Where can I find applications to request CME credits for conferences or other CME activities?
What are some questions I can ask my colleagues (and myself) in determining the topics that need to be addressed in the proposed CME activity?
What's the difference between competence and performance?
What is commitment to change?
Who needs to identify their relevant financial relationships?
How should we identify relevant financial relationships?
What is the 3-step process for identifying and resolving conflicts of interest and disclosing financial relationships to the learners?
How should the learners be informed of any relevant financial relationships or the absence of relevant financial relationships?
What needs to be disclosed to the audience when the educational activity receives commercial support from the pharmaceutical or medical device industry?
What is considered a commercial interest?
What is meant by a relevant financial relationship referenced on the application and disclosure forms?
When do relationships create "conflicts of interest"?
Which Letter of Agreement should be signed, MUSC OCME or the Letter of Agreement from the Commercial Interest providing support for the CME activity?
What should I do if the commercial suppporter asks me to accept the terms of their electronic letter of agreement online?
When can I acknowledge commercial support?
Can commercial interests receive exhibit space in exchange for providing CME grants for the CME activity?
Who is the CME Provider?
Why is it necessary for a representative of the CME office to attend a live CME activity?
MUSC OCME CME APPLICATION
Q: Where can I find applications to request CME credits for conferences or other CME activities?
The initial form “Request for CME Certification” can be found at the link below:
This form will provide basic information to the Office of CME on your proposed CME activity. Specific information about your activity will be required closer to the proposed date of the activity. We will put your proposed activity in our planning calendar and begin regular communication with you in the planning and implementation process. A meeting will be scheduled with the Activity Director and Planning Committee to discuss your plans and answer your questions. Please note, we require that this initial form be completed and received in our office no later than 6 months prior to the date of the proposed activity. This important requirement is included on the form.
Q: What are some questions I can ask my colleagues (and myself) in determining the topics that need to be addressed in the proposed CME activity?
Below are some suggestions:
What are some patient care scenarios that you find difficult to manage or resolve?
What are the key issues or obstacles to care you or your colleagues encounter?
What areas of practice in your hospital or clinical practice setting need improvement?
What areas of practice is there broad variation among your physicians?
Which clinical situations make you uncomfortable or keep you awake at night?
Q: What’s the difference between competence and performance?
Competence is the ability to put knowledge into action, the strategy, what learners would do if they could. Performance is putting action into practice to change outcomes.
Q: What is commitment to change?
Commitment to change is a simple way of discovering actual changes in the learner's practice that resulted from the educational activity. Learners are asked to write down those changes in their practice they intend to implement. At 1-3 months in the future, the learner is contacted and asked about the status of implementation of the intended changes, barriers identified, and the next steps identified. They can be used for evaluation at the performance level. The MUSC OCME can provide you with more details and assistance with instituting the commitment to change strategy. Please don’t hesitate to contact them at 843-876-1925.
COMPLYING WITH THE ACCME STANDARDS FOR COMMERCIAL SUPPORT
Q: Who needs to identify their relevant financial relationships?
Identifying relevant financial relationships with commercial interests is the first step in a 3-step process. Everyone who is in a position to control or influence the content is required to disclose their relevant financial relationships with commercial interests. 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.
The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.
It is not just the presenters who must disclose, but everyone who has any decision-making role whatsoever in the development and implementation of the CME activity. This includes conference directors, coordinators, planners, moderators, authors, editors and others.
Q: How should we identify relevant financial relationships?
You must be aware of the presence of a speaker's relevant financial interest very early in the planning process in order to avoid being faced with this type relationship downstream for which there can be no easy means for its resolution. When submitting your completed CME application to OCME, you are required to also submit completed disclosure forms for the Activity Director, planners and identified presenters or authors. As soon as additional presenters or authors are identified their completed disclosures must be submitted to the OCME also.
Q: What is the 3-step process for identifying and resolving conflicts of interest and disclosing financial relationships to the learners?
All 3 steps are required by ACCME and MUSC.
Everyone in a position to control content must disclose their relevant financial relationships. This includes all planners, speakers, moderators, all approvers and any others who can control or influence the instructional content in any manner.
All conflicts of interest are resolved and that resolution is documented through the MUSC OCME process.
Prior to the start of the educational activity, learners must be informed of any relevant financial relationships or the absence of relevant financial relationships for everyone who is in a position to control content. The details of what precisely was disclosed to the learners must be documented.
Q: How should the learners be informed of any relevant financial relationships or the absence of relevant financial relationships?
When there is a relevant financial relationship, the learners need to be informed of the name of the person with the relationship, the name of the company or companies with whom the relationship exists, and the nature of the relationship (research support, consultant, speakers bureau, employment and others).
For example: John Adams – Research Grant - XYZ Pharmaceuticals.
When no relevant relationships are disclosed the following language must be used:
John Adams has no relevant financial relationships to disclose. All disclosure must be made before the CME activity begins. This is required.
The method for disclosure may be one or more of the following:
Printed at the front of the course syllabus or on the first page of the speaker's handout
As part of the any announcements and reminders that are printed or distributed electronically by e-mail or posted.
Inserted as the 2nd slide in the presenter's PowerPoint series
Verbally disclosed from the podium, with a written attestation, signed by the moderator who was present in the room at the time, containing precise language that demonstrates that the presence or absence of a relevant financial relationship was disclosed to the audience prior to the beginning of the CME activity.
Q: What needs to be disclosed to the audience when the educational activity receives commercial support from the pharmaceutical or medical device industry?
The name of the commercial entity and the nature of their support must be disclosed to the audience prior to the activity. The nature of support may be through an educational grant or in-kind support (use of durable equipment, animal parts or tissue, disposable supplies, human parts or tissue, facilities/space or other).
Q: What is considered a commercial interest?
ACCME definition of a commercial interest as any entity producing, marketing, re- selling, or distributing health care goods or services consumed by, or used on, patients.
Q: What is meant by a relevant financial relationship referenced on the application and disclosure forms?
A relevant financial relationship is a financial relationship, in any amount, occurring within the past 12 months that creates a conflict of interest. It is a relationship relevant to the role of the individual participating in the activity to control or influence content development and implementation. This might include involvement in a speaker’s bureau, research support, consultant relationship, stockholder, paid honorarium, employment, etc.
Q: When do relationships create “conflicts of interest”?
The ACCME considers financial relationships to create actual conflict of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest.
Q: Which Letter of Agreement should be signed, MUSC OCME or the Letter of Agreement from the Commercial Interest providing support for the CME activity?
We would prefer to use the MUSC OCME Letter of Agreement as it has already been approved by the MUSC General Counsel. However, if the supporting company requires that their Letter of Agreement must be used we will forward their Letter of Agreement to the MUSC General Counsel’s Office for their review, editing (if needed) and signature. At that point the Letter of Agreement is signed by the Assistant Dean for CME and forwarded to the supporting company for their signature. The supporting company must forward the full executed Letter of Agreement to the MUSC OCME prior to the start of the CME activity. This is a requirement by ACCME and MUSC OCME. Only 1 signed letter of agreement per company per activity will be permitted.
Per the ACCME, the Letter of Agreement must be signed by the commercial interest and the Accredited Provider which is the MUSC OCME. Activity Directors, Department Coordinators, etc. cannot sign the Letter of Agreement as the accredited provider.
Q: What should I do if the commercial supporter asks me to accept the terms of their electronic letter of agreement online?
Terms cannot be accepted without prior approval by MUSC OCME. As soon as you receive a notice that a grant is approved pending acceptance of the terms online, provide MUSC OCME with your login information or a copy of the original grant request and the electronic agreement terms. MUSC OCME will review the terms and forward to the MUSC General Counsel’s Office for their review, if necessary. ACCME has specific requirements for acceptance of electronic Letters of Agreement.
Q: When can I acknowledge commercial support?
The grant letter of agreement must be fully executed (signed by MUSC OCME and the commercial interest) prior to being announced in marketing materials AND prior to the activity occurring.
Q: Can commercial interests receive exhibit space in exchange for providing CME grants for the CME activity?
No, receiving exhibit space in return for providing an educational grant would be placing a condition on the grant and that is not allowed. Selling exhibit space to commercial interests is considered to be a business transaction. Income from selling exhibit space is not considered to be commercial support as defined by the Accreditation Council for Continuing Medical Education. Educational grants should be kept completely separate and distinct from the purchase of exhibit space. Companies must pay an exhibit fee even if their company is providing an educational grant to support the CME activity.
Q: Who is the CME Provider?
The Accredited CME Provider is the Medical University of South Carolina, not individual MUSC Departments or Divisions or MUHA. The Accredited Provider must be listed as Medical University of South Carolina. The Office of CME is responsible for assuring regulatory compliance for all CME activities, awarding AMA PRA Category 1 Credit(s)TM to all physicians, maintenance of CME credit records and required annual and reaccreditation reports to our accrediting body, Accreditation Council for Continuing Medical Education (ACCME).
Q: Why is it necessary for a representative of the CME office to attend a live CME activity?
The MUSC OCME is responsible to ensure that all activities are in compliance with the ACCME policies and accreditation criteria. Onsite observation of the CME activity is a means for the OCME office to verify that the activity is in compliance.