1 CME Updates Douglas W. Hanto, M.D., PhD Associate Dean for Continuing Medical Education Professor of Surgery Vicki Tegethoff, RN, MHA Director of CME cme.wustl.edu
2 Purpose of this Presentation This presentation addresses: Processes to enhance compliance with the ACCME s Standards for Commercial Support Disclosure, resolution and documentation of financial relationships Increase interdisciplinary planning in educational activities 2
3 Primary Objectives At the end of this session, participants will be able to: Explain and apply processes for resolution and documentation of conflict of interest Review funding guidelines and processing Include nursing, pharmacy, social work, OT/PT, and other healthcare personnel, in active planning of educational activities. 3
4 Current Initiatives in CME Investigating new learning management system to increase automation of processes Joint accreditation to include nursing and pharmacy Maintenance of Certification (MOC) Currently the only credit available is AMA PRA Category 1 Credits TM 4
5 CME Activity for FY 2013 Type of CME Program Number of Programs Hours Accredited Hours Awarded Fully Planned ,028 Co-planned ,971 Jointly planned ,586 Rounds 187 5,476 61,699 Teleconference ,714 CME-Online ,359 5 Total 662 6, ,898
6 Review of 2004 Standards for Commercial Support CME Policy 6 Disclosure by all planners at the beginning of the planning process. If planners have financial relationships, those relationships must be reviewed, resolved, and have documentation of resolution. Disclosure by speakers must occur prior to participation. ANY financial interest IS a conflict and must be resolved and have resolution documented. Separation of commercial interest funds for marketing from funds/grants for education.
7 Review of 2004 Standards for Commercial Support CME Policy (2) All funding needs to be given in the form of an educational grant or display. No expenses should be paid directly by the commercial entity. Industry reps cannot wear company badges inside a CME meeting room. Pharmaceuticals and manufacturers of devices are beginning to post all payments to physicians on public websites. Sunshine Act (Open Payments) 7
8 Issues in CME-related Disclosure Regulatory groups that influence CME. Increased scrutiny on those planning CME activities and the resolution or mitigation of their potential conflicts. Definition of conflicts and how to resolve. Definition of commercial interest. Transparency to learners and the public. 8
9 Disclosure of Financial Interest The basic requirements of disclosure according to ACCME guidelines/standards have not changed. What has changed over the last few years? Definition of a commercial interest Scrutiny around those planning the activity Documentation that resolution/mitigation has occurred 9
10 Washington University Experience Within our CME disclosure database, approximately 25% of practitioners that have completed a disclosure form have financial relationships. Some relationships that are not allowed at other universities are allowed (speaker s bureau) These relationships are not banned, but it makes for increased potential for bias in education presentations (or the perception of such). 10
11 Definition of a Commercial Interest Any entity producing, marketing, re-selling or distributing healthcare goods or services consumed by or used on patients. (Exception: providers of clinical services directly to patients, government organizations or non-healthcare related companies.) Any dollar amount constitutes a relationship Includes relationships of spouse or partner 11
12 Our Procedures for CME Conflict Resolution Disclosure submitted and reviewed on-line within the past 12 months Review and resolution of all members of the planning committee Submission of presentations in advance of CME activity (all presentations from speakers with financial interests /conflicts). Review of presentations prior to CME activity by activity chairperson or, if chair is conflicted, by a designated peer reviewer(s). Presentation approved, modified or disapproved as recommended by reviewer(s). 12 Disclosures and resolution presented verbally & in slides. Documentation of resolution
13 RSS/Rounds application packet and changes to disclosure documentation 13 Will continue with having 2 types of RSS/rounds: Open discussion Speaker-based Planning process for a round activity (for a 2-year cycle) has not changed Need for documentation of planning committee resolution Session planning forms have changed for both types of activities Please use documents from website, as they may change over time.
14 14 Application packet Application/Renewal form Demographics: added additional planning committee members if someone other than the chair determines speakers or topics- ie. residents, nursing personnel, etc. Primary planners/moderator for the year-long activity Bottom half is a checklist of items needed to be turned in prior to approval: 5-page planning process (unchanged) CME disclosure form and Course Faculty Agreement for a CME activity for the round chair and any additional planners and independent reviewer if needed. Planning Attestation and Commitment regarding Conflict of Interest for round chair and any planners and independent reviewer if needed.
15 CME Disclosure of Financial Interest Form Can be completed either on-line at: cme.wustl.edu/disclosure.html or paper copy. Available as a fill in copy at cme.wustl.edu Only changes: Updated definition of a Commercial Interest Delineated the categories of relationships Reminder: This must be completed by ANYONE who presents at a CME activity, regardless of degree or training status. 15
16 Course Faculty Agreement for a CME Activity to be completed by all planners/ speakers New form to be completed for all CME activities Should be completed at least once a year Is now part of the online disclosure form (as of May 1, 2014) Outlines the attributes of a CME presentation and that those involved in planning a CME activity will adhere to these guidelines ALL presenters must complete this regardless of their degree or training status. 16
17 Planning Attestation and Commitment Regarding Conflict of Interest (COI) for all Chairs, Co-Chairs, Planners or anyone in control of content Should be completed by each member of the planning committee. For Open Discussion not all attendees on the sign in sheet are planners, they are most likely just considered presenters For RSS/rounds, do not need to fill in the financial relationship section as a printed disclosure should be included with the application Planners sign an attestation that they are planning the activity based on promotion of quality healthcare and not to promote commercial interest. If the chair(s) and planning committee members all have relevant financial interest to topics that may be chosen 17 throughout the year, an independent reviewer should be assigned.
18 18 Planning Attestation and Commitment Regarding COI example
19 Application Review process The completed application will be reviewed by the CME department. If the chair / planners have relevant financial interests and an independent reviewer has not been chosen, you will be contacted to add a reviewer. Once approved, you will receive an approval , along with: CME certificate for 2-years, Session planning forms based on type of round, and Letter of agreement forms if funding is anticipated. 19
20 20 Guidelines and requirements for Speaker-based Series Monthly requirements New requirements start 7/1/14 Session planning form Disclosure of Interest and Course faculty agreement form for each presenter (completed within the past 12 months) IF the presenter has a relevant financial interest, a completed Potential Conflict of Interest Resolution Form Sign-in sheets Documentation of any industry funding received If slides were utilized, department should keep copies (PDF is fine) All information to be turned into CME as one complete packet
21 21 Speaker based session planning form Example when speaker has no financial interests
22 22 Speaker based session planning form Example when speaker HAS financial interests
23 Speaker-based Conflict of Interest Resolution If a speaker has a relevant financial interest, a Potential Conflict of Interest (COI) Resolution Form must be completed by the course chair or independent reviewer, if the chair has relevant conflicts. Slides must be reviewed, and any perceived bias resolved prior to the presentation, and the resolution process documented. If the speaker does not have a relevant interest, then this documentation is not required. 23
24 24 Potential Conflict of Interest Resolution Form Example
26 Speaker-based Series Yearly requirements: Evaluations (summary) Financial summary, if industry funding was used Type of funding received and amount Expenses covered by funding 26
27 Open Discussion Form Series Guidelines and Requirements 27 Monthly requirements New requirements start 7/1/14 One session planning form for the month For Journal clubs, submit front page Sign in sheets with disclosure of interest included Any funding received If slides were utilized, department should keep copies (No need to keep slides referencing patient specific information) All information to be turned into CME as one complete packet
28 Open Discussion Forum Series 28 Yearly Requirements At beginning of fiscal year: Disclosure and Course Faculty Agreement At close of fiscal year: Evaluation (summary) Financial summary if industry funding was used: Type of funding received and amount Expenses covered by funding
29 29 Open Discussion Session Planning Example
30 Summary: Disclosure and Conflict Resolution 30 All planners need to disclose and attest prior to approval of the round or activity All speakers must disclose prior to the day of the presentation Session planning forms monthly For speaker-based, if speaker has relevant financial interest must be resolved and documented prior to presentation For rounds sessions that do not have a disclosure submitted and verified, that session will not receive CME credit. Monitoring CME programs for compliance with disclosure policy. (~40 per year)
31 Joint Accreditation Accreditation for physicians, nurses and pharmacists under one accreditation Must have activities that are planned not only for more than one discipline, but also by more than one Encourage to add disciplines other than physicians to the planning committee when appropriate Timeline apply within the next 2 years
32 32 Administration of Educational Grants
33 33 Processing Educational Grants
34 34 Administration of Exhibits/Displays
35 35 Financial summary when funding is used
36 Sunshine Act/ Open Payments 36 As part of the Affordable Care Act, the Centers for Medicare and Medicaid Services (CMS) is responsible for collecting and publishing all payments and transfers of value made to physicians and teaching hospitals by manufacturers of drugs, devices, biological and medical supplies covered by Medicare, Medicaid and the State Children's Health Insurance. This is referred to as the Physicians Payment Sunshine Act. Among the activities covered in this reporting are the Continuing Medical Education (CME) programs sponsored by WUSM with industry financial or in-kind support. It is anticipated that industry sponsors of our educational programs will ask for the Medical School s assistance in providing the information they need in order to report accurately to CMS. Accordingly, beginning in December, 2013, the WUSM CME office has begun collecting medical license number and NPI number from physicians who attend the Washington University CME events with such support.
37 Sunshine Act and CME 37 Not completely defined Interpretation from CMS may change It is only an issue for those activities that receive commercial funding CME activities are exempt for most categories Expenses associated with faculty (speaker) are not reported Expenses associated with attendees are not reported with the possible exception of food (as of now)
38 Sunshine Act and CME Per legal council if a CME activity receives commercial support and the company requests NPI and or license numbers of physicians, then we should supply the information. It is the company s responsibility to report We should tell attendees that we are collecting the information and why it may be reported 38
39 Summary Inclusion of interdisciplinary teams in planning process Updated processes for disclosure and resolution of commercial interest Updated documents for Planner and speaker attestation Resolution of conflicts Session planning forms Financial summary
40 Renewal Application Due Dates If having July sessions due to CME by June 10 If not having July sessions due to CME by June 30 40
41 Thank you!