“When the new draft Standards for Commercial Support were released in April, they were greeted with a big sigh of relief from CME providers — make that a big sigh of relief and some yawns,” says Jack Kues, PhD, assistant dean for CME, University of Cincinnati, Ohio.
As you may well know, Kues is referring to the April revision of the Accreditation Council for CME's Stan-dards for Commercial Support, which were unanimously approved by the's Board of Directors.
In contrast to yawns and sighs, the first draft revision of the Standards, released last January, elicited vociferous protest, particularly because the draft stipulated that doctors would be disqualified from teaching if they had a conflict of interest. There is no such requirement in the new version, which says that CME providers must identify and resolve all conflicts of interest — but leaves the decisions about how to do that up to providers.
CME professionals are not only pleased with the content, but also with the design and wording of the new Standards. Gone are the initial draft's five pages of themes, elements, and numerous footnotes. Instead, the new, two-page document comprises six Standards, each with several points clearly delineated.
“I read them an hour after they were on the Web, and I had to send Murray Kopelow [ACCME chief executive], an e-mail message telling him how pleased I was and that I would support their acceptance among my peers,” said Frederic S. Wilson, category manager CME, Procter & Gamble Pharmaceuticals, Mason, Ohio. “I think the [Standards] task force did a remarkable job. They certainly got a lot of heat from the draconian first draft. They obviously got the message. The new version clearly shows respect for CME providers, and [it] shows they are fully capable of self-regulating the relationship between themselves and industry.”
“I think from the providers' perspective, this is a much more tolerable approach than what we saw previously,” agrees Bruce Bellande, PhD, executive director, Alliance for CME, Birmingham, Ala.
“From the commercial supporters' perspective, this is much more in line with the Office of Inspector General Guidance, which is very specific on involvement in educational grants, the appropriate role and responsibility of a commercial supporter, and the separation of any promotion from education,” Bellande says.
While CME providers worried that the first draft would result in a decrease in commercial support, Bellande is optimistic about this new version. “I don't think this document will have any adverse impact, because it's very much in line with OIG,” he says. In fact, although the OIG guidance caused commercial supporters to tighten up their policies for funding CME, the overall effect of increased regulation has been positive for CME providers, Bellande says.
“What we've seen since OIG came out is a huge realignment [within pharma companies], but there also is a huge increase in funding, rather than any decreases.”
Although the response to the proposed Standards is positive for the most part, there will undoubtedly be challenges in the future for CME providers when it comes time to implement them.
If approved, the new guidelines will require providers to develop additional policies and processes and engage in due diligence regarding disclosure and resolving conflict of interest, says Bellande.
As for the time frame, the seven ACCME parent organizations have until the end of September to decide whether to approve the document. If they do approve it, CME providers will be expected to begin incorporating the changes immediately, says Kopelow. However, the ACCME will not begin making accreditation decisions about providers under the new Standards until November 2006 or beyond.
For more analysis of what the Standards will mean for CME providers, see our cover story on page 24.
For a comparison between the current and proposed Standards, visit the Alliance for CME's Web site at www.acme.assn.org.
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