IF YOU HAVE ANY DOUBT about how important CME guidelines are to the government, check out the Office of Inspector General's new guidance for pharmaceutical manufacturers, at www.oig.hhs.gov, issued as we went to press. Emphasizing that pharma firms should keep their hands off CME content development and choices, it says “codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing their CME arrangements.” (Watch for the July/August issue, for analysis of the guidance.)
Of paramount importance in regulating relationships between industry and CME providers, of course, will be the Accreditation Council for CME's revised Standards for Commercial Support. Now that the draft is written and the comments are in, I urge the CME community to spend as much time as necessary to ensure that the final version is clear, enforceable, and practical. The original Standards served well for 10 years. The new Standards, we can hope, will also stand strong for 10 years. After all, this is the document we will hold out to the wider medical community, the public, the government, and the media to demonstrate that the CME community is adamant about protecting the credibility and independence of educational activities.
To research the cover story, “Gag Rules?” (page 24), I read several organizations' responses and talked to numerous providers. What stands out to me is the tightly woven web of relationships between physicians, CME providers, industry, academic centers, and other healthcare institutions. The concerns and questions about the draft serve to highlight just how complex and confusing these relationships are — and how difficult it will be to draw lines of demarcation and develop workable rules. The intensity of the responses underscores how sensitive these issues are. This is the time to hammer them out.
Encourage Honest Dialogue
The open process used by thehas stimulated crucial discussion. Just because the official comment period is over doesn't mean the debate should stop. The Pharmaceutical Re-search and Manufacturers of America recommends that the ACCME make all the comments available to the public, perhaps by posting them on its Web site. I think that's an excellent idea. In addition, PhRMA asked the ACCME to consider accepting another round of public comments before a final version is adopted. Perhaps it would also be useful to hold another hearing, like the one the ACCME convened at the beginning of this process, bringing together different segments of the CME community to discuss the most controversial points.
While going through this daunting process, it's also important to take a step back and remember the bigger goal. In our Life Support column, “Enhancing CME Performance,” page 17, CME leaders talk about how providers, bogged down in tasks such as certifying activities and dealing with meeting logistics, don't have enough time to, for instance, develop CME that reduces medical errors. The purpose of the Standards should be to make things as streamlined as possible — so that CME providers can spend more time on what really counts — producing education that improves patient care and public health.