THE CME DOLLAR is regularly stretched to support activity planning, development, and implementation. On occasion, components of an event are compromised or eliminated because the funding is inadequate. When that's the case, do we behave as responsible stewards of financial resources when we designate ever-increasing portions of the CME dollar to duties associated with guideline compliance? Couldn't these monies be better spent developing methods to make measurable improvements in the educational process?
There is a cost associated with guideline compliance — a cost that inflates project budgets and is ultimately borne by the supporting organization or directly by the consumer of CME. In the case of large CME organizations, the cost of compliance includes hiring or reallocating staff to coordinate and manage documentation and to train and monitor staff and vendors to ensure compliance with regulations of the Office of Inspector General, Accreditation Council for CME, Food and Drug Administration, American Medical Association, Pharmaceutical Research and Manufacturers of America, and others. Smaller CME organizations, at the very least, must redirect a portion of staff time toward compliance activities. In either case, costs increase.
Consider, for example, that CME providers need to collect and interpret disclosure information while at the same time developing committees, policies, and procedures to resolve conflicts of interest. Or consider the many thousands of dollars invested to conduct on-site monitoring of programs previously approved by independent activity reviewers. CME providers also commit time and expense to the education and re-education of, grantors, and others whenever rules are revised or new regulations promulgated.
Depending on the term of accreditation, every several years CME providers must address the requirements of the re-accreditation survey and the accompanying sizeable task of compliance. In some organizations, this process takes almost a year, and for programs offering CME in multiple formats and in large volume, it may cost as much as $100,000 for staff time, consultants, and report review. And in the latter example, it is reasonable to ask whether given the high cost of labor, the re-accreditation timetable should be extended to perhaps seven to 10 years, thus bringing it more in line with medical board review standards while yielding appreciable cost savings. If extending time between reviews is not the answer, then maybe a retooling and reduction of submission requirements is in order.
Return to the Roots
It seems that compliance regulations should result in quality CME or at least in an improved CME product. But it's difficult if not impossible to prove that, for example, conflict resolution policies or specific disclosures improve the educational product, learning experience, or knowledge application.
CME must return to its roots. In recent years, policymakers have been all-too-responsive to exposés in the press and to the voices of medical sages who rarely find anything good to say about the CME process. It is time to accept the guidelines as they are, to verify their sufficiency, to modify them only infrequently and for carefully validated reasons, and to devote the resulting available time, effort, and funds to the restoration of bona fide educational and teaching principles. That is the core of CME, and it is subject to distortion and erosion when regulations override the process and absorb inordinate amounts of time, energy, resources, and funds.
Robert F. Orsetti is assistant vice president, continuing education, University of Medicine and Dentistry of New Jersey in Newark. Orsetti, a 24-year CME veteran, is a member of the AMA's National Task Force on CME Provider/Industry Collaboration. Contact him at (973) 972-8377 or send e-mail to firstname.lastname@example.org. For more of his columns, visit mm.meetingsnet.com.