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5: Content and Format Without Commercial BiasQUESTIONS RELATED TO SCS 5.1 ____________________________________________ 1) What if an activity does in fact imply that a certain product or service is better than another? (SCS 5.1) CME exists to support the physician change and learning -- so as to increase their ability to participate in providing quality healthcare or improved healthcare. ACCME expects that providers will always be able to demonstrate how each activity contributes to quality and/or improvement in healthcare, and is, therefore, aligned with what is in the best interest of the public. 2) Since the updated SCS do not mention off-label usage, does that mean that disclosure for off-label uses is no longer required or that discussion of off-label uses is not allowed in a CME activity? (SCS 5.1) Discussion of off-label uses are certainly allowed in CME activities. However, providers are no longer required to have a mechanism in place to ensure that off-label or investigational uses are disclosed as such. The ACCME adopted content validation statements in 2002 that are expectations of providers with regard to any recommendations for clinical care. Specifically, ‘all the recommendations involving clinical medicine in a CME activity [are] based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation [conforms] to the generally accepted standards of experimental design, data collection and analysis.’ QUESTIONS RELATED TO SCS 5.2 ____________________________________________ 1) Does CME have to give ‘equal time’ to all modalities of therapy (e.g., surgical vs. medical)? Does CME have to give ‘equal time’ to all formulations of a drug or all products in a class of products? (SCS 5.2) CME must be free of commercial bias. CME must not promote products or services. CME must promote improvements in healthcare. A ‘balanced view’ means that recommendations or emphasis must fairly represent, and be based on, a reasonable and valid interpretation of the information available on the subject (e.g., “On balance the data support the following …”). A ‘balanced view of therapeutic options’ also means that no single product or service is over represented in the education activity when other equal but competing products or services are available for inclusion. «Return to Overview |