New ACCME standards go into effect January 1, 2022
Since 1992, the Accreditation Council for Continuing Medical Education (ACCME) has set standards governing interactions between CME and industry. These standards have been recognized by accrediting bodies representing multiple health care professions in the U.S. as well as by international accrediting and regulatory bodies, the government, and industry to protect the integrity of CME and ensure independence from inappropriate industry influence. They are the standards that we as a provider of Joint Accreditation for Interprofessional Continuing Education must uphold.
In response to changes in the health care environment, ACCME in collaboration with other accrediting bodies and regulatory agencies revised, clarified, and streamlined the standards, which were released in December 2020 and will go into effect January 1, 2022. Below are highlights of these changes. For more information, visit the ACCME.org Standards Resources.
According to ACCME definitions, biomedical startups become ineligible companies (formerly commercial interests) when they begin a governmental regulatory approval process. In the U.S., the regulatory approval process operationally begins when an IND for drugs or PMA (premarket approval) for devices has been submitted; that is, before clinical trials have started.
Because owners and employees of ineligible companies are individuals who have a legal duty to act in the company’s best interests, which is considered an unmitigable conflict, they must be excluded from controlling content of an accredited continuing education (CE) activity as either a planner or speaker. There are only 3 circumstances in which owners or employees of ineligible companies can participate:
- when activity content is not related to business lines or products of the company,
- when activity content is limited to basic science research, and they do not make care recommendations, or
- when participating as technicians to teach safe and proper use of medical devices and do not recommend whether or when a device is used.
If you are an owner of an ineligible company, please do not agree to join a planning committee for or speak at an accredited CME activity that you think is related to your company’s business lines/products. If you’re not sure, ask us. If you do agree to participate in a CME activity, expect questions to determine whether your participation is permitted.
We are working on the infrastructure to support compliance with the new regulations and will be providing further information to activity planners and faculty (such as a revised independent reviewer/mitigation form) by the end of December 2021. WU employees should continue to disclose in the RMS COI system as they always have.
FREQUENTLY ASKED QUESTIONS
If I have research grants from ineligible companies but my institution manages the funds, do these need to be disclosed?
Yes, all financial relationships with ineligible companies within the prior 24 months need to be disclosed regardless of the amount or of your view of the relevance of a relationship to the education. This includes research support even if the money goes to the institution.
If I consult for an ineligible company on a product that is not relevant to my talk, do I need to disclose it?
Yes, all financial relationships with ineligible companies need to be disclosed. The regulation is that the relationship is relevant if any products developed or marketed by the company are relevant to the activity content, not just the product you are being consulted on or researching. So, for relationships with far-reaching pharmaceutical companies, there may be virtually no clinically based CE activity for which the relationship won’t be relevant even if the drug you are consulting on is still in preclinical studies.
I am planning a research symposium. Do I need to get disclosures from all authors on each abstract that is being presented or only from the individuals presenting?
Only the presenters. The individuals considered in control of content for a presentation on a research study are those who are involved in the planning, reviewing, and delivery of the actual CE presentation. Others who were involved in the research or who were authors of a published research paper would not be considered in control of the CE content if they were not involved in the presentation
If I own a biomedical startup that is developing technology for use in patients, but no products have FDA approval yet, can I plan a CE activity?
Not if you have submitted a premarket approval (PMA) for any devices. The point at which a biomedical startup becomes an ineligible company is when it has begun a governmental regulatory approval process. In the U.S., this is when an IND for drugs or a PMA for devices has been submitted. At that point, you may only control content of a CE activity if the activity content is not related to business lines or products of the company, activity content is limited to basic science research/no care recommendations will be made, or you will participate as a technician to teach safe and proper use of medical devices/will not recommend whether or when a device is used.
If I have ownership interest in a company that doesn’t produce, market, or sell healthcare products for patients but is a subsidiary of a one that does, can I speak at a CE activity?
No. For companies with subsidiaries, the exclusion of owners and employees applies both to subsidiaries of an ineligible parent company regardless of steps taken to firewall the subsidiaries and to those of an ineligible subsidiary of an eligible parent company.
Can an owner of an ineligible company participate as a speaker at a CE activity if the content of their talk is unrelated to the business lines or products of the company but other talks they have no role in may be related?
Yes, an owner of an ineligible company may control content unrelated to the products of their company as a speaker even if there are other sessions of the same activity (in which the owner is not involved) that are related to the products of their company
My wife owns an ineligible company. Can I speak at a CE activity?
Disclosures of spouses/partners are no longer collected because of concerns about privacy challenges. So your spouse’s financial relationships are irrelevant to your ability to control CE content.
I own a pharmacy. Can I speak at a CE activity?
Yes, as long as the pharmacy does not make proprietary compounds or serve as a pharmacy benefit manager. Same goes for diagnostic labs if they don’t sell proprietary products.
If I am planning a CE activity on leadership, do I need to mitigate financial relations with ineligible companies?
No, financial disclosures/mitigation are not needed if content of a CE activity is non-clinical, such as leadership, mentoring, or communication skills training.
If I am planning a CE activity and have no financial disclosures, can I continue to serve as an independent reviewer for speakers with disclosures?
When speaking at a CE activity, can I reference a book I wrote?
Yes. You can’t include ads for your book in your talk or sell your book in the lobby though.
Can I talk about the institution’s or department’s facilities and services?
Yes, you can talk about how you manage patients. Just be careful not to turn your talk into an infomercial since the purpose of a CE activity can’t be to generate referrals.
Can I encourage learners to go to a website for a clinical prediction rule I created?
Yes, as long as it is supported by current science, evidence, and clinical reasoning and you are not selling a product or service.
Can I give a list of meeting attendees to a pharmaceutical representative that is exhibiting at my CE activity?
No, not without the explicit approval of each attendee.
If in a CE course I am planning, I want to include an educational talk by an individual who is excluded from speaking at a CE activity, can I just not provide credit for that talk?
Learners must be easily able to distinguish accredited from non-accredited education. So, an educational talk from such an individual cannot be provided in the same space as accredited educational activities unless separated from it by at least 30 minutes.
Does there need to be a 30-minute interval between accredited and non-accredited education if my activity is being delivered virtually?
The requirement for a 30-minute interval applies to all live activities if learners will remain in the same space (i.e., the same physical or virtual room). If learners must physically leave one room or click a link to leave the accredited education and enter the non-accredited education, marketing, or exhibits, there is no longer a time-interval requirement.