"The Q&A The ACCME board of directors charged the staff with the responsibility, and gave us the authority, to interpret and explain its positions in the context of what we knew from the process of developing the SCS. The resource materials were created, I promise you, as educational resources to help bracket the landscape—not as instructions to say, 'Do this and you're going to be OK, and if you don't do these four things you are going to be out of compliance.'
But providers need to understand that those are just educational resources. If they stay on our website or if they disappear, if they get edited or changed, it doesn't mean we are changing policy, and it doesn't mean we are changing accreditation criteria. The decision-making criteria will be established over the next few years, as providers come forward with their approaches to compliance.
"Validity The standards are a key part of ACCME's overall strategy to ensure the credibility and validity of CME. Credibility and validity are, to a great extent, determined by who is in front of the audience teaching. It is important that the best and the brightest are teaching and that CME is independent of commercial interests. Transparency through disclosures is a large part of the credibility of CME.
I am not saying that education dependent on commercial interest is wrong, or invalid, or not true. It is just education created by commercial interests and not by the CME system."
Another example of external validation is the circumstance where the educational space contains the world's experts. When someone brings new information from his or her own research or offers personal thoughts of what should be done, it is effectively being subjected to a peer-review process because the room contains peers who can judge what they are being asked to learn. They can say, 'this is biased,' 'this is only because of your commercial interest,' or 'the data don't support that conclusion.' That process, that mechanism, resolves conflicts of interest. There are safeguards in place. This is the way professionals and clinical scientists interact, at the expert level."
"Enduring Materials The 1992 SCS said a commercial interest could distribute enduring materials, and the provider was responsible for their use as a CME activity. In element 4.5 of the 2004 Updated SCS, ACCME says providers must not use commercial supporters as a distribution vehicle for a CME activity. The goal of this [SCS] element is to separate detailing from the physician's participation in CME. 'Let's sit down and do this activity together while we are detailing the product,' fails to separate education from promotion. But it's not up to ACCME to say what commercial supporters can buy or do. ACCME does not regulate commercial supporters; they are accountable to other organizations or institutions."
"Timeline Implementing the Updated SCS is a process of change. After May 2005, as providers start new activities, we expect that they will implement the new elements of the Updated SCS. I need to emphasize that there are a limited number of new elements in the 2004 document. We understand that it will take some time, energy, and resources to implement something new, and we expect that providers will have the time to make this transition."
"Demonstrating Compliance The range of strategies and tactics that providers will adopt is yet to be seen; most mechanisms have not yet been described. ACCME has offered some clarification and examples, but ultimately the providers will decide how they will practice. Providers know that ACCME operates under an improvement model. When they are out of compliance, it is their responsibility to come into compliance within a designated period, usually a year. We require that providers demonstrate this improvement in an ACCME Progress Report, a description of current practice accompanied by documentation that verifies compliance. In our experience, 90 percent of providers who are not in compliance can and do demonstrate compliance by the end of one year. Virtually every time, the remaining 10 percent are in compliance after another six months. We know that this improvement model works. We rarely have to take away accreditation, but we do it on occasion."
"Implementation and Enforcement The ACCME considers itself a voluntary, self-regulated system—not a regulatory body. We fundamentally do not believe that enforcement is the major cause of compliance. We believe that we are an organization that articulates the standards that reflect the values of the profession to people who understand the values of the profession. In that context, no enforcement or regulation is required. We do not need to force providers into compliance. When people share your values and they know exactly what the requirements mean, they will implement them. That is the case with the vast majority of accredited providers within the ACCME system."
Special thanks to Andréa Azpeitia, conference producer, for her help with this article.
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