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.”