, ACCME solicited feedback on its proposed policy of differentiating CME programs that include relationships with the industry from those that do not. The proposal includes the creation of a new designation and review process for providers that wish to identify their program of CME as one that does not use funds from commercial interests that have been donated to support continuing medical education, such as commercial support-free. Standards suggested for this designation include not accepting any commercial support for any CME activity, or any part of a CME program, and not using funds from advertising or promotion, paid by an ACCME-defined commercial interest, to underwrite the costs of CME. A common theme emerging from the comments ACCME published on its Website is that while identifying commercial support-free CME is a good idea, its execution may prove difficult. In his comment to ACCME on the proposal, Jeffrey Uppington, M.B.B.S., a member of the California Society of Anesthesiologists and a faculty member of an academic department that organizes annual CME review courses, notes: “It is not clear in the proposal whether the designation applies only to a specific program offered, or if a provider that offers multiple CME programs would be regarded as polluted for all programs, even if unrestricted educational funding was received only for a single program. “In either event, the CSA and I believe these restrictions would limit our ability, as an ACCME-accredited CME provider, to provide high-quality and relevant CME programs to our members and to the practitioners our review course serves,” Dr. Uppington adds. Mary Manna Anderson, president of HLS, a CommonHealth company, says today, 90 of 125 U.S. academic medical centers now have policies regarding physician-industry interactions. “Such policies limit activity, as well as compensation, to an average of $15,000 to $20,000 per pharma company — not brand,” she says. “Pharma companies frequently engage national opinion leaders as consultants, advisors, and, to some extent, faculty trainers and speakers. These new dollar limits will necessitate that companies engage national opinion leaders more strategically and engage more regional and local opinion leaders in private practice.” (For more information, please see the VIEW on Increased Regulation and Mature Web Technology: Fertile Ground for a New Generation of Clinical Opinion Leader Engagements.) In her comment to ACCME, Sandra J.P. Dennis, deputy general counsel for healthcare for the Biotechnology Industry Organization (BIO), expresses concern that creating this kind of stratification of CME programs could impact the quality and availability of CME as a whole. “A designation process suggesting that there is an unsubstantiated problem with these activities could reduce learner participation, resulting in reduced interest in commercial support for CME and a decrease in overall activities,” Ms. Dennis notes. “BIO agrees with the ACCME’s belief that CME is a strategic asset, and therefore we encourage the ACCME to focus on how to meet this goal through the current accreditation process.” Mr. Bogan’s view on the proposal is twofold. “I do like the idea of the designation because I think it might be helpful in evaluating whether this hobgoblin of concerns about commercial funding and the impact on CME is real or just paranoia,” he says. “If CME is differentiated by funding designation, such as commercial support-free or commercial-supported, then everyone would be able to clearly see if there are quality and content-type differences between programs created through the different funding designations. I suspect that there’s a lot more concern about this conspiracy of funding influencing program quality and content than I have ever found to be the case, so I like the idea of shining a light on it to dispatch any concerns.” However, he cautions, the process could backfire in such a way that the adverse effect would be greater than the benefit. “The designation could mean commercially funded programs that aren’t available anywhere else could be eliminated from consideration because people might begin to worry that such funding means the program is compromised,” he observes. “This would slow the information diffusion process, the education process, and could cause the starvation of funds for a smaller set of program types. I think we would all ultimately lose out if this were the case.” Physicians’ Perspective Despite ongoing concerns about the potential bias of commercially funded CME, feedback from recent surveys conducted by ACCME and consulting groups show that physicians don’t appear overly troubled by it. For example, only 9% of U.S. physicians surveyed for a recent Manhattan Research study said they oppose commercial support for CME funding, and only 8% of physicians who participated in CME believe that it is biased. In fact, if commercial support is halted, nearly half of the physicians surveyed said they would decrease their use of CME. According to Ezra Ernst, general manager, Medscape LLC, more than ever, physicians are reaping the benefits of advances in technology and education and, consequently, are increasingly recognizing the value that CME affords them in their daily practices. This is evidenced by the 385% growth rate observed in online CME over the last five years. “The value of CME to practicing physicians seems obvious,” he says. “Precisely as the practice of medicine has become more complex, today’s physicians have diminished time to devote to learning about new disease management strategies. The broad accessibility of high-quality, interactive CME activities offers them unparalleled access to insights from key opinion leaders and myriad learning opportunities. (For more information, please see the VIEW on The Value of CME.) In a prepared statement announcing the study findings, Manhattan Research President Mark Bard observed: “While there’s been debate around the value of industry-supported CME, as our study reveals, it’s important to listen to the voice of the majority of physicians. Rather than pulling the plug on a vital source of CME funding, the primary beneficiaries of CME — physicians and patients — would be best served by continued improvements to course availability, offerings, and content through increased collaboration among medical and academic organizations, the pharmaceutical industry, CME providers, and accreditation bodies.” Physician feedback to ACCME’s proposed “commercial support-free” label for CME appears to reinforce this view. In its comment to ACCME, The American Academy of Family Physicians (AAFP) notes the proposed designation “conflicts with ACCME’s recent position on external funding and creates a perception of quality CME based on a hierarchy of funding source.” The AAFP comment further observes that an ACCME-commissioned study published in June 2008 found no evidence that commercial support-free accredited CME is superior to CME funded with external support. Interestingly, research conducted by Best Practices seems to indicate that many medical professionals believe commercial involvement is necessary if CME is to thrive. “We did one study reaching out to prestigious medical schools and teaching institutions that had programs that were supported commercially,” Mr. Bogan notes. “And that quick little poll of small but elite subgroups said that if all commercial funding were cut off, they thought probably anywhere from 60% to 80% of their funding for certain types of programs would disappear.” At a recent conference on industry support of CME co-sponsored by the Center for Medicine in the Public Interest (CMPI) and the Coalition for Healthcare Communications, Jack Lewin, M.D., CEO of the American College of Cardiology, explained that organizations such as his emphasize transparency of industry involvement in CME programs. “We make certain that CME activity is absolutely firewalled with a degree of scrutiny,” Dr. Lewin says. “Were we not to have these additional services, which we believe rapidly advance the education of our members and the translation of science to the point of care, the patients and doctors who serve them will be harmed.” Change is Constant It is always difficult to forecast the direction of a sector as dynamic as CME. In the short term, Mr. Bogan believes that the combination of a sluggish economy and increasingly restrictive funding guidelines could result in a shakeout in the sector. “The funding shortages will probably be felt in particular camps and quarters of the CME sector, especially the smaller firms,” he says. “Some really good CME vendors could disappear just because they were small boutique companies that couldn’t overcome the market pressure.” Aside from the continued debate on commercial funding, Mr. Bogan believes the greatest challenges facing CME in the next year or two include demonstrating the value and positive impact of CME and optimization of CME delivery. Michael Zilligen, general manager of ProCom, a CommonHealth company, says education has changed forever in the wake of the Internet, which has made information available to more people than ever before. “In medical education, the added benefit of instant access to a wealth of specialized subject matter delivered using many different methods provides a time-saving and cost-effective alternative to traditional learning,” he adds. (For more information, please see the VIEW on Adult Distance Learning in Promotional Education Programs.) Mr. Bogan contends that there is a general concern about the quality of CME programs and how educational impact can be demonstrated, which is articulated most coherently by the biopharma side that funds it. With most CMEs still favoring the in-person model of delivery, Mr. Bogan says the next step is broader adoption of technology. “We need to discover how to use technologies to deliver CME at a lower cost and potentially with more flexibility and higher quality, while helping to advance the practice of medicine,” he says. Karen Sullivan, editor/writer, ProCom, a CommonHealth company, says with the advent of the Internet, medical education developers can deliver information faster than ever. “Taking a cue from the success of online degree programs, today’s education programs use the power of the Internet to reach countless HCPs, and increase knowledge retention by blending electronic media with the methodologies of adult distance learning,” she says. (For more information, please see the VIEW on Adult Distance Learning in Promotional Education Programs.) F PharmaVOICE welcomes comments about this article. E-mail us at firstname.lastname@example.org. Chris Bogan Best Practices If CME is differentiated by funding, such as commercial support-free or commercial-supported, then everyone would be able to clearly see if there are quality and content-type differences between different programs.