Frequently Asked Questions about the New Standards
This FAQ is organized by the five Standards. Scroll down to find the Standard you are seeking help with to find related questions. If you don't see your question, please ask us at info@ocme.ucsf.edu.
STANDARD 1: Ensure content is valid.
What are “controversial topics”?
"Controversial topics" refers to unscientific approaches to diagnosis or therapy. Although accredited continuing education is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is the responsibility of you and the Accreditation Review Committees to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning.
It’s important for recommendations to be rooted in science, evidence, and data: the validity of clinical recommendations is not determined by legislation or advocacy. It is important and appropriate to help clinicians learn about issues such as medical marijuana — but it’s not allowable to train clinicians how to recommend therapies and treatments unless they are accepted by the medical profession and are based on scientifically valid evidence.
For an example of a controversial topic, see http://www.accme.org/news-publications/highlights/managing-cme-about-medical-marijuana-rules-risks-and-strategies
STANDARD 2: Prevent commercial bias and marketing in accredited continuing education.
What does “Faculty are prohibited from promoting or selling products or services in accredited education” mean!?
Faculty must not actively promote or sell products or services that serve their professional or financial interests during accredited education.
Can a faculty member reference a book that she wrote or would that be considered “sales”?
Yes, referencing a book for teaching purposes is not “sales.” Asking people to visit the bookseller in the foyer to buy it would benefit her financially and be considered promotional.
Can we raffle off a book written by a faculty member?
Yes.
Can a faculty member talk about a meeting they are organizing in a couple of months?
Yes, if it’s referenced in the context of the presentation (ie, makes sense to do so), and they are not personally benefitting financially as a result of having people attend.
What does “You must obtain consent of learners before sharing their information” mean?!
The names or contact information of learners cannot be shared with any ineligible company or its agents without the explicit consent of the individual learner. “Explicit consent” of learners is active, positive response: the learner must opt in to having their information shared with ineligible companies. This includes the displaying or distribution of rosters that contain only names and cities when exhibitors are present.
OCME is happy to add a question on your online registration form to ask people to opt in, however, we do not recommend it to avoid issues with privacy policies of UCSF, the State of California Consumer Privacy Act (CCPA) or EU's General Data Protection Regulation (GDPR). The easiest and safest bet is to not publish the names or any contact information of your participants.
STANDARD 3: Identify, mitigate, and disclose relevant financial relationships.
Step 1: Collect information from all individuals in control of content about all their financial relationships with ineligible companies with the prior 24 months.
Do I really need to identify, mitigate, and disclose relevant financial relationships?
Yes (except in 2 exceptions). Anyone in control of content of an accredited educational activity that addresses clinical topics or makes patient treatment recommendations must submit all financial relationships held within the 24 months prior to the activity’s start.
...But my activity is non-clinical.
Accredited education focused on skills training in leadership, management, ethics, communication, student instruction, or the like (often referred to as “faculty development”) does NOT require identification, mitigation, nor disclosure of financial relationships.
...But my activity is self-directed, planned and implemented by the learner alone.
Accredited self-directed education where the learner controls their educational goals and reports on changes that resulted, such as learning from teaching, remediation, or a personal development plan also does NOT require identification, mitigation, nor disclosure of financial relationships. Note that if you serve as a source of information for the self-directed learner, be sure to direct learners only to resources and methods for learning that are not controlled by ineligible companies.
Is there a minimum financial threshold?
No. Any amount is considered.
What information do I need to collect?
The name of the ineligible company and the nature of the relationship at a minimum. You might also collect the date a relationship has ended or will end, as this would be a mitigating factor for the financial relationship.
We are planning an education event for 2020? Do I have to re-obtain disclosure from my planning committee and faculty?
No. If the activity ends before December 31, 2021, continue to follow the current requirements. For grand rounds, case conferences, tumor boards, M&M's (RSS) and all on-demand learning (enduring materials) that will be accredited in 2021 and available after January 2022, please use the new disclosure form for your planning committee and faculty. Anyone logging in to the CE Portal who disclosed prior to this year, will be asked to re-complete their disclosure under the new rules. This should be activated by the end of July, 2021.
If my online modules have already been launched, do I need to re-obtain disclosures?
No. If your enduring material was launched prior to July, 2021, you do not need to recollect financial relationships from speakers. This will be corrected should you decide to extend the modules for another accreditation period.
Step 2: You must exclude owners or employees of ineligible companies from participating in accredited education.
Does this include founders of companies?
Yes, if the founder of an ineligible company still receives any kind of financial compensation from the company. If the founder is no longer associated with the company and any financial benefit has dissolved, then likely not.
Who is considered an owner or an employee of a company?
An individual is not considered an owner or employee if they do not meet the IRS definition of an employee: "Owners and employees are individuals who have a legal duty to act in the company's best interests. Owners are defined as individuals who have an ownership interest in a company, except for stockholders of publicly traded companies, or holders of shares through a pension or mutual fund. Employees are defined as individuals hired to work for another person or business (the employer) for compensation and who are subject to the employer's direction as to the details of how to perform the job."
Are there exceptions to employee participation in accredited CE?
Very seldomly! Employees are allowed to participate when they are not talking about an existing product or something used on humans but only about animal models, basic research, basic science, etc. Here are the specific exceptions:
- When the content of the activity is not related to the business lines or products of their employer/company.
- When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
- When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.
Please contact OCME for assistance if someone discloses an employee relationship.
My speaker has created a startup for a new healthcare technology device. Is the startup considered an ineligible company?
Only if the startup is currently manufacturing, selling, or distributing the device, OR has begun the process of regulatory approval of the device (for example, filing with the FDA). A company in the stages of research, design, consultancy, or clinical trials is not yet considered an ineligible company.
Step 3: Identify relevant financial relationships.
What does “relevant” mean?
Financial relationships are relevant if the educational content an individual can control is related to the business lines or products of the ineligible company.
Who determines if a financial relationship is relevant?
The accredited provider (“UCSF”) is responsible for determining if a financial relationship is relevant, which may include coordinators, conference managers, faculty with expertise on the subject, or OCME. The individual disclosing cannot determine the relevance of their own relationships.
My faculty member is the PI on a research project funded by an ineligible company. Is this a relevant financial relationship?
Yes, if the educational content is related to the business lines or products of the ineligible company. Research funding from ineligible companies should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.
Step 4: Mitigate relevant financial relationships prior to the individual assuming their role in the activity.
Does this include course directors, chairs and planning committee members?
Yes. Relevant financial relationships of all planners should be identified in advance of the planning stage of the activity, and mitigated appropriately.
Step 5: Disclose all relevant financial relationships to learners.
When does disclosure have to occur?
Disclosure to learners of all relevant financial relationships (or lack thereof) must be completed prior to learner engagement with the education.
How do we disclose to the learners?
Disclosure can be included on announcements, flyers, brochures, handouts distributed before the education, overview material for on-demand courses, verbally from the podium, or at the beginning of the presentation itself. You must document that disclosure occurred; materials demonstrating disclosure to learners should be submitted to OCME upon completion of the activity.
What do we need to disclose to learners?
Disclosure should include the name (or list of names) of each individual with relevant financial relationships, the name of the ineligible company(ies), and the nature of the relationship with each company. For example disclosure language, see Improved Sample Disclosure Statements for Learners. Disclosure must also include a statement that all relationships have been mitigated unless no-one has any relationships.
STANDARD 4: Manage commercial support appropriately.
Has anything changed with how we manage commercial support received for accredited continuing education activities?
No. Continue to use the current processes in place:
- Ensure OCME is aware of the commercial support; by policy, all commercial support should be forwarded to and deposited by OCME.
- Ensure that a letter of agreement, dually signed by OCME and the supporter, is in place PRIOR to the education. See the new Commercial Support Agreement form here.
- Disclose to learners the name of any ineligible company providing support, including those providing in-kind equipment or services. If in-kind, also disclose the nature of that support.
- Disclosure of commercial support must not include any corporate or product logos, trade names, or product group messaging.
STANDARD 5: Manage ancillary activities offered in conjunction with accredited continuing education.
“Live continuing education activities…must not occur in the educational space within 30 minutes before or after an accredited education activity.”
What is the definition of “educational space?”
Where the learner is engaging with content, material, & faculty in a structured way (general session room, class room, breakout, Zoom, etc.).
Is the “30 minute” separation requirement between marketing/non-accredited education and accredited education applicable only to live, in-person activities? What about live streamed, online activities?
All live, regardless of delivery format.
Can marketing or non-accredited education take place at the same time as accredited education as long as it is in a different room and is clearly communicated to learners?
Yes.
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