RECENT CRIMINAL TRIALS, prosecuted by the U.S. Attorney for Massachusetts, have subpoenaed detailed records from CME providers and their medical education and communication companies (MECCs), and required testimony from executives from these companies. The questions asked were related to the new Office of Inspector General rules and probed issues such as the clinical appropriateness of decisions in CME activities, control over content, influence by the supporter, and other matters directly related to the process of documenting strict compliance with the Accreditation Council for CME, FDA, Pharmaceutical Research and Manufacturers of America, and OIG guidelines and rules.
If your organization could be defined as an “agent” (a company that doesor promotion for the commercial supporter) and you collaborated in strategies and actions that inappropriately biased CME, then you could face criminal sanctions. If you partner with MECCs, the processes described below are behaviors that fit the new regulatory environment in which we live. If you are a MECC, use these guidelines to assess your capabilities to partner with accredited providers in developing CME.
Not All Firewalls Are the Same
Ensure that your MECC partner has a non-permeable firewall in place, separating educational from promotional activities. This means that the organization has
intentionally created an education division/department,
separate personnel who staff the division who don't float back-and-forth between education and promotion functions,
an educational mission that is compatible with your CE mission, and
policies that show an understanding ofEssential Areas and policies, and the AMA/PRA provider requirements.
Synthesizers — Not Sales Execs
Whether or not proposed ACCME changes to the Standards for Commercial Support regarding “manager and planner disclosure” go into place, those new terms have made their way into the CME planning process. While the course chair has a significant role in the final activity agenda, it is the MECC staff that performs the preliminary synthesis of needs, develops them into objectives, and shapes the actual agenda.
Make sure these “synthesizers” are not the same people who serve as account executives for sales of promotional services to the commercial supporter, and who therefore may have significant incentives to shape the agenda in a way that biases course content toward the supporter's product. Synthesizers should be independent of promotional activities offered by the company. Preferably, they should work only on education and have knowledge of the science underlying the activity.
Validation of CME Content
To further protect your CME program from a charge of bias, conduct a routine validation of the clinical content process. A good validation process involves the establishment of a panel of physicians with expertise in each of your content areas, who can review planned clinical content to ensure it is balanced and unbiased, scientifically accurate, evidence-based, and uses research data that is objective and conducted under appropriate rules acceptable to the U.S. scientific community. Make sure you develop a documentation format that demonstrates your content validation review process, allows for recommendations to correct areas of concern, and provides an expert's signature. Provide this documentation to commercial supporters to assure them that your CME program is committed to the highest standards.
For more tips, check out the online version of Consult at mm.meetingsnet.com.
Steve Passin is president of the CME consulting firm, Steve Passin & Associates in Newtown, Pa. An expert in public policy as well as education, Passin has served as deputy health secretary for California. Contact him at Passin@PassinAssociates.com.
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