Anger. Frustration. Finger-pointing. Emotions are running high in the CME community in reaction to the U.S. Senate Finance Committee report on CME. Issued in April, the report expressed strong concerns that the Accreditation Council for CME's oversight is not enough to guarantee that educational programs are independent of pharmaceutical industry influence. The ACCME will formulate a plan to respond during its July board meeting, says Murray Kopelow, MD, chief executive; the committee will decide its next steps after it hears from the ACCME, according to an SFC spokeswoman.

While the drug industry has been the focus of negative government, public, and media scrutiny for years, the CME profession has often escaped notice. Not anymore.

“[In the past] everybody wrung their hands, saying, ‘Why doesn't anybody pay attention to us?’ Now everybody's paying attention to us and the same people are wringing their hands saying, ‘Why is everyone looking at us?’” says John Kues, PhD, assistant dean for CME, University of Cincinnati College of Medicine. Instead of complaining about the increased scrutiny and about the report's failings, Kues and others say the CME community needs to take a hard look at itself. “People are very upset that CME was unfairly roughed up, but I think we need to step back and look carefully at the points that [the SFC] makes,” Kues says. “There are ways we can make things better and we need to be willing to try to do that.”

And the first step in making things better, many say, is for the ACCME to toughen up.

Teeth in the System

The SFC pointed out that the ACCME relies exclusively on information supplied by providers to assess compliance, and does not observe CME activities or collect information from audience members to determine whether programs were accurate and balanced.

These concerns have also been voiced by some CME professionals for years — but providers are concerned about how the ACCME might react to these perceived weaknesses.

“The ACCME has an unfortunate history of responding to these sorts of challenges by issuing new rules, while continuing to be reluctant to actually enforce the rules they have — and that was the most embarrassing aspect of the report,” says Eric Peterson, EdM, vice president, Continuing Education Academy for Healthcare Education Inc., New York. “Now, maybe enforcement will finally become a priority for the ACCME.”

“There's no teeth in the system,” says Maureen Doyle-Scharff, MBA, director, Health Education, Ross Products Division, Abbott Laboratories, Columbus, Ohio. “We don't have the best system to either remove those who violate guidelines entirely from the CME arena or to make certain that they go through some type of remedial training. The Senate Finance Committee report highlighted the fact that the industry in general falls short of holding people accountable. That recognition will be a catalyst for change.”

But those changes would mean a new role for the ACCME. “The question is: Does the ACCME want to get into reviewing content?” asks Kues. “They have defined their mission at a higher level. They want to make sure ACCME accredited providers have a higher sense of an educational model, and they use that educational model to address specific needs.”

With the new accreditation criteria, issued last year, the ACCME raised the bar for providers even further, calling on them to link education to public health and quality improvement and to collaborate with other areas of the wider healthcare system. As many CME professionals observed, this shift was not noted in the SFC report.

“I don't think focusing on improving care or physician practice is the ultimate solution to the problem the Senate Finance Committee identified,” Kues says. “But I certainly think that when you tie education more closely to patient care outcomes or to practice outcomes, it [can help prevent] inappropriate influence from pharmaceutical companies. The ACCME may already be going in the right direction. But, I don't think that the Senate Finance Committee would think that it had gone far enough.”

What would constitute going far enough — and who would shoulder the burden? CME providers are already struggling to implement the new criteria, and they're still coping with challenges posed by the updated Standards for Commercial Support, issued in 2004. “My first reaction was, we're going to see more rules and more regulations from ACCME [on top of the new criteria]” says Edeline Mitton, Med, CPP, director, Office of CME, SUNY Downstate Medical Center, Brooklyn, N.Y. “We can't handle it. We don't have the staff. We don't have the budget [to take on more].”

Surprise Inspections

Nevertheless, the ACCME may have to change its approach. In other industries, from restaurants to hospitals, inspectors make random, unannounced visits to check for violations, CME professionals point out. When the Joint Commission on Accreditation of Healthcare Organizations makes a site visit — it can be unannounced, and staff are not told which files to have ready, says Debra Gist, MPH, CME consultant, La Mesa, Calif. But when the ACCME does a document review, it sends providers a list of files it will inspect, and site visits are scheduled in advance.

The ACCME could conduct random audits, like the IRS does, suggests Steve Hunter, director, business development, Dannemiller Memorial Education Foundation, Seymour, Conn., speaking as an industry observer and not as a representative of Dannemiller. “Maybe it could operate with more of an OSHA mentality, where you have the fear of an audit, sort of like the fear of Mike Wallace walking into your office and you've got to cough up your files. I would hazard a guess that most organizations could function quite well with that,” he says. “If there are some that can't, then they shouldn't be here.”

Improved oversight of paperwork and documentation is not enough — as everyone knows, things can look good on paper that aren't necessarily good in practice. Some providers send observers to their own activities to monitor for bias and guideline infractions. To strengthen oversight, some suggest the ACCME should do the same. “If there is the possibility that someone could pop in and police your meeting, you're probably going to [be more careful about compliance],” says James Montague, president/CEO, Professional Meeting Planners Network, Durham, N.C.

Such a system would involve providers informing the ACCME about upcoming activities. “There would have to be some type of repository where providers were required to post [their schedule of] live programs in advance,” says Doyle-Scharff. “That might be a very foolish recommendation or logistically impossible to execute.”

Another roadblock is the question of ACCME's resources. “Are [monitoring processes] going to put some burden on ACCME? Yes,” says Montague. “But as an industry, if that's what we all agree we should do, then that's something we should work toward.”

Even if the ACCME developed a monitoring system, it would not catch all the problems. “I don't believe that the ACCME could realistically reach down into every activity to scrutinize the content [and determine] whether or not there was bias,” says Kues. However, many providers ask learners in their evaluation forms if they perceived any commercial bias in the activity. The ACCME could require providers to ask that question, he says. “It could be something as simple as a yes/no answer.”


Speaker Scrutiny

Under the updated Standards for Commercial Support, CME providers are not only required to obtain disclosures from faculty about their financial relationships with industry, they also must resolve any conflicts of interest those disclosures reveal. Nevertheless, the issue of speaker bias is still a difficult one. Some speakers, despite the best efforts of providers to prevent it, still stand up at the lectern and give product commercials; some continue to command exorbitant honoraria.

Stronger ACCME oversight and data collection could help mitigate these problems, CME professionals say. The ACCME could ask providers to report the fees paid to faculty for each of their activities, suggests Philip Dombrowski, president/CEO, Annenberg Center for Health Sciences, Rancho Mirage, Calif. “Then, it could publish averages, and look at whether the averages that the academic centers pay are much different from what MECCs pay. If we could get data and see what's being done there, perhaps we could clean up the people who are abusing [the system].”

To help clean up the offenders, Mark Fischl, MD, CME committee chair, Salem Clinic, Salem, Ore., proposes a nationwide system for reporting speakers who give biased talks. “Then, an independent review committee could determine if the talk was or wasn't biased, and if it was, the person could lose their right to give CME talks.”

Tech Solution

There's additional information the ACCME should require as well, says Kues. For example, providers gather detailed information about disclosure, conflict of interest resolution, and commercial support — most of which is never divulged to the ACCME. While collecting and managing such enormous amounts of data may sound daunting, Kues thinks that with technology, it's doable.

“Providers could support the creation of an electronic pipeline and a set of standards for transmitting additional data,” he says. “That would require some expenditure on the part of the providers to purchase software. It would require the ACCME to develop the ability to receive, organize, and make sense of the data. I don't see that as insurmountable.”

And that data would prove invaluable to all stakeholders. ”Pharmaceutical companies, the American Academy of Family Physicians, the American Medical Association, ACCME, and CME providers could use it,” he says. “It makes the entire CME enterprise much more transparent to everyone, including the public and legislators. If a question arose, the ACCME would be able to determine to what extent a particular pharmaceutical company is supporting CME with various providers and on specific topics. The more we know about ourselves, the easier it is to address concerns and to improve CME practice.”

Priority Enforcement

Even if the ACCME somehow finds the resources to create a system for monitoring activities and collecting more data, there is still a big hole in the system identified by the SFC: enforcement. For years, there have been rumblings and grumblings in the CME community about the ACCME's failure to penalize noncompliant providers. Currently, providers that are found in noncompliance or partial compliance with guidelines are given the opportunity to correct the problem — a process which, the SFC noted, can take up to nine years. (However, Kopelow says most of the noncompliant providers referenced in the SFC report became compliant within a year.) Providers that don't shape up may be put on probation or lose their accreditation.

CME professionals say that the ACCME must take stronger action against violators — again, a change of role. “The ACCME will need to take less of an adviser role and become more of a disciplinarian, and take bolder actions, requiring people to follow the rules,” says Dombrowski. “If they don't follow [the guidelines], there are [consequences]. ”

Instead of putting providers who violate the rules on probation, the ACCME could take away their accreditation for a year or two and have them start the process over again, Mitton proposes. “That would show them that this is serious and they should not let things happen.”

Providers also say the ACCME should take a more active role in helping providers when infractions are discovered. One CME professional suggested the ACCME offer mentors to help those organizations improve more quickly.

As with any other potential changes in the ACCME system, providers are concerned about shouldering additional burdens. “I hope they will focus on organizations that have difficulty complying and institute additional monitoring for those organizations as opposed to imposing onerous burdens on the entire system,” says Peterson. He suggests that the noncompliant organizations bear the expense of their own monitoring.

But not everyone agrees that ACCME enforcement is lax. “As a director of CME for two associations, I can tell you that both of these organizations take ACCME very seriously and try their darnedest to comply with the rules,” says Raymond Lanzafame, MD, MBA, FACS, director, CME, American Society for Laser Medicine and Surgery, Rochester, N.Y. “And I know of organizations that have lost their accreditation and organizations that have had to answer to ACCME when they didn't meet standards.” (During 2004 and 2005, according to the ACCME, six providers were put on probation, two providers lost their accreditation, and four initial applicants were rejected.)

Further, he says that even if the ACCME takes away noncompliant organizations' accreditation status, it may not stop their problem behavior or drive them from the education business. Instead of offering credits, he says, those organizations will provide certificates of attendance.

Pharma's Role

There has been great concern in the CME community about the impact of the government scrutiny and any additional regulations on commercial support. If the ACCME does tighten up, what will industry's reaction be? “From my perspective, anything they come out with — short of eliminating the concept of commercial support — will be protectionary for all stakeholders involved,” says Doyle-Scharff. “Holding providers accountable for the responsibility that they shoulder by getting into medical education in the first place is going to decrease my risk as a commercial supporter. This is probably going to sound ultra-conservative, but we need a zero-tolerance situation here. If it is discovered that you have violated [the CME guidelines] in any way, shape, or form — then you're out.”

And the responsibility for compliance has to be shared among all the stakeholders, she says, not just providers. “Physicians, faculty, all of the other payers and employers and the other bodies that are engaged in this — if you can't live up to those expectations, you shouldn't be allowed to participate in this enterprise.”

Those stakeholders include pharmaceutical companies. While the SFC report was favorable toward industry and the strides it has made separating marketing from medical education, CME professionals say more needs to be done.

“Industry has to say [to providers], ‘We have the dollars; we're willing to fund these [activities], but you have to step up and prove to us that you're going to run a compliant show. If you mess up, we're just not going to use you anymore.’ It's just got to be mandated that there's no room for error,” says Montague.

Commercial supporters also have a role to play in monitoring activities, says Susan Holtzman, president, Complete Conference Management, Miami, noting that occasionally grantors are sending observers to meetings to see whether speakers disclose their financial relationships and discussion of off-label uses. She thinks this will happen more and more.

It would also help if pharmaceutical companies had consistent operating standards regarding grants, says Mitton. “Representatives from company A do things one way, while another company will do things another way. If things were done straight across the board, it would alleviate all these problems.” She also thinks that the pharma reps should be fully trained in the regulations.

Dump the Bad Apples

While more rigorous ACCME oversight measures will no doubt add more responsibilities to an already overburdened CME provider community, and some think such tactics could be draconian, there is also a potential upside. Such strategies may shake out the bad apples that are giving CME a negative reputation, say CME professionals.

“Our whole profession will benefit if the marginal players or the players that are perhaps doing the things that are inappropriate drop out and pursue other endeavors,” says Dombrowski.

Those providers that do stay in business will have to exercise their authority to control the content, he says. “We're all going to have to get a better backbone. We're all going to realize that we are well within our rights to say no occasionally, for the betterment of education.”

Fischl agrees. Stricter enforcement and tougher standards would give CME providers the support they need to take a stand. “You can say, ‘This isn't me saying this; this is coming down from the national accreditation society driven by bias recognized by the U.S. Senate. [The guidelines] would carry more weight.”

Regardless of the challenges, it's critical that the CME profession make changes, say CME experts. “We as a profession ought to get our house in order,” says Dombrowski. “We've got to clearly demonstrate that across the board we are capable of doing things with high standards and high integrity. Then we won't have to fear that the government is going to try to regulate us or run us.”

Although she is leery of more regulations, Mitton agrees. “If we do not come up with a solution, the Food and Drug Administration might step in and that really will kill the business.”

Government oversight would not only probably add more bureaucracy and regulations for CME providers, but it could also impinge on freedom of education, experts say. Many CME professionals are especially concerned that the SFC flagged off-label discussion as a potential problem. Historically, certified CME activities have been a safe haven for talk about off-label and unapproved uses of products. The focus, say many CME professionals, should be on ensuring that content is valid and evidence-based, not on the FDA status of products.

“The idea that some oversight body would decide what views would be censored in CME is chilling,” says Peterson. “We need to preserve within CME a place for open, scientific debate. If some external truth czar decides what can be said, we've lost, we've all lost.”

Background Info

For an analysis of the Senate Finance Committee CME report and the Accreditation Council for CME's comments in response, see “CME in the Cross Hairs,” and “ACCME's Reaction” (Medical Meetings, June issue). Access the coverage online at meetingsnet.com/medicalmeetings. For the full SFC report, visit www.senate.gov/~finance/. For the ACCME's written response to the initial SFC inquiry, which includes details of its current oversight process, visit accme.org.

Alliance Goes to Washington

After the Senate Finance Committee released its report in April about CME, the Alliance for CME commissioned a task force to study the report and decide how to best address the issues it raised.

On June 12, the Alliance sent a letter to Senators Max Baucus (D-Mont.), SFC committee chairman, and Chuck Grassley (R-Iowa), ranking Republican. The letter, which is available at the Alliance's Web site, www.acme-assn.org, clarified the difference between certified activities and promotion, explained that content validation is a cornerstone of CME, and underscored that educational grants for CME activities are governed by letters of agreement between funders and providers that outline terms for compliance with CME guidelines.

The letter also stressed that the Alliance is committed to offering “valuable educational programming that is free of commercial bias” and would welcome the opportunity to meet with the committee and discuss the issues cited in the report, as well as work with the SFC to allay concerns about CME.

Toward that end, the Alliance has since been in contact with SFC staff. A contingent from the Alliance is scheduled to meet with them in October, says Alliance president Sue Ann Capizzi, MBA.

Commercial Support Conundrum

Does pharmaceutical industry funding of CME create an insurmountable conflict of interest? The Senate Finance Committee report on CME has reignited that debate. In an Op-Ed piece, “Diagnosis: Conflict of Interest,” (The New York Times, June 13, 2007) Daniel Carlat, MD, professor, Tufts Medical School, and editor-in-chief, Carlat Psychiatry Report, said that pharmaceutical industry funding has turned CME into a drug marketing enterprise and that these “shenanigans” were spotlighted in the SFC report. Citing the safety problems that have surfaced with drugs such as Avandia, Vioxx, and Zyprexa, Carlat says that because pharmaceutical companies set the CME agenda, information about the potential dangers of such drugs is played down. His suggestion: CME that is paid for by the drug industry should not be offered for credit.

Salem Clinic, Salem, Ore. has already drawn that line. “There's no direct funding of CME by the drug companies,” says Mark Fischl, MD, CME committee chair for the Clinic. “We'll let them have an advertising table, but the talk going on that day cannot relate to a drug that's sold by the company that has the advertising table.” Instead, CME is funded in part by the hospital, and pharma companies' exhibitor fees are put into a pool used for CME. “When drug company money is involved, you have to consider it advertising,” Fischl says. “We shouldn't be accrediting it as ‘medical education.’”

Others disagree. In a lengthy response to Carlat's piece, which she sent to the NYT, Sondra L. Moylan, MS, RN, president and founder, American Academy of CME, Skillman, N.J., explained that certified activities must meet strict standards, which are even more rigid if a pharmaceutical company provides funding. “It is only when physicians obtain fair balanced, nonbiased, and scientifically rigorous information and continuing education from accredited CME providers that we can expect to increase knowledge and improve physician practice, thus improving patient care,” she wrote. A much shortened version of her letter was published in the NYT on June 20.

Another option that is not as drastic as Carlat's is to create a central repository for CME grants. Pharma companies would allocate funds and an independent review board would decide which CME activities to fund. Lewis Miller, MS, principal, WentzMiller & Associates, Darien, Conn. proposed this idea in the January/February 2004 issue of MM, and discussion of it has resurfaced. (For Miller's proposal and CME professionals' responses, visit meetingsnet.com/medicalmeetings and do a keyword search for “New Funding Formula.”)