Regulatory Guidelines When the “CME Rules” Don’t Make Sense Mark Christmyer Managing Director Anyone with experience in delivering CME and third-party education understands that the status quo mentality needs to change. Serious offenses and abuses in the CME arena, which had prompted the implementation of new guidelines, have been addressed by industry, medical organizations, and regulators. This change has been good for the medical education industry, refocusing the principles and purpose of continuing education back to its original intent. More change may be needed, not only to provide better direction to sponsors and providers but, most importantly, to ensure that CME is both in the best interests of patient care and assists physicians and healthcare professionals in the delivery of that care. But the industry must guard against getting stuck on the letter of, rather than the intent of, the new guidelines. Here is an example of a curious CME dilemma: in a category of medicine where there is essentially only one therapy (with considerable redundant generic competition). The therapy is associated with significant complications that are not always well-considered by prescribing physicians or dispensing pharmacists. Because of this situation, the recommendation would be to develop a CME program that would “certify” each physician and pharmacist as a CME-accredited prescriber or dispenser. This would appear to be an almost foolproof way to test the knowledge of healthcare professionals once they had reviewed a thorough CME program and the category in general and the medication in particular. A “certification” of ability to prescribe and dispense this therapy would be the intent, similar to a state licensure, which certifies a healthcare professional to practice or continue to practice medicine in that state. But this is where a problem arises. The proposed solution is not acceptable to CME providers that must accredit the program because these accrediting bodies are not permitted under current CME guidelines to provide CME credit for a single therapy. There must be fair balance, and all products in that category must be considered equally. This rule makes sense in many circumstances to prevent usurpation of education for promotional purposes, but is it the real intent of current CME guidelines to prevent implementation of this certification program? Were the best interests of the public and of healthcare providers being served? Even though the CME program would address specific misinformation, poor prescribing behavior, and minimize mistakes that have led to harm (because no other standard of care matches the therapy when used appropriately or has the potential for harm when it is not), the effort would be viewed as too product-specific and would be considered promotion. Despite the best of intentions to adequately test healthcare professionals on their ability to prescribe and handle the therapy, while providing CME credit and attempting to apply a safeguard to those who receive treatment, the current guidelines can leave many content developers angry, confused, and scratching their heads in disappointment. Looking Forward How does CME need to evolve? And what’s the best forum for this debate and dialogue? Anyone with experience in delivering CME and third-party education understands that the status quo mentality needs to change. Healthcare professionals learn in many different ways. Some learn interactively, some learn visually, and some learn via audio. Consideration must be given to how audiences learn best, and designers of CME need to direct their educational efforts to provide information in formats that most effectively maximize the learning experience and, hopefully, change behavior and impact patient care. CME technology is evolving. Evidence-based medicine is on the rise and has the potential to drive some intriguing new possibilities. Physicians, associations, and payers are starting to link health outcomes with practice guidelines that will change care delivered to patients. Hand-held technology will rapidly enable CME to be provided “at the point of care,” where best practices and best outcomes will become almost instantaneous. If an inappropriate prescription or diagnostic test is written, a prompt should appear on the physician’s hand-held that offers a pertinent CME program and brings education and practice pattern change to the bedside. The industry is truly at a crossroads with regard to CME. The future holds intriguing opportunities to innovate, but this innovation needs to be medically savvy and not at the expense of the intent of CME guidelines. As we move forward as an industry, everyone needs to ensure that it is the intent of education, not merely the existence of guidelines, that effects change and advances patient care. ACCME, are you listening? InRx LLC, Philadelphia, a wholly owned medical education subsidiary of Dorland Global Corp., has core competencies in educational content development, project direction, clinical communications, and professional relationship management and provides a broad range of clinical, educational, CME, and third-party initiatives. For more information, visit inrx.com. August 2005 VIEW on Medical Education

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