1. Who wants to be accredited? A self-assessment tool © 2003-2005 ACCME

2. Fair use of this presentation The ACCME is developing materials to help accredited providers raise awareness and educate individuals on ACCME’s 2004 Standards for Commercial Support. This presentation is a resource to serve that purpose. Providers may find the presentation useful when providing training to staff, committees, teachers/authors, or other volunteers. The presentation is held as copyrighted © by the Accreditation Council for Continuing Medical Education. Through this notice, the ACCME grants permission for its use to ACCME accredited providers, ACCME recognized state medical societies, and intrastate accredited providers for educational purposes, and to any other organizations using the presentation for educational purposes. These materials may not be used, in whole or in part, for any commercial purposes, including but not limited to courses or seminars related to compliance with ACCME accreditation criteria, without the prior permission in writing from the copyright owner.

3. Documents needed to help you complete this assessment ACCME’s Criteria for Compliance ACCME’s Standards for Commercial Support (SCS) ACCME’s Policy on Commercial Support and Disclosure All are available on www.accme.orgwww.accme.org

4. Objective #1: Recognize practices to demonstrate compliance with components of ACCME’s SCS with which providers have had difficulty demonstrating compliance: These components relate to disclosure of relationships to learners and appropriate use of commercial support.

5. Objective #2: Identify your own needs for learning more about demonstrating compliance with these requirements.

6. Instructions: For each case, indicate if the scenario supports: Non Compliance? or and then provide support for your answer by citing the applicable Element of the SCS or policy

7. Scenario #1: Disclosure Provider X has the following disclosure information at the beginning of the syllabus for an activity. TopicSpeakerCompany Acute MIDr. Hart (ABC Drug Co.) HeadacheDr. Payne (XYZ Pharm. Co.) DiabetesDr. Krine (123 Incorporated)

8. Scenario #1: Disclosure Does this scenario support: Non Compliance? Partial Compliance? Review ACCME SCS 6.1 (Criterion 7) HINT

9. #1 scenario supports: Non Compliance Explanation: SCS Element 6.1 requires the following components of disclosure: 1) name of individual; 2) name of commercial interest, & 3) nature of the relationship. Scenario #1 does not include the nature of the relationship

10. Scenario #2: Disclosure In its self study report for reaccreditation, Provider Y indicates that faculty verbally disclose at the beginning of each presentation by using the disclosure slide seen here. Provider Y has many examples of the slide used in its activities.

11. Scenario #2: Disclosure Review SCS 6.1, 6.2 (Criterion 7) and ACCME Policy on Verbal Disclosure Does this scenario support: Non Compliance? Partial Compliance? HINT

12. #2 scenario supports: Non Compliance Explanation: According to ACCME’s policy on verbal disclosure, when a provider’s mechanism to disclose is a verbal announcement, the provider must have a representative who attended the activity provide written attestation that disclosure occurred and itemize the content of the disclosed information (SCS 6.1); or that there was nothing to disclose (SCS 6.2). Scenario #2 does not include an attestation or itemization of what was disclosed.

13. Scenario #3: Disclosure Dr. Smith begins her presentation with a disclosure slide. This slide is included in the syllabus. The syllabus is used as evidence that disclosure occurred.

14. Scenario #3: Disclosure No hints! Does this scenario support: Non Compliance? Partial Compliance?

15. #3 scenario supports: Compliance Why? This example includes the information outlined in SCS Element 6.1: 1) name of individual; 2) name of commercial interest, & 3) nature of the relationship.

16. Scenario #4: Disclosure Doctors’ Specialty Society (DSS) is holding its annual meeting. DSS utilizes a disclosure form to collect information about planners and teachers’ relationships. DSS submits in its self study report to the ACCME all of the signed disclosure forms as evidence of compliance with requirements on disclosure.

17. Scenario #4: Disclosure Does this scenario support: Non Compliance? Partial Compliance? Review ACCME SCS Element 6 (Criterion 7) HINT

18. #4 scenario supports: Non Compliance Explanation: SCS Element 6.5 requires providers to disclose information to the learners prior to the beginning of an activity. Scenario #4 does not include any evidence that disclosure to the learner occurred.

19. Scenario #5: Disclosure National Medical School (NMS) is holding a meeting that has 30 faculty members. All 30 faculty members have returned the disclosure form that NMS has asked them to complete. NMS staff creates a faculty disclosure list to include in the activity syllabus that looks like this:

20. Name Roy Brown, MD*Melanie Runter, MD, PhD**Bryan Daigle, MD** James Taylor, MD*Garfield Schnexnayder, MD*Ken Smith, MD** Jane Davis, MD*Jay Tyler, MD*Katherine Smart, MD* Mel Runter, MD, PhD**Jane Davis, MD**Ellen Front, MD* Ray Brown, MD*Melanie Runter, MD, PhD**Bryant William, MD Jill Taylor, MD*Bob Brown, MD**Lucy Tanner, MD** Jack Dawson, MD**Jack Maylor, MD**Kathi Douglas, MD* Lisa McDonald, MD **Janet Davison, MD**Elle Landry, MD** Jay Brown, MD*Ruth Olson, MD, PhD*Martin Canli, MD** Mimi Watson, MD*Sheila Bourg, MD**Ken Tarter, MD* NMS Faculty * indicates faculty member has nothing to disclose **indicates faculty member chose not provide information regarding relationships with manufacturers of products discussed

21. Scenario #5: Disclosure No hints! Does this scenario support: Non Compliance? Partial Compliance?

22. #5 scenario supports: Non Compliance Explanation: According to SCS Element 2.2, refusal to disclose leads to disqualification from the individual’s role in the CME activity. Scenario #5 describes a situation in which faculty members continued in their role after refusing to disclose.

23. Scenario # 6: Appropriate Use of Commercial Support Physician Foundation, an ACCME accredited provider, is jointly sponsoring an activity with New Medical Advances Society. There are five commercial supporters of the activity. Physician Foundation has copies of the written agreements signed by the commercial supporters and New Medical Advances Society.

24. Scenario # 6: Appropriate Use of Commercial Support Does this scenario support: Non Compliance? Partial Compliance? Review ACCME SCS 3.4 – 3.6 (Criterion 8) HINT

25. #6 scenario supports: Non Compliance Explanation: SCS Element 3.6 requires both the commercial supporter and the provider must sign the written agreement. In Scenario #6, the provider did not sign the written agreements.

26. Scenario # 7: Appropriate Use of Commercial Support New Medical Innovation, Inc., holds 10 CME activities per year, all of which receive commercial support. During NMI’s survey, ACCME surveyors reviewed activity files.

27. Scenario # 7: Appropriate Use of Commercial Support In each file, NMI included all of the necessary written agreements with commercial supporters that were signed by NMI and the commercial supporters. Each agreement has the commercial supporter’s name and logo at the top of the first page. All agreements were generated by the commercial supporters.

28. Scenario # 7: Appropriate Use of Commercial Support Does this scenario support: Non Compliance? Partial Compliance? Review ACCME SCS 3.4–3.6 (Criterion 8) HINT

29. #7 scenario supports: Compliance Explanation: There is no ACCME policy or SCS Element that prohibits a provider from using a written agreement generated by a commercial supporter.

30. Scenario # 8: Appropriate Use of Commercial Support Physician Testing Group (PTG) receives a signed written agreement and check (for the amount it expected) from its commercial supporter Better Treatments, Inc. Better Treatments includes with the agreement and check a memo that reads:

31. Scenario # 8: Appropriate Use of Commercial Support Enclosed is the list of physicians who should receive complimentary registration to your upcoming meeting. Better Treatments is providing this grant for the meeting under the condition that PTG provides these complimentary registrations.

32. Scenario # 8: Appropriate Use of Commercial Support Does this scenario support: Non Compliance? Partial Compliance? Review ACCME SCS 3.1 and 3.2 (Criterion 8) HINT

33. #8 scenario supports: Non compliance Explanation: According to SCS Element 3.2, a provider cannot be required to accept advice or services from a commercial interest as a condition of contributions of funds or services. In Scenario #8, advice from the commercial supporter is a condition of support.

34. #8 scenario supports: Non compliance Explanation: In addition, SCS Element 3.12 explicitly states that providers may not use commercial support to pay for personal expenses for non-teacher or non-author participants of a CME activity. In Scenario #8, commercial support would be used to pay for participant personal expenses (registration fees).

35. Have you identified a personal or organizational need? For more information to help you meet your needs, visit www.accme.org

36. Summary