A Bitter Pill?

For a select group of planners, change is on the horizon, and worrisome days lie ahead. Providers of continuing medical education are girding for a transformation in the way their educational meetings are funded and how administrative details are handled to keep the education honest. It promises to be a difficult transition.
    “There are a number of forces converging that are going to have an impact on how commercial support is provided,” says Sue Ann Cappizzi, a longtime CME provider who currently is acting as a consultant. “We have a new way of business evolving.”
    It’s a new way indeed, and it might well turn the world of CME into an administrative nightmare, say industry insiders. Some fear the changes won’t even fix the problem they’ve been designed to tackle.

Bias-free education
The roots of this story go back to 1997, when the U.S. Food and Drug Administration released a set of guidelines mandating a separation of promotion from education in pharmaceutical company marketing departments. Simply put, drug companies could no longer fund education through their marketing arm, because it might bias the education
toward that company’s medications.
    In 2001, the Office of the Inspector General began to put together a compliance protocol that banned pharmaceutical companies from spending money that would influence doctors’ prescribing practices. A year later, the Washington, D.C.-based Pharmaceutical Researchers and Manufacturers of America released the PhRMA Code, which essentially asked those companies to do the same thing, voluntarily. The PhRMA move was intended to broadcast to the world that member companies were happy to comply with the OIG, though its end result was to add another set of rules to the ever-growing list.
    Most recently, in late 2004, the Accreditation Council for Continuing Medical Education, based in Chicago, released its revised Standards for Commercial Support, intended for CME providers in an effort to keep a program’s funding from biasing that program’s education.
    Providers are just now beginning to understand how all these developments are going to affect them. Unfortunately, most of the news is not good.

Complex funding
Within pharmaceutical companies (where most of the funding for CME comes from), grant making is moving from the marketing department to the medical affairs department, per the recommendations of the FDA and OIG. This has a number of ramifications, including the following.
    " Pharmaceutical companies are no longer contracting their promotional and educational efforts through the same provider. This means many medical education and communication companies, those that traditionally handled both education and promotion for pharmaceutical companies, now have to choose between the two functions, according to Karen Overstreet, president of Nexus Communications, based in North Wales, Pa. Those that don’t pare down their offerings must be able to show that their promotion and education departments are run entirely separately.
    " Applications to pharmaceutical and medical-device companies for CME funding have become more arduous. “We are being asked to do more to get grant support,” says Marcia Jackson, senior adviser for education for the Bethesda, Md.-based American College of Cardiology and president of the Alliance for CME, based in Birmingham, Ala. “We are being asked by our commercial supporters for justification of our programming, needs assessment data and budgets. Some companies will do audits of the activity. They’re really working hard to make sure they’re in compliance with what the OIG is seeking, but it puts the burden on our part.”
    " Until a standardized grant application is implemented across pharmaceutical companies (and there is no indication this is going to happen), there are different requirements for every company’s application.
    For example, even the method of sending in the application varies. Aventis (now Sanofi-Aventis) and Merck have online applications, whereas both Eli Lilly and Co. and Bristol-Myers Squibb take applications via fax. Procter & Gamble awards grants through field representatives, who are required to keep their distance from the company’s promotional efforts. Still others mandate the use of that good old standby, “snail mail.”
    With grant-funding procedures changing all the time, Rick Whitbeck, director of CME at Cleveland’s Case Western Reserve University School of Medicine, finds it very difficult to keep track of where the money is. “It has become much more of a crapshoot. I have employees who check the pharmaceutical companies’ websites every hour,” Whitbeck says. “You have to fill out an online application. If you miss the window, the site says they don’t have money to give out.”
    " CME providers are having more trouble pinning down funding. In most cases, the marketing reps who infiltrate hospitals, universities and other medical practices, and who used to sign off on grant proposals, no longer have the power to fund projects. That’s all in the hands of a separate medical education group or a grant-review committee.
    “You used to be able to talk to a marketing rep with a huge discretionary fund to get funding,” says Tracy McKay, director of development for the Washington, D.C.-based Society of General Internal Medicine. “Now it has to go through a grants department.”
    Or, the marketing department still handles commercial support (i.e., CME program funding), but only through a special grants committee, says Eric Peterson, president of the North American Association of Medical Education and Communication Companies, based in Mount Airy, Md., and vice president and general manager of the Bimark Center for Medical Education in Hackensack, N.J.
    This means that after talking about a project with one department, providers might find it necessary to apply for funds through another. Or, because some pharmaceutical companies are in flux, the department that providers once applied to might no longer exist.
    As a result, grant applications are taking longer to be processed, sometimes up to six months, according to Rick Whitbeck.
    Peterson remains optimistic that most of these issues will iron themselves out. “It’s been a period of adjustment,” he says. “I’m not sure I’m prepared to say it has become better or worse. It’s just a little more complicated.

A NEW SOURCE OF CME

In November, Norwalk, Conn.-based Reed Exhibitions announced a partnership with Philadelphia-based Elsevier Health Sciences to create Reed Medical Education, which would combine Reed’s meeting planning sophistication with Elsevier’s medical expertise. M&C chatted with Julie Brown (right), vice president of Reed Medical Education, about the partnership’s first Oncology World Congress, to be held at the Marriott Marquis in New York City, Nov. 17-19, 2005.

M&C:  How will you ensure that your meeting follows the Revised Standards for Commercial Support?
Brown: We are producing, managing, coordinating and marketing the conference, while the education is completely driven by the advisory board from the oncology community. By working with the different oncology centers and coordinating with Elsevier, a nonaffiliated accrediting body, we're covering all our bases.

M&C: What do you think the Reed name adds to the program’s cachet?
Brown: For a physician looking at Reed, I don’t think the name necessarily will be a draw, but our background and expertise is what we really bring to it.

M&C: What trends do you see in the world of CME?
Brown: The trend is toward combining disciplines. Within oncology, you can be multidisciplinary. We’re also looking to do conferences using a collaborative model for example, combining nephrology and urology. -- J.V.

Varied meeting formats
Pharmaceutical companies are less willing to fund meetings that aren’t built around education, so more advisory and consultant meetings are being phased out for good. Such meetings, hosted by drug companies, would bring in a handful of physicians for a plush dinner to ask their opinions.
    “I think the OIG felt that many of these meetings were not about genuine consultation or advisory activities,” says Peterson. “Some of the symptoms of that were how many of them there were, and how many attendees went to each one.”
    Free trips for doctors are going by the wayside, too, notes Carlos R. Hamilton Jr., M.D., president of the American Association of Clinical Endocrinologists, in Jacksonville, Fla. “Hopefully, the absence of junkets and fancy dinners is going to take some of the expense out of the system,” Hamilton says, “and leave more for the support of some really valid scientific programs.”
    Traditional promotional meetings have continued, but these have become more modest. Doctors who once were treated to a fancy steak house might now go to a more moderate eatery.
    “The concern of the OIG is, what’s the focus?” Peterson rhetorically asks. “Is it the lecture, or is it the steaks?”

A silver lining
There is a glimmer of good news in the midst of all this pharmaceutical perestroika: Funding for education is up.
    A report released in 2004 by the Accreditation Council for Continuing Medical Education showed that in 2003, commercial support increased by 30 percent, to $971 million.
    The increased funding probably can be attributed to the new restrictions, says Murray Kopelow, M.D., chief executive of the ACCME. Since pharmaceutical companies are not allowed to spend as much on promotion, they seem simply to have funded more education.
    Data from the providers’ side is in agreement. A study by the Alliance for CME shows that educational spending by CME providers increased 11 percent from 2002 to 2003.
    “To what degree the PhRMA Code and the updated Standards for Commercial Support affected this figure remains to be seen,” says Bruce Bellande, Ph.D., executive director of the Alliance. “But it seems the trend for increased support is there.”
    The story is the same on the pharmaceutical end. Unrestricted educational funding from Procter & Gamble Pharmaceuticals is booming, according to Fred Wilson, category manager, CME, for P&G Healthcare Research Center in Mason, Ohio. It’s in the company’s best interest, though. “The PhRMA Code disallows physicians from bringing a spouse or a guest to a dinner meeting,” says Wilson, “whereas it says nothing about a physician bringing a spouse along to a CME activity if it should include a dinner.”
    Whether or not overall funding is increasing (and not all CME providers believe it to be true), medical specialty associations have reaped the most abundant rewards from these increases. The reason is twofold, says Tracy McKay: First, pharmaceutical companies know that funding education through well-regarded associations won’t get them into any hot water. Second, if a company has just released a medication for a specific ailment, it knows that the specialty association discussing that ailment will also discuss the new drug.
    For the Bethesda, Md.-based American Gastroenterological Association, the changes have spurred a flood of increased funding. From now on, pharmaceutical companies won’t sponsor their own parties; instead, they will fund educational dinners through AGA’s meetings department.
    There is a downside to the increased spending on education. Now that pharmaceutical companies want to see every dollar spent on education, it can be difficult to obtain financing for other aspects of the meeting. Carlos Hamilton has found some companies don’t want to support receptions and dinners. Tracy McKay often can’t get funding for anything that could be seen as a frill, including audience-response equipment, magnetic ID cards and bringing medical residents to the meeting.

New standards
Perhaps the biggest change CME providers are seeing is occurring within their own departments. For some, it amounts to very little bother; for others, it could become frustrating.
    In September 2004, the ACCME released the revised Standards for Commercial Support, marking the end of a three-year effort to update the decade-old standards. It’s the document that guides providers of continuing medical education, and it’s now somewhat more strict. Accredited providers need to adopt the new rules by  May.
    Besides structural changes for simplicity’s sake, the standards were revised in four ways.
    1. They now mention electronic media in addition to live lectures.
    2. Any mentions of off-label uses for medications now must be accompanied by a “content validation” statement demonstrating that the findings are supported by research.
    3. Rules regarding how commercial support can be used for residents and medical students have been scrapped. The ACCME used to allow commercial funds to pay for students’ travel and registration costs; now the council is silent on the issue.
    4. It is no longer enough to identify conflicts of interest in a lecture (i.e., if a speaker about a certain class of medications also does consulting about one of those medications). Now these conflicts must be resolved.
    This fourth item has caused quite an uproar in the CME community, and it is the one that likely will cause the most headaches for planners.
    “It’s perceived as silencing the best and the brightest,” says Murray Kopelow. “Our intention is for physicians to recognize that conflicts of interest do exist and need to be managed in education.”
    Exacerbating the problem was a guide to resolving conflicts of interest, which the ACCME released concomitantly with the standards. The examples it chose were impossible to execute, say planners.
    One suggestion was not to allow a conflicted physician to make a presentation. However, these physicians are often the experts in their fields; restricting them from presenting could be construed as censorship.
    “It’s ridiculous,” says P&G’s Fred Wilson. “As long as you have an expert presenting evidence-based information, where’s the conflict?”
    The other option offered was to ask the presenter to break off her relationship with the pharmaceutical company.
    A third option the ACCME later offered was to let conflicted physicians present data but not discuss applications. Both of those are impractical, says Karen Overstreet of Nexus Communications. “We’ve got to help physicians figure out how to apply what they learn to patient populations,” she says. “If we now have to limit what the best and brightest speakers can say, we’re potentially hampering that valuable link.”

To accredit or not?
The looming difficulties caused some CME providers to wonder if providing accredited education is worth the hassle, not to mention the cost of both applying for accredited status and complying with the standards.
    “The more regulations you put in place, the more difficult it’s perceived to be,” says Marcia Jackson of the Alliance for CME. “Certain organizations may decide if they’re not accredited, they don’t wish to be, or if they are, they may not want to run all their activities for credit.”
    Overstreet, whose company is not accredited at present, has struggled with this question. She doesn’t think an unaccredited program will drive away doctors, simply because many of them accumulate enough credit already and don’t need any more for the conferences they attend. And one pharmaceutical company she asked said it doesn’t matter if the activity offers credit, as long as it is independent of marketing.
    Indeed, Procter & Gamble isn’t so tied to accreditation that the company wouldn’t be willing to fund a different form of unbiased education. Wilson thinks the ACCME could be making itself irrelevant by tightening the noose too much. “If the ACCME makes it too difficult to collaborate in an ethical way with manufacturers, the medical profession is going to find another way to get that information,” he says.
    Unaccredited education might become an avenue for medical specialty associations, suggests Tracy McKay. “If you have an organization with an established membership that’s not interested in getting credits, what do they care?” she asks. “They’re more interested in cutting-edge therapies.”

ACCME’s response
According to Kopelow, ACCME is not out to keep education from becoming accredited. “It’s not a question of catching things wrong and being punitive,” he says, “but of giving feedback and providing support.”
    A few weeks after the initial storm of controversy, the council bent a little and allowed the use of peer or audience review to resolve conflicts. Thus, if planners can document uninterested parties going on record to say the talk was unbiased, it’s in the clear.
    “These are systems that we very often already have built into our processes,” notes Eric Peterson.
    Regardless, complying with the new standards likely will increase the amount of administrative duties planners face. Medical faculty have to be educated about the new rules, and CME providers will have to start soliciting disclosure forms far in advance to give them time to conduct a peer review.
    “We’re going to need a longer planning period,” says Peterson. “Certainly, some providers are going to have to invest in those resources to comply with the standards. But to the extent that this is an attempt to restore and maintain public trust, well, it’s something we have to do. Whether or not this is more effective than what we were doing before, that remains to be seen.”
    Most agree the extra work will be worth it. The American Association of Clinical Endocrinologists’ Carlos Hamilton, who both provides and receives CME, attests to the importance of the strictest of rules. “I go to conferences to get helpful information,” he says. “When it turns out to be hype from a company that is trying to sell you something, I don’t like that at all.”
    “The more we take the same tough stance, there will be a lot less regulation,” says Whitbeck. “On the other end of the continuum, if people are lax about the rules, everyone’s going to be edgy.”

MORE DOCS GO ONLINE FOR CME CREDITS

In 2003, an impressive 10 percent of continuing medical education was administered online, up 25 percent from 2002, notes a study by the Pri-Med Institute in Boston. In terms of the number of users, online CME grew by 76 percent, according to the Chicago-based Accreditation Council for Continuing Medical Education’s 2003 Annual Report, released in 2004.
    The growing figures reflect acceptance of the educational tool, which has been around for years but has so far been relegated to the background.
    Now, online CME is available through a growing number of universities, associations and private companies. For example, the Department of Continuing Education at Harvard Medical School in Boston recently introduced such a program in order to give its physicians exposure throughout the world. In just six months of operation, participants have logged on from 86 countries.
    Now Harvard is expanding its offerings from a handful of modules to about 50, and the university is working on translating the content into other languages for foreign associations’ websites.
    The increased interest reflects multiple factors. First, many doctors’ schedules have become so crammed that getting away for a meeting can be nigh impossible. To accommodate such hectic lives, the American College of Cardiology, based in Bethesda, Md., has worked to establish “granular” online CME, which allows doctors to receive credit for as short as 15-minute increments on the ACC website.
    Online CME also is gaining popularity because doctors of all ages are becoming increasingly comfortable with using the Internet, though a large portion of its following comes from the most recent crop of Internet-savvy physicians.
    Other common users include physicians in remote areas, where traveling to meetings can be both costly and time-prohibitive, and those in rare specialties that might not produce as much live CME, says Mike Zarski (above), director of the American Osteopathic Association’s Information Technology Department and executive director of the American Osteopathic Information Association, both based in Chicago.

An end to live instruction?
In 2004, Medscape, the giant of Internet CME, drew an estimated one million participants to its online activities. Medscape offers its education in a number of fields, in a variety of learning styles. And because it automatically compiles individual CME-credit reports for physicians, everyone’s administrative burden diminishes.
    The natural question arises: Will Medscape and other online education sources one day completely dominate the world of live CME?
    Not likely, say a number of experts. Indeed, live and web CME are complementary, according to Steven Zatz, M.D., executive vice president, professional information services, and chief medical officer for the New York City-based WebMD, the company that owns Medscape. The human interactions that live sessions help to foster cannot be replicated online, he notes, but the programs themselves can be, and then saved for posterity.
In such a way, live education “significantly extends the reach of the original CME program,” says Zatz.

The online bottom line
The major challenge for online CME providers will be profitability, states Pam Magnani, vice president, meetings and education, for the American Gastroenterological Association, based in Bethesda, Md. The AGA has a new online program; Magnani currently is determining how best to keep its finances in the black. “If web CME is given away free, are associations seeing a decrease in revenue?” she wonders.
    At least one successful program has fallen victim to money troubles. Palo Alto, Calif.-based Stanford Radiology Postgraduate Education, which began offering online programs in 1998, had to shut down its online segment last year, despite its popularity.
    Among the problems: Radiology education requires high-quality images, which are expensive to reproduce online; and streaming video is blocked in many medical institutions. In addition, the Radiological Society of North America began offering its own online education for free, and the Stanford CME department simply couldn’t recoup its costs.
    “There’s no way we could compete with free,” says Kathy Marsh (left), senior conference manager for the department.
    On the other hand, the future holds promise. If streaming-media technology becomes less expensive, and if the CME department finds a viable business model, Stanford just might relaunch the program.
    “We really believe in online education,” says Marsh. “We just have to focus our efforts in a way that’s a bit more productive.”
    At Harvard Medical School, it seems the online enterprise will prove profitable, according to Grace Huang, M.D. (right), project director, CME Online. After each module is launched, costs will be minimal. Also, she notes, “In comparison with live courses, our online courses aren’t incurring additional expenses like costs associated with hotels and catering.” -- J.V.