Hilary Schmidt's credentials suggest academic rigor. They also let colleagues know she's got their back. Schmidt has a PhD in psychology from the University of Pennsylvania and has spent years studying how medical students learn. Her experience includes founding three teaching and learning centers at academic hospitals, including one at Columbia University Medical Center. But when she joined Aventis two-and-a-half years ago as head of medical education, her new employer introduced her on stage at a national meeting wearing a white karate uniform and black belt—the trappings of years spent studying a very different discipline. Schmidt launched into a classic move, a wood break, using colleagues as holders. The demonstration served as a metaphor for teamwork. It also “assured everyone that they would be well protected and defended in my company,” says Schmidt.
Those assurances proved well-timed. The merger of Aventis into Sanofi-Synthélabo the following year—creating Franco superpower Sanofi-Aventis—may have put employees a little on edge. In terms of medical education, though, other than some minor differences, the two companies saw eye to eye. “We both had a big commitment to supporting medical education of the highest quality and ensuring compliance with… all the relevant regulatory bodies,” recalls Schmidt, who is now associate VP, medical education, for the company. The firm emerged with a Web-based process for receiving and responding to grants. Authority for grant decision-making moved to Medical Affairs, with voting by a three-person, medical-education-legal committee. A non-voting member of the finance group looks at the budget.
Self-defense training still comes in handy. “Our biggest challenge is public perception of CME supported by industry,” Schmidt says. Punches have been thrown by the Senate Finance Committee, which is concerned some education grants serve as product promotion, and by a group of academics who recently expressed a desire in the Journal of the American Medical Association to reform industry-supported CME due to conflicts of interest they say pervade industry-provider collaboration. While there have been some high-profile cases of marketing abuse, some say many of the recent jabs directed at pharma have been short on substance and long on innuendo. The industry's biggest counter-punch has been the vetting of proposals by medical affairs, regardless of where it is in the organization. Within Sanofi's multidisciplinary grant review committee, the education portion centers around individuals with scientific, clinical and educational expertise.
Schmidt's education team includes Ray Wolf, PharmD, senior national education manager; Julie Goslee, PharmD, senior director medical education, cardiovascular & internal medicine; Terry Dex, PharmD, senior director, medical education, diabetes & metabolism; and Patty Jassack, an advanced practice oncology nurse. Such changes have their roots in 2003, when the Office of Inspector General (OIG) released its landmark Program Guidance for Pharmaceutical Manufacturers. “To reduce the risks that an [educational] grant program is used improperly to induce or reward product purchases or to market product inappropriately,” the OIG wrote, “manufacturers should separate their grant-making functions from their sales and marketing functions [emphasis added].”
The medical affairs model
Most large companies have tried to achieve that separation through the medical affairs model, Pfizer being the latest. One company, Wyeth, has created a unique medical education unit as part of its operations division. Another PhRMA member company routes submissions for local activities through medical science liaisons operating in the field, while national activities are funded by managers at the home office. Managers report to medical affairs. The firm also is developing an e-submission process. Most of the top 10 pharma firms now have online grant systems, and many grantors are starting to require the same types of information in applications.
The new systems have their strengths and weaknesses. Electronic submissions should enable companies to keep detailed records of grant approvals—that's good from a compliance perspective. Centralization also has created a sense of parity. “You can log into any grant site at a pharmaceutical company and submit a proposal,” observes Larry Iaquinto, president, Interlink Group of Companies, which spun off a med ed firm called IneXel this year that handles non-accredited projects for Bristol-Myers Squibb and Merck. “Your ability is limited only by your expertise and time.” In fact, some pharma review committees are receiving more grant requests than ever.
“My sense is that everyone now has better access to monies, since they don't have to wait for sales associates to be available to them,” says Sanofi-Aventis' Wolf. But pharma's compliance moves have slowed down grant approvals. Pharma covers about half the $2.1 billion annual CME budget, but growth slowed in each of 2003 and 2004, according to the Accreditation Council for Continuing Medical Education (ACCME), and is flirting with the single digits for 2005. (ACCME had not yet released 2005 figures at press time.) According to Verispan's Physician Meeting & Event and ePromotions audit, funding for live and online events sunk to $2.99 billion in 2005, down 3.2% from 2004. Verispan's data are a projection based on accredited and nonaccredited promotional meetings attended by a panel of physicians in 2005.
Smaller providers like state societies and hospitals that lack the manpower to navigate online submissions are struggling for funding. A few are seeking alternate sources, such as selling display space in their own exhibit halls or asking physicians to foot the bill. Sanofi says that many small hospitals use its site to apply for grants and, based on surveys, find the portal straightforward. Moreover, Schmidt says she is committed to improving the process. Phone support is provided should applicants encounter problems. Nevertheless, other providers say that requesting a grant for CME is so fraught with complexity and delay that non-CME-oriented work is becoming their bread and butter.
“Easily 75%-80% of our [med-ed] business is now non-CME, whereas before it was maybe 50-50,” reports Matt Giegerich, CEO of CommonHealth, adding that the trend is playing out across both its med-ed divisions, Procom and HLS. “Part of [the funding] is going into promotional forums, thought leader advocacy and live meetings—areas focusing on in-label activity vs. out-of-label indications,” Giegerich says. Still others are speculating whether grantors will shift more educational funding to medical schools, a trend which would suggest an increase in the accredited type. At last count, medical education and communication companies (MECCs) received the lion's share of commercial support, more than double that of schools, according to ACCME. Schmidt says Sanofi's funding levels for accredited CME will remain fairly stable. A top-10 pharma company with flagship products like Plavix and Ambien in its portfolio, the company backs about $175 million worth of education (accredited and promotional), according to Verispan figures. Of that, 15% goes to accredited CME, although Sanofi says the proportion is higher.
Whether industry funding levels will continue their slow leak or begin to bounce back is an open question. Marty Cearnal, EVP, chief strategy officer, Jobson Medical Information, says many pharma firms are struggling to demonstrate that operating their CME activities with the required level of independence, and doing so outside their sales and marketing divisions, provides a benefit that they can justify to shareholders. What he doesn't want to see happen is for grantors to equate CME funding with charitable giving, as this “would result in no money for CME,” he says.
Does sales and marketing have a role?
Should marketing and/or sales have any role in the process? “Clearly [sales and marketing] can no longer be the decision makers in a grant award process,” says Anthony Iacono, president, Access Medical Network. But without at least a say—but no vote—during the committee review, Iacono asks how medical education can demonstrate a commercial value to those who allocate budgets? “Until these questions are answered, the future viability of grant funding remains in jeopardy.”
Complete independence may be too lofty a goal. Even if a company has done all it should to eradicate influence over content, “You can't completely separate CME from all commercial influences, because that's the major source of funding,” announced Heather Stewart, counsel, Bristol-Myers Squibb, at a recent meeting. ACCME rules require that activities remain “free of control” of commercial interest. Industry, then, can support medical education but not to the extent that it guides content. The FDA, whose 12 guidelines for industry act as a counterpart to ACCME elements, help grantors understand at what point their program will trigger regulatory scrutiny. To make sense of the regulation can be difficult, though. In the meantime, says Cearnal, 2007 may be companies' first chance for any sort of an upturn.
Pharma's best hope for resolving the tension between stricter standards and the need to disseminate quality information to professionals and on to patients may lie in outcomes measurement. The point behind it is to gauge whether an activity has met the needs of physicians and patients. By looking at how they can evaluate the educational effectiveness of their programs, pharma firms also can justify continued investment in CME. The commitment to measure and report outcomes has come at a price. Sanofi has supported chart reviews—one of the most expensive forms of assessment—to measure the extent to which important patient outcome indicators, such as hemoglobin A1C, are recorded pre- and post-education. The company also has engaged an outside firm, Outcomes Inc., to develop case vignettes, a less pricey way to study the enduring quality of education. The methodology presents cases and related questions to physicians in a Web- or fax-based format.
Vignettes “give us a non-invasive, inexpensive” method for looking at practice patterns, says Linda Casebeer, PhD, president, Outcomes Inc. Casebeer says her outfit works with nine of the top 10 pharma firms and will be working with another five or six in the next year.
In the past, medical education has been given money to spend and nothing to show for it, notes Wolf. “Now, we have the opportunity to say, ‘Look, our programs are truly effective in the way they are influencing care.' We have the ability to influence the funding we get.” Grant applicants are encouraged to include a comprehensive outcomes assessment piece along with their educational programming.
“One of our goals is to try and…give preference to educational grants that espouse the use of educational methodology that has been shown to translate into real decision-making at the bedside in ways that improve patient care,” Schmidt says. “That whole science of CME is a foundation for helping us decide what programs should be supported.” A number of pharma companies, including Sanofi, also are making a big push to publish findings for use by the provider community.
Sanofi also is moving toward supporting programs that are case-based, interactive, multimedia and multi-stage. Says Schmidt: “We have supported many grant applications that present information on the Web, so it's accessible any time, anywhere.” One, called Clinical Medicine Today, is aired live through a satellite TV network and beamed to 2,600 US hospitals and clinics before being made available as a Web cast for 12 months. Didactic programs have very minimal impact on physician behavior, adds Schmidt.
Available CME platforms have mirrored physician learning preferences. Smartphones have grown in popularity, as PDA sales are diminishing. Epocrates' mobileCME service is now available on the Motorola Q, one of the newest smartphones integrating e-mail and organizing functions. Onboard video capabilities may not be far behind. Another popular vendor, WebMD, offers its Medscape programming on a variety of different platforms and learning formats, from full-motion video to podcasts.
Very few providers, other than health systems, collect patient-level outcomes data. The provider community understands the need for outcomes. Yet, “as far as execution, everyone is far behind where they'd like to be,” said Mario Nacinovich, SVP, Fission Communications.
Why? “The attempts to measure outcomes have been immature, at best. Why are we using bad science to measure sound scientific presentations?” posed the director of one university CME department responding to a 2006 national survey. (All participants were anonymous.) “Outcomes don't measure what they say they will,” said another respondent who manages a MECC. “How do you know if the change in behavior resulted from a specific CME activity or just a conversation between colleagues two weeks after the conference?” These people—call them naysayers—registered the second-highest percentage (30%) among three camps, right between those who think outcomes are a panacea (18%) and those who believe they're just a good start (52%), in the survey of 150 medical education professionals.
“Outcomes measurement, at this point, is more of a journey and not a destination with a specific address,” says Stephen Lewis, CEO, Medical Education Collaborative (MEC), which commissioned the study. “People are trying lots of different things, and some of it's really bad and some of it's pretty decent. There's no specific gold standard, by far, that's been set.” Efforts to reach that gold standard include some very simple metrics, such as asking physicians to assess their behavior before and after learning takes place, a method that may have inspired some naysayer comments.
Nacinovich chalks that up to lack of guidance from regulatory bodies. “We need a clear definition,” he says. “Someone needs to say, ‘outcomes is no longer an option.'” Another obstacle, he says, is that physicians need more encouragement to participate in outcomes. Again, “no one is mandating it so individuals see it as less of a novelty.” The ACCME is planning to put a stronger emphasis on outcomes. Future ACCME changes will involve “streamlining the system to make manifest an alignment between what we are requiring of our accredited providers and what the quality improvement movement is requiring of physicians,” says Murray Kopelow, MD, ACCME chief executive. And the Conjoint Committee on CME, part of the Alliance for CME (ACME), has met several times to discuss the future of improving CME, including outcomes measurement. These efforts align with the two big US physician groups, the AMA and the AAFP. Both encourage CME through performance improvement and point-of-care learning to improve quality.
Another problem, Cearnal says, may be that grantors are demanding better outcomes data but are not universally committed to funding the “complete educational experience.” Cearnal calls for grantors to set a standard that they don't want to fund educational activities that don't result in a change in behavior and an improved outcome for physicians. “An under-funded activity is not providing the kind of outcome they can be proud of,” he says, “but a well-funded activity implemented correctly will provide that better outcome.” Craig Conoscenti, MD, associate director, clinical and scientific affairs, Boehringer-Ingelheim, says existing activities that examine the entire spectrum of treatment for a therapeutic area, covering several competing drugs, are “a good indicator that pharma believes in funding ‘the complete experience.'” Yet, he allows, these programs are “not as commonplace as some would like.”
Working together to improve outcomes
Signs of innovation can be found, many of which feature providers collaborating with other entities and institutions on the outcome pieces. The University of Alabama (UAB) School of Medicine and Vanderbilt University, along with Indicia Medical Communications, are collaborating to try and understand how to improve depression care in minority populations. This project, funded by Wyeth, has its own RFP process allowing UAB and Vanderbilt to award grants for innovative projects. And partners UAB and Blue Cross and Blue Shield of Alabama took home the 2006 award from the ACME for best CME collaboration for their Diabetes Quality of Care Program. “Collaboration has been critical to accomplishing our key strategic objectives,” says Robert Kristofco, division director, UAB Medical School, Division of Continuing Medical Education.
Look for more providers, in the short-to-midterm, to partner, says Steven Singer, PhD, co-director and director, educational services at PeerPoint Medical Education Institute, adding, “Every kind of CME provider has some unique perspective and core competency” that can be offered in a collaboration. In June, PeerPoint launched an initiative designed to bring evidence-based educational resources to members of the healthcare team who treat patients with cystic fibrosis, in order to improve patient outcomes. Genentech is funding the independent, CME-certified CF education initiative for clinicians. The CF Foundation, focused on patient advocacy and improving the delivery of CF healthcare, partners with PeerPoint.
For continuing education to continue, commercial funding must remain healthy. The future of CME depends on it. While it's naïve to think pharma will maintain its CME investment without being able to show a return, outcomes research may help separate money given for CME from charitable giving. In that case, Schmidt and her colleagues are on the right track. “We have to encourage these [outcomes] studies and make sure they're established and that everyone can benefit from that collaborative approach,” she says. “Maybe we're at the beginning of something like that.”
SIDEBAR: Consistencies between grant requirements
Inconsistency among pharma's grant review systems has frustrated providers. Who is reviewing requests and what should be listed in an application? Some unifying characteristics have emerged. “There's more clarity than there was two years ago on how to get a grant submitted,” says Marissa Seligman, VP, compliance and programs, Pri-Med. “There's a framework in which to operate.” Many grantors require minimum information with submissions, such as finances, needs assessment and agenda, according to a 2006 Pri-Med survey of 23 pharmaceutical firms.
But there's no uniform approach as to the use or composition of grant committees, Seligman said. Existing groups often include at least one member of legal, regulatory, clinical and a grant administrative person. Product managers typically do not take part. (There was no formal representation of product management in any of the companies surveyed.) Intake method also varies, with some firms using Web-based systems and others sticking by paper forms.
Among unifying factors found by Pri-Med:
■ 18 out of 23 pharma companies now require budgets be submitted, a 12.5% increase from 2005
■ 8 require a needs assessment—33% more than did in 2005
■ 4 ask for sample agendas, double the number that did in 2005
■ 48% use a letter of agreement (LOA), signed by both accreditor and grantor, and submitted under auspices of the grantor
■ 8 ask for a letter of request, down 27% from last year
■ Grantors in 2006 started requiring grants to include proof of accreditation from the Accreditation Council for Continuing Medical Education (ACCME).
Such requirements, Seligman said, are consistent with the ACCME updated Standards for Commercial Support, which require that an accreditor be able to provide the ACCME with a more detailed look at financials and that grantors be able to request “accountabilities” relevant to the budget.
SIDEBAR #2: CME ennui? Not at these meetings
While the Azzurri were tearing up the World Cup in Germany, another event was playing out in back in Italy—the 11th annual GAME (Global Alliance for Medical Education) meeting.
Convening in Rome—their first overseas venue—GAME organizers needed a strong showing from the Continent as a sign of support for their goals, which include advancing innovation in medical education worldwide. They got that and more. GAME Rome drew nearly 110 attendees from 21 countries, with the majority from Europe. North American attendance comprised about 30%. “A truly global meeting addressing global issues is a success story,” says James Arnott, GAME president. Attendee comments reveal broad country-to-country differences, revealing need for organization.
Another sign of progress in international efforts to improve physician education: Project Globe Consortium for Continuing Professional Development held its first board meeting in June. Years in the making, this not-for-profit became a legal entity in 2006, elected nine directors from seven countries and established a five-year plan to improve care in developing countries through the continuing professional development of front-line medical practitioners, particularly GPs. “Globe hopes to reach at least 20,000 physicians in 10 developing countries,” says Lew Miller, who co-founded Project Globe and is a principal at WentzMiller & Associates. For now he and others will identify two-to-four pilot countries to test the concept, eventually one each in Latin America, Africa, Asia and Eastern Europe. Pfizer is the major supporter of Project Globe for 2006.
As Globe and GAME work to narrow territorial boundaries, LiveMed is already crossing them. LiveMed enables Latin American doctors to get education from US medical associations and institutions via live and broadcast sessions with clinicians from organizations like the American College of Physicians (ACP), the Cleveland Clinic and Harvard University. LiveMed will produce the 2nd Annual FIC (Foro Internacional de Cardiologia) this month in Mexico, with Cleveland Clinic. That follows ACP International Update, held in Mexico City earlier this year (pictured), with about 30 talks targeted to internists. The latter “increased ACP's visibility and membership among Mexican physicians,” says John Tooker, MD, EVP and CEO, ACP.
SIDEBAR #3: Physician panel: What do they use & why?
James King, family physician at PrimeCare Medical Center, Selmer, Tenn. (pop. 7,500), says he doesn't attend medical meetings just for the CME. “It's just convenient,” says King, who's also a member of the board of directors of the AAFP. King has been a 20-year regular at one regional event. The GP gets 50% of his CME through seminars. The draw for King: the “face-to-face you can have as you talk about your practice and your practice situations.” Sometimes it's the speakers or hands-on experience that keep him coming back. The rest is 25% journal articles and 25% Internet, both of which he likes because, “I have control of my time.” King typically exceeds his state's biannual 40-hour minimum.
Donald Deye, an internist at Cambridge Medical Center, Cambridge, Minn., says he also exceeds his state's annual 25-credit minimum, sometimes fivefold, through 70% live meetings. Several times a week, Deye, who also hosts and edits “DocPod Hospital Medicine,” a monthly podcast aimed at hospitalists, taps into an online point-of-care learning service and audio journal clips, which he gets free as part-time medical director for Oakstone Publishing, producer of DocPod. To gather content for the podcast, he monitors 14 journal clubs online. For the 30% he gets via eCME, Deye says convenience and quality are his biggest criteria. “Time,” Deye says, is “a physician's most limited resource and most marketable product.”
The Road Warrior
Robert Osher, medical director emeritus of the Cincinnati Eye Institute and professor of ophthalmology at the University of Cincinnati, logs 100,000 miles a year teaching live courses.
“I'm in a meeting every week,” says Osher, who is usually the keynote speaker. Through the frenetic lecture circuit, the ophthalmologist far exceeds his state CME requirement of 100 hours biannually. A small portion also comes from reading. For instance, last month, on his way to a meeting in Japan, Osher completed a malpractice refresher course. “The more convenient a CME delivery system, the more appreciated it would be,” he says. “If a person doesn't have to travel and be away from family and office, that makes a lot of sense.”
Less time away from the office is also important to Robert Cykiert, a private practice ophthalmologist in New York City. Driving to local meetings, he says, allows quick return to the office. Lately he has increased his share of CME Web casts, as well. He does 40% through local meetings, 10 % via journals and the rest online. Online CME “presentations are getting better and better,” Cykiert says, citing improvements in video. “Online CME is like TiVo,” he says of the popular digital video recording device. “It allows you to time shift your CME demands to when it's convenient for you. That's a big, big factor.”