The ACCME defines ineligible companies as "those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients." See ACCME's Standards for Integrity and Independence in Accredited Continuing Education for more information. The ACCME provides a set of self-assessment questions that can help an organization determine whether it falls under the definition of an ineligible company. These questions are listed below:
Structured Self-Assessment Related to ACCME's Definition of an Ineligible company
- Does your organization, or a part of your organization, produce, market, re-sell, or distribute healthcare products used by or on patients?
- Does your organization advocate for, or on behalf of, an ineligible company?
- Does your organization have a parent company that…
- produces, markets, re-sells, or distributes healthcare products used by or on patients, and/or…
- advocates for, or on behalf of, an ineligible company?
- (A "parent company" is a separate legal entity that owns or fiscally controls an organization.)
- Does your organization have a sister company that…
- produces, markets, re-sells, or distributes healthcare products used by or on patients, and/or…
- advocates for, or on behalf of, ineligible companies?
- (A "sister company" is a separate legal entity which is a subsidiary of the same parent company that owns or fiscally controls an organization).
4a. If Yes to 4, does your organization share management, employees, or governance structure with the sister company? (An example of a corporate structure that meets ACCME’s requirements for independence can be found here.)
4b. If Yes to 4, are any owners, employees, or agents of the sister company involved in the planning, development, or implementation of educational content?
4c. If Yes to 4, does the sister company control or influence, in whole or in part, the operations of your organization?
If your organization answers yes to any of these questions, it would likely be defined by ACCME as an ineligible company. If after answering these questions your organization still has questions regarding its status, you may wish to request that the ACCME conduct a corporate structure review. An organization may contact the ACCME directly at firstname.lastname@example.org if they wish to request that ACCME perform a corporate structure review. There is a fee ($4,000) for organizations that wish to have a corporate structure review conducted.
Accredited CME must be free of commercial bias, and must not promote products or services. Accredited CME must promote improvements in healthcare. A "balanced view" means that recommendations or emphasis must fairly represent, and be based on, a reasonable and valid interpretation of the information available on the subject (e.g., "On balance the data support the following..."). A "balanced view of therapeutic options" also means that no single product or service is over represented in the education activity when other equal but competing products or services are available for inclusion.
ACCME requires the separation of education from all promotional activities, materials and messages. Many providers create a print or text based document that goes along with an activity and provides information that is supplementary to the education content - like reproductions of slides, graphics or other handouts. These documents, in print or electronic, are an integral part of the education and as such cannot have any advertising, corporate logo, trade name or a product-group message of an ineligible company associated with them.
Yes, a written agreement that has been accepted electronically by an accredited provider, that originates from the commercial supporter would meet ACCME's expectations as long as it is executed before the start or release of the accredited education.
No. If, however, an accredited provider chooses to do so, it must obtain the consent of each individual learner, per Standards for Independence and Integrity 2.3.
Yes. Verbal disclosure by those in control of content to the accredited provider is acceptable. The ACCME must be able to verify that the individual disclosing the information had sufficient knowledge of what the disclosure information was required, including the timeframe.
Yes. Distributing promotional materials for accredited education such as save the date announcements and brochures, is not prohibited by the ACCME's Standards for Integrity and Independence.
Note that Standard 5.3 prohibits ineligible companies from providing access to (such as a link), or distributing, the accredited education itself to learners.
Yes. Providers can use tabs, links, or other electronic mechanisms to make disclosure information available to learners. Regardless of the method of disclosure, all required ACCME information specified in Standards for Integrity and Independence 3.5 and 4.4. must be transmitted to the learner prior to the learner beginning the CME activity and should be clearly marked and accessible to learners.
All funds that originate from ineligible companies and are paid to reserve space to hold accredited CME activities (sometimes called satellite symposia) in conjunction with other organizations' meetings are considered commercial support. As with all commercial support, these funds must be paid directly to the accredited provider responsible for the activity or to a designated nonaccredited joint provider. The accredited provider responsible for the activity that is held in the reserved space must manage and report the funds as commercial support, in accordance with ACCME commercial support requirements in Standard 4.
Example: National Specialty Society announces that it is selling slots to hold satellite activities at its upcoming annual meeting for $10,000. USA Medical School, an ACCME-accredited provider, plans to reserve one of the slots and submits a request for the funds to pay the fee from Pharma Inc. There is a signed written agreement for the funds and Pharma Inc., an ineligible company, pays the funds directly to USA Medical School. USA Medical School uses the funds to pay National Specialty Society to reserve the space. Prior to the beginning of its CME activity, USA Medical School informs the learners about the commercial support from Pharma Inc. USA Medical School reports the funds as a commercial support to the ACCME through the Program and Activity Reporting System (PARS).
Note: The only entity that should report the receipt of these funds as commercial support in the ACCME's Program and Activity Reporting System (PARS) is the accredited provider taking responsibility for the CME activity.
Yes, only in the circumstances permitted by the ACCME as described in Standard 3.2.
ACCME expects to be able to review income and expense statements for all CME activities. These statements must reflect:
All sources of income: Including income from commercial support, advertising and exhibit fees, tuition and registration fees, internal budget allocations and any other source of total income.
Expenses grouped in major categories: Including, for example, staff salaries, meeting costs, honoraria, and faculty travel expenses. In addition, Standard 4.3 states that the accredited provider must keep a record of the amount or kind of commercial support received and how it was used, and must produce that accounting, upon request, by the accrediting body or by the ineligible company that provided the commercial support.
Yes. The ACCME considers faculty to be agents of the accredited provider. So, when the provider, after identifying that a financial relationship is relevant, directs teachers/authors to take actions to assist in the mitigation of relevant financial relationships, a provider's mechanism is implemented. The provider might then monitor the effectiveness of the actions taken by the teachers/authors to mitigate these relationships. Keep in mind that simply monitoring the CME content for commercial bias at the time of presentation is not an acceptable mitigation mechanism.
Yes. CME providers need to be sure that these people have bona fide teaching roles. In the United States, physician learners are not to be given compensation or reimbursement for attending CME activities (see Opinion 9.2.6 of the Code of Medical Ethics: Professional self-regulation, of the American Medical Association). It is unacceptable for anyone other than the Provider, or its agents, to receive direct financial benefit from commercial support.
ACCME has incorporated eligibility information directly into the Standards for Integrity and Independence
in Accredited Continuing Education. Companies that are ineligible to be accredited in the ACCME System (ineligible companies) are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:
- Advertising, marketing, or communication firms whose clients are ineligible companies
- Bio-medical startups that have begun a governmental regulatory approval process
- Compounding pharmacies that manufacture proprietary compounds
- Device manufacturers or distributors
- Diagnostic labs that sell proprietary products
- Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
- Manufacturers of health-related wearable products
- Pharmaceutical companies or distributors
- Pharmacy benefit managers
- Reagent manufacturers or sellers
Commercial support is used to underwrite the provider's expenses for developing and presenting an activity. Commercial support can be used to pay for the expenses of teachers and authors as well others who are engaged in the development of the activity for the provider.
Yes. The new CME activity, must demonstrate compliance with all applicable ACCME accreditation requirements, including the disclosure of relevant financial relationships to learners based on the disclosure information applicable at the time an individual last had control of content, and acknowledgement of any commercial support. This is true even if the commercial support was only for the original live activity.
Most likely, yes. Some mechanism(s) that providers employ to mitigate relevant financial relationships for authors, speakers, and reviewers (e.g., peer-review of content) do not address the role(s) that planners have in controlling decisions that occur before content is developed for a CME activity. This influence may include choosing topics and faculty for the CME activity. To mitigate the relevant financial relationships of individuals involved in the planning of CME activities, the provider needs to implement mechanisms that ensure independence in the planning process, itself, prior to the development of educational content and instruction. See the ACCME website Examples of Provider Compliance and Noncompliance for application of these concepts.
Yes. Scholarships for Residents and Fellows fall under the purview of other organizations' guidelines and standards (e.g., See the Ethical Opinion 9.6.2 (https://www.ama-assn.org/about-us/code-medical-ethics) (d) of the Council of Ethical and Judicial Affairs of the AMA). It is not a topic addressed by the ACCME in the Standards for Integrity and Independence. The existence of such scholarships and/or the compliance by the provider in the administration of such scholarships will not be reviewed by the ACCME's accreditation process.
No. The ACCME does not require that providers use a disclosure form to collect information about financial relationships of all persons in control of content of an educational activity. A disclosure form is one mechanism that providers may use to obtain (and show that they possess) this information. Other examples could include:
- Collecting the information verbally and recording it in a spreadsheet, table, or database
- Collecting disclosure information electronically (for example, via e-mail, web-based form, or database)
The ACCME requires accredited providers to obtain information about the financial relationships of all persons in control of content. The obtaining of this information is a key component of the process to ensure the independence of educational activities (see Standard 3). Providers may choose the mechanism(s) to obtain this information that best suit their organizational needs and can be used to demonstrate compliance to the ACCME.
No. The provider cannot delegate the responsibility for identifying relevant financial relationship solely to the person with the financial relationship.
Standard 3.1 states that the provider must "Collect information from all planners, faculty, and others in control of educational content about all their financial relationships with ineligible companies within the prior 24 months."
If someone in connection to the activity has the opportunity to affect the content, they are "in control of content." Those individuals in a position to control the content of an educational activity might include (but are not limited to):
- Committee members
- Content reviewers
- Staff (depending on the accredited provider's processes for developing educational activities)
Providers sometimes make the mistake of only collecting information about financial relationships from faculty or authors but do not collect that information from others, such as committee members, who may be in control of content. This would be a cause of noncompliance.
The ACCME expects that written agreements for commercial support will:
- be between the accredited provider and commercial supporter.
- include the name of the joint provider or third party that would be receiving and disbursing the funds (when applicable).
- be executed and agreed to by both the accredited provider and the ineligible company providing the commercial support. Third parties and/or joint providers may also be included in the written agreement but may not execute or agree to it instead of the accredited provider.
- be executed prior to the activity taking place.
No. There is no reason for a CME provider to request suggestions for speakers or topics from ineligible companies, since it is unacceptable to act upon their suggestions. CME providers cannot receive guidance, either nuanced or direct, from an ineligible company on the content of the activity or on who should deliver that content. If the provider implements the suggestions of the ineligible company then this creates a situation where the independence of CME from the ineligible company is undermined. The provider must ensure that the content of and the process to develop the CME remains beyond the control of any ineligible company.
The nature of the relationship means the role they play or service they provide in exchange for some form of compensation from an ineligible company (e.g., independent contractor including contracted research, consulting, promotional speaking and teaching, membership on advisory committees or review panels and board membership). ACCME has not set a minimum dollar amount for relationships to be disclosed. Inherent in any amount is the incentive to maintain or increase the value of the relationship therefore the dollar value of the relationship does not need to be disclosed.
No. It is not necessary to collect disclosure information on relevant financial relationships from a speaker, planner, or author each and every time that individual has control over the content of a CME activity. SCS Element 2.1 requires that the provider be able to show the ACCME that everyone who has control of CME content has disclosed all relevant financial relationships with any commercial interest to the provider. Disclosure can occur by the provider utilizing disclosure information from a database, previous CME activities, or another institution and then verifying that those relationships (or lack of relationships) are current and applicable to the applicable CME activity.
No. Standard for Independence and Integrity 3.1 requires the provider to identify relevant financial relationships of those who control the content of a CME activity. Two things must be present for there to be a relevant financial relationship: financial relationship(s) with an ineligible company(ies) and the ability to control content related to products/services of the ineligible companiy(ies). If no financial relationships exist, or the content of the CME activity is not related to the products or services of an ineligible company there are no relevant financial relationships to identify or mitigate.
The most common example that ACCME has seen of a corporate structure that involves an eligible organization in association with an ineligible company is one in which both organizations are owned by a separate holding (or parent) company. The holding company does not participate in or control the day to day operations of its subsidiaries, is responsible solely for the oversight of the profit and loss statements of its subsidiaries, and is controlled or managed by individuals who are different from those in control of its subsidiaries. In these circumstances, an accredited CME provider can have a sister company that is an ineligible company, as long as each company is a separate legal entity and there are proper firewalls in place between them. In order for accredited CME provider to be independent from an ineligible sister company, the CME provider must:
- Not be owned or controlled by an ineligible company;
- Have separate management;
- Be the employer of record;
- Have a governance structure which is separate from the governance structure of the ineligible company; and
- Receive any funds from an ineligible company only as commercial support or as payment for allowing associated commercial promotion with a CME activity.
It would depend on what the handout, with abstracts, is used for in relation to the CME activity. If the abstracts are referenced during the activity or serve as a component of the content, then there can be no advertising in the handout. If the abstracts are not referenced as part of the CME content, and appear in the handout with other logistical information about the activity, then advertising is allowed.
Yes. If the organization is not an ineligible company per the ACCME's Standards for Integrity and Independence in Accredited Continuing Education, the use of its corporate logo in the acknowledgement of support would be allowed. Standard 4.4 specifically prohibits use of ineligible companies’ corporate or product logos, trade names, or product group messages in the disclosure of commercial support.