1. CME Process and Accreditation Criteria 2016

2. Objectives Explain Updated ACCME Accreditation Criteria Utilize the revised CME Planning Process to incorporate ACCME Updated Criteria Implement evaluation to validate changes in knowledge, competence and performance. Begin to analyze changes in the professional practice gaps as a result of participation in the learning activities. Analyze Disclosure of Relationships form to determine completeness, relevance and to recognize conditions that indicate a conflict of interest. Explain independence of CME, appropriate use of commercial support, and proper management of commercial promotion. Review needs assessment and outcomes measurement methods

3. The Criteria A.Level 1 Compliance with 9 criteria Basic, entry level criteria for all new provider applicants to achieve Provisional Accreditation Provider is a change agent trying to change physician learners’ competence, performance, and patient outcomes Provider plans CME interventions compliant with ACCME Standards for Commercial Support and designed to improve healthcare in the context of their own CME Mission Measure effectiveness as change agents by success at meeting their CME Mission

4. The Criteria B.Level 2 Six additional criteria to be met in order to achieve Accreditation status Provider has plan in place to improve ability to meet their CME Mission, plan will be implemented and improvements underway Impact of the program improvements will be measured Educational interventions designed around knowledge or performance issues that underlie professional practice gaps Content related to the scope of practice of the learners and associated with current desirable physician attributes Provider is change agent actively engaged in improving quality of the CME program while facilitating practice based learning and improvement

5. The Criteria C.Level 3 Requires compliance with levels 1 and 2 plus additional seven criteria Operates beyond the provision of CME interventions-as a strategic asset to quality and safety initiatives Mechanisms in place to identify and overcome barriers to physician change and to integrate CME into healthcare improvement initiatives Takes advantage of non-educational strategies to enhance the learning and change process

6. Terminology Professional Practice Gap =A gap between what the professional is doing or accomplishing compared to what is achievable on the basis of current professional knowledge Knowledge, competence, performance =a way of looking at educational needs and evaluating outcomes (results of interventions) Outcome evaluation =assessment of change in knowledge, competence, performance or patient outcomes Interventions =educational formats, faculty, education design used to bring about the desired changes Performance Based Objectives =Desired outcomes stated behaviorally with an active verb

7. Review of CME Planning Process to Incorporate ACCME Updated Criteria CME Application and Planning Form

8. Participant Evaluation

9. Disclosure of Relationships Everyone in a position to control the content of a CME activity must disclose all relevant financial relationships with commercial interest ▫ Relevant financial relationship – Financial relationship in any amount, with commercial interest, occurring within the past 12 months ▫ Commercial interest – any entity producing, marketing, re-selling or distributing health care goods or services consumed by or used on patients Disclosure information must be provided to learners prior to the activity in writing (i.e. flyer, evaluation form, syllabus) Disclosure must include:  Name of individual  Name of commercial interest  Nature of relationship If there are no relationships learners must be informed that no relationships exist Refusal to disclose disqualifies a speaker from presenting at a CME activity CME office must receive disclosure information (Disclosure of Relationships form and COI Resolution form, if applicable) 30 days prior to activity

10. Commercial Interest The ACCME defines a “commercial interest” as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

11. Commercial interests are not:  Government organizations  Non-health care related companies  Liability insurance providers  Health insurance providers  Group medical practices  For-profit hospitals  For-profit rehabilitation centers  For-profit nursing homes  501-C Non-profit organizations - unless they advocate for ‘commercial interests’

12. What is a conflict of interest? When a significant relevant financial relationship with commercial interest is disclosed and when the content of an activity may be influenced by such a relationship, a conflict of interest is determined to exist

13. Resolving Conflicts of Interest Disclosure form completed indicating relevant financial relationship with commercial interest and that presentation will include products or services of the commercial interest indicated Conflict of Interest Resolution form completed indicating agreement with all statements Presenter is: Employee of commercial interest Non-physician speaker Topic/objective to include pharmaceutical/medical device content CME Office requests presentation/handouts for review Presentation reviewed by CME Manager and/or CME Director, CME COI Sub-committee Failure to resolve COI will result in disqualification of speaker

14. Q) Is it necessary to collect disclosure information from a speaker each and every time the speaker participates in a CME activity? A) No. Disclosure of Relationship forms must be completed for each speaker for each course or series.

15. ACCME Standards of Commercial Support (SCS) STANDARD 1: Independence STANDARD 3: Appropriate Use of Commercial Support STANDARD 4. Appropriate Management of Associated Commercial Promotion Acknowledgement of Commercial Support for a CME activity

16. STANDARD 1: Independence 1.1 A CME provider must ensure that the following decisions were made free of the control of a commercial interest. (a) Identification of CME needs; (b) Determination of educational objectives; (c) Selection and presentation of content; (d) Selection of all persons and organizations that will be in a position to control the content of the CME; (e) Selection of educational methods; (f) Evaluation of the activity.

17. STANDARD 3: Appropriate Use of Commercial Support Expenditures for learners ▫3.11 Social events or meals at CME activities cannot compete with or take precedence over the educational events. ▫How can meals or social events compete with educational events? Meals or social events compete with educational events when they happen at the same time in a different location or when they are the main attraction at the educational activity.

18. STANDARD 4. Appropriate Management of Associated Commercial Promotion 4.3 Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot contain any advertising, trade name or a product-group message.

19. Acknowledgement of Commercial support for a CME activity Source of all support from commercial interests must be disclosed  In-kind support – nature of support must be disclosed Disclosure must never include use of trade name or a product-group message Must be provided prior to activity

20. For samples of commercial support acknowledgement please contact the Division of CME

21. GRANT APPLICATIONS ONLINE New Items requested and considered in grant review process Today most major pharmaceutical companies require: Needs Assessment Methods/tools to Measure Outcomes Letters of Agreement (LOAs)

22. Needs Assessment should contain: Educational need or public interest to be addressed Identification of educational gap Rationale for Educational Design Educational outcomes Analysis Plan

23. Decisions are based on: Educational objectives supported by independent needs analysis Measurable learning objectives – How will you measure outcomes Promotion of excellence in patient care Compliance with Accredited provider’s guidelines related to content, venue, etc. Rationale for educational format Education of the broadest healthcare professional target audience at appropriate reasonable cost Effectiveness and efficiency of the meeting format ▫Evaluations – during and Post-event

24. How will Outcomes be Measured? Must answer … What is the activity designed to achieve? Are learning objectives measurable? How much change in knowledge may be expected? Competence Performance

25. Methods/tools to measure outcomes Participant Evaluation ▫ask attendees what they learned and how they plan to implement changes Send a survey 3 months after activity (Post-meeting) ▫Have they changed their behavior or practice as a result of this activity ▫If not, why? This will help determine future programming

26. Measuring Outcomes Participant Evaluation Ask attendees what they learned and how they plant to implement changes Send a survey 3 months after activity- Have they changed their behavior or practice as a result of this activity? If not, why not? This will help determine future programming Case Studies Can be used as a pre-test or post-meeting evaluation Studies show it appears to be reliable as an indicator of predicting physician behavior Chart Review Although a highly effective form of evaluation, it can be difficult to obtain outside a hospital system Standardized Patients Highly effective form of evaluation, but requires resources to develop and implement Review of Statistics If statistics were used to determine the need, a review of the data can be done post-activity for comparison

27. CME involvement Letters of Agreement (LOAs) LOAs must be received PRIOR to event The terms, conditions and purposes of the commercial support must be documented in LOA No Commercial Interest should be acknowledged unless an LOA is received and signed by both the Provider and the Commercial Supporter CME must receive copies of all LOAs and corresponding checks Pfizer grants must be applied for through Oscar Reyes oreyes@miami.edu LOAs for CME activities must be reviewed and signed by Oscar Reyes oreyes@miami.edu Use University of Miami CME LOA whenever possible