Does the commercial support system — as it exists today — inevitably compromise CME's independence? That's the question the Accreditation Council for CME will explore over the next year as it conducts its first-ever big-picture review of the funding process. It will examine a range of options, from leaving the system intact, to setting up a centralized grants repository, to limiting — or even prohibiting — pharmaceutical industry funding of CME. Since drug companies funnel about $1 billion annually into CME, accounting for about 50 percent of providers' income, any decisions themakes as a result of this review could have dramatic consequences for the entire enterprise.
The analysis is one part of the ACCME's action plan undertaken in response to the United States Senate Committee on Finance's report on CME and subsequent letter to the ACCME. The committee is concerned that the ACCME's oversight is not enough to guarantee that CME is independent of drug industry influence.
Many CME professionals believe the real crux of the issue is that the ACCME needs to strengthen enforcement of its existing guidelines, and impose stricter penalties for providers who violate the rules, as we reported in our July/August cover story, “Time to Clean Up.” But some also think there are changes that should be implemented in the funding system to further ensure CME's independence. Regardless of their views, many CME professionals think that the dialogue is healthy.
“Is business being conducted in a way that instills or inspires trust in the whole process by the public?” asks Mike Bigelow, assistant general counsel, Eli Lilly, Indianapolis. “Even if you can say we're doing things in a manner that's wholly legally compliant, I think everybody still has to ask themselves: What can be done to help further make sure that the public is confident in the process and that there isn't bias in the system?”
Central Pool: Sink or Swim?
One idea that has been proposed is to create a central pool or repository for CME funds. Pharmaceutical companies would contribute money into the pool; an independent board would then distribute grants to providers. The concept gets mostly negative reviews from CME professionals.
Damon Marquis, director of education and member services at the Society of Thoracic Surgeons, Chicago, says the idea illuminates an “in-your-face loophole that we all recognize — the assumption that there is such a thing as an unrestricted educational grant. Companies decide based on the content of the session whether they are going to support it or not.” With a central grants repository, the issue for industry would be: What's in it for me? “Will altruism be enough?” he asks.
“It's an excellent idea, but impractical,” agrees George Mejicano, MD, associate dean for continuing professional development, University of Wisconsin School of Medicine and Public Health, speaking as an individual and not in his capacity as an ACCME board member. “The more disconnect there is between pharma and the provider, the less funds are directed for a specific therapeutic area. If you get too far away from the interests of pharma, [CME funding is] going to become a charity,” he says. If that happens, he suspects that funding will drop way off.
Eli Lilly's Bigelow backs up providers' assessments. Pharmaceutical companies wouldn't support a funding pool, he says. “I don't think the company would necessarily feel comfortable without having any say in the final determination of how those monies are spent,” says Bigelow.
More Room for Bias
A further problem with the central pool idea, say providers, is that it creates another level of bureaucracy and raises many operational questions. Who would be in charge? What processes would be put in place for receiving and distributing funds?
In lieu of eliminating commercial support entirely, which he advocates, Daniel Carlat, MD, assistant clinical professor of psychiatry, Tufts University School of Medicine, and editor-in-chief, The Carlat Psychiatry Report, Newburyport, Mass., thinks the central pot idea has merit, but says it would be complicated to execute. Whether ACCME or some other independent body oversaw it, a fair system would need to be devised to distribute the money. Many commercial supporters would need to make commitments to contribute, because if all the funding came from a handful of companies, that might create a situation where only certain therapeutic areas were funded.
Christopher Bolwell, senior director, medical affairs, at Imedex, Alpharetta, Ga., believes the central repository idea would actually create more problems with bias. Instead of teams of experts at pharmaceutical companies making individual grant decisions, a small body or committee — whose members would have their own biases — would be empowered to make all CME funding decisions. “I can't see that as being a viable option,” he says.
Me, Too CME
As Marquis and others point out, one major problem with the current funding system is that pharma companies award grants in the therapeutic areas that support their business goals — which means the bulk of CME activities also focus on those areas. The result, says Carlat, is an explosion of CME that is redundant.
“People might say that pharmaceutical industry funding leads to a lot more medical education,” says Carlat, “but I would say that much of that is not particularly useful education.”
Mejicano concurs that there is a lot of “me too” CME. “Do we really need another conference on GERD [gastroesophageal reflux disease]?” he asks. “There's a bunch of stuff we ought to be dealing with and we're not, and there's a bunch of stuff we're putting tons of resources into that we frankly shouldn't be bothering with.”
To redress the imbalance, Lewis A. Miller, principal, WentzMiller & Associates, Darien, Conn., suggests requiring commercial supporters to contribute a small percentage, say 5 percent or 10 percent, of their CME budgets, to a central repository; those funds would be allocated to underfunded areas. Preventive health for adults and children are two areas, for example, that are critical to improving healthcare but traditionally don't receive much CME funding.
While pharmaceutical companies may argue that it doesn't make sense for them to devote a portion of their budget to areas outside of their business interests, Miller encourages them to see the big picture and consider how underwriting preventive health initiatives would draw public attention to their positive contributions.
“[Pharma companies] would benefit because they are under so many attacks now for all kinds of abuses, real or imagined, that anything they can do to burnish their image would help,” he says.
Building Block Grants
Another effort, already in place, that can help boost pharma's image and bolster CME's independence is a block-grant system developed by Robert Addleton, EdD, executive vice president, Physicians Institute for Excellence in Medicine, which is part of the Medical Association of Georgia in Atlanta. “Initially, I conceived of the plan as a firewall, as a way to ensure that commercial supporters had no influence over the development of continuing education activities,” says Addleton. But he also realized it was an opportunity to move providers towards outcomes-based CME by requiring the state associations to do outcomes measurement as a condition of participating in the block grant.
So far, Addleton has coordinated two block grants, one for depression and one for cardiovascular disease. The first one involved five state medical associations: Massachusetts, Colorado, Georgia, Florida, and Oklahoma. It was funded by Wyeth Pharmaceuticals. The second involved six states — Georgia, Florida, South Carolina, North Carolina, Kentucky, and Oklahoma, with funding provided by Pfizer. Two more are in the works.
The grants, each of which was over a half a million dollars, were split evenly among the participating state associations. These organizations were then responsible for awarding grants to CME providers in their states.
There are several benefits to the block-grant system, says Addleton. There is no contact or connection between the grantor and the recipient. In fact, industry is twice removed since the funds ultimately get doled out by state associations to local CME providers. While grantors do not control which activities are funded, they are allowed access to the outcomes measurements. This data is increasingly important for CME professionals within pharma companies, who are under pressure to demonstrate — both internally and externally — that the education they fund is effective in changing physician behavior and improving patient care. An additional benefit for all involved is that small state-level providers have access to large, national grants, which are usually beyond their reach.
Cutting the Strings
Another aspect of the system that raises red flags is the dependence of some providers on one grantor. Miller supports the idea of establishing a cap on the amount of money that a commercial supporter is allowed to allocate to an individual provider. “Any accredited provider that derives more than 50 percent of its funding from any one company, is at risk of being viewed as an agent of that company,” he says. Caps would be in the best interest of pharmaceutical companies, too, as they would mitigate the perception of undue influence, he adds. Some pharmaceutical companies even ask on grant applications how much the provider gets from them.
Others oppose any limitations on commercial support. “If certified CME is a good idea, which I think it is, why would you want to cap it?” asks John Kamp, PhD, JD, executive director, Coalition for Healthcare Communication, a New York-based organization dedicated to the free exchange of scientific information without undue government interference.
Marissa Seligman, vice president and compliance officer at Pri-Med Institute, Boston, says the idea of less funding for CME is not in anyone's best interest. “It's the provider's job to manage the funds; that's the charge we've been given, that's the expectation we have to meet.”
Instead of setting a cap on how much a company can give to a provider on an annual basis, Mejicano believes it would make more sense to put a limit on how much a company can allocate a provider in any given therapeutic area.
While Lilly's Bigelow doesn't support any funding caps, he does agree with the principle of decreasing provider dependence on individual companies. “Grant recipients need to make sure that the dollars they are receiving come from a wide array of different organizations and that they are not too dependent on any one company” he says.
Providers should also make every effort to solicit multiple grantors for an individual activity, say experts. Mark Schaffer, vice president, CME compliance, Professional Postgraduate Services, Secaucus, N.J., says, “The first thing providers can do is to stop working with a single grantor or at the very least, make a serious attempt to get other grantors for a program.” However, he acknowledges that the goal may be difficult to achieve, as despite providers' best efforts to attain multiple grants, only one company might approve the funding application.
Make Docs Pay
Another avenue to foster CME independence is to alleviate providers' reliance on grants by having participants foot the bill. The enormous amount of money the pharmaceutical industry pours into CME has meant that doctors don't have to pay much to get their credits. And, not surprisingly, they like that setup — at least according to the results of' physicians CME preferences survey (“Bias? What Bias?” January/February 2006). Most of the respondents were, first of all, not concerned that pharma funding inappropriately influences CME activities, and, second, 78 percent said they would not be willing to pay substantially higher fees for CME to offset the need for industry grants.
But Schaffer and others believe that doctors should be charged a fee to attend CME sessions. “You don't have to charge them [enough to cover the] actual cost of the program because that would be prohibitive, but you can charge them a reasonable amount,” Schaffer says.
To those who say that doctors won't pay fees to attend CME activities, Schaffer bristles. “Not true. Schools have been charging, hospitals sometimes charge. If a physician doesn't want to go to a program because there's a charge, I question one of two things: Is the program really valuable or what's the matter with the physician?” Most other professions, he says, charge participants for continuing education credits. “Doctors have been spoiled, no question about it,” says Schaffer.
Mejicano agrees that doctors should start paying for CME credits. “It would be the professional thing to do.”
But it's not just doctors' attitude of entitlement, but the cost of CME, that is an issue. “Unlike a lot of professions with continuing education programs, the continuing education programs that are developed for physicians often require high-level technology equipment and are very, very expensive to put on,” Marquis says. “It's not realistic to think that we would rely on surgeons or physicians to pay 100 percent of a very expensive education.”
Instituting funding caps, encouraging — or requiring — providers to solicit multiple grantors, developing block grants, and charging doctors higher fees, are all tactics that can reduce pharmaceutical influence on CME. But some CME professionals say none of those approaches are enough.
There is a small faction of people within the CME community who advocate prohibiting commercial support altogether. “We have to maintain accredited CME as a safe harbor of trustworthy education, so a doctor can look at a [certified] activity and be completely confident that there is not going to be any commercial or pharmaceutical industry influence over that content,” says Carlat. “The only way to make certain that happens is to not allow pharmaceutical companies to fund CME activities in any way.” Carlat, who published an opinion piece in June in The New York Times about industry influence over CME, funds education via subscription fees for his newsletter.
And Carlat doesn't think the CME world would fall apart without industry grants. “About 50 percent of CME is funded by pharmaceutical companies, so that means 50 percent of CME is not,” he says. “Clearly, we are able to provide an awful lot of CME in this country without commercial support, and if you go back to 1998, about 30 percent of CME was funded by pharma,” he adds. “We've had situations where we were able somehow to educate doctors without much pharma funding.”
Others argue that prohibiting commercial support would not eliminate the potential for bias; there are many other potential sources of influence, such asand institutional relationships with industry. And they say, it's just not realistic. The small group of people who oppose any commercial support are “looking through rose-colored glasses,” Marquis says.
“It's a great myth but I don't believe it,” says Kamp, talking about the prospect of CME thriving without industry funding. “It would severely impact patient care and that's what [Senate Committee on Finance members] and others ought to be focused on,” he says. “The best place for doctors to learn about new drugs and new uses for old drugs is certified CME. If that process were dampened, it would mean that practicing doctors in America would know less about that which they need to know more about. It would be a disaster for patient care.”
Follow the Funding
In 1998 providers received
$302 million in commercial support, representing 34 percent of their total income.
In 2006, providers received $1.2 billion in commercial support, representing 50 percent of their total income.
In 2006, 23 percent of providers (173 out of 729) received 90 percent of all the commercial support, and produced 44 percent of CME activities, accounting for 36 percent of total CME hours.
Source: Accreditation Council for CME
To Be Continued
We will continue this forum in future issues. If you've had success soliciting multiple grantors, creating block grants, establishing a central funding pool in your organization, reducing or eliminating your need for commercial support, or finding alternative funding sources, or you have developed other strategies to ensure CME's independence, we want to hear from you. Contact Editor Tamar Hosansky at (978) 466-6358, email@example.com; or Senior Writer Dave Kovaleski at (978)874-0804, firstname.lastname@example.org.
The Accreditation Council for CME needs to toughen up its enforcement of providers to hold off federal regulation, say CME providers, in our July/August cover story. Visit Time to Clean Up.