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Criterion Case Studies

This article discusses the compliance criteria for continuing medical education (CME) activities, specifically focusing on Criterion 2 and Criterion 7. It provides examples of how providers can incorporate educational needs and develop activities independent of commercial interests. The article also highlights best practices for identifying and resolving conflicts of interest.

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Criterion Case Studies

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  1. Criterion Case Studies Michael J. Madura, MD Kathy Collins

  2. Disclosures Michael J. Madura, MD, does not have any relevant financial relationships. Kathy Collins does not have any relevant financial relationship.

  3. Criterion Data (from 1/2013 – 5/2016)

  4. Discussion of Criterion 2 and 7 (SCS 1, 2, 6)

  5. Criterion 2 Criterion 2 -The provider incorporates into CME activities the educational needs (knowledge, competence, or performance) that underlie the professional practice gaps of their own learners.

  6. ACCME Example of Compliance • Criterion 2 The provider utilizes a variety of data sources, which it categorizes as “subjective” and “objective,” that include feedback from learners, risk consultant staff, claims adjustors and underwriters, as well as claim report data, risk assessment outcomes data, literature review of peer-reviewed journals, practice guidelines and other sources. In most cases, the underlying educational needs of their learners are developed specific to the individual physician who is participating in their primary CME activity, which comprises 98% of their current CME program. • ACCME Reference: # 15290

  7. ACCME Example of Compliance • Criterion 2 Practice gaps and needs are identified through staff and management discussions, data from other organizations with similar membership and audience, member opinion surveys, online member forums, activity evaluations and pre- and post-test scores, input from consultants and topic experts, and from government regulations with which physicians must comply. These gaps and needs are incorporated into their activities through learning objectives that articulate knowledge, competence, and/or performance expectations for the learner following participation in the activity. • ACCME Reference: # 15298

  8. Any Other Examples?

  9. Criterion 2 Case • The provider stated, "We offer CME that is federally or state-mandated for physician re-licensure". Does this provider’s practice meet expectations for Criterion 2? Yes? No?

  10. Answer

  11. Criterion 2 Case • Practice gaps are identified by reviewing reports from the CDC, the IOM, daily news clippings related to infectious disease, and from their membership input. The provider also conducts surveys of its membership to assess their needs as related to identified gaps. Does this provider’s practice meet expectations for Criterion 2? Yes? No?

  12. Answer

  13. Criterion 7 Criterion 7 -The provider develops activities/educational interventions independent of commercial interest. (SCS 1, 2, and 6)

  14. SCS 2: Resolution of Personal Conflicts of Interest Standard 2.1 The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

  15. SCS 2: Resolution of Personal Conflicts of Interest Cont’d Standard 2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity. Standard 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.  

  16. ACCME Example of Compliance • Criterion 7 The information submitted describes a planning process that clearly delineates the roles and responsibilities of the provider, its planners and faculty. The provider ensures that there is no control or input from commercial interests. All planners' and teachers' conflicts of interest have been identified and resolved. Disclosure of relevant, or no, financial relationships to learners has occurred. • ACCME Reference: # 7044

  17. ACCME Example of Non-Compliance • Criterion 7 The provider's commercial support policy, presented as evidence in the self-study report, states "the provider may request suggestions for presenters or sources of possible presenters from a commercial supporter." This is inconsistent with the ACCME's requirement that a provider must ensure such decisions are made free of the control of a commercial interest. (SCS 1) • ACCME Reference: # 7045

  18. ACCME Example of Compliance • Criterion 7 The provider collects disclosure information from all individuals in control of content. Those who refuse to disclose this information are disqualified from participating. For any person who reports a relevant financial relationship, the provider uses a peer review process to resolve the potential conflict of interest. For presentations that have the greatest potential for bias, the provider asks an independent third party reviewer to conduct a second peer review as an additional mechanism to resolve conflicts of interest. (SCS 2.1, SCS 2.2, SCS 2.3) • ACCME Reference: # 55971

  19. Small Group Discussion

  20. Criterion 7 SCS 1 Case • A provider states an employee of ACCME-defined commercial interest can be used as faculty but would not include the activity as part of its accredited CME program. Three employees of commercial interest presented sessions related to the business lines or products of their employers at several other accredited activities. Did this provider’s practice meet expectations for Criterion 7 SCS 1? Yes? No?

  21. Answer

  22. Criterion 7 SCS 2.3 Case • In County Medical Society’s performance-in-practice materials for its “2015 Annual Symposium on Prescribing Errors” activity, Dr. Apple is listed as a member of the planning committee. On the performance-in-practice structured abstract, Dr. Apple is listed in the table of those who control the content of the CME activity as a planner who possesses a relevant financial relationship: she is a member of the speaker’s bureau for Dynamic-Pharmacy Distributors, Inc. The table also includes information for the speakers/presenters involved in the symposium.

  23. Criterion 7 SCS 2.3 Case • In its evidence of implementing a process to resolve conflicts-of-interests of those in control of content who possess relevant financial relationships, the provider shows that conflicts of interest for all those in control of content were resolved by having each person sign an attestation to use, “best available evidence for clinical recommendations,” in their presentations. • Does County Medical Society’s process to resolve Dr. Apple’s potential conflict of interest meet the expectations for “resolving conflict-of-interest” in Standard 2.3? Yes? No? Why?

  24. Answer

  25. Criterion 7 SCS 2.3 Case Orthopedic Association is holding its annual meeting. One of its speakers has disclosed that he is a consultant for Medical Bone Company. The content of the presentation involves a surgical procedure using a device made by Medical Bone Company. After the provider determined that the speaker’s financial relationship was relevant to the content of the presentation, the CME Chair discussed expectations with the speaker that he abide by the provider’s content validation policy and limit clinical recommendations to those supported by best available evidence. The speaker’s conflict of interest was appropriately disclosed by the provider to learners prior to the activity. Several presentation slides show the Medical Bone Company device being used. The educational materials include the device’s trade name. No other medical devices (or manufacturers) are described in the activity.

  26. Criterion 7 SCS 2.3 Case Which of the following determinations is correct regarding this activity and the Standards for Commercial Support? • a.       Compliance with Standard 2.3 (resolving conflicts of interest) and Standard 5 (content and format without commercial bias) • b.      Noncompliance with Standard 2.3 (resolving conflicts of interest) and Standard 5 (content and format without commercial bias) • c.       Compliance with Standard 2.3 (resolving conflicts of interest); not enough information to determine compliance with Standard 5 (content and format without commercial bias) • d.      Compliance with Standard 2.3 (resolving conflicts of interest); noncompliance with Standard 5 (content and format without commercial bias)

  27. Criterion 7 SCS 2.3 Case Why?

  28. Answer

  29. SCS 6: Disclosures Relevant to Potential Commercial Bias Standard 6.1 An individual must disclose to learners any relevant financial relationship(s), to include the following information: The name of the individual; The name of the commercial interest(s); The nature of the relationship the person has with each commercial interest. Standard 6.2 For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.

  30. SCS 6: Disclosures Relevant to Potential Commercial Bias Cont’d Standard 6.3 The source of all support from commercial interests must be disclosed to learners. When commercial support is "in-kind‟ the nature of the support must be disclosed to learners. Standard 6.4 'Disclosure' must never include the use of a corporate logo, trade name or a product-group message of an ACCME-defined commercial interest.   Standard 6.5 A provider must disclose the above information to learners prior to the beginning of the educational activity.  

  31. ACCME Example of Compliance • SCS 6.1, 6.3, 6.5 • A standardized CME information page that includes all disclosures is provided to participants prior to the educational activity. Regularly Scheduled Series (RSS) are monitored on a regular basis for compliance through unannounced site visits by CME office staff. For all RSS, a CME coordinator is assigned to ensure that disclosures of relevant financial relationships for those in control of content are provided to learners prior to the beginning of the activity. Acknowledgement of commercial support is also included in the CME information page. (SCS 6.1, SCS 6.3, SCS 6.5)   • ACCME Reference: # 55978

  32. ACCME Example of Compliance • SCS 6.2 A standardized CME information page that includes all disclosures or lack of relevant financial relationship(s) exist. Summary of Financial Disclosures: Planners, reviewers or faculty presenters have the following to disclose: ORAll planners, reviewers, faculty presenters have nothing to disclose.

  33. ACCME Example of Compliance • SCS 6.5 A provider must disclose information to learners prior to the beginning of the educational activity. Michigan State University uses a 1-page document title Activity Information Page (AIP) to disclose all required information prior to the start of the educational session.

  34. Questions??

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